linjc16/ctgov huggingface dataset:
Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index

Study Overview
=================
Brief Summary
-----------------
To compare the rapid shallow breathing index (RSBI) values, the incidence of adverse reactions, and the predictive accuracy measured under 5 different ventilator strategies in the same patient group.

Detailed Description
-----------------
98 ready for weaning patients were included and divided into success (n=71) and failure (n=27) groups based upon their weaning outcome. Before weaning, the RSBI values were determined under the patients disconnecting from the ventilator (RA-no ventilator) and still connecting to the ventilator with 4 different settings (fraction of inspired oxygen (FiO2) 21 or 40% combined with continuous positive airway pressure (CPAP) 0 or 5 cm H2O). The patients were extubated after completing the weaning trials. Successful weaning was defined as patients free from the ventilator for over 48 hours.

Official Title
-----------------
Effect of Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index

Conditions
-----------------
Acute Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intubated medical patients with mechanically ventilated more than 48 hours clinically ready for weaning Glasgow coma scales were at least 8 their ventilator settings were: assist-controlled, pressure support (PS)or synchronized intermittent mandatory ventilation plus PS mode, FiO2 40% or less, positive end-expiratory pressure 5 cm H2O or less, and sensitivity setting on 1 L/min. Their arterial blood gases results were acceptable Exclusion Criteria: having ongoing lung or neuromuscular disease and signs of increased intracranial pressure
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| S, 1, A<br>group (success or failure), case number, measurement method | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patients connecting or disconnecting to the ventilators affected the RSBI values but not their predictive accuracies. |  | Before the patient processing weaning trials | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in FiO2 and CPAP settings have no effect on RSBI values but ventilator methods with FiO2 21% have higher incidence of adverse reactions. |  | Before the patient processing weaning trials | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventilator, mechanical, Ventilator weaning, Rapid shallow breathing index, Continuous positive airway pressure, Receiver operating characteristic curve, COPD
Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTan

Study Overview
=================
Brief Summary
-----------------
The Preempt study is likely to help determine the frequency of patients suffering from Minimal Hepatic Encephalopathy (MHE) and are cirrhotics. It will also enable us to know about the Quality of life of these patients.

Conditions
-----------------
Hepatic Encephalopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of either sex, 18-65 years of age, who have attended school at least till the 5th Class/Standard having an established diagnosis of liver cirrhosis without any overt symptoms at time of testing with Grade 0 of West Haven criteria. Patients willing to undergo the neuropsychological (NP) tests and to complete the SF-36 questionnaire for the estimation of Health Related Quality of Life (HRQOL). Patients willing to provide written authorization to provide data for the study. Exclusion Criteria: Patients with inability to perform neuropsychometric tests and to complete the SF-36 questionnaire as decided by the physician.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Frequency of MHE in Cirrhotic patients | Continuous variables with normal and non-normal distributions would be reported as mean (SD) and median [inter-quartile range (IQR)], respectively. Prevalence of MHE in cirrhotic patients with 95% confidence Interval (CI) will be calculated. Continuous variables between group will compared by using Independent sample t test, and categorical variables will compare by using the chi-square test. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The predisposing factors that might be associated with MHE in all enrolled patients with cirrhosis | Odds Ratios (OR) and their 95% Confidence Intervals (CI) will be estimated using Logistic Regression. The likelihood ratio test used to assess the association between the explanatory variables and the risk of the MHE. Invariable analyses will perform to examine the effect of each variable on the risk of MHE. In multivariate analysis all insignificant variables (p >0.05) will check for their confounding and interaction effects before their removal from the final model. | 18 months | 
| Quality of Life (QoL) of patients at baselines | Short Form (SF)-36v2 Quality of Life Questionnaire will be used | 18 months | 
| Management of MHE currently in practice | As per practice of the physician/Investigator. Management of MHE will be recorded. The information for medication which will be collected will be Name (preferably the generic name), Dose, Units (form of the medicine), Route and Frequency | 18 months |
Anatomical Feasibility of the Off-the-shelf E-nside Multibranch Stent Graft System for Thoracoabdominal and Para-renal Aortic Aneurysms.(E-nside Study)

Study Overview
=================
Brief Summary
-----------------
The study was created to evaluate the theoretical anatomical feasibility of the new E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) in patients with thoracoabdominal and para-renal aortic aneurysms based on retrospective review of pre-operative imaging studies of the patients treated with other techniques for this pathology in the vascular Unit of San Raffaele Hospital, in the past ten years. With this study, investigators want to analyze in how many cases the new prosthesis would be usable. E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) is in the pre-CE marking stage. At present, the certifying organism is evaluating the documentation for the release the CE mark certification and Declaration of Conformity.

Official Title
-----------------
Anatomical Feasibility of the Off-the-shelf E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) for Thoracoabdominal and Para-renal Aortic Aneurysms. (E-nside Study)

Conditions
-----------------
Aortic Aneurysm, Thoracoabdominal, Para-renal Aortic Aneurysms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patient who underwent treatment of thoracoabdominal or para-renal aortic aneurysm at San Raffaele Hospital between January 2007 and January 2017. Exclusion Criteria: - incomplete or inappropriate imaging quality defined as pre-operative CTAs with slice thickness >1-mm.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| extensive TAAA<br>including Crawford extent I and II TAAA | |
| Crawford extent III TAAA<br> | |
| supra-renal aortic aneurysms<br>Crawford extent IV TAAA and para-renal abdominal aortic aneurysms. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multi-planar and curved reconstruction of pre-operative contrast-enhanced computed tomography scans (CTA) | Number of patients (already treated in the Vascular Surgery Unit of San Raffaele Hospital) with anatomical characteristic for use (theoretic)of the new E-nside Multibranch Stent Graft System. | between January 2007 and January 2017 |
Dynamic and Static Stretching on Postural Stability, Reaction Time and Countermovement Jump of Sprinters

Study Overview
=================
Brief Summary
-----------------
All the athletes should perform a warm-up consisting of five minutes of jogging and static stretching (Experimental Group 1) or dynamic stretching (Experimental Group 2). Before the beginning of the study and right after performing the stretching protocol, the investigators evaluated the unipedal postural stability, the acustic reaction time, the joint position sense of the knee and the countermovement jump of the athletes.

Official Title
-----------------
Efectos de la Fatiga en el Rendimiento físico en el Ejercicio de Sentadillas

Conditions
-----------------
Postural Stability

Intervention / Treatment
-----------------
* Procedure: Static Stretching
* Procedure: Dynamic Stretching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: National level Sprinters Two years or more of experience Exclusion Criteria: Free of injuries in the last six months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 26 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental I<br>This group performed static stretching | Procedure: Static Stretching<br>* To analyze the immediate effects of static stretching on performance of sprinters<br>|
| Active Comparator: Experimental II<br>This group performed dynamic stretching | Procedure: Dynamic Stretching<br>* To analyze the immediate effects of dynamic stretching on performance of sprinters<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the unipedal postural balance of athletes | Monopodal postural stability (15 seconds as still as possible on a baropodometric platform in left-leg and right-leg monopodal support) | baseline and 15 minutes | 
| Change in counter-movement jump of athletes | A maximum vertical jump with counter-movement. | baseline and 17 minutes | 
| Change in Joint Position Sense of the knee of athletes | Acuity of repositioining a previous position of the knee joint | baseline and 20 minutes | 
| Change in Acustic Reaction Time of athletes | Time spent to rise the dominant leg after an acustic signal | baseline and 22 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proprioception, countermovement jump, postural balance
Prognostic Value of Progesterone for In Vitro Fertilization (IVF) Outcome

Study Overview
=================
Brief Summary
-----------------
This observational study attempts to investigate the potential role of serum progesterone levels on the day of hCG administration (thus, the end of the follicular phase) on the probability of pregnancy, in patients undergoing IVF with the use of GnRH antagonists and recombinant gonadotrophins. There has been evidence, that increased serum levels of progesterone are associated with a decreased probability of pregnancy after IVF. This study will attempt to explore the role of progesterone on the outcome of IVF, by closely monitoring its levels during the late follicular phase.

Official Title
-----------------
The Effect of Serum Progesterone Levels on the Day of hCG Administration on the Probability of Pregnancy in Patients Treated by IVF Using GnRH Antagonists and Recombinant Gonadotrophins

Conditions
-----------------
Subfertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 40 years Basal FSH < 12 IU/L Basal P < 1.6 ng/mL Exclusion Criteria: Presence of cystic formations at the ovaries during the basal ultrasound scan (prior the initiation of stimulation) Women with polycystic ovaries syndrome (PCOS) Women with Stage III-IV Endometriosis Women with a pathological condition of the adrenal glands

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing IVF with rFSH and GnRH antagonists<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy, defined as ultrasound evidence of fetal heart activity at 6-8 weeks of gestation |  | At 6-8 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy (defined as a b-hCG> 25 IU/L) |  | 12 days after embryo transfer |
AQP-1 Polymorphism on Fluid Status in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
It is a cross sectional observational study. It is to investigate whether AQP-1 polymorphism has any impact on fluid status in hemodialysis patients. The long term stable HD patients in the current center will be enrolled to the study after informed consent. Blood samples will be collected for gene-typing. Fluid status including blood pressure, weekly UF and intra-dialysis body weight change will be collected through their clinical records.

Official Title
-----------------
the Effect of AQP-1 Polymorphism on Fluid Status of Hemodialysis Patients

Conditions
-----------------
End Stage Renal Disease on Dialysis

Intervention / Treatment
-----------------
* Other: observational study, no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-70 ESRD maintained HD no target weight change during the last week of entering the study and achieve target weight at the end of HD section informed consented Exclusion Criteria: expected survival time less than 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observational study, no intervention|observational study, no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total ultrafiltration volume in mls from hemodialysis for the whole week of the recruitment | The ultrafiltration volume of each HD section of the enrollment week will be recorded. The total ultrafiltration volume of the week is the primary outcome measure. (In most cases, HD patients have three HD sections per week.) | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total weight gain in kgs of each HD section of the enrollment | The body weight gain of each HD section of the enrollment week will be recorded. The total body weight gain of the week is the secondary outcome measure. (In most cases, HD patients have three HD sections per week.) | up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AQP1, fluid status
Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the best role for capsule endoscopy in diagnosing Crohn's disease.

Detailed Description
-----------------
Wireless capsule endoscopy (CE) is a Food and Drug Administration (FDA) approved technology that allows viewing of the entire small-bowel. Capsule endoscopy involves swallowing a pill-sized camera that sends images to a data recorder worn on a vest. Because Crohn's disease (CD) often involves the small bowel, we would like to find out if capsule endoscopy is useful in diagnosing small-bowel Crohn's disease. Current methods for diagnosing small-bowel Crohn's disease include colonoscopy, esophagogastroduodenoscopy (EGD), enteroscopy (ENT), single contrast barium small-bowel follow through (SBFT), and double contrast small-bowel enteroclysis (SBE), but these tests are unable to identify the presence or extent of small-bowel disease in many patients.

Official Title
-----------------
A Prospective Trial of Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Device: Capsule Endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking adult patients (>18 years old) with known Crohn's disease Exclusion Criteria: Severe medical or psychiatric co-morbidities Active swallowing problems Bowel obstruction History of stricture or fistula Pregnancy Taking aspirin/non-steroidal anti-inflammatory drug (NSAID) or potassium chloride (KCl) within 4 weeks prior to the colonoscopy and anytime after colonoscopy Inability to consent Exclusion of patients whose colonoscopy was done for reasons other than signs/symptoms suggestive of Crohn's disease

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Capsule Endoscopy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare capsule endoscopy (CE) finding with traditional findings (colonoscopy and small-bowel follow through [SBFT]) in patients with known Crohn's disease |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn's disease |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capsule endoscopy in small bowel
NightOwl Pulse Oximeter Calibration Study

Study Overview
=================
Brief Summary
-----------------
Calibration of a software module that computes SpO2 based on photoplethysmography (PPG) traces acquired by a reflectance-based pulse oximeter which can be placed on the index finger or the forehead. The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601- 2-61:2011)

Official Title
-----------------
NightOwl Pulse Oximeter Calibration Study

Conditions
-----------------
Pulse Oximeter Calibration

Intervention / Treatment
-----------------
* Device: NightOwl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects (ASA 1 and ASA 2) upon signing the informed consent. (ASA : american society of anesthesiologist's health score) Exclusion Criteria: smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels. individuals subject to conditions that result in elevated levels of methaemoglobin. individuals with arterial cannulation or hypoxia at FiO2 = 0,21

Ages Eligible for Study
-----------------
Minimum Age: 13 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pulse oximeter calibration population<br> | Device: NightOwl<br>* The NightOwl is a finger and/or forehead mounted device with, among other functions, the capability to acquire double-wavelength PPG, from which SpO2 can be derived<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A_rms determination | After calibration of the NightOwl SpO2 software module, the A_rms metric will be computed. This metric constitutes the performance metric proposed by ISO 80601-2-61:2011 Annex CC: Determination of accuracy. This metric captures the bias and precision of the computed SpO2 values compared to the benchmark. | Within 3 months after subject recruitment, the calibration and ARMS determination should have been performed. |
Assessment of Interactions Between Methamphetamine and Aripiprazole - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the interactions between intravenous methamphetamine and aripiprazole.

Detailed Description
-----------------
This is a double-blind, placebo-controlled human laboratory clinical pharmacology study to assess potential interactions between intravenous d-methamphetamine infusion and treatment with oral aripiprazole.

Official Title
-----------------
Assessment of Interactions Between IV Methamphetamine and Aripiprazole

Conditions
-----------------
Amphetamine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must meet DSM-4 criteria for methamphetamine abuse or dependence and are non-treatment seeking. Ability to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures. Exclusion Criteria: Please contact the site for more information.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effect measures |  |  | 
| pharmacokinetic assessment |  |  |