cyrilzakka/clinical-trials huggingface dataset:
Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III (Phase II trial).

Endpoints:

safety and feasibility (primary) response, survival, time to progression (secondary)

Study entry examinations:

* blood cell count
* liver enzymes
* ventilatory function test
* pregnancy test (premenopausal women)
* CT of the thorax
* CT of the brain
* Ultrasound of the liver
* Bone scan
* FDG PET scan (after inclusion)

Follow-up examinations (2 months, than every 3 months):

* patients history and examination
* CT scan of the thorax
* ventilatory functions test
* FDG PET scan (at least at 6 months)
* bone scan (yearly)
* ultrasound of the liver (every 6 months)

Cetuximab administration:

* 450 mg / m\^2 body surface on week 1
* 250 mg /m\^2 body surface weekly, week 2 -21

Radiation therapy:

* intensity modulated radiation therapy of primary tumor and mediastinum (2 Gy single dose, total dose 50 Gy; 5 fractions per week) with boost to the PET positive sites (2 Gy single doses up to 66 Gy). Radiation therapy during weeks 2-8.

Amendment 1/07: 3D conformal RT possible, but not if FeV1 \< 1.5L of \< 50%

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified NSCLC
* Not eligible for Radiochemotherapy or patient refuses chemotherapy
* FeV1 \>1.5 L or min. 50%
* KPI \>= 70%
* Life expectancy \> 6 months
* Weight loss less than 10% of body weight in 12 months
* Compliance
* Adequate blood counts (LC \> 3000 x 10\^3/ml, Tc \>100000 x 10\^3/ml, Hb \> 10 g/dl)
* Effective contraception

Amendment 1/07: FeV1 \>1.2 L or min 40%

Exclusion Criteria:

* Active infection
* Reduced liver function
* Vena cava superior syndrome
* Malignant pleural effusion
* Pregnancy or breast feeding
* Additional serious systemic disease
* Secondary malignancy (except carcinoma in situ of the cervix, basalioma of the skin, secondary cancer in remission for \> 5 years)
* Known allergies against proteins
* History of former antibody therapy
* Allergy against i.v. contrast agents
Evaluation of a Medication Health Center to Promote Opioid Safety

This study will assess the impact of an opioid safety clinic intervention for patients prescribed chronic opioid therapy. Outcomes are visits to the clinic, naloxone dispensings, Prescription Drug Monitoring reviews, and Urine Drug Screens conducted

Given ongoing concerns about the risk of opioid overdose among people taking chronic opioid therapy for pain, Kaiser Permanente Colorado (KPCO) sought to develop a standardized approach to promote opioid safety. Operational stakeholders adapted an existing Opioid Safety Clinic model, tailored it for KPCO's context, and implemented it in three geographically dispersed KPCO clinics with leadership support. The approach was a multidisciplinary "Medication Health Center" to assess patients, educate them about overdose risk, provide naloxone, and ensure adherence to standard monitoring. Operations and the research team then collaborated to assess the effectiveness of the program to inform decisions to scale the program to other regions.

Eligibility Criteria:
Evaluation population:

1. Eligible Clinics
2. Patients prescribed Chronic Opioid Therapy

Eligibility Criteria for Clinics:

1. Clinic leadership willing to be randomized to order of implementation
2. Not a pilot location

Eligibility for an MHC visit included the following:

1. Patients in the KPCO chronic opioid registry
2. No Primary Care Physician (PCP) or MHC visit in the past 6 months
3. Not managed by the Integrated Pain Service, a specialty pain service that takes care of the highest risk and most complex pain patients

Patients enter the chronic opioid registry if they fulfill any of the following criteria:

* 2 opioid fills in the last 90 days; fills should be separated by 27 days, or
* 1 opioid fill with pill number ≥100 pills in the last 90 days, or
* 1 long-acting/extended-release opioid fill in the last 90 days
Comparative Cycle Control Europe

The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers aged between 18 and 50 years requiring contraception

Exclusion Criteria:

* Pregnancy or lactation
* Any conditions that might interfere with the outcome as well as all contraindications for OC use
The German Plug - Registry

In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the defect, a new procedure is required - with a not inconsiderable disease or even mortality risk

In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the defect, a new procedure is required - with a not inconsiderable disease or even mortality risk. For a number of years, the catheter-based closure of the defect has been increasingly used by means of the implantation of plug-devices as a new treatment method for patients with a high surgical risk. The existing data on the operation method and safety of the method already used at some centers are promising. In order to demonstrate the clinical routine of patients with an interventional occlusion of a PVL in a timely manner, the Stiftung IHF Ludwigshafen will publish a multicentric register entitled "Deutsches Plug Register" The goal is, among other things, the documentation of patient characteristics, indications, and complications of treated patients.The German Heart Foundation promotes the setting up of the plug register.

In this time, 200 patients with valve prosthesis defects, with which the indication for plug implantation was placed prospectively and retrospectively, are to be included in the register.

Eligibility Criteria:
Inclusion Criteria:

* heart valve replacement
* Valve Replacement Leaks
* Plug Device

Exclusion Criteria:

* no written consent
Genetic Susceptibility to Lung Cancer in Never Smokers

The purpose of this study is to help us better understand the cellular changes that may lead to the development of lung cancer. We want to compare people who have never smoked and yet have been diagnosed with lung cancer to never smokers who have not developed lung cancer. We hope to use the information obtained in this study as the basis for future studies and will not regard the results from this study as final.


Eligibility Criteria:
Inclusion Criteria:

* Cases will be eligible for inclusion if:
* They have been diagnosed with a lung cancer or have had previous surgical treatment for their lung cancer and have smoked fewer than 100 cigarettes in their lifetime, are/were not regular cigar or pipe smokers, and
* They have had no prior chemotherapy or radiation treatment within the last year (Exception: genotyping analysis/screening can be performed on specimens from individuals who had chemo/radiation treatment within the last year as germline DNA will not be affected)
* They speak and read English
* They understand and agree to sign informed consent, and
* They agree to give us a blood sample, and
* They agree to complete the study questionnaire, and
* They agree to have their pathology information reviewed by study personnel.
* Controls will be eligible for inclusion if:
* They have not been diagnosed with any type of cancer, exclusive of nonmelanoma skin cancer and have smoked fewer than 100 cigarettes in their lifetime, are/were not regular cigar or pipe smokers, and
* They speak and read English
* They understand and agree to sign informed consent, and
* They agree to give us a blood sample, and
* They agree to complete the study questionnaire.

Exclusion Criteria:

* Subjects who do not meet the inclusion criteria for either the case or control groups will not be eligible for this study.
* All individuals who otherwise meet the eligibility requirements above, but who have had chemotherapy or radiation therapy within 1 year of evaluation will be excluded (Exception: genotyping analysis/screening can be performed on specimens from individuals who had chemo/radiation treatment within the last year as germline DNA will not be affected).
The Effect of Myopic Optical Defocus on the Humphrey Matrix 30-2 Test

The purpose of this study is to examine the effect of the myopic optical defocus on the Humphrey Matrix 30-2 test.

The Humphery Matrix (Zeiss, Dublin, California, USA; in cooperation with Welch Allyn, Skaneateles, New York, USA), which is a recently developed version of FDT perimetry, showed more improved technology to detect early glaucomatous damage. The user's guide for the Humphrey Matrix (Humphrey® matrix visual field instrument user's guide. Zeiss, Dublin, California, USA; in cooperation with Welch Allyn, Skaneateles, New York, USA; 2003) suggests that myopic refractive errors more than -3.0 D need to be corrected before the 30-2 test. However, the proper correction of the optical defocus is not always easy because of a lack of trial frame.

The purpose of the present study is twofold. At first, the influence of the low-grade myopia on the Humphery Matrix 30-2 test will be evaluated and compared to the effect of moderate-grade myopia. Secondly, the influence of myopic optical defocus and the glaucomatous visual field damage on the pattern deviation plot change according to the severity of glaucomatous visual field damage will be estimated.

Eligibility Criteria:
Inclusion Criteria:

* intra-ocular pressure 23 or higher
* suspicious glaucomatous optic disc change
* suspicious defect of retinal nerve fiber layer
* or eyes with various degrees of glaucoma

Exclusion Criteria:

* a high myopic eye (SE more than -6.0 D)
* moderate to severe cataract
* evidence of diabetic or hypertensive retinopathy
* macular disease
* intra-ocular inflammation
* history of intraocular surgery and any other ocular lesion that could have an influence on the perimetry result
Influenza Viral Challenge Study of CC-42344 in Healthy Participants

Participants in this study will be given either CC-42344 (one of two dose levels) or placebo orally for 5 days after receiving an influenza (flu) challenge virus. Participants will not know whether they are getting placebo or CC-42344. The amount of virus in nasal samples will be measured over time. Side effects and pharmacokinetics (the amount of CC-42344 in blood) will also be measured.

This is a single-center, phase 2a, randomized, double-blind, placebo-controlled study in healthy adult participants. The primary goal of this study is to assess the antiviral activity of orally administered CC-42344 in an influenza human viral challenge model, and to explore the impact of different dose levels on efficacy. In addition, the safety, tolerability, and pharmacokinetics will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Body weight ≥50 kg
* Body mass index ≥18 kg/m2 and ≤35 kg/m2
* Serology results consistent with susceptibility to challenge virus infection

Exclusion Criteria:

* History of or current significant medical condition
* Upper or lower respiratory tract infection within 4 weeks
* Vaccination within 4 weeks
Pharmacokinetics and Safety of BILR 355 in Healthy Male Volunteers

Study to determine the single dose, relative BA of new SDS-containing formulations of BILR 355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet formulation (50 mg tablet)


Eligibility Criteria:
Inclusion Criteria:

1. Healthy HIV negative adult male volunteers
2. Age ≥18 and ≤60 years
3. BMI ≥18.5 and BMI ≤29.9 kg/m2
4. Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Surgery of gastrointestinal tract (except appendectomy)
3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. History of relevant orthostatic hypotension, fainting spells or blackouts
5. Chronic or relevant acute infections
6. History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
7. Intake of drugs with a long half-life (\>24 hours) within at least one month prior to study drug administration and during the trial
8. Use of drugs within 10 days prior to administration or during the trial which might reasonably influence the results of the trial
9. Participation in another trial with an investigational drug within two months prior to administration or during the trial
10. Current smoker
11. Alcohol abuse (more than 60 g/day)
12. Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
13. Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial)
14. Excessive physical activities (within one week prior to study drug administration or during the trial)
15. Any laboratory value outside the reference range that was of clinical relevance at screening, according to the judgment of the investigator
16. Inability to comply with dietary regimen required by the protocol
17. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein

The aim of this pilot study is to establish the success rate of catheterization of the lower jugular vein and the subclavian vein under ultrasound guidance in real time. The purpose is to compare the two techniques and to determine the best design for a full study (superiority, non-inferiority). This is a 2-arm randomized control study. The randomization ensures the comparability of the groups and allows evaluation of the feasibility and potential bias for further comparative studies.


Eligibility Criteria:
Inclusion Criteria:

* The patient has been, or will be, informed as soon as their state of health allows them to be entered into the study of its objectives, constraints and the patient's rights
* The patient have given their free and informed consent and signed the consent form
* The patient must be insured or a beneficiary of a health insurance plan
* The patient is over 18 years old
* The patient needs a venous catheter in the superior vena cava

Exclusion Criteria:

* The patient is already participating in another interventional study that could influence the results of this study
* The patient has participated in another interventional study within the previous 3 months that could influence the results of this study
* The patient is in a period of exclusion determined by a previous study
* The patient is under judicial protection or is an adult under guardianship
* The patient refuses to sign the consent form
* Non-echogenic patient
* Moribund patient
* The patient has a contra-indication to one or other of the approaches: infection of the insertion zone, known thrombosis, severely dyspneic
* Patient has severe coagulation problems: PT\<40%, platelets\<50 000 and curable anticoagulation with antiXa \> 0.5 or INR\>3.
* Patient has a congenital or acquired deformation at the entry site
Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation

Varicella zoster virus is part of the herpesvirus group and causes chickenpox in exposed individuals. The majority of the population is seropositive for this virus. Reactivation of varicella zoster virus occurs in up to 30% of the general population over 60 years old.

Solid organ transplant recipients receive lifelong immunosuppression drugs and are at great risk of reactivation of all herpesviruses including the varicella zoster virus regardless of age. The vaccine has been shown to be effective in preventing shingles in the general population. The investigators' purpose is to determine how well the vaccine works in patients on renal replacement therapy and post-transplant.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years
2. Listed or will likely be listed for live donor kidney transplant within one month

Exclusion Criteria:

1. Previous receipt of Zostavax
Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver

40000 patients are hemodialysis each year in France .

In the case of chronic care, 78% of patients have an arteriovenous fistula. In order to perform the hemodialysis session, 2 techniques of puncture of the fistula are possible:

* Bevel puncture upwards then flipping the needle
* or puncture bevel down. At present, there is no consensus or study on the technique of puncture fistula which generates different professional practices.


Eligibility Criteria:
Inclusion Criteria:

* Patient in chronic renal failure treated by hemodialysis with native arteriovenous fistula as a vascular approach.
* Adult of age and sex indifferent.
* Normal puncture of the fistula with two needles (bipuncture).
* Fistula use for more than 3 months.
* Beneficiary of Medicare or State Medical Aid.
* No opposition to participation in the study.

Exclusion Criteria:

* Patient who does not speak and does not understand French.
* Hemodialysis patient awaiting a transplant by a living donor.
* Patient with more than 2 AVF dilatations in the last 6 months.
* Patient with prosthetic arteriovenous fistula.
Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.

This will be a prospective, randomized controlled study. Subjects referred for a screening, surveillance, or diagnostic colonoscopy will be prospectively enrolled. This study aims to compare the number of adenomas detected per colonoscopy (APC) between an Endocuff colonoscopy and an AmplifEYE colonoscopy.

It is estimated that the Endocuff Vision will result in an APC of 2.3. The investigators consider that a clinically acceptable ADR for the Medivators device would be within 20% of this value or 1.5.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age or older
* Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
* Able to provide written informed consent

Exclusion Criteria:

* Active Inflammatory Bowel Disease
* Prior resection of the colon
* Referred for resection of a polyp identified by another physician
* Referred for a previous incomplete colonoscopy
Glutamatergic Modulation of Cocaine-related Deficits

Cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to cocaine cues, that may be responsive to pharmacological modulation of glutamatergic circuits. Despite promising preclinical findings with n-methyl-d-aspartate receptor (NMDAr) modulators, studies with human subjects have been unsuccessful to date. The purpose of this investigation is to examine the effects of the NMDAr antagonist ketamine, recently found to have potent therapeutic effects in humans, on cue-induced craving and impaired motivation for quitting cocaine in cocaine dependent participants, 24-hours post-infusion.

In this study, volunteers will undergo a 9 day inpatient trial during which they will receive three counter-balanced infusions (two doses of ketamine and a dose of lorazepam) on three separate days in a within-subject, double-blind, controlled design. Of the various glutamate antagonists available for human use, ketamine will be utilized because its safety profile, pharmacokinetics, and range of tolerable sub-anesthetic dosings have been very well studied. Also, ketamine has shown promise in managing opiate and alcohol use disorders in certain studies, and may therefore be the most likely glutamate antagonist to dampen cue reactivity and increase motivation in cocaine users. If ketamine significantly improves these deficits, this would suggest that the drug should be investigated further for potential utility as a treatment for cocaine dependence.

Eligibility Criteria:
Inclusion Criteria

1. Active free-base cocaine dependence (at least 4 days of use over the past month, with at least 1 use per week); if the participant uses through another route (IN, IV), then the FB route is dominant (\> 80% of occasions).
2. Physically healthy
3. No adverse reactions to study medications
4. 21-52 years of age
5. Normal body weight
6. Responsive to drug cues
7. Capacity to consent

Exclusion Criteria:

1. Seeking treatment or abstinence
2. DSM IV criteria for substance dependence (other than methamphetamine, cocaine, cannabis, or nicotine), or DSM IV criteria for abuse of ketamine or lorazepam
3. DSM-IV criteria for other Axis I psychiatric illness that may make participation hazardous such as schizophrenia, schizoaffective disorder, psychosis NOS, MDD, psychosis secondary to substances, or bipolar disorder
4. Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
5. Current suicide risk or a history of suicide attempt within the past 2 years
6. Current use of prescribed psychotropic medication
7. Pregnancy, nursing, or had a baby within the past 6 mo.
8. Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
9. Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (\>140/90), anemia, active hepatitis or other liver disease, or diabetes
10. "Bad" reaction/experience with prior exposure to ketamine or lorazepam
11. History of significant violence
12. First degree relative with a psychotic disorder
An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis

This field study is a post-marketing requirement from the FDA to evaluate the clinical benefit (course of illness and survival), safety and pharmacokinetics of obiltoxaximab administered to patients as part of their medical care for treatment or prophylaxis of inhalational anthrax infection following exposure to Bacillus anthracis (B. anthracis). The protocol can be implemented for any individual who receives obiltoxaximab for a suspected, probable, or confirmed case of inhalational anthrax due to B. anthracis in the United States, including sporadic cases, small incidents and/or a mass event. In case of a small anthrax incident, to the extent possible, the information will be collected prospectively at prespecified time points, except where it would interfere with management of the subject's illness. However, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study are anticipated to be collected retrospectively. Both retrospective and prospective data collection are allowed to maximize information collection. This study will collect data on the use of obiltoxaximab in anthrax infected or exposed subjects and the data collected will inform the understanding of the clinical benefit and safety of obiltoxaximab.


Eligibility Criteria:
Inclusion Criteria:

* Men and women (including pregnant and lactating women) and children of all ages who receive obiltoxaximab as part of their clinical care for anthrax infection and are willing and able to give written informed consent themselves or through legally acceptable representative (for minors, unconscious adults or deceased subjects) to participate in the study

Exclusion Criteria:

* There are no exclusion criteria defined for this study