linjc16/ctgov huggingface dataset:
Prevalence of Metabolic Syndrome in Atahualpa

Study Overview
=================
Brief Summary
-----------------
A recent epidemiologic survey demonstrated a high prevalence of type 2 diabetes mellitus in Atahualpa residents. Now, the investigators attempt to evaluate the prevalence of the metabolic syndrome in adults aged 40 years or more living in this rural village of coastal Ecuador.

Detailed Description
-----------------
Several studies have shown that the occurrence of the metabolic syndrome is a risk factor for the development of cerebrovascular and ischemic heart disease. To evaluate the prevalence of the metabolic syndrome, we will invite all Atahualpa residents aged 40 years or more to participate in this study. For the purposes of this study we will obtain the waist circumference of all individuals, will measure their blood pressure using a standard protocol, and will take a blood sample to determine fasting glucose levels, HDL cholesterol levels, triglyceride levels, and plasma insulin levels.

Official Title
-----------------
Evaluation of the Prevalence of Metabolic Syndrome in Atahualpa Residents Aged 40 Years or More.

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: obtention of a blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atahualpa resident aged 40 years or more Exclusion Criteria: non-consenting persons

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| obtention of a blood sample<br>all Atahualpa residents aged 40 years or more | Other: obtention of a blood sample<br>* a blood sample will be obtained to measure glucose, HDL cholesterol, triglycerides, and for genetic testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of metabolic syndrome | determination of the metabolic syndrome in subjects aged 40 years or more | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic testing | Blood will be taken to evaluate the ADN pattern of this population, to compare with other Amerindian populations with a proven high prevalence of diabetes mellitus and metabolic syndrome | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic syndrome, diabetes mellitus
Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus

Study Overview
=================
Brief Summary
-----------------
it is a randomized clinical trial to compare deep lamellar keratoplasty (DLK) Using big bubble technique and Penetrating Keratoplasty (PK) in patients with keratoconus

Detailed Description
-----------------
In this randomized clinical trial 50 keratoconic eyes of 50 patients randomly assigned in two groups: 25 patients underwent DLK with the big bubble technique and the other 25 patients underwent PK with the standard technique using hessburg - Barron trephine. One surgeon performed all operations using a 16 bites separate 10-0 nylon sutures. We used A-scan ultrasonic biometry for measuring vitreous length (VL) before surgery. If VL≥15.50mm, a trephine 0.25mm larger than recipient and if VL was <15.50mm, a trephine 0.50 mm larger than recipient were considered. Selective suture removal was started 3 months after operation. quality of vision endothelial cell changes and correlation between refractive outcome and VL in relation to donor-recipient disparity, were measured and analyzed in both PK and DLK 15 mos postoperatively.

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Procedure: keratoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to severe keratoconus contact lens intolerance low visual acuity due to anterior stromal scar age between 15 to 50 years Exclusion Criteria: posterior stromal scar with descemets membrane involvement history of hydrops fuchs endothelial dystrophy glaucoma cataract history of intraocular surgery history of vernal keratoconjunctivitis intraoperative complications reoperation (resuturing- regraft)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 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

| Intervention/Treatment |
| --- |
|Procedure: keratoplasty|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected visual acuity (UCVA), best corrected visual acuity(bcva), refractive astigmatism, endothelial cell density, mean cell area, polymegathism (CV), Contrast sensitivity, Root-mean-square (RMS) Wavefront error, Pearson correlation factor between |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
keratoconus, penetrating keratoplasty,, deep lamellar keratoplasty, big bubble technique
Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to develop a test to assess frontal lobe function using a rapid, inexpensive, objective, and standardized method, without the need for expertise in cognitive test administration. Such methods would be particularly helpful in traumatic brain injury (TBI), where objective measures are needed, and would greatly expand the capacity to make such assessments in clinical practice and research.

Official Title
-----------------
Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to read, write, speak and understand English history of having sustained a TBI prior to enrollment. Evidence will be any one of the following 3 criteria: GCS 3 - 12 Post-traumatic amnesia > 24 hours TBI-related abnormality on neuroimaging (either CT or MRI). (Some missing information about the initial injury (i.e. documentation of initial GCS) is not necessarily exclusionary if the bulk of the available history is indicative that the patient suffered a TBI and meets the inclusion criteria) Exclusion Criteria: Multiple sclerosis, pre- or co-existing Stroke (other than stroke at the time of TBI) Pre-existing developmental disorder Pre-existing epilepsy Pre-existing major depressive disorder Pre-existing schizophrenia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| History of having sustained TBI<br>Males and females between 18 and 60 years who have a diagnosis of TBI | |
| Control group<br>Control group with no history of TBI or concussion. Gender and age matched non-TBI volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of hemodynamic response function | In two population groups: TBI and non TBI, we will determine normative data for the cognitive parametric experiment by measuring the local hemodynamic response function with functional near infrared spectroscopy | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the degree of impairment | Determine the relationship between hemodynamic response as measured by fNIRS and measures of neuropsychological and behavioral functioning obtained using measures from the NINDS Common Data Elements. | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic brain injury, functional near infrared spectroscopy
ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to investigate the efficacy and safety of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.

Official Title
-----------------
ONO-4538 Multicenter, Open-label, Uncontrolled, Phase II Study in Advanced Non-small Cell Lung Cancer

Conditions
-----------------
Advanced Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: ONO-4538


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 20 years of age Histologically or cytologically confirmed non-small cell lung cancer Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1) Exclusion Criteria: Current or prior severe hypersensitivity to another antibody product Multiple primary cancers

Ages Eligible for Study
-----------------
Minimum Age: 20 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: ONO-4538<br>ONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle | Drug: ONO-4538<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (centrally assessed) |  | Approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (study site assessment by investigator) |  | Approximately 6 months | 
| Overall survival |  | Approximately 1 year | 
| Progression free survival |  | Approximately 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-4538, Advanced non-small cell lung cancer
A Study of Pemetrexed Plus Doxorubicin Given to Patients With Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a non-randomized Phase 2 study testing pemetrexed and doxorubicin in combination for locally advanced or metastatic breast cancer. Both pemetrexed and doxorubicin have been combined with other drugs, but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs. However, there is no guarantee that the patient will benefit from this treatment.

Official Title
-----------------
A Phase 2 Study of ALIMTA Plus Doxorubicin Administered Every 21 Days in Patients With Advanced Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Pemetrexed
* Drug: Doxorubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of locally advanced or metastatic breast cancer that is not amenable to local treatment. Patients must be chemo-naive or have received only neoadjuvant and/or adjuvant chemotherapy. At least one measurable lesion. No chemotherapy within 4 weeks prior to enrollment. Signed informed consent from the patient. Exclusion Criteria: Prior chemotherapy for metastatic breast cancer. Prior treatment with any anthracyclines or anthracenedione-containing regimen. Treatment within the last 30 days with any drug that has not received regulatory approval. Pregnancy and/or breast feeding. Inability or unwillingness to take folic acid or vitamin B12 supplementation.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pemetrexed|nan|
|Drug: Doxorubicin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the antitumor activity of pemetrexed plus doxorubicin, as measured by overall tumor response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progressive disease |  |  | 
| Progression-free survival |  |  | 
| Overall survival |  |  |
Rocuronium Effective Dose for Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
This is an adaptative study where each participant's rocuronium dose will depend on the previous patient's response, being higher if it was not enough and lower if it was more than enough.

Detailed Description
-----------------
Rocuronium is one of the most used neuromuscular blockers to help intubation and to relax abdominal wall for laparoscopic surgery. Rocuronium intubation dose can be enough for intubation but not last enough for excellent laparoscopic conditions. There is little variation in time from anesthesia induction to the end of the laparoscopy for cholecystectomy and avoiding excess rocuronium dose can help providing excellent conditions and fast track extubation. Dixon's up-and-down method will guide this dose-finding study for the ED50.

Official Title
-----------------
Rocuronium ED50 for Excellent Laparoscopic Conditions for Cholecistectomy: Dose-finding Adaptative Clinical Trial

Conditions
-----------------
Muscle Relaxation

Intervention / Treatment
-----------------
* Drug: rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: general anesthesia Exclusion Criteria: deny participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Dose-finding using Dixon's up-and-down adaptative clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dose-finding group<br>The first patient will receive rocuronium 0,6mg/kg. After that, every patient's dose will depend on the outcome of the previous patient. It will go up 0,1mg/kg if the laparoscopic conditions were not excellent or go down 0,1mg/kg otherwise. | Drug: rocuronium<br>* intravenous rocuronium infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excellent laparoscopic conditions | Subjective laparoscopic conditions for surgery, assessed by the main surgeon, as excellent or not | 30 minutes |
The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province

Study Overview
=================
Brief Summary
-----------------
The antimicrobial resistance of helicobacter pylori in Shandong province was analyzed by helicobacter pylori antibiotic sensitivity test.And the map of antimicrobial resistance of helicobacter pylori was constructed to provide clinical guidance for selecting effective eradication program and improve the eradication rate.

Detailed Description
-----------------
The patients with positive H. pylori infection that was not eradicated by previous therapies will accept the gastroscopy. The mucosa of the lesser curvature of gastric antrum and the greater curvature of the stomach will progress helicobacter pylori antibiotic sensitivity test to detect the antimicrobial resistance of helicobacter pylori.The antimicrobial resistance of helicobacter pylori in Shandong province will be described by frequency and percentage.

Official Title
-----------------
The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province

Conditions
-----------------
Helicobacter Pylori

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test. Exclusion Criteria: Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial resistance rate | The antimicrobial resistance rate will be described by the frequency and percentage. | 3years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influence factors of the antimicrobial resistance rate | The chi-square test will be used to compare the influence factors of the antimicrobial resistance rate. | 3years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antimicrobial resistance
Transpulmonary Pressure in One Lung Ventilation and Open Pneumothorax

Study Overview
=================
Brief Summary
-----------------
Esophageal Pressure During one lung ventilation

Detailed Description
-----------------
Esophageal pressure comparison during positive pressure ventilation, one lung ventilation, lateral position and open pneumothorax

Official Title
-----------------
Effect 0ne Lung Ventilation and Open Pneumothorax on Respiratory Mechanics and Transpulmonary Pressure

Conditions
-----------------
Pneumothorax

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for VATS requiring one lung ventilation Body mass index below 35 kg/m^2 Exclusion Criteria: esophageal pathology preventing insertion of orogatric tube scoliosys

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in esophageal pressure | esophageal pressure in supine and lateral positions, and following one lung ventilation and open pneumothorax | from tracheal intubation untill fiveminutes after induction of open pneumothorax |
Retrospective Collection of Safety and Performance Data

Study Overview
=================
Brief Summary
-----------------
This is a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.

Official Title
-----------------
Retrospective Collection of Safety and Performance Data

Conditions
-----------------
Bone Defects

Intervention / Treatment
-----------------
* Device: Bone graft substitute


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with Bioceramed bone substitutes at the Center. Long bone & extremities: bone grafting after post-traumatic or surgically created bone defects. Spine: degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies. Exclusion Criteria: Serious infection within two months before surgery, active malignancy, cellulitis, osteomyelitis, diseases interfering with bone metabolism (primary hyperparathyroidism, severe renal or hepatic insufficiency, non-treated hyperthyroidism), other bone metabolic diseases (osteomalacia, Paget disease, osteogenesis imperfecta), bone metastasis, primary bone tumors.

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 |
| --- | --- |
| Granules in long bone & extremities<br>Filling of post-traumatic or surgically created bone defects | Device: Bone graft substitute<br>* Orthopaedic or Spine bony defects<br>|
| Wedges in long bone & extremities<br>Osteotomies with fixation | Device: Bone graft substitute<br>* Orthopaedic or Spine bony defects<br>|
| HA paste in long bone & extremities<br>Filling of post-traumatic or surgically created bone defects | Device: Bone graft substitute<br>* Orthopaedic or Spine bony defects<br>|
| Granules in Spine<br>Spinal cage filling | Device: Bone graft substitute<br>* Orthopaedic or Spine bony defects<br>|
| HA paste in Spine<br>Spinal cage filling | Device: Bone graft substitute<br>* Orthopaedic or Spine bony defects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone healing, observable by x-ray/MRI | Primary endpoint will be successful radiographic bone repair. | 6 months | 
| Bone healing, observable by x-ray/MRI | Primary endpoint will be successful radiographic bone repair. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and description of any adverse event during the follow-up | Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. | 6 - 12 months |