linjc16/ctgov huggingface dataset:
Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells

Study Overview
=================
Brief Summary
-----------------
Collection of tissues for analysis from patients undergoing elective neck dissection. The hypothesis of the study is that specific genetic alterations occur in head and neck cancers that have spread to regional and/or distant sites, and these alterations can be identified from biopsy specimens to allow more accurate staging of tumor and better treatment planning.

Detailed Description
-----------------
The standard of care for the treatment of most squamous cell carcinoma of the head and neck is surgical extirpation of the primary tumor and elective neck dissection to remove regional nodes at risk for spread. Via this treatment regimen, the investigators will be able to prospectively obtain tissues for analysis from patients undergoing elective neck dissection. The specific aims of this study are to compare gene expression between head and neck tumors with and without regional lymph node metastases, and to compare gene expression between head and neck tumor with and without distant metastases.

Official Title
-----------------
Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells

Conditions
-----------------
Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with biochemical evidence of squamous cell carcinoma of the head and neck. Exclusion Criteria: Patients without biomedical evidence of squamous cell carcinoma.

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- | --- |
The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

Detailed Description
-----------------
To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin/Ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypercholesterolemic patient Exclusion Criteria: Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: R5<br>Rosuvastatin 5mg | Drug: Rosuvastatin/Ezetimibe<br>* Rosuvastatin 5mg<br>|
| Active Comparator: R10<br>Rosuvastatin 10mg | Drug: Rosuvastatin/Ezetimibe<br>* Rosuvastatin 5mg<br>|
| Active Comparator: R20<br>Rosuvastatin 20mg | Drug: Rosuvastatin/Ezetimibe<br>* Rosuvastatin 5mg<br>|
| Experimental: R5/E10<br>Rosuvastatin 5mg/ezetimibe 10mg | Drug: Rosuvastatin/Ezetimibe<br>* Rosuvastatin 5mg<br>|
| Experimental: R10/E10<br>Rosuvastatin 10mg/ezetimibe 10mg | Drug: Rosuvastatin/Ezetimibe<br>* Rosuvastatin 5mg<br>|
| Experimental: R20/E10<br>Rosuvastatin 20mg/ezetimibe 10mg | Drug: Rosuvastatin/Ezetimibe<br>* Rosuvastatin 5mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 8 week in LDL-Cholesterol |  | baseline and 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 4 week in LDL-Cholesterol |  | baseline and 4 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholesterol
Impact of Diet on Functional Gastrointestinal Symptoms

Study Overview
=================
Brief Summary
-----------------
This cross-sectional survey study is to determine the prevalence of functional gastrointestinal (GI) disorders in the general population and to describe common triggers for food-related GI symptoms.

Detailed Description
-----------------
Functional gastrointestinal disorders, involving symptoms such as gas/bloating, diarrhea, constipation and abdominal pain, are estimated to impact between 35 and 45 million Americans, an overwhelming 15-20% of the population. These symptoms are responsible for upwards of 20 billion dollars in healthcare costs and extensive loss of quality of life for sufferers. Moreover, many patients suffer in silence, with 67% of subjects waiting more than a year before treatment, and 11% waiting over 10 years. Irritable bowel syndrome is the most prevalent functional gastrointestinal disorder, and several recent studies support the idea that dietary modifications may be key to alleviating this condition. The purpose of this study is to document gastrointestinal symptoms among the US population, as well as to ascertain awareness and utilization of dietary treatments that exist.

Official Title
-----------------
Impact of Diet on Functional Gastrointestinal Symptoms; a National Population Based Survey

Conditions
-----------------
Gastrointestinal Disorder, Functional

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Visual impairment Inability to read Inability to understand English Inability to use a computer to respond to questions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Most Common Triggers for Food-related GI Symptoms (Top 5) | Percentages for foods chosen as triggers ( a subject can check more than one answer - Bread, Oats, Chili, Corn, Onion, Garlic, Beans, Chocolate, Fried or greasy foods, Eggs, Soy, Red meat, Fish or shellfish, Dairy products, Nuts and seeds, Apples, Bananas, Citrus fruit, Alcohol, Coffee, Carbonated drinks, Sugar-free gum) | During the past 3 months before the survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Functional GI Disorders | Percentages of self-reported functional GI disorders ( a subject can check more than one answer - Acid reflux (GERD), Irritable bowel syndrome (IBS), Celiac disease, Inflammatory bowel disease - Crohn's or Ulcerative Colitis, Diverticulities, Gastroparesis, Leaky gut, small intestinal bacterial overgrowth (SIBO), None of the above) | During the past 3 months before the survey |
Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
The aim is to conduct a single centre retrospective study of all patients with stage IV melanoma that underwent surgery for metastases at Sahlgrenska University Hospital between 2010-01-01 and 2018-12-31. Pre- and postoperative data will be collected from digital medical records, the Swedish Cancer Registry, the Swedish Cause of Death Register as well as from the national Swedish cancer patient database (INCA). If needed, patient records will be collected from other hospitals. Results will be presented in written format as a summary and analysis of the characteristics of the cases operated on during the inclusion period. The aim is to identify predictive and prognostic factors for outcome and complications in the surgical treatment of stage IV metastatic melanoma.

Official Title
-----------------
Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study

Conditions
-----------------
Melanoma Stage Iv, Melanoma Metastatic, Abdominal Tumor

Intervention / Treatment
-----------------
* Procedure: Abdominal surgery with metastasectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy verified stage IV malignant melanoma, stage M1c. Having undergone surgery with metastasectomy of melanoma tumors. Exclusion Criteria: retroperitoneal tumors

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 |
| --- | --- |
| Cohort<br>Patients with stage IV malignant melanoma with abdominal metastasis (M1c) that underwent abdominal surgery with metastasectomy during the study period. | Procedure: Abdominal surgery with metastasectomy<br>* Emergency or elective surgery on indications related to abdominally metastasized malignant melanoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | December 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications according to Clavien-Dindo within 90 days. | Complications according to Clavien-Dindo within 90 days. | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma, abdominal metastasis, metastasectomy, tumor resection, M1c
Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Icotinib is efficient and safe in treating advanced non-small cell lung cancer (NSCLC) patients with hepatic insufficiency.

Detailed Description
-----------------
Patients with hepatic insufficiency is an important subgroup of who receive EGFR TKIs. Phase I/II studies showed that Icotinib has good security. Based on the above considerations, this single-arm, open-label study is designed to evaluate the safety of icotinib 125mg three times daily for histologically or cytologically confirmed NSCLC patients with hepatic insufficiency.

Official Title
-----------------
Safety Assessment of Icotinib in Advanced NSCLC Patients With Hepatic Insufficiency: A Multi-center, Open-label, Single-arm Study

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: icotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of IIIB/IV stage NSCLC patients who are not suitable for surgery or radiotherapy ECOG performance status points (PS) is 0-2 Liver function: A (mild hepatic dysfunction): A1) total bilirubin within normal limit (ULN), while AST> ULN; A2) total bilirubin within1.0-1 .5 × ULN; B (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × ULN No malabsorption or other gastrointestinal disorders effecting drug absorption Life expectancy: more than 12 weeks. Exclusion Criteria: Previous usage of HER/EGFR inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy ) Patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process . Patients with active hepatitis and cirrhosis.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icotinib<br>Icotinib is administered orally 125 mg three times per day continuously for four weeks | Drug: icotinib<br>* Icotinib is administered orally 125 mg three times per day continuously for four weeks<br>* Other names: Commana;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | Up to 4 weeks |
Risk and Importance of Peroperative Nasal Hemorrhage in the Treatment of Lacrimal Duct Obstruction in Young Children

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a pushed probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO). In the investigator's experience, this risk seemed to minus using a pushed probe rather than the classical pulled-type probes. A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the use of an orolaryngeal mask. A forthcoming study will evaluate the results of this anesthetic change.

Conditions
-----------------
Lacrimal Duct Obstruction

Intervention / Treatment
-----------------
* Procedure: pushed mono-canaliculonasal intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 6 years of age Unilateral lacrimal duct obstruction with programmed surgery Surgery scheduled wih a pushed mono-canaliculonasal intubation No opposition of parents for he participation of their child Exclusion Criteria: Coagulation disorder Previous history of nasolacrimal intubation (homo or contra-lateral) Non covered by health insurance

Ages Eligible for Study
-----------------
Maximum Age: 6 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 |
| --- | --- |
| Nasolacrimal duct obstruction<br> | Procedure: pushed mono-canaliculonasal intubation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal hemorrhage |  | Through surgery completion, an average of 1 hour |
DIETary Intake, Death and Hospitalization in Adult With End-stage Kidney Disease Treated With HemoDialysis (DIET-HD) Study

Study Overview
=================
Brief Summary
-----------------
The DIETary intake, death and hospitalisation in adults with end-stage kidney disease treated with HaemoDialysis (DIET-HD) study is a multinational prospective cohort study designed to evaluate the association between nutrition and dietary patterns and health outcomes in prevalent adult haemodialysis patients in Europe and South America.

Official Title
-----------------
DIETary Intake, Death and Hospitalization in Adult With End-stage Kidney Disease Treated With HemoDialysis (DIET-HD) Study

Conditions
-----------------
Diet Habit, End Stage Renal Disease

Intervention / Treatment
-----------------
* Other: dietary intake of omega-3 and omega-6 polyunsaturated fatty acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End-stage kidney disease Long-term haemodialysis for at least the previous 90 days 18 years or older Treating team agrees to the patient's involvement in the study Participant willing to provide written and informed consent.- Exclusion Criteria: significant neurocognitive disability or medical comorbidity that would preclude them from understanding the dietary questionnaire even if assisted a life expectancy less than 6 months according to their treating physician planned kidney transplantation within 6 months of baseline

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

| Intervention/Treatment |
| --- |
|Other: dietary intake of omega-3 and omega-6 polyunsaturated fatty acids|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality | Defined as sudden death or death attributed to acute myocardial infarction, pericarditis, atherosclerotic heart disease, cardiomyopathy, cardiac arrhythmia, cardiac arrest, valvular heart disease, pulmonary edema, or congestive cardiac failure | 12 months since baseline dietary evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 12 months since baseline dietary evaluation | 
| Infection-related mortality |  | 12 months since baseline dietary evaluation | 
| All-cause and cardiovascular related hospitalisation |  | 12 months since baseline dietary evaluation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition, hemodialysis, mortality, omega 3
Descriptive Study of a French Sample of at Risk and Pathological Gamblers Followed in a French Structure Specialised in Addictive Disorders.

Study Overview
=================
Brief Summary
-----------------
International surveys about pathological gambling estimate that there are about 1 to 3 per cent of gamblers who develop a pathological behavior about gamble.In France, pathological gambling is not a priority of public health, in contrast with other addictive disorders, like alcoholism or nicotine addiction. The aim of our study is to describe accurately for the first time in France, a sample of at risk and pathological French gamblers. We want to collect socio-demographical and clinical data from this subjects (story of the addictive behaviour, co morbidities, and more specifically, detailed study of pathological gamblers' personality), in order to compare our data with those of international literature.Secondarily, we want to test the feasibility of this kind of detailed evaluations for another study planned for 2007-2008 and which purpose will be to compare pathological gamblers' personality characteristics according to the kind of game that they mainly practice.The participation at the study will be proposed to every patient consulting in the service d'addictologie du CHU de Nantes. The study consists in a single evaluation (about 8 hours) with standardized tools used all other the world.

Official Title
-----------------
Descriptive Study of a French Sample of at Risk and Pathological Gamblers Followed in a French Structure Specialised in Addictive Disorders.

Conditions
-----------------
Pathological Gambling

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18 and 70 Consulting or ex-consulting since 2000 in the service d'addictologie du CHU de Nantes Who meet sufficient criteria of pathological or at risk gambling in the DSM-IV section about pathological gambling Who accept to participate Who give their consent Who don't have any exclusion criteria Exclusion Criteria: Gambling behaviour directly and chronologically explain by an acute maniac fit Superior function trouble Who don't agree to participate Difficulties in reading or writing in French

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |
Feedback on Perioperative Temperature Management and Patient Outcomes: Three-arm Trial to Compare Feedback

Study Overview
=================
Brief Summary
-----------------
The investigators aim to assess the impact of benchmarked and ranked feedback on anesthesiologists' perioperative temperature management and subsequent patient outcomes.

Official Title
-----------------
Effect of Audit and Feedback on Physicians' Perioperative Temperature Management and Patient Outcomes: A Three-arm Cluster Randomized Controlled Trial to Compare Benchmarked and Ranked Feedback

Conditions
-----------------
Surgical Site Infections, Hypothermia

Intervention / Treatment
-----------------
* Behavioral: Benchmarked Feedback
* Behavioral: Ranked Feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Staff Anesthesiologists at The Ottawa Hospital Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants in this study arm will receive no form of feedback. | |
| Other: Benchmarked Feedback<br>Participants in this study arm will receive benchmarked feedback regarding their perioperative temperature management. | Behavioral: Benchmarked Feedback<br>* Participants receive data, during the 6 month intervention phase, regarding their monthly temperature management performance in the form of benchmarked feedback, which is the measure of their performance in comparison the standard set by the hospital.<br>|
| Other: Ranked Feedback<br>Participants in this study arm will receive ranked feedback regarding their perioperative temperature management. | Behavioral: Ranked Feedback<br>* Participants receive data, during the 6 month intervention phase, regarding their monthly temperature management performance in the form of ranked feedback, which is the measure of their performance in comparison to their peers.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient peri-operative temperature |  | Within the 30 minutes immediately before or the 15 minutes immediately after anesthesia end time. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative warming device usage perioperative |  | intraoperative | 
| Patient post-operative surgical site infection (SSI) rate |  | Within 30 days of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Feedback, Temperature management, Anesthesia