linjc16/ctgov huggingface dataset:
Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether chemotherapy before surgery is more effective than surgery alone in treating cancer of the esophagus. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients with stage II or stage III cancer of the esophagus.

Detailed Description
-----------------
OBJECTIVES: I. Compare resectability and survival in patients with stage II/III esophageal cancer treated with neoadjuvant cisplatin/fluorouracil vs. surgery alone. OUTLINE: This is a randomized study. Patients are randomized to one of two groups. The first group receives cisplatin and fluorouracil every 4 weeks for 3 courses followed by esophagectomy and regional lymphadenectomy. The second group undergoes esophagectomy and regional lymphadenectomy alone. All patients are followed for survival. PROJECTED ACCRUAL: A total of 240 patients will be entered over 4 years.

Official Title
-----------------
RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: cisplatin
* Drug: fluorouracil
* Procedure: conventional surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed esophageal squamous cell cancer that is stage T2-3 Nx M0 PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within 5 years except: Basal cell skin carcinoma Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: fluorouracil|nan|
|Procedure: conventional surgery|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
-----------------
stage II esophageal cancer, stage III esophageal cancer, squamous cell carcinoma of the esophagus
Pilot Study - Putative Penetration of Nanoparticles in Sunscreen in Intact or Sunburned Skin

Study Overview
=================
Brief Summary
-----------------
The investigators want to study if nanoparticles of titaniumdioxide are penetrating skin when the skin is intact and when the skin is sunburned. The hypothesis is Does nanotitandioxide penetrate intact or sunburned skin?

Detailed Description
-----------------
In this pilotstudy there are two human volunteers. The study comprises two phases. The first phase: The volunteers are applying a commercially available sunscreen lotion containing titanium dioxide nano particles 6 times a day for one week in an area of the back that is 30x20 cm. Before the first application a 2mm punch biopsy is to be taken and examined by scanning electron microscopy. After applying sunscreen lotion for a week, a new biopsy will be taken in order to see how far down in the skin the particles have penetrated. In the second phase: An artificial sunburn will be induced in the same area of the back. They will thereafter apply the sunscreen lotion 6 times a day like in the first phase. After two days (estimated time of maximum skin irritation) a biopsy will be taken in order to see if the nanoparticles have penetrated down in the layers of the skin, and the investigators will also take a biopsy after a full week of applying the sunscreen lotion. The investigators will also examine the urine, before and after the use of sunscreen, to see if the investigators can find the particles there.

Official Title
-----------------
Pilot Study - Does Nanoparticles in Sunscreen Penetrate Intact or Sunburned Skin?

Conditions
-----------------
Healthy Skin, Sunburned Skin, Titanium Dioxide, Nanoparticles, Penetrate Skin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men above 50 years old

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>Healthy men above 50 years old | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of penetration of nano particles in skin |  | One Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of nano particles in urine |  | Two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
titanium dioxide, nanoparticles, skin, penetrate
Mitochondria and Metabolic Syndrome in a Southern California Chinese Cohort

Study Overview
=================
Brief Summary
-----------------
There has been increasing support for our hypothesis that mitochondrial dysfunction plays an important role in the etiology of Type 2 Diabetes Mellitus and the overlapping Metabolic Syndrome.

Detailed Description
-----------------
Once the mitochondrial defect(s) of these subjects has been defined, the data will be used to develop two non-invasive screening tools to detect mitochondrial defects in Diabetes Mellitus and Metabolic Syndrome patients. The device call Diffuse Optical Spectroscopy develope at Beckman Laser Instituteis is non-invasive measurement technique, to measure the properties of the muscle tisuue and vascular activity (calf, bicep, or the brain)to evaluate the patient's metabolic status and and to assess muscle mitochondrial OXPHOS function.

Official Title
-----------------
Diffuse Optical Spectroscopy Measurement Technique is Helping Develop More Effective Diagnostic Tools and Therapeutic Regimes for Diabetes, Metabolic Syndrome and Other Mitochondrial Diseases Some Time in the Future

Conditions
-----------------
Metabolic Syndrome, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Diffuse Optical Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese descent and have been clinically diagnosed with diabetes mellitus (DM) or have met the study criteria for metabolic syndrome (MS). Exclusion Criteria: non chiness descent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diffuse Optical Spectroscopy<br>muscle properties scanning | Device: Diffuse Optical Spectroscopy<br>* muscle properties scanning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near Infrared Spectroscopy to assess muscle mitochondrial OXPHOS function. |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mitochondria and Metabolic Syndrome
Normative Data for the Qmci-TW in a Taiwanese Sample

Study Overview
=================
Brief Summary
-----------------
Many perioperative factors have been pointed out as the risk factors for postoperative cognitive dysfunction, which may occur immediately after the surgery, days after the surgery, or months after the surgery. Quick mild cognitive impairment screen (Qmci) is a sensitive and specific test to differentiate mild postoperative cognitive dysfunction. However, the learning effect have been raised as a bias when we repeated the same test for one person at different timing. Thus the study is designed to collected the Normative Data in series for the Qmci-TW in a Taiwanese Sample.

Official Title
-----------------
Normative Data for the Quick Mild Cognitive Impairment-Taiwan Version (Qmci- TQ) in a Taiwanese Sample

Conditions
-----------------
Postoperative Cognitive Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults no less than 20years old Exclusion Criteria: pregnant women patients with respiratory failure [forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) < 70 % and FEV1 < 50%] patients with heart failure(NYHA score =III、IV) patients with chronic kidney disease (eGFR< 60 ml.min-1.1.73m-2) patients with liver failure patients with ongoing infection patients have surgery or hospital admission in the past half year

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Taiwan Cohort<br>For normative Taiwan people, cognitive function will be assessed by the Taiwan version of questionnaire Qmci (Qmci-TW) on Day 0, Day 2, Day 180. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function by the Taiwan version of questionnaire Qmci (Qmci-TW) | Qmci is a screening assessment developed to detect mild cognitive impairment. It's a 100-point test administered in approximately 10 minutes. A score of 60 or over is considered to be normal. The validity of the Taiwan version of Qmci has been established. | 180 days |
Usefulness of a Mobile Information Management System for Haemodialysis Patient

Study Overview
=================
Brief Summary
-----------------
The investigators developed and used the DialysisNet mobile application for physicians and Avatar Beans mobile application for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record standard. The investigators enrolled 10 patients and 4 physicians. Questionnaires to evaluate user experience and usefulness were administered before and after use.

Official Title
-----------------
Usefulness of a Mobile Information Management System for Haemodialysis Patients and the Prospect of Participatory Medicine

Conditions
-----------------
Quality of Life, Drug Habit

Intervention / Treatment
-----------------
* Device: Use of DialysisNet for doctor
* Device: Use of Avatar Beans for patient


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have maintenance hemodialysis treatment accept consent form Exclusion Criteria: pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: before and after use of program<br>one arm (10 patients and 4 physicians) before and after use of dialysisNet (for doctors) and Avatar Beans (for patients) | Device: Use of DialysisNet for doctor<br>* DialysisNet is mobile application for physicians for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record standard.<br>Device: Use of Avatar Beans for patient<br>* Avatar Beans is mobile application for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Short Form 36 questionnaire for quality of life |  | 3 month after the use of DialysisNet (for doctors) and Avatar Beans (for patients) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of morisky medication adherence scale (MMAS) for drug compliance |  | 3 month Before and after the use of DialysisNet (for doctors) and Avatar Beans (for patients) |
Measurement of Gastric Emptying During and After COLOKIT® Intake

Study Overview
=================
Brief Summary
-----------------
Ultra-sound study to assess changes in intragastric volume after bowel preparation.

Official Title
-----------------
Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Drug: Sodium phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject who signed an informed consent to participate in the trial. Subject affiliated with Social Security Men and women aged 18 to 75 years. Subject with an indication of scheduled outpatient colonoscopy. colonoscopy performed within six hours after the second sequence COLOKIT®. Subject able to swallow tablets. Exclusion Criteria: Women pregnant or likely to be (without contraception) or nursing. Subject having any of the following diseases or conditions: allergy or hypersensitivity to the product tested or any of its excipients, nausea, vomiting or abdominal pain, clinically significant renal failure, primary hyperparathyroidism associated with hypercalcemia, congestive heart failure, ascites, a known or suspected bowel obstruction, megacolon (congenital or acquired) intestinal perforation, ileus, an inflammatory disease or suspected inflammatory bowel disease, swallowing disorders, known digestive motor disorders (gastroparesis, scleroderma, mega-esophagus), diabetes mellitus (insulin or non insulin-dependent) a history of gastric surgery (partial or total) a contraindication to the anesthesia required for the completion of the colonoscopy, Any clinical condition which, in the opinion of the investigator, would not allow the subject to perform the test in good conditions.

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COLOKIT®<br> | Drug: Sodium phosphate<br>* 32 tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a residual antral volume lower than 20 mL |  | after 2nd treatment regimen intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | After drug intake | 
| Acceptability of COLOKIT®. |  | After drug intake | 
| Colonoscopy results |  | After colonoscopy. |
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Vaccinated With MenBVac® (Extension MenbVac)

Study Overview
=================
Brief Summary
-----------------
This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.

Official Title
-----------------
Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac®

Conditions
-----------------
Vaccination With MenbVac

Intervention / Treatment
-----------------
* Biological: MenbVac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated with four doses of MenBVac in the first MenbVac clinical trial study, parental authority(ies)assent. Exclusion Criteria: no parental authority(ies)assent, no parental authority(ies)assent, no blood sample during the third vaccination, impossibility of third vaccination.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bras A<br> | Biological: MenbVac<br>* Blood test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaccine Immunity | assessment of vaccine Immunity with measure of percentage of children with an hSBA title >= 4 four years after four doses of MenbVac | two and a half years after the fouth vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menbvac, Neisseria meningitidis B:14, P1-7, 16, Serum bactericidal activity
An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute pelvic infections.

Detailed Description
-----------------
The duration of treatment is 18 months.

Official Title
-----------------
A Prospective, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Ertapenem Sodium ( MK0826) Versus Ticarcillin/Clavulanate in the Treatment of Hospital-Acquired Pneumonia, Complicated Intra-Abdominal Infections, and Acute Pelvic Infections in Pediatric Patients

Conditions
-----------------
Infections, Pelvic Infections

Intervention / Treatment
-----------------
* Drug: MK0826, ertapenem sodium
* Drug: Comparator: Ticarcillin/Clavulanate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 3 months to 17 years with intra-abdominal infection or acute pelvic infection Exclusion Criteria: Immune problems Kidney problems

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0826, ertapenem sodium|nan|
|Drug: Comparator: Ticarcillin/Clavulanate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intra-abdominal infections, Acute pelvic infections
Macroscopic Deciduosis in Pregnancy is Finally a Common Entity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the prevalence of macroscopic deciduosis found randomly in Cesarean sections and the secondary objective to determine the association with any obstetrical complications or adverse effects.

Detailed Description
-----------------
Ectopic decidua or deciduosis is defined as the extrauterine location of decidual tissue and can occur in the cervix, vagina and various abdominal organs like the ovary omentum, appendix, peritoneum, the pelvic lymph nodes. Other rare sites with deciduosis include the kidneys , the lungs and even the skin . Decidualization is a physiologic process during pregnancy, under the influence of ovarian and placental steroid secretion, with total involution in the four to six week post partum period.

Official Title
-----------------
Macroscopic Deciduosis in Pregnancy is Finally a Common Entity

Conditions
-----------------
Deciduitis; Complicating Pregnancy

Intervention / Treatment
-----------------
* Other: Macroscopic deciduosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cesarean section Exclusion Criteria: Patients refusing to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Macroscopic deciduosis|Deciduosis is a benign lesion during pregnancy that is not correlated with obstetrical complications. Our study has shown that this physiological phenomenon is more frequent that originally thought, being present in 10% of the Cesarean sections, and is associated with abdominal pain during pregnancy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cases of cesarean section. | The purpose of this study is to measure the number of participants who developed macroscopic decidosis in caesareans. | During cesarean section. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frequency, Macroscopic, Deciduosis, Ovarian, Neoplasm, Pregnancy