linjc16/ctgov huggingface dataset:
Antiemetic Effect of the Addition of Ondansetron to the Morphine Solution in Patient-Controlled Analgesia (PCA)

Study Overview
=================
Brief Summary
-----------------
PCA morphine always introduces nausea and vomiting during the postoperative period. Ondansetron can reduce PONV (postoperative nausea vomiting). We, the researchers at Khon Kaen University, are trying to add ondansetron in PCA morphine. Patients receive a small dose of ondansetron when they request morphine.

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: ondansetron adding in PCA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 15-60 years old Exclusion Criteria: History of motion sickness, smoking

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Drug: ondansetron adding in PCA|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PONV |  | 24 hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ondansetron, PCA
Treatment Rates and Compliance to Treatment in Patients With Familial Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
Familial hypercholesterolemia is a genetic disease characterized by increased levels of low density lipoprotein cholesterol (LDL-C). It is underdiagnosed and undertreated despite relatively high prevalence and significant association with increased mortality.

Detailed Description
-----------------
Patients older than 18 years old and have a serum low density LDL-C≥250 mg/dL were identified from the hospital database. A questionnaire was completed via phone. Patients were classified as definite, probable and possible familial hypercholesterolemia according to Dutch Lipid Clinical Network Criteria

Official Title
-----------------
Awareness, Treatment Rates and Compliance to Treatment in Patients With Serum LDL Cholesterol Higher Than 250 mg/dL, and Possible, Probable or Definite Familial Hypercholesterolemia

Conditions
-----------------
Familial Hypercholesterolemia

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years old and have a serum LDL-C≥250 mg/dL Exclusion Criteria: Patients who refuse dto interview Serum TSH≥10 mIU/mL Glomerulonephritis or nephrotic syndrome ALT or AST higher than 3 times of normal limits Serum triglyceride >400 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with LDL cholesterol ≥250 mg/dL<br>Patients older than 18 years old and have a serum LDL-C≥250 mg/dL between January 2010 and December 2016. Patients with a serum TSH≥10 mIU/mL, patients with glomerulonephritis or nephrotic syndrome, patients with ALT or AST higher than 3 times of normal limits and patients with serum triglyceride >400 mg/dL were excluded. | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment rates | Patients with a serum LDL-C≥250 mg/dL were identified from the database of our hospital. Dutch Lipid Clinical Network Criteria was used to classify patients as definite, probable and possible FH. Patients were reached by phone and a questionnaire was applied. The questionnaire consisted of questions related with clinical and physical examination findings defined in theDutch Lipid Clinical Network Criteria. Total cholesterol, LDL-C, HDL-C, triglyceride levels were obtained from the medical records. Patients were asked whether they were using lipid lowering drugs. If they were not using, the cause of this was asked. By this way, we determined the rate of use of lipid lowering drugs in patients with LDL-C≥250 mg/dL and have definite, probable or possible familial hypercholesterolemia | January 2010 and December 2016 |
French and EuRopean Outcome Registry in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify within a cohort of ICU patients admitted for severe illness those who are at risk of death in the year following the discharge from ICU.

Detailed Description
-----------------
FROG-ICU is an epidemiological, observational, prospective, multi centric, cohort study designed for description, prognostic and evaluation. This trial includes as a first step a complete registry of patients admitted to the ICU and as a second step, the outcome of the patients at 1 year after they have been discharged alive from ICU. Plasma and urine samples will be with drawn biomarkers measurements at admission and ICU discharge. It is a multicentric study involving 1 center in Belgium et 24 centers in France.

Official Title
-----------------
French and EuRopean Outcome Registry in Intensive Care Unit

Conditions
-----------------
Intensive Care Unit Syndrome, Tracheal Intubation Morbidity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patients hospitalized in ICU Patients should have been intubated more than 24 hours or treated with a positive inotropic agent for more than 24 hours (if not ventilated Exclusion Criteria: age < 18 years pregnancy women Breast-feeding women Not affiliated with social security Dying man End of life patient Traumatic Brain Injury (IGCS < 8) NTBR vegetative coma Transplanted for less than year no french speaking patient out of france resident end of life decision during the following

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 |
| --- | --- |
| ICU patients admitted for severe illness<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality at one year after ICU discharge |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess quality of life in the year following a stay in ICU |  | one year | 
| To identify key determinants of cardiovascular morbidity and mortality in the year following a stay in ICU |  | one year | 
| To investigate the performance of plasma biomarkers usually measured in ICU, to assess the risk of death during the stay in ICU and one year after the discharge. |  | one year | 
| To set up a biological collection of plasma and urine, in order to measure new plasma biomarkers in the assessment of prognosis in the year following a stay in ICU. |  | one year | 
| to evaluate social conditions |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BIOLOGICAL MARKERS, INTENSIVE CARE UNIT, MORTALITY, QUALITY OF LIFE, CARDIOVASCULAR
Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution

Study Overview
=================
Brief Summary
-----------------
To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution

Official Title
-----------------
Product Performance of Bausch & Lomb Multi-Purpose Solution Compared to Alcon Opti-Free Replenish Multi-Purpose Solution When Used With Silicone Hydrogel Contact Lenses Worn on a Daily Wear Basis

Conditions
-----------------
Adverse Effect of Contact Lens Solution

Intervention / Treatment
-----------------
* Device: Bausch & Lomb Multipurpose Solution
* Device: Alcon OptiFree Replenish Multipurpose Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are adapted wearers of silicone hydrogel contact lenses VA correctable to 0.3 LogMAR or better (driving vision) Clear central cornea Subject uses a lens care system on a regular basis Exclusion Criteria: Systemic disease affecting ocular health Using systemic or topical medications wear a monovision, multifocal or toric contact lenses Any grade 2 or greater slit lamp findings

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B&L Multipurpose solution<br>Bausch & Lomb Multipurpose Contact Lens Solution | Device: Bausch & Lomb Multipurpose Solution<br>* daily care of contact lenses<br>|
| Active Comparator: Alcon Multipurpose Solution<br>Alcon OptiFree Replenish Multipurpose Contact Lens Solution | Device: Alcon OptiFree Replenish Multipurpose Solution<br>* daily care for contact lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Assessment of Comfort and Cleanliness | Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms and Complaints | Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score. | 2 weeks | 
| Graded Slit Lamp Findings > Grade 2 | Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2. | 2 week follow-up visit |
Miromatrix Biological Mesh for Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to gather long-term data of the performance of the Miromatrix Biological Mesh.

Detailed Description
-----------------
Miromatrix Medical Inc. has developed a new biologic mesh, called MIROMESH®. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. Miromatrix Biologic Mesh is a non cross-linked, acellular surgical mesh that is derived from the highly vascularized porcine liver. This study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting MIROMESH for ventral hernia repair.

Official Title
-----------------
A Prospective Post-Market Clinical Evaluation of Miromatrix Biological Mesh for Ventral Hernia Repair

Conditions
-----------------
Ventral Hernia

Intervention / Treatment
-----------------
* Device: MIROMESH®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 18 and 80 years old on the day of study enrollment ventral or incisional hernia greater than 9 cm2 for which the physician anticipates ability to achieve midline fascia closure following a retro-rectus repair/component separation hernia classified as CDC class 1 or 2 preoperatively able and willing to sign the consent form and comply with all study visits and procedures commit to non-smoking for at least 4 weeks prior to procedure Exclusion Criteria: sensitivity to porcine material scheduled for a concomitant procedure of a wound classified as other than clean immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as determined by the Investigator BMI ≥40 A1C level ≥10.0 participating in another clinical study cirrhosis, and/or ascites diagnosed with a collagen vascular disorder American Society of Anesthesiology (ASA) Class 4 or 5 allergic to tetracycline or kanacmycin life expectancy of less than 2 years at the time of enrollment any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MIROMESH<br>Single-arm study. MIROMESH will be used in the surgical repair of ventral hernia. | Device: MIROMESH®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence requiring surgical intervention |  | 1 year |
Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.

Official Title
-----------------
A Multi-center, Prospective, Single-arm, Open Label Phase II Study of Chidamide Combined With Chemotherapy in the Treatment of Peripheral T Cell Lymphoma

Conditions
-----------------
Peripheral T Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Chidamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone) Age ≧16 years, ≦75 years ECOG (Eastern Cooperative Oncology Group) =0,1,2 No previous history of malignancy Radiologically measurable disease Life expectancy>6 months Informed consented Exclusion Criteria: Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy Lab at enrollment(unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<75*10^9/L Hemoglobulin<90g/L ALT(alanine aminotransferase) or AST (aspartate aminotransferase ) >2*ULN,AKP(alkaline phosphatase) or bilirubin >1.5*ULN (upper limit of normal ) Creatinine>1.5*ULN Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation HIV infection

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Chidamide plus previous chemotherapy<br>Chidamide 20mg/d Biw p.o. on d1,4,8,11 for of each cycle for 3 cycles | Drug: Chidamide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response |  | 21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 1 year | 
| Overall survival |  | 1 year | 
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |  | Each cycle of treatment and then every 3 months for 1 year（each cycle is 21 days） |
Digital Signals in Chronic Pain (DiSCover Project)

Study Overview
=================
Brief Summary
-----------------
The DiSCover Project is a 1-year longitudinal case-control observational study. In this study, the investigators plan to collect different types of data including self-reported health outcomes and quality of life data, behavioral data from activity trackers and health and fitness apps, data from lab tests, genetic data, and environmental data. One of the goals of this study is to develop digital biomarkers for chronic pain severity, flare ups and quality of life.

Official Title
-----------------
Digital Signals in Chronic Pain (DiSCover Project)

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Resides in the United States Case Inclusion Criteria: Self-reported diagnosis of chronic pain and experiences moderate chronic pain as assessed by scoring at least 4 on the Numeric Pain Rating Scale Control Inclusion Criteria: Self-reported not having chronic pain Exclusion Criteria: Less than 18 years old Is not able to read or understand English

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 |
| --- | --- |
| Case<br>Individuals diagnosed with chronic pain | Other: No intervention<br>* No intervention<br>|
| Control<br>Individuals without chronic pain | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported chronic pain severity measured by BPI-SF |  | 1 year | 
| Quality of Life Scale for Pain |  | 1 year |
Effectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression

Study Overview
=================
Brief Summary
-----------------
Online self-help is an innovative way of providing self-help. The investigators want to study the effect of an interactive online self-help-program (Deprexis) in the treatment of severe depressive symptoms. Participants will be randomised to either twelve weeks of online-self help or a waiting-list control. Symptoms of depression and other aspects will be assessed over a six months period. The investigators hypothesise that online self-help is superior to the control condition in alleviating depressive symptoms and preventing full blown depression.

Conditions
-----------------
Severe Depressive Symptoms

Intervention / Treatment
-----------------
* Behavioral: Deprexis
* Other: CAU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 65, ability to read German, willingness to participate in a telephone diagnostic interview, achieving a score of at least 15 on the PHQ-9 in an initial screening, and providing written informed consent Exclusion Criteria: Lifetime diagnosis of schizophrenia or bipolar disorder (as determined by a telephone diagnostic interview) or current suicidality (as determined in a telephone interview)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deprexis<br>Online self-help | Behavioral: Deprexis<br>* Online self-help<br>|
| Active Comparator: CAU<br>Care as usual | Other: CAU<br>* Care as usual<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire - 9 items (PHQ-9) |  | Change from Baseline to post (3mths). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depressive Symptoms - Self-Rreport (QIDS-SR16) |  | Baseline, post (3 mths), follow-up (6 mths) | 
| Generalized Anxiety Disorder - 7 (GAD-7) |  | Baseline, post (3 mths), follow-up (6 mths) | 
| Patient Health Questionnaire - 15 items (PHQ-15) |  | Baseline, post (3 mths), follow-up (6 mths) | 
| Short Form Health Survey - 12 (SF-12) |  | Baseline, post (3 mths), follow-up (6 mths) |