linjc16/ctgov huggingface dataset:
Choroidal Thickness in Optic Neuropathy

Study Overview
=================
Brief Summary
-----------------
This study plans to learn more about the thickness of the choroid in patients with optic neuropathy. The choroid is a layer of blood vessels that supplies oxygen and nourishment to the outer layers of the retina. Patients are being asked to be in this research study because they have optic neuropathy and are receiving care at the University of Colorado Hospital.

Official Title
-----------------
Choroidal Thickness in Optic Neuropathy

Conditions
-----------------
Optic Nerve Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age greater than 18 years, diagnosis of optic neuropathy, willing and able to sign an informed consent. Exclusion criteria: steroid use within the past 4 weeks, inability to cooperate with optical coherence tomography (OCT) testing, relevant ocular comorbidities in the affected or unaffected eye, such as glaucoma, uveitis, optic nerve hypoplasia, age related macular degeneration, refractive error greater than 5 spherical diopters.

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 |
| --- | --- | --- |
| Difference of the subfoveal and parafoveal choroidal thickness in affected and unaffected eye of the same patient. |  | 1 time |
Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization

Study Overview
=================
Brief Summary
-----------------
Evaluation of the neurosensory disturbances after inferior alveolar nerve lateralization with and without isolation of the simultaneously placed implants using collagen membrane And measuring the stability of implants after placement .

Official Title
-----------------
Evaluation of the Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization With and Without Isolation of the Simultaneously Placed Implants Using Collagen Membrane

Conditions
-----------------
Implant Site Reaction

Intervention / Treatment
-----------------
* Other: isolation of IAN from implant with collagen membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with with atrophied posterior mandibular ridge Both sexes. No intraoral soft and hard tissue pathology. No systemic condition that contraindicate implant placement. Exclusion Criteria: Presence pathological lesions Heavy smokers more than 20 cigarettes per day .(24) Patients with systemic disease that may affect normal healing. Psychiatric problems Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Atrophied posterior mandible
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: isolation of IAN nerve with collagen membrane<br> | Other: isolation of IAN from implant with collagen membrane<br>* comparing between the neurosensory disturbances with and without isolation of the inferior alveolar nerve from implant<br>|
| Experimental: without isolation of the IAN with collagen<br> | Other: isolation of IAN from implant with collagen membrane<br>* comparing between the neurosensory disturbances with and without isolation of the inferior alveolar nerve from implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurosensory disturbances - sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area | Assessing the sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area of sensation regaining | Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability - Osstell device to assess the primary stability of placed dental implant | Osstell device to assess the primary stability of placed dental implant after nerve lateraliztion | Year |
Metadoxine as a Therapy for Severe Alcoholic Hepatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.

Official Title
-----------------
Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis

Conditions
-----------------
Severe Alcoholic Hepatitis

Intervention / Treatment
-----------------
* Drug: Prednisone plus Metadoxine
* Drug: Pentoxifylline plus Metadoxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinical and biochemical criteria for severe alcoholic hepatitis: Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound, history of chronic alcohol intake, leukocytosis, neutrophilia, elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2, discriminant function greater than 32. Exclusion Criteria: Diabetes, chronic kidney disease, hepatitis C, hepatitis B and or human immunodeficiency virus infection, asthma or history of atopy or allergic reactions, therapy in the previous two years with steroids, pentoxifylline, metadoxine, S-adenosyl L- methionine, antioxidants or multivitamins.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Prednisone<br>Prednisone 40 mg daily by mouth during 30 days. | |
| No Intervention: Pentoxifylline<br>Pentoxifylline 400 mg thrice in day by mouth during 30 days | |
| Experimental: Prednisone plus metadoxine<br>Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days. | Drug: Prednisone plus Metadoxine<br> <br> |
| Experimental: Pentoxifylline plus metadoxine<br>Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days. | Drug: Pentoxifylline plus Metadoxine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day-survival |  | 30 days | 
| Malondialdehyde serum levels |  | 14 and 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 month-survival |  | 3 months | 
| 6 month-survival |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe alcoholic hepatitis, survival, oxidative stress
Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims.

Official Title
-----------------
Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Device: Nellcor USB Pulse Oximeter Monitor Interface Cable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects 18 or older (inclusive) Subject is able to participate for the duration of the study Subject is willing to sign an informed consent Exclusion Criteria: Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors Physiologic abnormalities that prevent proper application of pulse oximetry sensor Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nellcor USB Pulse Oximeter Monitor Interface Cable Sensor Test<br> | Device: Nellcor USB Pulse Oximeter Monitor Interface Cable<br>* Volunteers are subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature. Such conditions include exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report the Time Until the Device Posts Sensor Off After the Sensor is Removed | A series of sensor-off events were collected from subjects in the study using marketed, off-the-shelf sensors. Each event was marked as pass if event duration (Timeend - Timestart) was less than or equal to 60 seconds; otherwise, the event was marked as greater than or equal to 60 seconds. The acceptance criteria is if 90% of the time the product posts Sensor Off, or any equal or higher priority alarm, within 60 seconds after sensor is removed. | 1 minute per event, multiple events per subject. Total duration up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Focus of Study: Healthy Volunteers
Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris

Study Overview
=================
Brief Summary
-----------------
To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris

Official Title
-----------------
Evaluation of the Anti-anginal Efficacy and Safety of Oral Administration of Ivabradine Compared to Placebo on Top of Background Therapy With Atenolol in Patients With Stable Angina Pectoris. A Four-month Randomised Double-blind, Parallel Group International Multicentre Study.

Conditions
-----------------
Angina Pectoris

Intervention / Treatment
-----------------
* Drug: Ivabradine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic stable angina pectoris Documented coronary artery disease Previous treatment with atenolol or other beta-blocker agent Exercise tolerance test positivity and stability Exclusion Criteria: Heart rate < 60 bpm Congestive heart failure

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: Ivabradine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement between baseline and end of treatment of the treadmill exercise tolerance test |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate pressure product |  |  | 
| Clinical evaluation |  |  |
Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)

Study Overview
=================
Brief Summary
-----------------
Obstructive Sleep apnea carries a variety of complications and implications. While the disease could be treated using continuous positive airway pressure (CPAP) and lifestyle changes, many patients find it difficult to adjust to the mask, and turn to surgical options. The conventional surgical options to date ranges from radical (UPPP) to individualized, with or without Drug-induced sleep endoscopy (DISE). Previous studies showed that dise directed surgery can be useful for specific conditions. No trials were found to test in-office encompassing minimal invasive surgical treatment (RF palatoplasty , RF tonsillotomy, RF turbinectomy, and RF base-of-tongue reduction) as a viable alternative..

Official Title
-----------------
Possible Efficacy of Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)

Conditions
-----------------
Sleep Apnea Syndromes, Obstructive

Intervention / Treatment
-----------------
* Procedure: Minimally invasive, in-office, RF reduction of the affected area


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from OSA, defined as AHI > 5 Exclusion Criteria: Patients who can use CPAP. Patients suffering from confounding factors with higher risk (Coagulation problems, Heart conditions, chronic obstructive pulmonary disease (COPD), or other dangerous conditions as decided by the surgeon) Patients suffering from other problems aggravating the OSA (Respiratory, Neurologic conditions)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Patient suffering from OSA, and found to suffer from obstruction of one or more of the following areas - Lower turbines, Soft Palate, Tonsils, Base-of-tongue. | Procedure: Minimally invasive, in-office, RF reduction of the affected area<br>* Usage of RF needle to treat one or more of the affected areas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| More than 50% improvement in Apnea-Hypopnea index (AHI) | Measuring the AHI score using sleep laboratory | 6 months following the procedure | 
| More than 50% improvement in Apnea-Hypopnea index (AHI) | Measuring the AHI score using sleep laboratory | 12 months following the procedure | 
| Reduction of AHI to below 20 | Measuring the AHI score using sleep laboratory | 6 months following the procedure | 
| Reduction of AHI to below 20 | Measuring the AHI score using sleep laboratory | 12 months following the procedure |
Intraoperative Mitomycin C in Lacrimal Sac Mucocele

Study Overview
=================
Brief Summary
-----------------
30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with intraoperative mitomycin C was added to decrease postoperative fibrosis and recurrence.

Official Title
-----------------
Evaluation of Intraoperative Mitomycin C in Surgical Management of Lacrimal Sac Mucocele

Conditions
-----------------
Lacrimal Mucocele

Intervention / Treatment
-----------------
* Procedure: Canaliculo- Dacryocystorhinostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lacrimal sac mucocele Exclusion Criteria: Paediatric patients (less than 16 years old). Previous lacrimal passage procedure. Neoplasms as secondary causes of obstruction.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Chronic dacryocystitis patients<br> | Procedure: Canaliculo- Dacryocystorhinostomy<br>* Bypass lacrimal passage obstruction by opening a shunt between the lacrimal sac and the nasal mucosa<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test | Patency of the lacrimal passage | 1 month | 
| Disappearance of lacrimal sac swelling | No evident swelling in the medial side of the eye | 1 month |
From Known to New Genes in Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
The mechanism of the majority of the dyslipidemia is multifactorial at the molecular level and remains elusive in more than 50% of the patients in many clinical conditions. Next generation sequencing, a booming strategy, improves the molecular diagnosis efficiency in both monogenic and polygenic dyslipidemia. In order to decipher the mechanisms involved in the occurrence of dyslipidemia, in addition to the exploration of known candidate genes and Single Nucleotide Polymorphisms (SNP) involved in polygenic modulation, new genes involved in the regulation of lipoprotein metabolism or associated with lipids concentrations need to be sequenced in large groups of dyslipidemic patients. The goal of this project is to gain new insight into genotype/phenotype correlation.

Official Title
-----------------
Genetical Characterization of Patients Presenting With Dyslipidemia

Conditions
-----------------
Dyslipidemias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a family documented history of primary hypercholesterolemia, hypertriglyceridemia, hypobetalipoproteinemia, combined hypolipidemia and combined hyperlipidemia according to the European Atherosclerosis Society and/or published data. patients with major secondary dyslipidemia. Exclusion Criteria: inability to provide written informed consent lack of legal representative
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 |
| --- | --- |
| Dyslipidemia<br>Genotype/phenotype correlation in patients with dyslipidemia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetical exploration in dyslipidemic patients | Deoxyribonucleic Acid (DNA) sequencing will allow the study of rare gene variants and their frequency in known and new genes in patients with dyslipidemia. | 25 years |
Tocopherol is a Novel Treatment for Cancer Related Mucositis

Study Overview
=================
Brief Summary
-----------------
The present protocol is an attempt to prevent/treat mucositis in highly susceptible patients subjected to maximally tolerated doses of subsequently-myeloablative or myeloablative doses of chemoradiotherapy supported by autologous or allogeneic stem cell transplantation at the Department of Bone Marrow Transplantation. Mucositis is a major problem in the management of transplant recipients which subjects the patients to the risk of sepsis, need for parenteral nutrition and need of narcotics. We are planning a 2 arm study, comparing 2 safe vitamin E based formulations with placebo.

Official Title
-----------------
A Randomized Double Blind Placebo Controlled Clinical Trial Aim to Assess the Efficacy of Vitamin E Formulation (Tocopherol) in the Treatment of Chemotherapy Induced Stomatitis in Patients Undergoing Stem Cell Transplantation

Conditions
-----------------
Oral Mucositis

Intervention / Treatment
-----------------
* Drug: Tocopherol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and non-pregnant and non-lactating females, 18 years of age or older at the time of screening, who are to receive myeloablative agonists with or without total body irradiation (TBI) in preparation for either allogeneic or autologous HSCT. Patients who are to be hospitalized and are expected to remain hospitalized until marrow recovery. Karnofsky performance status of 60 or greater or ECOG performance status of 2 or less. Normal dental examination as assessed by the investigator. Exclusion Criteria: Clinically significant acute and active oral cavity infection. Patients taking any investigational or other non-approved oral therapy for oral mucositis. Known hypersensitivity to Vitamin E.

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tocopherol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the tolerability and the safety of a Tocopherol formulation in the prevention or suppression of the serverity of oral mucositis induced by myeloablative agonist. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the toxicity and the safety of a Tocopherol formulation in the prevention or suppression of the serverity of oral mucositis induced by myeloablative agonist. |  |  |
Chart Review of Laparoscopic Radical Cystectomy

Study Overview
=================
Brief Summary
-----------------
The investigator intends to review retrospective de-identified data of patients who have had Laparoscopic Radical Cystectomies by the Department of Urology at UCIMC.

Detailed Description
-----------------
The investigator fills out a standardized form for each patient undergoing a laparoscopic radical cystectomy.

Official Title
-----------------
Retrospective Chart Review of Laparoscopic Radical Cystectomy

Conditions
-----------------
Laparoscopic Radical Cystectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Review information on patients who had laparoscopic Radical cystectomy at UCIMC

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 |
| --- | --- | --- |

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