linjc16/ctgov huggingface dataset:
Preoperative Psychological Evaluation as Predictor of Outcomes

Study Overview
=================
Brief Summary
-----------------
Perioperative psychological care is increasingly recognized as an essential part in the surgical environment. Previous studies have developed a strategy to evaluate the psychological influence after operations and found that postoperative psychological states significantly associated with the outcomes of patients. However, preoperative evaluation of patients the physicians do thus far is mainly the physical status assessment following the scale of American Society of Anesthesiologists (ASA). Whether a full-scale evaluation of preoperative psychological status to surgical patients could be a predictor to postoperative outcomes or not is not still completely understood. The investigators hypothesized that the preoperative psychological assessment would be an important predictor to outcomes.

Official Title
-----------------
Preoperative Psychological Evaluation as Predictor of Post-surgical Outcomes

Conditions
-----------------
Elective Surgery

Intervention / Treatment
-----------------
* Other: ASA scale
* Other: Full-scale psychological assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective surgical operation Age from 18-65 years Exclusion Criteria: Age <18 years or >65 years Not willing to participate in this study Patients from emergency department

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients assessed with ASA physical status scale | Other: ASA scale<br>* ASA scale evaluation before operation<br>|
| 2<br>Patients assessed with full-scale psychological factors | Other: Full-scale psychological assessment<br>* Full-scale psychological evaluation before operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of recovery |  | Since the end of the operation (1 day) to six-month follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative consumption of drugs |  | From the time of start of operation (0 min) to the end of the surgical procedures, this time will undergo alteration in different individuals | 
| Hospitalization days |  | Time length of staying at hospital from the day of inpatient to discharge home, this time will undergo alteration in different individuals | 
| Life quality |  | Since the end of the operation (1 day) to six-month follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychology, Postoperative outcome, Surgical Operation
Sleep Disordered Breathing, APOE, and Lipid Metabolism

Study Overview
=================
Brief Summary
-----------------
To examine the relationship between obstructive sleep apnea and lipid metabolism.

Detailed Description
-----------------
BACKGROUND: Recent findings suggest interrelationships between obstructive sleep apnea, lipid metabolism, and neurodegeneration. Apolipoprotein E epsilon4 (APOE e4), a genetic marker linked to increased cardiovascular disease (CVD) risk and Alzheimer's disease (AD), is associated with a two fold increased risk of sleep disordered breathing (SDB), and an increase in severity of apnea symptoms. Preliminary data suggest that this association is stronger between the ages of 50 and 65. Other experiments suggest dysregulated leptin levels in obstructive sleep apnea (OSA). Taken together, these findings suggest common pathophysiological mechanisms involving dysregulated lipid metabolism in OSA. An understanding of these mechanisms is essential for the prevention and treatment of SDB. DESIGN NARRATIVE: Using case/control and family designs, the study: 1) extends the finding that apolipoprotein E epsilon4 (APOE e4) increases the risk of sleep apnea in the general population; 2) examines if polymorphisms in other genes regulating lipid levels are associated with sleep apnea; 3) studies the relationship between lipid regulatory gene polymorphisms, lipid profile (LDL- cholesterol, HDL-cholesterol, triglycerides), plasma leptin (and other lipid regulatory hormones), and sleep apnea levels. T

Conditions
-----------------
Sleep Apnea Syndromes, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
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 |
| --- | --- | --- |
Antiarrhythmic Effects of N-3 Fatty Acids

Study Overview
=================
Brief Summary
-----------------
To determine the antiarrhythmic effects of dietary N-3 fatty acids in patients with implanted defibrillators.

Detailed Description
-----------------
BACKGROUND: Ventricular tachycardia (VT) and ventricular fibrillation (VF) are common causes of the 300,000 sudden deaths occurring in the United States each year. Most of these victims have associated heart disease, most commonly coronary artery disease. Populations consuming considerable quantities of fish and marine mammals have lower than expected mortality rates from coronary disease. Interventional and observational trials have indicated that fatty fish consumption decreases the death rate from coronary artery disease, in part by reducing the number of sudden deaths. Animal and tissue culture studies both support the hypothesis that these beneficial effects are from the antiarrhythmic properties of n-3 long chained polyunsaturated fatty acids (eicosapentaenoic and docosahexaenoic acids). DESIGN NARRATIVE: Prospective, randomized, double blinded trial. Survivors of VT and VF with an implantable defibrillator were randomized, 100 to dietary supplementation with n-3 polyunsaturated fatty acids(PUFA) or 100 to a placebo. Adherence to the supplement were assessed by measurements of plasma, red cell, and adipose tissue n-3 fatty acid concentrations. The primary outcome variable was the incidence of recurrent VT or VF, but secondary variables were also assessed using serial implantable cardioverter defibrillator (ICD) assessment, correlation of the rhythms with the biochemical measurements of n-3 fatty acids, hospitalization rates and quality of life. The (ICD) was the best protection available to patients and stored rhythm electrograms which allowed documentation of rhythm endpoints. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Arrhythmia, Heart Diseases, Tachycardia, Ventricular, Ventricular Fibrillation

Intervention / Treatment
-----------------
* Behavioral: dietary n-3 polyunsaturated fatty acids


Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: dietary n-3 polyunsaturated fatty acids|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
DP-R213 Phase 1 Pharmacokinetics Study

Study Overview
=================
Brief Summary
-----------------
A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.

Official Title
-----------------
An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Fixed Dose Combination of Raloxifen/Cholecalciferol Compared With Coadministration of Raloxifen and Cholecalciferol in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: DP-R213
* Drug: Raloxifene
* Drug: Cholecaliferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBW ±20% Signed the informed consent form prior to the study participation Exclusion Criteria: Clinically significant disease Previously donate whole blood within 2 months or component blood within 1 month Clinically significant allergic disease Taken IP in other trial within 3 months An impossible one who participates in clinical trial by investigator's decision including laboratory test result

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT group<br>combination dose of Raloxifene and Cholecaliferol and DP-R213 in order | Drug: DP-R213<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Raloxifene<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Cholecaliferol<br>* Investigational product is prescribed to all of randomized subjects<br>|
| Experimental: TR group<br>combination dose of Raloxifene and Cholecaliferol and DP-R213 in order | Drug: DP-R213<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Raloxifene<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Cholecaliferol<br>* Investigational product is prescribed to all of randomized subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) |  | up to 96 hours post dose | 
| Peak Plasma Concentration (Cmax) |  | up to 96 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DP-R213
Study Comparing Quantitative Assessments in Open-angle Glaucoma (OAG) and/or Ocular Hypertension (OHT)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate assessments from the Goniometric Lens compared with those from anterior segment imaging in patients with open-angle glaucoma (OAG) and/or ocular hypertension (OHT).

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Other: No Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open-angle glaucoma or ocular hypertension Exclusion Criteria: Allergy or sensitivity to diagnostic agents used in 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with OAG and/or OHT<br>Patients with OAG and/or OHT | Other: No Treatment<br>* No treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra- Examiner Agreement in Angle Width by Goniometric Lens | Intra-rater agreement (for each of the 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect. | Day 1 | 
| Inter- Examiner Agreement in Angle Width by Goniometric Lens | Inter-rater agreement (among 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect. | Day 1 |
TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN

Study Overview
=================
Brief Summary
-----------------
To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.

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

Intervention / Treatment
-----------------
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically proven squamous cell carcinoma of the head and neck with locally advanced inoperable disease. Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx , larynx or nasopharynx. Patients are required to have at least one (bi-or uni-dimensionally) measurable lesion. WHO performance status 0 or 1. Adequate bone marrow, hepatic and renal functions. Exclusion Criteria: Pregnant and lactating women Previous chemotherapy Previous radiotherapy for H&N Previous surgery for H&N The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed |  | After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic response if clinical response of primary tumor is CR at the end of chemotherapy and end of concurrent chemo/ radiotherapy, biopsy of primary tumor site will be performed to evaluate pathologic response rate. |  |  |
A Study of Tafetinib in Chinese Patients With Advanced Solid Tumor

Study Overview
=================
Brief Summary
-----------------
Tafetinib is an oral multitargeted tyrosine kinase inhibitor that inhibits Vascular Endothelial Growth Factor Receptor (VEGFR). This phase I trial was conducted to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of tafetinib in Chinese patients with advance solid tumor. The study are conducting in Cancer Hospital Chinese Academy of Medical Sciences.

Official Title
-----------------
A Phase I Study to Determine the Safety and Pharmacokinetic Study of Tafetinib in Patients With Advanced Solid Tumors

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: tafetinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with histologically confirmed advanced solid malignancies. ECOG score 0-1. 18-65 years old. Withdrawal other chemotherapy drugs more than 30 days. No nitrosoureas or mitomycin C within the previous 6 weeks. Function of organs must meet the following requirements: Neutrophil count ≥1500/ul; AST and ALT≤1.5 times the upper limit of normal (ULN); Total serum bilirubin≤1.5 times ULN; Hemoglobin≥90g/L; Platelet≥100000/ul; The creatinine in the normal range or creatinine clearance rate ≥60ml/min; Left ventricular ejection fraction (LVEF) ≥50%; Females of childbearing age are required to be practicing effective contraceptive measures and to have a negative serum or urine pregnancy test before study. Written informed consent is obtained. Exclusion Criteria: included a history of or current brain metastases, clinically significant cardiovascular disease or uncontrolled hypertension.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tafetinib<br>tafetinib administered daily for 2 weeks, followed by a 1-week off period | Drug: tafetinib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity | Dose-limiting toxicity was defined as any one of the following (NCI-CTCAE Version 4.0): (a) hypertension: uncontrollable grade 3 hypertensive or grade 4. (b) reduced LVEF: 2 degrees or above. (c) neutropenia : 3 degrees or above. (d) thrombopenia: 3 degrees or above. (e) Other Non-hematologic toxicity (not including alopecia, nausea or vomiting): 3 degrees or above. | 3 weeks |
Study to Evaluate Novel Gastric Space Occupying Device

Study Overview
=================
Brief Summary
-----------------
This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.

Official Title
-----------------
A Single Centre 30-day Observational Non-randomised Study to Evaluate Preliminary Safety and Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 21-64 years BMI 27-40 Kg/m2 No history of weight reduction of more than 5% of total body weight in the past 6 months Exclusion Criteria: Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity; Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure; Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months; Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin; History or symptoms of thyroid disease which is not controlled by medication; Have severe renal, hepatic, pulmonary disease or cancer; Past history of gastrointestinal surgery (excluding uncomplicated appendectomy); Have a history of adhesive peritonitis; History or symptoms of esophageal and/or gastric varices; Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula); History or symptoms of inflammatory bowel disease, such as Chron's disease; History of/ signs and /or symptoms of duodenal or gastric ulcer; Have gastroparesis; Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential); Currently using pharmaceutical agents for weight loss;

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 64 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
-----------------
medical device, space-occupying device
MK0686 in Postsurgery Dental Pain (0686-002)

Study Overview
=================
Brief Summary
-----------------
To compare the pain relieving effect of MK0686 to placebo or ibuprofen after dental surgery.

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: MK0686


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women ages 18-45 years who are scheduled to have 2 or more third molars (wisdom teeth) removed Patients must agree to remain in the clinic for 24 hours after surgery Exclusion Criteria: Patient has history of heart disease, asthma, pulmonary disease Patient must discontinue use of certain pain medicines 24-72 hours prior to the surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0686|nan|

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

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