linjc16/ctgov huggingface dataset:
Has Inflammation a Significant Implication in Lung Cancer Evolution?

Study Overview
=================
Brief Summary
-----------------
Systemic inflammation is a potential prognostic factor in cancer. Inflammation scores as the Glasgow score have been tested in cancer and specifically in lung cancer patients. The aim of the study is to look at the prognostic and predictive value of inflammation during cancer evolution, on the risk of complications leading to ICU admission and the risk of death.

Detailed Description
-----------------
Patients with newly diagnosed lung cancer will be eligible. All patients will have a blood sampling allowing testing inflammation and cytokine analyses at diagnosis, during work-up and in case of complication.

Official Title
-----------------
L'Inflammation A-t-elle Une Implication Significative Dans l'évolution du Cancer Bronchique?

Conditions
-----------------
Lung Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung neoplasms irrespective of stage, histology Exclusion Criteria: Previously treated lung neoplasms A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)

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 |
| --- | --- |
| Lung neoplasms<br>Lung neoplasms irrespective of stage and histology | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Measured from diagnosis until death or last date known to be alive, or at least 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications leading to emergency/ICU | Recording any complication leading to consultation at the emergency department or admission into the intensive care unit | From inclusion until death, or a least 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammation, Glasgow score, Intensive Care Unit, Emergency
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.

Official Title
-----------------
Efficacy of WelChol® as an Add-on to Simvastatin Therapy

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: colesevelam HCl tablets, and simvastatin tablets
* Drug: simvastatin tablets and colesevelam HCl placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females > or = to 18 years of age On a stable dose of simvastatin for 4 or more weeks LDL-C > or = to 115 mg/dL and < or = to 250 mg/dL TG < 300 mg/dL Women are not pregnant or breast-feeding or planning to become pregnant Women had a hysterectomy or tubal ligation or are post menopausal or are practicing an acceptable method of contraception Exclusion Criteria: BMI > 40 Allergic to colesevelam HCl History of swallowing disorder History of gastrointestinal motility disorder Any disorder that might interfere with the study History of drug or alcohol abuse

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>colesevelam HCl Tablets and simvastatin tablets | Drug: colesevelam HCl tablets, and simvastatin tablets<br>* colesevelam HCl tablets, 6/day simvastatin tablet, 1/day<br>|
| Placebo Comparator: 2<br>simvastatin and Welchol placebo | Drug: simvastatin tablets and colesevelam HCl placebo<br>* simvastatin tablet, 1/day; Welchol placebo tablets, 6/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change in LDL-C from baseline to endpoint |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute change in LDL-C from baseline to endpoint |  | 6 weeks | 
| The absolute and % change of total cholesterol |  | 6 Weeks | 
| The absolute and % change in triglycerides |  | 6 Weeks | 
| The absolute and % change in HDL-C |  | 6 Weeks |
Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction

Study Overview
=================
Brief Summary
-----------------
The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain.

Official Title
-----------------
Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US Study)

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Latella Knee Implant System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of pain due to medial osteoarthritis Qualifying baseline pain scores Kellgren-Lawrence Grades 2-3 Exclusion Criteria: Osteoporosis Rheumatoid arthritis Joint instability Metal ion allergy Permanent implant in or around the knee joint Prior anterior cruciate ligament reconstruction

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Latella Knee Implant System<br> | Device: Latella Knee Implant System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months | Mean change in KOOS pain score at 6 months after treatment with the Latella Implant. | 6 Months | 
| Primary Safety Endpoint: Surgical re-intervention rate at 6 months | Surgical re-intervention rate during the 6 month period following implantation of the Latella device. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in KOOS function score |  | 6, 12 and 24 months | 
| Change in medial knee pain NRS (while walking) |  | 6, 12 and 24 months | 
| Change in IKDC score |  | 6, 12 and 24 months | 
| Device-related complications rate |  | 24 months | 
| KOOS responder rate based on OARSI-OMERACT criteria |  | 6, 12 and 24 months | 
| Proportion of subjects reaching MCID in KOOS pain score |  | 6, 12 and 24 months | 
| Change in KOOS pain score |  | 12 and 24 months | 
| Surgical re-intervention rate |  | 12 and 24 months | 
| Procedure-related complications rate |  | 24 Months |
Effect of Chili Pepper Extract on Weight and Fat Loss and Metabolism Increase

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the safety and effectiveness of a purified extract of CH-19 Sweet, containing capsinoids.

Official Title
-----------------
A Randomized Double-Blind Placebo-Controlled Clinical Trial of a Purified Chili Pepper Extract (CH-19 Sweet Extract) to Evaluate Its Safety and Efficacy for Weight and Fat Loss and Metabolism Change in Overweight or Obese Healthy Male and Female Adults

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Chronic consumption of chili pepper extract
* Dietary Supplement: Chronic consumption of matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is overweight or obese but otherwise generally healthy who interested in losing weight BMI of 25 to 35 kg/m2 Waist/hip ratio of 0.9 or more for male and 0.85 for female. Exclusion Criteria: Type 1 or 2 diabetes mellitus cardiovascular disease (other than mild, controlled hypertension or dislidemia) On a weight-loss program within six months

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oral ingestion of 6mg chili pepper extract | Dietary Supplement: Chronic consumption of chili pepper extract<br>* 6mg chili pepper extract per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks.<br>|
| Placebo Comparator: 2<br>Oral ingestion of 0 mg chili pepper extract (matching placebo) | Dietary Supplement: Chronic consumption of matching placebo<br>* 0mg chili pepper extract (matching placebo) per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight and body composition |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting metabolic rate and substrate oxidation |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body weight, Body composition, Resting metabolic rate and fat oxidation in men, class I obese
Swedish Macrolane Registry

Study Overview
=================
Brief Summary
-----------------
A Registry to monitor long term safety in female subjects after treatment with Macrolane VRF20 and/or MacrolaneT VRF30 in the breasts.

Conditions
-----------------
Breast Augmentation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females previously treated with Macrolane VRF in the breasts Females continuously being treated with Macrolane VRF in the breasts, initial treatment or re-treatment. Exclusion Criteria: No exclusion criteria
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Females previously treated with Macrolane in their breasts.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document the incidence of breast cancer in female subjects after treatment with Macrolane VRFs in the breasts when the product is used in clinical practice. |  | 2010-2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast augmentation with Macrolane
A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.

Official Title
-----------------
Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas

Conditions
-----------------
Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Neoplasm

Intervention / Treatment
-----------------
* Drug: Motexafin Gadolinium Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma) ECOG performance status score of 0, 1, or 2 Each patient must sign a study-specific informed consent form Exclusion Criteria: Laboratory values of: Absolute neutrophil count < 2000/µL Platelet count < 100,000/µL AST or ALT > 2 x the upper limit of normal (ULN) Alkaline phosphatase > 5 x ULN Bilirubin > 2 x ULN Creatinine > 2.0 mg/µL and Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period Women who are pregnant or lactating

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Motexafin Gadolinium Injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant Glioma, Glioblastoma multiforme, GBM, Anaplastic astrocytoma, AA, Anaplastic oligodendroglioma, Anaplastic mixed glioma, Brain tumor, Brain neoplasm, Glioma
Cerebral Effects of Pulsed Radiofrequency on the Lumbar Dorsal Root Ganglion With Functional Magnetic Resonance Imaging.

Study Overview
=================
Brief Summary
-----------------
Evaluation of central (cerebral) effects of Pulsed RadioFrequency (PRF) on the lumbar DRG (Dorsal Root Ganglion), using fMRI (functional Magnetic Resonance Imaging ). Feasibility study (after which an interim analysis is done): 5 subjects in order to detect measurable central effects inducted by PRF on DRG, follow up study 20. Total amount of subjects 25.

Detailed Description
-----------------
Detect and prove the central effects of PRF and show the objective working mechanism. PRF is often used technique to alleviate chronic radicular neuropathic pain, although good clinical results are observed the precise (central ) working mechanism is still unknown. This study aims to find the central working mechanism. The investigator postulate the existence of central -cerebral effect of PRF on the DRG (dorsal root ganglion). If the investigator can detect the effect using fMRI and demonstrate the objective unequivocal proof that PRF on the DRG works than the investigator will be able to promote this technique for further use in the chronic pain states.

Official Title
-----------------
Evaluation of Central Cerebral Effects of Pulsed Dosed Radiofrequency (PRF) on the Lumbar Dorsal Root Ganglion (DRG) Using Functional Magnetic Resonance Imaging (fMRI).

Conditions
-----------------
Lumbar Radiculopathy, Chronic Disease

Intervention / Treatment
-----------------
* Device: Pulsed Radiofrequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 y Radicular pain in lumbar region more than 6 weeks, neuropathic Exclusion Criteria: Coagulopathy Implanted PM or SCS device Pregnancy Unwilling to undergo MRI Psychiatric disorders

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRF-fMRI<br> | Device: Pulsed Radiofrequency<br>* Pulsed Radiofrequency is performed if the sensory threshold is below 0.5 volts, the PRF consists of 380 pulses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central working mechanism | fMRI-BOLD | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central working mechanism | Numeric Rating Scale (NRS) | 3 times in 6 weeks | 
| Central working mechanism | Douleur Neuropathique Questionnaire 4 (DN 4) | 2 times in 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRF, fMRI
Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice

Study Overview
=================
Brief Summary
-----------------
To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.

Official Title
-----------------
Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice Multinational, Prospective, Non-randomized, Multi-centre, Non-interventional Trial

Conditions
-----------------
De Novo and Re-stenosed Coronary Artery Lesions

Intervention / Treatment
-----------------
* Device: Pro Kinetic Energy bare metal stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient signed informed consent for data release Patient eligible for percutaneous coronary intervention (PCI) De novo and re-stenosed coronary artery lesions Patient is geographically stable and willing to participate at all follow up assessments Patient is > 18 years of age Exclusion Criteria: Patient receives more than one stent, which is not a PRO-Kinetic ENERGY stent within the same vessel Patient has a known allergy against aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI Patient presents with ISR (in-stent restenosis)

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 |
| --- | --- |
| ENERGY-Population<br>Patient population in standard clinical care, according to the instructions for use and the inclusion / exclusion criteria. Registry patients should be enrolled consecutively to represent a typical set of patients at each site. The registry will collect clinical data from patients that have given their prior written consent. All data will be anonymized prior to data entry. | Device: Pro Kinetic Energy bare metal stent<br>* PCI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • MACE after 12 and 24 months • TVR after 6, 12 and 24 months • Stent Thrombosis at 6, 12 and 24 months acc. to the academic research consortium -ARC (13) |  | 6,12, 24 Months |
Ambulation Study in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
This is a study comparing clinical tests of walking and balance. The goal of this study is to discover which of those tests are best at predicting walking problems due to MS.

Detailed Description
-----------------
This study includes: Three study visits to the MS Center at Evergreen; wearing a pedometer for two, one-week periods to record walking during regular daily activities; keeping a diary for any walking problems such as falls and slips. Subjects must meet the following criteria: Diagnosis of MS (any form); 18-70 years of age; be on stable MS treatment OR no MS treatment for the last three months; no scheduled hospitalization in the next six months.

Official Title
-----------------
A Prospective Study of Clinical Indices as Predictors of Ambulatory Effectiveness in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have sufficient cognitive ability to maintain a falls diary and follow instructions for wearing the pedometer Subject must have clinically definite MS according to McDonald criteria Subject must have EDSS between 0-6.5 Subject must be aged 18-70 Subjects must be given informed consent Subjects must be stable on disease modifying therapy or no therapy for at least three months before entry into study Exclusion Criteria: No MS relapse within the last 30 days Subjects must have no scheduled major hospitalizations or surgical procedures during the study time frame. Hospitalization during the study may result in removal from the study Medical conditions other than MS that might significantly impact ambulatory activity (such as angina pectoris) in the judgement of the investigators History or suspicion of non-compliance in the judgement of the investigators

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mulitple Sclerosis, Ambulation