linjc16/ctgov huggingface dataset:
A Trial to Assess the Efficacy and Safety of SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
This trial was conducted at about 50 sites in Europe and has been clinically completed. Patients had symptoms of painful diabetic neuropathy for 6 months up to 5 years with an optimized diabetic control and at least moderate pain. Patients were not eligible with other chronic pain or any other medical or psychiatric condition, that would have jeopardized or compromised the patient's ability to participate in the trial. After a 2-week run-in phase patients were randomly assigned to one of three treatment arms. All patients who had completed the 6-week titration phase to reach their target dose entered a 12-week maintenance phase. At the end of the maintenance phase, subjects were offered the option of entering the open-label, follow-on trial. The change in pain was measured daily as well as interference of pain with sleep and general activity.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day and 600mg/Day SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy

Conditions
-----------------
Diabetic Neuropathy

Intervention / Treatment
-----------------
* Drug: SPM 927


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Painful distal diabetic neuropathy Exclusion Criteria: Symptoms of painful distal diabetic neuropathy for less than six months or greater than 5 years

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: SPM 927|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the efficacy of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy will be determined by pain score ratings assessed in a patient's diary and at clinic visits. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate effect of lacosmide on subjects' perception of sleep, activity, quality of life, and safety, determined by rating scales assessed in a patient's diary and at the clinic visits. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
painful distal diabetic neuropathy
Platelet Activation in Chronic Inflammatory Skin Diseases

Study Overview
=================
Brief Summary
-----------------
Platelets are blood cells that are important in coagulation of the blood. These cells have recently been shown to play a role in a number of other biologic processes, for example inflammation. In this study the investigators will determine the extent of platelet activation in people suffering from common chronic skin inflammation-urticaria and allergic dermatitis.

Conditions
-----------------
Urticaria, Atopic Dermatitis

Intervention / Treatment
-----------------
* Procedure: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Urticaria or atopic dermatitis - Exclusion Criteria:Lack of informed consent -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Skin disease<br>Patients with urticaria or atopic dermatitis | Procedure: Blood sampling<br>* Blood sampling<br>|
| Control<br>Healthy volunteers | Procedure: Blood sampling<br>* Blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet activation | Platelet function will be assessed at enrollment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean platelet volume | Mean platelet volume will be assessed at enrollment | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet activation
Screening for Liver Fibrosis by Using Non-invasive Methods in Patients With Diabetes. A Prospective Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients with diabetes.

Detailed Description
-----------------
Patients with diabetes are at risk for nonalcoholic fatty liver disease (NAFLD) leading to advanced fibrosis, cirrhosis, and liver cancer. However, liver fibrosis screening in this large population needs non-invasive methods. Recently, FibroScan was shown to be a good method for the diagnosis of advanced fibrosis in NAFLD patients. We examined the efficacy of a screening strategy with a noninvasive fibrosis biomarker (FibroTest) and transient elastography (FibroScan) in patients with diabetes.

Official Title
-----------------
Screening for Liver Fibrosis by Using Non-invasive Methods in Patients With Diabetes. A Prospective Study

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects More than 18 years of age Patients with Diabetes Written informed consent Exclusion Criteria: Patients refusing to participate to the study and to provide written 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
-----------------
Liver fibrosis, diabetes, Fibroscan, Fibrotest, noninvasive fibrosis biomarkers
Pulmonary Hypertension in Patients With Myeloproliferative Neoplasms

Study Overview
=================
Brief Summary
-----------------
This is an observational prospective study aiming to clarify the prevalence of pulmonary hypertension in patients with Myeloproliferative Neoplasms and their prognosis. All patients attending our department with the above mentioned neoplasms will be offered inclusion in this study. All will have an echo performed and patients identified as being at risk of pulmonary hypertension will be offered complete investigation as specified by the European Cardiology Association. All patients will be followed up for a total of five years to identify prognosis.

Official Title
-----------------
Pulmonary Hypertension in Patients With Philadelphia Chromosome Negative Myeloproliferative Neoplasms; an Observational Prospective Study

Conditions
-----------------
Myeloproliferative Disorders, Pulmonary Hypertension

Intervention / Treatment
-----------------
* Radiation: Radiology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myeloproliferative Neoplasms (PV, ET, PMF according to WHO classification) Exclusion Criteria: Pregnancy Lack of informed consent Age < 18 years Cognitive dysfunctions

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 |
| --- |
|Radiation: Radiology|Only a small subsample will require CT and right heart catherisation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pulmonary hypertension at initial presentation and first echo |  | Initial recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 and 5 years | 
| Incidence of pulmonary hypertension while under follow-up |  | 5 years |
Identification of New Inborn Errors of Immunity

Study Overview
=================
Brief Summary
-----------------
Analysis of DNA samples of patients with molecularly undetermined PID by whole exome/genome sequencing. Transcriptome analysis of patients with molecularly undetermined PID.

Official Title
-----------------
Towards Identification of New Inborn Errors of Immunity by Whole Exome/Genome Sequencing

Conditions
-----------------
Primary Immune Deficiency Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary immunodeficiency (PID) Male and Female participants 0 years to adult age (any) Written informed consent by the participant after information about the research project Exclusion Criteria: Secondary immunodeficiency Refusal to enter the study
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 |
| --- | --- |
| Patients with PID<br> | Diagnostic Test: Diagnostic Test<br>* Analysis of DNA samples of patients with molecularly undetermined PID by whole exome/genome sequencing Transcriptome analysis of patients with molecularly undetermined PID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of the genetic defects | Whole exome/Genome sequencing will be done to identify new mutations leading to immunodeficiency | 10 years |
Pulse Waveform and ECG Analysis in Postoperative Cardiac Surgical Patients

Study Overview
=================
Brief Summary
-----------------
Observational study of 20 postoperative cardiac surgery patients. On admission to the ICU the patients will receive a noninvasive monitor recording arterial pulse waveform and ECG. The monitoring will continue to the ward for two days. The data will be compared with the routine monitoring methods.

Detailed Description
-----------------
Observational study of 20 adult postoperative cardiac surgery patients. The observation will last from 0 to 2. postoperative day. On admission to the ICU the patients will receive a noninvasive monitor recording arterial pulse waveform and ECG. The monitoring will continue to the ward for two days. The data will be compared with the routine monitoring methods in the ICU and the ward.

Official Title
-----------------
Pulse Waveform and ECG Analysis in Postoperative Cardiac Surgical Patients

Conditions
-----------------
Blood Pressure, Arrhythmias, Cardiac

Intervention / Treatment
-----------------
* Device: Noninvasive monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult cardiac surgery patients, informed consent Exclusion Criteria: Poor co-operation, age less than 18 years

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: Noninvasive monitor|A novel technique on noninvasive blood pressure monitoring.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of arrythmia |  | 2 days |
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Incidence in Patients With Central Versus Peripheral Embolism

Study Overview
=================
Brief Summary
-----------------
Chronic thromboembolic pulmonary hypertension (CTEPH) has been associated with increased morbidity and mortality. Patients with pulmonary embolism (PE) have elevated risk for development of CTEPH. It is not known, whether the location of pulmonary embolism (central vs. peripheral) nor fibrinolysis have an impact of CTEPH incidence. This study has been performed to assess the CTEPH incidence in different populations: in patients with central vs. peripheral PE and in patients with or without fibrinolysis therapy for PE.

Detailed Description
-----------------
The embolus localization during index pulmonary embolism might be of potential relevance for CTEPH development. In the present study patients with confirmed pulmonary embolism for at least 12 months will be screened for CTEPH. The incidence of CTEPH will be correlated to thrombus location (central vs. peripheral) and the index use of fibrinolysis.

Official Title
-----------------
Incidence of CTEPH in Dependence of Thrombus Location in Patients With Acute Pulmonary Embolism and Index Fibrinolysis

Conditions
-----------------
CTEPH

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute pulmonary embolism for at least 12 months Exclusion Criteria: known pulmonary hypertension other than CTEPH

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| PE peripheral with fibrinolysis<br>Patients with peripheral PE who received fibrinolysis therapy | |
| PE peripheral, no fibrinolysis<br>Patients with peripheral PE who did not receive fibrinolysis | |
| PE central with fibrinolysis<br>Patients with central PE who received fibrinolysis therapy | |
| PE central, no fibrinolysis<br>Patients with central PE who did not receive fibrinolysis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTEPH | Incidence of CTEPH | participants will be followed at least one year after acute pulmonary embolism, an expected average of 5 years follow-up is estimated |
Obesity and Mortality

Study Overview
=================
Brief Summary
-----------------
Previous analyses of the National Health and Nutrition Examination Survey have suggested that the mortality rate associated with obesity has decreased over calendar time in the U.S. population, potentially due to improvements in the medical care of obesity and its associated diseases. The primary aim of this project is to evaluate whether this reduction in the detrimental association of obesity with mortality rate over calendar time is supported by other data from U.S. prospective studies.

Conditions
-----------------
Obesity and Overweight

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: U.S. based studies with at least 1500 subjects At least 5 years of mortality follow-up BMI measured or self-reported available at 2 or more separate calendar time Subjects varied in age at baseline Exclusion Criteria: Any study that does not meet the inclusion criteria was excluded

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 |
| --- | --- |
| Multiple Risk Factor Intervention Trial - Usual Group<br> | |
| Multiple Risk Factor Intervention Trial - Referred Group<br> | |
| Framingham Heart study<br> | |
| Framingham Offspring cohort<br> | |
| Atherosclerosis Risk In Communities<br> | |
| Charleston Heart study<br> | |
| Cardiovascular Health study<br> | |
| Rancho Bernardo study<br> | |
| Nurses' Health I study<br> | |
| Panel Study Income Dynamics<br> | |
| MRFIT Referred Care<br> | |
| HDFP Referral Care<br> | |
| Alameda County Health and Ways of Living Study<br> | |
| Nurses' Health II study<br> | |
| Tecumseh County Health study<br> | |
| EPESE-East Boston<br>Established Populations for Epidemiologic Studies of the Elderly-East Boston | |
| EPESE-Duke<br>Established Populations for Epidemiologic Studies of the Elderly-Duke | |
| EPESE-Iowa<br>Established Populations for Epidemiologic Studies of the Elderly-Iowa | |
| EPESE-New Haven<br>Established Populations for Epidemiologic Studies of the Elderly-New Haven | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Years of Life Lost Associated with Standard BMI categories Over Calendar Time |  | Between 1960 and 2000 (up to 40 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adjusted Hazard Ratio Over Calendar Time for Standard BMI Categories |  | Between 1960 and 2000 (up to 40 years) |
HPV Integration Testing for Human Papillomavirus-Positive Women

Study Overview
=================
Brief Summary
-----------------
Papanicolaou (Pap) triage, with high specificity, has been recommended for primary Human papillomavirus (HPV) testing but is flawed by poor sensitivity and cytologist dependence. the investigators evaluated the potential role of HPV Integration detection in cervical exfoliated cells in HPV-positive women from a clinic-based population.

Conditions
-----------------
Cervical Intraepithelial Neoplasia, Cervical Cancer

Intervention / Treatment
-----------------
* Procedure: TCT，HPV，colposcopic inspection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 30-65 years old visiting the gynecologic clinic of hospital Exclusion Criteria: Not providing informed consent previously confirmed CIN, cervical cancer, or other malignancies previous therapeutic procedure to cervix pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HPV-positive women，30-65 years of age<br> | Procedure: TCT，HPV，colposcopic inspection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of the HPV integration screening test with comparison to HPV testing or TCT |  | 14 Months |
Effectiveness of Anti-Psychotic in GPs Setting

Study Overview
=================
Brief Summary
-----------------
Evaluating the effectiveness of atypical antipsychotics in the community - a prospective, multicentre, observational study to evaluate the impact on Quality of Life of GP-based management of antipsychotic treatment in Belgium

Official Title
-----------------
SERENITY: Evaluating the Effectiveness of Atypical Antipsychotics in the Community - a Prospective, Multicentre, Observational Study to Evaluate the Impact on Quality of Life of GP-Bases Management of Antipsychotic Treatment in Belgium.

Conditions
-----------------
Schizophrenia, Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Schizophrenia or Bipolar Disorder (currently in a manic episode)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| to evaluate the patient's functioning, by measuring the Quality of Life. Quality of Life will be assessed by the Q-LES-Q-16 (PRO). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical efficacy & tolerability of atypical antipsychotics as assessed by the Clinical Global Impression(CGI) & Patient Global Impression of Change(PGIC)scores. |  |  | 
| The wellbeing of the patients taking atypical antipsychotics as assessed by the Sheehan Disability Scale(SDS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Bipolar Disorder, manic episode, atypical antipsychotic, Schizophrenia or Bipolar Disorder (currently in a manic episode)