linjc16/ctgov huggingface dataset:
Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Televancin (TD-6424) for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Conditions
-----------------
Gram-Positive Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Telavancin
* Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - Documented S. aureus bacteremia Exclusion Criteria - Patients who had received or would have received more than 72 hours of potentially effective systemic antistaphylococcal therapy within 7 days prior to randomization. The following agents were considered potentially effective antistaphylococcal therapy: antistaphylococcal penicillins (including nafcillin, oxacillin, or cloxacillin), cephalosporins, fluoroquinolones, glycopeptides (including vancomycin and teicoplanin) and linezolid

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telavancin<br> | Drug: Telavancin<br>* Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days<br>* Other names: VIBATIV;|
| Active Comparator: Vancomycin, nafcillin, oxacillin, or cloxacillin<br>Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously | Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin<br>* Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation | Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size. | 12 weeks after start of treatment |
Plan of the Day Radiotherapy

Study Overview
=================
Brief Summary
-----------------
The study objectives are to improve the treatment of LACC patients and to increase knowledge of the potential benefit of the plan-of-the-day concept on side effects during and after radiotherapy.

Official Title
-----------------
Plan-of-the-day Radiotherapy for Patients With Locally Advanced Cervical Cancer - a Prospective Randomized Controlled Trial (the POD-protocol)

Conditions
-----------------
Cervix Cancer

Intervention / Treatment
-----------------
* Radiation: Plan of the day
* Radiation: Standard plan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed cervical cancer eligible for definitve radiochemotherapy FIGO stage IB1-IVa Over 18 years Speaks and understands Norwegian or English. ECOG 0-2 Histology: Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma Ability to understand and fill in patient questionnaires, and willing to sign a written informed consent Large movers (LM), fundus movement ≥2,5 cm. Exclusion Criteria: Evidence of distant metastasis. Suspicious paraaortic lymphnodes below the renal vessels is allowed if they are covered by the radiation field Patients with previous surgery for their cervical cancer Uncontrolled intercurrent somatic illness. Psychiatric illness /social situations limiting study compliance Prior radiotherapy to the pelvis Patients who are pregnant or breastfeeding is excluded due to risk of teratogenic and abortifacient effects of radiotherapy and cisplatin, and the potential risk of adverse effect of nursing infants Patients under current treatment for other invasive s except non-melanoma skin cancers Nephrostomy Patients with inflammatory bowel disease

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

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

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

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: Intervention arm<br> | Radiation: Plan of the day<br>* Several treatment plans are prepared and the appropriate plan is used at each treatment session.<br>|
| Active Comparator: Control arm<br> | Radiation: Standard plan<br>* One treatment plan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate whether implementation of the plan of the day concept results in less gastro-intestinal toxicity. | To compare the change in patient reported acute diarrhea from baseline to week 4 from start of the treatment and to the end of external radiotherapy. Item 17 in EORTC QLQ-C30 | 5 weeks |
Evaluation of Physical Activity of Patients Admitted to Addiction Service

Study Overview
=================
Brief Summary
-----------------
Addiction is a public health issue that affects nearly 30% of French people according to INSEE. For several years now, the investigators have known that sport is a real help in the fight against addictions, with recent medical authorization to prescribe physical activities. A study from August 2016 claims that regular physical activity may offset the harmful effects of alcohol. (1) Based on the answers given by 36,370 Britons between 1994 and 2006, the researchers showed the existence of a link between the practice of 150 minutes of physical activity per week and the decrease in deaths linked to consumption. alcohol. These results, compared to 18 other studies (2), reveal the benefits of physical activity in the management of addictions. But what about current practice and addictions and sports practice in general ?

Official Title
-----------------
Evaluation of Physical Activity of Patients Admitted to Addiction Service

Conditions
-----------------
Alcoholism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Any patient entering the addictology service for a reason related to addiction (withdrawal, VMI, etc.) at the CHU de St Eloi between January 01, 2020 and May 31, 2020 aged at least 18 years old Exclusion criteria: Patient whose hospitalization is not related to addictology (accommodation, medical examination, etc.) Minor patient (age <18 years)

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 |
| --- | --- | --- |
| Assess the relationship between the level of physical activity of patients hospitalized for drug addiction withdrawal | Assess the relationship between the level of physical activity of patients hospitalized for drug addiction withdrawal | 5 months | 
| Assess the relationship between the level of physical activity of patients hospitalized for dependence on alcohol and tobacco | Assess the relationship between the level of physical activity of patients hospitalized for dependence on alcohol and tobacco | 5 months | 
| level of physical activity of patients | level of physical activity of patients | 5 months | 
| The relationship between the level of physical activity before the onset of dependence | The relationship between the level of physical activity before the onset of dependence | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychoactive substances consumption, Physical activity, Alcohol withdrawal, Dependence level, Drug users
Imipenem in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Extracorporeal membrane oxygenation (ECMO) has become increasingly used for lifesaving respiratory and/or cardiac failure support in critically ill patients, including those with life-threatening severe infections. This cardiopulmonary bypass device has been shown to enhance the profound pathophysiological changes in this patient population, resulting in an alteration of the pharmacokinetics (PK) of antimicrobial agents. The aim of this study was to determine the effect of ECMO on the PK of imipenem in critically ill patients supported by this cardiopulmonary bypass device. Methods The study was conducted in critically ill patients with respiratory and/or cardiac failure and suspected severe nosocomial infections who were supported by ECMO. All patients received a 1-h infusion of 0.5 g of imipenem every 6 h and imipenem PK studies were carried out on the fourth dose of drug administration.

Official Title
-----------------
Pharmacokinetics of Imipenem in Critically Ill Patients With Life-threatening Severe Infections During Support With Extracorporeal Membrane Oxygenation

Conditions
-----------------
Critically Ill Patients With ECMO

Intervention / Treatment
-----------------
* Drug: Imipenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age >18 year Patients who diagnosed as severe sepsis Admitted into the ICU Supported with ECMO Exclusion Criteria: Patients who pregnant Patients who have documented hypersensitivity to carbapenem

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imipenem ECMO<br>1-h infusion of 0.5 g of imipenem, q6h | Drug: Imipenem<br>* 1-h infusion of 0.5 g of imipenem diluted in 100 mL of normal saline solution, delivered via infusion pump at a constant flow rate, every 6 h. The imipenem PK studies were carried out during administration of the fourth dose of each regimen (18-24 h after the start of the regimen). Blood samples were obtained by direct venipuncture at the following times: before (time zero) and 0.25, 0.5, 0.75, 1, 2, 3, 4, 5 and 6 h after the fourth dose of each regimen.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of imipenem in plasma | Individual concentration of imipenem in plasma | 6 hour after the imipenem dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetic, imipenem, extracorporeal membrane oxygenation
Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
The human BK polyomavirus is a significant risk factor for renal transplant dysfunction and allograft loss. The prevalence of BK viremia (BKV) following kidney transplantation is estimated to be 10-20%.

Detailed Description
-----------------
The human BK polyomavirus is a significant risk factor for renal transplant dysfunction and allograft loss. The prevalence of BK viremia (BKV) following kidney transplantation is estimated to be 10-20%. Immunosuppression reduction is the management cornerstone for BKV and has been shown to be effective at clearing the virus while maintaining graft function in both kidney alone and simultaneous kidney-pancreas transplant recipients. However, there is a lack of published data on the prevalence and outcomes in simultaneous liver-kidney (SLK) transplant recipients.

Official Title
-----------------
Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant Recipients: A Retrospective Single-Center Review

Conditions
-----------------
Polyomavirus Infections, BK Viremia, Liver Transplant Infection, Kidney Transplant Infection

Intervention / Treatment
-----------------
* Procedure: Simultaneous Liver-Kidney Transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older SLK recipients transplanted at MDMC between 2015-2020 Exclusion Criteria: Below 18 years of age Patients who did not undergo SLK transplant at MDMC

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Simultaneous Liver-Kidney Transplant patients population at MDMC<br>Consecutive SLK transplant recipients who were transplanted at MDMC over a 6-year period (2015 to 2020). | Procedure: Simultaneous Liver-Kidney Transplant<br>* Simultaneous Liver-Kidney Transplant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the prevalence of BKV in the SLK patient population at MDMC. | number of SLK transplant recipients who were transplanted at MDMC | over a 6-year period (2015 to 2020). |
Examining the Efficacy of tDCS in the Attenuation of Epileptic Paroxysmal Discharges and Clinical Seizures

Study Overview
=================
Brief Summary
-----------------
The current study examined the feasibility of High-Definition tDCS (HD-tDCS) in reducing epileptiform activity in a 30-month-old child suffering from early onset epileptic encephalopathy. HD-tDCS was administered over 10 intervention days spanning two weeks including pre- and post-intervention video-electroencephalography (EEG) monitoring.

Official Title
-----------------
Examining the Efficacy of tDCS in the Attenuation of Epileptic Paroxysmal Discharges and Clinical Seizures

Conditions
-----------------
Ohtahara Syndrome

Intervention / Treatment
-----------------
* Device: High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Initial diagnosis of Ohtahara syndrome/West syndrome/ Lennox-Gastaut syndrome by a pediatric neurologist using video-EEG Ongoing synchronous Hypsarrhythmia Modified Hypsarrhythmia with a consistent focus of paroxysmal discharges Signed informed consent of parents/immediate legal guardian Age 10 to 36 months Infant should be in a steady state indicated by a baseline test of electrolytes and biochemistry blood test, heart rate, temperature, respiratory rate, and saturation. Exclusion Criteria: Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. History of adverse reaction to neurostimulation Significant ECG abnormality

Ages Eligible for Study
-----------------
Minimum Age: 10 Months
Maximum Age: 36 Months

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

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: Active tDCS<br>open label active tDCS treatment | Device: High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor<br>* Non-invasive focal neuromodulation<br>* Other names: tDCS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in seizure frequency from baseline |  | day 1, day 3, day 5, day 6, day 8, day 10, day 13, day 20, day 27, day 33, day 40, day 50 |
Effects of Coenzyme Q10 in PSP and CBD

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy, safety and tolerability of Coenzyme Q 10 versus placebo in patients with atypical parkinsonian syndromes corticobasal degeneration (CBD) and progressive supranuclear palsy (PSP) ).

Official Title
-----------------
Effects of Coenzyme Q10 in PSP and CBD, A Randomized, Placebo-Controlled, Double Blind Cross Over Pilot Study

Conditions
-----------------
Progressive Supranuclear Palsy, Neurological Disorders

Intervention / Treatment
-----------------
* Drug: CoQ10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients fulfilling the diagnostic criteria of PSP and CBD (above) and who were diagnosed within the past 5 years Age > 40 Subjects receiving anticholinergics, amantadine, dopamine agonists, carbidopa/levodopa, eldepryl, or comtan must be on a stable dose for at least 30 days prior to baseline visit. Patients agreeable to participate in the study. Exclusion Criteria: Prior or concurrent therapy with anticholinergics, amantadine,a dopamine agonist,carbidopa/levodopa or comtan within 30 days of the baseline visit. Parkinsons disease or any other atypical parkinsonism; Parkinsonism due to drugs. History of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant. Previous use of coenzyme Q10 within 60 days of the baseline visit.

Ages Eligible for Study
-----------------
Minimum Age: 40 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

| Intervention/Treatment |
| --- |
|Drug: CoQ10|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
-----------------
CoQ10, PSP, CBD
Analysis of Angiogenic Factor Levels in Eyes With Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
This study was conducted to investigate the levels of angiogenic factors and anti-angiogenic factors in the aqueous humor of patients with diabetic retinopathy.

Detailed Description
-----------------
This prospective, case-control study included 50 patients(50eyes) with severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy and 50 patient with nondiabetic retinopathy or cataract. Aqueous humor was taken before injection of anti-vascular endothelial growth factor agent or pars plana vitrectomy for other retinal disease. Angiogenic and non-angiogenic proteins were analyzed.

Official Title
-----------------
Analysis of Angiogenic Protein and Anti-angiogenic Levels in Eyes With Diabetic Retinopathy.

Conditions
-----------------
Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 20 years diabetic patients requiring opthalmologic treatments for different degrees of decreasing of visual acuity. diabetic patients requiring intravitreal injection,cataract surgery or vitrectomy nondiabetic patients asking cataract surgery or vitrectomy for posterior segment nonproliferative disorders. Exclusion Criteria: under the age of 20 years patients that received any anti-vascular endothelial growth factor agent for proliferative disease before taking sample of aqueous humor patients that did not signed the informed consent of the trial patients with intraocular inflammations or infections that requiring any pharmaceutical agent patients with recent ocular trauma

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Diabetic retinopathy,humor,angiogenic<br>Samples of aqueous humor was taken before injection and before surgery. The injection include bevacizumab or triamcinolone. | |
| Nondiabetic,angiogenic,humor<br>Aqueous humor was taken before surgery. Surgery include pars plana vitrectomy of macular hole, epiretinal membrane, cataract surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aqueous secretory angiogenic and anti-angiogenic protein concentration | To establish if certain type of diabetic retinopathy and nondiabetic retinal disease group are associated to different concentrations of angiogenic or anti-angiogenic protein concentration. | one month |