linjc16/ctgov huggingface dataset:
The Efficacy of Vocal Function Exercises for Laryngeal Cancers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the systematic practice of Vocal Function Exercises (VFE) improves selected measures of voice production in participants who have previously been irradiated for early glottic cancers compared to participants who receive the present standard of care, namely, vocal hygiene counseling. It is hypothesized that a prescriptive vocal exercise program (VFE) will improve the voice production of individuals who have been previously treated for laryngeal cancers when compared to participants who receive vocal hygiene alone.

Official Title
-----------------
Investigating the Efficacy of Vocal Function Exercises in the Treatment of Voice Problems in Adults Treated With Radiation Therapy for Laryngeal Cancers

Conditions
-----------------
Vocal Folds

Intervention / Treatment
-----------------
* Procedure: Vocal Function Exercises
* Procedure: Vocal Hygiene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hearing level and cognitive ability to follow test directions Laryngeal cancer Radiation Therapy completed >= 6 months Deemed disease free by the treating physician Subjects have to be willing to attend weekly voice therapy sessions Exclusion Criteria: Adjuvant treatment: laser or any surgical intervention Neurological or cognitive impairment Hearing levels that interfere with following test instruction Vocal fold paralysis

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vocal Function Exercises<br>Vocal Function Exercises | Procedure: Vocal Function Exercises<br>* Vocal Function Exercises<br>|
| Active Comparator: Vocal hygiene<br>Vocal hygiene | Procedure: Vocal Hygiene<br>* Vocal Hygiene<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice production | Voice Handicap Index, a validated self- assessment tool was used as the primary outcome measure. A score of 0 indicates no handicap, and a score of 120 indicates complete impairment. Data will be presented as pre and post treatment score (pre and post 6 weeks of therapy). | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation therapy, laryngeal cancer, voice therapy, vocal function exercises
Gastroprotective Agent Utilization and Compliance in Patients > 60 Years Taking Low-dose Aspirin in France

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess in general population low-dose aspirin and gastroprotective agent compliance and reasons for bad compliance

Official Title
-----------------
Gastroprotective Agent Utilization and Compliance in Patients > 60 Years Taking Low-dose Aspirin in France

Conditions
-----------------
Self-administered Questionnaire to Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: French people > 60 years old, part of Kantar Health Access Sant� panel Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| low-dose aspirin and gastroprotective treatment compliance (Girerd questionnaire: a 6-item self-administered and validated questionnaire to evaluate adherence to treatments) |  | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Compliance, France
A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.

Official Title
-----------------
An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.

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

Intervention / Treatment
-----------------
* Drug: RG1507
* Drug: Letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal female patients; stage IV or locally advanced breast cancer; measurable disease; letrozole failure (Part 2); Eastern Cooperative Oncology Group (ECOG) performance status <=2. Exclusion Criteria: previous chemotherapy for metastatic breast cancer; concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug; history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix; concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: R1507 in Combination With Letrozole<br>Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment. | Drug: RG1507<br>* R1507 was administered at a dose 16 mg/kg every 3 weeks.<br>Drug: Letrozole<br>* Letrozole was administered orally at a dose 2.5 mg daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Tumor Response (Part 2) |  | Up to 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) Profile (Part 2) |  | Up to 14 months | 
| Progression-free Survival (Part 2) |  | Up to 14 months | 
| Number of Participants With Adverse Events (Part 2) |  | Up to 14 months |
To Demonstrate the Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc)
* Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Promethazine HCl 50 mg Tablets (Sandoz, Inc) | Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc)<br> <br> |
| Active Comparator: 2<br>Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) | Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 12 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antihistamine
US-Doppler and Procoagulant Microparticles for the Diagnosis of Asymptomatic DVT in Advanced Cancer Patients With Poor Performance Status

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT detected by US-Doppler and procoagulant microparticles in a selected group of cancer patients suffering from an advanced stage of the disease. An attempt will be made to determine whether there is a correlation between this prevalence and various clinical and laboratory parameters.

Detailed Description
-----------------
The association between malignancy and venous thromboembolism(VTE) is well known. VTE is one of the most common complications seen in cancer patients Early detection of VTE can identify patients who may benefit from anticoagulant therapy and prevent morbidity and mortality. There are recommendations for hospitalized cancer patients who are bedridden with an acute medical illness to receive prophylaxis, but in practice this is not clear cut.It has been shown, in other selected groups of patients that Ultrasound Doppler can be used in order to diagnose asymptomatic DVT (deep vein thrombosis). Hematological coagulation tests, including procoagulant microparticles will be performed for the evaluation of coagulation profile, in order to evaluate the possible correlation between the prevalence of asymptomatic DVT and these laboratory parameters.

Official Title
-----------------
US-Doppler and Procoagulant Microparticles for the Diagnosis of Asymptomatic DVT in Advanced Cancer Patients With Poor Performance Status

Conditions
-----------------
Deep Vein Thrombosis, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer patients with an advanced stage of the disease, hospitalized in the oncology department. WHO performance status of 3( i.e. spends more than half his/her time in bed or seated) - or 4 ( i.e. completely confined to bed or to chair) : for at least a week; according to the treating physician, the poor performance status results from advanced malignancy. Patient is asymptomatic for lower extremity DVT according to the treating physician Exclusion Criteria: major surgery during more than a month, from the time of investigation anticoagulant therapy for more than one month, from the time of investigation

Ages Eligible for Study
-----------------
Minimum Age: 18 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
-----------------
Deep Vein Thrombosis, Cancer, US- Doppler, Procoagulant Microparticles, Asymptomatic
Circulatory Oscillations in Post Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
In this observational study investigators examine the presence of circulatory oscillations in blood pressure, heart rate, and doppler laser flow before and after planned cardiac surgery.

Official Title
-----------------
Circulatory Oscillations in Post Cardiac Surgery Patients

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Procedure: Heart surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for routine coronary artery bypass graft (CABG) surgery, single procedure only Exclusion Criteria: no sinus or pacemaker rhythm ejection fraction below 0.5 serious valvular disease right ventricular failure pulmonary hypertension serious postoperative 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Heart surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and amplitude of oscillations of electrocardiogram (ECG) | analyzed by continuous wavelet transform | First day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood circulation, Cardiac surgical procedures, Homeostasis
Antipsychotic Response in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Motor slowing is a hallmark, clinical sign in mental illness. Slowness can be related to a specific disease process, as in negative schizophrenia or depression or it can be the result of medications used to treat forms of mental illness. Prior research has lead to a novel instrumental approach for distinguishing subtypes of motor slowing - one type related to cognitive processes and another related to parkinsonism. The purpose of this study is to test whether new medications used to treat schizophrenia improve the cognitive or parkinsonian components of motor slowing. Patients will be studied in the laboratory before and 8-weeks after starting a new antipsychotic. The n of this study = 60 patients. The results of this study will improve our understanding of the complex interactions between cognitive processing and motor behavior in patients with psychotic illnesses and how drugs work to treat these problems.

Official Title
-----------------
Psychopharmacologic Aspects of Motor Slowing in Schizophrenia

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

Intervention / Treatment
-----------------
* Drug: Risperidone
* Drug: Olanzapine
* Drug: Quetiapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Schizophrenia diagnosis currently treated with conventional antipsychotic willing to be switched to an atypical antipsychotic.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risperidone|nan|
|Drug: Olanzapine|nan|
|Drug: Quetiapine|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
-----------------
Antipsychotics, schizophrenia, motor retardation, bradykinesia
Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation

Study Overview
=================
Brief Summary
-----------------
Bronchiolitis obliterans syndrome (BOS), an obstructive airway disease as a result of chronic rejection, is one of the major causes of morbidity and mortality in long-term survivors of allogeneic bone marrow transplantation (BMT). Although augmentation of immunosuppressive treatment might help but the only effective treatment for BOS is by lung transplantation. Macrolide antibiotics, which have been licensed to use as antibacterial agents for decades, have been found to have immunomodulatory properties in addition to their antibacterial activity. Low dose Azithromycin, an antibiotic of the macrolide family, has been shown to have promising result in a pilot study in treating BOS associated with lung transplantation. We propose to perform a prospective, randomised, double blind study to test the efficacy of Azithromycin in treating BOS after BMT. Patients with proven BOS after BMT will be randomised into two groups based on lung function parameters. One group will receive low dose Azithromycin while placebo will be provided for the other group. Lung function will be serially monitored at 3 month, 6 months and 12 months after commencement of treatment with drug/placebo. If Azithromycin was proven effective in treating BOS then all patient with proven BOS should be treated with this drug.

Official Title
-----------------
Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation

Conditions
-----------------
Bronchiolitis Obliterans, Bone Marrow Transplantation

Intervention / Treatment
-----------------
* Drug: Azithromycin
* Drug: Placebo tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed BOS post BMT Informed consent Exclusion Criteria: Women currently pregnant or nursing Allergy to macrolide

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

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

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: Azithromycin|nan|
|Drug: Placebo tablet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment by questionnaires |  | 3 months after treatment | 
| Spirometry |  | 3 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchiolitis obliterans in bone marrow transplant recipients
Phoniatric Evaluation and Comparison of Patients Who Underwent Sutureless Thyroidectomy With Vessel Closure Devices and Conventional Total Thyroidectomy With Suture

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare effect of sutureless thyroidectomy with vessel closure devices and conventional thyroidectomy with suturing on voice quality with phoniatric evaluation.

Official Title
-----------------
Phoniatric Evaluation and Comparison of Patients Who Underwent Sutureless Thyroidectomy With Vessel Closure Devices and Conventional Total Thyroidectomy With Suture

Conditions
-----------------
Phoniatric Evaluation of Total Thyroidectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Pre-operative voice problems Pre-operative vocal cord paralysis Singers and teachers Pre-operative known advanced stage malignity Previously operated for thyroid diseases.

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 |
| --- | --- |
| Ligasure LF1212<br> | |
| Ultracision<br> | |
| Conventional<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice quality change in relation with operative technique | Voice quality change between postoperative 1st week and 2nd month in relation with operative technique (either sutureless (with Ligasure or Ultracision) or conventional technique) via Voice handicap index, videolaryngostroboscope, CSL MDVP advanced software, and Glottography. | Postoperative 1st week and 2nd month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice quality change in relation with histopathology. | Voice quality change between postoperative 1st week and 2nd month in relation with histopathology via Voice handicap index, videolaryngostroboscope, CSL MDVP advanced software, and Glottography. | 1st week and 2nd month |