linjc16/ctgov huggingface dataset:
The Role of Biofeedback in Improving Continence After Anterior Resection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer.

Detailed Description
-----------------
See above

Official Title
-----------------
The Role of Biofeedback in Improving Continence After Anterior Resection

Conditions
-----------------
Rectal Neoplasms, Fecal Incontinence, Aged

Intervention / Treatment
-----------------
* Behavioral: Biofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectosigmoid or rectal cancer Exclusion Criteria: Inoperable

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback<br>Received feedback | Behavioral: Biofeedback<br>* Biofeedback sessions or biofeedback exercises<br>|
| No Intervention: No biofeedback<br>Did not received feedback | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cleveland Clinic Incontinence (CCI) Score | The Cleveland Clinic incontinence score (CCI) is an anal incontinence severity score. It is easy to use and gives the patient a score of 0 to 20, where zero equates to perfect continence and twenty equates to complete anal incontinence. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectal neoplasms, Biofeedback (Psychology), Fecal Incontinence, Aged, Anterior resection
Evaluation of Non Specific Symptoms and Quality of Life Before and After Surgery for Mild Primary Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the evolution of the non specific symptoms for 116 patients with mild primary hyperparathyroidism before and 3, 6 and 12 months after surgery. A clinical score predicting clinical improvement at one year will be created.

Official Title
-----------------
A Prospective, Non Randomized, Open, Multicenter Trial to Evaluate Non Specific Symptoms and Quality of Life (SF 36) Before and After Surgery for Mild Primary Hyperparathyroidism

Conditions
-----------------
Primary Hyperparathyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with known moderate HPTI will be considered for participation. Patients with sporadic mild HPTI defined by: calcemia > 2.6 mmol/L , PTH > 25 ng/L and creatininemia < 160µmol/L OR calcemia between 2.5 and 2.6 mmol/L and PTH > 35 ng/L calcemia ≤2.85 mmol/L urine calcium level / 24 hours < 10 mmol (400 mg), decrease of the creatinin's clearance : 30% lower than normal population with the same age patients younger than 50 patients who can't be followed Exclusion Criteria: familial hypercalcemia multiple endocrinal neoplasia treatment with lithium or thiazides impossibility for the patient to complete the forms impossibility to follow the patient patient with serious disease which impact the quality of life

Ages Eligible for Study
-----------------
Maximum Age: 50 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 |
| --- | --- |
| Patients with Hyperparathyroidism<br>The cohort of patients is made of patients with primary mild hyperparathyroidism and who have received a surgery at Nantes, Angers, Limoges or Marseille University Hospitals | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of the evolution of neuropsychic disorders, digestive disorders, asthenia and polydipsia symptoms (non specific symptoms) one year after surgery for patients with moderate HPTI. |  | one year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the quality of life with a quality of life questionnaire (SF36) given preoperatively and at months 3, 6, 12 |  | preoperatively and at months 3, 6, 12 | 
| evaluation of the evolution of neuropsychic disorders, digestive disorders, asthenia and polydipsia symptoms (non specific symptoms) at months 3 and 6 |  | at months 3 and 6 |
The Charlson Comorbidity Index: Predicting Severity in Emergency Departments

Study Overview
=================
Brief Summary
-----------------
Objective: The Charlson Comorbidity Index (CCI) is a comorbidity scale used widely throughout the world. It uses patients' preoperative and intraoperative morbidity factors to evaluate morbidity and mortality risk. Though the CCI has widespread use, it has not been evaluated in patients attending at ES, and its relationship with patient readmission has not been shown previously. In this study, we aimed to show whether there is a correlation between the CCI value and the number of repeated admissions to emergency services and that the CCI value can be used as a predicted factor for the serious patients. Matherials and Methods: This was a prospective observational cross-sectional study. Age, gender, vital signs of the patients who agreed to participate in the study was recorded. Numbers of emergency service applications in the last 6 months and CCI score have been recorded.

Detailed Description
-----------------
This study showed that CCI score can be used for identify serious patient in emergency service.

Official Title
-----------------
The Charlson Comorbidity Index: Predicting Severity in Emergency Departments

Conditions
-----------------
Emergency Medicine

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted patients were told about the study, and those who agreed to participate were included Exclusion Criteria: Patients who did not wish to participate in the study Patients who were unable to work or who had problems with consciousness Patients with non-hospital cardiopulmonary arrest Patients who had previously participated in the study (readmitted patients) Patients who had accessed ES for the same or a similar complaint within the last seven days < 18 years' old

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 |
| --- | --- |
| patient(hospitalized)<br>patients who are admitted to the emergency department and hospitalized. | Other: observation<br>* observation<br>|
| control(not hospitalized)<br>patients who are admitted to the emergency department and not hospitalized. | Other: observation<br>* observation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the severity of patients. to identify patients who need hospitalization. determine the severity of patients. | to identify patients who need hospitalization. | 2018 |
Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorsolumbar Spine Fracture

Study Overview
=================
Brief Summary
-----------------
Recording incidence of metal failure in transpedicular screws fixation of dorsal umbra spine fracture during first year follow up

Official Title
-----------------
Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorso Lumbar Spine Fracture

Conditions
-----------------
SPINAL Fracture

Intervention / Treatment
-----------------
* Radiation: Xrays


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients post traumatic dorsolumbar spine fracture fixed with short or long segment transpedicular screws With or without decompression Exclusion Criteria: pediatric patients Pathological fractures

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xrays<br> | Radiation: Xrays<br>* Plain x-rays anteroposterior and lateral views to determine system failure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiological assessment of transpedicular screws after dorsolumbar fixation | Broken rods screws loosening of screws and nuts | 1 year |
Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use

Study Overview
=================
Brief Summary
-----------------
Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.

Detailed Description
-----------------
Antibiotics resistant is serious problem in helicobacter pylori eradication. Clarithromycin is very important antibiotics in eradication. But clarithromycin resistance is increased. Major cause of clarithromycin resistance is past consumption of macrolide. Thus the investigators propose eradication of macrolide used group bismuth contained four drugs therapy.

Conditions
-----------------
Helicobacter Eradication

Intervention / Treatment
-----------------
* Drug: Helicobacter pylori eradication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peptic ulcer disease Gastric MALT lymphoma Early gastric cancer Familial history of gastric cancer Idiopathic iron deficiency Chronic idiopathic thrombocytopenia Atrophic gastritis Helicobacter infected dyspepsia Long term NSAIDs use Exclusion Criteria: Pregnant Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks Previous stomach surgery Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder) Previous Helicobacter eradication Allergy for Helicobacter eradication medicine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Experimental<br>Omeprazole 30mg twice Clarithromycin 500mg twice Amoxicillin 1000mg twice for 10 days | Drug: Helicobacter pylori eradication<br> <br> |
| Active Comparator: Control<br>Tetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days | Drug: Helicobacter pylori eradication<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori |  | one month |
Clinical Trial to Evaluate ANT-1401 in Crow's Feet

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines.

Official Title
-----------------
Clinical Trial to Evaluate ANT-1401 in Subjects With Lateral Canthal Lines

Conditions
-----------------
Lateral Canthal Lines, Crows Feet

Intervention / Treatment
-----------------
* Biological: ANT-1401
* Biological: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30 - 60 years of age mild to moderate Crow's Feet wrinkles (IGA 1-2) at rest moderate to severe Crow's Feet (IGA 2-3) on contraction moderate to severe Crow's Feet (SSA 2-3) on contraction Have adequate vision to assess facial wrinkles in a mirror Exclusion Criteria: botulinum toxin treatment in the prior 6 months history of periocular surgery, brow lift or related procedures soft tissue augmentation in the lateral canthal region in the prior 12 months dermabrasion or laser treatment in the periocular region in the last 6 months topical prescription-strength retinoids in the prior 3 months present or history of neuromuscular disease present or history of dry eye systemic aminoglycoside use in the week prior to treatment application

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br>ANT-1401 | Biological: ANT-1401<br> <br> |
| Experimental: Dose 2<br>ANT-1401 | Biological: ANT-1401<br> <br> |
| Placebo Comparator: Vehicle<br>Placebo Vehicle | Biological: Vehicle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment Scale |  | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Self-Assessment |  | Week 4 |
Study of Heat and Intravenous Fluids for Exogenous Rewarming

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two novel active rewarming techniques in mildly hypothermic people. Volunteers will undergo 3 cooling trials in a circulating bath at 14 degrees celsius and will then be rewarmed with either shivering alone, warmed iv fluids (IVF), or water perfusion pads applied to the hands and feet. The investigators hypothesize that both heated IVF and water perfusion pads to the arteriovenous anastomoses (AVAs) will prove to provide significantly superior rewarming rates than shivering alone.

Official Title
-----------------
Study of Heat and Intravenous Fluids for Exogenous Rewarming (SHIVER)

Conditions
-----------------
Hypothermia

Intervention / Treatment
-----------------
* Other: Warmed IV fluids
* Other: Warmed perfusion pads


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any healthy male or female over 18 years of age Exclusion Criteria: No heart/blood pressure/cholesterol medications. No history of Raynaud's disease or any other condition (including asthma) that could be aggravated by cold-water immersion

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: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Shivering only<br>Pt placed in sleeping bag and warmed by shivering only | |
| Experimental: Warmed IV fluids<br>2 Liter of 42 degree celsius normal saline | Other: Warmed IV fluids<br>* 1 Liter of warmed IV fluids at 42 degrees celsius<br>|
| Experimental: Warmed perfusion pads<br>Warmed perfusion pads placed to palms and soles to rewarm through arteriovenous anastomoses | Other: Warmed perfusion pads<br>* Neoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of rewarming | Track to rate of rewarming of each arm | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arteriovenous anastomoses, accidental hypothermia, rewarming
Necrotizing Enterocolitis (NEC) Surgical Database

Study Overview
=================
Brief Summary
-----------------
The general objectives of this protocol are to develop a multi-center prospective data collection process to identify risk factors for progression of Necrotizing Enterocolitis (NEC). These data will be used as a basis for identifying management strategies appropriate for further evaluation (randomized controlled trials), to develop evidence-based standards of care, and as a tool to facilitate quality-assessment at individual centers through comparison of outcomes with the entire database.

Official Title
-----------------
GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol

Conditions
-----------------
Necrotizing Enterocolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet at least one criterion from each of the following three categories: Historical Factors: Feeding intolerance defined as vomiting of 2 or more feedings within 24 hours or any vomitus containing bile, or the presence of gastric residuals of volume greater than 6cc/kg or any aspirate containing bile Apneic/bradycardic episodes Oxygen desaturation episode not otherwise explained Guaiac positive or grossly bloody stools Physical Examination Findings: Abdominal distention recorded by practitioner Capillary refill time greater than 2 seconds Abdominal wall discoloration Abdominal tenderness Radiographic Findings: Pneumatosis intestinalis Portal venous gas Ileus Dilated bowel Pneumoperitoneum Air/fluid levels Thickened bowel walls Ascites or peritoneal fluid Free intraperitoneal air Exclusion Criteria: Patients will be excluded for any of the following: Major gastrointestinal anomaly Prior abdominal operation Family does not consent to participate (A list of patients for whom consent was refused will be maintained in order to avoid contacting these families repeatedly. All families who refuse consent will be queried as to the reason for refusal).

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 2 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
-----------------
Necrotizing Enterocolitis
A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics following a single oral dose.

Official Title
-----------------
A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Subjects

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: PF-04620110


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years Body Mass Index (BMI) of approximately 27 to 35 kg/m2; and a total body weight >50 kg (110 lbs) Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Subjects will be given placebo or PF-04620110<br>|
| Experimental: PF-04620110<br> | Drug: PF-04620110<br>* A single oral dose of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned and the period of the cross-over for that cohort. Initial planned doses are 0.3-30 mg but may be modified based on emerging PK and safety data.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements. |  | 4 days/dose group | 
| The single dose pharmacokinetics of PF-04620110 will be assessed |  | 4 days/dose group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary pharmacodynamic endpoints will include postprandial lipid metabolism measures |  | 1 day/dose group | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single Ascending Dose Study in Overweight subjects