linjc16/ctgov huggingface dataset:
Mechanisms of Exacerbation of Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the causes of asthma that were not previously suspected, to better understand the effects of inhaled steroids on asthma and to identify new way to treat asthma.

Detailed Description
-----------------
In this study, we will explore mechanisms of exacerbation in asthma by careful characterization studies in asthmatics presenting in acute severe exacerbation. Specifically, we will determine the frequency of secretor status in these subjects by blood and saliva testing, and we will also perform a detailed cellular and biochemical analysis of their airway secretions. We will collect airway secretions using two methods. One method will be to have subjects cough sputum into a clean plastic container. The other method only applies to asthmatics with near-fatal asthma requiring intubation and mechanical ventilation. In these asthmatics, we will collect airway secretions by tracheal aspirate using methods normally applied in their clinical care.

Official Title
-----------------
Mechanisms of Exacerbation of Asthma

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects with a history of asthma between the ages of 18 to 75 years. Physician diagnosis of asthma. Currently experiencing an acute exacerbation of asthma. This exacerbation may be severe necessitating treatment in the emergency room, ICU, or hospital ward. Ability to provide informed consent. Exclusion Criteria: Lung disease other than asthma. Females who are lactating or who are pregnant. Use of recreational drugs in the 1 month preceding the study.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthma<br>People who have been diagnosed with Asthma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rheological measurements (viscosity and elasticity) in sputum from patients with acute severe asthma |  | 1-2 years |
Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask

Study Overview
=================
Brief Summary
-----------------
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.

Detailed Description
-----------------
20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.

Official Title
-----------------
Investigative Headgear With Nasal Pillows CPAP Mask

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Investigative Headgear with CPAP mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AHI≥5 from the diagnostic night ≥18 years of age Prescribed CPAP or Bi-level therapy for OSA Existing F&P Pilairo Q, Eson, Simplus mask users Exclusion Criteria: Inability to give informed consent Patient intolerant to CPAP Anatomical or physiological conditions making CPAP therapy inappropriate History of respiratory disease or carbon dioxide (CO2) retention Pregnant or think they may be pregnant Investigated by Land Transport Safety Authority

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Headgear<br>Investigative Headgear with CPAP mask | Device: Investigative Headgear with CPAP mask<br>* Investigative Headgear with CPAP mask<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of the headgear using a Questionnaire | Assessment of headgear properties on a monthly basis via custom questionnaire via phone call | Monthly over a period of 6 months | 
| Durability of the headgear by testing | Assessment of headgear properties on a monthly basis, and changes to the headgear | Monthly over a period of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance in regards to leak of the headgear | Objective Leak Data (L/min) from the device download | Monthly over a period of 6 months | 
| Performance in regards to comfort of the headgear | Custom Questionnaire | Monthly over a period of 6 months |
Sunitinib in Metastatic Renal Cancer

Study Overview
=================
Brief Summary
-----------------
Sunitinib is the registered treatment for first-line therapy of metastatic clear-cell carcinoma of the kidney.Data from the Expanded Access Study have shown activity also in non-clear cell renal cancer (NCCRC). The aim of this study is to prospectively evaluate the anti-tumor activity and safety of sunitinib as a first-line therapy in metastatic NCCRC patients.

Detailed Description
-----------------
This is a prospective, open label, multicenter phase II study to evaluate efficacy of Sunitinib (in advanced/metastatic renal cancer with non-clear cell histology (papillary or chromophobe). Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks on treatment followed by 2 weeks off. Treatment with the study drug will continue until tumor progression or unacceptable toxicity. The planned total sample size for this study is 55 patients. Approximately 10 study sites will be involved.

Official Title
-----------------
Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Drug: Sunitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven diagnosis of metastatic renal cancer with non-clear cell No previous treatment Exclusion Criteria: Prior treatment with an antiangiogenetic compound Symptomatic and/or unstable pre-existing brain metastases Severe or uncontrolled cardiovascular 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunitinib<br>50 mg once daily 6 weeks cycle 4 weeks on and 2 weeks off | Drug: Sunitinib<br>* Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks of treatment followed by 2 weeks without treatment.<br>* Other names: Sutent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The antitumor activity in terms of progression free survival |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the objective response rate |  | two years | 
| To evaluate the toxicity and the safety profile |  | two years | 
| To evaluate the overall survival |  | two years |
Collection of Autologous Blood Products by Double Erythrocytapheresis

Study Overview
=================
Brief Summary
-----------------
The project will determine the advantages of double erythrocytapheresis in the collection of preoperative autologous erythrocytes as compared to the standard collections of whole blood. The study will assess the total reduction in the number of procedures required to obtain the preoperative units ordered by the surgeon. Also, successfulness of erythrocytaphereses versus classical whole blood collection for these patients will be compared.

Detailed Description
-----------------
The project will determine the advantages of double erythrocytapheresis in the collection of preoperative autologous erythrocytes as compared to the standard collections of whole blood. The study will assess the total reduction in the number of procedures required to obtain the preoperative units ordered by the surgeon. Also, successfulness of erythrocytaphereses versus classical whole blood collection for these patients will be compared.

Official Title
-----------------
Collection of Autologous Blood Products by Double Erythrocytapheresis - Cost Effectiveness Study

Conditions
-----------------
Pre Operative Autologous Donation

Intervention / Treatment
-----------------
* Procedure: eythrocytapheresis
* Procedure: whole blood collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery Exclusion Criteria: Malignancies Severe arrhythmias Congestive heart failure Recent angina Epileptic seizures in the last 3 months before collection

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Procedure: eythrocytapheresis<br>* machinal collection of erythrocytes<br>* Other names: apheresis;|
| Active Comparator: 2<br> | Procedure: whole blood collection<br>* collection of whole blood<br>* Other names: blood donation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decline in Hemoglobine levels |  | surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Storage parameters- ATP |  | 35 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dubble eerythrocytapheresis
The Objective is to Respond to Patients' Needs in the Field of Larynx Replacement

Study Overview
=================
Brief Summary
-----------------
Supplement pharyngolaryngeal deficient functions by insertion of a prosthesis with valves in order to allow tracheotomy closing (when applicable) and / or to allow restoration of god swallowing capacity. The secondary objective is to study the concept of a special valves system for the development of an artificial larynx

Official Title
-----------------
Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles

Conditions
-----------------
Swallowing Disorders, Dysphagia, Laryngeal Neoplasms

Intervention / Treatment
-----------------
* Device: Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age more than 18 Swallowing troubles Exclusion criteria: Pregnant women Contraindications to general anesthesia

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 |
| --- |
|Device: Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing|An artificial Larynx composed of a tracheobronxane ® Dumon ST prosthesis and a valves system will be implant under general anesthesia by endoscopy. The 3 first patients will be patients with tracheotomy, in order to allow breathing through this tracheotomy in case of valves dysfunction.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory evaluation |  | Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasofibroscopy |  | Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Larynx, tracheotomy, titanium beads
Shoulder Rotational Flexibility and Throwing Arm Injuries of Baseball Pitchers

Study Overview
=================
Brief Summary
-----------------
The evaluation of any relationship between the rotational resistance of the shoulder and shoulder flexibility with throwing arm injuries in professional and college level pitchers.

Official Title
-----------------
Shoulder Internal/External Rotational Flexibility is Related to Throwing Arm Injuries in Professional Baseball Players

Conditions
-----------------
Shoulder Injuries, Shoulder Flexibility, Rotational Resistance of Shoulder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently competing Healthy pitching arm Exclusion Criteria: Inactive status Previous injury

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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
-----------------
Shoulder, Injuries, Flexiblity, Rotational resistance
Effect of Low Frequency Ultrasound on Kidney Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out what effect, if any, Low Frequency Therapeutic Ultrasound (LOTUS) has on kidney function in patients with chronic kidney disease.

Official Title
-----------------
Evaluation of the Effect of Low Frequency Therapeutic Ultrasound (LOTUS) on Kidney Function in Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Device: Low Frequency Therapeutic Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be >/= 18 years of age Must have documented Stage 3 to Stage 4 (eGFR 15 - 59) chronic kidney disease Females with childbearing potential must not be pregnant at the time of study Subject must provide written informed consent Exclusion Criteria: Unable or unwilling to cooperate with study procedures Currently enrolled in another clinical study for which the follow-up period is not complete

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Frequency Therapeutic Ultrasound<br>Low Frequency Therapeutic Ultrasound (LOTUS) applied transcutaneously | Device: Low Frequency Therapeutic Ultrasound<br>* 29 kHz (kilohertz) low frequency therapeutic ultrasound delivered transcutaneously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular Filtration Rate (GFR) | Absolute change in glomerular filtration rate, GFR, measured by Tc-99m DTPA (diethylenetriamine pentaacetic acid) imaging (Gates Method) in the treated kidney(s) from baseline to during LOTUS | Baseline and 15 minutes after start of Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in GFR | Percent change in GFR in the treated kidney(s) from baseline to during LOTUS. | Baseline and 15 minutes after start of Intervention | 
| Blood Pressure | Blood pressure is measured at baseline, during LOTUS intervention, and immediately after LOTUS intervention | Baseline and 15 minutes after start of Intervention, and 5 minutes after end of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low frequency ultrasound, glomerular filtration rate
Safe Water Techniques in Kenya

Study Overview
=================
Brief Summary
-----------------
Consumer preferences for POU technologies vary across consumers and products, and largely determine their adoption and subsequent usage. This is a marketing study that asks which products consumers prefer and why, and what is their willingness to pay, as understanding this is crucial to attain their widespread adoption and usage.

Detailed Description
-----------------
Visit 400 households and distribute 1 of 3 different POU technologies on randomized basis for a two-month trial. Cycle each household through trials with all 3 technologies in random order such that at the end of 6 months all households have experienced 2-month trials with each technology.

Official Title
-----------------
A Study of End-User Preferences for and Use of POU Safe Water Technologies in Kenya

Conditions
-----------------
Consumer Willingness to Pay for POU Products, Consumer Preferences and Use of POU Products

Intervention / Treatment
-----------------
* Behavioral: biases towards products


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least partial reliance on turbid water supply Exclusion Criteria: At least partial reliance on turbid water supply
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: biases towards products|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumer preferences and use of POU products |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumer willingness to pay for POU products |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safewater, randomized
External Ankle Supports - 3D Motion Analysis

Study Overview
=================
Brief Summary
-----------------
Untreated ankle sprains often remain symptomatic and may end in chronic instability. The aim of our study is to quantify the stabilizing effect of different devices. Through the use of a foot measurement model in 3D motion analysis the influence of the devices with respect to a mechanical effect is examined by means of different tests. The dynamic postural control is quantified. The hypothesis was that the devices would stabilize differently the foot segments.

Conditions
-----------------
Chronic Ankle Instability

Intervention / Treatment
-----------------
* Device: Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic ankle instability giving way repeated ankle sprains Exclusion Criteria: other injuries of the lower extremities surgery on the lower extremities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: ankle supports<br> | Device: Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of the range of motion of the subtalar inversion/eversion in degree |  | baseline (=before) and immediately after applying the device |