linjc16/ctgov huggingface dataset:
Forced Oscillation Technique (FOT) and Expiratory Flow Limitation (EFL)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to distinguish COPD patients with expiratory flow limitation in body plethysmography (open loop) from the patients without expiratory flow limitation in body plethysmography (closed loop) with the obtained FOT parameters.

Detailed Description
-----------------
In daily practice the expiratory flow limitation is measured by body plethysmography. An open loop in body plethysmography shows expiratory flow limitation in COPD patients. But body plethysmography requires that the patient quietly sits in a closed box and is not able to follow changes breath by breath. The goal of this study is to validate the Forced oscillation technique (FOT) for measuring expiratory flow limitation in COPD patients.30 COPD patients with an open loop in body plethysmography are compared to 30 COPD patients with a closed loop. The methods used in this study are the maximal overlap discrete short time Fourier transform (MODFT) combined with a total least squares analysis. It is hypothesized that the obtained FOT parameters are able to distinguish the patients with expiratory flow limitation in body plethysmography from the patients without expiratory flow limitation in body plethysmography.Secondary study questions are: 1) to what extend are the FOT parameters distorted by breathing artifacts and measurement noise. 2)What changes can be detected by FOT in expiratory flow limitation after administration of salbutamol.

Official Title
-----------------
Diagnosing Expiratory Flow Limitation in COPD Patients With the Forced Oscillation Technique Using Linear Regression in the Time Frequency Domain

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting to the outpatient clinic Age 50-80 years Diagnosed with COPD according to the standard criteria Gold Stage II to IV COPD Current or ex-smokers (at least 10 PY) Stable disease (No current exacerbation or exacerbation during the 4 weeks previous to the inclusion) Exclusion Criteria: History of exacerbation of COPD in the preceding month Upper airway obstruction Allergic Asthma OSAS (obstructive sleep apnea syndrome) Extreme obesity (BMI>35) Clinically manifest cardiac disease (for example clinically relevant congestive heart failure, unstable angina pectoris)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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
-----------------
Forced oscillation Technique (FOT), Expiratory flow limitation (EFL), Breathing artifacts, COPD
Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe

Study Overview
=================
Brief Summary
-----------------
The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE). Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.

Detailed Description
-----------------
Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure monitoring. The probe will be inserted the predetermined required distance in the esophagus using a guide wire. Once the SECM imaging probe is in place, spiral SECM image data will be continuously collected over a pre-determined length (approximately 5cm).

Official Title
-----------------
Pilot Study to Image the Esophagus Using a SECM Probe

Conditions
-----------------
Barrett's Esophagus

Intervention / Treatment
-----------------
* Device: SECM Probe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A previous diagnosis of Barrett's Esophagus Patients must be over the age of 18 Patient must be able to give informed consent Exclusion Criteria: Subjects with any history of intestinal strictures OR subjects with a history of prior GI surgery OR subjects with a history of intestinal Crohn's disease.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SECM Probe Imaging<br>SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System. | Device: SECM Probe<br>* Imaging of the esophagus using SECM probe and system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Tolerability of the Procedure | We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire. | During the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SECM, Esophagus, Imaging
Sleep Apnea: Age Effects On Prevalence and Natural History

Study Overview
=================
Brief Summary
-----------------
To identify the prevalence of sleep apnea in men and its relationship to age, assess the natural history of the disorder, and predict those men at risk.

Detailed Description
-----------------
BACKGROUND: Sleep apnea is potentially a life-threatening disorder commonly associated with the aging process. Often sleep apnea is accompanied by considerable morbidity for both physical and mental health; the associated excessive daytime sleepiness, cardiovascular abnormalities, and cognitive impairment impact greatly on daytime functioning. In 1990, the prevalence of sleep apnea in the general population was undetermined, and there was much speculation regarding its natural history. DESIGN NARRATIVE: For the prevalence study, 4,364 randomly-sampled men selected from the general population and stratified by age were evaluated for risk factors for sleep apnea. A total of 741 men found to be at risk were evaluated in the sleep laboratory to determine the degree, if any, of sleep apnea or sleep disordered breathing. Prior to recording subjects in the sleep laboratory, a thorough history was obtained from each subject and a physical examination completed. All men entering into the first four years of the prevalence portion of the study who were found to have sleep apnea or sleep disordered breathing were reevaluated yearly over a five year period in the natural history part of the study. The natural history portion also included 150 men previously studied in the sleep laboratory for apnea but who were not part of the random sample of 4,000 and who were not part of the prevalence study.

Official Title
-----------------
Sleep Apnea: Age Effects On Prevalence and Natural History

Conditions
-----------------
Lung Diseases, Sleep Apnea Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
stratified random sample based on risk severity for sleep disordered breathing based on phone interview

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| sleep disordered breathing | Apnea/hypopnea index | immediately upon time of recording |
Preoperative Catastrophizing Predicts Pain Outcome After Shoulder, Knee and Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Psychologic status is associated with poor outcome after joint arthroplasty and perhaps chronic pain. To enhance the therapeutic effect of a psychologic intervention, the specific disorders or pain-related beliefs that contributed to chronic pain should be identified. We therefore determined whether specific psychologic disorders (depression, anxiety disorder) or health-related beliefs (self-efficacy, pain catastrophizing) are associated with chronic pain after joint arthroplasty for osteoarthritis.

Official Title
-----------------
Preoperative Catastrophizing Predicts Pain Outcome After Shoulder, Knee and Hip Arthroplasty

Conditions
-----------------
Osteoarthritis, Chronic Pain, Catastrophization

Intervention / Treatment
-----------------
* Other: Psychological questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: joint arthgroplasty (shoulder, hip ou knee) osteoarthritis Exclusion Criteria: previous surgery in the same joint

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 |
| --- |
|Other: Psychological questionnaires|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | 1 year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional score |  | 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty
Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients.

Official Title
-----------------
A Rapamune Follow-up Registry in Transplant Recipients in the Nordic Countries, Wrap-up

Conditions
-----------------
Transplantation

Intervention / Treatment
-----------------
* Drug: Sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transplantation patients treated with sirolimus (Rapamune). Exclusion Criteria: Patients must be able to give informed consent.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Sirolimus | Drug: Sirolimus<br>* Transplantation patients treated with sirolimus who consent to participate in the study (register)<br>* Other names: Rapamune;|

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
-----------------
Transplantation
Iron Supplementation Among Adolescent Girls in India

Study Overview
=================
Brief Summary
-----------------
This study will implement and evaluate a community-based intervention to distribute and promote consumption of weekly iron-folic acid supplements and to provide nutrition education to reduce the prevalence of iron deficiency anemia among adolescent girls in West Bengal, India.

Official Title
-----------------
Iron Supplementation Among Adolescent Girls in India

Conditions
-----------------
Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Drug: Iron-folic acid supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Girl 12-19 years of age Resides in study area Exclusion Criteria: Does not reside in study area

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iron-folic acid supplement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anemia after 1 year of intervention |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of anemia |  |  | 
| Practices regarding treatment and prevention of anemia |  |  | 
| Knowledge of iron supplements |  |  | 
| Practices regarding iron supplements |  |  | 
| Dietary iron intake |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron deficiency anemia, Adolescent girls, India
A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to learn about how food affects selpercatinib in healthy participants. The selpercatinib will be administered in fed and fasted states. Participation could last about 7 weeks.

Official Title
-----------------
An Open-Label, Randomized, Two-Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Selpercatinib in Healthy Participants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Selpercatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs and clinical laboratory tests. Exclusion Criteria: Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selpercatinib (Period 1)<br>Selpercatinib will be administered orally on Day 1 either in fast or fed state. | Drug: Selpercatinib<br>* Administered orally.<br>* Other names: LOXO-292;|
| Experimental: Selpercatinib (Period 2)<br>Selpercatinib will be administered orally on Day 8 either in fast or fed state. | Drug: Selpercatinib<br>* Administered orally.<br>* Other names: LOXO-292;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics(PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib | PK: AUC[0-∞] of Selpercatinib | Predose on day 1 until Day 4, and Predose on Day 8 until Day 11 | 
| PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib | PK: AUC[0-tlast] of Selpercatinib | Predose on day 1 until Day 4, and Predose on Day 8 until Day 11 | 
| PK: Maximum Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib | Predose on day 1 until Day 4, and Predose on Day 8 until Day 11 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Selpercatinib, Food, Pharmacokinetics
Freder1k-Study - Testing Infants for Type 1 Diabetes Risk

Study Overview
=================
Brief Summary
-----------------
The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.

Detailed Description
-----------------
Type 1 diabetes is a common chronic disease in childhood and is increasing in incidence. Type 1 diabetes is diagnosed by hyperglycemia often in combination with symptoms of weight loss, thirst, fatigue and frequent urination, sometimes with ketoacidosis. The clinical onset is preceded by an asymptomatic phase identified by serum multiple beta-cell autoantibodies. Neonates and infants who are at increased risk to develop multiple beta-cell autoantibodies and type 1 diabetes can now be identified using genetic markers. This provides opportunity for introducing early therapies to prevent beta-cell autoimmunity and type 1 diabetes.

Official Title
-----------------
Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials

Conditions
-----------------
Identification of Infants at Risk for Type 1 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: up to age 7 days provided written informed consent by custodial parent Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 7 Days

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 |
| --- | --- | --- |
| greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes | increased risk will be identified by risk scores derived from SNPs | one-time testing before age 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infants, type 1 diabetes, Freder1k
Nudging Effect of Timer on Surgical Rub

Study Overview
=================
Brief Summary
-----------------
To study whether a device has a nudging effect on the time spend on surgical rub.

Detailed Description
-----------------
The investigators observed the time spend on surgical rub prior to an operation. The investigators do not record names, age, sex or orther features about the health care workers who perform the surgical rub. After 200 observations a device will be attach to the dispenser that might help increase the time spend on the surgical rub in the operathing theather. The investigatos will then make another 200 observations to see if the device cause an increase in the time spend on surgical rub.

Official Title
-----------------
The Effect on a Timer-device on the Time Spend on Surgical Rub

Conditions
-----------------
Operation Wound; Infection, Bacterial Infections, Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Device: Alcohol rub timer device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • All professional health care workers, who perform surgical ru Exclusion Criteria: Students and other persons at a hospital, who are not paid to be working at the hospital.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prior to installation of device<br>Health care workers who perform the surgical rub prior to installation of the device that should increase the time spend on surgical rub. | Device: Alcohol rub timer device<br>* A device that should help the surgeon to increase the time spend on surgical rub. Further detail cannot be described due to confidence<br>|
| Post device installation<br>Health care workers who perform the surgical rub following installation of the device that should increase the time spend on surgical rub. | Device: Alcohol rub timer device<br>* A device that should help the surgeon to increase the time spend on surgical rub. Further detail cannot be described due to confidence<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | time used on surgical rub | Seconds used on surgical rub at least 300 seconds. Observation begin from start of surgical rub (defined as the time when the dispenser is activated) to the end of surgical rub (defined as the time when the surgeon pick up the surgical gown) |
A Study to Evaluate the Effect of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.

Official Title
-----------------
A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Effects of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 2 diabetes for at least 6 months Patients whose diabetes is controlled by diet and exercise only or patients taking metformin BMI in the range 22-45 Blood glucose criteria must be met Exclusion Criteria: Pregnancy or lactation Type 1 diabetes or diabetes resulting from pancreatic injury Cardiovascular complications as defined by the protocol Significant diabetic complications as defined by the protocol Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 30 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in maximal insulin secretory capacity at 12 weeks |  |  | 
| Durability of this effect after a 2-week washout |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in beta-cell sensitivity to glucose at 12 weeks |  |  | 
| Durability of this effect after a 2-week washout |  |  | 
| Chance from baseline in glucagon secretion at 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vildagliptin, Type 2 diabetes, Insulin secretion, Beta cell