linjc16/ctgov huggingface dataset:
Additive Beneficial Effects of Atorvastatin Combined With Amlodipine In Treatment of Hypertension

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized combination therapy would be superior to monotherapy.

Official Title
-----------------
Additive Beneficial Effects of Atorvastatin Combined With Amlodipine In Treatment of Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: statin, amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension Exclusion Criteria: Chronic renal disease Severe hypertension

Ages Eligible for Study
-----------------
Minimum Age: 25 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
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: atorvastatin, amlodipine<br> | Drug: statin, amlodipine<br> <br> |

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
-----------------
endothelial, function, insulin, sensitivity
Evaluation of an Oral Nutrition Supplement

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.

Official Title
-----------------
Evaluation of an Oral Nutrition Supplement

Conditions
-----------------
Gastrointestinal Tolerance

Intervention / Treatment
-----------------
* Other: Oral Nutritional Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following inclusion criteria: Male or female ≥ 60 and ≤ 90 years of age. Body Mass Index (BMI) > 20 but < 35. Exclusion Criteria: Subjects will be excluded from the study if they meet any of the following criteria: History of diabetes Antibiotic use within 1 week prior to enrollment Undergone major surgery less than 3 months prior to enrollment. Current active malignant disease or was treated within the last 6 months for cancer. Immunodeficiency disorder. Myocardial infarction within the last 3 months. Chronic obstructive pulmonary disease (COPD). Allergy to any of the ingredients in the study product. Obstruction of the gastrointestinal tract or other major gastrointestinal disease. Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder. Unintentional weight loss or weight gain ≥ 5% in last 4 weeks. Taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Nutritional Supplement<br>2 servings a day | Other: Oral Nutritional Supplement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastro-Intestinal Tolerance | Subject questionnaire | Study Day (SD) 1-8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ONS Consumption | Consumption Record | SD 1-8 | 
| Weight |  | Screening and SD 8 |
Reduction of Postoperative Pain, Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
Aim of this prospective study was to assess the quality of postoperative care in a postoperative anaesthesia care unit (PACU) using postoperative pain, nausea and vomiting as well as their reduction as quality markers. So far, only sparse data related to this topic are available and there are currently no established quality markers of a PACU service.

Official Title
-----------------
Reduction of Postoperative Pain, Nausea and Vomiting

Conditions
-----------------
Post Operative Pain, Nausea and Vomiting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients that have been transferred to the postanesthesia care unit postoperatively

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 |
| --- | --- |
| postoperative patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of the anaesthetic care in a PACU, reduction of postoperative pain, reduction of postoperative nausea and vomiting, quality markers
Agreement and Precision of Capstesia, a New Smarphone Application for PPV and CO Monitoring

Study Overview
=================
Brief Summary
-----------------
This study test the agreement and precision of Pulse Pressure Variation (PPV) and Cardiac Output (CO) obtained by the Android application Capstesia™ against another pulse contour CO monitoring ( EV-1000, Edwards Lefesciences, USA)

Detailed Description
-----------------
Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the OR. However, PPV can be time-consuming to calculate (manual determination), is not always displayed on monitoring screens nor reliable through visual assessment and needs additional devices to be displayed. A new Android application (Captesia) automatically calculates the PPV utilizing a digital photograph of the arterial waveform from the monitor. The application determines the PPV by selecting peaks and troughs of the arterial curve.

Official Title
-----------------
Agreement and Precision of Capstesia, a New Smarphone Application for PPV and CO Monitoring.

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: Capstesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for major surgery which requires a CO and PPV monitoring as standard of care Exclusion Criteria: patients with arrhythmias like atrial fibrillation patients with valvular insufficiency

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 |
| --- |
|Device: Capstesia|Picture of the arterial waveform taken with a smartphone|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement and precision of PPV and CO during 5 surgical phases (postinduction, pre incision, postincision, end of surgery and at least one episode of hypotension) | We will compare PPV and CO given with the EV-1000 and the capstesia app at different phases of the surgery | during surgery |
Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA

Study Overview
=================
Brief Summary
-----------------
Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment of nasopharyngeal CA

Detailed Description
-----------------
It's a phase III study to assess conventional Rad Therapy with conventional Plus accelerated boost Rad Therapy in the treatment of nasopharyngeal carcinoma.

Official Title
-----------------
A Phase III Study to Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Radiation: Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with nasopharyngeal Carcinoma Exclusion Criteria: Patients with carcinoma other than histo-pathologically confirmed nasopharyngeal CA
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 |
| --- | --- |
| Active Comparator: 1<br>Conventional Radiation Therapy (XRT), one fraction per day, from Sunday to Thursday every week. | Radiation: Radiation Therapy<br>* Radiation Therapy<br>|
| Experimental: 2<br>Conventional Plus accelerated boost Radiation Therapy (XRT), from Sunday to Thursday every week. | Radiation: Radiation Therapy<br>* Radiation Therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and efficacy |  | 5 years |
A Phase II Study of CCX282-B in Patients With Celiac Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether CCX282-B is effective in mitigating the effects of gluten ingestion in patients with celiac disease

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Testing CCX282-B in the Treatment of Celiac Disease

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Drug: CCX282-B
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Male or female, between 18 and 75 years of age Established diagnosis of celiac disease Subject has been following a strict gluten-free diet for at least 24 months Key Exclusion Criteria: History of any infection requiring intravenous antibiotics, a serious local infection, systemic infection, or gastrointestinal infection within 12 weeks of randomization Use of any immunosuppressants, TNF inhibitors, or natalizumab during the 12 weeks prior to study randomization Use of steroids during the 4 weeks prior to study randomization Receipt of an experimental treatment for any disease within 4 weeks prior to randomization Known IgE-mediated atopy or allergy or anaphylactic reactions to gluten The subject suffers from a condition that carries a risk at endoscopy or is on anticoagulant treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: CCX282-B<br>* 250mg capsule, twice daily, 13 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo capsule, twice daily, 13 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect of CCX282-B compared to placebo on the villous height/crypt depth ratio of small intestinal biopsy specimens taken from subjects with celiac disease, before and after gluten exposure. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure |  |  | 
| Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure |  |  | 
| Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure |  |  |
A Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy

Study Overview
=================
Brief Summary
-----------------
To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.

Detailed Description
-----------------
Study OXN2502 is a pilot, exploratory, randomised, placebo-controlled, double-blind, single-dummy, parallel group study to assess efficacy and safety of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone in opioid-naïve subjects treated with pregabalin suffering from moderate to severe pain due to diabetic polyneuropathy.

Official Title
-----------------
An Exploratory, Randomised, Double-blind, Single-dummy, Placebo Controlled, Parallel Group Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy

Conditions
-----------------
Moderate to Severe Pain Due to Diabetic Polyneuropathy

Intervention / Treatment
-----------------
* Drug: Oxycodone Naloxone
* Drug: Placebo tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Moderate to severe pain due diabetic polyneuropathy Opioid-naive subjects Exclusion criteria: Females who are pregnant or lactating Subjects with evidence of significant structural abnormalities of the gastrointestinal tract Subjects with evidence of impaired liver/kidney function upon entry into the study

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Tablets<br>A placebo tablet to match the active reference treatment | Drug: Placebo tablets<br>* Placebo Oxycodone Naloxone tablets<br>|
| Active Comparator: Tablet<br>Oxycodone Naloxone tablets | Drug: Oxycodone Naloxone<br>* Oxycodone Naloxone tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form McGill Pain Score. | The McGill Pain Score is the sum of the answers to three questions: A - describe your pain during the last week, 15 descriptors, (from 0 to 45 total), B - rate your pain during the last week (from 0 to 100), C: present pain intensity (0 to 5). Total pain score will be out of 150, with 0 being least pain and 150 being most pain. | Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal) |
A Prospective Longitudinal Collection of Subjects Diagnosed With Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect samples to evaluate the ProGRP and NSE assays independently as aids for monitoring the course of disease and therapy in subjects diagnosed with SCLC.

Official Title
-----------------
A Prospective Longitudinal Collection of Subjects Diagnosed With Small Cell

Conditions
-----------------
Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Confirmed diagnosis of SCLC or mixed SCLC/non-SCLC per histopathology results Scheduled to undergo first-, second- or third-line treatment for SCLC, including chemotherapy, chemotherapy + radiation therapy, or combined concurrent chemoradiotherapy. Able to understand and willing to provide Informed Consent Exclusion Criteria: No diagnosis of SCLC Not scheduled to undergo treatment for the diagnosis of SCLC Unable to provide Informed Consent

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Small Cell Lung Cancer, SCLC, Lung Cancer, Subjects diagnosed with SCLC who will undergo treatment
Very Long Term VHI Voice Outcome After MTIS

Study Overview
=================
Brief Summary
-----------------
Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of operated patients using the voice handicap index scale

Official Title
-----------------
Very Long Term VHI Voice Outcome After MTIS

Conditions
-----------------
Laryngeal Paralysis

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients presenting UVFP of neurogenic origin treated by MTIS > 2 years before inclusion. No superior limit in terms of years. Age 18-80 years at the time of MTIS No other treatment before MTIS other than resorbing material injection laryngoplasty (maximum twice) No further voice treatment after MTIS except speech therapy. VHI or VHI-10 performed before MTIS and within the 6 months after MTIS. In case of multiple post-op VHI tests, only the earliest post-op. VHI test will be taken into account VHI tests validated for the utilized language Exclusion Criteria: patient not able to answer VHI questionnaire personally Post MTIS new health condition affecting the voice tract and/ or the respiratory function. Post MTIS appearance of other voice/ vocal cord pathology

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Questionnaire<br>Questionnaire to previously operated patients | Other: Questionnaires<br>* evaluating the voice outcome by the fullfilment of the voice handicap index<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice handicap index | Questionnaire | 2 years |
Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Study Overview
=================
Brief Summary
-----------------
The study is designed to assess the efficacy of an investigational drug called SR121463B (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH). This double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.

Detailed Description
-----------------
This is a multicenter worldwide study with 32 participating men and women aimed to figure out whether SR121463B is safe and effective in correcting low levels of sodium in blood in subjects with SIADH. The participation in the study lasts up to 34 days. After screening, during the first part of the study (maximum 5 days), the subjects receive either capsules of SR121463B or a matching placebo. During the second part of the study (23 days), subjects receive either capsules of SR121463B or no treatment. The subjects will be assessed by physical examinations, electrocardiograms, blood samplings, and urine collections. Women of childbearing potential must have an approved method of contraception.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion.

Conditions
-----------------
Syndrome of Inappropriate ADH (SIADH) Secretion, Hyponatremia

Intervention / Treatment
-----------------
* Drug: satavaptan (SR121463B)


Participation Criteria
=================
Eligibility Criteria
-----------------
SIADH of any origin

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: satavaptan (SR121463B)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum sodium concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety assessment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Blood Sodium (Hyponatremia), SIADH, Inappropriate ADH Syndrome