linjc16/ctgov huggingface dataset:
Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined modality therapy.

Official Title
-----------------
Phase II, Randomized, Double-Blind, Multicenter Trial of Subcutaneous Amifostine (Ethyol®) Versus Placebo in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer

Conditions
-----------------
Esophagitis, Pneumonitis, Non-Small Cell Lung Carcinoma

Intervention / Treatment
-----------------
* Drug: Amifostine


Participation Criteria
=================
Eligibility Criteria
-----------------
You may be eligible for this study if you are 18 years of age or older and: Have UnResectable Stage IIIA or IIIB Non Small Cell Lung Cancer Have never had prior chemotherapy with Paclitaxel or Carboplatin Have never had prior thoracic radiation therapy (XRT)

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
- Non-Small cell lung cancer
Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.

Official Title
-----------------
A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies

Conditions
-----------------
Cancer, Solid Tumors, Advanced Solid Malignancies

Intervention / Treatment
-----------------
* Drug: AZD7762
* Drug: gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective. Must be suitable for treatment with gemcitabine Relatively good overall health other than cancer Exclusion Criteria: Poor bone marrow function (not producing enough blood cells). Poor liver or kidney function. Serious heart conditions

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AZD7762 + gemcitabine<br>AZD7762 administered alone and in combination with gemcitabine | Drug: AZD7762<br>* solution, intravenous, weekly<br>Drug: gemcitabine<br>* intravenous, weekly<br>* Other names: Gemzar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram |  | Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine |  | According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1 | 
| Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST) |  | Every 2-3 cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, cancer, solid tumors, advanced solid malignancies, dose escalation, combination treatment, CHK inhibitor, Japanese
Videofluoroscopic of Deglutition Study of the Initiation of Pharyngeal Phase in Young Adults

Study Overview
=================
Brief Summary
-----------------
This study has as objective to characterize the start of pharyngeal phase of swallowing, in the various food consistencies and volumes, with and without the influence of verbal orders, observed on videofluoroscopy of deglutition.

Detailed Description
-----------------
Quantitative study, transverse and observational study, in the period January to March 2010, in the Center Advanced Diagnosis and Treatment Trajan Almeida, in the city of Fortaleza, Ceará. The sample was composed by 40 individuals, with mean age 23.5 years, 35 (87.5 %) female and five (12.5%) male gender. was carried out an assessment videofluoroscopy swallowing in net consistencies (15 ml of water added to 15 ml of barium net), liquid paste (25ml of barium net), paste (two spoons of 5ml of thickening for 30ml of barium net) and solid (1/2 cracker waffer immersed the barium net), where the individuals remained seated and the images were carried out in the lateral position. From the beginning of the rapid movement of hyoid bone, verified the beginning of pharyngeal phase of swallowing in each consistency.

Official Title
-----------------
The Start of Pharyngeal Phase of Swallowing in Healthy Individuals

Conditions
-----------------
Young, Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with ages ranging between 20 and 30 years Without complaint of deglutition Not submitted to surgeries and/or other treatments in the region of head and neck, with the exception of dental equipment. Exclusion Criteria: Individuals submitted to cardiac surgeries, chest and/or abdominal prior Patients with diabetes mellitus and/or neurological diseases beyond craniofacial abnormalities.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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
-----------------
Deglutition, Fluoroscopy
Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the procedure and reducing intraoperative complications as bleeding and infections.

Official Title
-----------------
Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract

Conditions
-----------------
Kidney Stone, Unexplained Haematuria, Benignant Tumour Mass in the Upper Urinary Tract

Intervention / Treatment
-----------------
* Drug: Isoproterenol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for ureterorenoscopy Age> 18 years Normal blood pressure Exclusion Criteria: Malignant disease in the upper urinary tract Heart disease Allergy to Isoproterenol Use of α-blocking or β-blocking medicine Use of Calcium-antagonists Use of NSAIDs the last 48 hours Present stone or JJ-stent in the ureter Neurologic disease in the bladder Pregnancy Nursing mothers

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Saline irrigation | Drug: Isoproterenol<br>* ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation<br>|
| Active Comparator: 2<br>ISO irrigation | Drug: Isoproterenol<br>* ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pelvic pressure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ureteroscopy, kidney stone
Effect of High-carbohydrate or High-monounsaturated Fat on Blood Pressure: Meta-analysis of Randomized Clinical Trials

Study Overview
=================
Brief Summary
-----------------
High saturated fat acids diets are associated with elevated blood pressure which is associated with cardiovascular morbidity and mortality. For this reason, a change of diet is recommended to manage blood pressure and prevent cardiovascular complications. To achieve this nutritional goal, a high-carbohydrate diet or high-monounsaturated fat diet can be advised in the replacement of a saturated fat diet. Previous meta-analysis of Garg (1998) cited randomized articles with inconsistent blood pressure lowering after consumption of a high-monounsaturated-fat diet compared with a high-carbohydrate diet only in type 2 diabetes patients. Moreover, another meta-analysis of Shah et al. (2007) showed slightly high blood pressure on diets rich in carbohydrates than diets rich in cis-monounsaturated fat after randomized and nonrandomized articles. For this reason, a new meta-analysis of a randomized clinical trial will be performed to clarify the effects of high-carbohydrate or high-monounsaturated fat diets on blood pressure. Results from this meta-analysis will help health professionals take important decisions on patient diet and minimize cardiovascular morbidity and mortality.

Official Title
-----------------
Effect of High-carbohydrate or High-monounsaturated Fatty Acids on Blood Pressure: a Meta-analysis of Randomized Clinical Trials

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Other: High-carbohydrate or High-monounsaturated fat diets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Randomized controlled trials Parallel or Crossover Design Duration: at least 3 weeks Isocaloric diet
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: High-carbohydrate or High-monounsaturated fat diets|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 3 weeks | 
| Mean arterial pressure |  | 3 weeks |
Renin Angiotensin System - CoronaVirus

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to demonstrate overactivation of Renin Angiotensine System (RAS) in positives COVID-19 patient, especially in those with the most serious clinical forms where the mortality of patients in intensive care is on average 50%. We are expecting two groups: a group of 25 positive COVID 19 patients in intensive care and a group of 25 positive COVID 19 hospitalized patients in conventional hospitalisation. We will measure RAS, serum potassium and collect data on the treatment of these patients (especially antihypertensive therapy) one week apart (at the patient'entry into hospital and 7 days later). This is a preliminary study that could possibly allow the start of a therapeutic trial in order to test the effectiveness of RAS blocker treatments in this condition.

Official Title
-----------------
Renin Angiotensin System - CoronaVirus

Conditions
-----------------
COVID 19

Intervention / Treatment
-----------------
* Other: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive COVID 19 patients hospitalized in conventionnal hospitalisation Patients hospitalized in intensive care secondary to COVID-19 : Patient under invasive mechanical ventilation (PaO2 / FiO2 ratio <300; PEEP> = 5 cmH20; PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample; PaO2 / FiO2 ratio> 300) Exclusion Criteria: Minor patient Patient deprived of liberty Patient's refusal to participate in the study Patient for whom therapeutic limitation measures such as non-admission to intensive care have been issued

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Positive COVID 19 patient with no respiratory distress<br> | Other: blood draw<br>* 20 mL blood draw will be performed at J1 et J7<br>|
| Experimental: Positive COVID 19 patient with respiratory distress<br> | Other: blood draw<br>* 20 mL blood draw will be performed at J1 et J7<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overactivity of the renin / aldosterone system | demonstrate overactivity of RAS in patients hospitalised in intensive car secondary to COVID-19 compared to control patients (COVID -19 hospitalised patients without complications ). | 7 days |
Innovative Patient-partner-guided Virtual Group Speech Pathology Intervention Model in Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
This project aims to study an innovative intervention, the eG2 Intervention, developed by speech-language pathologists at the Centre hospitalier de l'Université de Montréal to improve therapeutic adherence and prevent dysphagia in patients treated with chemoradiotherapy for head and neck cancer. The innovation consists in offering a speech therapy intervention that is 1) virtual, 2) group-based (whereas it is usually individual) and 3) involves a patient partner. This intervention has the potential to improve quality of care, accessibility to services and optimize health care resources.

Official Title
-----------------
Impacts of an Innovative Patient-partner-guided Virtual Group Speech Pathology Intervention Model to Prevent Swallowing Disorders in Patients Treated With Chemoradiotherapy for Head and Neck Cancer

Conditions
-----------------
Dysphagia

Intervention / Treatment
-----------------
* Procedure: virtual group speech therapy intervention guided by a patient partner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥ 18 years of age with a diagnosis of head or neck cancer Chemoradiotherapy treatments planned for curative purposes Planned external radiation therapy dose of at least ≥60 Grays Sufficient proficiency in French to complete self-reported questionnaires Exclusion Criteria: Remote metastases Previous or planned total laryngectomy Previous moderate/severe dysphagia known and/or evaluated by speech therapy Diagnosis of a second synchronous cancer at the time of study enrollment History of prior radiation therapy to the head and neck area Have a cognitive impairment (diagnosed or suspected) that may significantly interfere with participation in the intervention and various measurement procedures.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual group speech therapy intervention guided by a patient partner<br> | Procedure: virtual group speech therapy intervention guided by a patient partner<br>* virtual group speech therapy intervention guided by a patient partner<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of nasogastric tube | To evaluate the rate of nasogastric tube placement in the acute and subacute period in patients who participated in the group intervention. | within 6 weeks post radiation |
Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC

Study Overview
=================
Brief Summary
-----------------
To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Official Title
-----------------
A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Zactima (ZD6474)
* Drug: Vinorelbine plus cisplatin
* Drug: Gemcitabine plus cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed non small cell lung cancer (stage IIIB-IV) Life expectancy greater than 12 weeks At least 1 measurable lesion greater than 10mm in smallest diameter. Exclusion Criteria: Prior treatment with anticancer agent Brain metastases Major surgery within last 4 weeks

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zactima (ZD6474)|nan|
|Drug: Vinorelbine plus cisplatin|nan|
|Drug: Gemcitabine plus cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered |  | Predetermined timepoints after dose administration | 
| Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, ZACTIMA
Outcomes Following Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation is to determine both patient-reported and performance-based outcomes, specifically muscle function and kinematic/kinetic outcomes, between four different surgical total knee prostheses in individuals following TKA. Change scores will be determined based on patient-reported outcomes, kinematic/kinetic data, knee extension strength/power, static/dynamic balance control, mobility measures and functional performance testing during functional tasks (i.e. walking, ascending/descending stairs, sit-to-stand). After evaluating the pattern of change in lower-extremity function, the investigators will be better prepared to address residual functional impairments and prognostic factors linked to maximal recovery over two years.

Official Title
-----------------
Clinical and Biomechanical Outcomes Following Total Knee Arthroplasty

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults > 40 years of age that are scheduled for primary TKA if they have had a previous TKA, it needs to have been performed on the opposite leg at least 3 months prior to the current TKA willing to return for follow-up visits and should be willing and able to be transported from the UOC to the Skeletal Muscle Exercise Research Facility (SMERF), in the Department of Physical Therapy study site for scheduled research follow-up appointments Exclusion Criteria: adult with previous additional orthopaedic, neurological, visual or surgical conditions that may affect gait or balance

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Patient Reported Outcome Scores following TKA |  | Follow Up Visits up to 2-Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomechanics, Primary Total Knee Arthroplasty, TKA Bearings, Osteoarthritis, Total Knee Replacement