linjc16/ctgov huggingface dataset:
Drug Concentration Monitoring of Pembrolizumab in Non-Small Cell Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This observational study explores associations between drug trough-levels and clinical outcomes in Non Small Cell Lung Cancer (NSCLC) patients treated with immunotherapy (pembrolizumab) either alone or combined with chemotherapy. Through-levels of pembrolizumab will be examined in blood samples collected during the first-line treatment period. In addition T-cell responses in peripheral blood and anti-drug antibodies will be monitored. Results of drug trough-levels and T-cell responses will be linked to clinical outcome. 250 patients with NSCLC will be enrolled in this trial.

Official Title
-----------------
Drug Concentration Monitoring of Pembrolizumab in Treatment-naive Non-Small Cell Lung Cancer Patients

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: Pembrolizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be > 18 years and must voluntary sign an informed consent Treatment-naïve patients with advanced NSCLC receiving immunotherapy alone (pembrolizumab) or combined with chemotherapy Exclusion Criteria: Any anti-cancer therapy < 6 months prior to inclusion

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 |
| --- | --- |
| Treatment-naive NSCLC patients<br>Treatment-naive NSCLC patients receiving immunotherapy (pembrolizumab) alone or in combination With chemotherapy divided in groups based on treatment administered. Clinical information will be gathered at start of treatment and at evaluations every 3rd month. | Drug: Pembrolizumab<br>* Drug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response | Radiological response (Partial response/stable disease/Complete response) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events >= 3 | 2 years | 
| PD-1 Expression on CD-8 T-cells | Proliferation of PD-1 Expression CD-8 T-cells | First 3 months | 
| Overall survival | Overall survival related to drug trough-level | 5 years observation | 
| Progression-Free survival | Radiological evaluation | 1 year |
Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs. established treatment of acute bacterial infection in adults.

Official Title
-----------------
A Multicenter,Investigator-blinded,Randomized, Comparative Study to Evaluate the Efficacy and Safety of Oral NXL103 Versus Oral Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Conditions
-----------------
Acute Bacterial Skin and Skin Structure Infections

Intervention / Treatment
-----------------
* Drug: NXL103
* Drug: Linezolid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with acute bacterial skin and skin structure infection (ABSSSI) with at least 3 signs or symptoms Exclusion Criteria: Uncomplicated acute bacterial skin and skin structure infections ABSSSI suspected or proven to be due to Gram negative and/or anaerobic pathogens Pregnant or lactating women Inadequately controlled diabetes mellitus Inadequately controlled arterial hypertension Moderate-to-severe renal impairment Moderate-to-severe liver disease Conditions associated with immunodeficiency Known hypersensitivity or any contraindication for the use of any of the 2 study drugs

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NXL103<br>BID for 7-14 days orally | Drug: NXL103<br>* BID for 7-14 days<br>|
| Active Comparator: Linezolid<br>BID for 7-14 days orally | Drug: Linezolid<br>* BID for 7-14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response at the early follow-up visit (Test of cure) |  | 7 days post therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome at the late follow-up visit |  | 21 days post therapy | 
| Clinical outcome at the end of treatment |  | 10-14 days therapy | 
| Microbiological outcome at the early follow-up visit (Test of cure) |  | 7 days post-therapy | 
| Safety Profiles (safety and tolerability) |  | throughout the study | 
| Population pharmacokinetic profile of the experimental study drug |  | Day 1-5 while on study drug |
A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This Phase 1 study is designed to determine the photoirritation potential of PEP005 Gel, 0.01% when application is followed by light exposure.

Official Title
-----------------
A 4-Day, Randomized, Controlled, Open Application Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers, Using a Phototoxicity Test Design

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: PEP005 (ingenol mebutate) Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy males or females; in the case of females of childbearing potential, must be using effective contraception and must provide a negative pregnancy test; must read, understand and provide signed informed consent. Exclusion Criteria: are not willing to refrain from using topical/systemic analgesics within 72 hours prior to and during the study; are using systemic/locally-acting medications during the study and within 2 weeks prior to the beginning of the study; are using systemic/locally-acting anti-inflammatories during the study and within 72 hours prior to the beginning of the study; have participated in any clinical testing of an investigational drug within 28 days or any clinical patch application within 14 days prior to enrollment or are currently participating in any clinical testing.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PEP005 (ingenol mebutate) Gel<br>* PEP005 (ingenol mebutate) Gel, 0.01%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure. |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peplin, PEP005
Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence.

Official Title
-----------------
Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.

Conditions
-----------------
Urinary Incontinence, Urge

Intervention / Treatment
-----------------
* Device: Electrical Field Stimulation Device
* Device: Sham Nerve Stimulation Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Urinary Urge Incontinence Urinary Frequency Exclusion Criteria: Primary complaint of Stress Incontinence Neurogenic bladder Overflow Incontinence Functional Incontinence

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Device<br>Treatment using electrical field stimulation of peripheral nerves | Device: Electrical Field Stimulation Device<br>* Treatment with Electrical Field Stimulation Device<br>|
| Sham Comparator: Sham Device<br>Control group using sham device to mimic sound and sensation of investigational device | Device: Sham Nerve Stimulation Device<br>* Use of the sham device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm | Significant increase in the percentage of patients reporting a reduction in number of incontinence episodes per day for the investigational device vs. sham | One week after final treatment visit | 
| No Serious Adverse Events or Unanticipated Adverse Device Effects | Freedom from Serious Adverse Events or Unanticipated Adverse Device Effects related to procedure and/or investigational device through follow-up | First treatment through follow-up (one week after last treatment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary Incontinence, Urge, Peripheral Nerve Stimulation
Pharmacodynamics Study of MRX34, MicroRNA Liposomal Injection in Melanoma Patients With Biopsy Accessible Lesions

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with easily accessible lesions will undergo serial biopsies and serial blood samples will be collected.

Detailed Description
-----------------
MRX34 Induction Therapy consists of 3 cycles of MRX34 treatment given over an approximately 8 week period. Dexamethasone 10 mg PO (or IV) will be given as premedication. On Days 1-5 of each treatment cycle, MRX34 will be given as a daily infusion followed by 16 days of rest. At screening a tumor biopsy sample will be required from all patients. Additional biopsies will be collected at Cycle 1 Day 3 and the end of Cycles 1 and 3 (Day 18 +/- 1 day)

Official Title
-----------------
A Multicenter Phase 1B Pharmacodynamics Study of MRX34, MicroRNA miR-Rx34 Liposomal Injection, in Patients With Advanced Melanoma and Biopsy Accessible Lesions

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: MRX34
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age Advanced or metastatic cutaneous, acral or mucosal melanoma Tumor lesions accessible to serial biopsies ECOG ≤ 1 ANC ≥, Plts ≥100,000 /mm3 Exclusion Criteria: Serious active non-malignant disease Central Nervous System metastasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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: Treatment with MRX34<br>Liposomal Injection of MRX34 for 5 days followed by 16 days rest with premedication of dexamethasone daily. | Drug: MRX34<br>* Treatment of melanoma with pharmacodynamics biopsy of tissue and blood<br>* Other names: miR-Rx34;Drug: Dexamethasone<br>* Premedication during the week of treatment<br>* Other names: Decadron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of adverse events associated with MRX34 treatment |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biosy accessible melanoma
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol esters (PS-ester), consumed within dairy products.

Detailed Description
-----------------
Forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline) completed the double-blind, randomized, crossover study.

Official Title
-----------------
Naturalis Clinical Trial for a Novel Phytosterol Formulation

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

Intervention / Treatment
-----------------
* Dietary Supplement: WD-PS intervention phase
* Dietary Supplement: PS-Ester intervention phase
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individuals aged 19-60 yr plasma LDL-C levels > 3.0mmol/l TG < 4.5mmol/l body mass index (BMI) between 20 and 30 kg/m2. Exclusion Criteria: history of recent or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months history of chronic use of alcohol (>2 drinks/d) smoking myocardial infarction, coronary artery bypass, sitosterolaemia, kidney disease, liver disease or other major surgical procedures within the last six months

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water dispersible Plant Sterol (WD-PS)<br>WD-PS dairy product (a novel formulation for dispersible free sterols in aqueous media produced)2g/d of free plant sterol | Dietary Supplement: WD-PS intervention phase<br>* 2g/d of free plant sterol in 100g yogurt<br>|
| Experimental: Esterified plant sterol (PS-Ester)<br>PS-Ester enriched dairy product (2g/d free plant sterol) | Dietary Supplement: PS-Ester intervention phase<br>* 2g/d of free plant sterol in 100g yogurt<br>|
| Placebo Comparator: placebo<br>100 g/d yogurt with no added plant sterol | Dietary Supplement: placebo<br>* 100g/d yogurt with no added plant sterol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Profile |  | Change from Baseline in lipid profile at 4 weeks (end of the phase) |
Follow-up of Adult Phenylketonuria (PKU) Patients

Study Overview
=================
Brief Summary
-----------------
Adult patients with phenylketonuria (PKU) at the age around 40 years belong to the first patients generation with early treatment of the disease. PKU is caused by an inborn error of the amino acid metabolism and the so far best suitable therapy is an early and strict diet, which is low in phenylalanine. Besides an early and continuously treatment in childhood, the nutritional and medical support during adolescence and adulthood have been suggested to influence the long-term physical health of adult PKU patients. As many adult PKU patients tend to neglect the necessarily strict diet, they do not get a balanced diet. For PKU patients some nutrients, which may be rare in an unbalanced diet, might help to improve health status, physical and neurological performance and quality of life. Information about the longitudinal development of the patients status and the influence of the type of their medical care is not available. In this 5 year follow-up the investigators aim to study the quality of life and the medical, nutritional and psychological status of adult PKU patients, in whom corresponding information has already been collected previously.

Official Title
-----------------
5-year Follow-up of the Comparison of Life and Physical Health in Adult Patients With PKU and Healthy Age Matched Controls

Conditions
-----------------
Nutritional Deficiencies, Phenylketonuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: assured clinical diagnose of PKU or proof of mutation in the phenylalanine hydroxylase gene (for PKU patients only) both groups need to hand in a signed consent to participate in the study controls: have to be omnivores and should not be on drugs, which influence the lipid metabolism, during the last 3 months attendance of the last study trial Exclusion Criteria: not fulfill the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 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 |
| --- | --- |
| PKU patients<br> | |
| healthy controls<br> | |

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
-----------------
PKU, phenylketonuria, adult, patient, development, nutritional deficiencies, neurological outcome, psychological and neurological development, comparison with healthy adults, longitudinal development, quality of life
Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study is to show that NeisVac-C does not influence the seroconversion rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP) vaccines in infants.

Official Title
-----------------
A Randomized, Open-Label Trial of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

Conditions
-----------------
Meningitis, Meningococcal

Intervention / Treatment
-----------------
* Biological: Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female volunteers infants, aged 2 to 6 months Clinically healthy, (i.e. the physician would have no reservations vaccinating with a meningococcal C vaccine outside the scope of a clinical trial) Parent(s)/legal guardian understands the study and has provided written informed consent for his/her infant's study participation Parent(s)/legal guardian and infant will be available for the duration of the study Exclusion Criteria: History of any vaccine-related contraindicating event (e.g. anaphylaxis) Rash or other dermatological condition at the injection site which could interfere with injection site reaction monitoring or lead to a dermatological reaction Subjects who have received or will receive other vaccine(s) ± 30 days before or after the study period Concurrent participation in or previous participation in a clinical trial with an investigational medicinal product Subjects who suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions Subjects who have previously received a vaccination against Hep B or meningococcal C Subjects who have received banked human blood or immunoglobulins within one month of study entry

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 6 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)|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
-----------------
Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis