linjc16/ctgov huggingface dataset:
Study on Breast Cancer Patient Perspectives of Exercise

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to establish the feasibility/willingness of breast cancer patients to delay surgery to do an exercise program, or be randomized to an exercise training program following treatment, and to see if that willingness correlates with prior physical activity history.

Official Title
-----------------
Study on Breast Cancer Patient Perspectives of Exercise

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women, breast cancer diagnosis, all races will be included. Exclusion Criteria: men, those with no breast cancer (ductal carcinoma in situ), pregnant women, children

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

| Intervention/Treatment |
| --- |
|Behavioral: Survey|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects providing completed surveys |  | 1 year |
Primary Care in AURA for COVID-19

Study Overview
=================
Brief Summary
-----------------
As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic.

Official Title
-----------------
Primary Care in AURA for Covid-19: Implementation of a Regional Practice-based Surveillance Network

Conditions
-----------------
Primary Care : Suspected and Confirmed Cases of COVID-19, Primary Health Care, COVID-19 Pandemic

Intervention / Treatment
-----------------
* Other: No intervention (surveillance system)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspect or confirmed COVID-19 case consulting in primary care in the Aura region Exclusion Criteria: Patient with a COVID-19 diagnosis excluded after clinical examination or investigation. Patient refusing to participate to the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surveillance network<br>The surveillance network is made of 200 health professionals from 85 practices | Other: No intervention (surveillance system)<br>* The surveillance network will collect data on all consecutive COVID-19 cases<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of the weekly incidence of COVID-19 confirmed cases | Confirmed cases will be defined by the positivity of the detection of SARS-CoV-2 in RT-PCR and possibly by serology (for patients in whom a test is performed). The incidence rate of confirmed cases will be estimated from the number of new cases confirmed by a positive biological test reported in the patient population of the participating facilities. | 30 days after the COVID-19 suspected | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Primary care, Clinical epidemiology, Practice assessment
Effect of Intrathorathic Oscillations on Pulmonary Functions in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Aim: To investigate the effect of intrathoracic oscillations on forced expiratory volume at first second and peak expiratory flow in the children with cerebral palsy. Methods and Procedures: Children were randomly assigned into two groups (study group and control group). Each child was evaluated before and after 6 successive weeks.

Detailed Description
-----------------
Methods and Procedures: 24 children with spastic cerebral palsy from both sexes, There ages from 6 to 8 years old. Children were randomly assigned into two groups (study group and control group). Each child was evaluated before and after 6 successive weeks. The children of the control group received traditional chest physiotherapy. while, the children of the study group received 4 sessions per week for 6 weeks with quake device.

Official Title
-----------------
Effect of Intrathorathic Oscillations on Pulmonary Functions in Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Procedure: Quake device training
* Procedure: Traditional chest physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with cerebral palsy Age from 6 to 8 years old the degree of spasticity from 2 to 2+ grade 4, 5 according to GMFCs Exclusion Criteria: Uncontrolled convulsions Any psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Quake breathing, patients were advised to take a deep breath and hold it for 3-5 seconds. | Procedure: Quake device training<br>* In Quake breathing, patients were advised to take a deep breath and hold it for 3-5 seconds. The patient had the mouthpiece firmly sealed to the lips and were asked to inhale and exhale completely<br>|
| Active Comparator: Control group<br>Percussion, vibration and shaking were used accompanied with postural drainage. | Procedure: Traditional chest physiotherapy<br>* postural drainage - percussion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | Forced expiratory volume at first second | After 6 weeks | 
| PEF | Peak expiratory flow | After 6 weeks |
Serum Lactate in Acute Mesenteric Ischemia

Study Overview
=================
Brief Summary
-----------------
Background: Acute mesenteric ischemia is a vascular emergency with high mortality because of ambiguous symptomatology and a lack of early diagnostic markers. Lactate dehydrogenase has been described as a mortality biomarker and bowel necrosis length too. Nevertheless, the association between them has been mildly studied. Our objective was to evaluate the association between serum lactate admission levels, bowel necrosis extension, and mortality. Additionally, we performed a mortality characterization. Materials and Methods: A retrospective cross-sectional study was designed. We reviewed patients' clinical records with acute mesenteric ischemia that attended a hospital between 2012 and 2018. We compared serum lactate admission levels with bowel necrosis length and mortality. A receiver operating characteristic curve was performed on the last association. As post hoc analysis, a classification and regression tree on mortality was fitted.

Official Title
-----------------
Lactate Dehydrogenase, Bowel Necrosis and Mortality in Acute Mesenteric Ischemia: Retrospective Cross-Sectional

Conditions
-----------------
Mesenteric Ischemia

Intervention / Treatment
-----------------
* Diagnostic Test: Lactate Dehydrogenase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years of age Required urgent laparotomy with a postoperative diagnosis of acute mesenteric ischemia Attended the private academic hospital, between 2012 and 2018 Had a registered serum lactate dehydrogenase at admission Exclusion Criteria: Secondary causes of AMI Chronic intestinal ischemic Patient records with no description of the serum lactate dehydrogenase or extension of intestinal necrosis

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Lactate Dehydrogenase|All the patients that arrived at the hospital with symptoms of mesenteric ischemia, had a registered lactate dehydrogenase. We compared the value with the patient's outcomes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Lactate in mmol/l |  | 30 days | 
| Bowel necrosis length in cm |  | 30 days | 
| Percentage of patients that died between 30 postsurgical days, % |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut value of lactate levels as a predictor of mortality, in mmol/l | A receiver operating characteristics curve | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarker, L-Lactate, Mortality
Study of Endoscopic Sphincterotomy With Needle Knife Papillotome in Patients of Ampullary Impacted Stone

Study Overview
=================
Brief Summary
-----------------
Using a needle knife papillotome by an experienced endoscopist, endoscopic sphincterotomies were performed in difficult cannulation cases. In a prospectively collected database, we investigate the complications of those with ampullary impacted stone.

Detailed Description
-----------------
The endoscopic sphincterotomy with needle knife papillotome is a well-established advanced endoscopic technique in difficult cannulation cases. Choledocholithiasis impacted at the ampulla of Vater is occasionally seen. Inflammed surrounding mucosa frequently accompanies. Whether sphincterotomy with a needle knife increases the bleeding complications is to be elucidated in this study.

Conditions
-----------------
Choledocholithiasis, Endoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: choledocholithiasis patients and an ampullary impacted stone Exclusion Criteria: patients with liver cirrhosis , pregnancy, history of abdominal malignancy, bleeding diathesis, ileus, renal failure

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sphincterotomy, needle knife, hemorrhage, complication
TIVA, Inhalation Anesthesia, and Surgical Site Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this retrospective study was to evaluate the incidence of SSI after colorectal surgery under the general anesthesia by different general anesthetic technique: inhalation versus total intravenous anesthesia.

Conditions
-----------------
Colorectal Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| Total intravenous anesthesia<br>Total intravenous anesthesia using propofol and remifentanil | |
| Inhalation<br>Balanced inhalation anesthesia using volatile anesthetics and remifentanil | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Number of participants with surgical site infection | Postoperative 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative C-reactive protein | Plasma concentration | Postoperative 1 day | 
| Segmented neutrophil count | Segmented neutrophil count | Preoperaitve 1 day, postoperative 1 day | 
| Transfusion | Number of unit of transfused red blood cells | The day of operation, postoperative 30 day |
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients who are currently on metformin monotherapy.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Phase II Study to Evaluate the Efficacy and Safety of 3 Months of Twice-a-week Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy

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

Intervention / Treatment
-----------------
* Drug: 1.5 mg or 2.0 mg CJC-1134-PC
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: BMI: 27 to 45 kg/m2 Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator Stable life-style, i.e. diet & physical activity, as determined by the Investigator Stable metformin daily dose ≥1000 mg for at least 3 months Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%

Ages Eligible for Study
-----------------
Minimum Age: 25 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>Twice-a-week dose of 1.5 mg CJC-1134-PC | Drug: 1.5 mg or 2.0 mg CJC-1134-PC<br>* twice-a-week<br>|
| Experimental: 2<br>Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo | Drug: 1.5 mg or 2.0 mg CJC-1134-PC<br>* twice-a-week<br>|
| Placebo Comparator: 3<br>Twice-a-week placebo for CJC-1134-PC | Drug: Placebo<br>* twice-a-week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of HbA1c From Baseline | Change from baseline | Screening and Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Fasting Plasma Glucose From Baseline | Change from baseline | Screening and Day 85 | 
| Reduction in Fasting Body Weight From Baseline | Change from baseline | Screening and Day 85 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GLP-1, incretin, type 2 diabetes
The Results and Outcomes of the Modified Swedish Adjustable Gastric Band (SAGB-VC)

Study Overview
=================
Brief Summary
-----------------
Since a few years the SAGB-VC is used in our clinic. This type of band has a number of advantages when compared to the earlier versions of the adjustable gastric band (AGB), reducing the chances on leakage, tube disconnection and port problems. In our clinic the follow up is strict. All patients are required to follow a special follow-up program in which the patient is seen 19 times during the first two years after SAGB-VC placement. This is the first retrospective clinical study of a large study population of >800 patients in which a SAGB-VC was placed. This study was conducted to evaluate the results and the efficiency of the SAGB-VC in our clinic.

Official Title
-----------------
The Results and Outcomes of the SAGB-VC in a High Volume Bariatric Centre

Conditions
-----------------
Weight Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SAGB band placed from 2004-2008 Exclusion Criteria: None

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 |
| --- | --- |
| SAGB VC group<br>Retrospectively patients with a SAGB-VC gastric band are inventorized. They will also be interviewed and BAROS scores will be taken. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | The amount of weight loss over time is researched | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bariatric Analysis and Reporting Outcome System (BAROS) score | A specific score for quality of life (QOL) and outcome for bariatric surgery is inventorized | 2 months | 
| Operating time | Operating time is inventorized | 2 months | 
| Complications | Complications are inventorized | 2 months | 
| Co-morbidities | The reduction of co-morbidities is inventorized | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss after SAGB VC band placement
Antibiotic Prophylaxis in Open Fractures

Study Overview
=================
Brief Summary
-----------------
Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures

Detailed Description
-----------------
Determine if antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures is a safe and effective alternative to standard combination therapy

Official Title
-----------------
Antibiotic Prophylaxis With Ceftaroline for Type II and II Open Fractures: a Phase 4, Open-label, Prospective Clinical Trial

Conditions
-----------------
Open Fractures

Intervention / Treatment
-----------------
* Drug: Ceftaroline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female >= 18 years old complete an informed consent patients are diagnosed with a type II or III open fracture Exclusion Criteria: allergy to beta-lactam antibiotics prior to screening prior to enrollment: patients received 3 or more doses of antibiotic prophylaxis pregnant female inability to provide consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open fractures type II and III<br>Every patients will receive Ceftaroline in an open label, single arm | Drug: Ceftaroline<br>* IV Ceftaroline will be given for 72 hours<br>* Other names: Teflaro;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury |  | 30 days |
A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine: If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone. The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be associated with the combination of these three drugs. Whether LY900003 plus gemcitabine and cisplatin can make your tumor smaller or disappear, and for how long, compared with gemcitabine and cisplatin alone. It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate LY900003 plus gemcitabine and cisplatin for other possible uses or for other medical or scientific purposes other than those currently proposed. LY900003 may not add any benefit to gemcitabine plus cisplatin.

Official Title
-----------------
A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: LY900003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage IIIB or IV non-small lung cancer Able to visit the doctor's office At least 18 years of age Adequate kidney, adrenal, and liver function Exclusion Criteria: Prior chemotherapy or biologic therapy for NSCLC Central nervous system tumors Pregnant or breastfeeding

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LY900003|nan|

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
-----------------
non-small cell lung cancer, Stage IIIB or IV non-small cell lung cancer (NSCLC)