cyrilzakka/clinical-trials huggingface dataset:
Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Mask Airway

Control the airways by endotracheal intubation is an important part of treatment for a trauma casualty. The use of the Laryngeal Mask Airway for fast control of the airway is known for many years. The aim of this study is to examine the effectiveness of the Intubating Laryngeal Mask Airway to achieve a definitive airway by unskilled practitioners.

The hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will be more success and faster compared to the standard way of direct laryngoscope.

Control the airways and respiration are an important part of treatment for a trauma casualty. Tracheal intubation an action that allows the insertion of a tube through the vocal cords and fixation by the balloon inflation is a definitive airway. The use of the Laryngeal Mask Airway for fast control of the airway is known for many years. The Laryngeal Mask Airway and others similar devices are known as Supraglottic Airway Devices and are inserted blind in the oropharynx and allow a fast oxygenation and ventilation of the patients.The aim of this study is to examine the effectiveness of the Laryngeal Mask Airway to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model)

The hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will be more success and faster compared to the standard way of direct laryngoscope. If the hypothesis is proven, this research will be very important implications for the management of the airway describing pre-hospital and in particular military scenarios.

Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesiology class I and II

Exclusion Criteria:

* Difficult airway
* Cervical pathology
* Full stomach
Unwinding Physician Anxiety

The purpose of this study is to test an app-based mindfulness training program to see if it can reduce anxiety and burnout in physicians.

In this study, 50 clinicians will be provided access to the Unwinding Anxiety program. The intervention period will last 3 months and changes in anxiety and burnout along with program engagement will be assessed at baseline, 1 month, and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Currently employed as a physician
* Direct patient interaction
* Owns a smartphone
* Endorsed anxiety based on answering yes to following questions:

  1. Do you feel nervous, anxious, or on edge?
  2. Do you feel you worry too much about different things?
* Endorsed willingness to use smartphone app for 10+ minutes/day for 30 days
* Endorsed willingness to complete online surveys

Exclusion Criteria:

* None
Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies (LIQPLAT)

The goal of this study is to assess the implementation and feasibility of ctDNA measurements from blood samples obtained during routine clinical care of cancer patients in the University Hospital Basel.

Researchers will compare clinical and patient reported outcomes from the LIQPLAT study with patients who did not receive ctDNA measurements (external comparator from registry AO_2023-00091).

Blood samples will be drawn from the patients as part of routine care and ctDNA measurements will be performed on these samples.

Liquid biopsies, in particular the analysis of circulating tumor DNA (ctDNA), have emerged as a promising tool for detecting and monitoring cancer. Measuring ctDNA in patients with solid malignancies may help to identify targetable alterations, measure disease burden, identify early mutations of resistance, tailor and deescalate cancer treatment, and predict patient prognosis. Although the adoption and application of ctDNA measurements for patients with solid tumors in routine clinical care is increasing, evidence supporting the integration of ctDNA into current practice is limited, especially for patients with advanced cancers.

This is a trial using routinely collected health care data from an ongoing registry (AO_2023-00091) in cancer patients with advanced solid malignancies receiving first line systemic anticancer treatment for advanced disease.

This trial will assess the feasibility and implementation of routine measurement of ctDNA and its association with clinical outcomes, including quality of life and survival. All patients will receive routine diagnostics, treatment and follow-up. All patients with a new cancer diagnosis will be assessed for eligibility based on the routinely collected information available in the registry. We will then randomly decide which eligible patients are invited to participate in the trial. If patients accept the invitation and intend to get a measurement of ctDNA, they have to provide written informed consent.

Results from ctDNA analyses will be discussed at the molecular tumor board, an established regular interdisciplinary meeting at the University Hospital Basel (part of routine care) to discuss patients with complex findings from tumor sequencing analyses. Treatment changes occurring during the trial duration will be at the discretion of treating physician and according to patient's preference as is routine standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a proven solid malignant disease, i.e. with solid malignant tumors where no primary surgical resection is planned OR solid malignant tumors that are locally advanced and inoperable OR solid tumors that are metastatic
* No prior treatment for advanced/metastatic disease
* Indication for medical anti-cancer treatment (including combined chemoradiotherapy) as judged by the treating physician
* Patient age 18 years and older
* General research consent of the University Hospital Basel

Exclusion Criteria:

● Patients with primary brain tumors
Back2School - CBT Intervention for School Absenteeism

The main objective of this study is to examine the efficacy of a new psychological intervention, called Back2School, in helping youths with problematic school absenteeism to return to school. Furthermore, the study will examine how well this program fares against the treatment or interventions that are usually given to youths with school absenteeism (treatment as usual or TAU).

Based on previous studies we hypothesize that the Back2School intervention will be better at improving levels of school attendance as compared with treatment as usual (TAU).

Primary objective The main objective of this study is to examine the efficacy on school attendance and wellbeing of a modular trans-diagnostic CBT intervention for youths with problematic school absenteeism in a randomized controlled trial. Based on previous studies we hypothesize that the B2S intervention will show a significant difference in impact for school attendance, in favor of Back2School intervention as compared with TAU

Trial design The study is a randomized controlled superiority trial (RCT) that compares a modular trans-diagnostic CBT intervention (Back2School), treating school absenteeism in youths aged 7-17 years with treatment as usual (TAU). The design will follow a two (Back2School and TAU) by four (Time: pre, post, 3-month, and 1-year assessment) mixed between-within design.

The study is a collaboration project between Aarhus University and Aarhus Municipality, Denmark. The setting for both the B2S and TAU interventions are within Aarhus municipality. The Back2School intervention is organized and conducted by the University Clinic, at Aarhus University. Treatment as usual interventions are organized and conducted by Aarhus Municipality.

There are considerable negative long-term consequences related to youths with school absenteeism. If the B2S intervention proves to be effective in reducing school absenteeism, it could be implemented in other municipalities in Denmark, and help to systematically treat and help youths with school absenteeism. This could possibly reduce both personal and societal costs significantly

Eligibility Criteria:
Inclusion Criteria:

* Youths are enrolled in a public school within the municipality of Aarhus.
* Aged 7-18 years and in 0-9th grade (excluding second semester of the 9th grade).
* Report more than 10% absenteeism during the last 3 months of school (excluding legal absence, e.g. permitted extra holidays).
* The youth and at least one of the two parents understand and speak Danish sufficiently to participate in treatment and complete questionnaires.
* At least one of the parents is motivated for working on increasing the youths' school attendance.
* The participating families are willing to participate in assessment, intervention procedures, and acceptance of random assignment to intervention.
* Written informed consent from the holders of the parental rights and responsibilities (usually both parents).
ZR-CHOP in DLBCL With Specific Gene Abnormality

This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality.

This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality, including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation. all patients received 6 cycle therapy.

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old;
2. histological confirmed, newly-diagnosed diffuse large B-cell lymphoma with one of the following gene abnormality including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation;
3. Eastern Cooperative Oncology Group (ECOG) status of 0-1; 4) hospitalized patients and received the whole cycle treatment in Fudan University Shanghai Cancer Center-
4. normal hematological, hepatic and renal function.
5. Life expectancy of more than 3 months;
6. Patients had at least one measurable target lesion;
7. LVEF ≥ 50%
8. signed informed consent forms

Exclusion Criteria:

1. hypersensitivity to immunoglobulin;
2. primary central nerves lymphoma
3. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
4. With contraindication of steroid including uncontrolled diabetes;
5. Serious uncontrolled diseases and intercurrent infection;
6. Pregnant or lactating women;
7. hepatitis B infection with HBV-DNA ≥ 104
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Subjects will be randomized in a 1:1 ratio to the following dose groups:

* Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye
* Fovista® sham + Lucentis® 0.5 mg/eye

Subjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis® with the primary endpoint at 12 months.

Primary Efficacy Endpoint:

The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit.

Safety Endpoints:

Safety endpoints include adverse events, vital signs, ophthalmic variables \[ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)\], ECG, and laboratory variables.

Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender aged ≥ 50 years
* Active subfoveal choroidal neovascularization (CNV) secondary to AMD
* Presence of sub-retinal hyper-reflective material (SD-OCT)

Exclusion Criteria:

* Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals
* Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)
* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
* Subjects with subfoveal scar or subfoveal atrophy are excluded
* Diabetes mellitus
Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence

In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the device's 8-17 g/dL specification range.

The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must understand and consent to be in the study.
* American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

* Subjects who have any systemic disease at all.
* Subjects who do not understand the study and the risks.
* Smokers.
* Subjects who are pregnant.
* Subjects having either signs or history or peripheral ischemia. Others deemed ineligible by the clinical staff.
Impact of Primary Care COPD Screening Strategies on the Smoking Cessation Process (DISCO-SET)

The general practitioner is confronted with unselected smokers whose attempts to quit smoking are often repeated over time before leading to a definitive cessation.

Each year, 3-5% of smokers succeed in quitting in the general population. The corollary is that the majority of smokers are in a situation of failure in their attempt to quit: 33% declared during the 2019 French Health Barometer to have made an attempt of at least 7 days in the past year. Thus, this status of "smoker" can cover a wide variety of situations: no attempt to stop smoking, attempt(s) of more or less clinical significance, previous support or not by a health professional, etc. Currently, the HAS recommendations do not determine a specific course of action for these smokers, whose experiences may be very different. It could therefore be interesting to objectivize the smoking cessation process of these patients who have or have not succeeded in quitting, in order to deduce profiles of smokers according to their previous smoking cessation experiences. Furthermore, the choice and relevance of the cessation criteria used are debated.

Following the randomized controlled trial DISCO on COPD screening interventions in primary care (3 intervention arms, 1 control arm), the investigators will carry out a pilot cross-sectional survey on the cessation process of smokers during the 2 years following their participation, evaluating the incidence and modalities of cessation attempts of smokers belonging to an age group at risk of COPD (40-80 years) and who initially consulted their general practitioner for any reason 2 years ago at the time of their inclusion.

The impact on future management could be the personalization of cessation advice given to smokers according to quantitative and qualitative indicators specific to their experience, their previous history of smoking cessation, their health situation and socio-demographic characteristics. Eventually, a gradation of the levels of support offered to patients in general practice on the basis of predictive factors of smoking cessation could be studied.

The investigators hypothesize that participation in COPD screening with the GP may be associated with patient progress in quitting smoking. This pilot study will be conducted on a random sample of 120 participants from the subgroup of 544 patients who were smokers at inclusion in DISCO.


Eligibility Criteria:
Inclusion Criteria:

* Active smoker patient at inclusion in the DISCO study,
* No objection to participate in the study,
* Patient still followed in the active file of general practitioners' offices (GP).
* Patient's telephone and postal details available

Exclusion Criteria:

* Patient not physically or mentally able to complete the phone survey,
* Patient deceased,
* Patient not reachable despite 5 phone calls and message left on answering machine.
* Patient under curatorship, guardianship or safeguard of justice
Low Intensity Aerobic Exercise and Active Exercises in Cancer Patients Receiving Palliative Care

To compare the effect of low intensity aerobic exercise and active ROM exercises on cancer related fatigue and its associated symptoms and quality of life in cancer patients receiving palliative care.


Eligibility Criteria:
Inclusion Criteria:

* ability to give written consent.
* Diagnosed advance cancer specifically gastrointestinal tract (GIT) cancer, Lung cancer and Breast cancer etc. (stage 2 and 3).
* Intensity of fatigue ≥4 out of 10 on fatigue Numerical Rating Scale in first visit observation
* Survival expectancy more than one month,
* Functional status allowing the participants to participate in the proposed therapy.

Exclusion Criteria:

* Anemia (Hb ≤ 8g/dl),
* Existence of other comorbidities causing fatigue (i.e. Parkinson's, Multiple sclerosis, Heart failure),
* Infection requiring antibodies
* bone metastases,
* thrombocytopenia (\<50×109/l),
* myocardial infarction within the past three months
* uncontrolled hypertension (diastolic pressure \>95 mm Hg).
Physical Status of OSA Patients

To investigate the differences in postural stability, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* Getting a diagnosis of OSAS with polysomnography.
* Agree to participate in the study.

Exclusion Criteria:

* Having respiratory system disease (COPD, asthma, bronchiectasis, lung cancer, etc.).
* Sedative, hypnotic drug intake. Use of medical supplements such as diazepam.
* Hypothyroidism, acromegaly.
* Diagnosis of a psychiatric illness.
* Uncontrolled arrhythmia causing symptoms or hemodynamic impairment.
* Pulmonary edema. Pregnancy.
TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.

This study is an open-label study to treat patients with refractory metastatic colorectal cancer and non-small cell lung cancer with liver metastasis. Patients enrolled in the mCRC cohort will be randomized to receive study treatment Trans-arterial Tirapazamine Embolization (TATE)+Pembrolizumab or FDA-approved standard of care, such as TAS-102 or regorafenib, and their Overall Survival (OS) will be compared in the two cohorts as the primary endpoint. Patients enrolled in the NSCLC cohort will all receive study treatment TATE+Pembrolizaumb and Overall Response Rate (ORR) will be the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Liver metastatic MSS-mCRC or NSCLC without EGFR or AKT mutations
* mCRC progressed on at least two lines of standard chemotherapy; or
* NSCLC progressed on chemotherapy and an immune checkpoint inhibitor
* Measurable disease
* ECOG 0-1
* At least 4 weeks from prior chemotherapy and free from chemo-related toxicity
* Adequate organ function

Exclusion Criteria:

* Prior organ transplantation
* Liver metastasis more than 50%
* Oxygen saturation less than 92% in room air
* Prior autoimmune disorder
* CNS metastasis
* Major GI bleeding in the last 2 months
TEC4Home Heart Failure: Using Home Health Monitoring to Support the Transition of Care

TEC4Home Heart Failure is a randomized controlled trial (RCT) that examines how home health monitoring (HHM) can support Heart Failure (HF) patients during the transition of care from hospital to home. The HHM solution includes a weight scale, blood pressure cuff, pulse oximeter and tablet computer, which patients use daily for 60 days to record these metrics and answer questions on their symptoms. This data is sent to a nurse who is able to monitor the patient's condition remotely. The hypothesis is that the TEC4Home HHM solution will be a cost-effective strategy to decrease 90-day Emergency Department (ED) revisits and hospital admission rates, and improve quality of life and self-management for patients living with Heart Failure.


Eligibility Criteria:
Inclusion Criteria:

* Be 19 years of age or older (age of majority in British Columbia)
* Have one or more typical symptoms of Heart Failure (i.e. dyspnoea at rest or minimal exertion (includes orthopnoea, reduced exercise tolerance)) AND
* Have one or more typical signs of Heart Failure (i.e. elevated jugular venous pressure, pulmonary crepitations, pleural effusions, peripheral oedema) AND
* Have one or more objective measures of heart failure:
* Radiological congestion.
* Elevated BNP ≥ 400 pg/mL or NT-proBNP ≥ 1000 pg/mL.
* Reduced left ventricular ejection fraction \<40% (or \<45%) in previous 12 months.
* Diastolic dysfunction including tissue Doppler E/e' ratio \> 15 in previous 12 months.
* Pulmonary capillary wedge pressure \>20 mmHg.
* Diuretic therapy. The additional value of diuretic therapy (IV or oral) is debatable, as presumably unlikely (or unsafe) that patient with genuine HF will be discharged without diuretic.

Exclusion Criteria:

* Physical barriers e.g. unable to stand on scales.
* Cognitive impairment (e.g. MMSE \<20), unless suitable caregiver support.
* Language (must be able to read and understand English), unless suitable caregiver support.
* Documented history of current and active substance misuse (within 3 months).
* Lack digital connectivity or landline phone connection.
* No regular care provider e.g. GP, or at least regular walk-in clinic.
* Existing intensive system of care: LVAD, transplant, dialysis.
* Anticipated improvement due to revascularization (PCI/CABG) or valve intervention during index hospitalization.
* Anticipated survival \<90 days. Active palliative care, less-than level III care, disseminated malignancy.
Study of Biological Determinants of Bleeding Postpartum

At the entry of the delivery room, a standard blood analysis will be performed (Blood count, PT, aPTT, Fibrinogen, and D-Dimer) for each women (if they are agree), according to the center's practices.

The percentage of the immature platelets is a an additional parameter on the hemogram.

The clinical assessments (recorded in medical records) and biological values will be used to determine if there is a correlation between these data and the occurrence of postpartum hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Woman giving birth in a maternity of Finistère

Exclusion Criteria:

* Refuse to participate in the study
intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)

The purpose of this study is to Investigate the feasibility of a high-quality, high-dose, high-intensity upper extremity therapy program and to assess the treatment effects of a high-quality, high-dose, high-intensity upper extremity therapy program on functional outcomes, motor impairment, and quality of life


Eligibility Criteria:
Inclusion Criteria:

* Single qualifying stroke event as confirmed by CT or MRI
* At least 6 months post stroke
* Fugl-Meyer upper extremity (UE) score of 20-45
* Able to follow written instructions
* Able to tolerate 6 hours of therapy a day

Exclusion Criteria:

* Prior arm injury impacting available passive or active range of motion or significant arm pain with movement
* Active drug or alcohol abuse
* Diagnosed with advanced dementia
* Pre-stroke baseline mRS\>3
* History of clinically significant ischemic or hemorrhagic stroke resulting in prior arm weakness in the same territory as the index stroke
* Medical instability assessed by the treating stroke physician to participate to the study.