linjc16/ctgov huggingface dataset:
Impact of the Third Molars in Oral Health-related Quality of Life

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the impact of the third molars in oral health-related quality of life, before and after surgical removal using a validated and frequently used in international investigations instrument (OHIP-14).

Detailed Description
-----------------
This is a prospective study that evaluates the oral health-related quality of life through the application of the self-administered OHIP-14 before and after the surgical removal of third molars. The inclusion criteria were adults' patients older than 18 years, referred for oral surgery. Patients with chronic diseases and acute pericoronitis were excluded. The assessment was performed at three times: pre-surgical planning 1 day before surgery (T0), 10 days (T1) and 2 - 3 months after surgery (T2)

Official Title
-----------------
Impact of the Third Molars in Oral Health-related Quality of Life

Conditions
-----------------
Health-related Quality of Life, Third Molar

Intervention / Treatment
-----------------
* Procedure: third molar surgical removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients over 18 years old Exclusion Criteria: Patients with chronic diseases and acute pericoronitis

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

| Intervention/Treatment |
| --- |
|Procedure: third molar surgical removal|ambulatory surgical intervention of the maxilla and / or mandible for third molar removal|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14) | Short form Oral Health Impact Profile (OHIP-14) was applied at 3 times: baseline, one week before surgery (T1), 10 days after surgery (T2) and 2 - 3 months after surgery (T3). A paired t-test was used to assess the mean (SD) changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean (SRM). The Short Form Oral Health Impact Profile (OHIP-14) is an instrument for assessment oral health-related quality of life. 14 ítems values: min = 0 / max = 56 higher scores mean a worse outcome | baseline to 10 days and 2 - 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health-related quality of life, third molar
Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-006)

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase III, open-label study is to determine the safety and tolerability of cyclosporine in the treatment of dry eye syndrome.

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: cyclosporine A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of dry eye syndrome Exclusion Criteria: Intraocular or refractive surgery in the study eye within 3 months prior to study start Unwilling to discontinue use of contact lenses during the study Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclosporine A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)

Study Overview
=================
Brief Summary
-----------------
To define the pharmacokinetic characteristics of Nystatin LF IV (intravenous) in human subjects with AIDS-related complex (ARC) after administration of a single IV dose at each of 4 dose levels.

Official Title
-----------------
Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Nystatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have the following: Positive HIV antibody test. Diagnosis of AIDS-related complex (ARC). CD4+ cell count between 100 and 300 cells/mm3. Estimated life expectancy of at least 6 months. Normal neurological status. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active opportunistic infection requiring ongoing therapy except patients being treated topically for oral thrush. Patients with the following are excluded: Active opportunistic infection. Known hypersensitivity to polyene antibiotics. Unwillingness to sign an informed consent or to be in compliance of protocol requirements. Prior Medication: Excluded within 72 hours of study entry: Biologic response modifier agents. Corticosteroids. Cytotoxic chemotherapeutic agents. Potential nephrotoxins. Potential neutropenic agents. Rifampin or rifampin derivatives. Systemic anti-infectives. Phenytoin or barbiturates (inducers of microsomal enzymes). All systemic medications. Prior Treatment: Excluded within 72 hours prior to study entry: Radiation therapy. Active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks prior to start of 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?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nystatin|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
-----------------
Nystatin, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Registry for Chronic Obstructive Pulmonary Disease With Sleep Apnea Hypopnea Syndrome in China

Study Overview
=================
Brief Summary
-----------------
COPD and sleep apnea dyspnea syndrome represent two of the most common chronic lung diseases. It is reported that the prevalence of COPD with sleep apnea dyspnea syndrome is also very high. COPD and sleep apnea may have pathological or genetics interactions so that patients having both disorders tend to have worse outcomes than either condition alone. Data reflecting the prevalence, disease course and outcome of overlap syndrome is very limited in China. Therefore, the aim of the study is to describe the prevalence, treatment and outcome in Chinese patients and exploring the underlying interaction mechanism.

Official Title
-----------------
The Prevalence, Disease Course, Prognosis and Interaction of Chronic Obstructive Pulmonary Disease With Sleep Apnea Hypopnea Syndrome

Conditions
-----------------
COPD, Sleep Apnea Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients with informed consent Exclusion Criteria: pregnant patients, patients with serious respiratory diseases other than COPD, patients with limited life expectancy, patients that can't coordinate well

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| COPD acute exacerbation | record the exacerbation events and related hospitalizations | 3 years |
Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
We randomized patients who received laparoscopic surgery for benign gynecologic disease into double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared the degree of postoperative nausea and vomiting in experimental and control groups.

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopy for benign gynecologic disease Exclusion Criteria: Vomiting within 24 hours before surgery Not using patient controlled analgesics postoperatively
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Single dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, placebo will be intravenously injected at 4 hours after surgery. | Drug: Ramosetron<br> <br> |
| Experimental: Experimental<br>Double dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, Ramosetron 0.3 mg will be intravenously injected at 4 hours after surgery. | Drug: Ramosetron<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response Rate | The percentage of patients who experienced neither nausea nor vomiting within 24 hours after surgery | Postoperative 24 hours |
Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer) whose cancer has progressed despite prior treatment.

Official Title
-----------------
A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment

Conditions
-----------------
Advanced Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Histological proven gastric adenocarcinoma Progressive disease during/ after prior treatment Treated with 1 or 2 chemotherapy regimen for advanced disease At least one measurable lesion by RECIST criteria Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion criteria: History of another primary malignancy within 3 years Treated with 3 or more regimens for advanced gastric cancer Chronic treatment with steroids or another immunosuppressive agent A known history of HIV or hepatitis B seropositive, or active hepatitis C infection Patients with active, bleeding diathesis Other protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAD001<br> | Drug: Everolimus<br>* 10 mg/day (2 tablets of 5 mg each)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) assessed by RECIST criteria |  | 18 months | 
| To assess progression free survival (PFS) and overall survival (OS) |  | 18 months | 
| To describe the safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0 |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RAD001, Gastric Cancer, mTOR
What Influences Patient Outcome in Obstructive Airway Disease?

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study is to utilise the established record linkage data available in Tayside to investigate hospital admissions, exacerbations and mortality in COPD.

Official Title
-----------------
Beta-Blockers Reduce Mortality and Exacerbations When Added to Stepwise Inhaled Therapy for COPD Without Adverse Effects on Lung Function.

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Data collected through TARDIS database Exclusion Criteria: History of asthma or malignancy. Less than 50 years of age

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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 |
| --- | --- |
| Beta Blocker Use<br> | |
| No beta blocker use<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality | All-cause Mortality | 3000 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Admissions | Hospital Admissions | 3000 days | 
| COPD exacerbations | COPD exacerbations | 3000 days |
Establishing Malnutrition Diagnosis System by Using Artificial-intelligence Technology

Study Overview
=================
Brief Summary
-----------------
The prevalence of malnutrition is estimated at 30-50% of hospitalized patients in China. Disease-related malnutrition increases the risk of infection, mortality, length of hospitalization as well as the economic burden. National Nutrition Plan proposed to reduce malnutrition, but a clear, effective roadmap and protocol has not existed yet. Several factors impede to resolve the above challenges. They include :1) the low efficiency of current malnutrition diagnosis methods; 2) the lack of dynamic, standard method that can evaluate nutritional status in quantitative way. To this end, the investigators aim to establish an artificial-intelligence malnutrition diagnosis system to improve the application of malnutrition Clinical Pathway. Firstly, the investigators will establish a multidimensional malnutrition large data set, based on our previously built national hospital nutrition screening data set. It will contain deep 3D facial images, semi-structured and structured electronic medical record. Then, the investigators will use ensemble learning algorithm to establish a fully automatic, artificial-intelligence malnutrition diagnosis model that includes both etiological and phenotypic diagnosis.

Official Title
-----------------
Establishing Malnutrition Diagnosis System by Using Artificial-intelligence Technology to Improve the Application of Clinical Pathway

Conditions
-----------------
Disease-related Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (≥18 years old); Within 48 hours of admission; Inpatients at high risk of malnutrition, such as malignant tumors, chronic obstructive pulmonary disease, etc; Han nationality; Able to given informed consent. Exclusion Criteria: Patients with artificial facial changes (such as plastic surgery , head and neck radiotherapy , head and neck trauma); Diseases with special facial changes (such as acromegaly); High dose glucocorticoid users; Patients with facial edema; Emergency admission with an expected length of stay of less than 3 days; Other conditions researchers thought could not be included

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| malnutrition diagnosis | Using Global Leadership Initiative on Malnutrition(GLIM) to diagnose malnutrition among hospitalized patients | Within 48 hours of admission |
The Acute Cardiovascular Effects of Marathon Running Using Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
Using blood testing and cardiac magnetic resonance imaging (MRI), the investigators aim to determine if there are necrotic areas of myocardium in participants who complete a marathon. In addition, the investigators aim to describe the acute and chronic structural abnormalities that occur as a result of endurance training. The study hypothesis is that myocardial necrosis is present in runners completing a marathon competition.

Detailed Description
-----------------
MARATHON-MI is a prospective, observational study of twenty-five (25) participants with plans of completing the Detroit Free Press Marathon in Detroit, Michigan on October 19, 2008. All participants will undergo a rigorous pre-marathon screening process which will include: 1) blood testing, 2) complete cardiopulmonary exercise testing, 3) ECG testing, 4) Holter monitoring, 5) cardiac MRI. Blood work will be check after the marathon immediately after and one day after the event. Cardiac MRI will be repeated within 12 hours of finishing the marathon. Using the information derived from the blood work and radiological testing, we will attempt to determine if there is an association between marathon running and myocardial necrosis.

Official Title
-----------------
The Acute Cardiovascular Effects of Marathon Running Using Magnetic Resonance Imaging

Conditions
-----------------
Myocardial Ischemia, Left Ventricular Systolic Dysfunction, Elevated Cardiac Enzymes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Detroit Free Press Marathon participant on October 19, 2008, Age > 18 years old, Ability to provide informed consent. Exclusion Criteria: Known coronary or structural heart disease Pregnancy, Extreme claustrophobia, Metal implants, Renal dysfunction.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Marathon Running, Cardiac Ischemia, Magnetic Resonance Imaging
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate whether an investigational monoclonal antibody, CT-011, is safe to give and if it helps patients with hepatitis C virus (HCV). Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Results of this trial will help doctors obtain additional information with regard to the safety and efficacy of CT-011 as a potential treatment for HCV.

Official Title
-----------------
Phase I/II Study to Evaluate the Safety and Tolerability of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: CT-011


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is between 18 and 60 years of age, both genders. Biopsy proven infection with Hepatitis C genotype 1. Positive for anti-HCV. Chronically infected for at least 3 months from diagnosis. ECOG performance status ≤ 1. Previous therapy with interferon +/- Ribavirin or Peginterferon +/- Ribavirin or ineligibility for this type of therapy or for liver transplantation. Exclusion Criteria: Patients who received any type of anti viral treatment during the 3 months prior to enrollment. Any history or active malignancy. History of major organ transplantation with an existing functional graft. Patients who received any systemic concurrent therapy within the last 4 weeks. Patients progressing to acute liver failure (ALF).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: CT-011<br> | Drug: CT-011<br>* CT-011<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Hepatitis C, HCV Genotype I infection, Liver disease