linjc16/ctgov huggingface dataset:
Revaluation of Wells' Clinical Prediction Score of Deep Vein Thrombosis (DVT) in Inpatients With Thromboprophylaxis Treatment

Study Overview
=================
Brief Summary
-----------------
This study aimed (1) revaluating the efficacy of the Wells' clinical prediction score for an inpatient population; and the weight of the presence of thromboprophylaxis treatment on the score, and (2) evaluating the correlation of a risk stratification established between a physician specialised in thrombosis and any other doctor.

Official Title
-----------------
R-WITT Study : Revaluation of Wells' Clinical Prediction Score in Inpatients With Thromboprophylaxis Treatment

Conditions
-----------------
Deep Vein Thrombosis, Thromboses, Venous

Intervention / Treatment
-----------------
* Diagnostic Test: Doppler ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient addressed to an Vascular Medicine unit for a clinical suspicion of DVT, with risk stratification through the modified Wells score by the referent doctor. Exclusion Criteria: Patient addressed to our Vascular Medicine unit for any other reason. Patient addressed to our Vascular Medicine unit for DVT detection to help in a pulmonary embolism suspicion. Age under 18 yo Patients unable to express their 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Doppler ultrasound|Each patient received Doppler ultrasound for research of DVT, no matter the risk stratification.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the Wells Clinical prediction score | Analyse area under the curve (AUC) of the Wells' score ROC (Receiver Operating Characteristic) curve for an inpatient population | For enrollment to end of enrollment at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of thromboprophylaxis treatment | Compare area under curve of ROC curves of Wells' score between an inpatient population with or without thromboprophylaxis treatment | For enrollment to end of enrollment at 12 months | 
| Coherency of Wells' score between an doctor specialized in thrombosis and any other doctor. | Compare Area under curve for ROC curves of Wells' score between an doctor specialized in thrombosis and any other doctor. | For enrollment to end of enrollment at 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wells Clinical score, Thromboprophylaxis
Surgical Treatment of Cervical Spondylotic Myelopathy

Study Overview
=================
Brief Summary
-----------------
The primary purposes of this study are to compare anterior and posterior surgical approach in treatment of CSM ad to compare variations in treatment and outcomes of CSM worldwide.

Official Title
-----------------
An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy

Conditions
-----------------
Cervical Spondylotic Myelopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Willing and able to give written informed consent to participate in the study Willing and able to participate in the study follow-up according to the protocol Willing and able to comply with post-operative management program Understand and read country language at elementary level Patients who undergo surgery for symptomatic CSM defined as a combination of one or more of the following symptoms: Numb hands Clumsy hands Impairment of gait Bilateral arm paresthesiae l'Hermitte's phenomena Weakness AND one or more of the following signs: Corticospinal distribution motor deficits Atrophy of hand intrinsic muscles Hyperreflexia Positive Hoffman sign Upgoing plantar responses Lower limb spasticity Broad based, unstable gait Exclusion Criteria: Asymptomatic CSM Previous surgery for CSM Active infection Neoplastic disease Rheumatoid arthritis Ankylosing spondylitis Trauma Concomitant symptomatic lumbar stenosis Pregnant women or women planning to get pregnant during the study period Has a history of substance abuse (recreational drugs, alcohol) Is a prisoner Is currently involved in a study with similar purpose Has a disease process that would preclude accurate evaluation (eg., neuromuscular disease, significant psychiatric disease) Patients seen by other services (eg., physical medicine, neurology, family practice), managed conservatively and not referred for surgical consultation are ineligible.

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 |
| --- | --- |
| Posterior surgical approaches<br>Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM) | |
| Anterior surgical approaches<br>Anterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications and neurological, functional, disease-specific and quality of life measures |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in patient presentation, treatment approaches and treatment outcomes among ethnic/racial groups, health care systems and regions of the world |  | 24 months |
To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
GSK945237 is the first molecule of a new chemical class that is being developed for treatment of respiratory tract and other infections such as skin and soft tissue. This study drug has been tested in animals but has never been given to humans. This is a two part study. The purpose of the first part is to study the side effects of this drug in humans, and to study how much of the drug gets absorbed in the blood stream The second part of this study will compare absorption of the study drug in the blood stream when given with food and when given under fasting conditions

Official Title
-----------------
A Two-Part Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of GSK945237 and the Effect of Food on Single Oral Doses of GSK945237 in Healthy Adult Subjects

Conditions
-----------------
Healthy Subjects, Infections, Bacterial

Intervention / Treatment
-----------------
* Drug: GSK945237
* Drug: Sugar Pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female adults between 18 and 60 years of age. Body weight proportional to height. Female subjects must be of non-childbearing potential. QTc less than 450 msec at screening Exclusion Criteria: Any clinically relevant abnormality identified on the screening history and physical, or on laboratory evaluations or the 12-lead surface electrocardiogram at screening or pre-dose. A positive pre-study alcohol/urine drug screen. Use of nicotine-containing products. A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody result. Recent participation in another study, use of certain medications, consumption certain fruits, juices, or red wine

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK945237<br>Active Study Drug | Drug: GSK945237<br> <br> |
| Placebo Comparator: Sugar Pill<br>Placebo | Drug: Sugar Pill<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | Day 1 to follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | Day 1 to Day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteer
Thiol/Disulfide and Oxidative Stress

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries

Official Title
-----------------
Evaluation of Saliva Thiol/Disulfide Homeostasis and Oxidative Stress in Children With Severe Early Childhood Caries by a Novel Method- Part 1

Conditions
-----------------
Severe Early Childhood Caries

Intervention / Treatment
-----------------
* Diagnostic Test: saliva cotton swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3-5 years Exclusion Criteria: the children with systemic illness, using anti-inflammatory drug

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| severe early childhood caries<br> | Diagnostic Test: saliva cotton swab<br>* evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries and healthy group<br>|
| healthy children<br> | Diagnostic Test: saliva cotton swab<br>* evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries and healthy group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thiol/disulfide homeostasis | Unstimulated saliva samples were taken from all children. Then, thiol/disulfide homeostasis and antioxidant levels were evaluated. | six months |
Metabolome and Microbiomic in Fecal Samples

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of storage and handling on fecal samples collected for metabolomic, proteomic and microbiomic and analysis.

Detailed Description
-----------------
Background Human fecal collection for clinical or research studies usually occurs at the residence of the subject, an environment not equipped with measures to accommodate proper preparation and storage of samples for microbiome and metabolome analysis. Aims To evaluate the effects of storage and handling on fecal samples collected for metabolomic, proteomic and microbiomic and analysis. Methods Fecal samples will be collected within several minutes of voiding from healthy infants at the time of diaper change at day-care center. Samples will be divided into 7 tubes, and subjected to different storage temperatures, before preforming microbial analysis by DNA sequencing, and metabolome analysis by H1NMR spectroscoty.

Official Title
-----------------
Fecal Samples for Metabolomic and Microbiomic Studies: Effects of Preparation and Storage

Conditions
-----------------
Infant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy age 12-20 months

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 20 Months

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 |
| --- | --- |
| Microbiome, Metabolome, Stool, Toddler<br>healthy infant stool samples | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome and metabolome yield |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microbiome, metabolome, stool, fecal samples, handling, toddler
Predicting Pathological Response Within the 1st Week of Chemotherapy Using Diffuse Optical Spectroscopic Imaging

Study Overview
=================
Brief Summary
-----------------
Women with Breast Cancer who do not respond to chemotherapy may undergo months of treatment with little or no change in tumor size or overall outcome. The Researchers have demonstrated a previously undescribed metabolic flare response observed very early in neoadjuvant treatment in breast cancer patients. The research can determine that this flare is predictive of overall therapy response and is due to both an inflammatory reaction and cell death induced by cytotoxic therapy.

Detailed Description
-----------------
The researcher can use Diffuse Optical Spectroscopic Imaging device to measure and predict the markers of the response in the first weeks of chemo-therapy. The oxyhemoglobin flare response can predictive of overall pathological response to chemotherapy in human subjects. These vascular changes can indicate the rapid transient increase and then decrease in oxyhemoglobin concentration in the first hours and days after therapeutic administration. The magnitude and time course of the flare response in patients receiving cytotoxic therapy will differ between pathological responders and non-responders. This oxyhemoglobin flare response can be observed In tumors where vascular dynamics are intact.

Official Title
-----------------
Predicting Pathological Response Within the 1st Week of Neoadjuvant Chemotherapy Using Functional Parameters Measured With Diffuse Optical Spectroscopic Imaging

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, not pregnant, not breastfeeding greater than 21 years of age but less than 75 years of age will be receiving neoadjuvant chemotherapy for breast cancer as prescribed by their oncologist Exclusion Criteria: Under 21 year of age Female pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Diffuse Optical Spectroscopy Imaging|Monitoring Breast Cancer during chemo therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improve treatment prognosis for breast cancer patients | The proposed research plan has the ability to significantly impact breast cancer research and treatment | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer
ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.

Official Title
-----------------
A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Study to Investigate the Efficacy, Mechanism of Action, Pharmacokinetics, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 as Monotherapy in Patients With Gastroesophageal Reflux Disease (GERD)

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: ADX10059
* Drug: ADX10059 Matching Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of typical GERD well controlled on a standard clinical symptoms controlled dose of PPI treatment body mass index ≤32 kg/m2 Exclusion Criteria: exclusively atypical symptoms of GERD symptoms that have been shown not to be associated with GERD erosive oesophagitis hiatus hernia > 3 cm current diagnosis of co-existing psychiatric disease known clinically significant allergy or known hypersensitivity to drugs pregnant or breast-feeding has received sodium valproate or topiramate within 30 days of Screening has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADX10059 120 mg<br>Twice-daily | Drug: ADX10059<br>* oral administration<br>|
| Placebo Comparator: ADX10059 Matching Placebo<br>twice-daily | Drug: ADX10059 Matching Placebo<br>* oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of GERD symptom free days in week 2 of study medication treatment |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD symptoms |  | 2 weeks | 
| Sleep disturbance |  | 2 weeks | 
| Use of antacid rescue medication |  | 2 weeks | 
| Global assessment of GERD |  | 2 weeks | 
| Effect on lower oesophageal sphincter and reflux episodes |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal reflux, Heartburn, Regurgitation
Combination of Glinides With Premixed Insulin

Study Overview
=================
Brief Summary
-----------------
Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.

Detailed Description
-----------------
Type 2 diabetic patients undergoing twice daily injections of premixed insulin are administered glinides (10mg of mitiglinide or 90 mg of nateglinide) at lunchtime without changing their insulin regimen. Twelve weeks after administration of the glinides, they are discontinued. HbA1c levels at the start of glinide administration, 12 weeks after administration, and 12 weeks after discontinuation are measured.

Official Title
-----------------
Evaluation of Usefulness of Combination Therapy of Rapid Acting Insulin Secretagogue (Glinide) With Premixed Insulin in Type 2 Diabetes

Conditions
-----------------
Type 2 Diabets Mellitus

Intervention / Treatment
-----------------
* Drug: nateglinide(drug) mitiglinide(drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of type 2 diabetes Who undergoes twice daily injection of premixed insulin Whose HbA1c is more than 6.5% and less than 8.0% Exclusion Criteria: Whose change of HbA1c is more than 1.0% during 12 weeks observational period
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: nateglinide(drug) mitiglinide(drug)|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anhydroglucitol |  |  | 
| lipid profile |  |  | 
| body weight |  |  | 
| blood pressure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glinides, premixed insulin, combination therapy, glycemic control
Indirect Measurement of Respiratory Quotient in Coelioscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2) which is a reflection of human energy metabolism and therefore of anaerobiosis. A study has been conducted in our department to demonstrate the ability of the indirectly measured RQ from the inspired and exhaled breath analysis of the anesthetic respirator to predict the onset of anaerobic metabolism and postoperative complications in the operating room. But, because of artificially increase of carbon dioxide due to insufflation, coelioscopic surgery was an exclusion criteria of our pilot study. However, no study has examined the impact of coelioscopy on the indirect measurement of RQ

Official Title
-----------------
Validation of the Respiratory Quotient Measurement Measured Indirectly in Coelioscopic Surgery

Conditions
-----------------
Respiratory Quotient Measurement

Intervention / Treatment
-----------------
* Procedure: coelioscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years old Adults admitted to the operating room for coelioscopic surgery Exclusion Criteria: Cardiac and thoracic surgery Preoperative oxygen therapy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: coelioscopic surgery|observational study based on the computation of respiratory quotient in patient cohort treated by routine coelioscopic surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indirect respiratory quotient by measurement of VO2 and VCO2 | The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2) | during coelioscopic surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurence of at least one post-operative complication | the aim is to predict the occurence of at least one complication with the use of indirect respiratory quotient | through study completion, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coelioscopic, surgery complications, respiratory quotient