linjc16/ctgov huggingface dataset:
Fimasartan Optimal Reduction Targeting Elevated Blood Pressure: the FORTE Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of home blood pressure monitoring on controlling blood pressure and correlation between home blood pressure and clinic blood pressure in hypertensive patients receiving two or more concomitant antihypertensive agents including fimasartan

Detailed Description
-----------------
A multi-center, cluster-randomized, prospective, observational study

Official Title
-----------------
A Multi-center, Cluster-randomized, Prospective, Observational Study

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

Intervention / Treatment
-----------------
* Procedure: Home Blood Pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who voluntarily signed informed consent for participating in this clinical study Male and female over the age of 19 Hypertensive patients receiving two or more concomitant anti-hypertensive agents including fimasartan Exclusion Criteria: Renal dialysis patients. Diabetic nephropathy patients taking angiotensin-converting enzyme inhibitor. Severe renal disorder Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Medical history with hypersensitivity to Fimasartan Pregnant women or lactating female. Participate in another clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Control Site<br>Measure Clinic Blood Pressure | |
| Test Site<br>Measure Clinic Blood Pressure and Home Blood Pressure | Procedure: Home Blood Pressure<br>* Measure Home Blood Pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reaching target blood pressure | Rate of reaching target blood pressure after treatment for 12 weeks | 12 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Home Blood Pressure, Fimasartan
The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Objectives: to evaluate the effect of brushing with Salvadora persica (Miswak) on streptococcus mutants compared to brushing with fluoridated tooth paste (FTP) in children. Methods: A total of 94 healthy children (8 years old) from an elementary governmental school in Jeddah, Saudi Arabia were grouped to Miswak and FTP groups. They were assessed for their salivary level of mutans streptococci species, and lactobacillus at the baseline and three weeks after brushing. Caries level using DMFT/dmft, and plaque amount using Greene Vermillion simplified oral hygiene index were recorded.

Official Title
-----------------
The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial

Conditions
-----------------
Plaque, Dental

Intervention / Treatment
-----------------
* Combination Product: brushing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children age from 8 to 9 parents signed the consent form they attended morning session for brushing Exclusion Criteria: medical compromised children parents did not sign the consent form Did not attend morning session

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 9 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salvadora persica<br>brush teeth with Salvadora persica Miswak | Combination Product: brushing<br>* mechanical and chemical plaque removal<br>|
| Active Comparator: tooth brush<br>brush with fluoridated tooth paste | Combination Product: brushing<br>* mechanical and chemical plaque removal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| green and vermillion | plaque level | 4 months |
Use of MEOPA (Equimolar Mixture of Nitrogen Protoxide and Oxygen) for Elderly With Dementia

Study Overview
=================
Brief Summary
-----------------
Acute pain is frequent in elderly especially in geriatrics acute care units where painful procedures are often occurring. MEOPA represents an alternative to opioïd therapy to prevent procedural pain during the treatment of pressure ulcers. In this study, cognitive impairment and dementia do not limit the use of MEOPA. The new approach in the management of acute procedural pain provides effective and safe analgesia in frail old patients.

Official Title
-----------------
Use of MEOPA for Elderly With Dementia.

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Drug: MEOPA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dementia (Folstein scoring between 0 and 25) older than 75 health necessitating of painful care for example eschar care Exclusion Criteria: bullous emphysema pneumothorax

Ages Eligible for Study
-----------------
Minimum 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Use of MEOPA during the painful care | Drug: MEOPA<br>* inhalation of MEOPA during the painful care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of use of MEOPA as tolerance to mask, MEOPA inhalation |  | one time, at the first care with MEOPA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction rate of patient |  | one time, at the first care with MEOPA | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute pain, MEOPA, Dementia
Quality of Life in Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Recording cancer data in cancer registries is essential for producing reliable population-based data for service planning, monitoring and evaluation. Prostate cancer (PCa) remains the most frequent type of cancer in terms of incidence and mortality in men in the Caribbean. The quality of life PCa cohort will assess quality of life and patient outcomes in Martinique using a digital platform for patient-reported outcome measures.

Detailed Description
-----------------
The Martinique Cancer Registry database is the largest clinical database among the French population-based cancer registries in the Caribbean, including more than 38 000 cancer cases, with 1650 new cancer cases per year, including 550 new PCa cases per year (2010-2014 latest period). In 2020, follow-up will include vital status, assessment of quality of life with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 and the Prostate cancer module QLQ-PR25. Urinary incontinence and erectile dysfunction recorded prior to treatment will be analysed 1, 3 and 5 years after treatment.

Official Title
-----------------
Quality of Life in Prostate Cancer Patients: Challenges and Prospects for Reducing Disparities in the Caribbean

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years and residing in Martinique, with prostate cancer diagnosed from 2020 The patient has provided informed consent Patient with social security coverage Exclusion Criteria: Refusal to participate Patient with a second cancer, five years after diagnosis Patient who could not answer the quality of life questionnaires Patient not fluent in French Person under legal protection

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

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

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 |
| --- | --- | --- |
| Evaluation of overall Quality of Life: Questionnaire | Change of quality of life questionnaire related to sexual dysfunction | At the date of diagnosis of the disease, at 1 year, 3 years and 5 years | 
| Evaluation of overall Quality of Life: Questionnaire | Change of quality of life questionnaire related to urinary troubles | At the date of diagnosis of the disease, at 1 year, 3 years and 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Public Health, Quality of life
Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia

Study Overview
=================
Brief Summary
-----------------
Patients with an incisional hernia in the midline and controls with an intact abdominal wall are examined twice with one week apart, in order to establish the test-retest reliability and internal and external validity of the Goodstrength trunk dynamometer.

Official Title
-----------------
Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia

Conditions
-----------------
Incisional Hernia

Intervention / Treatment
-----------------
* Device: Measurement of abdominal wall strength


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists score 1-3 Age equal to or above 18 Ventral incisional hernia OR intact abdominal wall Exclusion Criteria: Pregnancy Severe heart disease (New York Heart Association class III-IV) Severe pulmonary disease Severe musculoskeletal disease Systemic treatment with glucocorticoid

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No incisional hernia group<br>Healthy volunteers with an intact abdominal wall. | Device: Measurement of abdominal wall strength<br>* Test-retest examination of the reliability of the Goodstrength trunk dynamometer<br>|
| Incisional hernia group<br>Patients with a ventral incisional hernia. | Device: Measurement of abdominal wall strength<br>* Test-retest examination of the reliability of the Goodstrength trunk dynamometer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal wall strength measured by the Goodstrength system | Change in abdominal wall strength from baseline to follow-up. | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity the last week, assessed by the International Physical Activity Questionnaire |  | Once, at baseline examination | 
| Self-assessed abdominal wall strength, as measured on a visual analogue scale |  | Once, at baseline examination | 
| Trunk extensor strength measured by the Goodstrength system | Change in trunk extensor strength from baseline to follow-up. | One week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incisional hernia, hernia, abdominal wall strength, validation, physical activity
Lebanese Interhospital Pneumococcal Surveillance Program

Study Overview
=================
Brief Summary
-----------------
Streptococcus pneumoniae (pneumococcus) is a bacterium that causes severe infections in children and adults such as meningitis, pneumonia, and blood stream infection. There are many types of these bacteria defined by the type of sugar coat that they have. These are classified as serotypes. There are common serotypes that cause severe disease and are preventable by vaccination of children. Other less common types are more difficult to prevent. The investigators aim to determine the serotypes that cause invasive pneumococcal disease in Lebanon and to study their sensitivity to different antibiotics. The investigators will collect bacterial isolates from different hospitals in Lebanon isolated from the blood or spinal fluid of patients with invasive pneumococcal disease. This information will help the investigators determine the usefulness of available pneumococcal vaccines in preventing these infections. The data will be distributed to all primary care physicians treating children in Lebanon and will be shared with the Ministry of Health.

Official Title
-----------------
Lebanese Interhospital Pneumococcal Surveillance Program (LIPSP)

Conditions
-----------------
Pneumonia, Meningitis, Sepsis, Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Samples included in the study are those that are: culture proven invasive pneumococcal infections in patients of all ages admitted to different hospitals all over Lebanon Acceptable samples include: positive isolates from blood cerebrospinal fluid other normally sterile body sites such as empyema fluid, abscesses, joint fluid, middle ear fluid obtained by tympanocentesis in the operating room, and lung needle aspiration Exclusion Criteria: non S. pneumoniae isolates

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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 |
| --- | --- | --- |
| Serotype prevalence of S. pneumoniae in invasive pneumococcal disease |  | yearly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the antibiotic sensitivity of S. pneumoniae and the association with specific serotypes |  | yearly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
streptococcus pneumoniae, pneumococcus, pneumonia, meningitis, serotypes, bacteremia, sepsis
A Study of the Safety and Effects of ADH-1 Given Daily to Subjects With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.

Official Title
-----------------
Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Daily for 5 Consecutive Days by Intravenous Infusion in Subjects With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX 01 003)

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: ADH -1 (Exherin™)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Signed written informed consent Male and female patients > or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists Clinically or radiologically documented measurable disease. Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG) Exclusion criteria: Receipt of ADH-1 prior to this clinical study Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry History of primary brain tumors or brain metastases History of spinal cord compression or tumors that have shown any evidence of active bleeding within 30 days before study entry. Stroke, major surgery, or other major tissue injury within 30 days before study entry History of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ADH -1 (Exherin™)|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
-----------------
Cancer;, Tumors;, Neoplasms;, Anticarcinogenic Agents;, Antineoplastic Agents;, Cadherins
Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Metastatic gastric cancer patients who failed standard treatment will be enrolled in this study. After consent form, patient-derived cancer cell will be collected and tested with 3 kinds of drugs (sunitinib, gefitinib, imatinib). Drug sensitivity prediction software (IRCR-DReSS) will present level of sensitivity and patients will be treated with sensitive drugs. Patients will be evaluated every 6 weeks.

Official Title
-----------------
Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer

Conditions
-----------------
Stomach Neoplasms

Intervention / Treatment
-----------------
* Drug: Sunitinib
* Drug: Gefitinib
* Drug: Imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>-20 metastatic gastric cancer life expectancy >-3 months ascites and pleural effusion that can be drained ECOG 0-2 Proper organ function Patients who will be enrolled in sunitinib, gefitinib, imatinib clinical trial Exclusion Criteria: HBeAg, HCV, HIV (+) Active infection Uncontrolled systemic disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sunitinib<br> | Drug: Sunitinib<br>* sunitinib 37.5mg daily<br>|
| Experimental: gefitinib<br> | Drug: Gefitinib<br>* Gefitinib 250mg daily<br>|
| Experimental: imatinib<br> | Drug: Imatinib<br>* Imatinib 400mg daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | 2 years |
Homocysteine in Patients With Sepsis

Study Overview
=================
Brief Summary
-----------------
After stimulation by lipopolysaccharide (LPS), the one-carbon metabolism of macrophages was significantly up-regulated, the expression of key enzyme 5,10-methylenetetrahydrofolate reductase increased. In vitro experiments we found that LPS stimulation can increase the expression of MTHFR mRNA and protein in macrophages, suggesting that aerobic glycolysis may trigger cytokine storm through one-carbon metabolism. Homocysteine (homocysteine, Hcy) is an important intermediate product of one-carbon metabolism. A number of studies have shown that Hcy is positively correlated with the level of pro-inflammatory factors, significantly enhancing cytokine storm. However, the relationship between Hcy and serum pro-inflammatory factors in patients with sepsis and the effect of Hcy on the prognosis of patients with sepsis are still unclear. Based on the previous work, our research group intends to carry out single-center, prospective, observational clinical research to observe the relationship between homocysteine and the mortality of patients with sepsis, and to provide new indicators for accurately judging the prognosis of sepsis , To provide new targets for clinical development of drugs for the treatment of sepsis.

Official Title
-----------------
The Effect of Homocysteine on the Prognosis of Patients With sepsis-an Observational Study

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: No.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sepsis and the age limits between 18-80 years. Exclusion Criteria: Non-septic patients with hyperhomocysteinemia caused by various reasons. ②After the onset, other medicines for the treatment of folate deficiency and hyperhomocysteinemia have been used. ③Women during pregnancy and lactation. ④ Suspected or did have a history of alcohol or drug abuse. ⑤Patients who are participating in clinical trials of other drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Sepsis group<br>The patients in this group are diagnosed sepsis with the sepsis 3.0 definition. | Other: No.<br>* This is an observational study with no intervention.<br>|
| Control group<br>The recruited volunteers in this group are healthy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | the correlation with the level of Hcy and 28-day mortality | one month |