linjc16/ctgov huggingface dataset:
Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Therapies that target specific molecules markedly inhibit cancer growth in several malignancies, and provide valuable strategies for the treatment of advanced melanoma. In recent years, BRAF and KIT have become established therapeutic targets in melanoma patients showing activating mutations in these oncogenes. However, it is crucial that genetic mutations present in the melanoma lesions are identified if the investigators are to design tailormade therapies for individual patients. The tumour genotypes that determine the selection of molecular-targeted therapies are usually identified in primary tumours; however, primary tumours are not always representative of metastases. Circulating free DNA may be a source of valuable information because it can be obtained via routine blood sampling, it provides real-time information about a patient's current disease state, and it allows monitoring and molecular characterization before and after chemotherapy. The aim of the study is to determine the mutational status in circulating DNA in melanoma metastatic patients, with the Sequenom Mass Array, a next generation sequencing technology. Results obtained before and after treatment will be compared with the primary tumor genotype.

Official Title
-----------------
Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy.

Conditions
-----------------
Metastatic (Stage IV) Melanoma

Intervention / Treatment
-----------------
* Procedure: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years Surgical biopsy for histologic diagnostic All melanoma subtypes Known genotype BRAF V600 Affiliation social security Consent form signed Exclusion Criteria: Patient with histories of cancer or the other synchronous cancer Pregnant women Breast-feeding women Vulnerable patients: major under guardianship; patient deprived of its rights

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metastatic (stage IV) melanoma<br> | Procedure: blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment (MRI, Scanner) | Comparison between first day and third months | at three months |
Transversus Abdominis Plane Block in Acute Appendicitis Pain Managment

Study Overview
=================
Brief Summary
-----------------
In this study, it was aimed to investigate the analgesic efficacy of the preoperatively applied Transversus Abdominis Plane (TAP) Block in the management of acute appendicitis-related abdominal pain and post-appendectomy pain.

Detailed Description
-----------------
TAP block creates an analgesic effect by blocking both sensory skin dermotams and viscerosomatic transmission. TAP block with ultrasound was first performed by Hebbard, and the use of USG made the procedure faster and safer. TAP block has been successfully applied for analgesia in procedures such as laparoscopic colocystectomy, inguinal hernia repair, abdominal hysterectomy, prostatectomy and appendectomy. According to the surgical incision to be applied, TAP block is performed from different anatomical regions. It is also applied for pain palliation in intra-abdominal etiologies or rarely for anesthesia in surgical procedures. The analgesic efficacy of TAP block on preoperative abdominal pain and postoperative surgical pain in acute appendicitis was investigated.

Official Title
-----------------
Efficacy of Preoperative Transversus Abdominis Plane Block in Acute Appendicitis Pain and Its Success in Postoperative Pain

Conditions
-----------------
Acute Appendicitis, Acute Abdomen, Postoperative Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age of 18 with a diagnosis of acute appendicitis, with abdominal pain, tap block applied for perioperative pain management. Exclusion Criteria: The data of patients who underwent laparoscopic appendectomy additional surgical procedure other than appendectomy (right hemicolectomy, etc.) who were diagnosed other than acute appendicitis after the surgical procedure (diverticulitis, tumor, etc.),

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 |
| --- | --- | --- |
| Verbal Numerical Pain Scale | <4 good pain managment , >4-10 bad pain managment | postoperative time 24 hour time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | kg/(m2) | preoperative | 
| weight | kg | preoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transversus abdominis plane nerve block, acute appendicitis, acute pain, postoperative pain
Long-term Pleiotropic Effect of Statins in Patients With Peripheral Arterial Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the long-term effects of statins, atorvastatin, upon Nitric Oxide, as an endothelial function assessment, and C-Reactive Protein, an inflammatory marker, levels in patients with Peripheral Arterial Disease. These long-term biological pleiotropic effects of statins will offer information on the role of endothelial function and systemic inflammation in the etiopathogenesis of PAD.

Official Title
-----------------
Phase IV Study of Statins for Assess the Long-term Pleiotropic Effect Upon Nitric Oxide and C-Reactive Protein Levels in Patients With Peripheral Arterial Disease

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Standard Medical Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients at the time of diagnosis of Fontaine grade II peripheral arterial disease (PAD), confirmed by hemodynamic evaluation (Doppler ultrasound) over 18 years old Exclusion Criteria: patients had previously undergone revascularization patients were receiving treatment with statins patients with contraindications to statin use. patients with coexistence of chronic inflammatory diseases or steroidal medication

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br>Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months | Drug: Atorvastatin<br>* Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months<br>|
| Active Comparator: Control<br>Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months. Standard Medical Treatment | Drug: Standard Medical Treatment<br>* Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months. Standard Medical Treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High-sensitivity C-Reactive Protein (hsCRP) and nitrites plasma levels at baseline and after one month and one year of inclusion. |  | Baseline and after one month and one year of inclusion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile |  | baseline and after one month and one year of inclusion. |
Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify risk factors for low lymphocyte count among patients with type 2 diabetes who are treated with oral antidiabetic drugs.

Detailed Description
-----------------
Involving a secondary analysis of data collected prospectively from a defined cohort, for the SAVOR trial.

Official Title
-----------------
Identification of Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes: An Analysis of Data From the SAVOR Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in SAVOR Diagnosed with T2DM Baseline HbA1c ≥6.5% (based on the last measured and documented laboratory measurement within 6 months) Age 40 or older High risk for a cardiovascular event Exclusion Criteria: Not enrolled in SAVOR Current or previous treatment with DPP4 inhibitors and/or GLP-1 or incretin mimetics. Acute vascular event Pregnancy HIV/AIDS Severe autoimmune disease Current chronic steroid use

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Patients treated with saxagliptin or placebo<br>Patients will be treated with saxagliptin or placebo, on top of whatever baseline treatment for diabetes the patient is already receiving. | |
| Patients currently or previously on treatment<br>Patients currently or previously on (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics are excluded. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify risk factors for lymphopenia, defined as an absolute lymphocyte count < 500 cells/μl, or investigator reported lymphopenia, in the SAVOR study population. |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify risk factors for absolute lymphocyte count <750 cells/µl or investigator reported lymphopenia. |  | 60 months | 
| To identify risk factors for decreased lymphocyte count (>=30% decrease from baseline. |  | 60 months | 
| To evaluate whether risk factors for low lymphocyte counts or decreasing lymphocyte count differ between saxagliptin users and non-users. |  | 60 months |
Predictors of Malnutrition in Patients With Haematological Cancer

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to conduct an exploratory study of which predictors are most significant for LBM loss in patients with lymphoma. Patients are measured by weight and bio impedance and furthermore, their physical activity, nutritional status, diet and quality of life during the course are estimated. This is done in order to determine any changes in the aforementioned factors during the course of the cancer treatment that may have a bearing on the loss of LBM.

Detailed Description
-----------------
It was assessed by the National Ethics Committee that the experiment was not subject to notification, cf. section 14 (1) of the Committee Act. 2. The project has been approved by the Ethical Research Committee for SUND and SCIENCE, University of Copenhagen.. The project was also approved by the Danish Data Protection Agency at Region Zealand with case no .: REG-166-2020. A data processor agreement was established between Region Zealand and thesis students. Data is presented as mean +/- SD. Continuous data are analyzed using Pearson correlation analysis presented by correlation coefficient r and a p-value. Pearson correlation analysis is used to measure the strength of the linear relationship between normally distributed variables. A significance level of 5% is used. Binary values are assigned for data assessing secondary endpoints. Subsequently, a multiple linear regression analysis is performed to examine the influence of discrete variables on the primary endpoint. For statistical analysis and design of plots, the programs, R Studio (version 1.4.1106) and Excel (version 16.43) is used.

Official Title
-----------------
Predictors of Malnutrition in Patients With Haematological Cancer

Conditions
-----------------
Malnutrition, Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with haematological cancer Patients receiving myelosuppressive chemotherapy for haematological disease Adult patients Exclusion Criteria: Patients who cannot understand and speak Danish or English Pregnant and breastfeeding Patients who suffer from dementia

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 |
| --- | --- | --- |
| Loss of Lean Body Mass | Lean Body Mass measured by bioimpedance | 2 months |
A Comparison of Sample Collection Methods for SARS-COV-2 Antibody Testing

Study Overview
=================
Brief Summary
-----------------
The negative global consequences of the COVID-19 pandemic has prompted efforts to develop efficient laboratory testing protocols that can be quickly scaled in a practical way. Traditional phlebotomy requirements for antibody testing (venipuncture) often serve as a barrier to widespread population testing since they typically require dedicated facilities and personnel training. Conversely, antibodies are typically very stable in blood and require very little testing volume, which make antibody tests well suited to be run on samples collected via finger-stick, saliva, or other self-administered collection devices. Salveo Diagnostics is a CLIA/CAP certified clinical laboratory that routinely performs testing for anti-SARS-Cov-2 antibodies. The purposes of this protocol are to 1) assess the feasibility of streamlined sample collection procedures for assessing COVID-related immune status, and 2) to provide a mechanism for securing sequential samples in COVID positive and negative patients to support additional studies (e.g. investigating timing of anti-SARS-CoV-2 antibody class switching and antibody persistence).

Official Title
-----------------
A Comparison of Sample Collection Methods for SARS-COV-2 Antibody Testing

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: comparison of sample collection methods


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed presence (N = 200) or absence (N = 100) of anti-SARS-COV2 antibodies >17 years old Exclusion Criteria: Refusal or inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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 |
| --- | --- |
| Other: Sample Collection Method<br>All subjects will provide samples via traditional phlebotomy, finger-stick, and saliva collection. | Diagnostic Test: comparison of sample collection methods<br>* Samples will be collected via finger-stick, saliva collection, and traditional phlebotomy to determine effects on COVID-19 antibody test results.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory determination of presence of anti-SARS-COV2 antibodies (IgM, IgA, and IgG) |  | testing will be performed within 2 days of collection |
A Study to Compare Two Paracetamol Formulations.

Study Overview
=================
Brief Summary
-----------------
A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.

Official Title
-----------------
A Pharmacokinetic Study Investigating the Rate and Extent of Absorption of Paracetamol and an Adjuvant From Two Different Paracetamol Formulations.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Marketed paracetamol
* Drug: Experimental paracetamol formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Marketed paracetamol<br>Marketed paracetamol | Drug: Marketed paracetamol<br>* Marketed paracetamol<br>|
| Experimental: Experimental paracetamol formulation<br>Experimental formulations | Drug: Experimental paracetamol formulation<br>* Experimental paracetamol formulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states |  | baseline to 10 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of absorption in fasted and semi-fed states |  | baseline to 10 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy volunteer, pharmacokinetics, paracetamol
Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled

Study Overview
=================
Brief Summary
-----------------
To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.

Detailed Description
-----------------
Study design: Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in period and prescribed KI1107 or Rosuvastatin for 8 weeks.

Official Title
-----------------
A Multi-center, Randomized, Double Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Drug: KI1107 4 Capsules, QD
* Drug: Rosuvastatin Calcium 20 MG, QD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Screening Visit Age: 19-80 High risk for cardiovascular disease according to NCEP APT III TG≥130mg/dL and 160mg/dL>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks 500mg/dL>TG≥200mg/dL and LDL-C<110mg/dL for subjects who were taking statins for 4 weeks Baseline Visit 500mg/dL>TG≥200mg/dL LDL-C<110mg/dL Reduction of LDL-C dompairng screening visit Exclusion criteria: The patient has histories of acute artery disease within 3 months The patient has histories of operation revasculatiation or aneurysm within 6 months The patient has histories of Unexplained myaliga or diagnosed myalgia or rhabdomyolysis The patient has histories of Effectable disease to the procedrue and clinical trial result

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>KI1107 | Drug: KI1107 4 Capsules, QD<br>* KI1107 4 Capsules<br>|
| Active Comparator: Control<br>Rosuvastatin calcium | Drug: Rosuvastatin Calcium 20 MG, QD<br>* Rosuvastatin Calcium 20mg, QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation rate of Non HDL-C |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation rate of TG |  | 4 weeks, 8 weeks | 
| Variation rate of Non HDL-C |  | 4 weeks | 
| Variation rate of TC |  | 4 weeks, 8 weeks | 
| Variation rate of LDL-C |  | 4 weeks, 8 weeks | 
| Variation rate of VLDL-C |  | 4 weeks, 8 weeks | 
| Variation rate of Apo A-I |  | 4 weeks, 8 weeks | 
| Variation rate of Apo B |  | 4 weeks, 8 weeks |