linjc16/ctgov huggingface dataset:
Recombinant Versus Highly Purified FSH in Polycystic Ovary Syndrome (PCOS)

Study Overview
=================
Brief Summary
-----------------
Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when either recombinant or highly purified follicle stimulating hormone (FSH) is used.

Detailed Description
-----------------
Patients will be randomized using sealed and numbered envelopes and will be assigned to receive a similar ovarian stimulation regime incorporating either Gonal-F or highly purified Fostimon as the hormonal analog. Ovarian response using either of the two compounds, pregnancy rates and miscarriage rates will be compared to define possible statistical significance.

Official Title
-----------------
Recombinant FSH Versus Highly Purified FSH in PCOS Patients Undergoing Control Ovarian Stimulation and IVF: a Prospective Randomized Study

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Gonal-F, Fostimon
* Drug: Gonal-F, Fostimon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOS Primary infertility No other fertility manifestation Exclusion Criteria: Non PCOS Secondary infertility

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gonadotropin<br>recombinant or highly purified gonadotropin | Drug: Gonal-F, Fostimon<br>* dosage form<br>* Other names: Recombinant Gonadotropin, Highly purified Gonadotropin;|
| Active Comparator: Gonadotropins<br>recombinant versus highly purified gonadotropin | Drug: Gonal-F, Fostimon<br>* injection, daily, 10-15 days<br>* Other names: Fostimon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian Response |  | 0-15 days post gonadotropin administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | 12-15 days post embryo replacement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian Response in PCOS, pregnancy rate in PCOS, miscarriage rate in PCOS
A Study of Plasmatic Concentrations of Endothelin-1 (ET1), Atrial Natriuretic Peptide (ANP) and Brain Natriuretic Peptide (BNP) in Acute Ischemic Stroke.

Study Overview
=================
Brief Summary
-----------------
A study of plasmatic concentrations of endothelin-1 (ET1), atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) in acute ischemic stroke.

Official Title
-----------------
A Study of Plasmatic Concentrations of Endothelin-1 (ET1), Atrial Natriuretic Peptide (ANP) and Brain Natriuretic Peptide (BNP) in Acute Ischemic Stroke.

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female age > 18 with an ischemic stroke Exclusion Criteria: cardiac failure renal failure

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AreET1, ANP, BNP pronostic markers of stroke
Quality of Life in Patients That Undergo J Pouch or Side to End Coloanal Anastomosis for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a J pouch.

Detailed Description
-----------------
The side to end anastomosis has become popular in recent years as it is technically simple to construct. The difference between the Baker type(side to end) of anastomosis and the J pouch, is that no formal pouch is constructed in the side to end. It has one staple line and the anastomosis. The investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a J pouch.

Official Title
-----------------
A Randomized, Controlled Trial to Compare the Functional Outcome and Quality of Life in Patients With Low Rectal Cancer Who Undergo a J Pouch or a Side to End Coloanal Anastomosis

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: J Pouch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with distal rectal cancers who will be having an abdominal proctocolectomy with a low colorectal anastomosis within 4 cm of the dentate line or a coloanal anastomosis will be candidates for this study. No evidence of distant metastatsis - Exclusion Criteria: Stage IV rectal cancer History of radiation to the pelvis ( eg. for uterine or prostatic cancer) Evidence of synchronus or metachronus disease H/o dementia Prisoners Women who are pregnant History of previous Right Colectomy History of inflammatory bowel disease -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: J Pouch side to end<br>Colorectal surgery Function Quality of Life | Procedure: J Pouch<br>* Comparing J pouch, side to end coloanal surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved function and capacity of the neorectum. |  | 2 years from date of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
J pouch, colorectal, rectal cancer, coloplasty
Patients Decision Making in Choosing Between Colonic Investigation Alternatives

Study Overview
=================
Brief Summary
-----------------
This is a qualitative interview study to understand patients' priorities for different aspects of tests when considering a colonic investigation. Patients currently waiting for colon capsule endoscopy (CCE), and colonoscopy will be invited to take part. Semi-structured interviews will be carried out over the telephone following an interview guide. Recorded interviews will be transcribed and undergo thematic analysis. We will seek to publish the results of this study to inform future research and developments for colonic investigations.

Official Title
-----------------
Patients Decision Making in Choosing Between Colonic Investigation Alternatives

Conditions
-----------------
Colonic Disease

Intervention / Treatment
-----------------
* Behavioral: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 who are on the waiting list for a colonoscopy or CCE. Only patients who can provide valid consent will be included. English language speaking (translation services are not available for this study). Exclusion Criteria: Patients undergoing colonoscopy due to positive bowel screening test or due to surveillance of known colonic pathology.

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 |
| --- | --- |
| Colonoscopy<br>Patients awaiting colonoscopy | Behavioral: Interview<br>* Semi structured patient interview via telephone<br>|
| CCE<br>Patients awaiting colon capsule endoscopy | Behavioral: Interview<br>* Semi structured patient interview via telephone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of a qualitative interview discussing the patients priorities for different aspects of tests when considering a colonic investigation | We will invite patients to undergo qualitative telephone interviews to establish their priorities for different aspects of tests when considering a colonic investigation. | Through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of a qualitative interview discussing what patients' perceptions of the decision-making process are when choosing between colonic investigations | We will invite patients to undergo qualitative telephone interviews to establish their perceptions of the decision making process when choosing between colonic investigations. | Through study completion, an average of 6 months |
Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
The major goal of this project is to determine whether the use of physiologic doses of corticosteroids will decrease time to shock reversal, alters the inflammatory cascade, and alters microcirculatory flow in post-cardiac arrest patients.

Official Title
-----------------
Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Drug: Normal Saline
* Drug: Hydrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 18 years old Either pre-hospital cardiac arrest and ROSC or Inpatient Cardiac Arrest with resultant ROSC Vasopressor dependent for a minimum of 1 hour post-arrest Exclusion Criteria: Pregnant Indication for Corticosteroids outside of current research proposal DNR or comfort care measures Presence of septic shock Chronic Use (>1week) of oral Corticosteroids in the last year

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Normal Saline | Drug: Normal Saline<br>* Normal Saline<br>|
| Experimental: 1<br>Hydrocortisone 100mg every 8 hours. | Drug: Hydrocortisone<br>* Hydrocortisone 100mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Shock Reversal | The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications. | 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Length of hospital stay, an average of 9 days with a maximum of 36 days | 
| Sub-group Analysis of Patients With Adrenal Insufficiency | Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL | At time of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Arrest, Shock, Steroids
Bone Health of People With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
People with cystic fibrosis (CF) now frequently live into adulthood and with this extended life expectancy has come new clinical problems. Poor bone health, including osteoporosis and bone fractures, is one of these increasingly important conditions. Preventing the negative outcomes of poor bone health in later life is primarily related to ensuring optimal growth (weight and height) and obtaining maximal amount of bone mass during growth and development. This study will identify factors that influence bone health in a sample of children, adolescents and young adults as measured by dual energy x-ray absorptiometry and new bone densitometry methods (peripheral quantitative computerized tomography [p-QCT] and bone sonometer). We will also identify factors which influence changes in bone status over a 12-month follow-up period in a subsample of people with CF.

Detailed Description
-----------------
A total of 100 subjects with CF and pancreatic insufficiency (8-25 y, half female) will be recruited from the Children's Hospital of Philadelphia (CHOP) and the Delaware Valley region. All subjects will have baseline measurements obtained at the Nutrition and Growth Lab at CHOP. A subset of subjects will return for 12-month follow-up measurements. We will evaluate the influences on bone health, including: gender, stage of pubertal development, body weight and height, food intake (especially calcium and vitamin D), use of steroid medications by mouth, IV administration or inhalation, physical activity and lung health. We will also follow the changes in bone health and growth over 12 months, and see what factors are associated with good and poor bone development. In addition, the information from this study will be very important to planning the future trials of medication and other interventions to treat and, hopefully, to prevent poor bone health in people with CF.

Official Title
-----------------
Bone Health of People With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Diagnosis of cystic fibrosis with pancreatic insufficiency FEV-1 ? 40% predicted

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- | --- |
QuickVue Influenza A + B Test Field Study

Study Overview
=================
Brief Summary
-----------------
Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.

Detailed Description
-----------------
The objective of this study is to demonstrate an improved clinical performance of the visually read QuickVue Influenza A+B test with nasal and nasopharyngeal swab specimens. Clinical performance will be based on comparison of QuickVue results to either cell culture or an FDA-cleared molecular test at one or more Reference Laboratories.

Official Title
-----------------
QuickVue Influenza A + B Test Field Study

Conditions
-----------------
Influenza A, Influenza B

Intervention / Treatment
-----------------
* Device: QuickVue Influenza A+B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. They must meet the following criteria to be eligible for enrollment: Male or Female of all ages (with appropriate consent). The subject must have had of a fever, ≥ 37.8º C (100º F), within the last two days. Must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ILI). Nasal congestion Rhinorrhea Sore throat Cough Headache Myalgia Malaise Exclusion Criteria: 1. Has undergone treatment with anti-influenza antivirals within the previous 7 days, to include but not be limited to, Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes. 2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days. 3. Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: QuickVue Influenza A+B|Rapid diagnostic test with IVD, QuickVue Influenza A+B|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza Diagnostic test result | rapid IVD test | 10 minutes |
Corticosteroids and Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation

Study Overview
=================
Brief Summary
-----------------
Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to significantly increase hemoglobin A1C levels

Detailed Description
-----------------
HbA1C levels were evaluated in diabetic patients with COPD exacerbation on admission to the hospital and 3-months later. Demographic, clinical, laboratory variables and total steroid dose were documented. Age- and sex-matched group of diabetic patients with COPD who were admitted for other reasons, were asked to participate as a control group. Mann-Whitney and Chi square/Fischer's exact tests were used to compare between the parameters of the two groups. Wilcoxon signed rank test was used to compare between HbA1C levels at baseline and 3 months later. Multi-variate linear regression analysis was used to find predictors for increase in HbA1C levels in the patients' group.

Official Title
-----------------
The Impact of Corticosteroid Treatment on Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation

Conditions
-----------------
Diabetes, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patients with COPD exacerbation Exclusion Criteria: Patients treated with steroids during the previous 3 months

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 |
| --- | --- |
| Corticosteroid<br> | |
| non-corticosteroid group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C LEVEL |  | 3 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose levels |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Diabetes, steroids, Hemoglobin A1C DIFFERENCE
Expiratory Flow Limitation and Postoperative Complications

Study Overview
=================
Brief Summary
-----------------
Expiratory flow limitation (EFL) occurs when flow ceases to increase with increasing expiratory effort. In any circumstances EFL predisposes to pulmonary dynamic hyperinflation and its unfavorable effects such as increased elastic work of breathing, inspiratory muscles dysfunction, and progressive neuroventilatory dissociation, leading to reduced exercise tolerance, marked breathlessness during effort, and severe chronic dyspnea. Our hypothesis is that EFL should affect post operative outcomes like incidence of pulmonary complication and length of stay in hospital

Conditions
-----------------
Postoperative Respiratory Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General anesthesia Duration of the surgery >2 hours Exclusion Criteria: <18 years Consensus not given

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 |
| --- | --- |
| EFL patients<br>Patients with Expiratory Flow Limitation undergoing surgery | |
| Control group<br>Patients withouth Expiratory Flow Limitation undergoing surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary complication | Postoperative pulmonary complication such infection, acute respiratory distress, post operative desaturation | 28 days |
A Randomized Comparison Study of Aquacel Ag and Glucan II as Donor Site Dressings

Study Overview
=================
Brief Summary
-----------------
The research will be looking at patient outcomes for healing of donor sites after a split-thickness skin graft procedure for a burn or skin tissue loss. Donor site healing time, infection rate, cosmetic outcome, and patient's rating of pain will be compared between two donor site dressings, Glucan II and Aquacel Ag.

Official Title
-----------------
A Randomized Comparison Study of Aquacel Ag and Glucan II as Donor Site Dressings With Regards to Healing Time, Cosmesis, Infection Rate, and Patient's Perceived Pain: a Pilot Study.

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Other: Aquacel Ag
* Other: Glucan II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over age 18 who have sustained a 1 - 30% total body surface area burn or skin tissue loss and require skin grafting Exclusion Criteria: Individuals under the age of 18.

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 |
| --- | --- |
| Single arm study<br>Burn patients or patients with skin loss requiring split-thickness skin graft | Other: Aquacel Ag<br>* Aquacel Ag will be applied to one donor site.<br>Other: Glucan II<br>* Glucan II to be applied to a donor site on same patient for comparison<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing time |  | 7 - 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection rate |  | 1-21 days | 
| Cosmetic outcome |  | 6 months | 
| Pain rating |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn injury, Skin graft, Donor site dressing, Outcomes, Infection rate, Healing time, Cosmetic Result, Pain, Burn injured patients requiring skin grafting