cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)

This open-label, multi-center, three-period, one-sequence study will investigate the effect of rifampin on the PK of vemurafenib in participants with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Eligible participants will have the option to continue treatment with vemurafenib as part of an extension study GO28399 (NCT01739764).


Eligibility Criteria:
Inclusion Criteria:

* Participants with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAF V600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600 mutation test or a Deoxyribonucleic acid (DNA) sequencing method, and who have no acceptable standard treatment options
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Life expectancy of greater than or equal to (\>/=) 12 weeks
* Full recovery from the effects of any major surgery or significant traumatic injury within 14 days prior to the first dose of study treatment
* Adequate hematologic and end organ function
* Female participants of childbearing potential and male participants with partners of childbearing potential must agree to always use 2 effective methods of contraception
* Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential

Exclusion Criteria:

* Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of first dose of study drug
* Requirement for immediate or urgent treatment with daily vemurafenib and for whom the intermittent schedule of vemurafenib employed during the 24-day period for this trial is not clinically acceptable
* Allergy or hypersensitivity to components of the vemurafenib formulation
* Experimental therapy within 4 weeks prior to first dose of study drug
* Major surgical procedure or significant traumatic injury within 14 days prior to first dose of study drug, or anticipation of the need for major surgery during study treatment
* Prior anti-cancer therapy within 28 days before the first dose of study drug
* History of clinically significant cardiac or pulmonary dysfunction
* History of symptomatic congestive heart failure of any New York Heart Association class or serious cardiac arrhythmia requiring treatment
* History of myocardial infarction within 6 months prior to first dose of study drug
* Current dyspnea at rest, owing to complications of advanced malignancy or any requirement for supplemental oxygen to perform activities of daily living
* History of congenital long QT syndrome or corrected QT interval (QTc) greater than (\>) 450 milliseconds
* Active central nervous system lesions
* Uncontrolled or poorly controlled diabetes
* Current severe, uncontrolled systemic disease
Bariatric Surgery and Pharmacokinetics of Methylphenidate

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on methylphenidate.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI

The NSCLC patients who experienced good clinical responses to an EGFR-TKI will inevitably develop acquired resistance. A great deal of research are focusing on this issue. Arsenic trioxide showed efficacy and safety in acute promyelocytic leukemia, multiple myeloma and other solid tumors. Moreover, preclinical studies showed arsenic trioxide can reduce the resistance of tumor cells to chemotherapy and TKIs.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB/IV lung cancer with EGFR mutation
* Progressed after platinum-based chemotherapy
* The last anti-tumor therapy before entering this study must be gefitinib, erlotinib or icotinib, and the duration for tumor response must be no less than 4 months, or the duration for stable disease must be no less than 6 months
* With a measurable disease with conventional CT) according to RECIST Criteria
* WHO performance status(PS)\<= 2
* N\>=1.5×109/L, Plt\>=1.0×109/L,Hb\>=9g/dL; AST\&ALT should \<2.5ULN(without liver metastasis) or \<5ULN(with liver metastasis).TBIL\<=1.5ULN.
* Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

* Allergic to icotinib or arsenic trioxide.
* Patients with metastatic brain tumors with symptoms.
* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake

The aim of this study is to determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals.

Sodium intake is a major contributor to the development of hypertension in the developed world. Interestingly, it has been recently revealed that, in addition to the cardiovascular dysfunction associated with high sodium intake-induced hypertension, individuals who have unaltered blood pressure after chronic high sodium intake, termed salt resistant, report similar reductions in cardiovascular function when compared to salt sensitive individuals. While the extent to which this high sodium intake negatively alters cardiovascular structure as well as function is currently being explored, little is known about how high sodium intake impacts vascular function and blood flow regulation during exercise. Therefore, this study will determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals. The investigators hypothesize that increases in sodium intake will reduce exercise-induced arterial dilation in response to shear and result in exercise intolerance, via impaired functional sympatholysis, at moderate-to-high exercise workloads. Furthermore, the investigators hypothesize that these changes in blood flow regulation and exercise tolerance in young individuals will be reversed following antioxidant supplementation, implicating the role of oxidative stress in this dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* normotensive blood pressure (Systolic \<120 AND Diastolic \<80
* free of cardiovascular disease and any evidence of thyroid, renal, metabolic, pulmonary or neurological disease
* non-obese (BMI \<30 and/or Body fat \< 25% for men, and \< 30% for women)
* no tobacco use
* no medications that could affect vascular function or oxidative stress
* not sedentary

Exclusion Criteria:

* individual with cardiovascular, pulmonary, or metabolic disease or taking medications that may alter cardiovascular, pulmonary, or metabolic function
* subjects will be asked to maintain a dietary record for one week subsequent to the pre-screening and if this reveals a diet that differs substantially from the "typical" average diet, the subject will not be eligible
* subjects will be excluded from the study if dietary records reveal significant caloric restriction and/or vitamin/mineral deficiencies
* pregnant women, prisoners, and children will not be eligible for this study
Side Effects of Antibiotics in Bone and Joint Infections

Treatment for bone and joint infection (BJI) is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.

Treatment for bone and joint infection is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. Although patients with BJI receive regular follow-up, the impact of adverse events during treatments lasting more than a month is still poorly developed in the literature.

The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.

The investigators believe that this study will improve the management of osteoarticular infections through a better understanding of the adverse effects associated with prolonged, high-dose antibiotic therapy, and encourage more multidisciplinary follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Microbiologically proven osteoarticular infection with or without material, requiring antibiotic therapy (single or multiple) of 6 weeks or more
* Oral antibiotic therapy (minimum 4 weeks)

Exclusion Criteria:

* Opposition to data processing
* Patient under guardianship or trusteeship
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media

The primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.

Reduction of pain symptoms will be measured by using the Face, Legs, Activity, Cry, Consolability Scale (FLACC) and the Faces pain Scale Revised (FPS-R).

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Acute Otitis Media
* Moderate to severe pain
* Normally active and in good health as determined by the PI
* Parent or legal guardian consent
* Caregiver available to complete diaries during study

Exclusion Criteria:

* History of or current Perforated tympanic membrane
* Tympanostomy tubes
* Acute or chronic otitis externa
* seborrheic dermatitis
* Received any otic topical or systemic antibiotic within 14 days of enrollment
* Receiving medication on a chronic basis for pain
* Known hypersensitivity to investigational product.
* clinical significant mental illness as determined by the PI
* Exposed to another investigational agent within 30 days before study entry. Any condition the PI believed will interfere with the ability to comply with all study procedures
* History of glucose 6-phosphate dehydrogenase deficiency
* History or currently anemic
* Congenital methemoglobinemia
* Recent history of acute gastroenteritis within 14 days of enrollment
Dorsal Genital Nerve Stimulation for Bladder Management After SCI

Following spinal cord injury signals between the brain and the bladder are disrupted. As a result the bladder often becomes overactive which can lead to the need for frequent trips to the toilet, regular incontinence episodes and a decreased quality-of-life. Neuromodulation is a therapy that aims to target the nerves that become overactive controlling the bladder, stopping the bladder overactivity on demand using an external (non-invasive) nerve stimulation box and sticker electrodes placed on the penis or clitoris.

This study is a pilot study that aims to investigate neuromodulation for improving symptoms of bladder overactivity when used by 10 people over eight weeks at home. We will assess whether using the device improves bladder capacity, incontinence, frequency of needing the toilet and whether there are any longer lasting changes after 8 weeks. Finally, the study will aim to find out the acceptability of using this type of therapy for participants and the acceptability of the device we are using.

Participants in this trial will participate over 13 weeks and need to visit our centre in Stanmore to have urodynamics tests in the 1st, 9th and 13th week. At home they will use a small stimulation device on a daily basis for 8 weeks to control overactivity in the bladder. Whilst at home they will record relevant outcomes in several three-day diaries and questionnaires. They will record baseline data before starting stimulation and for 4 weeks after.


Eligibility Criteria:
Inclusion Criteria:

* Spinal Cord Injury (suprasacral, AIS A-D);
* \>18 years old, no upper age limit;
* SCI sustained \>6 months ago;
* NDO;
* Capable of using the device at home either independently or with existing support.
* Male or female
* Willing and able to provide informed consent

Exclusion Criteria:

* recipient of intra-detrusor botulinum toxin injections within the last 6 months;
* previous surgical intervention on bladder sphincters;
* pregnancy;
* cardiac pacemaker;
* active sepsis;
* history of significant autonomic dysreflexia;
* poorly controlled epilepsy;
* patients with a cancerous tumour in the area of electrical stimulation
Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG

This trial is designed to test the impact of adjuvant BEC2 (2.5 mg)/BCG vaccination on survival in patients with LD Small Cell Lung Cancer (SCLC). Patients will be stratified by institution, KPS (60 - 70% vs 80 - 100%), and response to first line combined modality therapy (CR vs PR) that consisted of at least a 2 drug regimen (4 - 6 cycles) and a chest radiotherapy regimen. Patients will be randomized to one of two treatment arms: standard arm (Observational cohort) or best supportive care, or the treatment arm (5 intradermal vaccinations of BEC2 (2.5 mg) + BCG given on day 1 of weeks 0, 2, 4, 6, and 10.


Eligibility Criteria:
Inclusion Criteria:

* Histo-cytologically proven SCLC
* Limited disease at diagnosis
* Age greater than or equal to 18
* Patients with a clinical response of CR or PR to first line combined modality therapy
* KPS greater than or equal to 60
* Adequate bone marrow, liver and heart functions
* Written informed Consent

Exclusion Criteria:

* Prior surgical treatment for SCLC
* History of tuberculosis
* NCIC CTG grade 3 local skin toxicity reaction (ulceration) to \> IU PPD test \> 5 IU
* HIV positive
* Splenectomy or spleen radiation therapy in medical history
* Prior therapy to proteins of murine origin
* Any second line therapy for SCLC
* Investigational agent or immune therapy within 4 weeks prior to study randomization
* Severe active infections
* Active infections requiring systemic antibiotics, antiviral, or antifungal treatments
* Serious unstable chronic illness
* The use of systemic anti-histamines, NSAID or systemic corticosteroids
* Any previous malignancy except adequately treated CIS of the cervix or non melanoma skin cancer or if previous malignancy was more than 5 years prior and there are no signs of recurrence
* Pregnancy or breast feeding or absence of adequate contraception for fertile patients
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before randomization in the trial.
Community Intervention for Minority Children With Asthma

To test the effectiveness of school-based asthma education interventions, community-based asthma health workers' programs and the combination of these on asthmatic children. Also, to examine the separate and combined impact of asthma interventions designed to address problems associated with effective asthma self-management amd difficulties in establishing and maintaining continuity of medical care.

BACKGROUND:

Asthma is a leading cause of childhood illness that disproportionately affects minority children. The causes of higher hospitalization and death rates among minority children with asthma are not understood. It is commonly assumed that barriers related to poverty underlie this public health issue. Two proposed causes of this increased morbidity and mortality are problems associated with effective asthma self-management and difficulties in establishing and maintaining continuity of medical care.

The study was part of a demonstration and education initiative "Interventions for Control of Asthma Among Black and Hispanic Children" which was released by the NHLBI in June 1989.

DESIGN NARRATIVE:

A school-based asthma self-management program was developed to promote children's self-management skills within predominately minority schools. A community-based asthma health worker program was developed to assist minority families in establishing and maintaining asthma health care within the community. It was hypothesized that the most effective control of asthma would be achieved with the combination of these two interventions. Twenty elementary schools each in inner-city Baltimore, Maryland and inner-city Washington D.C. served as study sites. Asthmatic children grades 1-5 were identified by school records and parent surveys. After obtaining consent, schools were randomly assigned to one of four intervention groups: 1) a control/minimal intervention, 2) a school-based asthma education program, 3) a community-based asthma health worker program, and 4) a combined intervention that included both the school-based education program and the community-based health worker program. The duration of both the school program and the Community health worker program was twelve months. Baseline measures were collected after obtaining consent and prior to school randomization. Followup measures were collected from children and families at 6, 12, 18, and 24 months. Data were collected on hospitalization, emergency or urgent care, acute episodes, health care utilization, medications, school absences, academic performance, self-esteem, self and family asthma management, and family coping.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Non-COVID Patient-safety Incidents Reported by Primary Care Professionals in Time of Lockdown: Protocol for a Cross-sectional Descriptive Study

The COVID-19 epidemic is causing a global health crisis. In France, it has imposed a major reorganization of the healthcare system. This emergency reorganization is unprecedented. It involved first, second and third line care. Following this reorganization and from the first days of confinement, a decrease in care activity not related to COVID-19 was observed in médical offices, in emergency services, and in secondary and tertiary care services. This decrease in activity could indicate a decrease in pathologies related to work, transportation or non-COVID-19 infections, due to a favourable effect of lockdown. Nevertheless, some health professionals report the opposite in the media and on social networks, an unusual increase in events (appendicular peritonitis treated late, increase in domestic violence, etc.), while others are surprised by a decrease in activity that is difficult to explain (leukaemia diagnoses by biologists, for example). One hypothesis is that such changes could be related to the reorganisation of the health care system or to the consequences of lockdown.

The World Health Organization (WHO) recommends a systematic collection and analysis of patient safety incidents (also called "adverse events" in France). The objective is to assess the roles of the system and human factors in patient safety, in order to propose changes to the global system and local organisation. In France, there is a system for reporting serious adverse events related to care. Only 4% of the 820 serious adverse events reported in 2018 were reported by primary healthcare professionals (1). However, patient safety incidents in primary care are known to have specific mechanisms, types and mechanisms (2).

We hypothesize that the COVID-19 health crisis may have induced unusual patient safety incidents through new mechanisms in a context associating reorganization of the healthcare system and population lockdown. Such a scenario requires the implementation of a massive collection of potential incidents and their systematic and well-structured analysis.

Thus, the objective of our study is to describe patient safety incidents related to the reorganization of care and/or lockdown in the context of the COVID-19 health crisis (types, severity, mechanisms) reported by primary care professionals in France.

1. - HAS. Retour d'expérience sur les événements indésirables graves associés à des soins (EIGS) \[Internet\]. \[cited 2020 Apr 7\]. Available from: https://www.has-sante.fr/jcms/c_2882289/fr/retour-d-experience-sur-les-evenements-indesirables-graves-associes-a-des-soins-eigs
2. - Carson-Stevens A, Hibbert P, Avery A, Butlin A, Carter B, Cooper A, et al. A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice. BMJ Open. 2015 Dec 1;5(12):e009079.


Eligibility Criteria:
Inclusion Criteria:

* Primary care professionals practising in primary care in France
* Any patient undergoing primary care

Exclusion Criteria:

* None
Using the SEDLine for the Titration of Sevoflurane in Elderly Patients Recovery Using the SEDLine TM for the Titration of Sevoflurane in Elderly Patients Undergoing Non-Cardiac Surgery After Beta-Adrenergic Blockade

Asses the effect of the use of Patient State Index (PSI) monitoring on difference in emergence profiles in the elderly (age \>65 yrs) population to develop a cost-benefit profile.

Assess differences in Quality of Life using the QoR-40 (a validated 40-item questionnaire on quality of recovery from anesthesia) between the two treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female.
* Patient is 65 years of age or older.
* Patient has a physical status between ASA I and III. (Appendix C).
* Patient scheduled for general anesthesia for non-cardiac surgery expected to last at least one hour.
* Patient able to communicate in English.
* Patient has signed an approved informed consent.

Exclusion Criteria:

* Patient's age is less than 65 years
* Anesthetic duration of less than one hour expected
* Treatment of beta blockers contra-indicated
* Not a candidate for general anesthesia
* Patient requires regional anesthesia with general anesthesia.
* ASA physical status of IV or V. (Appendix C)
* Patient has known drug or alcohol abuse.
* Patient has scalp or skull abnormalities such as psoriasis, eczema, angioma, scar tissue, burr holes, cranial implants (such as plates, shunts, etc.).
* Patient has experienced a head injury with loss of consciousness within the last year.
* Patient has known neurological and psychiatric disorder that interferes with the patient's level of consciousness.
* Known concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, SSRIs, neuroleptics, anxiolytics or antipsychotics).
* Patient has any medical condition which, in the judgment of the investigator, renders them inappropriate for participation in this study, such as Guillen Bare syndrome
* Known hypersensitivity to the intended anesthetic agents including significant post-operative nausea or vomiting.
* Uncontrolled hypertension (unresponsive to medication): Systolic BP \> 180 mmHg or Diastolic BP \> 105 mmHg
* Pre-Op baseline heart rate \< 45 beats per minute
* Weight 50% greater than ideal body weight
* Already monitored for EP or EEG, i.e., Spinal cord cases
* Actual anesthetic duration \< 1 hour (assessed after emergence).