linjc16/ctgov huggingface dataset:
Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that intramedullary nailing of the ulna and plating of the radius will result in a superior outcome as evidenced by two primary end points: a lower rate of implant pain a lower re-operation rate to remove painful hardware.

Detailed Description
-----------------
This is a prospective, randomized study to determine if intramedullary nailing of the ulna and plating of the radius is equal to, or superior to plating of both the radius and ulna for the treatment of both bone forearm fractures.

Official Title
-----------------
Prospective Randomized Trial for Forearm Shaft Fractures: Plating of Radius and Ulna vs. Plating of Radius and Nailing of Ulna

Conditions
-----------------
Fractures of Radius and Ulna

Intervention / Treatment
-----------------
* Procedure: intramedullary nailing and plating
* Procedure: plating


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diaphyseal fractures of both radius and ulna Ulna fractures that are oblique or transverse Fractures may be closed or Grade I-IIIA open Patients must be over 18 and skeletally mature Exclusion Criteria: Children under the age of 18 Pregnancy Comminuted ulna fractures Those with associated bony elbow or wrist trauma Elbow dislocation Subjects with bone pathology (osteoporosis, OI, Paget's disease, bone cancer)

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: intramedullary nailing and plating<br>intramedullary nailing of the ulna and plating of the radius in the treatment of both bone forearm fractures | Procedure: intramedullary nailing and plating<br>* Surgical intramedullary nailing of the ulna and plating of the radius<br>* Other names: forearm fractures;|
| Active Comparator: plating<br>plating of both the radius and ulna in the treatment of both bone forearm fractures | Procedure: plating<br>* Surgical plating of both bonforearm fractures<br>* Other names: Forearm fractures;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant pain | a visual analog scale (VAS) will be used to assess pain in the forearm | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-operation rate to remove painful hardware | repeat surgical intervention will be captured | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fractures of both radius and ulna
Does Muscle Wasting Always Mean Muscle Weakness? A Prevalence Study in COPD

Study Overview
=================
Brief Summary
-----------------
Peripheral muscle mass and strength are relevant indicators of COPD survival. Current guidelines recommend to assess muscle strength only in muscle wasted patients. However, a recent study reported quadriceps weakness without muscle wasting (Menon, M et al. Resp. Res.2012, 13:119). Thus, these guidelines raise the risk to miss out some weak patients. In clinical settings, fat-free-mass index (FFMI) is indicated as a simple index to assess muscle wasting. We aimed at determining the prevalence of patients entering in pulmonary rehabilitation (PR) a priori not eligible for muscle strength evaluation given the lack of muscle wasting clinical signs.

Official Title
-----------------
Does Muscle Wasting Always Mean Muscle Weakness? A Prevalence Study in COPD

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have got FFMI (bioimpedance) Patients who have done quadriceps muscle strenght evaluation Exclusion Criteria: Patients without FFMI Patients without quadriceps muscle strenght
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 |
| --- | --- | --- |
| Muscle wasting in COPD patient |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle weakness in COPD patient |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Experimental approaches, Peripheral muscle Keyword, Rehabilitation
Evaluation of Endobronchial Ultrasound (EBUS) for Staging Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study will compare two different methods of staging lung cancer to determine whether endobronchial ultrasound (EBUS) staging of mediastinal lymph nodes will provide good diagnostic yield in detecting lung cancer, when compared to current methods of a staging bronchoscopy and cervical mediastinoscopy.

Official Title
-----------------
Evaluation of Endobronchial Ultrasound (EBUS) for Staging Lung Cancer

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, > 18 years of age, Gender- Males and Female Diagnosis of Non Small Cell Lung Cancer. Patients who have consented on an Ottawa Hospital consent form to undergo a mediastinoscopy procedure or EBUS-TBNA, and a Positron emission tomography (PET) of the chest for lung cancer staging. Exclusion Criteria: Females who are pregnant (or found to be pregnant) during the course of this research study. Patients who do not provide their Ottawa Hospital consent to undergo a staging bronchoscopy , cervical mediastinoscopy or EBUS-TBNA.

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 |
| --- | --- |
| Cervical mediastinoscopy<br>This group will undergo cervical mediastinoscopy before surgery to stage their lung cancer (procedure decided by the surgeon). | |
| Endo-bronchial ultrasound<br>This group will undergo endobronchial ultrasound before surgery to stage their lung cancer (procedure decided by the surgeon). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung cancer staging | Lung cancer staging (assessed by either cervical mediastinoscopy or EBUS) will be compared both pre-op and post-op. | Pre-op and post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Cervical mediastinoscopy, Endobronchial ultrasound, Staging
Study on VCD/IE in the Patients With Ewing's Sarcoma Family of Tumors (ESFT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial was to evaluate the efficacy and tolerability of the sequential therapy of VCD/IE in the patients with ESFT.

Detailed Description
-----------------
80-90% patients of ESFT will develope disease progression during the period of local treatment (surgery or radiation). The survival has been improved in these 30 years due to chemotherapy. VCD/IE is widely used in the world for the patients with ESFT, but it is rarely used in China due to its high dosage.

Official Title
-----------------
Phase II Study of VCD/IE in the Treatment of the Patients With Ewing's Sarcoma Family of Tumors

Conditions
-----------------
Ewing's Sarcoma

Intervention / Treatment
-----------------
* Drug: VCR, CTX, ADM; IFO, VP-16


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range 10-65 years old Histological confirmed ESFT No previous therapy ECOG performance status less than 2 Life expectancy of more than 12 weeks Normal laboratory values: hemoglobin>8.0g/dl, neutrophil>2×109/L, platelet > 80×109/L, Hb > 80×1012/L, serum creatine < 1×upper limitation of normal(ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN Exclusion Criteria: Pregnant or lactating women Received treatment for the disease previously Serious uncontrolled diseases and intercurrent infection The evidence of CNS metastasis and bone marrow involvement History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix History of allergy to the drugs in this trial Abnormal LVEF level

Ages Eligible for Study
-----------------
Minimum Age: 10 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: VCR, CTX, ADM; IFO, VP-16<br>* VCD: VCR 2 mg d1, CTX 1200 mg/m2 d1, Mesna 240 mg/m2 tid d1, ADM 75mg/m2 d1, G-CSF 300 ug/d d5-11; IE: IFO 1800mg/m2 d1-5,Mesna 360 mg/m2 tid d1-5,VP-16 100 mg/m2 d1-5,G-CSF 300 ug/d d6-12; q3w. Surgery or radiation will be done to the patients with local diseases after four cycles of VCD/IE.<br>* Other names: VCD/IE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | every two cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | every cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESFT (Ewing's sarcoma family of tumors), Response rate, TTP, OS, Toxicity
Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin

Study Overview
=================
Brief Summary
-----------------
Estradiol valerate in the form of cycloprogenova™ (white tablet only) was started on day 2 or 3 of cycle with oral dose 4 mg divided on 2 doses in addition to Aspocid 75 mg once daily with folic acid 500 mcg once daily.

Detailed Description
-----------------
U/S was done on day 9 or 10 of cycle to assess endometrial thickness, then every other day until endometrial thickness of 8 mm or more is reached and when endometrial thickness reaches 8 mm or more FET was planned. Progesterone in the form of prontogest™ 400 mg vaginal suppository twice dTwo to Four Day 5 Embryos was transferred

Official Title
-----------------
Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin in IVF Cycles

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Agonist (decapeptyl )
* Drug: HCG ( eg. Choriomon )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOS patients according to Rotterdam criteria Female age between 20 and 40 years. Primary or secondary infertility. Body mass index (BMI) between 18 and 40 kg/m2. Exclusion Criteria: Ovarian endometriosis. Ovarian cysts before induction. Known uncontrolled endocrinal abnormalities (like hypo or hyperthyroidism)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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: giving agonist ( eg. decapeptyl )<br>Giving women agonist | Drug: Agonist (decapeptyl )<br>* giving agonist<br>|
| Active Comparator: Giving HCG (eg. choriomon )<br>Giving women HCG | Drug: HCG ( eg. Choriomon )<br>* giving HCG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of good quality embryos | how many good quality embryos | within 5 months |
A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin

Study Overview
=================
Brief Summary
-----------------
This is a single cohort observational safety study. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. Data will be collected from centre's medical records for up to 5 years or death.

Official Title
-----------------
An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin

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

Intervention / Treatment
-----------------
* Drug: trastuzumab [Herceptin]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who are considered candidates to receive Herceptin for this indication Exclusion Criteria: Patients for whom Herceptin is contraindicated

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> | Drug: trastuzumab [Herceptin]<br>* There is no planned investigational product or a treatment regimen prescribed by this protocol. Decision about a treatment regimen will be made according to the local practice and in the best interest of individual patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death |  | On treatment and up to 5 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset and the time to recovery of symptomatic congestive heart failure |  | On treatment and up to 5 years follow-up | 
| Incidence of asymptomatic cardiac failure and other significant cardiac conditions |  | On treatment and up to 5 years follow-up |
Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Examining biomarkers in abnormal cervical cells may improve the ability to detect these cells and plan effective treatment. PURPOSE: Diagnostic trial to detect specific biomarkers in abnormal cervical cells in women who have abnormal Pap test results.

Detailed Description
-----------------
OBJECTIVES: I. Compare the detection of transferrin receptor, epidermal growth factor receptor, and the MaTu-MN protein in exfoliated cervical epithelial cells from women with abnormal Pap test using fluorescent labeled antibody probe vs histology. OUTLINE: Patients undergo a Pap test and a colposcopy. Cervical epithelial cells are collected from the most abnormal appearing lesion. Cells are examined for molecular markers using a fluorescent antibody test. The presence or absence of these markers is compared to results of the Pap test and the histology of the cells. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 6 months.

Official Title
-----------------
Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Other: Papanicolaou test
* Other: cytology specimen collection procedure
* Other: fluorescent antibody technique
* Procedure: colposcopic biopsy
* Procedure: study of high risk factors


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of abnormal Pap test, as indicated by one of the following: Atypical squamous cells of undetermined significance (ASCUS) Low grade squamous intraepithelial lesion (LGSIL) High grade squamous intraepithelial lesion (HGSIL) Visible lesion on cervix by colposcopy PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-4 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Pregnant or nursing women allowed PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior pelvic irradiation Surgery: No prior total hysterectomy
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Papanicolaou test|nan|
|Other: cytology specimen collection procedure|nan|
|Other: fluorescent antibody technique|nan|
|Procedure: colposcopic biopsy|nan|
|Procedure: study of high risk factors|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
-----------------
cervical cancer
Sildenafil For Meniere's Disease

Study Overview
=================
Brief Summary
-----------------
Meniere's disease affects a person's sense of balance. An attack can last 20 minutes to 2 hours or longer. Symptoms include rotational vertigo, hearing loss, tinnitus and a sensation of fullness in the affected ear and may be associated with nausea and vomiting. One hypothesis is that Meniere's disease is caused by the excessive accumulation of fluid in the balance tubes within the inner ear. Sildenafil may alleviate the symptoms due to its vasodilatory activity. The purpose of this study is to assess the safety and efficacy of sildenafil (Viagra) compared with placebo on symptoms during one acute attack.

Official Title
-----------------
A Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study Of The Efficacy and Safety Of Sildenafil Given For The Acute Treatment Of Meniere's Disease

Conditions
-----------------
Meniere's Disease

Intervention / Treatment
-----------------
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active Meniere's disease (2 or more definitive spontaneous episodes of vertigo 20 minutes or longer, plus hearing loss on at least 1 occasion, tinnitus or aural fullness) with confirmed diagnosis Exclusion Criteria: Pregnant or breast feeding females or fertile females unwilling to use agreed contraceptive methods severe Meniere's diseased (more than 8 attacks per month) previous ear surgery intratympanic perfusions of steroids or gentamicin; requiring other medications contraindicated for Viagra (eg. nitrates) with medical conditions that make Viagra contraindicated

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertigo Response (4 x 6 point scale); Balance (6 point scale) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing/Tinnitus; Ear, Nose & Pressure/Fullness; Perf. daily activities; Nausea; Vomiting; Func. Response; Duration of the Attack and Vertigo; Rescue Medications Use; Acceptability to subject; Composite Assessment Score; Comparison to Previous Attack |  |  |
Korean Post-marketing Surveillance for Reyataz®

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Reyataz® so that the regulatory authority can manage the marketing approval properly

Official Title
-----------------
Korean Post-marketing Surveillance for Reyataz®

Conditions
-----------------
HIV-1

Intervention / Treatment
-----------------
* Drug: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA Exclusion Criteria: According to Warning/Caution in local label
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 ≥ 13 years of age with HIV-1<br>Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA | Drug: No Intervention<br>* Patients are previously on Reyataz® treatment or initiated Reyataz® for the first time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events occurrence | Incidence (per person-time) and confidence interval of overall adverse events and each adverse event will be computed per surveillance period | 30 days after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) level before and after drug administration |  | Baseline and 16 weeks after first treatment | 
| CD 4 T-cell count before and after drug administration |  | Baseline and 16 weeks after first treatment | 
| Overall efficacy evaluation by investigator's discretion | Based on laboratory test results including HIV RNA (viral load) and CD4 T-cell count, clinical findings, subjective findings and objective findings in comparison to baseline | Baseline and 16 weeks after first treatment |