cyrilzakka/clinical-trials huggingface dataset:
A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

Part 1 is complete. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, phase 2 segment that will commence upon identification of the maximum tolerated dose in part 1. The Primary objective of Part 2 of the study is to estimate efficacy in combination with carboplatin and paclitaxel. Subjects will be randomized at a 1:1:1 ratio to 1 of 3 treatment arms. Subjects in each of the 3 arms will receive up to 6 cycles of paclitaxel/carboplatin (at the same dose and schedule in part 1) in combination with either AMG 655 at the maximum tolerated dose (Arm 1), AMG 655 at a lower dose (Arm 2), or AMG 655 placebo (Arm 3) IV Q3W. Randomization will be stratified by ECOG (0 or 1) and disease stage (IIIb or IV/recurrent).


Eligibility Criteria:
Inclusion Criteria:

* Disease Related

  * Histologically or cytologically confirmed non-small cell lung cancer.
  * Subjects must have advanced non-small cell lung cancer defined as stage IIIB with malignant pleural effusion or stage IV or recurrent disease.
  * Planning to receive up to 6 cycles of chemotherapy
  * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic
  * Men or women \> 18 years of age Ethical
  * Adequate Hematological, renal, hepatic and coagulation function General
  * Plan to begin protocol specific therapy \< 7 days after enrollment/randomization

Exclusion Criteria:

* Disease Related

  * Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
  * Prior chemotherapy as follows:
  * Any prior chemotherapy for advanced non-small cell lung cancer
  * Any prior adjuvant chemotherapy for non-small cell lung cancer \< 52 weeks prior to enrollment/randomization. Adjuvant chemotherapy completed \> 52 weeks prior to randomization is permitted.
  * Any prior chemoradiation.
  * Central (chest) radiation therapy \< 28 days prior to randomization, radiation therapy for peripheral lesions \< 14 days prior to enrollment/randomization
  * Other abnormal medical conditions
  * Documented myocardial infarction or unstable/uncontrolled cardiac condition
  * History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
  * Major surgical procedure \< 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, Minor surgical procedure \< 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
The Impact of the Therapeutic Virtual Reality Headset on Patient Anxiety in the Waiting Room Before Flexible Bronchoscopy in Vigil

Bronchial fibroscopy is a frequently used procedure in the management of pneumology patients, and can be a source of anxiety, particularly while waiting for the examination.

Investigator's professional experience has shown us that many patients are anxious in the waiting room before a flexible bronchoscopy in vigile.

A great deal of research has been carried out into the use of virtual reality to reduce anxiety and pain during care but shortly before bronchoscopy. The innovative aspect is to target the patient's waiting time for the examination. Waiting is a highly anxiety-provoking time, and nurses play a vital role in supporting patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with no age or gender restrictions, seen on an outpatient basis at Le Mans Hospital.
* In whom bronchial fibroscopy is indicated.
* Person affiliated with or benefiting from a social security .
* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
* Patient able and willing to answer questionnaires

Exclusion Criteria:

* Patient refusing to participate in research
* Patient who has already undergone bronchoscopy in vigil
* Patient premedicated for bronchial fibroscopy (anxiolytic, etc.)
* Patients with a history of epilepsy or psychiatric pathology
* Patient with vertigo
* Patient uncooperative, demented or unable to tolerate headgear.
* patient under guardianship or curatorship
* Patients suffering from blindness or deafness
* Patient with known significant intolerance to screens and/or virtual reality devices
* Pregnant, nursing or parturient women
* Unscheduled patients: emergencies, etc.
* Hospitalized patients
Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (MDI) (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers.

The current study is designed to complement and expand the previous PK studies, API-E004-CL-B and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100 mcg per inhalation), for a more thorough evaluation of the E004 PK profiles. Safety of E004 will also be evaluated, under augmented dose conditions.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy at screening;
* Body weight ≥ 50 kg for men and ≥ 45 kg for women;
* Sitting blood pressure ≤ 135/90 mmHg;
* Demonstrating negative hIV, HBsAG and DCV-Ab screen tests;
* Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
* Properly consented
* Other criteria apply

Exclusion Criteria:

* A smoking history of ≥10 pack-years, or having smoked within 6 months prior to Screening;
* Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
* Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs;
* Known intolerance or hypersensitivity to the study MDI ingredients;
* Having been on other investigational drug/device studies, or donated blood, in the last 30 days prior to Screening;
* Other criteria apply
Study Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males

The purpose of this study is to look at how much of a new drug, GSK163090, binds to proteins in the brain and how much stays in the blood over a range of different doses. This study will use a medical imaging technique called Positron Emission Tomography (PET) which uses an imaging agent called \[11C\]-WAY100635.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, aged 18-45 years Body weight \> 50 kg
* Non-Smoker
* Normal ECG, heart rate and blood pressure

Exclusion Criteria:

* History of any cardiac disease
* History of regular alcohol consumption averaging \>14 drinks/week
* Current or recent gastrointestinal disease; History of psychiatric illness including any history of suicidal attempts
* Positive for Hepatitis B and C, and HIV.
* History of drug abuse.
* Exposure to research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden
* Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
* Suffers from claustrophobia
* History or presence of neurological or psychiatric conditions
* Presence of a cardiac pacemaker or other implanted electronic device or metal implants
Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

The purpose of this study is to assess the immune memory induced by primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through evaluation of the immune responses following vaccination with a booster dose of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in age-matched unprimed children.

The study also aims to assess the antibody persistence in the fourth year of life following primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life.

The study is also designed to evaluate the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the fourth year of life.

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307034)


Eligibility Criteria:
Inclusion Criteria:

* Male or female between, and including, +- 36-46 months of age at the time of vaccination.
* For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034).
* Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent(s)/guardian(s) of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination.
* For primed subjects: administration of any pneumococcal vaccine since the end of the primary study (NCT00307034).
* For unprimed subjects: previous vaccination with any pneumococcal vaccine.
* Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine.
* Acute disease at the time of enrolment.
Pramipexole Conversion to Ropinirole Controlled Release (CR)

A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio and side effects related to the drug.

Three different arms will be used in this study. Each of the three cohorts will be treated sequentially. Each participant will be taking Mirapex for PD and will be converted to Requip CR by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from Mirapex to once a day Requip CR. The first five subjects of each cohort will have their initial dose administered in the clinic and be monitored for orthostatic changes. Assessments of motor function before and after conversion will be done.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson Disease
* Currently taking pramipexole
* Never have taken Requip CR

Exclusion Criteria:

* Can not have significant adverse effects to standard Requip
* Can not have atypical PD due to drugs, metabolic disorders, encephalitis or degenerative diseases
* Can not have unstable medical conditions
* Can not be taking concurrent monoamine oxidase inhibitors except for selegiline (10mg per day or less)
* Female patients of childbearing potential must be using an effective method of contraception.
* Can not be pregnant or lactating.

This may not be a complete list; there may be additional criteria which may apply.
Cartilage Tympanoplasty for Recurrent Perforation Full Thickness Versus Partial Thickness Graft

Cartilage tympanoplasty for recurrent perforation full thickness versus partial thickness graft.

To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer

Eligibility Criteria:
Inclusion Criteria:

1 -patients with safe chronic suppurative otitis media 2- patients with recurrent perforations 3- patients with conductive hearing loss- 4- patients above 18 years

Exclusion Criteria:

1. active infection
2. sensorineural hearing loss
3. compromised immune system 4 - patients age below 18 years
Predictive Value of the PBS-score in Children With Clubfoot

Evaluate the predictive value of the PBS-score in predicting recurrence of idiopathic clubfoot, measured as need for additional treatment.

Using a consecutive inclusion, we aim to include 60 children and register data proposed by the COS for PEVA. All items of the PBS-score are video-documented, and dynamic foot pressure during walking is recorded during a clinical visit at the Motion Analysis Lab at Karolinska University Hospital. Children and caregivers will complete Roye's score, a disease-specific PROM and Oxford Foot and Ankle Questionaire-child (OxFAQc). For children aged 6 years or older, standing radiographic imaging of both feet will be performed. Inclusion criteria include: age 4-8 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish or English. Included children will be followed prospectively during five years through clinical visits and medical records, where need for additional treatment (casting, braces and/or surgery) is the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* age 4-10 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish or English.

Exclusion Criteria:

* Syndromic clubfoot
Hormone Replacement Therapy and Insulin Action: A Double-Blind, Parallel, Placebo-Controlled Hormone Intervention Study in Postmenopausal Women

Considerable controversy exists regarding the effect of estrogen and progesterone on insulin sensitivity in postmenopausal women. Thus, the goal is to examine the effect of estradiol and progestin on in vivo insulin sensitivity and pathways of intracellular glucose metabolism in postmenopausal women. This will be accomplished by examining the effects of unopposed estrogen (CEE) or combination estrogen and progestin (CEE/MPA) versus placebo therapy in 30 early menopausal women (defined from 6 months to 3 years post-cessation of menses). Women will be treated for 16 weeks and the outcome measures will be: 1) insulin sensitivity and glucose oxidation as determined by euglycemic clamp, 2) assessments of insulin sensitivity on muscle biopsy cultures with the primary endpoints being glucose uptake and glycogen accumulation/synthesis, 3) protein levels of insulin action cascade steps based on muscle biopsy Western blots.


Eligibility Criteria:
Inclusion Criteria:

* 6 months to 3 years since cessation of menses
* BMD 24-33
* no surgically induced menopause
A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)

This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. This study will also make a preliminary assessment of the anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI regimen plus bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years
* Histologically confirmed CRC with evidence of metastases and measurable tumor lesions
* Documented disease progression following, or intolerance to, treatment with 5-fluorouracil, oxaliplatin, and bevacizumab-based therapy
* Life expectancy \> 3 months
* For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device \[IUD\], physical barrier) throughout the trial and for 6 months following their final exposure to study treatment
* Willingness and capability to be accessible for study follow-up

Exclusion Criteria:

* Patients who have a Kras mutation will be excluded from receiving cetuximab-containing regimens
* Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
* Recent radiotherapy to a peripheral lesion, thoracic, abdominal, or pelvic field
* Recent chemotherapy, hormonal therapy, or immunotherapy
* Evidence of clinically detectable ascites
* Other invasive malignancies within 5 years
* History or evidence of active central nervous system (CNS) disease
* Current or recent participation in another experimental drug study
* Clinically significant cardiovascular disease
* Active infection requiring parenteral antibiotics
* Recent major surgical procedure, open biopsy, significant traumatic injury, fine needle aspirations, or anticipation of need for major surgical procedure during the course of the study
* Known or suspected to be positive for the human immunodeficiency virus (HIV)
* Known to be positive for hepatitis C or hepatitis B surface antigen
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or specified study treatment
* Pregnancy (positive pregnancy test) or breast feeding
* Serious, non-healing wound, ulcer, or bone fracture
* Known sensitivity to any of the products administered during the study
* Any disorder that compromises the ability of the patient to provide written informed consent and/or comply with study procedures
Efficacy Analysis of Comparison of CAMS（Chinese Academy of Medical Sciences）-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia

The investigators adopted the CAMS（Chinese Academy of Medical Sciences）-2009 trial for pediatric acute myeloid leukemia (AML) patients between 2009 to 2015, in which a risk-stratified strategy and dose-dense intensive chemotherapy were introduced. The outcomes of CAMS-2009 trial were retrospectively analyzed, and compared to the CAMS-2005 trial.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed AML

Exclusion Criteria:

* children with Down's syndrome and acute promyelocytic leukemia (APL)
User Performance Evaluation of Contour Plus, Accu-Chek Active, Accu-Chek Performa and OneTouch Select Simple Blood Glucose Monitoring Systems Following ISO 15197:2013

The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care), Accu-Chek Active (Roche Diagnostics), Accu-Chek Performa (Roche Diagnostics) and OneTouch Select Simple (LifeScan) following ISO 15197:2013, clause 8.

The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS.

For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects.

The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, with type 1 diabetes, type 2 diabetes or no diabetes
* For provoked blood glucose excursions due to insulin dose adjustment: Male or female with type 1 diabetes or type 2 diabetes and intensified insulin therapy or insulin pump therapy.
* Minimum age of 18 years
* Signed informed consent form
* Legally competent and capable to understand character, meaning and consequences of the study

Exclusion Criteria:

* Pregnancy or lactation period
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
* Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* Incapability of giving informed consent
* \< 18 years
* Legally incompetent
* Accommodated in an institution (e.g. psychiatric clinic)
* Language barriers potentially compromising an adequate compliance with study procedures
* Dependent from investigator or sponsor
* For provoked blood glucose excursions 50 - 80 mg/dl:
* Coronary heart disease
* Condition after myocardial infarction
* Cerebral incidence
* Peripheral arterial occlusive disease
* Hypoglycemia unawareness
Effects of Repeated Mesenchymal Stem Cells (MSC) in Patients With Progressive Multiple Sclerosis

An open prospective study with multiple (every 6-12 months) intrathecal or intravenous injections of autologous MSC in patients with progressive forms of MS (secondary progressive, primary progressive or relapsing-progressive), who failed to respond to first and second lines of immunomodulatory treatments and deteriorated (at least 0.5 degree in the EDSS scale) during the year preceding their inclusion to our study or had at least one major relapse without sufficient recovery.

An open prospective study with multiple intrathecal or intravenous injections of autologous MSC in 24 patients with progressive forms of MS (secondary progressive, primary progressive or relapsing-progressive), who failed to respond to first and second lines of immunomodulatory treatments and deteriorated (at least 0.5 degree in the EDSS scale) during the year preceding their inclusion to our study or had at least one major relapse without sufficient recovery. Patients will be treated with 1x10 million MSC per kg of body weight, intrathecally and intravenously and subsequently with up to 8 courses of IT- or IV-injections of MSC (at the same dose), at intervals of 6-12 months. The duration of the trial is 4 years.

Patients will be followed up every 3 months for the whole duration of the trial, for safety assessment and changes in the disability scores (EDSS).

Immunological analysis will be performed at 4 time points (day 1, month 1, month 3 and month 6) following the first MSC-treatment and will include a fluorescent cell sorter (FACS) analysis to evaluate the proportions of the lymphocytes expressing markers of immune activation or of regulatory cell phenotype.

Eligibility Criteria:
Inclusion Criteria:

1. Consenting patients fulfilling the Poser's criteria for definite MS
2. Age 18-70
3. Male and female
4. EDSS rate 5.5-7.5 (moderate to high disability)
5. Failure to two lines of the currently available registered immunomodulatory treatments for MS. The lack of response to these treatments was determined by either an increase in EDSS or the appearance of at least two relapses of MS during the year prior to inclusion.

Exclusion Criteria:

1. Patients who were treated with cytotoxic medications during the last three months prior to the infusion.
2. Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results.
3. Patients with active infections.
4. Patients with cognitive decline or inability to understand and sign the informed consent.