cyrilzakka/clinical-trials huggingface dataset:
The DAnish VIdeo IntubaTION (DA-VITION) Study

This study aims to train an AI for video-directed endotracheal intubation (VITION) to recognise the anatomical structures of the upper airway during video-directed endotracheal intubations.

Study design

The VITION study protocol describes the design of a prospective, observational study. Inclusion will commence in 2023 at the anesthesia and intensive care departments in the Capital Region of Denmark.

Participants

Patients across all ages are eligible for inclusion if they are undergoing video-directed oral or nasal endotracheal intubation.

Exclusion criteria

Patients are excluded if they adhere to one of the exclusion criteria:

* Upper airway malformations (e.g., laryngomalacia, vocal cord paralysis, and subglottic stenosis17,18).
* Failed attempt by video laryngoscopy due to malfunctioning equipment.
* Missing or corrupted video recording.
* Informed consent is not obtained from the participants or participants' parents / legal guardians.

Interventions and comparisons

This prospective, observational study will have no interventions or comparisons.

Primary objective

The primary objective is to characterize anatomical landmarks and performances of intubations in a large and diverse pool of clinicians and patients.

Eligibility Criteria:
Patients are eligible if they adhere to all the following inclusion criteria:

● Undergoing video-directed oral or nasal endotracheal intubation.

Exclusion criteria

Patients are excluded if they adhere to one of the exclusion criteria:

* Upper airway malformations (e.g., laryngomalacia, vocal cord paralysis, and subglottic stenosis).
* Failed attempt by video laryngoscopy due to malfunctioning equipment.
* Missing or corrupted video recording.
* Informed consent is not obtained from the participants or participants' parents / legal guardians.
The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use

This research is a stage 1b developmental trial evaluating an intervention called "The Men's Domestic Abuse Check-Up" with adult men abusing their intimate partners and also struggling with alcohol or drug use.

One hundred and forty adult men concerned about their substance use and behaviors toward intimate partners, recruited in Washington State, will be enrolled in the trial. Participants are recruited through print and radio ads. Following a baseline assessment, participants are then randomly assigned to receive one of two interventions:

* The experimental intervention is a two-session motivational enhancement treatment. A personalized feedback report, containing information from the participant's assessment as well as normative comparison data, is reviewed, with the counselor employing motivational interviewing strategies intended to impact study outcomes.
* The comparison condition involves an educational brochure focusing on the legal, health and behavioral effects of intimate partner violence, substance abuse, and HIV risky behaviors.

Following the two interventions, participants are reassessed at 1 week, 1 month, and 4 months following either intervention.

Eligibility Criteria:
Inclusion Criteria:

* age (18 years and older)
* gender (male)
* self-reported abusive behaviors
* concerned about alcohol or drug use

Exclusion Criteria:

* not fluent in English
* they have a thought disorder that precludes full participation
* they refuse to accept randomization to condition
A Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Asthmatic Patients Allergic to House-dust Mites

A phase III study to assess the efficacy and safety of sublingual immunotherapy with STALORAL dust mites solution compared with placebo for reduction of asthma symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients aged 16 to 50 years (inclusive).
2. House dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year.
3. Sensitised to D. pteronyssinus and D.farinae (positive skin prick test (SPT) with wheal diameter ≥ 4 mm and specific IgE level ≥ 0.70 kU/L
4. Patients treated with inhaled corticosteroids (ICS) before the screening visit at a dose ≥ 200 µg and \< 1,000 µg equivalent budesonide/day.

Exclusion Criteria:

1. Mild intermittent asthma needed to be treated only with β2-agonist (GINA level 1).
2. Severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide.
3. FEV1 \< 70% of predicted value at Visit 1.
4. Co-sensitisation to other inhalant allergens than dust mites leading to clinically relevant allergic asthma and proven by a positive skin prick test with wheal diameter ≥ 4 mm and serum specific IgE ≥ 0.70 KU/L .
5. Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of the study. These diseases include, but are not limited to, past or current cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
A Retrospective Study: Evaluation of the Efficacy of Immunotherapy With Rare Mutations in Non-small Cell Lung Cancer

In advanced non-small cell lung cancer, there will be some rare mutations, such as ALK, KRAS, etc. The efficacy of these immunotherapies on these different rare mutations has not been reported. Therefore, we conducted this retrospective clinical study to explore the efficacy of immunotherapy for different rare mutations.


Eligibility Criteria:
Inclusion Criteria:

* 1.Diagnosed as advanced non-small cell lung cancer
* 2.Confirmed as KARS, ALK, ERBB2, MET, RET, BRAF mutation

Exclusion Criteria:

* The patient is diagnosed with small cell lung cancer
Precision Medicine for Combined Hepatocellular-Cholangiocarcinoma

Our project is a large-scale characterisation of cHCC-CCA will allow us to determine which subsets harbor actionable gene alterations. We will also aim to improve diagnosis of this tumor type by the use of immunohistochemical biomarkers and the development of deep-learning based models able to help cHCC-CCA diagnosis. This will represent an important step towards precision medicine for the patients with this highly aggressive malignancy.

* Scientific background Combined hepatocellular-cholangiocarcinoma (cHCC-CCA) is a rare liver cancer characterized by a dual hepatocytic and biliary differentiation. It is resistant to conventional anti-cancer treatments and there is currently no effective systemic therapy available. Inter-observer agreement for diagnosis of cHCC-CCA is low, even among expert pathologists, and the development of clinical trials remain thus challenging. The molecular mechanisms that drive its progression also remain under-investigated.
* Project objectives and brief description of the methods which will be used to achieve them We aim to perform an integrative molecular, immune and phenotypical study of cHCC-CCA that will allow the distinction of different tumor subgroups linked to particular actionable genetic/immune alterations. The development of immunohistochemical markers and artificial intelligence-based approaches is also likely to improve the diagnosis of cHCC-CCA.

A overall multicentric series of 357 cHCC-CCA samples, already available in our biobanks, will be investigated by means of gene and RNA sequencing, digital pathology and immunohistochemistry in order to build a morphomolecular classification of this tumor. Spatial transcriptomics and in situ proteomics will be performed to decipher the intra-tumor heterogeneity and identify biomarkers of the different subclasses. Finally, deep-learning based models will be developed in order to 1) improve the diagnosis of cHCC-CCA and 2) identify the morphological features linked to prognosis.

• Expected results This large-scale characterisation of cHCC-CCA will allow us to determine which subsets harbor actionable gene alterations. We will also aim to improve diagnosis of this tumor type by the use of immunohistochemical biomarkers and the development of deep-learning based models able to help cHCC-CCA diagnosis. This will represent an important step towards precision medicine for the patients with this highly aggressive malignancy.

Eligibility Criteria:
Inclusion Criteria:

histological diagnosis of combined tumor biological sample available

Exclusion Criteria:

unequivocal histological features
Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery

A prospective double-blinded randomized controlled study to determine efficacy of ephedrine in preserving core temperature in patients under neuraxial spinal anesthesia for knee and ankle arthroscopic surgery.

To determine the effect of ephedrine on preserving core temperature (tympanic) when given at finishing of local anesthetic administration for spinal neuraxial anesthesia comparing to normal saline (120 minutes period)

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing knee or ankle arthroscopic surgery under spinal block at department of orthopaedic Ramathibodi Hospital
* BMI 17-30 kg/m2
* ASA physical status 1-3
* Age 18-70
* Last oral intake more than 6 hours (2 hours for water)
* Consent form acquired

Exclusion Criteria:

* Patient who are contraindicated for spinal block
* Anesthesia level higher than T4 or lower than T10
* Tympanic temperature more than 37.5 or less than 35.5 degrees Celsius
* Otitis or other ear infection
* Patients who receive alpha adrenergic blocker or beta adrenergic blocker
* Initial blood pressure presenting in operating theater 140 90 mmHg repeat after rest 5 minutes
* Patient refusal
Tolerance of PICC Line Versus Implanted Port for Adjuvant Chemotherapy in Early Breast Cancer

Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in case of high risk of recurrence (large tumors, node involvement, high grade...). Due to its toxicity toward veins, chemotherapy must be administered through a central venous device. Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port is subcutaneous and lets patients lead a normal life, but its implant and explant require a cutaneous incision with possible complications (bleeding, pain, infection). For both venous devices, complications such as thrombosis or infection may happen. Published data comparing the two devices are heterogeneous and do not often distinguish patients treated for different diseases at various stages. Empirically in daily practice, for long term use (\>6 months) a port is usually preferred, whereas for short-term treatments (\<6 weeks) a PICC line is used. In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5 months. There is no scientific evidence for preferring one device to the other for these patients.

The aim of this study is to prospectively compare the patients' satisfaction and tolerance of each of the two devices.

The intravenous device will be randomly attributed. The adjuvant chemotherapy regimen will be selected according the standards of the center ( 6 cycles of FEC100 or 3 cycles of FEC100 then 3 cycles of Taxotere (docetaxel). The patient will be followed as per center's standards and visits (prior, during and after every drug administration, then monthly for six months). All Adverse Events will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Women age \> 18
* Documented breast cancer
* No Her2 overexpression
* Patients operated with curative intent (no distant metastasis at diagnosis)
* Patients undergoing an adjuvant chemotherapy consisting of 3 courses of FEC 100 (5-fluorouracil, epirubicin 100mg/m² and cyclophosphamide ) followed by 3 courses of Taxotere, or 6FEC100 (according to CHB refencial for localised breast cancer treatment).
* Signed informed consent

Exclusion Criteria:

* Bilateral axillary node dissection
* History of bilateral upper thoracic irradiation
* Cutaneous disease (eczema, scleroderma, infection...) at catheter insertion site (arm or upper thorax)
* Recent thrombosis of the upper body
* Therapeutic anticoagulation
* Tracheotomy
* Treatment for bacteriemia in process
* Altered hemostasis: INR \> 1.5 ; APTT \> 1.5 , platelets \< 60 G/l
* Renal failure with creatinine clearance \< 60mL/min
* Involvement in another trial
* Contraindication to chemotherapy by FEC 100 or taxotere
* Pregnancy or breast feeding
* Protected major patient (under guardianship).
* Psychosocial disorders : decompensated mental disorders, no social security coverage, patient who does not speak french
NEWS and Rapid Lactate Testing for Early Identification of High Risk Patients in the Emergency Department

To validate the NEWS and rapid lactate testing for early identification of high risk \[triage Category 3 (urgent)\] patients in the Emergency Department.

To compare qSOFA and SIRS criteria in patients in the Emergency Department.

Background:

Sepsis is a potentially life-threatening complication of an infection. Early identification and early intervention are two main elements in improving patient care.

Objectives:

1. To validate the NEWS and rapid lactate testing for early identification of high risk \[triage Category 3 (urgent)\] patients in the Emergency Department.
2. To compare qSOFA and SIRS criteria in patients in the Emergency Department.

Study design:

This is a prospective, cohort study. Patients aged 18 or above presenting to the ED triaged as Category 3 (urgent) will be recruited. The required data for calculating NEWS will be collected at triage and triage lactate level will be measured by point-of-care analyzer.

Outcomes:

The primary outcome is referral for intensive care unit (ICU) admission during the patient's ED stay. The secondary outcomes are length of stay in hospital (LOS), hospital admission, admission to ICU, length of ICU-free admission (defined as days alive outside the ICU from admission to day 30) 30-day mortality and time to processes-of-care.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above who are triage category 3 in emergency department
* Presenting to emergency department between 9am and 4pm, Monday to Friday

Exclusion Criteria:

* Aged below 18 years
* Pregnant
Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement

Lateral epicondylalgia affects people of both gender between 1 and 3% of the world population, with up to 15% in the working population reaching an average of 12 weeks off work for this reason. One of the conservative treatments that have shown effective is the mobilization with movement, whose mechanisms of action are not known. According Bialosky et al., possible effects of manual therapy are based on the neurophysiological mechanisms at peripheral, spinal and supraspinal level. Among the mechanisms to supraspinal level is the placebo effect, which is influenced by psychological factors such as conditioning and expectations.

Changing expectations to determine the influence on the treatment has been studied in healthy subjects, showing improvement with positive expectations and worsening to negative and neutral expectations.

However the result of modifying the previous expectations for treatment in patients with pain has not been studied.

The aim of our study is to test the influence that positive expectations have on the effectiveness of treatment with mobilization with movement in patients with lateral epicondylalgia.


Eligibility Criteria:
Inclusion Criteria:

* Lateral Epicondylalgia Diagnosis

Exclusion Criteria:

* Previous Treatment with Manual Therapy
* Previous Treatment with injection 6 months before
* Radiculopathy
* Bilateral Symptoms
* Fracture
Trial of Smoking Cessation Programs in Black Churches

To provide a comprehensive description of smoking beliefs and behavior among rural Blacks, and to test the effectiveness of smoking cessation strategies delivered through Black churches.

DESIGN NARRATIVE:

Two demographically similar rural counties in central Virginia were compared, one intervention and one control site. In each country, two cohorts were assembled, a random sample of all Black smokers (the community cohort), and all members of randomly sampled Black churches (the church cohort). The descriptive component of the study elicited the knowledge, beliefs, attitudes, and behavior concerning smoking from these cohorts. Cardiovascular risk factors, including blood pressure and cholesterol levels, were also determined in the community cohort. For the experimental component, a variety of interventions which have proven to be efficacious in other settings were implemented through Black churches. These included fostering a supportive environment, distributing self-help materials, and providing individual support and counselling through the use of peer facilitators. The results of the baseline psychosocial survey were used to modify these methods for local use. They were then implemented in a culturally appropriate fashion at the intervention sites. Baseline smoking rates were determined using the initial surveys in both counties. Smokers were surveyed again at the end of the interventions and one year later to establish one-year abstinence rates. These were used as the primary outcome variables for the analysis of effect. The principal effect of the interventions were measured by comparing smoking abstinence rates between the church cohorts in the intervention and control counties. Due to the extended nature of the social networks associated with the churches, the interventions may also have had an effect on individuals not directly exposed, and this was determined by comparing the outcomes in the community cohorts. Finally, the associations between the baseline psychosocial and physiologic variables, exposure to the interventions, and smoking cessation behavior were also analyzed, to characterize on a population basis those who were and were not influenced by these church-based programs.

Eligibility Criteria:
No eligibility criteria
Non-pharmacological Intervention for Colonoscopy

The purpose of this study is to determine whether a non-pharmacological intervention reduces consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce side effects. This non-pharmacological intervention may increase patient's comfort and security.

Sedative and analgesic drugs are used in most patients related to pain and anxiety during the colonoscopy. Analgesia and sedation has adverse effects such as central respiratory depression, obstruction of the upper airways, hypoxia, hypotension and bradycardia. Non-pharmacological interventions had beneficial effects during percutaneous vascular or renal procedures. In this study we test the hypothesis that the adjunction of hypnosis to pharmacological sedation will decrease the quantity of sedative drugs used and will reduce the patient's anxiety and discomfort.

Eligibility Criteria:
Inclusion Criteria:

* patients classified as ASA 1 to 3
* colonoscopy with anesthesiological support
* capacity of consenting

Exclusion Criteria:

* pregnancy
* colonoscopy with gastroscopy
* emergency
* psychotic diseases
* deafness
* incapacity to understand french
* addiction of drugs and alcohol
* psychoactive drugs
Can Simple Perioperative Measures Improve Quality of Recovery Following Ambulatory Laparoscopic Surgery in Females?

The aim of this study was to assess whether it was possible to improve patients' self-assessed quality of recovery and reduce the level of post-operative nausea and vomiting in female patient undergoing laparoscopic cholecystectomy by simple perioperative measures in the form of a preoperative 200 ml nutritional drink and chewing gum during early recovery.

Patients were randomised to an active group receiving the intervention, and controls provided with standard care only. Patients were followed by questionnaire interviews preoperatively and at 2, 24 and 48 hours after surgery.

Abstract One major goal in modern perioperative anaesthesia care is to facilitate a rapid, yet safe recovery process, with focus on improving time to regained consciousness and subsequent resuming of activities of daily living. Laparoscopic cholecystectomy and gynaecological laparoscopy are a "high volume" procedure commonly performed in young females expecting rapid resumption of health.

The aim of this study was to assess whether it was possible to improve patients' self-assessed quality of recovery and reduce the level of post-operative nausea and vomiting in female patient undergoing laparoscopic cholecystectomy by simple perioperative measures in the form of a preoperative 200 ml nutritional drink and chewing gum during early recovery.

Methods Patients were randomised to an active group receiving the intervention, and controls provided with standard care only. Patients were followed by questionnaire interviews preoperatively and at 2, 24 and 48 hours after surgery. The Quality of Recovery scale (QoR) 15 items and 5 additional questions around gastro-intestinal symptoms were self-assessed by patients at each occasion.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2

Exclusion Criteria:

* ASA 3-4, obese
Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients

The purpose of this study is to evaluate the safety and tolerability of single ascending IV dose administrations of GIGA-2050 in patients hospitalized with COVID-19.

This is a Phase 1, first in human (FIH) study utilizing a 3+3 design to assess the safety and pharmacology of single ascending doses (SAD) of GIGA-2050 in patients hospitalized with confirmed COVID-19. Participants will receive a single intravenous (IV) infusion dose of GIGA-2050 and followed for safety, pharmacology and efficacy assessments during hospitalization, after discharge (if applicable), and through study discontinuation or end of study visit (Day 56).

Eligibility Criteria:
Inclusion Criteria:

* Participant is ≥ 18 years of age.
* Positive result of a SARS CoV-2 RNA diagnostic test result ≤48 hours before enrollment, warranting hospital admission as per Investigator's judgement.
* COVID-19 pneumonia findings on imaging (chest X-ray or CT Scan).
* Requires oxygen supplementation with FIO2 approximately 30% or greater administered by nasal cannula, mask, or NIV.
* Participants can be on other medication on-label to treat COVID-19 respiratory disease that the Investigator deems clinically relevant in combination with the study drug, including corticosteroids. Passage of 24 hours after administration of the EUA drug will be required prior to dosing GIGA-2050.
* Men or non-lactating female participants who are surgically sterile or post-menopausal, or a Woman of Childbearing Potential (WCBP) with a negative pregnancy test at screening willing to use highly effective contraception methods.

Exclusion Criteria:

* Acute respiratory failure requiring invasive mechanical ventilation or ECMO at enrollment.
* Systolic Blood Pressure (SBP) \<110 mmHg or heart rate \>120 bpm.
* Pre-existing heart failure or unstable angina or myocardial infarction in the last month prior to screening.
* Pre-existing chronic respiratory condition(s).
* Evidence of acute kidney injury, increase of serum creatinine of ≥1.5 x baseline, or urine output of \<0.5mL/kg/hr sustained for at least 6 hours once volume repleted.
* Aspartate aminotransferase (AST) ≥2.5 x ULN, alanine aminotransferase (ALT) ≥2.5 x ULN, and/or total bilirubin \>1.5 x ULN, or severe hepatic impairment.
* Known systemic hypersensitivity to recombinant antibody therapies.
* Female participant who is pregnant.
* Participant is expected to transfer to a non-investigative facility from the investigation site and cannot be monitored for compliance with protocol-required safety monitoring procedures.
* Participants who are currently participating or have participated in another clinical trial within 30 days prior to screening.