linjc16/ctgov huggingface dataset:
Metabolic Changes as a Diagnostic Indicator for Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims to determine whether metabolic changes occur in blood plasma of cancer patients, and whether these changes can be used as a biomarker to detect cancer. These analyses will be done by means of nuclear magnetic resonance (NMR) spectroscopy.

Official Title
-----------------
Metabolic Changes as a Diagnostic Indicator for Cancer

Conditions
-----------------
Breast Cancer, Lung Cancer

Intervention / Treatment
-----------------
* Other: Venous blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of breast or lung cancer (new lesion) Exclusion Criteria: Not fasted for at least 6 hours Plasma glucose concentration ≥ 200 mg/dl Intake of medication at the day of investigation History/treatment of cancer in the previous 5 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 |
| --- | --- |
| breast cancer patients<br> | Other: Venous blood sample<br>* Collection of a venous blood sample to investigate metabolic changes in blood<br>|
| lung cancer patients<br> | Other: Venous blood sample<br>* Collection of a venous blood sample to investigate metabolic changes in blood<br>|
| control subjects<br> | Other: Venous blood sample<br>* Collection of a venous blood sample to investigate metabolic changes in blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic phenotype of cancer | Significant metabolic changes in blood between cancer patients & control subjects | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NMR spectroscopy, metabolic changes, blood plasma, biomarker, cancer
Platelet Rich Fibrin Versus Melatonin Around Dental Implants

Study Overview
=================
Brief Summary
-----------------
Dental implant is a dental treatment that allow oral rehabilitation for partial and fully edentulous patients. Osteointegration is the factor that control success s or failure of dental implant that can be improved by addition of different adjunctive biological materials. Platelets Rich fibrin plays a significant role in tissue regeneration and wound healing. Melatonin is biological hormone that secreted from pineal gland and played an important role in human growth.

Official Title
-----------------
Evaluation of Local Delivered Platelet Rich Fibrin Versus Melatonin Gel on the Osseointegration of Dental Implant. A Randomized Controlled Clinical Trial

Conditions
-----------------
Patients With Missing Teeth

Intervention / Treatment
-----------------
* Biological: dental implants with melatonin gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good oral hygiene participants, free of any systemic diseases, Patients' age ranged from 20 to 40 years old. Patients who can complete surgery and the study protocol. Partially edentulous patients in the posterior mandibular region (at least a single-mandibular edentulous area) with periodontal health. Exclusion Criteria: patients who had parafunctional habits, current and former smokers, pregnant lactating women unmotivated patients patients with psychological problems patients who were not able to follow the treatment protocol -

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dental implants alone<br>dental implants alone | Biological: dental implants with melatonin gel<br>* platelet rich fibrin membrane around dental implants<br>* Other names: dental implants with platelet rich fibrin;|
| Active Comparator: platelet rich fibrin<br>dental implants with platelet rich fibrin membrane | Biological: dental implants with melatonin gel<br>* platelet rich fibrin membrane around dental implants<br>* Other names: dental implants with platelet rich fibrin;|
| Active Comparator: melatonin gel<br>dental implants with melatonin gel around dental implants | Biological: dental implants with melatonin gel<br>* platelet rich fibrin membrane around dental implants<br>* Other names: dental implants with platelet rich fibrin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gingival thickness |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone density |  | 6 months | 
| marginal bone loss |  | 6 months |
Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

Study Overview
=================
Brief Summary
-----------------
This is a Post-Marketing Surveillance (PMS) of Abilify Maintena® Injections in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: Ministry of Food and Drug Safety(MFDS) Notification).

Official Title
-----------------
Post-Marketing Surveillance of Safety and Effectiveness of Abilify Maintena® Injections in Korean Patients With Schizophrenia or Bipolar 1 Disorder Under the New Drug Re-Examination

Conditions
-----------------
Schizophrenia, Bipolar 1 Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with schizophrenia or bipolar 1 disorder Patients who are prescribed Abilify Maintena® Injections treatment as per investigator's medical judgment Patients giving written authorization to use their personal and health data and starting Abilify Maintena® Injections treatment after agreement is in place and investigators provide the explanation about objective and feature of the surveillance Exclusion Criteria: Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify Maintena® Injections Elderly patients with dementia related psychosis Patients who have been treated with Abilify Maintena® Injections Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the Clinical Global Impression-Severity(CGI-S) Patients participating in other clinical trial All patients who in medical judgment of the investigator would not be appropriate for inclusion criteria in the surveillance

Ages Eligible for Study
-----------------
Minimum Age: 19 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 incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR |  | until 28 days after discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to last visit in Clinical Global Impression - Severity of Illness scale (CGI-S) score. |  | at least 12, 24 weeks interval from baseline | 
| Clinical Global Impression - Improvement scale (CGI-I) score at the last visit |  | at least 12, 24 weeks interval from baseline | 
| Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score. |  | at least 12, 24 weeks interval from baseline | 
| Overall judgement at last visit compared to baseline, judged holistically according to clinical symptoms: Effective, No effect, Worsen |  | at least 12, 24 weeks interval from baseline |
Green Hospital Awareness

Study Overview
=================
Brief Summary
-----------------
Environmentally conscious hospitals plan their designs as green hospitals and aim to use resources efficiently. Green buildings are defined as buildings that respect nature, are ecological, comfortable and reduce energy consumption. The aim of our study is to investigate the awareness level and satisfaction of the employees of a small private hospital in the city center without a green hospital certificate regarding the green hospital elements.

Official Title
-----------------
Green Hospital Awareness Level and Satisfaction of Health Practitioners - A Private Hospital Experience in Turkey

Conditions
-----------------
Satisfaction, Personal

Intervention / Treatment
-----------------
* Behavioral: Awareness Level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consisting of health professionals and employees working in a small private hospital that does not have a green hospital certificate Exclusion Criteria: who refused to participate in the survey

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 |
| --- |
|Behavioral: Awareness Level|Demands and expectations about the green hospital were measured with a questionnaire applied to 287 people, consisting of health professionals and employees in a small private hospital that does not have a green hospital certificate in the province of Istanbul.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of awareness | A 5-point Likert type scal | 15 DAYS |
HCV Post-Exposure Prophylaxis for Health Care Workers

Study Overview
=================
Brief Summary
-----------------
This is an unblinded, observational trial of sofosbuvir-velpatasvir in adult health care workers who are exposed to hepatitis C virus from needlestick injury with hollow-bore needles.

Detailed Description
-----------------
The goal of this study is to assess the safety and tolerability of the use of sofosbuvir-velpatasvir in the setting of post-exposure prophylaxis among Health Care Workers exposed to HCV from needlestick injury with hollow-bore needles

Official Title
-----------------
Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers

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

Intervention / Treatment
-----------------
* Drug: Sofosbuvir/Velpatasvir Treatment for 14 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthcare worker with exposure through needlestick injury with hollow-bore needles to source patients who are HCV positive Healthcare worker must be HCV Ab- Exclusion Criteria: HCV Ab positive HCV Ab negative and HCV RNA greater than 1000 IU/ml Active malignancy Positive urine pregnancy test

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Sofosbuvir/Velpatasvir<br>14 days of treatment with Sofosbuvir/Velpatasvir tablet | Drug: Sofosbuvir/Velpatasvir Treatment for 14 days<br>* 14 day therapy with Sofosbuvir/Velpatasvir<br>* Other names: Epclusa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undetectable HCV RNA | Negative HCV viral RNA at 12 weeks after the last dose of treatment. | 12 weeks post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV, Needlestick
Multi-center Study on Surgical or Non-surgical Treatment for Children Type 1 Humeral Condyle Fracture

Study Overview
=================
Brief Summary
-----------------
The study evaluates the effectiveness of surgical or non-surgical treatment for children type 1 humeral condyle fracture.Half of the participants receive surgical treatment and the other half receive non-surgical treatment

Conditions
-----------------
Treatment for Type I Humeral Condyle Fracture

Intervention / Treatment
-----------------
* Procedure: Surgical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children Type 1 humeral Condyle Fracture，Fracture displacement less than 2mm Exclusion Criteria: Other type humeral Condyle Fracture

Ages Eligible for Study
-----------------
Maximum Age: 14 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 |
| --- | --- |
| Other: Bone healing<br>Bone healing in surgical or conservative treatment for children type 1 humeral condyle fracture | Procedure: Surgical treatment<br>* Closed reduction and Kirschner wire fixation<br>|
| Other: Fracture displacement<br>Fracture displacement in surgical or conservative treatment for children type 1 humeral condyle fracture | Procedure: Surgical treatment<br>* Closed reduction and Kirschner wire fixation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture displacement rate |  | 1 months | 
| Fracture healing rate |  | 3 years |
Short-Term Follow-up Indicator for Total Knee Arthroplasty and Body Mass Index

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to determine the influence of obesity on the short term follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee arthroplasty. It is a retrospective, comparative study The secondary purposes are to explore the links between length of stay and short-term follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee arthroplasty.

Official Title
-----------------
Impact of Elevated Body Mass Index on Short-term Follow-up Indicators for Total Knee Arthroplasty : a Retrospective Study

Conditions
-----------------
Total Knee Arthroplasty, Body Mass Index, Rehabilitation

Intervention / Treatment
-----------------
* Procedure: Rehabilitation after total knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted after total knee arthroplasty in Polyvalent Geriatric Rehabilitation Clinic during the january 2007/October 2016 period Exclusion Criteria: Uncompleted case file or case file anterior to 2007 ; Inter-current orthopedic complication ; Evolutive or inter-current pathology written in the case-file (neurologic affection, etc...).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BMI <30 kg.m-2<br>Patients with a BMI inferior to the obesity limit defined by the World Health Organization. | Procedure: Rehabilitation after total knee arthroplasty<br>* All the included patients followed a rehabilitation program in the Polyvalent Geriatric Rehabilitation Clinic after total knee arthroplasty.<br>|
| BMI >30 kg.m-2<br>Patients with a BMI superior to the obesity limit defined by the World Health Organization. | Procedure: Rehabilitation after total knee arthroplasty<br>* All the included patients followed a rehabilitation program in the Polyvalent Geriatric Rehabilitation Clinic after total knee arthroplasty.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index |  | 2 Month | 
| Range Of Motion of the Knee | The investigators will report the initial, final flexion and extension and calculate the total gain of flexion and extension of the knee for each participant. | 2 Month | 
| Age |  | 2 Month | 
| Mansat Score | This score is a composite score recommended by the French Authority of Health. | 2 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | The investigators will report the length of stay in the rehabilitation clinic for each participant. | 2 month |
Controlled Sedation for Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation

Detailed Description
-----------------
This is a double blind, randomized study which evaluates surgeon and patient´s satisfaction whom undergoes cataract surgery. The surgery was done under local anesthesia and sedation.

Official Title
-----------------
Dexmedetomidine vs. Remifentanil for Patient and Surgeon Satisfaction in Cataract Surgery Under Controlled Sedation

Conditions
-----------------
Failed Conscious Sedation During Procedure

Intervention / Treatment
-----------------
* Drug: remifentanil
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject has cataract, subject older than 18 years, local anesthesia and sedation. Exclusion Criteria: general anesthesia, history of consumption of sedatives.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remifentanil<br>remifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished. | Drug: remifentanil<br>* remifentanil, 0.25 ng/mL, given intravenous, infusion, until surgery finished<br>|
| Active Comparator: Dexmedetomidine<br>dexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished | Drug: Dexmedetomidine<br>* dexmedetomidine, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon and patient satisfaction | It was evaluated with an absolute numerical subjective scale from 1 to 7, where a score of 1 means total dissatisfaction, and 7 complete satisfaction. Scores were evaluated 30 minutes after surgery begun and at the end of the procedure. Results are presented in median and interquartile ranges. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Beats per minute (bpm) | Intraoperative | 
| Mean arterial pressure | Millimeters of mercury (mmHg) | Intraoperative | 
| Hemoglobin oxygen saturation | Oxygen saturation (%) | Intraoperative | 
| Surgery duration | Minutes | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedation, dexmedetomidine, remifentanil, cataract surgery, surgeon satisfaction, patient satisfaction
Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.

Study Overview
=================
Brief Summary
-----------------
Patients presenting to the emergency room with upper gastrointestinal bleeding and a Glasgow Blatchford score of zero will be randomly assigned to further care in the inpatient vs. outpatient setting. The hypothesis of this study is that patients who are managed as outpatients will require interventions at a rate not higher than those managed as inpatients and will have lower direct healthcare costs.

Official Title
-----------------
Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.

Conditions
-----------------
Upper Gastrointestinal Bleeding

Intervention / Treatment
-----------------
* Other: Outpatient Management of Low-risk Patients
* Other: Inpatient Management of Low-risk Patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood Urea Nitrogen < 18.2 mg/dl Hemoglobin ≥ 13.0 g/dl for men and ≥ 12.0 g/dl for women Systolic blood pressure ≥ 110 mm Hg Heart rate < 100 beats/min Exclusion Criteria: Inability to obtain informed consent Pregnancy History of liver disease History of heart failure Syncope that is temporally related to ongoing bleeding Melena Contraindication to proton pump inhibitor use Other conditions that necessitate inpatient evaluation. Inpatients with new onset of GI bleeding

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 |
| --- | --- |
| Active Comparator: Outpatient<br> | Other: Outpatient Management of Low-risk Patients<br>* Labs will be obtained within 2-3 days of discharge from ED Clinic visit will be scheduled within 3 days of discharge from ED EGD will be scheduled within 7 days of discharge from ED Phone follow-up at day 7 and 30<br>|
| Active Comparator: Inpatient<br> | Other: Inpatient Management of Low-risk Patients<br>* Labs will be obtained on day of discharge or day 2-3 EGD will be performed in the hospital Phone follow-up at day 7 and 30<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients requiring intervention for UGIB (endoscopic therapy, blood transfusion, surgery, interventional radiology) |  | Within 7 days of the index presentation to the emergency room |