linjc16/ctgov huggingface dataset:
The New Strategy for Pharmacological Treatment in People With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Switching from Risperidone to Aripiprazole in early stage of pharmacotherapy will demonstrate the same efficacy as compared to risperidone continuation treatment in the treatment of schizophrenia.

Detailed Description
-----------------
It has been thought that D2 Blocking agent is necessary in acute as well as maintenance phase of pharmacological treatment of patients with schizophrenia. However, this classical strategy produces long term adverse events of drug such as TD, osteoporosis and some metabolic syndrome. To overcome these adverse events, new strategy for pharmacological treatment is needed.

Official Title
-----------------
Switch Risperidone to Aripiprazole in Early Stage of Pharmacotherapy of Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Rispridoen and Aripiprazole
* Drug: Risperidne
* Drug: Abilify


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia, DSM-IV Acute phase Exclusion Criteria: Refractory Schizophrenia Substance Abuse High risk for suicide

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aripiprazole<br>switching group (from risperidone to aripiprazole) | Drug: Rispridoen and Aripiprazole<br>* Start with risperidone and switch it to aripiprazole. Flexible dose<br>|
| Active Comparator: Risperidone<br>Start with risperidone and keep it through the end of study | Drug: Risperidne<br>* Start with risperidne and keep it through the end of study. Risperidne:flexible dose<br>|
| Active Comparator: Abilify<br>Start with aripiprazole and keep it through the end of study | Drug: Abilify<br>* Start with abilify and keep it through the end of study<br>* Other names: abilify is a generic name of aripiprazole;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SANS(Scale for the Assessment of Negative Symptoms) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS(Simpson-Angus Rating Scale) |  | 12 weeks | 
| Drug Attitude Inventory |  | 12 weeks | 
| Side effect checklist |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Switching, Early stage, Risperidone, Aripirazole
The Effect of Dexmedetomidine on Postoperative Analgesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether additional Dexmedetomidine to patient controlled analgesia can reduce fentanyl consumption.

Official Title
-----------------
Assessment of the Effect of Dexmedetomidine in the Management of Postoperative Pain When Combined With Fentanyl in the Patient-controlled Analgesia

Conditions
-----------------
Colon Cancer, Rectal Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery for colon cancer Exclusion Criteria: Liver disease Kidney disease Allergy for study drugs Inability to receive patient controlled analgesia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: F<br>Fentanyl+Normal saline | Drug: Fentanyl<br>* Fentanyl 2500mcg+NS50ml<br>|
| Experimental: D<br>Fentanyl+Dexmedetomidine | Drug: Dexmedetomidine<br>* Fentanyl 2500mcg+Dexmedetomidine 500mcg + NS 45ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total amount of administered fentanyl |  | during first 24 hours after surgery |
DIALOOG: Crestor in Patients With Diabetes Mellitus Type 2: Lowering of LDL-C Levels to New European Guidelines

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine in DM II patients the efficacy of Crestor in obtaining the new European LDL cholesterol guidelines.

Official Title
-----------------
DIALOOG: Crestor in Patients With Diabetes Mellitus Type 2: Lowering of LDL-C Levels to New European Guidelines

Conditions
-----------------
Diabetes Mellitus Type 2, Crestor, Rosuvastatin, LDL Cholesterol, Observational

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Mellitus Type 2, LDL-C > 2,5 mmol/l, no cholesterol lowering medication used last 3 months, starts with Crestor 10 mg, permission to use patient data by AZ

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Novel Method of Clipped Axillary Lymph Node Localization Post Neoadjuvant Chemotherapy in Breast Cancer Patients .

Study Overview
=================
Brief Summary
-----------------
to determine the feasibility of a novel technique of localization of clipped LN post neoadjuvant chemotherapy

Official Title
-----------------
Feasibility of a Novel Method of Axilla Staging by Using Ultrasound Visible Clips to Mark the Involved Axillary Lymph Nodes Before Neoadjuvant Chemotherapy in Breast Cancer Patients

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Procedure: skin marking of clip axillary lymph node for localisation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer patients with involved axillary LN <3, going for neoadjuvant chemotherapy Exclusion Criteria: -stage 4 breast cancer patients

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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: skin marking of clipped axillary LN<br>all eligible patients underwent skin marking of their clipped axillary LN post neoadjuvant chemotherapy to determine the retrieval rate of the clipped nodes | Procedure: skin marking of clip axillary lymph node for localisation<br>* to determine the feasibility of skin marking to localize clipped ln<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retrieval rates of the clipped node using this novel technique |  | at an average of a year |
Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants

Study Overview
=================
Brief Summary
-----------------
Serious adverse events in patients treated with new oral anticoagulants are underreported.

Detailed Description
-----------------
The study investigates if serious adverse events in patients treated with NOAC are reported to the Health and Medicines Authority.

Official Title
-----------------
Serious Adverse Events in Patients Treated With New Oral Anticoagulants Are Underreported

Conditions
-----------------
Bleeding as Complication to Anticoagulation Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted for GI bleeding while in treatment with NOAC Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NOAC<br>Patients admitted for GI bleeding while in treatment with NOAC | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients admitted with adverse event reported to authorities |  | Within one year of admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bleeding, Anticoagulation
Magnetic Resonance Imaging (MRI) in Asymptomatic Patients With Juvenile Idiopathic Arthritis (JIA)

Study Overview
=================
Brief Summary
-----------------
Juvenile idiopathic arthritis (JIA) may progress asymptomatically leading to joint destruction despite treatment. The aim of the observational study is to describe patients with silent arthritis comparing symptoms, clinical findings with results of ultrasound and magnetic resonance imaging (MRI).

Official Title
-----------------
Diagnostic Value of MRI and Ultrasound in Patients With JIA

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Procedure: intra-articular steroid injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children without symptoms or with only mild joints swelling or with only minimal limited range of motion Exclusion Criteria: patients with manifest arthritis

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 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 |
| --- | --- |
| JIA<br>Patients with JIA | Procedure: intra-articular steroid injection<br>* Steroid injection into otherwise noncontrollable arthritis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definition of patients with silent arthritis. |  | every three to six months from recruitment to end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of diagnostic value of MRI and ultrasound. |  | every three to six months from recruitment to end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
JIA
Treatment of Mild and Moderate Cases of Gynaecomastia

Study Overview
=================
Brief Summary
-----------------
This study aims to compare liposuction and periareolar surgical excision in mild and moderate cases of gynecomastia as regard cosmosis, complications, patient satisfaction, operation time, and hospital stay. This study will be carried out on patients with gynecomastia presented to the Plastic Surgery Department, Sohag University, in the period between January 2021 to January 2022 as a retrospective and prospective study. Patients will be divided into 2 groups: group A treated with suction-assisted liposuction. group B treated with peri-areolar surgical excision. Each group contains 20 patients.

Official Title
-----------------
Comparison Between Liposuction and Peri-areolar Surgical Excision in Mild and Moderate Cases of Gynaecomastia

Conditions
-----------------
Gynecomastia

Intervention / Treatment
-----------------
* Procedure: liposuction
* Procedure: surgical excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - The age of patients ranges from 18-60yrs. Mild and moderate cases of gynecomastia. Exclusion Criteria: Patients with endocrine causes. Patients with genetic causes. Severe cases of gynecomastia. Patients who refused surgical intervention. Patients who are not fit for surgery. Patients with chronic illness.

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

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

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: liposuction<br>group A will be treated with liposuction | Procedure: liposuction<br>* suction-assisted liposuction<br>|
| Active Comparator: periareolar surgical excision<br>Group B will be treated with periareolar surgical excision | Procedure: surgical excision<br>* periareolar surgical excision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between group A and B in aesthetic satisfaction | A 100 -point visual analogue scale (VAS) for the assessment of aesthetic satisfaction with 0 as the worst cosmosis and 100 as the best aesthetic result With filled standardized charts. | difference between group A and B in aesthetic results according to visual analogue scale at 3 month post-operative |
Study of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact Dermatitis

Study Overview
=================
Brief Summary
-----------------
A study of subjects with a known nickel allergy comparing Tacrolimus to placebo, both associated with nickel patches to determine the safety and efficacy of treating Chronic Allergic Contact Dermatitis with Tacrolimus Ointment

Official Title
-----------------
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Trial to Assess the Safety and Efficacy of 0.1% Tacrolimus Ointment in the Treatment of Chronic Allergic Contact Dermatitis

Conditions
-----------------
Dermatitis

Intervention / Treatment
-----------------
* Drug: tacrolimus ointment
* Drug: placebo ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a history of allergy to nickel Exclusion Criteria: Subject is pregnant or lactating Subject fails to react to the nickel disks (grade 0), reacts with a questionable (grade 1) or extreme (grade 4) reaction or the subject's reactions on the left and right arms are not of the same grade of intensity Subject has a known hypersensitivity to any component of the test medications Subject has any other significant dermatological condition that affects >10% of the body surface area or general medical condition that could interfere with the study evaluation Subject has any significant medical condition that could compromise immune responsiveness

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tacrolimus ointment<br>* topical<br>* Other names: FK506 ointment;|
| Placebo Comparator: 2<br> | Drug: placebo ointment<br>* topical<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success using the Physician's Global Assessment (PGA) |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator and subject ACD Sign and Symptoms |  | 8 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Allergic Contact Dermatitis, Protopic
Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate the interest of the recourse of a staff dedicated as CRA to data collection in clinical research

Detailed Description
-----------------
Objectives of clinical studies are notably to evaluate new therapies, to improve diagnostic techniques, to make medico-economic decisions and to enrich scientific knowledge. Clinical studies findings can influence medical practice, or even motivate decisions by public health authorities. The rigor in their behavior is therefore an imperative to respect. Thus, the quality of the data collected is essential. However, even if the reliability of the clinical data is guaranteed by the monitoring, the completeness of the data remains exceptional. The increase of data required in clinical studies has led to the emergence of a specialized staff to assist investigators: the clinical research assistants. With dedicated time and specialization in data collection, they facilitate the conduct of clinical studies. However, this data collection aid has not been evaluated.

Official Title
-----------------
Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff

Conditions
-----------------
Clinical Research Inclusion

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - clinical research visit performed in Reims university hospital between January 2010 and January 2015

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 |
| --- | --- |
| clinical research visit<br> | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Missing data | Data was considered missing because of its absence when finalizing the data | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
missing data, clinical research, clinical research assistant
Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: bepotastine besilate nasal product - low dose
* Drug: bepotastine besilate nasal product - medium dose
* Drug: bepotastine besilate nasal product - high dose
* Drug: placebo comparator nasal product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen Exclusion Criteria: No active respiratory tract infection

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - Low Dose<br>bepotastine besilate nasal product - low dose | Drug: bepotastine besilate nasal product - low dose<br>* sterile nasal product<br>|
| Experimental: Arm 2 - Medium Dose<br>bepotastine besilate nasal product - medium dose | Drug: bepotastine besilate nasal product - medium dose<br>* sterile nasal product<br>|
| Experimental: Arm 3 - High Dose<br>bepotastine besilate nasal product - high dose | Drug: bepotastine besilate nasal product - high dose<br>* sterile nasal product<br>|
| Placebo Comparator: Arm 4 - Placebo<br>placebo comparator nasal product | Drug: placebo comparator nasal product<br>* sterile nasal product<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS | Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a maximum score for increased allergic response of 12 units. The minimum possible total score was 0. | Baseline, 20 days |