linjc16/ctgov huggingface dataset:
Pre-admission Hyperglycemia and Its Effect on Morbidity and Mortality

Study Overview
=================
Brief Summary
-----------------
It is currently standard of care in many Medical and Surgical ICU's to institute a nurse driven insulin protocol in maintaining tight glucose control in the critical patient. Many articles have been written to address this topic. However, there is no current data regarding the use of glycohemoglobin as a marker of risk of morbidity and mortality. In our study we would like to determine whether or not the HbA1C could be used as a marker of morbidity and mortality. The HbA1C is a simple blood test that may be added on to any CBC collection tube; a blood sample that critical patients have drawn up to several times a day. The investigators would analyze this information in respect to the rest of the clinical data collected regarding the patient's illness.

Official Title
-----------------
To Evaluate if Pre-admission Hyperglycemia Measured by Glycosylated Hemoglobin Level Affects the Morbidity and Mortality of Patients in a Mixed Medical and Surgical Intensive Care Unit

Conditions
-----------------
Hyperglycemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to the medical and surgical ICU, and CCU that are 18 year's or older and speak English that give 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity and mortality | looking to see if HbA1C correlates with morbidity (i.e. sepsis, renal failure, length of stay) or death | at time of review | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperglycemia, HgA1c, mortality
Postoperative Treatment After Endoscopic Sinus Surgery

Study Overview
=================
Brief Summary
-----------------
Objective: Even though postoperative debridement is commonly considered as an essential part of endoscopic sinus surgery (ESS), the scientific data on the efficacy or the optimal timing of debridement is limited. In the present study, the effect of repeated debridement during the first week after ESS on the endoscopic and subjective outcome was evaluated. Study Design: Open, prospective, randomized, controlled clinical trial with two parallel groups. Methods: A total of 90 patients suffering from either recurrent or chronic maxillary sinusitis were randomized into two groups after ESS. In the active group, the nasal cavities were debrided three times on the first postoperative week, while in the control group the patients were debrided only once on the 7th postoperative day. The primary outcome measure was the presence of scarring in the middle meatus at four weeks after ESS.

Official Title
-----------------
Postoperative Treatment After Endoscopic Sinus Surgery

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Procedure: active debridement
* Procedure: control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A total of 90 patients (age 18-70 years), who underwent ESS in Kuopio University Hospital, Kuopio, Finland were included in this study. The patients suffered from either recurrent or chronic maxillary sinusitis and had American Society of Anaesthesiologists physical status 1 or 2.{{331 Sakland,M. 1941; }} Exclusion Criteria: The patients were excluded if they had: Undergone previous sinus surgery or if they had severe nasal polyposis (radiological opacification more than 50 % of the sinuses (Lund-McKay classification) Hemorrhagic diathesis Liver or kidney dysfunction Chronic malnutrition Alcoholism or inflammatory bowel disease. Other exclusion criteria were pregnancy and ongoing anticoagulant therapy.

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>debridement on 1st, 3-5th and 7th postoperative days | Procedure: active debridement<br>* debridement on 1st, 3-5th and 7th postoperative days<br>|
| Active Comparator: 2<br> | Procedure: control group<br>* Postoperative debridement on 7th postoperative day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scarring in middle meatus 4 weeks after ESS |  | 4 weeks |
Study of Assisted Hatching of Cleavage Stage Embryos

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine if assisted embryo hatching can improve pregnancy rates for good prognosis patients undergoing in vitro fertilization (IVF) with day 3 embryo transfer.

Detailed Description
-----------------
Assisted hatching is a procedure in which a hole is made in the hard covering of a developing embryo to allow the embryo to hatch more easily from this shell. This procedure is sometimes used before transferring embryos to patients after in vitro fertilization (IVF) in an attempt to improve resulting pregnancy rates. Assisted hatching has been shown to improve outcomes among certain groups of patients, such as older patients or patients with a history of IVF treatment and embryo transfer without success. Whether this procedure could benefit the broader patient population remains unclear. The purpose of this study was to evaluate potential benefits of assisted hatching for good prognosis patients who would not typically be treated with assisted hatching under current standard protocols. Pregnancy rates were compared between good prognosis patients undergoing IVF with day-3 embryo transfer with or without assisted hatching of the transferred embryos.

Official Title
-----------------
Prospective Randomized Trial of Assisted Hatching of Cleavage Stage Embryos

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

Intervention / Treatment
-----------------
* Procedure: Assisted embryo hatching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IVF patients with day 3 embryo transfer Maximum age of 39 years Maximum FSH 9 mIU/ml Maximum E2 75 pg/ml Ovulatory menstrual cycles Good embryo quality Exclusion Criteria: Diagnosis of diminished ovarian reserve, polycystic ovarian syndrome, uterine or egg factor infertility More than one previous unsuccessful IVF cycle

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Assisted embryo hatching|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy (with fetal cardiac activity) at 5 to 6 weeks after embryo transfer |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assisted Hatching, Cleavage Stage, Ovum, Embryo Transfer, Pregnancy, Embryo Implantation
Pilot Study to Determine Safety and Efficacy of Orbital Injections of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease (TED)

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.

Official Title
-----------------
A Single-masked, Placebo Controlled, Multi-center Pilot Study to Determine the Safety and Efficacy of Orbital Injections of a Fixed Dose of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease

Conditions
-----------------
Thyroid-Related Eye Disease

Intervention / Treatment
-----------------
* Drug: LIPO-102
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Non pregnant female Symptomatic exophthalmos Inactive Thyroid Eye Disease Signed informed consent Exclusion Criteria: Known hypersensitivity to study drugs Treatment with an investigational agent within 30 days of first dose History of Thyroid Eye Disease less than 6 months Previous decompression surgery Glaucoma

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIPO-102<br>Intraorbital Injection | Drug: LIPO-102<br>* intraorbital injection<br>|
| Placebo Comparator: Placebo<br>Intraorbital Injection | Drug: Placebo<br>* intraorbital injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: physical examinations, laboratory tests, VISA activity score, AE assessments |  | 8 weeks treatment and 1 week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction |  | 8 weeks treatment and 1 week follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TED
Evaluation of the Efficacy and Safety of Advantage® Strips in Women Stress Urinary Incontinence (SUI )

Study Overview
=================
Brief Summary
-----------------
This is a single-center retrospective study that evaluates the effectiveness and long-term safety of the TVT tape ( advantage Boston Scientific) in the treatment of stress urinary incontinence in women on a population of 500 patients with a mean follow-up of 6 years.

Conditions
-----------------
Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who received the laying of a strip ADVANTAGE between 1/1/2015 and 1/6/2012 Exclusion Criteria: no

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 89 Years

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

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 |
| --- | --- | --- |
| Patient global improvement scale |  | 6 years | 
| Complications |  | 6 years | 
| Urinary symptom questionnaire |  | 6 years |
Hysteroscopic Tubal Occlusion Using Iso-Amyl 2-Cyano Acrylate (Amcrylate) in Patients With Hydrosalpinx

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of infertile women with hydrosalpinx, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF.

Detailed Description
-----------------
The study will be conducted according to the guidelines on human experimentation of the 1975 Declaration of Helsinki. For all patients after taking signed informed consent , transcervical hysteroscopic cannulation of the proximal one centimeter of fallopian tubes with hydrosalpinx, will be done using a 4 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected. All the surgical procedures will be performed without anesthesia, only premedication with an NSAID (e.g. NaproxenR) is given orally one hour before the procedure. Each patient will be under close observation for the first 24 hours postprocedure for any signs of inflammation as abdominal pain, tenderness or fever and for the vital data. Hysterosalpingography will be done for all patients 0ne and 3 months postinjection to confirm tubal occlusion prior to IVF.

Official Title
-----------------
Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate in Patients With Hydrosalpinx

Conditions
-----------------
Hydrosalpinx, Infertility, Female

Intervention / Treatment
-----------------
* Drug: Isoamyl 2-Cyanoacrylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile women due to tubal factor with hydrosalpinx (unilateral or bilateral) prepared for IVF. Exclusion Criteria: Acute Pelvic inflammatory disease. Intra uterine pathology

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iso-Amyl 2-Cyano Acrylate<br>Hysteroscopic Tubal Occlusion Using Iso-Amyl 2-Cyano Acrylate (Amcrylate) in Patients With Hydrosalpinx | Drug: Isoamyl 2-Cyanoacrylate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fallopian tubal occlusion in patients with hydrosalpinx. |  | from one to three months |
Thrombophilia Screening After Severe IUGR

Study Overview
=================
Brief Summary
-----------------
This retrospective study aims to assess the input of thrombophilia screening in pregnant women with severe intra-uterine growth restricted babies.

Official Title
-----------------
Thrombophilia Screening in Women After Severe IUGR

Conditions
-----------------
IUGR, Thrombophilia, Pregnancy Complications

Intervention / Treatment
-----------------
* Biological: thrombophilia screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women over 18 years old Pregnant women IUGR defined by an EFW <3rd centile IUGR before 25 GW Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| pregnant women with severe IUGR<br> | Biological: thrombophilia screening<br>* In the IUGR group systematic thrombophilia screening had already been performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of positive's thrombophilia screening |  | 5 years |
Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data from published literature.

Official Title
-----------------
Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis

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

Intervention / Treatment
-----------------
* Drug: Tobramycin solution for inhalation
* Drug: Aztreonam lysine for inhalation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 6 years of age with a documented Cystic fibrosis (CF) diagnosis, moderate-to severe lung disease, the ability to perform reproducible pulmonary function tests, Pseudomonas aeruginosa (PA) airway infection. Exclusion Criteria: Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Tobramycin Solution<br> | Drug: Tobramycin solution for inhalation<br> <br> |
| Aztreonam lysine<br> | Drug: Aztreonam lysine for inhalation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline |  | Baseline, Weeks 2, 4 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the density of Pseudomonas aeruginosa (PA) from baseline |  | Baseline, Weeks 2, 4 and 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic fibrosis
S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine S.endotoxins , inflammatory mediators and Magnetic Resonance Spectroscopy (MRS) before and after treatment in patients of cirrhosis and minimal hepatic encephalopathy.

Detailed Description
-----------------
60 patients of cirrhosis with Minimal Hepatic Encephalopathy (MHE) who fulfills the inclusion & exclusion criteria will be the part of study. Study patients will be divided in to two groups ( n=30 in each group). Group L patients will receive lactulose therapy while Group NL will receive placebo. After 3 months , S.endotoxins , inflammatory mediators and MRS will be repeated in each group.

Official Title
-----------------
Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy

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

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: Lactulose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Cirrhosis (Age 15 yr -70 yr ) Exclusion Criteria: Recent history of gastrointestinal bleed in last 6 weeks Active ongoing infection Creatinine >1.5mg% Electrolyte impairment. (S. Sodium < 130 meq/L, S. Potassium 3.5 meq/L or >5.0meq/L) H/O use of psychotropic drugs in last 6 weeks Recent alcohol use (< 6 week ) H/O TIPS or shunt surgery. Hepatocellular Carcinoma Severe comorbidity as Congestive Heart Failure, Pulmonary disease, Neurological and Psychiatric problems impairing quality of life Poor vision precluding neuropsychological assessment

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lactulose<br>Group L receives lactulose Group NL receives placebo | Drug: Lactulose<br>* Syrup 30 ml BD for 12 weeks<br>* Other names: Duphalac , Looz;|
| Placebo Comparator: Placebo<br>Group NL receives placebo | Drug: placebo<br>* Syrup, 30 ml BD for 3 months in Gr. NL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of minimal hepatic encephalopathy |  | Baseline and at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between inflammatory mediators and grades of encephalopathy | To measure values of inflammatory mediators in different grades of encephalopathy | Baseline and at 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endotoxins HE
Prospective Registry of Patients With Pancreas Adenocarcinoma Resectable and Borderline

Study Overview
=================
Brief Summary
-----------------
Unlike other types of gastrointestinal tumors, there is controversial evidence of the efficacy of neoadjuvant therapy in patients with borderline and resectable adenocarcinoma (ADK) of the pancreas, the objective of this study is to perform a snapshot of the usual practice in our setting in terms of neoadjuvant therapy in ADK, both in terms of the different regimens used as well as the results in terms of morbidity, mortality and survival. Likewise, in a second phase, a prospective registry of patients included in the neoadjuvant regimen for both resectable and borderline ADK diagnosed in Catalonia will be launched, which will provide us with valuable information to try to answer open questions in the context of borderline and resectable ADK treatment.

Official Title
-----------------
PROSPECTIVE REGISTRY OF PATIENTS WITH BORDERLINE AND RESECTABLE PANCREATIC ADENOCARCINOMA IN CATALONIA (PaNLoCat)

Conditions
-----------------
Chemotherapy Effect, Pancreas Cancer

Intervention / Treatment
-----------------
* Procedure: Neoadyuvant therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resectable or borderline pancreas ADK with or without radiotherapy any type of approach any type of surgery Exclusion Criteria: locally advanced ADK No 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neoadyuvant therapy<br>Patients with borderline or resectable ADK subjected to neoadyuvant therapy | Procedure: Neoadyuvant therapy<br>* Patients of group neoadyuvant therapy will receive any chemotherapy treatment before surgery<br>|
| Upfront surgery<br>Patients with borderline or resectable ADK who undergo upfront surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | Three years follow-up |