linjc16/ctgov huggingface dataset:
Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.

Detailed Description
-----------------
Patients from the NK-104-3.01EU and NK-104-3.02EU studies will continue to receive either pitavastatin or the comparator statin for 1 year.

Official Title
-----------------
Open-Label, Long-Term (1 Year) Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Conditions
-----------------
Hypercholesterolemia, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Pitavastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or NK-104-302 (NCT00309777) Patients who have not developed any treatment emergent and, in the opinion of the investigator, related adverse event (AE) of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin. Patients who have been following a fat and cholesterol restrictive diet. Exclusion Criteria: Any conditions which may cause secondary dyslipidemia should be reassessed at the beginning of the follow-up study. Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up study. Abnormal pancreatic, liver, or renal function Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the pre-specified level Significant heart disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin 4 mg QD<br>Pitavastatin 4 mg once daily | Drug: Pitavastatin<br>* Pitavastatin 4 mg once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) | Baseline to 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Cholesterol | Mean percent change from baseline in total cholesterol | Baseline to 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypercholesterolemia, dyslipidemia, pitavastatin, NK-104, Hypercholesterolemia or combined dyslipidemia, Kowa
Tryptophan Depletion in Acute Mania

Study Overview
=================
Brief Summary
-----------------
Serotonin (5-HT) is important in mood regulation and is believed to play a major role in the pathophysiology of major depression (MD). Selective serotonin reuptake inhibitors (SSRIs) are currently the most widely used drugs for the treatment of depression. Patients with bipolar disorder (BD) who are treated for depression with SSRIs might develop mania, which is believed to be triggered by antidepressant treatment. Rapid tryptophan depletion (RTD) has been shown to induce transient depressive symptoms in remitted depressed patients treated with SSRIs. In remitted manic patients treated with lithium, RTD does not seem to have clinical effects. However, RTD was not studied in acutely manic patients and could theoretically have antimanic properties. In this double blind randomized placebo controlled study RTD will be used as a tool to assess the role of 5-HT in mania and will be evaluated for its antimanic properties and potential use as augmentation to drug treatment in acute mania.

Official Title
-----------------
Tryptophan Depletion in Acute Mania - A Randomized Controlled Trial

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Other: rapid tryptophan depletion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute mania Ability to provide written informed consent Exclusion Criteria: Mixed affective states Suicidal ideation Uncontrolled systemic illness

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 |
| --- |
|Other: rapid tryptophan depletion|Amino-acid mixture without tryptophan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Young Mania Rating Scale score |  | Before and after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression |  | Before and after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bipolar disorder, acute mania, tryptophan depletion, placebo controlled add-on, Bipolar disorder- manic type
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients

Study Overview
=================
Brief Summary
-----------------
This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders.

Official Title
-----------------
Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: tacrolimus
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe refractory UC patients Disease activity: more than 4 times of stool a day, bloody stool, moderate to severe endoscopic finding Steroid resistance or dependence to meet at least one of the following condition:no efficacy with more than 40mg/day or 1mg/kg/day of steroid over at least 1 week, no efficacy with 30-40mg/day of steroid over at least 2 weeks,exacerbation along with steroid reduction Exclusion Criteria: Mild or fulminant type Renal failure patients, hepatic failure patients Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry Patients who received LCAP or GCAP within 2 weeks prior to entry Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry. Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before the study.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 64 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: 1<br> | Drug: tacrolimus<br>* oral<br>* Other names: Prograf;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Disease activity index score (DAI score) |  | 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of DAI score ( Total & each item) |  | 2 Weeks | 
| Changes of clinical severity and symptom |  | 2 Weeks | 
| Endoscopic finding |  | 2 Weeks | 
| Patients impression |  | 2 Weeks | 
| Amount of steroid |  | 2 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative colitis, tacrolimus, FK506, treatment outcome
Thyroid Nodule Gene Sequencing in a Danish Population

Study Overview
=================
Brief Summary
-----------------
This pilot study aims at describing the prevalence and distribution of molecular alterations in thyroid nodules of benign and malignant origin at the level of DNA and RNA in a Danish population. Patients with thyroid nodules suspected of malignancy is included prospectively. Tissue samples are collected for molecular analyses form surgical specimens and bloodsamples, and preoperative clincial features are registered.

Official Title
-----------------
Thyroid Nodule Gene Sequencing in a Danish Population - A Pilot Study

Conditions
-----------------
Thyroid Nodule (Diagnosis), Thyroid Cancer

Intervention / Treatment
-----------------
* Genetic: Molecular analyses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thyroid nodule >1.5 cm BSRTC: IV, V, og VI Exclusion Criteria: No surgical specimen available Purely cystic nodules

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Molecular testing<br>Descriptive and explorative study including identical molecular analyses applied to all included patients | Genetic: Molecular analyses<br>* Collect thyroid tissue for molecular analysis from the histological specimen collected by routine surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA alterations | Whole genome sequencing by next generation sequencing | Two years | 
| RNA alterations | Total RNA sequencing including circular RNA, micro RNA and messenger RNA | Two years | 
| DNA methylation | Whole Genome Bisulfite Sequencing | Two years | 
| Circulating tumor DNA | Whole genome sequencing of leucocyt DNA and circularing DNA | Two years |
Non-Invasive ctDNA Methylation Detection for Lung Nodule Patients

Study Overview
=================
Brief Summary
-----------------
Low-dose computed tomography (LDCT) is recommended for early-stage lung cancer screening. However, it is often difficult to determine indolent lesions from more aggressive tumors without an invasive intervention or prolonged follow-up period. Thus, the main purpose of this study is to develop a non-invasive method to detect lung-cancer specific circulating tumor DNA (ctDNA) in blood, which can greatly improve the specificity of lung cancer early screening.

Detailed Description
-----------------
In this study, the investigators sought to explore sensitive and specific methylation biomarkers that are highly prevalent in lung cancer. It is the first time to perform screening assay on healthy, lung nodule, and lung cancer tissues to identify preliminary set of highly prevalent methylation markers, and then refined these markers by removing regions were unstable in matched plasma samples. Next, investigators interrogated significant methylation marker regions enriched in lung nodules of training sample set to buildup a non-invasive biomarker classification model to discriminate cancerous nodules from benign lesions. Eventually, the model in patient lung nodule samples were validated.

Official Title
-----------------
Detection of Early-stage Lung Cancer by Using Methylation Signatures in Circulating Tumor DNA

Conditions
-----------------
Lung Nodule

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or above with pulmonary nodule(s) found by LDCT, mean diameter below 30mm. The nodule lesion is peripheral, no signs of lymphatic infiltration or distal metastasis. Fit and consent to surgical resection. Agree to participate in this study and sign informed consents. Exclusion Criteria: Fail to understand or agree to sign informed consent. Patients who did not follow the test plan for timely blood collection or did not cooperate with the study follow-up work. Patients with previous history of cancer and/or cancer treatment such as surgery, radiotherapy, chemotherapy or targeted therapy. Failing to meet the requirements for blood sampling.

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 |
| --- | --- |
| Lung nodule group<br> | |
| Healthy Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noninvasive assisted diagnosis of benign and malignant pulmonary nodules | The biomarker classification model can be used to differentiate patients, who had positive LDCT results, with benign or malignant lung nodules. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA methylation, ctDNA
Study Evaluating Long-Term Safety of Effexor XR in Patients With Major Depression.

Study Overview
=================
Brief Summary
-----------------
Phase III long-term safety study of Effexor XR in patients with major depression.

Official Title
-----------------
Phase III Long-Term Administration Study of Effexor XR for the Treatment of Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Effexor XR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who complete the Phase III double-blind study (Protocol Number 0600B1-816) Exclusion Criteria: Patients with schizophrenia or any other psychotic disorder Patients with history or presence of bipolar disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Effexor XR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative data for laboratory data |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression
Polyp Artificial Intelligence Study

Study Overview
=================
Brief Summary
-----------------
Background We are developing artificial intelligence based polyp histology prediction (AIPHP) method to automatically classify Narrow Band Imaging (NBI) magnifying colonoscopy images to predict the non-neoplastic or neoplastic histology of polyps. Aim Our aim was to analyse the accuracy of AIPHP and NICE classification based histology predictions and also to compare the results of the two methods. Methods We examined colorectal polyps obtained from colonoscopy patients who had polypectomy or endoscopic mucosectomy. Polyps detected by white light colonoscopy were observed then by using NBI at the optical maximum magnificent (60x). The obtained and stored NBI magnifying images were analysed by NICE classification and by AIPHP method parallelly. Pathology examinations were performed blinded to the NICE and AIPHP diagnosis, as well. Our AIPHP software is based on a machine learning method. This program measures five geometrical and colour features on the endoscopic image.

Official Title
-----------------
Artificial Intelligence Based Colorectal Polyp Histology Prediction by Using Narrow-band Imaging Magnifying Colonoscopy

Conditions
-----------------
Software Analysis on Polyp Histology Prediction

Intervention / Treatment
-----------------
* Other: artificial intelligence diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endoscopic diagnosis of colorectal polyp Exclusion Criteria: colonoscopy result without polyps or IBD diagnosis

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

| Intervention/Treatment |
| --- |
|Other: artificial intelligence diagnosis|artificial intelligence prediction of colorectal polyp histology|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Software accuracy of polyp histology prediction | Artificial intelligence software diagnosis in comparison with the polyp histology | 2014-2020 |
SRS Sequential Sindilimab in Brain Metastasis of NSLSC

Study Overview
=================
Brief Summary
-----------------
A phase II study on the treatment of advanced non-small cell lung cancer with brain metastasis by SRS sequential sintilimab

Official Title
-----------------
A Phase II Study on the Treatment of Advanced Non-small Cell Lung Cancer With Brain Metastasis by SRS Sequential Sintilimab

Conditions
-----------------
NSCLC Stage IV, Brain Metastases, SRS, Sintilimab

Intervention / Treatment
-----------------
* Combination Product: SRS sequential sintilimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-small cell lung cancer patients with less than brain metastases Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment Patients who have not received intracranial local treatment before Exclusion Criteria: Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds Patients with hemorrhage in intracranial metastasis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SRS sequential sintilimab<br> | Combination Product: SRS sequential sintilimab<br>* The subjects first received a targeted radiotherapy of SRS, and started the treatment of sintilimab per 3 weeks within 35 days after SRS.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iPFSof NSCLC patients receiving SRS sequential sintilimab | From the beginning of treatment to the end of follow-up study, when the longest diameter of brain metastases treated by SRS was more than 30% smaller than the baseline level at any time of efficacy evaluation, the objective remission of the lesions was achieved. The time from the objective remission to the next progress of the intracranial lesions was recorded as the intracranial progression-free survival(iPFS). | 1 year |
FDG-PET/CT for Simulation and Radiation Treatment Planning of Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is: to assess the potential benefits of 18F-[FDG] PET/CT and PET/MRI for operable breast cancer in order to define the size and location of the primary tumor, as well as axillary, supraclavicular and internal mammary lymph nodes. to apply the imaging results to the simulation and the radiation treatment planning and partial breast for 3-D radiation treatment and partial breast irradiation with intensity modulated radiation treatment (IMRT).

Detailed Description
-----------------
Pre-operative FDG PET/CT, and in option PET/IRM, are intended for women with histologically confirmed operable clinically node-negative breast cancer, in whom breast conserving and post-operative radiotherapy are planned.

Official Title
-----------------
Application of 18F-[FDG] PET/CT to Simulation and Planning of Radiotherapy (RT) for Breast Cancer. Definition of Target Volume for 3-D RT and for Partial Breast Irradiation (PBI) by IMRT Technique

Conditions
-----------------
Breast Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed breast carcinoma Clinical stage T1-2 N0 M0 Age > 18 years Signed informed consent Exclusion Criteria: WHO performance index 3 Premenopausal women without contraception Gestation Lactating Prior surgery or radiotherapy on the same breast Unable to understand study participation Bilateral breast cancer Prior CT thorax-abdomen and breast MRI within 4 months of interview Presence of electromechanical implant and/or body ferromagnetic material Previous history of renal insufficiency requiring dialysis and/or hospitalisation Ureum and/or creatinine within 2 weeks of interview above lab's reference limits History of contrast allergy Hyperthyroidy Claustrophobia.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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 |
| --- | --- | --- |
| Drawing of target volumes | Compare the drawing of target volumes using the PET/CT, PET/IRM information, or without these imaging informations. | Up to 12 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate the FDG PET/CT PET/IRM with surgical pathology findings | Compare the pre-operative imaging information with histopathological description of the resected primary tumor, and with the extent of lymph node involvement. | Up to 12 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FDG, breast carcinoma, PET/CT, PET/IRM