cyrilzakka/clinical-trials huggingface dataset:
An Observational Study of Tarceva (Erlotinib) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With Wild-Type Epidermal Growth Factor Receptor (EGFR) Gene (WILT)

This prospective observational study will evaluate the efficacy and safety of second-line Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer with confirmed wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study is to identify from baseline clinical and demographic patient characteristics prognostic factors related to overall survival with second-line Tarceva treatment. Data will be collected from eligible patients for up to 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)
* Patients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria:
* squamous cell carcinoma lung cancer histology, and
* current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of \>15 pack-years of smoking
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Patients having failed one prior chemotherapy regimen and eligible for a second-line treatment with Tarceva

Exclusion Criteria:

* Current treatment with an investigational drug or participation in another investigational study
* Severe or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
* Clinically active interstitial lung disease
* Recent myocardial infarction or unstable angina
* Progressive or uncontrolled brain metastases
Evaluation of the New Variant 501Y.V2 of COVID-19

In January 2021, the incidence of COVID-19-and its mortality started rising for the third time in France. This rise may associate with three emerging variants, namely, V1, V2, and V3, which are the 20I/501Y.V1 ("English"), 20H/501Y.V2 ("South African"), and 20J/501Y.V3 ("Brazilian") variants, respectively. V1 was recently suggested to increase mortality in people in the United Kingdom who tested positive for COVID-19 on community screening. Very little is known about V2 infection, including its outcomes relative to other strains. In early 2021, V2 spread to the Grand-Est region (northeastern France). Here, the investigators aimed to report mortality data of patients admitted in ICU between February and April 2021 in 3 hospitals in Grand-Est: Metz, Thionville and Nancy.


Eligibility Criteria:
Inclusion Criteria:

* Admission in ICU in February, March or April 2021
* Patient with a SARS-CoV-2 positive polymerase-chain reaction test
* Patient with 20I/501Y.V1 ("English") or 20H/501Y.V2 ("South African") SARS-CoV-2 variants

Exclusion Criteria:

* Opposed to use data
Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.

Randomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* Woman over 18
* hysterectomized patient with endometrial cancer (stage I, stage II and histological type I, without chemotherapy, with brachytherapy and/or radiotherapy) OR patient with cervical cancer (stage IA2 and IB1 with emboli or positive lymphadenopathy and IB2 stages with or without chemotherapy, with brachytherapy and / or radiotherapy)
* Only for patients with cervical cancer, premenopausal and non-hysterectomized: patient on contraception at least one month before V0 and throughout the study
* Only for patients with cervical cancer: complete remission
* Patient capable of receiving and understanding information related to the study, giving informed written consent, and easily completing a quality of life questionnaire
* Patient affiliated to the French social security system

Exclusion Criteria:

* Patient with clinically observed vulvovaginal infections
* Patient with endometrial cancer treated with chemotherapy
* Patient already participating in another study
* Patient under legal protection, or under guardianship or curatorship
* Only for patients with cervical cancer: local treatment with estrogen
* Only for patients with cervical cancer, premenopausal and non-hysterectomized: pregnancy (pregnancy test to be performed at V0)
Radiomic and Pathomic Study of Pituitary Adenoma Using Machine Learning

Refractory pituitary adenoma is characterized by invasive tumor growth, continuous growth and/or hormone hypersecretion in spite of standardized multi-modal treatment such as surgeries, medications or radiations. Quality of life or even lives are threatened by these tumors. According to the 2017 World Health Organization's new classification guideline of pituitary adenoma, patients have to suffer from symptoms or complications caused by these tumors, to bear a heavy financial burden, and to accept additional therapeutic side effects when the diagnosis of "refractory pituitary adenoma" is made. If refractory pituitary adenoma could be predicted at early stage, these patients would be able to have a more frequent clinical follow-up, receive multiple effective treatment as early as possible, or even be enrolled in clinical trials of investigational medications, so as to prevent or delay the recurrence or persistent of the tumor growth. Therefore, the unmet clinical need falls into an early prediction system for refractory pituitary adenomas, which could provide accurate guidance for subsequent treatment in the early stage. The investigators have constructed a pituitary adenoma database including clinical data, radiological images, pathological images and genetic information. The investigators are proposing a study using machine learning to extract features from these multi-dimensional, multi-omics data, which could be further used to train a prediction model for the risk of refractory pituitary adenoma. The proposed model would also be validated in another prospectively collected database. The established model would be able to identify potential medication targets and provide guidance for personalized therapy of refractory pituitary adenoma.


Eligibility Criteria:
Inclusion Criteria:

* All patients with pituitary adenoma

Exclusion Criteria:

* Patients who were not able to sign the informed consent
Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients

This research study is a prospective, randomized, blinded, placebo controlled trial evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip fracture patients. IV acetaminophen has received FDA approval. IV acetaminophen does not have the liver toxicity as oral acetaminophen. No oral acetaminophen will be administered. All patients diagnosed with a hip fracture aged at least 65 years and expected to undergo surgical intervention are eligible to participate. Hip fractures affect greater than 300,000 geriatric patients annually, representing the second leading cause of hospitalization for this patient population. Pain control in these patients is often problematic due to co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles. Subjects may receive the normal DVT prophylactic treatments post-op.

Approximately 46 subjects will be enrolled at LGH. Subjects will be randomized 1:1 to receive either IV acetaminophen 1000 mg q6 hours (FDA recommended dose) or IV placebo. While receiving the study drug/placebo the subject's blood pressure, heart rate, respiratory rate, \& pain intensity will be monitored. Additional pain meds will be given if needed. Study treatment will continue until subject is taken into the operating room; at that time the intervention will be discontinued and other pain medication will be provided. Participation in the study will end at time of discharge from the hospital. Researchers are expecting a 33% decrease in opioid use for subjects randomized to treatment group.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged at least 65 years with a diagnosis of hip fracture with whom surgical intervention is expected
* Patients with the following surgeons ( David Hughes MD, Gerald Rothacker MD, Frank Essis MD, James Carson MD, Michael Gish MD, Vincent Battista MD)

Exclusion Criteria:

* Documented drug or alcohol addiction or abuse
* Documented serum sodium levels \> 145 mmol/L
* Documented serum chloride levels \> 107 mmol/L
* Impaired liver function defined as an ALT or AST \> 3 times the upper limit of normal, Child-Pugh class C, or patients with documented active liver disease
* Known allergy or intolerance to acetaminophen
* Weight ≤ 50 kg
* Creatinine clearance (CrCl) ≤ 30 ml/min as determined by the Cockcroft-Gault equation
* Documented dementia
* Acetaminophen (\> 650 mg) or opioid (\> 7 mg IV morphine equivalence) use within the previous 24 hours
* Documented chronic opioid use
The Impact of Bispectral Index Monitoring on Sedation Administration in Mechanically Ventilated Patients

This prospective randomised controlled trial was designed to assess the effectiveness of the Bispectral Index Sedation (BIS) monitor in supporting clinical, sedation management decisions in mechanically ventilated ICU patients.

The primary hypothesis for the study is that patients with Bispectral Index Sedation (BIS) monitoring will receive less sedation then those receiving standard sedation management.

The secondary hypotheses are:

1. Patients with BIS have fewer ventilation days than those receiving standard sedation management.
2. Level of sedation administered will differ according to the critical care experience and qualification of the nurse.

Patients in intensive care units (ICUs) frequently require sedatives and analgesics as part of therapy. Assessing the appropriate dose of sedative and analgesic drugs can be difficult due to the severity of the patient's illness, inability of the patient to communicate, multiple procedures and transports for investigations and the subjectivity of clinical sedation assessment tools. Poorly assessed and managed levels of sedation can result in over sedation, extended ventilation time and a potentially extended ICU stay.

The BIS monitor is derived from the electroencephalogram and provides a numeric value that represents a measure of cerebral activity. Such an objective measure of the patient's level of sedation may provide a useful tool that will enable nurses to titrate sedation more accurately in an attempt to provide the optimal level of sedation for all ICU patients.

The study will be conducted in the Intensive Care Unit at the Alfred Hospital. This study is designed as a prospective randomised control trial with parallel design. This means that participants' will be randomly allocated into either one of two groups - an intervention or control group. Participant's randomised to the intervention group will receive BIS monitoring. The control group will receive standard ICU sedation assessment and management.

To determine if BIS monitoring is useful in ICU, information will be collected by auditing patient charts and determining the average amounts of sedation medication for each nursing shift. In addition, the years of critical care experience and critical care qualification will be recorded for each nurse managing patients recruited to the study.

Eligibility Criteria:
Inclusion Criteria:

* Intubated and ventilated for at least 24 hours
* Sedated on morphine and midazelam infusions

Exclusion Criteria:

* Intracranial injury
* Status epilepticus
* Facial Burns
Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

This work is an implementation science study that examines different aspects of implementing a single intervention. The intervention consists of asking community health centers to implement an outreach strategy to screen patients for colorectal cancer and for social determinants of health in community health centers at the same contact point. These are both clinical targets that the CHCs feel that their patients need and want to offer at a higher rate. The intervention consists of outreach to patients in need of colorectal cancer screening (CRC) to offer fecal immunochemical test (FIT) screening and screening for social determinants of health (SDOH). In this implementation science study, the intervention is an evidence-based intervention being implemented in real-world clinical practice. The intervention is the outreach to offer FIT and SDOH, conducted by clinic staff. Both evidence-based screening activities-FIT and SDOH screening-are used in the practices included in the study but pairing them is intended to increase efficiency and patient-centeredness by addressing health related social needs that may impact patients' ability to engage in cancer screening. The study aims to test the effect of implementing the intervention on clinical and process outcomes. Clinical outcomes are CRC screening and SDOH screening. Analysis of process outcomes includes measuring what organizational factors influence implementation.


Eligibility Criteria:
Study participants include community health center staff participating in interviews about the implementation of the intervention. Up to four community health center staff members at each of the four community health centers will participate in key informant interviews twice per year. Patients will receive the paired screening intervention as part of their routine care and will not be individually recruited for the study because the intervention is being offered as part of routine care.

Staff Participants

Inclusion Criteria:

* Staff from community health centers who facilitate screening
* Age 18 and older

Exclusion Criteria:

* Have not participated in the implementation of the paired screening intervention
Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy

The goal of this prospective, waitlist-controlled, 1:1 randomized study is to evaluate if an online mindfulness-based stress reduction (MBSR) intervention reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy.

The main questions it aims to answer are:

* Does an online MBSR intervention reduce stress levels (measured through the Perceived Stress Scale) among participants?
* Does an online MBSR intervention reduce anxiety, depression, insomnia, fatigue, nausea, diarrhea, constipation, pain, and peripheral neuropathy (measured through the PRO-CTCAE of the National Cancer Institute) among participants?

Researchers will compare the online MBSR intervention to no intervention to see if online MBSR reduces treatment-related stress.

Participants will:

* Participate in an online MBSR intervention or no intervention for 6 weeks
* Answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up


Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Age ≥18 years
* Diagnosis of non-metastatic breast cancer
* Plan to start neoadjuvant or adjuvant chemotherapy in \<4 weeks
* Internet access at home or in their mobile phone
* Availability to participate in the online MBSR intervention for 6 weeks
* Availability to answer the study surveys
* Provision of signed informed consent

Exclusion Criteria:

* Disease recurrence
* Current meditation or mindfulness practice
* Inability to read or write
Intravascular Radiofrequency Ablation of Sympathetic Nerves for the Treatment of Hepatocellular Carcinoma

Patients who met the inclusion criteria were treated with endovascular radiofrequency ablation and desympathetic nerve surgery. After enrollment, endovascular radiofrequency ablation and desympathetic surgery were performed. After radiofrequency ablation, the safety and efficacy of follow-up treatment will be carried out every 1 month or so, including blood routine, liver and kidney function, tumor indicators, abdominal CT/magnetic resonance, etc.


Eligibility Criteria:
Inclusion Criteria:

* Clinically or pathologically confirmed hepatocellular carcinoma (HCC)
* Locally progressed or distant metastatic unresectable advanced HCC
* Progressed after second-line therapy
* Agree to participate in the study and sign the informed consent form

Exclusion Criteria:

* Not suitable for ablation surgery
* Pregnant, lactating and planning to become pregnant
* Orthostatic hypotension
* Mixed liver cancer
* Intestinal obstruction
* Obvious bleeding tendencies and hematologic diseases
* Acute or severe systemic infection;
* Stroke or transient ischemic attack (TIA) within two weeks;
* Acute coronary syndrome within two weeks;
* Evaluated to be not suitable for this trial by investigators
Repetitive Transcranial Magnetic Stimulation Compared or Associated With Venlafaxine for Depressive Disorder

The purpose of this study is to treat participants with a diagnosis of depressive disorder to assess the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of depressive disorders compared venlafaxine only (the optimal medication) and to rTMS only. fMRI will be performed to determine if treatment response is related to changes in fMRI, and use it to investigate the respondence to the treatments.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Clinical diagnosis of major depressive disorder (DSM-IV)
* HDRS-17 items \> 20
* Failure of one antidepressant treatment (efficacious doses for 6 weeks at least)

Exclusion Criteria:

* Psychotic features
* Failure of one previous venlafaxine treatment
* Addiction comorbidity or schizophrenia comorbidity
* Involuntary hospitalization
* Seizures history
* Pregnancy or breastfeeding
* Somatic comorbidity able to impact on cognitive functions
Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 9 years of age and older.
* Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
* Subject must have an Evaluator's Global Severity Score (EGSS) of 3 (moderate) or 4 (severe) at the baseline visit.
* Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 30, but no more than 100.
* Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than 150.
* Subjects with 2 or fewer facial nodules.

Exclusion Criteria:

* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema.
* Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
* Subjects with more than 2 facial nodules.
* Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
* Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study.
* Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area.
* Subjects who have not undergone specified washout period(s) for topical preparations/physical treatments used on the face or subjects who require the concurrent use in the treatment area.
* Subjects who have not undergone specified washout period(s) for systemic medications or subjects who require the concurrent use of systemic medications.
* Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.
Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease

The purpose of this research study is to learn about ways to help children and adults with sickle cell disease who are taking the medication, hydroxyurea.

Sickle cell disease (SCD) is an inherited chronic multi-organ system disorder that affects approximately 100,000 individuals in the United States, mostly belonging to minority, under-served populations. SCD is associated with substantial morbidity, premature mortality, individual suffering, health care costs and loss of productivity. Hydroxyurea (HU) the only disease modifying therapy for SCD is efficacious in reducing complications such as pain crisis and acute chest syndrome and improving survival. It is however, vastly underutilized and poorly adhered to because of barriers at the health care system, provider, treatment, socioeconomic, and patient levels. The investigator's overarching hypothesis is that barriers to acceptance and adherence to HU are multi-factorial and that a structured set of interventions can lead to improved adherence to medication and patient centered outcomes.

Eligibility Criteria:
Inclusion Criteria:

* be \>2 years of age up to 65 years of age, inclusive
* have a diagnosis of SCD, with either βS/βS, βS/βC, βS/βD, βS/β0, βS/βO-Arab, or βS/β+ genotype
* prescribed Hydroxyurea for at least the 6 months prior to study entry
* have daily access to a smart phone, tablet, personal computer or other device capable of producing and transmitting videos over the internet
* be willing and able to record and transmit videos

Exclusion Criteria:

* patient or caregiver refuses to take Hydroxyurea as treatment for SCD
* diagnosis of significant psychiatric disorder of the subject that could seriously impede the ability to participate in the study
* an assessment by the investigator that the subject will not comply with the study procedures outlined in the study protocol
* patients receiving automatic home delivery of medications since medication possession ratio is reflective of the patient initiation the refill when they have exhausted the home supply of HU