linjc16/ctgov huggingface dataset:
Sensitivity of Hyomental Distance Ratio as a Single Predictor of Difficult Intubation in Obstetrics

Study Overview
=================
Brief Summary
-----------------
This is a study to detect the sensitivity of thyromental distance ratio as a single predictor for difficult intubation in patients undergoing cesarean section under general anesthesia.

Detailed Description
-----------------
The authors intend to use the HMDR for detection of difficult intubation in parturient undergoing cesarean section that is either elective or emergency.

Official Title
-----------------
Hyomental Distance Ratio as a Predictor for Difficult Intubation in Elective and Emergency Cesarean Section.

Conditions
-----------------
Caesarean Section

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting for cesarean section under general anesthesia Exclusion Criteria: None

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of difficult intubation |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Difficult intubation, Hyomental distance, Obstetric, Mallampati classification, Thyromental distance, Sternomental distance
Evaluation of the Risk for Radiographic and Clinical Nonunion in Patients With Previous Bisphosphonates Therapy.

Study Overview
=================
Brief Summary
-----------------
Dose and duration of bisphosphonate therapy will increase the likelihood that patients experience delayed healing of non-union fractures.

Detailed Description
-----------------
We intend to review the UWHealth patient database to identify individuals with delayed or nonunion fractures. Subsequently, we will collect associated medical information related to fractures such as age of osteoporosis diagnosis, BMI, previous bisphosphonate treatment, type and location of fracture, time to complete union, other treatment needed for nonunion etc. With this information, we will evaluate the risk of delayed and nonunion fractures in patients previously receiving bisphosphonate treatment compared to a normal population. We also will investigate other potential causes of delayed or nonunion fractures in this population.

Official Title
-----------------
Evaluation of the Risk for Radiographic and Clinical Nonunion in Patients With Previous Bisphosphonates Therapy.

Conditions
-----------------
Non-union or Delayed Healing Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women older than 60 years old with delayed or nonunion low trauma fracture between 01/01/2000 - 12/31/2011. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Prior bisphosphonate users<br>Patients with record of using bisphosphonate medication | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with delayed healing or non-union fractures with prior bisphosphonate use | This variable will be generated by reviewing diagnosis codes from patients seen at the University of Wisconsin Hospital and Clinics during the time period identified above. | 01/01/2000 - 12/31/2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of patient variables (demographic or medical history) related to non-union or delayed healing fractures. | Patients with non-union or delayed healing fractures obtaining care at the University of Wisconsin Hospital or Clinics will have a medical record review conducted. | 1/1/2000-12-31-2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, low trauma fracture, non-union fracture, delayed healing fracture, bisphosphonate
Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

Conditions
-----------------
Subjective Tinnitus

Intervention / Treatment
-----------------
* Drug: Neramexane mesylate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 to 75 years with a clinical diagnosis of first onset, Persistent (i.e. tinnitus should never be absent for > 24 hours in a row), subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 12 months Exclusion Criteria: Clinical diagnosis of intermittent or pulsatile tinnitus Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Menière's disease, otosclerosis, etc)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Neramexane mesylate<br>* Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Double-blind treatment period of 17 weeks placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 Tinnitus Handicap Inventory-12) total score change from baseline to end of treatment |  | Screening, Baseline, week 5, 13, 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics |  | 17 weeks | 
| safety parameters |  | 17 weeks |
Collecting Ducts Carcinoma: in Depth Exploration and Biologically Driven Therapy (CICERONE)

Study Overview
=================
Brief Summary
-----------------
Collect a large number of samples with certain / suspected diagnosis of collecting duct carcinoma in order to confirm the diagnosis (centralized review) and standardize according to WHO 2016 criteria Build an extensive tissue bank (DNA and RNA extraction) aimed at defining the molecular taxonomy of the tumor through 1) transcriptomic analysis 2) gene expression profile Define specific molecular signatures

Official Title
-----------------
Collecting Ducts Carcinoma: in Depth Exploration and Biologically Driven Therapy (CICERONE)

Conditions
-----------------
Collecting Duct Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Signature of consent (for patients enrolled in the prospective part of the study) Histological diagnosis of renal cell carcinoma of the Bellini collecting duct RCC Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| samples to confirm and standardize | Collect a large number of samples with certain / suspected diagnosis of collecting duct carcinoma in order to confirm the diagnosis (centralized review) and standardize it according to WHO 2016 criteria | 15 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Bank | Build an extensive tissue bank (DNA and RNA extraction) aimed at defining the molecular taxonomy of the tumor through 1) transcriptomic analysis 2) gene expression profile | 15 month | 
| specific molecular signatures | Define specific molecular signatures | 15 month |
Long-term Treatment Outcome for Stage III NPC Patients and Risk Grouping by Plasma EBV DNA

Study Overview
=================
Brief Summary
-----------------
No previous study reported the treatment outcome of stage III nasopharyngeal carcinoma (NPC) patients. The investigators try to investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by plasma Epstein-Barr virus (EBV) DNA assay for future therapy improvement.

Detailed Description
-----------------
The stage III NPC patients were the majority group of the patient population of NPC. But most clinical trials focused on the treatment of American Joint Committee on Cancer (AJCC) 7th edition stage IVA/IVB treatment for high risk of recurrence or metastasis. No previous study reported the treatment outcome of stage III NPC patients. The investigators tried to investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by plasma EBV DNA assay for future therapy improvement.

Official Title
-----------------
Long-term Treatment Outcome for Stage III Nasopharyngeal Carcinoma Patients and Risk Grouping by Plasma Epstein-Barr Virus DNA

Conditions
-----------------
Nasopharyngeal Carcinoma, EBV Related Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy-proven stage III nasopharyngeal carcinoma (NPC) Finished curative chemoradiotherapy Have Pre-treatment and post-radiotherapy plasma EBV DNA Exclusion Criteria: No tissue proven NPC Not finished curative treatment No Pre-treatment and post- radiotherapy plasma EBV DNA

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Overall survival (OS) | Diagnosis to death | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Diagnosis to death to recurrence or metastasis | 5 year | 
| Distant metastasis failure-free survival (DMFFS) | Diagnosis to death to distant metastasis | 5 year | 
| Locoregional failure-free survival (LRFFS) | Diagnosis to death to locoregional failure | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharyngeal Carcinoma, plasma EBV DNA
Buphenyl Therapy for Byler's Disease

Study Overview
=================
Brief Summary
-----------------
This is a single patient compassionate use protocol to determine whether Buphenyl (4-phenylbutyrate) will improve the poor bile flow associated with Byler Disease.

Official Title
-----------------
Compassionate Use of Buphenyl® in the Treatment of Byler's Disease

Conditions
-----------------
Byler Disease

Intervention / Treatment
-----------------
* Drug: Buphenyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Byler Disease Cholestasis unresponsive to pharmacologic therapy Exclusion Criteria: Allergy/Hypersensitivity to Buphenyl

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study in Adult and Pediatric Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis

Official Title
-----------------
Ph 1b/2a Study to Assess Levels of INS37217 and Placebo Treatment With Maximum Tolerated Dose Administered by Inhalation Via the Pari LC Star Nebulizer in Adult and Pediatric CF Patients

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

Intervention / Treatment
-----------------
* Drug: denufosol tetrasodium (INS37217) Inhalation Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FEV1 40-70% (adults) FEV1 >/=50% (pediatrics) oxygen saturation >90% clinically stable willing to stay overnight Exclusion Criteria: abnormal renal or liver function receiving corticosteroids exceeding 10mg/day or 20 mg every other day received intravenous or aerosolized antibiotics 1 week prior to dosing

Ages Eligible for Study
-----------------
Minimum Age: 5 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: denufosol tetrasodium (INS37217) Inhalation Solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess effects of INS37217 on sputum weight and symptoms |  |  |
IMproved PREdiction of Severe Sepsis in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used as a marker of severe sepsis (including septic shock) in patients presenting to the emergency department with suspected infection.

Official Title
-----------------
Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein (HBP) Assay for Indicating the Presence, or Outcome, of Severe Sepsis (Including Septic Shock), Over 72 Hours, in Patients With Suspected Infection Following Emergency Department Admission.

Conditions
-----------------
Systemic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 18 years Suspected Infection one or more SIRS criteria

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 |
| --- | --- | --- |
Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a 52-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Official Title
-----------------
Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients successfully completing study CLAF237A2309 are eligible Written informed consent Ability to comply with all study requirements Exclusion Criteria: Premature discontinuation from CLAF237A2309 Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety during 104 weeks of treatment |  |  | 
| Change from baseline in HbA1c at 104 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c between 52 weeks and 104 weeks |  |  | 
| Change in fasting plasma glucose between 52 weeks and 104 weeks |  |  | 
| Change from baseline in fasting plasma glucose at 104 weeks |  |  | 
| Change from baseline in HOMA B at 104 weeks |  |  | 
| Change in HOMA B between 52 weeks and 104 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Freedom Study: Myfortic in Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.

Official Title
-----------------
Study to Investigate the Clinical Outcomes of Different Regimens of Myfortic® in De Novo Kidney Tx Pts Using Simulect® and Neoral® With or Without Steroids

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Myfortic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged 18 to 75 years. Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression. Exclusion Criteria: Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ. Kidneys from non-heart beating donors or HLA identical living related donors. ABO incompatibility against the donor.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated glomerular filtration rate after 12 months treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months. |  |  | 
| Patient and graft survival after 12 months. |  |  | 
| Incidence of AEs and SAEs after 3 and 12 months. |  |  | 
| Blood pressure, lipids and glucose profiles after 3 and 12 months. |  |  | 
| Percentage of patients free of steroids at 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MPA, Kidney Transplantation, Acute rejection, Kidney function