linjc16/ctgov huggingface dataset:
A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis

Study Overview
=================
Brief Summary
-----------------
To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.

Detailed Description
-----------------
Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.

Official Title
-----------------
A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV positive or negative status. Blastomycosis or histoplasmosis. Life expectancy of at least 1 week. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Liver disease. Self-limiting fungal disease. Very severe fungal disease such as meningeal involvement. Acute respiratory disease. Concurrent Medication: Excluded at any time: Terfenadine. Astemizole. Oral midazolam. Triazolam. Cisapride. Phenytoin. Phenobarbital. Rifampin. Rifabutin. Excluded during oral consolidation: H2 blockers. Chronic antacids. Omeprazole. Lansoprazole. Patients with the following prior condition are excluded: Hypersensitivity to azole antifungals. Prior Medication: Excluded at any time: More than 3 days of amphotericin B, fluconazole, or ketoconazole. Excluded within 2 weeks prior to study entry: Phenytoin. Phenobarbital. Rifampin. Rifabutin.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Itraconazole|nan|
|Drug: Amphotericin B|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, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B, AIDS-Related Complex, Blastomycosis, Antibiotics, Antifungal
Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).

Official Title
-----------------
A Randomized, Active-Controlled, Double-Blind Multi-Center Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: Zemplar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Zemplar|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the number of days to achieve the first of 2 consecutive > or = 30% decreases from baseline in PTH |  |  | 
| The incidence rate for hypercalcemia |  |  | 
| The incidence rate for hyperphosphatemia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage V Chronic Kidney Disease
Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy. A Randomized Controlled Trial.

Detailed Description
-----------------
10 ml of 2% lidocaine hydrochloride added on saline infusion media versus 100 mg diclofenac tablet 1 hour before office hysteroscopy , to test their efficacy in reducing pain .

Official Title
-----------------
Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy: A Randomized Controlled Trial

Conditions
-----------------
Nulliparity

Intervention / Treatment
-----------------
* Drug: Lidocaine Hydrochloride
* Drug: Diclofenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-35 years. BMI 18.5-30 Kg. Nulliparous women assigned for diagnostic hysteroscopy. Informed written consent. Exclusion Criteria: Previous cervical surgery. Cervical stenosis. Known gastritis. Recent or active PID. Cardiac patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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: Lidacaine hydrochloride<br>Adding 10 ml of 2% Lidocaine hydrochloride on hysteroscopic saline media during office hysteroscopy to test its efficacy in reducing pain. 22 women. | Drug: Lidocaine Hydrochloride<br>* 10 ml of 2% lidocaine on hysteroscopic infusion media during office hysteroscopy.<br>|
| Active Comparator: Diclofenac<br>100 mg Diclofenac oral tablet is administered 1 hour before the procedure to test its efficacy in reducing pain. 22 women. | Drug: Diclofenac<br>* 100 mg Diclofenac oral tablet one hour before the procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction using Visual Analogue Scale | Efficacy of lidocaine on saline media and oral diclofenac in reducing pain during office hysteroscopy from start of the procedure till 30 minutes after, using visual analogue scale to assess the severity of pain | 30 minutes |
Clinical Evaluation of the OtoSight

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of OtoSight imaging will not affect patient standard of care.

Official Title
-----------------
Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Device: OtoSight Middle Ear Scope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children (17 years old or younger) scheduled for tympanostomy tube placement Exclusion Criteria: Otoscopy contra-indicated or not possible per attending physician's decision

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- |
| Pediatric tympanostomy tube patients<br>Patients diagnosed with otitis media and scheduled for tympanostomy tube placement will be imaged with the OtoSight | Device: OtoSight Middle Ear Scope<br>* OtoSight imaging using a near-infrared laser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OtoSight imaging exam | Optical coherence tomography imaging to evaluate the middle ear. | 1-5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Rate of adverse events | Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ear Infection, Ear tubes, Myringotomy, Otitis Media, Tympanostomy
Evaluation of the COGNISION(TM) System as an Event-related Potential (ERP) Collection System.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate a handheld event-related potential (ERP) testing device from Neuronetrix, Inc. as a method to collect ERP data in an outpatient setting. An ERP system records electrical signals at the scalp that are produced by the brain when performing cognitive tasks. By doing this study, we hope to evaluate various performance parameters of the COGNISION(TM) system.

Detailed Description
-----------------
Patients who have a current diagnosis of mild-moderate dementia and suspected of having Alzheimer's disease (AD) along with cognitively normal age-matched controls will be recruited for this study. The Alzheimer's subjects either will have had a complete clinical and neuropsychiatric workup or will have those tests performed during the study. Both groups, AD and controls will be asked to listen to a series of sounds and press a button on a handheld control box when a target sound is heard. The COGNISION(TM) headset on each subject's head will then record the electrical signals during this task. Four important features of the COGNISION(TM) will be investigated: Patient tolerance Ease of use Data quality Network architecture

Official Title
-----------------
Evaluation of a Handheld Evoked Response Potentials (ERP) System as an Effective Method to Diagnose Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for AD: Age 60 to 85 Mild to moderate diagnosis of Alzhiemer's disease Inclusion Criteria for Control: Age 60 to 85 Cognitively healthy with no complaints Exclusion Criteria: Subjects with advanced AD and severe impairment (CDR > 2, MMSE less than 15) Neurological disorders such as stroke, Parkinson's disease, Huntington's disease, multiple sclerosis, brain tumor, delirium, or psychiatric disorder other than depression (e.g. schizophrenia) Subjects with life threatening illnesses and subjects with significant hearing or visual impairments Subjects with a current prescription for psychoactive pharmaceuticals

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Mild-moderate Alzheimer's Disease | |
| 2<br>Age-matched Controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal to noise ratio (SNR) of ERPs |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient tolerance of the COGNISION(TM) system. |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
senile, dementia
Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.

Official Title
-----------------
A Phase 3, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study of NRP104 in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: NRP104
* Drug: NRP104
* Drug: NRp104
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary diagnosis of ADHD combined subtype or the predominantly hyperactive-impulsive subtype based on a psychiatric evaluation that reviews DSM-IV criteria functioning at age appropriate levels intellectually blood pressure measurements within the 95th percentile for their gender, height and age ECG results are within the normal range Exclusion Criteria: comorbid psychiatric diagnosis (such as psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations history of seizures (exclusive of febrile seizure), a tic disorder, or a family history of Tourette's disorder weighs less than 55 lbs (25 kg)or is significantly overweight or obese clinically significant ECG abnormality documented allergy or intolerance to amphetamines

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- |
| Experimental: 1<br> | Drug: NRP104<br>* NRP104 30mg capsule once daily in a.m.<br>|
| Experimental: 2<br> | Drug: NRP104<br>* NRP104 50mg capsule once daily in a.m.<br>|
| Experimental: 3<br> | Drug: NRp104<br>* NRP104 70mg capsule once daily in a.m.<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change score from baseline of the ADHD-RS |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of therapeutic responses using the CPRS ADHD Index |  | At treatment endpoint, separately for morning, afternoon and evening responses | 
| Clinical global impression of severity(CGI-S) and improvement (CGI-I) |  | Treatment endpoint | 
| Treatment emergent AEs |  | 4 weeks |
On Demand Treatment of Reflux Disease

Study Overview
=================
Brief Summary
-----------------
A comparison of the effect of on demand treatment with a pectin-containing natural product (Aflurax) with that esomeprazole (Nexium)

Detailed Description
-----------------
A randomized, controlled, open trial comparing the symptomatic effect of a pectin-containing product (Aflurax) with that of esomeprazole (Nexium 20 mg) given on-demand for 6 weeks.

Official Title
-----------------
Aflurax Versus Nexium Given on Demand to Patients With Gastro-esophageal Reflux Disease.

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: Aflurax
* Drug: esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild and moderate reflux symptoms Age > 17 years Informed consent - Exclusion Criteria: Other conditions that might explain the symptoms Abuse of drugs or alcohol -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aflurax<br>pectin-containing natural product | Drug: Aflurax<br> <br> * Other names: Pectin-containing nature product;|
| Active Comparator: esomeprazole (Nexium)<br>esomeprazole (Nexium) | Drug: esomeprazole<br> <br> * Other names: Nexium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic relief |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal Reflux, Esomeprazole, Drug treatment
Predictive Factors of Conversion in Laparoscopic Colorectal Cancer Resection

Study Overview
=================
Brief Summary
-----------------
Background Laparoscopic resection is the treatment of choice for colorectal cancer. Rates of conversion to open surgery range between 7% and 30% and controversy exists as to the effect of this on oncologic outcomes. The objective of this study was to analyze what factors are predictive of conversion and what effect they have on oncologic outcomes. Material & Methods From a prospective database of patients undergoing laparoscopic surgery between 2000 and 2018 a uni- and multivariate analyses were made of demographic, pathological and surgical variables together with complementary treatments comparing purely laparoscopic resection with conversions to open surgery. Overall and disease-free survival were compared using the Kaplan-Meier method.

Detailed Description
-----------------
Laparoscopic resection of colorectal cancer is the surgical option of choice provided that established oncologic principles are guaranteed [1-4]. Apart from the well-known advantages of minimally invasive surgery (shorter hospital stays, lower pain levels, faster return of bowel functions and rapid return to normal daily activities) reductions in operative morbidity and mortality have been reported together with oncologic outcomes which are similar to those of open surgery [5-7]. However, reported conversion rates to open surgery are highly variable (7% - 30%) as is the impact of conversion on oncologic outcomes [8-10]). The objectives of this study were to identify the risk factors associated with conversion and to assess their impact on operative morbidity and mortality and long-term oncologic outcomes.

Official Title
-----------------
CONVERSION TO OPEN SURGERY IN LAPAROSCOPIC COLORECTAL CANCER RESECTION: PREDICTIVE FACTORS AND ITS IMPACT ON LONG-TERM OUTCOMES. A RETROSPECTIVE COHORT STUDY

Conditions
-----------------
Surgery, Colorectal Neoplasm, Laparoscopy

Intervention / Treatment
-----------------
* Procedure: laparoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All laparoscopic colorectal neoplasia, laparoscopic resected Exclusion Criteria: Palliative and emergency procedures
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: laparoscopic surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to open rate: predictive factors oncological outcomes |  | 2000-2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic surgery, colorectal cancer
Testing New Method of Analyzing MR Images

Study Overview
=================
Brief Summary
-----------------
Preliminary imaging study to test for future use of this MRI-imaging for evaluating anti-angiogenesis treatment.

Detailed Description
-----------------
The purpose of this study is to develop and evaluate new MR imaging techniques and protocols for non-invasive monitoring of anti-angiogenesis treatment of breast cancer. This feasibility study is a preliminary imaging study to test this imaging protocol on subjects already undergoing MR for clinical purposes. The specific objective of this research study is to develop and validate both MRI and functional MRI data acquisition methods, task paradigms, and post-processing techniques to ensure reliability of results. The information derived from this research is intended to be applied to a future study of subjects undergoing experimental anti-angiogenesis drug therapy.

Official Title
-----------------
Imaging Protocol Design for Anti-Angiogenesis Tracking With MRI

Conditions
-----------------
Breast Abnormalities

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females Age 18 years or greater Undergoing breast MRI exam Exclusion Criteria: Pregnancy Contraindication for MRI on standard screening checklist for clinically indicated examinations (i.e. metal devices/implants; history of claustrophobia) History/presence of any of the following to the breast: injury; breast implant; surgical or interventional procedure; clinically significant abnormality

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

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

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

| Intervention/Treatment |
| --- |
|Device: MRI|15-20 minutes MR imaging|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide preliminary data for a larger study that this type of imaging can be used to monitor the effectiveness of anti-angiogenic therapy. |  | After analysis of images | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MR scanning