cyrilzakka/clinical-trials huggingface dataset:
Tobacco Treatment in the Context of Lung Cancer Screening

The proposed study will test a medication plus text messaging intervention specifically designed for lung cancer screening patients. Half of the patients will receive standard of care, and half will receive the treatment intervention.

Screening for lung cancer at earlier, more treatable stages has the potential to reduce mortality from the U.S.'s most deadly cancer. Annual lung cancer screening with low-dose computed tomography is now recommended for high risk individuals based on age and smoking history. This study will evaluate a smoking cessation intervention for lung cancer screening patients. We will evaluate quit rates after a standard intervention (brief counseling session at time of lung cancer screening) versus a dual nicotine replacement therapy (NRT) and gain-framed text messaging intervention.

Eligibility Criteria:
Inclusion:

1. 55 years or older
2. 30 pack year history of smoking
3. current smoker (defined as breath carbon monoxide\>6ppm)
4. willing to be randomized
5. English speaking

Exclusion:

1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, substance abuse, or dementia
2. in the immediate (within 2 weeks) post myocardial infarction period
3. serious arrhythmias
4. unstable angina pectoris
5. hemodynamically or electrically unstable
6. currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking NRT or other cessation medications, enrolled in the Quitline, in another drug study).
Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer

Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC), though many clinical questions remain. Prior experience has revealed locoregional control (LRC), disease free survival (DFS) and overall survival (OS) at 3 years exceeding 80% after treatment with the use of hyperfractionated intensity modulated radiation therapy (IMRT) and concurrent weekly cisplatin chemotherapy for patients with locally advanced HNSCC. This multi-institutional phase II ZCC00204 trial resulted in an acceptable quality of life (QOL) and toxicity profile. The current trial is an attempt to maintain high LRC, while further minimizing both acute and chronic toxicities, and maximizing QOL.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx
* No surgical resection of primary site or neck dissection (excisional biopsy of lymph node is permitted)
* Human Papilloma Virus (HPV) testing of tumor performed; HPV p16 by immunohistochemistry
* Stage III or IVa disease (T1-2N1-3M0, T3-4N0-3M0) excluding T1-2N1 oral cavity and tonsil primaries and any N2C or bilateral N3 disease. Patients with T2N0 cancer of the base of tongue and hypopharynx are eligible
* ECOG performance status 0-1
* Age \>18 years
* No current pregnancy
* No other invasive malignancies within the last 2 years Patients with basal cell or squamous cell skin cancers or carcinoma in situ of any site are eligible.
* No prior radiotherapy to the head and neck region
* No prior cisplatin chemotherapy
* No symptomatic coronary disease or myocardial infarction within the last 6 months
* Laboratory evaluation: ANC \> 2,000/mm3, platelets \>100,000/mm3, creatinine \< 1.5 mg/dl, creatinine clearance \> 50 ml/min, bilirubin \< 1.5 mg/dl, AST or ALT \< 2X upper normal limit
* Study-specific consent signed prior to entry

Exclusion Criteria:

* Second primary malignancy that is clinically detectable
* Inability or unwillingness to comply with chemoRT
* Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell carcinoma of head and neck.
* Metastatic disease (M1)
* Pregnant or breast-feeding women.
Bisoprolol Plasma Residual Concentrations in Chronic Heart Failure

This study evaluate the dosage of bisoprolol plasma residual concentrations in chronic heart failure with mild to reduced ejection fraction adult patients by dose and renal function.

The clinical relevance of bisoprolol plasma residual concentration in the management of HF medical therapy and the impact of renal function on reaching the maximum tolerated dose has never been studied. The investigators will perform an observational study to answer this issue.

In this study, there will be no changes of the doses of bisoprolol, whatever the bisoprolol plasma concentration, with the exception of vital threatening concentrations. This study is a pilot study.

Participants will be consecutive ambulatory chronic heart failure patients followed at the CHU de Caen, treated with maximum tolerated dose of bisoprolol with mild to reduced ejection fraction. Participants can benefit of the other heart failure recommended treatment at the exception of ivabradine that would confound the bisoprolol effect on heart rate. Participants will be subsequently studied by renal function.

Patients will be followed at one year with the electronic health record of the CHU de Caen for clinical events.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive ambulatory patients with chronic heart failure with mild to reduced ejection fraction (LVEF \< 50%) at the CHU de Caen
* Aged 18 y.o. or older
* With a stable heart failure (see exclusion criteria)
* At the maximum tolerated dose of bisoprolol for at least one week (maximum dose reached without adverse tolerance event: orthostatic hypotension, symptomatic bradycardia, fatigue related to the treatment)

Exclusion Criteria:

* Unstable HF, that are patients who presented in the last 3 months before inclusion an hospitalization for any cardiovascular event including HF, new onset or worsening of HF or coronary artery disease symptoms
* Patient refusing to participate
* Patients with a non maximum tolerated dose of bisoprolol
* Patients with ivabradine intakes
* Body weight \< 60kg or \> 100kg
* Severe liver insufficiency
* Pregnancy
* Liberty deprived patients
Augmented Reality (AR) Chile

This is an international, collaborative study evaluating the non-technical skills (NTS) of anesthesiology residents. The goal is to explore the capability of performing a remote, international AR simulation for the purpose of assessing NTS during a neonatal medical crisis. Simulation experts in the United States will facilitate the AR simulations with anesthesiology residents in Chile. The medical simulation itself is grounded in traditional best practices in accordance with the American Heart Association and Neonatal Resuscitation Program.


Eligibility Criteria:
Inclusion Criteria:

* age above 18

Exclusion Criteria:

* a history of severe motion sickness
* currently have nausea, a history of seizures
* wear corrective glasses (they are not compatible with the AR hardware).
Validity and Reliability of the Turkish St. Marks Incontinence Score

For the Turkish validity and reliability study of St.Mark's (Vaizey) Incontinence Score, which consists of 7 questions, it will be applied to 65 people diagnosed with anal incontinence after it is translated by translation-retranslation method.


Eligibility Criteria:
Inclusion Criteria:

* people with the complatint of anal incontinence
* being volunteered to participate

Exclusion Criteria:

- having difficulties in understanding and speaking Turkish
Palliative Management of Inoperable Malignant Bowel Obstruction

To identify the role of palliative medical management of inoperable malignant bowel obstruction (MBO) with Octreotide, Dexamethasone and Metoclopramide given together as triple therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age.
* Diagnosis of partial bowel obstruction secondary to active or prior malignancy (primary or metastatic GI, GYN, and carcinomatosis) caused either by tumor itself or adhesions inthe setting of active malignancy.
* Cross-sectional imaging performed within 24 hours of clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain) during hospital admission.
* Patient must have an inoperable MBO
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved writteninformed consent form prior to receiving any study related procedure.

Exclusion Criteria:

* Evidence of complete bowel obstruction by imaging.
* Bacteremia/septicemia with a documented positive blood culture: If a blood culture comes back positive after study enrollment, patient will be excluded.
* Patients already taking a steroid equivalent to 8 mg of dexamethasone per day prior to study enrollment.
* Patients undergoing bowel surgery or stent placement for bowel obstruction.
* Those patients with MBO in setting of incarcerated hernia.
* Known history of QT prolongation syndrome or if QTc is \> 450 msec in males or \> 470 msec in females on baseline EKG within 2 weeks of enrollment.
* Lack of decision making capacity/delirium.
* Pregnant or nursing female participants.
* Actively suicidal patients.
* Acute cholecystitis
Efficacy of Acute Intake of Ketones on Performance in Professional Road Cyclists

Randomized, controlled, double-blind, crossover clinical trial, depending on the product consumed, to analyze the efficacy on physical performance of a sports supplement consumed prior to and during competition or training.

Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product or placebo, depending on the group to which they have been assigned). On the second day, participants will consume the product that subjects did not consume on the first day.

The product to be consumed will be ketone monoester. Participants will consume 800 mg/kg body weight, distributed in two intakes. The first one, half an hour before exercise and the same dose will be consumed one hour and a half after the first dose. The intakes will be accompanied by carbohydrates and bicarbonate.

The tests that the cyclists will perform are a time trial on a cycloergometer to measure performance, as well as a 30" sprint. Afterwards, the cyclists will do a 4 and a half hour training session at competition pace. After this training session, the participants will do the same time trial and the 30'' sprint.

Eligibility Criteria:
Inclusion Criteria:

* Male professional cyclists.
* Start the study with previous rest.

Exclusion Criteria:

* Participant suffering from chronic illness.
* Suffering a long-term injury that prevents her from training in the month prior to the intervention.
* Inability to understand the informed consent.
* Having consumed ketone bodies chronically in the previous four weeks.
* To have undergone cholecystectomy.
Adjuvant Durvalumab for Esophageal Cancer

Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer following neoadjuvant CCRT.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous esophageal cancer, irrespective of PD-L1 status
* The enrolment should be done during the time interval from 20 days to 56 days after complete resection after neoadjvuant CCRT (no residual tumor after operation)
* Clinical tumor stage before neoadjuvant CCRT should be T3-4N0M0 or T1-4N1-3M0
* Available tumor specimen for biomarker analysis acquired before neoadjuvant CCRT or at operation

Exclusion Criteria:

* Other PD-1 or PD-L1 inhibitors history
* Mean QT interval corrected for heart rate (QTc) ≥470 ms using Bazett's correction
* Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
* Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
Hybrid Resin Composite Vs. Hybrid Ceramic Onlays for Restoring Carious Molars

The goal of this clinical trial is to compare the clinical performance of hybrid resin composite and hybrid ceramic onlays in restoring carious molars. It will also evaluate the wear resistance of both materials. The main questions it aims to answer are:

* Does the hybrid resin composite or hybrid ceramic onlay perform better in clinical settings over time?
* How much wear occurs in each type of onlay over 18 months?

Researchers will compare SHOFU Ceramage (hybrid resin composite) to SHOFU HC (hybrid ceramic) to see which material performs better in restoring molars with extensive caries.

Participants will:

* Receive either a hybrid resin composite or hybrid ceramic onlay for their molar cavities.
* Visit the clinic for checkups at baseline, 6 months, 12 months, and 18 months.
* Undergo visual assessments of their restorations and quantitative wear analysis during follow-ups.


Eligibility Criteria:
Inclusion Criteria:

* Able to tolerate necessary restorative procedures
* Willing to sign the informed consent
* Accepts the follow-up period

Exclusion Criteria:

* ICDAS 4/5 cavities in first and second permanent molars
* Onlay cavities with at least one cusp coverage
* Patients with acceptable oral hygiene
Phase II Trial of Vistusertib（AZD2014） Single Agent in TSC1or 2 Null or TSC 1/2 Mutation Solid Cancer Patients Refractory to Standard Chemotherapy

Patients with TSC1/2 mutated refractory solid cancer will receive vistusertib(AZD2014) monotherapy. Study-arm is composed of 27 patients. Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle as a monotherapy

Patients with TSC1/2 mutated refractory solid cancer will receive vistusertib(AZD2014) monotherapy. Study-arm is composed of 27 patients.

Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle as a monotherapy Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date).

Study treatment will be continued until objective disease progression (unless other criteria for treatment discontinuation are met). Patients may continue vistusertib(AZD2014) beyond progression (according to RECIST 1.1), at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria.

If a patient discontinues study treatment prior to disease progression, they should continue to be assessed using RECIST 1.1 until disease progression and then followed up for survival.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced solid cancers (including histologically or cytologically documented gastric cancer, colorectal cancer, hepatoma, biliary tract cancers, pancreatic cancer and rare cancers.) that has progressed after standard chemotherapy.
2. Provision of tumor sample (from either a resection or biopsy)
3. Patients with TSC1or 2 null or TSC 1/2 mutation through IHC.
4. Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:

   * Haemoglobin ≥9.0 g/dL (transfusion allowed)
   * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
   * White blood cells (WBC) \> 3 x 109/L
   * Platelet count ≥100 x 109/L (transfusion allowed)
   * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
   * AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
   * Serum creatinine ≤1.5 x institutional ULN

Exclusion Criteria:

1. Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity.
2. For vistusertib(AZD2014):

   Exposure to potent or moderate inhibitors or inducers of CYP3A4/5 if taken within the stated washout periods before the first dose of study treatment With the exception of alopecia, any ongoing toxicities (\>CTCAE grade 1) caused by previous cancer therapy.
3. Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
Subclinical Cardiovascular Disease in Psoriatic Disease

This study will look at how chronic inflammation seen in psoriatic disease translates into the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk. The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic disease and measures of vascular function. 2) Evaluate the association between moderate to severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional medications used in cardiovascular disease (CVD) prevention such as aspirin and statins affect vascular function and thrombotic risk in those with moderate to severe psoriatic disease.

Cardiovascular disease (CVD) remains the leading cause of death in the US. Five modifiable risk factors: smoking, hyperlipidemia, diabetes, hypertension and obesity, account for 50% of CVD mortality between the ages of 45 - 79.1 These traditional cardiac risk factors dictate who to treat with primary prevention measures but do not take into account patient-specific disease states such as psoriatic disease including psoriasis and psoriatic arthritis, which predispose to chronic inflammation. Patients with psoriatic disease have an increased risk of atherosclerotic heart disease and myocardial infarctions compared to matched controls.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of moderate to severe psoriatic disease
* Group 2: Healthy subjects without known psoriatic disease or cardiovascular disease

Exclusion Criteria:

* Unable to speak Spanish or English
* Active smoking (within the past year)
* Autoimmune, rheumatologic or inflammatory disease which are not psoriasis or psoriatic arthritis
* Known active cancer receiving treatment
* Pregnancy
* Anemia (hemoglobin \< 9 mg/dl) or thrombocytopenia (Platelet count \<75), or thrombocytosis (Platelet count \>600)
* A history of severe bleeding or bleeding disorders
* Current medication use which interact with either aspirin or atorvastatin
* Chronic kidney disease (CrCl \< 30ml/min)
* Congestive heart failure
* Currently taking aspirin or a statin.
* NSAID use within the past 48 hours
Mitigating Racial Disparities in Shared Decision Making in the Intensive Care Unit

This is a non randomized pilot trial aimed to:

Test the feasibility of an intervention to support intensive care unit clinicians in conducting shared decision making conversations with families of patients with acute respiratory failure. The goal of this intervention is to mitigate racial disparities in shared decision making.

The care of critically ill patients with acute respiratory failure involves life-or-death decisions. Ideally, intensive care unit (ICU) clinicians should include patients or their families in shared decision making, which promotes goal-concordant care (i.e., care aligned with patients' preferences), reduces psychological distress for both families and clinicians, and shortens ICU length of stay. However, racial disparities have been documented in shared decision making and associated outcomes. In outpatient settings, clinicians treat Black patients differently from White patients, providing fewer treatment options, less prognostic information, and less emotional support, and making assumptions about rather than eliciting patient preferences. Disparities in shared decision making are likely to be amplified in the ICU because clinicians often do not have long-standing relationships with patients or families, and decisions are complex, emotional, and time-pressured. Yet, no interventions currently exist to address racial disparities in shared decision making about acute respiratory failure. This research will directly fill this gap.

Eligibility Criteria:
Physician inclusion criterion:

- ICU attending physician with at least 6 weeks of clinical service time in the 12 months preceding and following enrollment

Physician exclusion criterion:

- Board certified in palliative care medicine

Patient inclusion criteria:

* Admitted to the ICU
* Being treated by a study physician currently and at least for the next 48 hours
* ≥ 18 years of age upon admission to hospital
* Mechanically ventilated ≥ 4 days

Patient exclusion criterion:

* Tracheostomy tube present or decision to pursue tracheostomy within next 7 days
* Has decision making capacity as assessed by medical team
* Extubation planned or death anticipated in next 24 hours
* Patients who are prisoners or are pregnant
* Awaiting organ transplantation during this hospitalization
* Acute respiratory failure due to progression of chronic neuromuscular disease
* No family decision maker available

Family member inclusion criteria:

* Identified by medical team as person most involved in medical decision making for the patient
* Confirmed to be patient's legally authorized representative
* Self-identifies as non-Hispanic, Black or White
* ≥ 18 years of age at time of consent
* Confirms conversational fluency in English
Validation of the Hospital Frailty Score in France

Older people are increasing users of health care globally. Constraints in bed capacity and resources raise important challenges with regards to management of older people with complex needs, which usually require assertive and holistic assessment. It is important, therefore, to identify aged patients most likely to benefit from such frailty-attuned approaches of care. A previous study using national Hospital Episodes Statistics conducted in the United Kingdom (UK) showed that patients aged over 75 years with characteristics of frailty and at risk of adverse health-care outcomes can be identified using routinely collected data (Gilbert T et al., Lancet 2018). This study lead to the development of the Hospital Frailty Risk Score (HFRS), which is based on International Statistical Classification of Diseases and Related Health Problems 10 (ICD-10) diagnosis codes and has the potential to be used in other countries worldwide, using the ICD-10 coding framework, to identify patients at risk of frailty at the hospital and commissioners levels, as well as for database research purposes. This score has successfully been validated in Canada, Australia and Switzerland. The aim of the present study is to evaluate the ability of the HFRS to predict 30-day in-patient mortality of patients aged 75 years and older admitted to French hospitals as an emergency.


Eligibility Criteria:
Inclusion Criteria:

* age 75 years or over (on the day of the index admission)
* hospitalized as an emergency (i.e. after visit to ED)

Exclusion Criteria:

* none