linjc16/ctgov huggingface dataset:
Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test

Study Overview
=================
Brief Summary
-----------------
To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction (BOO) in men with benign prostatic hyperplasia. Penile cuff test provides a means of obtaining a urodynamic diagnosis with a high level of accuracy without the morbidity and expense of invasive Pressure flow study. Penile cuff test may be particularly useful in the counseling of patients prior to benign prostatic hyperplasia operation. Patients diagnosed as obstructed following a penile cuff test can be reassured that surgery has a high chance of resulting in symptomatic benefit

Conditions
-----------------
Bladder Outlet Obstruction, Pressure Flow Study

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients with Low Urinary Tract Symptoms over 6 months. (International prostatic symptom score >= 12) Patients scheduled to have pressure flow study. Able to give fully informed consent Exclusion Criteria: Patients with urologic malignancies such as prostate cancer and bladder cancer Patients underwent urethral, prostate surgery Patients with urethral stricture or bladder diverticulum or bladder neck contracture seems not to be appropriate to this study by the decision of investigators because of any other reasons

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Positive/Negative Predictive Value of Penile cuff test |  | 5 hours | 
| The proportion comparison of Good responder between obstructed and unobstructed patients in penile cuff test | good responder: The reduction in the International Prostatic Symptom Scores of more than 50% from the initial scores 3 months after operation. | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation of intra-vesical Pressure between Pressure flow study and penile cuff test |  | 5 hours | 
| The difference of Pain visual analogue scale score between two diagnostic tests |  | 5 hours | 
| The categorical change of penile cuff test normogram after BPH operation |  | up to 3 months | 
| The PSA level change after benign prostatic hyperplasia operation in obstructed and non-obstructed patients. |  | up to 3 months . | 
| The changes of International Prostatic Symptom Scores after BPH operation. |  | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Penile Cuff Test
Effect of a Fatty Meal on Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Overview
=================
Brief Summary
-----------------
This study is to determine if a fatty meal would improve the ERCP procedure.

Detailed Description
-----------------
A fatty meal is a potent stimulator of cholecystikinin (CCK) in human body. The biological effect of CCK is increasing bile secretion and relaxing the sphincter of Oddi. Theoretically, a fatty meal should facilitate the effect on cannulation at ERCP. If a fatty meal can make the major papilla cannulation easier, it may significantly shorten the procedure time for ERCP and even decrease complications of the procedure, since the complication rate of post-ERCP is positively related to the time of the procedure. Comparison: Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group.

Official Title
-----------------
Effect of a Fatty Meal on Cannulation at Endoscopic Retrograde Cholangiopancreatography

Conditions
-----------------
Biliary Tract Disease

Intervention / Treatment
-----------------
* Behavioral: a fatty meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, 18 years and older, who are scheduled for ERCP at Emory University Hospital and signed consent before the procedure. Exclusion Criteria: Patients with a known allergy to milk or those who choose not to sign the consent.

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
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: a fatty meal vs normal saline<br>Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group | Behavioral: a fatty meal<br>* Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a fatty meal in the study group and normal saline in control group |  | the procedure time for ERCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follow up within 3 days for complication with relation to the cannulation time |  | within 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
a fatty meal, ERCP
Maternal Hypotension During Cesarean Section and Short Term Neonatal Outcome.

Study Overview
=================
Brief Summary
-----------------
About 20-25% of deliveries are by cesarean section. Most are elective with use of regional anesthesia (spinal/epidural). Drop of blood pressure after regional anesthesia is common. It have the risk of reduction of blood flow to the placenta and the fetus. No studies had followed the newborns their first days of live,of mothers who developed hypotension in durins CS.

Detailed Description
-----------------
A reterospective study of all full term babies, born in elective cesarean section with use of regional anesthesia. Two groups will be define rgarding maternal hypotention following regional anesthesia - maternal hypotention (study group) or normal maternal BP. The definition of Maternal hypotension: decrease in 10% or more in mean BP in compared to first BP taken at admition. Data will colect from mothers and neonates records as well as operation data. Maternal data: gravida, parity, diseases, medications, demographics, and all data regarding the operation (blood pressures, Heart rates, saturation, treatment given etc.). Infant data: gestational age, birth weight, sex, Apgar, cord pH, clinical manifestations, medications, time of hospitalization.

Official Title
-----------------
Maternal Hypotension During Elective Cesarean Section and Short Term Neonatal Outcome.

Conditions
-----------------
Elective Cesarean Section, Maternal Hypotention

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fullterm infants, born by elective cesarean section using regional anasthesia. Exclusion Criteria: preterms, urgent CS, CS using general anasthesia, Multiple pregnancy, Congenital malformations.

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

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
-----------------
regional anestesia, cesarean section, hypotention, newborn
Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program using 68Ga PSMA-HBED-CC (68Ga-PSMA-11). The primary goal of this expanded access program is to make 68Ga PSMA-11 PET/CT imaging available to patients.

Detailed Description
-----------------
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) has recently been approved by the FDA for clinical use in a formulation utilized at the University of California in Los Angeles UCLA) and San Francisco (UCSF). The production process for 68Ga-PSMA-11 at the University of Michigan (UM) is different and not FDA approved. This expanded access program was established to allow a continued use of 68Ga-PSMA-11 produced at the University of Michigan for clinical management for prostate cancer at the University of Michigan.

Official Title
-----------------
Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer

Conditions
-----------------
Prostate Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: 68Ga-PSMA-11


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathological proven prostate adenocarcinoma Elevated PSA after initial therapy: Post radical prostatectomy (RP) - AUA recommendation. PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL Elevated PSA after initial therapy: Post radiation therapy or post focal therapy of prostate gland. Nadir + greater than or equal to 2 ng/mL rise in PSA Ability to understand a written informed consent document and the willingness to sign it Exclusion Criteria: Current investigational therapy for prostate cancer Unable to lie flat, still, or tolerate a PET/CT scan

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 68Ga-PSMA-11|68Ga-PSMA-11 is a radiopharmaceutical for the detection of prostate cancer using PET/CT imaging|

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
-----------------
Prostate Cancer
FGF-21 and Exercise in Relation to Insulin Secretion

Study Overview
=================
Brief Summary
-----------------
FGF-21 and insulin are key hormones in the regulation of glucose metabolism. Furthermore, both hormones are influenced by physical activity. The following hypothesis will be tested: FGF-21 is regulated insulin-dependent during exercise.

Detailed Description
-----------------
Type 2 diabetes mellitus (T2DM) is a metabolic disorder characterized by rising global importance. In Germany alone, more than seven million people are being treated currently. T2DM is characterized by permanently elevated blood glucose levels, based on insulin resistance and followed by associated beta cell failure. In our previous work the investigators could already shown that increased FGF-21 levels are accompanied by an increased risk of T2DM. Physical activity is essential in the treatment and the prevention of T2DM. Interestingly, it was shown that acute physical exercise was leading to decreased insulin levels and increased FGF-21 values. In this study the effects of acute physical activity on FGF-21 values should be investigated in 3 groups: a) Healthy volunteers b) persons with T2DM c) persons with T1DM.

Official Title
-----------------
FGF-21 During Physical Exercise in Patients With Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus and Healthy Controls

Conditions
-----------------
Physical Activity

Intervention / Treatment
-----------------
* Other: spiroergometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers,persons with T2DM, persons with T1DM Exclusion Criteria: Patients with contraindications to an exercise ECG or spirometry be excluded from participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy controls<br>Spiroergometry | Other: spiroergometry<br>* Spiroergometry on a bicycle ergometer<br>|
| Other: Patients with T2DM<br>Spiroergometry | Other: spiroergometry<br>* Spiroergometry on a bicycle ergometer<br>|
| Other: Patients with T1DM<br>Spiroergometry | Other: spiroergometry<br>* Spiroergometry on a bicycle ergometer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FGF-21 change after physical activity |  | FGF-21 before and 1 h after spiroergometry |
Early Versus Late Use of Hi-VNI in Covid-19

Study Overview
=================
Brief Summary
-----------------
This study evaluate early administration of high-velocity nasal insufflation in COVID-19 patients presented with acute respiratory failure after failure of conventional low flow nasal cannula bypassing the escalating step of Non re-breathing mask where early use of High velocity nasal insufflations achieved better improvement of respiratory distress, lower oxygen requirements and shorter ICU stay.

Detailed Description
-----------------
The study included 30 COVID-19 patients admitted to intensive care of COVID-19 zone, chest Department, quarantine section, Assiut University hospital. All patients were positive for COVID-19 infection by nasopharyngeal swab for detection of viral RNA by real time PCR for SAR-COV-2 RNA assay on 7500 Applied Bio-system. All patients received treatment based on the protocol of Egyptian Ministry of Health, Patients enrolled in the study were categorized into 2 groups, the 1st group included patients whom were shifted to Hi-VNI after failure of high flow nasal cannula, while the 2nd group included patients shifted to Hi-VNI after failure of non-rebreathing mask, using a Precision flow vapotherm (vapotherm, Inc, 100 Domain device Exeter, NH 03833, T: 603-658-0011, USA), that provide high velocity humidified flow through narrow bore nasl prongs

Official Title
-----------------
The Outcome of Early Use of High-velocity Nasal Insufflation in Acute Respiratory Failure Complicating Covid-19

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-severe COVID Patients with hypoxemic respiratory failure. 2- Patients with no comorbidities Exclusion Criteria: Non severe COVID Patients Patients with comorbidities (e.g chronic chest dis, DM, renal failure and hepatic failure Patients indicated for mechanical ventilation Patients with marked hypercapnia in need for non-invasive ventilation

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early Hi-VNI<br>Group 1 of early shift to Hi-VNI after nasal cannula | |
| Late Hi-VNI<br>Group 2 of late use of Hi-VNI after NRM | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved oxygenation | Patients with early use of Hi-VNI had better improvement of oxygenation than those with late use of Hi-VNI | through the study completion, average 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hi-VNI, Covid-19
Comparison of the Laryngeal Mask Ambu Aura-i Versus AirQ in Children

Study Overview
=================
Brief Summary
-----------------
The investigators will evaluate the first attempt visualized blind intubation through an Ambu Aura-i versus an AirQ.

Detailed Description
-----------------
After induction of anesthesia, one of the 2 laryngeal masks (Ambu or AirQ) is going to be inserted. Following this, a tracheal tube is mounted on a fiberoptic scope with the tip of the scope behind the tip of the tube. This way, the tracheal tube is not guided by the scope, but the scope visualizes the course of the tracheal tube in the laryngeal mask and the glottic opening as if the tracheal tube was advanced blindly: Visualized blind intubation

Official Title
-----------------
Comparison of the Pediatric Intubation on Laryngeal Masks Ambu Aira-i and AirQ for Simulated Blind Intubation in Anesthetized Children

Conditions
-----------------
Intubation; Difficult

Intervention / Treatment
-----------------
* Procedure: Intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0-16 years max 50kg ASA I-III Exclusion Criteria: risk of aspiration known difficult airway congenital malformations respiratory tract

Ages Eligible for Study
-----------------
Maximum Age: 16 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambu Aura-i<br>intubation | Procedure: Intubation<br>* visualized blind intubation<br>|
| Active Comparator: AirQ<br>intubation | Procedure: Intubation<br>* visualized blind intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First attempt visualized blind intubation success rate |  | how many seconds needed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall intubation success rate |  | how many seconds needed |
Observational Study of the Incidence of Pressure Ulcers on the Help Support of Prevention of Bedsores POLYAIR®

Study Overview
=================
Brief Summary
-----------------
The support of help to the prevention of sores include a big diversity of devices. The clinical experiment of these support comes up against the problem of the large number of factors participants in the genesis of bedsores. Nevertheless, it seems to be interesting to estimate the incidence of bedsores in these supports, with control of other factors

Conditions
-----------------
Pressure Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Norton Index <9, No sores in ischiatic zone, Sitting position not less than 2 hours per day Exclusion Criteria: Sores in ischiatic zone, Sitting position >2 hours per day

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 98 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 |
| --- | --- | --- |
| Incidence of sores in ischiatic zone |  | 30 days |
Single Pass Albumin Dialysis in Patients With Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.

Detailed Description
-----------------
Albumin dialysis has beneficial effects in patients with acute on chronic liver failure. However, current devices are complex and costly. The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.

Official Title
-----------------
Prospective Pilot Study Assessing Safety and Efficacy of Single Pass Albumin Dialysis in Patients With Acute on Chronic Liver Failure

Conditions
-----------------
Cirrhosis, Acute on Chronic Hepatic Failure, Hepatorenal Syndrome, Encephalopathy

Intervention / Treatment
-----------------
* Device: Single pass albumin dialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age of 18 years Written consent after information of the patient or, in case of inability, by a parent or a close if he is present. Patient having a cirrhosis researched by previous exams (liver biopsy) or, in the absence of previous diagnosis, diagnosed in view of the results of clinical, biological and morphological data, whatever the origin of the cirrhosis (virus of hepatitis B, virus of hepatitis C, extreme consumption of alcohol or other reasons) Exclusion Criteria: Participation to an other study in the 4 weeks before Active digestive bleeding, unchecked by the pharmacological treatments and the endoscopic techniques.

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: 1: Single pass albumin dialysis<br>Patients entered in the pilot study. | Device: Single pass albumin dialysis<br>* 6 hours sessions of albumin dialysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on clinical and biochemical variables |  | 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Albumin dialysis, Artificial liver support, Acute on chronic liver failure