linjc16/ctgov huggingface dataset:
Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech PLD Device

Study Overview
=================
Brief Summary
-----------------
Collect patient data and to monitor the clinical use (safety and efficacy) of the device

Conditions
-----------------
Mitral Paravalvular Leaks (PVL), Aortic Paravalvular Leaks (PVL)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patients with PVL associated hemolysis, recurrent blood transfusions, or hemodynamically significant heart failure Exclusion criteria The device is contraindicated for patients known to have any of the following: Known coagulation dysfunction Leak reversal with separate or significant residual or recurrent leak Acute infection Known intra-cardiac thrombi Recent pelvic venous thrombosis Recent myocardial infarction or a surgical bypass operation in the last 30 days If adequate oral anticoagulation therapy / antiplatelet aggregation inhibition is not possible post-procedurally Intolerance of contrast agent

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 |
| --- | --- | --- |
| Proper closure of the PVL (defined as Reduction in paravalvular regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions. |  | 6 month following implantation | 
| Absence of device -and/or procedure-related Serious Adverse Events (SAEs) including deaths, stroke (ischemic stroke that occurs within 24 hours following implantation), systemic embolism or device embolizations. |  | 6 month following implantation |
Efficacy Study in Patients With Acne Vulgaris.

Study Overview
=================
Brief Summary
-----------------
Safety and efficacy study in patients with acne vulgaris

Detailed Description
-----------------
randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS in the treatment of acne vulgaris.

Official Title
-----------------
A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study to Evaluate the Efficacy and Safety of ADPS in the Treatment of Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: ADPS topical product
* Drug: Placebo Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non pregnant female aged ≥ 9 years with a clinical diagnosis of acne vulgaris Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years

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

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

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: ADPS topical product<br>A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks | Drug: ADPS topical product<br>* topical product<br>* Other names: Active;|
| Placebo Comparator: Placebo Control<br>A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks | Drug: Placebo Control<br>* topical product<br>* Other names: vehicle;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face |  | Baseline to week 12 (study day 84) | 
| Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face |  | Baseline to week 12 (study day 84) | 
| The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12 on the Face. | Success was defined as an IGA score that was at least two grades less than the baseline assessment. | Baseline to Week 12 (study day 84) |
Testing of the Apnea Prevention Device

Study Overview
=================
Brief Summary
-----------------
This study is designed to test the ability of a computer-based algorithm to detect and intervene in cases of narcotic-induced respiratory depression.

Official Title
-----------------
Testing of the Apnea Prevention Device

Conditions
-----------------
Respiratory Depression, Elective Surgery

Intervention / Treatment
-----------------
* Other: Verbal prompt
* Other: Skin Stimulus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgical patients Exclusion Criteria: Refusal to consent to study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verbal prompt, cutaneous stimulation<br>Patient receives either or both a verbal stimulus or cutaneous stimulus | Other: Verbal prompt<br>* Patient hears a voice recording<br>Other: Skin Stimulus<br>* Patient receives either a skin stimulus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy in treating respiratory depression |  | seconds after desaturation |
Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether XPF-001 is safe and effective in the treatment of pain caused by Inherited Erythromelalgia (IEM).

Official Title
-----------------
Phase 2a, Double-blind, Placebo-controlled, 2-period, Crossover Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Oral Doses of XPF-001 in Patients With Inherited Erythromelalgia.

Conditions
-----------------
Primary Erythromelalgia, Inherited Erythromelalgia

Intervention / Treatment
-----------------
* Drug: XPF-001
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study requires you to: Be18-75 years old Have inherited erythromelalgia Be experiencing pain caused by erythromelalgia (Moderate pain score 4/10) Be generally healthy (apart from your pain) Stop taking your usual pain medications for 9 days Not be pregnant or breast-feeding Your role in the study includes: An out-patient screening visit 9-days/8 nights-in-patient treatment visit at Nijmegen Medical Center (where you will be closely monitored) A follow up phone call (after your return home) Taking the investigational medication daily Recording your pain levels daily during stay at the Medical Center. Exclusion Criteria: Coexistent source of pain from other conditions Receiving professional psychological support for dealing with IEM Treatment for significant depression within 6 months of screening Active HIV, Hepatitis B or C Use of prescription or OTC medication between check-in and discharge Women who are pregnant, or lactating Not currently using adequate contraception Alcoholism or alcohol or substance abuse Presence or history of major psychiatric disturbance Unwilling or unable to comply with all dietary and activity restrictions Any other condition or finding that may pose undue risk for participation Use of any other investigational drug in the 60 days prior to dosing

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Matching Placebo<br> | Drug: Placebo<br>* Oral capsule<br>|
| Experimental: XPF-001<br> | Drug: XPF-001<br>* Oral capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity difference (PID) in each treatment period based on an 11-point Pain Intensity-NRS (where 0 = No pain and 10 = worst pain you can imagine) |  | 2 days |
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical investigation is to evaluate the safety and effects of CCCR-modified NK92(CCCR-NK92)infusions in previously treated advanced non-small cell lung carcinoma(NSCLC).

Official Title
-----------------
Clinical Investigation of Chimeric Costimulatory Converting Receptor(CCCR)-Modified NK92 Cells in Previously Treated Advanced Non-small Cell Lung Carcinoma

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Biological: CCCR-NK92 cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Male and female subjects with non-small cell lung carcinoma in patients with no available curative treatment options who have limited prognosis(≧3 months)with currently available therapies will be enrolled. 2.The last cytotoxic drug, radiotherapy or surgery≧4 weeks. 3.HB≧90g/L, ANC≧1.5×10e9/L, PLT≧80×10e9/L, TBIL≦1.5×upper limit of nomal, ALT/AST≦2.5×upper limit of nomal, ALT/AST≦5×upper limit of nomal if have liver metastasis, Cr≦1.5×upper limit of nomal or CCr≧60ml/min. Exclusion Criteria: 1.Pregnancy or breastfeeding. 2.Known HIV, HBV or HCV infection. 3.Active antoimmune disease. 4.History of severe immediate hypersensitivity to any of the biological products including penicillin. 5.Severe psychiatric disorder which might interfere with the study treatment or examination. 6.Chronic heart failure NYHA≧III. 7.Simultaneous participation in another clinical trial within 4 weeks.

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: CCCR-NK92 cells immunotherapy<br>Preparation of CCCR-NK92 cells suspended in a saline and plasma solution. | Biological: CCCR-NK92 cells<br>* CCCR-NK92 cells will be administered intravenously over 1h. The starting dose of CCCR-NK92 cells will be 1×10e7-1×10e8,twice a week. The first evaluation of the efficacy after 3 weeks of treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events evaluated with CTCAE,version 4.0 | Safety evaluation | 3 months | 
| Objective Response Rate | Non-small cell lung carcinoma to CCCR-NK92 cell infusions | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate |  | up to one year | 
| Progression-free Survival |  | up to one year | 
| Overall Survival |  | up to one year |
Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting.

Detailed Description
-----------------
The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting. It will be compared to placebo.

Official Title
-----------------
Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Depodur


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female, 18-99 years old All patients who will have surgery for OP-CABG Exclusion Criteria: Pregnant females Patients with allergy to morphine Patients nursing an infant Patients with migraine headaches Patients taking Coumadin within 7 days or demonstrating INR > 13 Patients taking Heparin unless documented normal partial thromboplastin time Patients taking Clopidogrel in previous 7 days Patients taking Ticlopidine in previous 14 days Patients taking Aspirin in previous 48 hours Patients receiving low molecular weight heparin therapy within 24 hours previous Patients with Narcolepsy and/or sleep apnea Patients on chronic opioid therapy Patients participating in another study

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depodur<br>Depodur arm | Drug: Depodur<br>* Depodur vs. traditional management<br>* Other names: Traditional;|
| Active Comparator: Traditional<br>traditional management | Drug: Depodur<br>* Depodur vs. traditional management<br>* Other names: Traditional;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OP-CABG, Depodur traditional drug
Epidemiology of Blood Pressure, Insulin, Salt Transport

Study Overview
=================
Brief Summary
-----------------
To determine the roles of insulin, lipids, body weight and ion transport in blood pressure regulation.

Detailed Description
-----------------
BACKGROUND: Insulin levels are consistently related to blood pressure, obesity, and blood lipids. Insulin level correlation with sodium-lithium countertransport is limited to only one available study done in white, normotensive, predominantly normal weight women aged 45-52. The relationship between cellular sodium-hydrogen exchange activity and hypertension has been studied in rats and in a small study in humans. Correlation of this transport with weight, fasting insulin and lipid levels, and sodium-lithium countertransport was not available in 1989. DESIGN NARRATIVE: The study was cross-sectional. Subjects were stratified by weight: plus or minus 10 percent of desirable weight; 11 to 30 percent over desirable weight; and 30 percent over desirable weight; and by diastolic blood pressure: 80; 80-89; 90-99 mmHg. Blood pressure, height, weight, waist and hip girth, skinfold, fasting and post-glucose load insulin, glucose, lipids, creatinine, maximal rates of red blood cell sodium-lithium countertransport and platelet sodium-hydrogen exchange, pH, and calcium concentrations were measured. The strength and independence among these continuous variables were measured by Pearson correlations, partial correlations, and multiple regressions within each stratum, and if appropriate, over all strata. The study examined the hypotheses that: part of the relationship between obesity and blood pressure was due to insulin effects and/or lipid effects on ion transport; the relationship between ion transport and blood pressure was related to an abnormality of sodium-hydrogen exchange, for which the observed increase in sodium-lithium countertransport was a marker; increased blood pressure was related to the alteration of intracellular pH and/or calcium concentration. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.

Study Overview
=================
Brief Summary
-----------------
The role of gut microbiota in anastomosis insufficiency in patients operated for colorectal cancer and for peritoneal carcinomatosis is going to be investigated. This is a pilot study.

Official Title
-----------------
The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.

Conditions
-----------------
Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis Insufficiency

Intervention / Treatment
-----------------
* Procedure: Colectomy, CRS+HIPEC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Colorectal group adenocarcinom in colon or rektum curative operation planed direct anastomose plan elective surgery Inclusion Criteria HIPEC group : All patients with appendix, colon or rectal cancer accepted for CRS+HIPEC Exclusion Criteria: Ongoing antibiotics treatment antibiotics treatment in the last 6 months acute surgery palliative surgery Ulcerös colitis or Crohns disease Prior colectomy Small intestine stoma before the operation neoadjuvant treatment Colon preparation

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal<br>30 patients operated for colorectal cancer | Procedure: Colectomy, CRS+HIPEC<br>* No special interventions are going to be performed. Fecal samples are going to be taken and analysed<br>|
| HIPEC<br>15 patients operated with CRS+HIPEC for peritoneal carcinomatosis | Procedure: Colectomy, CRS+HIPEC<br>* No special interventions are going to be performed. Fecal samples are going to be taken and analysed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome | Change in microbiome in case of insufficiency of the anastomosis | 30 days |
Bleeding Prediction in Patients Following Cardiac Surgery Using Whole Blood Aggregometry and Thromboelastometry

Study Overview
=================
Brief Summary
-----------------
Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful data about platelet function and viscoelastic properties of blood clot in patients undergoing cardiac surgery. The purpose of this study is to clarify whether it is possible to predict patients on excessive risk of perioperative bleeding using whole blood impedance aggregometry and rotational thromoelastometry. Antiplatelet therapy is the cornerstone in treatment of patients with coronary artery disease. Another research goal is to determine the degree of response to antiplatelet therapy before and after surgery and to investigate whether patients by level of response to antiplatelet therapy before surgery have a higher risk of perioperative bleeding.

Official Title
-----------------
Bleeding Prediction in Patients Undergoing Cardiac Surgery Using Whole Blood Impedance Aggregometry and Rotational Thromboelastometry

Conditions
-----------------
Heart Disease, Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old Elective cardiac surgery patients Coronary artery disease Aortic valve disease Mitral valve disease Ascendent aorta aneurysm Combine coronary and valve disease Cardiac surgery procedures using cardiopulmonary bypass Exclusion Criteria: Missing consent Patients with emergent cardiac surgical procedures Patients on antiplatelet therapy other than aspirin or clopidogrel Patients with inaccurate antiplatelet therapy administration documentation Missing data Off-pump procedures Patients younger than 18 years old Patients with severe mental disorders Intrinsic coagulopathy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing elective cardiac surgery<br>Patients undergoing elective cardiac surgery will be enrolled in study. Data about antiplatelet therapy ingestion prior to surgery will be included. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest tube output in first 24 hours |  | 24 hours after surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allogenic blood products transfusion |  | 7 days after surgery including the day of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, aggregometry, thromboelastometry, platelet function, bleeding, antiplatelet therapy