cyrilzakka/clinical-trials huggingface dataset:
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Sufentanil

This study will examine how sufentanil (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in the research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.

Pain management on the battlefield is critical for the wellbeing of the soldier. Given that a hemorrhagic injury on the battlefield is virtually always associated with pain, it is paramount that the selected pain medication does not disrupt appropriate physiological mechanisms that are beneficial towards the maintenance of blood pressure and vital organ blood flow during that hemorrhagic insult. Current guidelines for the selection of pain medications of a hemorrhaging soldier are based upon limited scientific evidence, with the vast majority of supporting studies being conducted on anesthetized animals. Thus, the interaction between hemorrhagic shock and pain medications commonly employed on the battlefield is yet to be determined in the conscious humans.

This study will test the hypothesis that sufentanil will impair the capacity for a conscious human to tolerate a hemorrhagic insult.

The obtained data will provide the necessary scientific evidence in humans to support the Committee on Tactical Combat Casualty Care (CoTCCC) guidelines on the analgesic of choice for moderate to severe injuries where the casualty is in hemorrhagic shock. Notably, such data will identify the analgesic that least compromises a human's ability to tolerate a hemorrhagic insult, ultimately providing critical information to the combat medic on which analgesic should be employed for such an injury.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age
* Healthy
* Non-obese (body mass index less than 30 kg/m2)
* Body mass greater than or equal to 65 kg
* Speak English

Exclusion Criteria:

* Subjects not in the defined age range
* Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
* Any known history of renal or hepatic insufficiency/disease
* Pregnancy or breast feeding
* Body mass less than 65 kg
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* Subjects who cannot speak or read English
* Positive urine drug screen
* Currently taking pain modifying medication(s)
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
2. Active UC confirmed by endoscopy

Exclusion criteria:

1. Severe extensive colitis
2. Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Clinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation

This study is to evaluated the interruption schedule of NOAC in patients who undergo atrial fibrillation ablation. The investigators will compare the bleeding complications were classified as major and minor bleeding, thromboembolic, vascular complications, Re-admission and increased in the length of hospital stay during the 30-day post-radiofrequency catheter ablation(RFCA) period among patients who interrupt NOAc 24hours before ablation and patients who stop NOAC in the morning of the procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who consent with study
2. Patients with Atrial fibrillation (20-80 years old)
3. patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation
4. Patients possible to NOAC

Exclusion Criteria:

1. Patients who do not agree with study inclusion
2. eGRF \< 30ml/min
3. Impossible to NOAC
4. Structural cardiac disease
5. Major hemorrhagic complication
6. CHA2DS2-VASc score \> 5
7. Patients who have experienced Ischemic cerebellar infarction more than 2times
Ongoing Registry of Treatment of Chronic Venous Diseases

Ongoing registration of patients with varicose veins disease treated by means of conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods

Data of patients treated in different Russian medical centers are entered in a prospective digital database, and continuously updated.

There is planned to conduct prospective randomized, cohort and observational studies on the site of register

Eligibility Criteria:
Inclusion Criteria:

* Varicose veins with any source of pathological reflux, C2 - C6 according to the CEAP classification

Exclusion Criteria:

* no exclusion criteria
Influence of Body Posture on Pulmonary Aerosol Deposition

To compare deposition in two different positions.


Eligibility Criteria:
Inclusion Criteria:

* Free of respiratory disease

Exclusion Criteria:

* Smokers
Diet and Exercise on Ambulatory Blood Pressure

This is a multicenter, randomized, single-blinded clinical trial investigating the effect of dietary management and active aerobic exercise training on reduction of 24-hour ambulatory blood pressure in subjects with prehypertension and drug-naïve stage 1 hypertension.

Most guidelines recommend lifestyle modifications such as exercise or dietary programs for stage 1 hypertension or prehypertension, before initiation of antihypertensive drug treatment. Epidemiological and observational studies have shown that cardiovascular risk increases progressively from blood pressure levels as low as 115/75 mmHg and that patients with prehypertension or stage 1 hypertension are likely to progress to hypertension requiring medications. From a previous clinical trial, a 12-week aerobic exercise program reduced 24-hour and daytime ambulatory blood pressure in patients with resistant hypertension. Aerobic exercise and DASH (Dietary Approaches to Stop Hypertension) diet are currently recommended in subjects with prehypertension and stage 1 hypertension without a clear randomized, controlled clinical trial. The present trial, thus, seeks to evaluate the effect of dietary management and active aerobic exercise training, preferably moderate-intensity exercise, on 24-hour ambulatory blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Prehypertension or grade 1 hypertension, defined as a systolic blood pressure of 130 to 159 mm Hg and/or a diastolic blood pressure of 85 to 99 mm Hg
* Patients without previous use of anti-hypertensive medication

Exclusion Criteria:

* Patients under anti-hypertensive medications
* Patients with suspected or confirmed secondary hypertension
* Patients with abnormal liver function tests (transaminases more than three times the upper limit of normal)
* Patients without aerobic exercise tolerance
* Patients under hormone replacement therapy or other steroids
* Patients with peripheral edemas and/or baseline serum creatinine level above 2.0 mg/dL
* Patients with medical conditions that potentially affect blood pressure, including neurological disorders, gastrointestinal diseases, or malignancy.
Evaluation of Oxygen Delivery Through Nasal Cannula in Volunteers

This study will evaluate patient comfort and oxygen delivery efficiency when providing supplemental oxygen through a nasal cannula to volunteers using an instrumented oxygen delivery system. The goals of the study are to evaluate different oxygen flow rates and oxygen delivery modes. In addition, the investigators will investigate if the system can detect apnea (cessation of breathing) and removal of the nasal cannula. The investigators will also investigate how well high flow oxygen delivered only during inspiration is tolerated and how much the end-tidal oxygen increases after two minutes of high oxygen flow delivered only during the inhalation phase of the breath.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers drawn from the general public and students, staff, and faculty of the University of Utah.

Exclusion Criteria:

* Volunteers who self report respiratory diseases such as acute respiratory distress syndrome, pneumonia and lung cancer will be excluded. In addition, volunteers who self report respiratory conditions such as nasal or bronchial congestion due to a cold or allergies will be excluded.
An Integrative Intervention for Loss of Control Eating Among Adolescent Girls

This study aims to develop a manualized and culturally sensitive intervention for adolescent girls targeting binge and loss of control (LOC) eating. The investigators will evaluate the feasibility and acceptability of the intervention in a controlled pilot trial. The investigators hypothesize that this intervention will serve to reduce binge and LOC eating, as well as improve psychosocial functioning as evidenced by decreased depression, anxiety, eating disorder cognitions, and impulsivity, and improved quality of life.


Eligibility Criteria:
Inclusion Criteria:

* currently meeting criteria for loss of control (LOC) eating or binge eating disorder (BED) as defined by Marcus and Kalarchian
* age 13-22
* female
* lives with parent/primary caregiver most of the time

Exclusion Criteria:

* alcohol or drug dependence in the last three months
* current suicidal intent or clinically significant self-harm behaviors reported during the assessment
* diagnosis of bulimia nervosa or anorexia nervosa in the last three months
* presence of a developmental disability or neurological impairment that would impair the individual's ability to participate in the intervention
* psychosis, including schizophrenia, or bipolar I disorder
* not fluent in English (participant and parents/primary caregivers
89Zr-Bevacizumab PET/CT Imaging in NF2 Patients

Bevacizumab can be an effective treatment for individuals with NF2 and improve different nerve functions (like hearing, tinnitus or balance problems) and the quality of life of NF2 patients. However, bevacizumab is not effective in all patients or all tumors, at the cost of moderate toxicity and considerable financial burden.

Therefore, this observational study will validate an imaging biomarker method to predict bevacizumab efficacy in order to avoid adverse effects and high costs in non-responders to bevacizumab treatment. Patients will undergo standard-of-care treatment with the sole addition of a pre-treatment 89Zr-Bevacizumab PET/CT-scan. Per standard-of-care bevacizumab therapy is administered every three weeks for six months. To monitor treatment effect, follow-up is performed at 3-month intervals.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Confirmed diagnosis of NF2 by revised Manchester criteria
* Provided written informed consent
* Patients must have measurable disease, defined as at least one VS \> 0.4 ml (on volumetric analysis) that can be accurately measured by contrast-enhanced T1-weighted cranial MRI scan.
* Eligible and planned for bevacizumab treatment

Exclusion Criteria:

* Patients with a contra-indication for PET and MRI, such as pregnancy and metal elements.
* Patients with a known allergy to substances used in this study
* Concurrent treatment with Everolimus
Gerontechnology Evaluation Framework: Outcome Validation

The project aims to validate the evaluation indicators applicability of 9 Gerontechnology Evaluation Frameworks. The outcome is the perceived importance of the evaluation indicators described in the 9 Evaluation Frameworks. Participants will be invited to complete a questionnaire indicating the importance of the outcomes.

This study is a cross-sectional survey. 165 to 300 participants will be recruited to complete a questionnaire. For each product theme that they are familiar with, they will rate anonymously the perceived importance of the evaluation indicators on a 5-point Likert scale, give reasons for their ratings and suggest revisions.

Participants will be recruited through convenience sampling in 3 subgroups, including (1) members of Gerontechnology Application and Testing Working Group under Gerontechnology Platform, (2) successful applicants of Innovation and Technology Fund for buying gerontechnology products under the 9 themes, and (3) visitors of Gerontech and Innovation Expo. It is expected that 35% participants will be recruited in subgroup 1, 5% in subgroup 2, and 60% in subgroup 3.

Gerontechnology Platform will invite (1) its members of Gerontechnology Application and Testing Working Group, who are the Users, Caregivers, Staff and Suppliers of gerontechnology products, to fill in the questionnaire online. 3 email reminders will be sent to remind them to complete the questionnaire. (2) The list of successful applicants of Innovation and Technology Fund who applied for the product themes covered in the 9 Evaluation Frameworks will be downloaded from the Social Welfare Department website and their Staff will be invited to fill in the questionnaire online. (3) In Gerontech and Innovation Expo, which is a local exhibition that provides a platform for stakeholders to discuss and collaborate for broader adoption of gerontechnology, research staff will approach all visitors of the Gerontechnology Platform booth. The visitors who fulfil the inclusion and exclusion criteria will be invited to complete the questionnaire.

To ensure the validity of their responses, they will only answer the questionnaire items of the themes they have known, have used, or are most interested. For each product theme that they are familiar with, they will rate anonymously the perceived importance of the evaluation indicators on a 5-point Likert scale, give reasons for their ratings and suggest revisions. Their voluntary written consent will be sought before they complete the questionnaire. Each questionnaire will take around 5 - 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* People in one of these categories: Working or has worked in a social service setting for the elderly or person with disability (Staff), an elderly aged 60 or above (User), a person with physical or disability (User), an informal caregiver for an elderly or a person with disability (Caregiver), or belonging to a company/or that has developed or retailed gerontechnology products (Supplier)

Exclusion Criteria:

* Unable to read or write in Chinese
A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma

This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.


Eligibility Criteria:
Inclusion Criteria\*:

* Good General Health (with or without allergic rhinitis and/or controlled asthma)
* Non-smoker for at least 2 years
* Normal lung function (DLCO)
* Able to provide informed consent and to understand and comply with the requirements of the study

Exclusion Criteria\*:

* Clinically significant medical history or condition which precludes participation
* Clinically significant ECG abnormality
* Clinically significant VS or PE abnormality
* Clinically significant screening lab abnormality
* Abnormal lung function (FEV1 \<80% predicted)
* Respiratory infection within 14 days of randomization
* HBV, HCV, or HIV
* Breastfeeding or pregnant female
* History of alcohol abuse or illicit drug use within past 24 months
* Use of any tobacco or nicotine-containing product within past 6 months
* Use of any herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol
* Use of any investigational drug within past 30 days
* Use of any investigational monoclonal antibody or recombinant protein within past 90 days
* Donation of plasma within past 7 days
* Donation or loss of whole blood within past 56 days

  * Simplified list of I/E criteria; unabridged list available upon request.
Study on the Carcinogenesis of Gα12 in Oral Cancer, and the Treatment of Oral Cancer Using Ga12 Inhibitor.

Study on the carcinogenesis of Gα12 in oral cancer, and chemopreventive possibility for the treatment of oral cancer using Ga12 inhibitor.

To find out if there is prognostic value which to the performance of Gα12 of oral cancer in Taiwan and provide some reference for future treatment.

We anticipate to enroll 40 persons with normal oral mucosa, 65 persons with oral dysplasia and 150 persons with oral cancer and collect the tissue which was stained for pathological sections over a 3 year period.

We also collect the blood and saliva samples from patients and the results along with patient-specific information such as tumor phases, tumor size, lymph node metastasis, cancer metastasis, prognosis and betel nut chewing, smoking and drinking habits and other parameters are statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Dysplasia or cancer of the oral cavity.

Exclusion Criteria:

* pregnant woman
A Safety Study of Sabin Inactivated Poliovirus Vaccine in Infants

The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell)(sIPV)in the primary immunization of infants at the age of 2 months and booster immunization of children at the age of 18 months, and the simultaneous immunization with other vaccines of children at the age of 2 months and older, so as to provide reference for the improvement of immunization strategy.

This study is an open and observational phase Ⅳ clinical trial of Sabin Inactivated Poliovirus Vaccine.The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell)(sIPV)in the primary immunization of infants at the age of 2 months and booster immunization of children at the age of 18 months, and the simultaneous immunization with other vaccines of children at the age of 2 months and older, so as to provide reference for the improvement of immunization strategy.A total of 3200 subjects including 2000 subjects aged 2\~3 months in primary immunization group,1200 subjects aged 18 months in primary immunization group will be enrolled and will receive sIPV vaccine or sIPV vaccine and other vaccines simultaneously.

Eligibility Criteria:
Inclusion Criteria:

* Infants aged 2-3 months should be involved in primary immunization and they have not received Sabin strain inactivated polio vaccine (Vero Cell) in the past;
* Children aged 18 months should be immunized with the first three doses of Sabin strain inactivated polio vaccine (Vero Cell) and they have not received any inactivated or attenuated live vaccines in the past 14 days;
* The guardian agrees to sign the informed consent and voluntarily use the mobile APP to participate in the follow-up visits.

Exclusion Criteria:

* Allergic to the active ingredient in the vaccine, any inactive ingredient, or substance used in the manufacturing process;
* Allergic to this product or similar vaccines in the past;
* Patients with severe chronic diseases or allergies;
* Patients with fever or acute illness.

The Exclusion Criteria for the Second and Third Doses:

* Any serious adverse events that are causally related to vaccination;
* Severe anaphylaxis or hypersensitivity after vaccination (including hives and rashes within 30 minutes of vaccination);
* Any confirmed or suspected autoimmune or immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
* Acute or newly emerging chronic diseases occur at the time of vaccination;
* Other reactions (including severe pain, severe swelling, severe limitation of movement, persistent high fever, severe headache, or other systemic or local reactions), as determined by the investigator;
* Having an acute illness at the time of vaccination (acute illness is defined as moderate or severe illness with or without fever);
* Axillary temperature \>37℃ during vaccination.
A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.


Eligibility Criteria:
Inclusion Criteria:

* The participant has a diagnosis of migraine as defined by ICHD-3 guidelines confirmed at the Screening Visit.
* The participant has a history of migraine onset ≥12 months prior to the Screening Visit.
* The participant has ≥2 migraine days and headache occurring on \<15 days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has a body mass index (BMI) ≥18.5 and ≤ 35 kilograms per meter squared (kg/m\^2) at the Screening Visit.

Exclusion Criteria:

* The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (PACAP) treatment.
* The participant has participated in a clinical trial \<30 days prior to the Screening Visit.
* The participant has taken any investigational medicinal product (IMP) \<3 months or \<5 half-lives of that product, whichever is longer, prior to Visit 1.
* The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
* The participant has known or suspected hypersensitivity or intolerance to the IMP, auxiliary medicinal product (AxMP), or their excipients.

Note: Other inclusion and exclusion criteria may apply.
Evaluation of the Animated Cartoon-aided Teaching of Intranasal Corticosteroid Allergic Rhinitis

Correct methods and compliance of intranasal corticosteroid (INCS) is very important for the treatment of allergic rhinitis (AR). The animated cartoon-aided teaching of INCS administration was created to decrease workload of health care professionals. The aim of this study is to compare the achievement of the children with AR in using INCS between the group which were instructed by animated cartoon-aided teaching or oral presentation without demonstration.

The study was a prospective randomized control trial in children aged 5 - 16 years with moderate to severe intermittent or persistent AR who had never used INCS. The patients were randomly divided into 2 groups; 1) Teaching how to use INCS by oral presentation and 2) by animated cartoon-aided teaching. Successful achievements were recorded when the patients were able to use INCS (all five-point checklists) correctly. If they were unable to use the INCS correctly after the first teaching, the same instruction would be repeated and the second assessment would be performed.

Eligibility Criteria:
Inclusion Criteria:

* Children with 5 - 16 year old
* children with allergic rhinitis

Exclusion Criteria:

* history of intranasal corticosteroid use
* history of other underlying disease