linjc16/ctgov huggingface dataset:
Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to estimate the incidence of posttraumatic hypopituitarism, and to identify predisposing factors in order to establish a rational responsible socioeconomic screening program.

Official Title
-----------------
Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

Conditions
-----------------
Traumatic Brain Injury, Hypopituitarism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: International Classification of Diseases (ICD) 10 code S06.0-06.9 Age 18 - 65 years at time of traumatic brain injury Duration of hospitalization > 24 hours. Exclusion Criteria: Known pituitary disease Clinically significant liver or renal disease Breast-feeding Pregnancy Alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Hypopituitarism |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 5 years | 
| Fatigue |  | 5 years | 
| Hypopituitary specific symptoms |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic brain injury, Hypopituitarism, Incidence
GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles

Study Overview
=================
Brief Summary
-----------------
A single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles was reported to increase pregnancy and birth rates. This study was done to evaluate the reproducibility of previous findings.

Detailed Description
-----------------
GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the long GnRH agonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist protocol were included. In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: triptorelin acetate
* Drug: Na Cl %0.9


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist protocol, oocyte pick-up and ICSI. Embryo transfer performed on day 3. Exclusion Criteria: Participation in another trial that was being conducted in our unit at the same time. Preimplantation genetic screening cycles. Day 5 embryo transfers.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>GnRH agonist administration | Drug: triptorelin acetate<br>* Single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer<br>* Other names: Decapeptyl Ferring GmBH Kiel Germany;|
| Placebo Comparator: 2<br>Sterile saline injection | Drug: Na Cl %0.9<br>* 0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer<br>* Other names: Isotonik NaCl %0.09 Eczacibasi-Baxter Istanbul Turkey;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate beyond 20 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy |  |  | 
| Embryo implantation rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GnRH agonist, IVF/ICSI outcome, luteal phase
Yellow Pea Fractions and Short-term Food Intake, Subjective Appetite and Glycemic Response

Study Overview
=================
Brief Summary
-----------------
It is hypothesized that yellow pea protein and fiber will reduce short-term food intake, subjective appetite and glycemic response.

Detailed Description
-----------------
A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10 or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea fractions. Food intake was measured at an ad libitum pizza meal served 2 hours after treatment. Satiety and blood glucose (via finger prick) were measured throughout the treatment period.

Official Title
-----------------
Effect of Yellow Pea Fractions on Short-term Food Intake at 120 Minutes, Subjective Appetite and Glycemic Response in Young Adult Males

Conditions
-----------------
Obesity, Type II Diabetes Mellitus, Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: yellow pea protein
* Other: yellow pea fiber
* Dietary Supplement: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male 20-30 years old healthy weight Exclusion Criteria: smoking restrictive eating metabolic diseases breakfast skippers dieters

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 29 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Tomato Soup<br> | Dietary Supplement: Control<br>* Served in a tomato soup<br>|
| Experimental: 10 g of yellow pea fiber<br> | Other: yellow pea fiber<br>* Served in a tomato soup<br>|
| Experimental: 20 g of yellow pea fiber<br> | Other: yellow pea fiber<br>* Served in a tomato soup<br>|
| Experimental: 10 g of yellow pea protein<br> | Dietary Supplement: yellow pea protein<br>* Served in a tomato soup<br>|
| Experimental: 20 g of yellow pea protein<br> | Dietary Supplement: yellow pea protein<br>* Served in a tomato soup<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy Intake | Energy intake at an ad libitum pizza meal | at 120 minutes after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Response |  | 200 minutes | 
| Subjective Appetite |  | 200 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Food intake regulation, blood glucose regulation, protein, fiber, pulses, yellow peas
High Resolution Ultrasound in Pancreatic Ductal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Pancreatic cancer patients at UHN who have had a CT at UHN and have surgery planned will undergo a high resolution ultrasound pre-operatively and intra-operatively. This study is being done to see if using high resolution ultrasound before and during surgery will help the doctors accurately diagnose pancreatic ductal adenocarcinoma and identify if the disease has spread to other areas of the body.

Official Title
-----------------
Advancing The Local Staging Of Pancreatic Ductal Adenocarcinoma Through High-Resolution Ultrasound: A Pilot Study

Conditions
-----------------
Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females > 18 y PDAC diagnosed by typical imaging findings or pathology Scheduled for surgical resection Contrast enhanced CT scan performed locally at UHN Exclusion Criteria: 1) Inability or unwillingness to provide informed 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High Resolution Ultasound<br>Diagnostic high resolution ultrasound pre-operatively and intraoperatively | Device: Ultrasound<br>* High resolution ultrasound pre-operatively and intra-operatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High-resolution U/S will be used to measure vascular invasion and regional lymph node metastases in PDAC | The U/S results will be compared to pre-operative CT scan to help determine the diagnostic effectiveness of High Resolution US | within 2 weeks of surgery |
A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the effect of hepatic impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with hepatic impairment compared to healthy subjects.

Official Title
-----------------
A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function

Conditions
-----------------
Hepatic Impairment

Intervention / Treatment
-----------------
* Drug: Udenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 20 to 64 years at screening. Non-smokers In case of hepatic impaired patients In case of healthy volunteers, the subjects aged ± 10 years old of hepatic impaired patients Subjects within ±20% of the ideal body weight Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol. Exclusion Criteria: 1.History of portosystemic shunt surgery.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Child-Pugh A<br> | Drug: Udenafil<br>* 100mg Single Oral Dose of Udenafil<br>* Other names: DA-8159; Zydena;|
| Experimental: Child-Pugh B<br> | Drug: Udenafil<br>* 100mg Single Oral Dose of Udenafil<br>* Other names: DA-8159; Zydena;|
| Experimental: Healthy Volunteers<br> | Drug: Udenafil<br>* 100mg Single Oral Dose of Udenafil<br>* Other names: DA-8159; Zydena;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (AUC and Cmax), Safety |  | up to 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Udenafil,DA-8159,hepatic impairment,healthy volunteers
Intracuff Pressure During One-lung Ventilation in Infants and Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the initial pressure and changes of the intracuff pressure during one-lung ventilation (OLV) in infants and children during thoracic surgery.

Official Title
-----------------
Intracuff Pressure During One-lung Ventilation in Infants and Children

Conditions
-----------------
One-lung Ventilation (OLV)

Intervention / Treatment
-----------------
* Procedure: Intracuff pressure measurement in one-lung ventilation during thoracic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 0-18 yars old. Patients requiring intubation with a cuffed specialized endotracheal tube or bronchial blocker. Patients having thoracic surgery. Patients that require one-lung ventilation (OLV). Exclusion Criteria: Patients that do not require to have cuffed specialized endotracheal tube or bronchial blocker. Patients not requiring one-lung ventilation. Patients not having thoracic surgery.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Intracuff pressure during one-lung ventilation<br>Measurement of changes in intracuff pressure with one-lung ventilation during thoracic surgery. | Procedure: Intracuff pressure measurement in one-lung ventilation during thoracic surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracuff pressure during OLV | Evaluate changes in intracuff pressure with OLV during thoracic surgery. | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Initial pressure, changes of intracuff pressure, infants and children
NPDT Evaluation in Children With CFTR and (PSC)

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that PSC in children is associated with mutations and functional changes of the cystic fibrosis (CF) gene.

Detailed Description
-----------------
The purpose of this protocol is to perform Nasal Transepithelial Potential Difference (NTPD) testing to assess the function of the cystic fibrosis gene product, a chloride channel referred to as CFTR, in patients diagnosed with PSC and/or inflammatory bowel disease in childhood and currently 12 years of age and greater. Dr. Freedman's laboratory has shown that there is an increased prevalence of CFTR abnormalities in adults with PSC as demonstrated by genotype and phenotype analysis. We hypothesize that abnormalities in CFTR based on exhaustive genotype and phenotype assessments are associated with the presence of PSC in children. We would like to enroll patients with inflammatory bowel disease and no PSC to use as a control group. Subjects with PSC and/or inflammatory bowel disease diagnosed in childhood, currently aged 12 years and above, will be enrolled in study protocols at Children's Hospital in Boston, which will have received their local IRB approval. The only role for BIDMC will be to perform NTPD testing on these subjects. No other assessment or testing will be performed at our site. We will not be involved in any other aspect of care for these subjects.

Official Title
-----------------
Nasal Potential Difference Testing: Evaluation of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Function in Children With Primary Sclerosing Cholangitis (PSC)

Conditions
-----------------
Primary Sclerosing Cholangitis, Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Procedure: nasal potential difference testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 years of age and older Must have diagnosis of primary sclerosing cholangitis and/or inflammatory bowel disease Absence of other liver disease, such as viral hepatitis, drug-induced liver disease, and metabolic/hereditary liver disease No exclusion based on sex, race, and ethnic background

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: nasal potential difference testing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CFTR DNA analysis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal potential difference testing |  |  | 
| Sweat test |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PSC, IBD, CFTR
Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing SBRT Using Audiovisual Biofeedback

Study Overview
=================
Brief Summary
-----------------
Investigation of respiratory-related tumour motion in liver cancer patients undergoing stereotactic body radiotherapy treatment (SBRT) using audiovisual (AV) biofeedback.

Official Title
-----------------
Investigation of Respiratory-related Tumour Motion in Liver Cancer Patients Undergoing Stereotactic Body Radiotherapy Treatment (SBRT) Using Audiovisual (AV) Biofeedback

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: Breathe Well


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cancer patients, either primary hepatocellular carcinoma or liver metastases, eligible for stereotactic radiotherapy. >18 years old Radio-opaque markers implanted (fiducials and/or surgical clips previously implanted in the liver) Able to give written informed consent and willingness to participate and comply with the study Exclusion Criteria: Pregnant / lactating women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Free breathing or Breathe Well<br>Free breathing or Breathe Well | Device: Breathe Well<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in reproducibility of respiratory-related tumour motion (via fiducial maker surrogacy) for liver cancer patients treated with the AV biofeedback respiratory guidance system. |  | 2 years |
Monitoring Movement for Pressure Ulcer Prevention

Study Overview
=================
Brief Summary
-----------------
The goal of this work is to develop and test an automated movement detection monitoring tool that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence rates. Ten healthy participants will perform video-recorded bed movements while weight distribution and interface pressures at bony prominences on the pelvis are recorded.

Detailed Description
-----------------
The incidence rate and subsequent costs of preventable pressure ulcers is astounding. Although pressure ulcer risk assessment tools and prevention approaches have been a topic of research and for many years, the incidence rate has remained relatively consistent. One reason that progress has not been made to lower the incidence rate is that there is no objective monitoring tool to determine how much a person is moving or is being moved in their bed. Current practices are time-intensive and have not yet leveraged intelligent monitoring technology that could reduce clinical burden and increase accuracy of the risk assessment and efficacy of prevention protocols. The goal of this work is to develop and test an automated movement detection monitoring tool that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence rates. This monitoring tool will be an extension of our intelligent bed sensor we developed named the Embedded Scale, or E-Scale. The E-Scale currently has software modules that detect bed exit, individual weight, and multi-person weight. The project described here would develop a movement module for the E- Scale to monitor people's movements in bed in an attempt to eventually reduce incidence of pressure ulcers in clinical care.

Official Title
-----------------
Monitoring Movement for Pressure Ulcer Prevention

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

Intervention / Treatment
-----------------
* Device: E-Scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older Exclusion Criteria: Not able to independently get onto a bed and reposition themselves Skin lesions in the area where sensors will be placed

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-Scale<br>Weight monitoring | Device: E-Scale<br>* The E-Scale is comprised of a series of weight monitoring 'pods' and a set of software modules that facilitate data transfer and analysis.<br>* Other names: Embedded Scale;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | Weight change at each load cell | 1 hour |