linjc16/ctgov huggingface dataset:
Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collaborators at Rice University and provides > 1000x magnified images of the esophageal mucosa. The purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.

Official Title
-----------------
Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer

Conditions
-----------------
Squamous Cell Cancer

Intervention / Treatment
-----------------
* Drug: proflavine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: known or suspected squamous cell neoplasia 18 years or older

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>imaging with proflavine | Drug: proflavine<br>* 1-10 ml of proflavine (derived form dissolving 10mg proflavine hemisulfate USP in 100 ml sterile water)<br>* Other names: Proflavine hemisulfate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine whether or not tissue is neoplastic or non-neoplastic |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
squamous cell cancer, squamous cell neoplasia
A Concordance Study Comparing Insulin Treatments in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
A study to compare insulin use and its effect on glucose control and other outcomes in patients with Type 2 diabetes who together with their healthcare provider manage their disease by discussing and agreeing on the diabetes treatment chosen from a selection of available treatment options.

Official Title
-----------------
A Phase 3, Open-Label, Parallel Group Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in Patients With Type 2 Diabetes Mellitus: Two Populations With Different Insulin Treatment Options

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Human Insulin Inhalation Powder
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Insulin-naive Non-smoker Exclusion Criteria: Significant pulmonary, hepatic or renal disease severe congestive heart failure active malignancy or malignancy within the last 5 years systemic glucocorticoid therapy

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: 1<br>Treatment options available on the market plus the option of taking Human Insulin Inhalation Powder. | Drug: Human Insulin Inhalation Powder<br>* patient specific dose, inhaled, before meals, 9 months ( if patient chooses Human Insulin Inhalation Powder option)<br>* Other names: LY041001;|
| Active Comparator: 2<br>Treatment Options available on the market. | Drug: Insulin<br>* patient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess acceptance of insulin therapy |  | 9 months | 
| To assess blood sugar control as measured by HbA1c |  | baseline, 1,3,5,7,9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure changes in HbA1c over time |  | baseline, 1,3,5,7,9 months | 
| To assess safety by review of adverse events |  | throughout study | 
| To assess patient-reported outcomes based on the W-BQ12 questionnaire |  | screening, baseline, months 5, and 9 | 
| To assess patient-reported outcomes based on the DSC-R questionnaire |  | screening,baseline, months 5 and 9 | 
| To assess patient-reported outcomes based on the DTSQ Questionnaire |  | Screening,baseline, months 5 and 9 |
Study Evaluating Health Related Utility in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine in Australia what effect rheumatoid arthritis has on quality of life, and also to determine the costs that are associated with having rheumatoid arthritis.

Detailed Description
-----------------
At a routine visit to the clinic, patients will be asked to answer questions about their symptoms, have a routine examination by the doctor, fill out a questionnaire that will ask questions about them, about their arthritis, about how it affects their well being and quality of life, and about treatment and costs. The questionnaire will take them about 30 minutes to complete. A blood test may also be required. This ends the patient's involvement with the study.

Official Title
-----------------
An Observational Study to Examine the Relationship Between Rheumatoid Arthritis Disease Severity and Health Related Utility

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient with clinically defined rheumatoid arthritis diagnosed for at least 3 months Age 18 years or older Ability to complete the study documents in English Exclusion Criteria: · Current participation in a blinded trial of an investigational treatment

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 |
| --- | --- | --- |
A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to generate a registry of Chinese patients with AL amyloidosis treated with subcutaneous/intravenous daratumumab alone or subcutaneous/intravenous daratumumab combined with chemotherapy.

Official Title
-----------------
A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab

Conditions
-----------------
AL Amyloidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older newly diagnosed or refractory/relapsed AL amyloidosis treated with subcutaneous/intravenous daratumumab alone or subcutaneous/intravenous daratumumab combined with chemotherapy Exclusion Criteria: co-diagnosis of multiple myeloma or Waldenström's macroglobulinemia

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematologic complete response at 3 months |  | 3 months |
Comparison of Preoperative Screening Score for Obstructive Sleep Apnea (OSA)

Study Overview
=================
Brief Summary
-----------------
Comparison of preoperative screening score for OSA. In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.

Detailed Description
-----------------
Comparison of preoperative screening score for OSA (Obstructive Sleep Apnea). In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score. Comparison between scores and if applied with the results of a polysomnography (PSG).

Official Title
-----------------
Comparison of Preoperative Screening Score for OSA

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

Intervention / Treatment
-----------------
* Other: Comparison of the four screening score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults patients (> 18 years) performing a preoperative assessment at the ASTES Doctor's Office (ASTES is an acronym with the name of Medical Doctors involved in this office) Exclusion Criteria: Patients < 18 years

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>Comparison of the four screening score | Other: Comparison of the four screening score<br>* Comparison of the four screening score, for patient making a preoperative assessment for SLBO (clinique Saint-Luc de BOuge)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a positive DES-OSA score | Comparison of the result of the DES-OSA score with results of previously describes scores (STOP-BANG, OSA50 and P-SAP). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a positive STOP-Bang score and a positive PSG (PolySomnoGraphy) | For the patients with a positive STOP-Bang score: we will make a PSG. After this one, we will compare the result of four scores (STOP-Bang, OSA50, P-SAP and DES-OSA) and the result of the PSG (especially AHI: Apnea Hypopnea Index) | Baseline |
Impact of Sleeve Gastrectomy on Monocyte-to-High-Density Lipoprotein Cholesterol Ratio

Study Overview
=================
Brief Summary
-----------------
The present study hypothesized that significant weight loss is associated with a reduction in the inflammatory markers, leading to diminished cardiovascular risks in patients undergoing laparoscopic sleeve gastrectomy (LGS). We found a decrease in MHR at postoperative 6 months from baseline in patients undergoing LSG. The decrease in MHR was more remarkable with increasing percentage of EWL, but no relationship between the %EWL and MHR.

Detailed Description
-----------------
The present study aims to evaluate the relationship between MHR, metabolic parameters and the percentage of excess weight loss (%EWL) in participants undergoing laparoscopic sleeve gastrectomy (LSG). This prospective cohort study will evaluate obese participants undergoing LSG. Demographic data of the participants and blood glucose level, monocyte count and lipid parameters baseline and at 6 months after surgery will record. The MHR baseline and at 6 months after surgery and the %EWL at 6 months after surgery will calculate. The participants will be divide into two groups as participants with %EWL of <50 and patients with a %EWL of ≥50. The parameters will compare between the two groups.

Official Title
-----------------
The Relationship Between Monocyte-to-High-Density Lipoprotein Cholesterol Ratio, Metabolic Parameters and Excess Weight Loss in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Conditions
-----------------
Laparoscopic Sleeve Gastrectomy, Cardiovascular Risk Factor, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese patients (BMI ≥40 or >35+ and accompanying DM, HT and hyperlipidemia) Underwent laparoscopic sleeve gastrectomy. Exclusion Criteria: Receiving antihyperlipidemic therapy, Important complications that continue within 6 months after surgery (anastomotic leaks, pulmonary embolism, deep vein thrombosis, soft tissue infection) Did not attend 6-month control visit were excluded from 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes | Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes after Sleeve Gastrectomy | 6 months |
Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the mandibular advancement by Herbst device is effective in the treatment of moderate obstructive sleep apnea patients.

Official Title
-----------------
Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Herbst oral appliance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate sleep apnea syndrome (10 < Respiratory Disorder Index < 30) Body mass index (BMI) < 35 Kg/m2 Able to give their informed consent Exclusion Criteria: Pregnant women Professional drivers requiring continuous positive airway pressure (CPAP) treatment Psychiatric disorders, and patients unable to realise to study Severe respiratory pathology which could interfere with the study Morpheic epilepsy Benzodiazepines intake Chronic nasal obstruction Ear, nose, and throat (ENT) pathology requiring surgery Previous uvulopalatoplasty surgery Temporomandibular joint pathology Gum disease Insufficient number of teeth to apply the oral appliance Mobile teeth

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Herbst oral appliance|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of polysomnographic data after 3 months of treatment by oral appliance in 2 groups: one with Herbst device adjusted in maximal mandibular advancement and a placebo group |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy on clinical symptoms |  |  | 
| Tolerance of the oral appliance |  |  | 
| Identification of predictive factors of efficacy |  |  | 
| Feasibility of this therapeutic method |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prospective, randomized, polysomnography, orthodontic appliance, removable
Mucociliary Clearance Time in Chronic Rhinosinusitis (CRS) Patients After Sinus Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators are looking at the effects of baby shampoo nasal irrigation on the movement of mucous in the nose in patients who have undergone sinus surgery for chronic sinus problems.

Official Title
-----------------
Effect of Baby Shampoo Nasal Irrigation on Mucociliary Clearance Time in Patients After Sinus Surgery

Conditions
-----------------
Chronic Rhinosinusitis

Intervention / Treatment
-----------------
* Other: 1% Johnson's Baby Shampoo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CRS s/p sinus surgery Exclusion Criteria: nasal polyps

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Johnson's Baby Shampoo<br>1% diluted solution | Other: 1% Johnson's Baby Shampoo<br>* nasal irrigation 2x a day for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mucociliary clearance time (MCT) |  | 4 weeks |
Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
Experimental data suggest that transplantation of endothelial progenitor cells (EPCs) attenuates monocrotaline-induced pulmonary hypertension in rats and dogs. In addition, clinical studies suggest that autogolous progenitor cells transplantation is feasible and safe in patients with ischemic disease. This study will investigate the feasibility, safety, and initial clinical outcome of intravenous infusion of autologous EPCs in patients with idiopathic pulmonary arterial hypertension.

Conditions
-----------------
Idiopathic Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Procedure: Transplantation of autologous endothelial progenitor cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of idiopathic pulmonary arterial hypertension in New York Heart Association (NYHA) functional class II to III a mean pulmonary artery pressure more than 30 mmHg on right heart catheterization the ability to walk ≥50 m during a standardized 6-minute walk test. Exclusion Criteria: Pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, HIV infection, liver disease, NYHA functional class IV, major bleeding requiring blood transfusion, diabetes, renal dysfunction, and evidence for malignant diseases were excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transplantation of autologous endothelial progenitor cells|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study to Evaluate Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)

Study Overview
=================
Brief Summary
-----------------
This was a multicenter, prospective, 5-year surveillance study of approximately 5000 Raptiva-treated patients and approximately 500 non-Raptiva treated patients (formerly 2500 comparison patients who were treated with a biologic therapy other than Raptiva) with chronic moderate to severe plaque psoriasis who were candidates for treatment with Raptiva.

Official Title
-----------------
Raptiva Epidemiologic Study of Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)

Conditions
-----------------
Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have ever had a physician's diagnosis of chronic moderate to severe plaque psoriasis and be a candidate for treatment with Raptiva Are being treated with or initiating Raptiva therapy at the time of enrollment Be able to provide written informed consent Be willing and able to fully to participate for the duration of patient follow-up (5 years) Exclusion Criterion: Have previously received at least one dose of Raptiva and are not currently using or restarting treatment with Raptiva at the time of enrollment
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
-----------------
Plaque Psoriasis, RESPONSE, Raptiva, efalizumab
Mutation Analysis of 17α-Hydroxylase

Study Overview
=================
Brief Summary
-----------------
To elucidate the molecular pathology of the 4 families with 17α-hydroxylase/17,20-lyase deficiency.

Detailed Description
-----------------
17α-hydroxylase is a rare form of congenital adrenal hyperplasia. Patients with complete 17α-hydroxylase deficiency may come to attention to the doctor at their early adulthood due to hypertension or disordered puberty. 17α-hydroxylase is a form of cytochrome P450 enzyme in the adrenal cortex for the production of cortisol, while 17,20-lyase is required in both adrenal glands and the gonads for the production of androgen precursors of sex hormones. Therefore, patients with 17α-hydroxylase will presented with elevated deoxycorticosterone (DOC) level and decreased aldosterone and cortisol level. Because DOC is the second most important naturally occurring mineralocorticoid hormone, hypertension and hypokalemic alkalosis will be noted in these patients. Besides, deficiency of 17,20-lyase activity will lead to impairment of virilization in 46 XY patients and deficient estrogen production in 46 XX patients. The P450c17 has both 17α-hydroxylase and 17,20-lyase activity and are encoded by the CYP17 gene. The sequence of CYP17 gene was established in 1987 and more than 40 mutations were identified till now. The purpose of this study is to elucidate the molecular pathology of the 4 families with 17α-hydroxylase/17,20-lyase deficiency.

Conditions
-----------------
Pseudohermaphroditism, Congenital Adrenal Hyperplasia, Hypertension

Intervention / Treatment
-----------------
* Procedure: blood drawing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with 17α-hydroxylase deficiency and their family Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood drawing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |