linjc16/ctgov huggingface dataset:
Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Study Overview
=================
Brief Summary
-----------------
To analyze efficacy of fluvastatin on patients with chronic renal disease by analyzing certain inflammatory markers. In addition, tolerability and safety will also be evaluated in a Spanish population.

Official Title
-----------------
Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Fluvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years Patients that give their inform consent Exclusion Criteria: Pregnant women Diabetic patients Treated with statins for the year prior to study inclusion Patients with contraindications listed in fluvastatin prescribing information Other protocol-defined in and exclusion criteria may apply

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum inflammatory markers after 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fibrosis parameters and endothelial function after 52 weeks |  |  | 
| Adverse events and serious adverse events after 52 weeks |  |  | 
| Change from baseline in laboratory tests of kidney function after 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyslipidemia, chronic renal disease, fluvastatin
Diagnostic Reasoning and Sense of Alarm at Dyspnoea and / or Chest Pain

Study Overview
=================
Brief Summary
-----------------
Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. The sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. Gut Feelings plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring the Gut Feelings was validated in French after a linguistic validation procedure.

Detailed Description
-----------------
Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. The sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. Gut Feelings plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring the Gut Feelings was validated in French after a linguistic validation procedure. The objective of the research is to calculate the precision of the sense of alarm the general practitioner facing a consultant for chest pain or dyspnea and patient

Official Title
-----------------
Diagnostic Reasoning and Sense of Alarm at Dyspnoea and / or Chest Pain

Conditions
-----------------
Chest Pain, Dyspnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 and 80 years Patients consulting on primary care for chest pain or dyspnea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| calculate the accuracy of the sense of alarm the general practitioner face a patient consultant for chest pain or dyspnea. | Questionary | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary care, chest pain, dyspnea
CT Diagnoses in Crohns Disease Activity

Study Overview
=================
Brief Summary
-----------------
The study focused on the clinical value of CT in assessing the activity of Crohn's disease.

Detailed Description
-----------------
Crohn's disease is an inflammatory disease with non-specific clinical manifestations. The lesions are more common in the ileocecal area and the end of the ileum, and also can affect the entire digestive tract. In recent years, the domestic incidence of Crohn's disease has been increasing. At present, CT diagnosis still lacks the gold standard and requirescombination of clinical manifestations, endoscopic examination, imaging examination and laboratory examination results. CT has showed advantages of non-invasive inspection, fast imaging speed, high tissue density resolution, and strong patient acceptability. In addition, the examination can clearly show the internal and external tissue structure of the digestive tract, which has been widely used in the diagnosis and activity evaluation of Crohn's disease. In order to clarify the clinical value of CT in assessing the activity of Crohn's disease, this study mainly used retrospective analysis of the CT manifestations and clinical data of patients with Crohn's disease to explore the clinical value of CT in assessing the activity of patients with Crohn's disease.

Official Title
-----------------
Applications of CT in Differentiating Crohn's Disease Activity

Conditions
-----------------
Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crohn's disease patients with confirmed endoscopic or pathological examination results Complete laboratory data such as CRP, erythrocyte sedimentation rate, etc. Exclusion Criteria: Related inspection results are not complete The interval between endoscopic and laboratory examination results exceeds 2 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CDAI≤220<br>According to the Crohn's disease activity index (CDAI) scores, all the patients included in the study were divided into group A (CDAI≤220) | |
| CDAI>220<br>According to the Crohn's disease activity index (CDAI) scores, all the patients included in the study were divided into group B (CDAI>220) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crohn's disease activity index (CDAI) scores | Crohn's disease activity index (CDAI) scores | 1year |
Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.

Official Title
-----------------
A Randomised, Single Centre, Double-blind, Two-period Cross-over Glucose Clamp Trial to Demonstrate Bioequivalence Between Insulin Detemir Produced by the NN729 Process and Insulin Detemir Produced by the Current Process in Healthy Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator Body mass index (BMI) between 18.0 and 27.0 kg/m^2, inclusive Non-smoker Fasting plasma glucose (FPG) maximum 6.0 mmol/L Exclusion Criteria: Known or suspected allergy to trial products or related products Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant) A history of alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment period 1<br> | Drug: insulin detemir<br>* One single dose of insulin detemir produced by current process and the NN729 process injected subcutaneously on two separate dosing visits in varying order<br>|
| Active Comparator: Treatment period 2<br> | Drug: insulin detemir<br>* One single dose of insulin detemir produced by current process and the NN729 process injected subcutaneously on two separate dosing visits in varying order<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-36h, area under the serum insulin detemir concentration curve |  | From 0 to 36 hours | 
| Cmax, maximum serum insulin detemir concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC, area under the serum insulin detemir concentration curve |  |  | 
| Time to maximum concentration (tmax) |  |  | 
| Terminal half life (t½) |  |  | 
| Area under the Curve Glucose Infusion Rate (AUCGIR) |  |  | 
| Adverse events |  |  |
Anemia Management in Chronic Kidney Disease Not on Dialysis Patients After the European Renal Best Practice (ERBP) Working Group Recommendations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of the last recommendations of the European Anemia Working Group ERBP in the anemia management in the achievement of the therapeutic goal of Hb 11-12 g/dL.

Official Title
-----------------
ANEMIA MANAGEMENT IN CHRONIC KIDNEY DISEASE NOT ON DIALYSIS PATIENTS AFTER THE ERBP WORKING GROUP RECOMMENDATIONS

Conditions
-----------------
ANEMIA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients with anemia secondary to chronic kidney disease (CKD) not on dialysis. Patients starting anemia treatment (naïve) after six months of the last recommendations of the European Anemia Working Group ERBP (January 2011). Patients in treatment who changed from previous ESA treatment since January 2011 (converted patients Exclusion Criteria: Patients in Erythropoiesis Stimulating Agents (ESA) dose adjustment period. Kidney transplant patients.

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 |
| --- | --- | --- |
| % Patients Achieving Target Hemoglobin Levels | % patients with Hb levels between 11-12 mg/dl | 1 day because is a crosssectional study with only a visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Levels Per Type of Patients | levels Hb and type of patients | 1 day | 
| Patients With Hb>12 |  | 1 day | 
| % Patients With Erythropoiesis Stimulating Agents (ESA) Therapy | know the treatments ESA for maintenance of hb levels | 1 day | 
| Iron Treatment | Patients with supplementary Iron treatment to ESA | 1 day | 
| Patients With Hb<11 |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS
CAMPUS Expanded Classification and Assessment of Mental Health Performance Using Semantics Expanded

Study Overview
=================
Brief Summary
-----------------
Open enrollment study to collect data for the optimization of machine learning models for use in an app for the early detection of mental health and suicidal risk.

Official Title
-----------------
CAMPUS Expanded Classification and Assessment of Mental Health Performance Using Semantics Expanded

Conditions
-----------------
Suicide, Suicidal, Suicide, Attempted, Suicidal Ideation, Depression, Anxiety, Aggression, Trauma, Psychological

Intervention / Treatment
-----------------
* Behavioral: MHSAFE app recording


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently a client receiving services from a MHP at a school or outpatient setting, or at a college/university counseling center Age ≥ 8 years old Able to provide informed consent, parental permission or assent English as a primary language Exclusion Criteria: Participants with communication disorders (linguistic or articulation) Any minor participants for whom parental or legal guardian consent cannot be obtained. Any adult participant for whom Legal Authorized Representative (LAR) consent cannot be obtained. History of any other serious medical or psychiatric condition that would interfere with the ability of the patient to complete the study or would make it ethically unfeasible to enroll them Participants with an intellectual and / or neurocognitive disability that the MHP deems a barrier to participation Any participant, who at the discretion of the MHP, should not be enrolled

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Any person receiving services from a mental health provider who is able to either consent or for whom parental consent is able to be obtained. | Behavioral: MHSAFE app recording<br>* Participants are asked a series of questions to elicit their feelings and emotions as part of an audio recorded interview along with their normal therapy session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Mental Health State | Optimize machine learning models will detect the presence of a mental state as evidenced by scores on standardized tests and clinical assessment. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate the Usability of the platform | Demonstrate the usability of the MHSAFE recording platform and the dashboard output in different settings, including outpatient community mental health settings, schools (K-12), colleges/universities, and residential mental health facilities. | 1 year |
Ambulatory Urodynamic Evaluation of Sacral Neuromodulation for Non-Obstructive Urinary Retention

Study Overview
=================
Brief Summary
-----------------
Ambulatory Urodynamic measurement on patients with diminished or absent bladder contractility before and after trial with Sacral Neuromodulation therapy.

Official Title
-----------------
Ambulatory Urodynamic Evaluation of Sacral Neuromodulation for Non-obstructive Urinary Retention

Conditions
-----------------
Acontractile Bladder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diminished or absent bladder contraction Exclusion Criteria: Prior Neuromodulation therapy
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 |
| --- | --- | --- |
Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis.

Detailed Description
-----------------
Patients were randomized to receive either low-dose hydrocortisone or matching placebo.Severity of coagulopathy was estimated using ISTH DIC score. We determined the complications and mortality in two groups, and analyzed the relationship between hydrocortisone and coagulopathy.

Official Title
-----------------
Research of Little Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

Conditions
-----------------
Septic Shock, Sepsis

Intervention / Treatment
-----------------
* Drug: Hydrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients(age≧18y) Admitted for septic shock were considered eligible if they had no life-threatening systemic disease (ASA groups 1 3) Exclusion Criteria: Lactation Mental disorders Disseminated cancer Secondary cancers Inflammatory bowel disease, or diseases hindering epidural analgesia

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocortisone<br>little doses of hydrocortisone | Drug: Hydrocortisone<br>* Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs<br>|
| No Intervention: Placebo<br>Placebo | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coagulopathy | ISTH score | 30 days after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 30 days after inclusion | 
| clinical complications | MODS SOFA score | 30 days after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coagulopathy, hydrocortisone, organ failure, hemodynamic improvement induced by hydrocortisone
Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing

Study Overview
=================
Brief Summary
-----------------
Analyse immune repertoire and genetic mutations of benign and malignant pulmonary nodule，and evaluate peripheral blood detection for identifying nature of pulmonary nodule.

Detailed Description
-----------------
Early diagnosis of lung cancer is of vital importance in lung cancer treatment. This research will first analyse the features of immune repertoire and genetic mutations from tissue of benign and malignant pulmonary nodule，then explore the feasibility of detecting these features from peripheral blood sample, and finally evaluate peripheral blood detection of lung cancer related immune repertoire and genetic mutations for identifying nature of pulmonary nodule.

Official Title
-----------------
Genetic Variations,Immuno-sequencing and Circulating Tumor DNA(ctDNA) for Early Diagnosis of Small Pulmonary Nodules

Conditions
-----------------
Carcinoma, Non-small-cell Lung Cancer, Lung Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign informed consent and consent to participate in this study; Found small nodules in pulmonary by CT and prepare for surgery; Exclusion Criteria: Malignant tumor history within the past 5 years; Receiving chemotherapy, radiotherapy or targeted therapy before surgery; Histology confirmed not non-small cell lung cancer No matching tissue or blood samplesUnqualified blood samples

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 |
| --- | --- | --- |
| The sensitivity and specificity of combining peripheral plasma circulating tumor DNA and white cell immuno-sequencing in diagnosis of early stage non-small cell lung cancer |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of tissue immune repertoire in diagnosis of early stage non-small cell lung cancer |  | 6 months | 
| The concordance of peripheral plasma circulating tumor DNA and tumor tissue DNA in diagnosis of early stage non-small cell lung cancer |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating Tumor DNA, Lung cancer Surgery, early diagnosis, immuno-sequencing