linjc16/ctgov huggingface dataset:
Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages

Study Overview
=================
Brief Summary
-----------------
The NICE study is a prospective, multi-site study to train and validate a blood-based, glycoproteomic test for the early detection of advanced adenoma and colorectal cancer by collecting blood samples and associated relevant clinical information from average-risk participants who undergo routine screening colonoscopy as well as participants undergoing colonoscopy for surveillance or diagnostic indications

Detailed Description
-----------------
InterVenn is using its glycoprotein profiling technology platform that couples high-resolution liquid chromatography (LC)-mass spectrometry (MS) with an artificial intelligence (AI), neural network (NN)-based high-throughput data processing software to identify patterns uniquely associated with colon adenoma and colon adenocarcinoma in order to detect (pre)cancerous events early. The purpose of this prospective multi-center observational study is to train and validate a blood-based, glycoproteomic test for the early detection of advanced adenoma and colorectal cancer by collecting blood samples and associated relevant clinical information from average-risk participants who undergo routine screening colonoscopy as well as participants undergoing colonoscopy for surveillance or diagnostic indications.

Official Title
-----------------
Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages

Conditions
-----------------
Colorectal Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects between the ages of 45-85. Able to provide an informed consent and who understand and agree to all study procedures required Subject is scheduled or will soon be scheduled to receive a colonoscopy as ordered by their doctor. Exclusion Criteria: Any active malignancy Any other illness that in the opinion of the investigator, makes the subject not a good candidate for the study.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Non-Interventional|This is an observational, non interventional study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the InterVenn test | To determine the sensitivity of the InterVenn test | up to 90 days from baseline | 
| Specificity of the InterVenn test | To determine the specificity of the InterVenn test | up to 90 days from baseline |
First-in-Human Single Ascending and Multiple Dose of GLPG0555

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0555 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Official Title
-----------------
Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0555 in Healthy Subjects.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: GLPG0555
* Drug: placebo
* Drug: GLPG0555
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male, age 18-50 years BMI between 18-30 kg/m², inclusive. Exclusion Criteria: significantly abnormal platelet function or coagulopathy smoking drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>single ascending doses | Drug: GLPG0555<br>* single ascending doses, oral solution<br>|
| Placebo Comparator: 2<br>single dose placebo | Drug: placebo<br>* single dose, oral solution<br>|
| Experimental: 3<br>multiple dose, 7 or 14 days, oral solution | Drug: GLPG0555<br>* multiple dose, oral solution, 7 or 14 days<br>|
| Placebo Comparator: 4<br>multiple dose, 7 or 14 days, oral solution | Drug: placebo<br>* multiple dose, oral solution, 7 or 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single and multiple dosing |  | up to 10 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of single and repeated doses, including effect of food. |  | up to 10 days postdose | 
| To characterize the in/ex vivo pharmacodynamics (PD) of GLPG0555 after single and repeated oral administration |  | up to 72 hours postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Pharmacokinetics
Dynamic Neural Mechanisms of Audiovisual Speech Perception

Study Overview
=================
Brief Summary
-----------------
Understanding speech is one of the most important functions of the human brain. We use information from both the auditory modality (the voice the of person we are talking to) and the visual modality (the facial movements of the person we are talking to) to understand speech. We will use intracranial encephalography to study the organization and operation of the brain during audiovisual speech perception.

Official Title
-----------------
Dynamic Neural Mechanisms of Audiovisual Speech Perception

Conditions
-----------------
Speech Perception

Intervention / Treatment
-----------------
* Other: Measurement of brain activity using electrodes.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be undergoing neurosurgery for the treatment of a brain disorder Exclusion Criteria: must have corrected-to-normal vision and hearing

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Measurement of brain activity using electrodes.|We will present audiovisual speech and record neural responses.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of neural activity | The name of the measurement is the broadband high-frequency activity (BHA) in the brain in response to audiovisual speech. The unit of measure is % increase in power from pre-stimulus baseline. The name of the measurement tool is intracranial EEG, recordings of the raw voltage signal from each electrode implanted in the brain. The voltage-by-time signal will be converted to spectral space using a wavelet transform, and the magnitude of the power between 70 and 150 Hz inclusive in a time window between 0 ms and 500 ms after stimulus onset will be calculated. | During the procedure. |
Study on the Correlation Between Gene Mutation and TCM Syndrome Types in Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
To explore the correlation between gene mutations of metastatic colorectal cancer and TCM syndrome types based on Second-generation sequencing technology.

Official Title
-----------------
Study on the Correlation Between Gene Mutation and TCM Syndrome Types in Metastatic Colorectal Cancer

Conditions
-----------------
Gene Mutation-Related Cancer, Traditional Chinese Medicine

Intervention / Treatment
-----------------
* Drug: Traditional Chinese Medicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clear pathological diagnosis is a patient with colorectal cancer; Have complete TNM staging information; There is a clear diagnosis of the location and time of metastasis; Age ≥18 years old, ≤80 years old, male or female; There is a clear time for the first treatment with Chinese medicine; Patients who can receive long-term follow-up. - Exclusion Criteria: Patients with colorectal cancer diagnosed pathologically as adenosquamous carcinoma, squamous cell carcinoma, carcinoid, small cell carcinoma, malignant lymphoma, etc.; Patients with double cancer, multiple or metastatic colorectal cancer; Combined with severe acute and chronic diseases that may affect treatment and prognosis, such as myocardial infarction, stroke, severe renal insufficiency and mental illness;-

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCM Syndrome Types<br>Traditional Chinese Medicine | Drug: Traditional Chinese Medicine<br>* Chinese medicine prescription<br>* Other names: TCM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | OS | 2 years | 
| Progression Free Survival | PFS | 2 years |
Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-interventional, post marketing surveillance study to determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, serious and non-serious, that would occur among Filipino patients with type 2 diabetes mellitus who are treated with exenatide who are taking metformin, a sulfonylurea or a combination of metformin and a sulfonylurea but have not achieved adequate glycemic control.

Official Title
-----------------
Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients

Conditions
-----------------
Type 2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: are male or female outpatients at least 18 years of age provide written consent to the release of their data after being informed of the study diagnosed with type 2 diabetes mellitus and are taking metformin, or a sulfonylurea or both are reliable, and agree to keep all appointments for clinic visits, complete tests and procedures as may be required by the attending physician in the course of routine clinical care are treated with exenatide according to the approved Product Insert, as prescribed by the investigator in the routine care of the patient Exclusion Criteria: are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug. are currently taking insulin. are pregnant or have intentions of becoming pregnant within the duration of the study. are the investigators or their immediate families. Immediate family is defined as the investigator's spouse, parents, natural or legally adopted child (including stepchild living in the investigator's household), grandparents, or grandchild. Employees of investigators are also not eligible.

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 |
| --- | --- | --- |
| To determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, that would occur among Filipino patients with type 2 diabetes and inadequate glycemic control treated with exenatide |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the change from baseline to endpoint in HbA1c and body weight of Filipino patients with type 2 diabetes mellitus treated with exenatide who are taking metformin and/or a sulfonylurea but have not achieved adequate glycemic control. |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, exenatide, metformin, sulfonylurea, Byetta, Amylin, Lilly
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect safety and efficacy information for evaluating the results of its clinical use.

Detailed Description
-----------------
The Surveillance will be conducted per the standards required by the Ministry of Health, Labour and Welfare (MHLW) and in the standards for post-marketing surveillances and studies [except for those defined in the Ministerial Ordinance on Good Clinical Practice for Medical Devices (MHLW Ordinance No. 36, 2005)] based on Paragraph 4, Article 23-2-9 (including application mutatis mutandis per Article 23-2-19 of Revised PAL) of the Law on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, etc. (Law No. 145, 1960, hereinafter referred to as Revised PAL) by the Marketing Authorization Holder or accredited foreign manufacturer of a medical device defined in Paragraph 1, Article 23-2-5 of Revised PAL.

Official Title
-----------------
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Conditions
-----------------
Patent Ductus Arteriosus

Intervention / Treatment
-----------------
* Device: Amplatzer Piccolo Occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The device is used to percutaneously close the PDA of a patient who meets all of the following: PDA ≤4 mm in diameter PDA ≥3 mm in length Weight ≥700 g Exclusion Criteria: Age <3 days Coarctation of the aorta Left pulmonary artery stenosis Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension Thrombus in the implant site, or sign of venous thrombus in a vessel in which the occluder is inserted and delivered Endocarditis, or infection that can cause bacteremia Allergic or potentially allergic to nickel

Ages Eligible for Study
-----------------
Minimum Age: 3 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amplatzer Piccolo Occluder<br>Amplatzer Piccolo Occluder device implant | Device: Amplatzer Piccolo Occluder<br>* Interventional placement of vascular occluder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of major complications through 180 days after an attempted Piccolo device implant |  | Through 180 days after an attempted Piccolo device implant | 
| The rate of effective closure of the ductus arteriosus among subjects with a successful Piccolo implant as assessed by the presence of either a Grade 0 or Grade 1 shunt at the 6-month follow-up by transthoracic echocardiography |  | At the 6-month follow-up |
Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy

Study Overview
=================
Brief Summary
-----------------
The objective of this project is to determine if directly addressing disturbed sleep and nightmares will impact client reports of suicidal ideation.

Official Title
-----------------
CBT-I Versus ERRT: Impact on Sleep, Nightmares, and Suicidal Ideation

Conditions
-----------------
Insomnia, Nightmare, Trauma

Intervention / Treatment
-----------------
* Behavioral: CBT-I
* Behavioral: ERRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: experiences at least one nightmare per week for the past month having previously experienced a traumatic event difficulty falling or staying asleep suicidal ideation actively under the care of another health care provider Exclusion Criteria: untreated obstructive sleep apnea acute or apparent psychosis untreated or unstable bipolar disorder past history of seizure disorder or neurological disorder intellectual disability current substance dependence or in past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT-I<br>5 sessions of treating insomnia | Behavioral: CBT-I<br>* Targeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience.<br>* Other names: Cognitive Behavioral Therapy for Insomnia;|
| Active Comparator: ERRT<br>5 sessions of treating post-trauma nightmares | Behavioral: ERRT<br>* Targeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience.<br>* Other names: Exposure, Relaxation, Rescripting Therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index | Change in frequency of insomnia symptoms | From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion | 
| Change in Insomnia Severity Index | Change in severity of insomnia symptoms | From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion | 
| Change in Sleep log | Change in frequency of nightmares | From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion | 
| Change in Sleep log | Change in severity of nightmares | From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion | 
| Change in Beck Suicide Scale | Change in severity of suicidal ideation | From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion |
The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates

Study Overview
=================
Brief Summary
-----------------
Patients with panel reactive antibodies have many difficulties to find a crossmatch-negative kidney for transplantation and are at the risk of post transplantation rejection more than other transplanted patients. We evaluated the effect of simvastatin on PRA and post transplant outcome of these sensitized patients. We also performed a descriptive study.

Detailed Description
-----------------
The presence of panel reactive antibodies (PRAs) in the sera of renal transplant candidates is associated with hyperacute or delayed humoral immune responses against the graft after transplantation . In addition, these sensitized patients wait for a long time to find a cross-match negative kidney for renal transplantation . As a result, some modalities have been used for desensitization including plasmapheresis and intravenous immunoglobulin (IVIG) in combination with immunosuppressive drugs . However, recently, the use of statins such as simvastatin, pravastatin and etc. has been proposed to be safer and more effective for desensitization .

Official Title
-----------------
The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with ESRD on hemodialysis or peritoneal dialysis On the waiting list for renal transplant PRA more than 25% Exclusion Criteria: Pregnant women Patients who need ongoing blood products Patients taking other therapies to decrease PRA Patients listed for multi-organ transplant other than kidney Patients with liver failure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>patients who will take simvastatin 20 mg daily | Drug: simvastatin<br>* 20 mg simvastatin daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of simvastatin on panel reactive antibody |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal transplant, panel reactive antibody, sensitization, simvastatin, immunological