cyrilzakka/clinical-trials huggingface dataset:
Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 2

This study will test the hypothesis that constitutionally poorer Eustachian tube function predisposes to middle-ear pathology during a viral upper respiratory infection.

The most well supported immediate cause of Otitis media (OM) is a pre-existing or concurrent viral upper respiratory tract infection (vURI). However, not all vURI episodes cause OM and a variety of predisposing factors has been suggested to explain this selectivity. Based on our preliminary work using a model of experimental viral infections in adults, we hypothesize that the constitutional efficiency of the Eustachian tube (ET) to supply the middle ear (ME) with gas and thereby stabilize ME pressure at near ambient is a primary risk factor for OM during vURI. Here, we test the hypothesis that constitutionally poorer ET function (F) predisposes to ME pathology during a vURI. Specifically, we will use ETF testing protocols relevant to the pressure-chamber to evaluate constitutional ETF in ≈ 160 susceptible, adult volunteers who will be exposed to rhinovirus as part of our funded study entitled "Social and Psychological Risks for Infectious Disease" (PI: S. Cohen, PI: CHP subcontract: WJ Doyle) and document the ETF and ME responses to infection over a 5-day post-exposure, cloister period.

Also, using protocols relevant to the pressure-chamber, we will evaluate constitutional ETF in 80 children who will be enrolled into our funded study entitled "Role of Virus and Genetic Susceptibility in Otitis Media" (PI: CM Alper) and followed for vURI and OM from October through April. From both data sets, we will extract measures of ETF efficiency and determine using logistic regression with appropriate control variables (e.g. demographic data etc) if a single or combination of ETF variables predicts an abnormal ME response in rhinovirus infected adults or OM during a rhinovirus cold in children.

Eligibility Criteria:
Inclusion Criteria:

* Participating/participated in one of the two identified studies

Exclusion Criteria:

* No longer meet inclusion/exclusion criteria of parent studies
Decoding the Association of Imaging and Tumor Microenvironment in Lung Cancer Using Radiogenomic Approach（Radiogenomics-Lung）

This is the prospective, observational cohort study (Radiogenomics-Lung), which aims to explore the relationship between the imaging information of lung cancer patients, tumor microenvironment and the prognosis of lung cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients were treated for lung cancer in Wuhan Union Hospital from July 2024 to July 2027;
2. Aged \> 18 years old;
3. At least one chest CT scan before treatment;
4. Tissue biopsy pathological examination confirmed the diagnosis of the above tumors.

Exclusion Criteria:

1. Poor image quality;
2. Incomplete clinical data or loss of follow-up;
3. Presence of another primary malignancy other than lung cancer;
4. Unclear pathological diagnosis。
Skin Imaging With Technologies in Development

The purpose of this research is to develop non-invasive imaging modalities for assessment of skin. This is a pilot study which will use multiple imaging modalities to collect information on normal and lesional skin. The researchers understand that the purpose of this study is not to evaluate any particular treatment and an investigation of a new therapeutic intervention would require an additional protocol. Skin conditions to be studied include vascular lesions, pigmentary disorders, inflammatory conditions and neoplasms.

Normal and lesional skin will be assessed by the following imaging modalities:

1. Laser Speckle Imaging can provide information about relative blood flow in a tissue. In skin it can be used to determine what areas have more blood flow and whether a particular intervention or treatment affects blood flow.
2. Optical Coherence Tomography and Optical Doppler Tomography can provide pictures of blood vessels in an area of the body and can also tell how fast blood is flowing in that area.
3. Photon Migration Spectroscopy can provide information about the amount of blood, oxygen, fat and water is in a tissue.
4. Multi-Spectral Imaging can provide a 3 dimensional image of structures within the skin.
5. Multiphoton Microscopy can provide images of structures of the skin.

Eligibility Criteria:
Inclusion Criteria:

* adult male or female 7 and older; able to carry out study instructions

Exclusion Criteria:

* Younger than 7 years old
* pregnant woman
* breast feeding
Phase 3 Study Randomized Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors

Auriculotherapy is a complementary medicine, with few side effects, without contraindication, inexpensive and not very restrictive.Its efficacy has been found in several tests especially for the treatment of intraoperative pain. It remains more controversial in other indications. Evaluation of the value of auriculotherapy is often difficult because of the methodological limitations of the trials conducted. In the daily practice, the auriculotherapy is proposed to improve the articular pains of patients treated by AA. This Phase III study aims at validate this approach.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patients with anti-aromatases in adjuvant treatment of breast cancer
* Menopausal women
* Treatment with aromatase inhibitors (anti-aromatase, AA) initiated for more than 3 months. In the case of a change in anti-aromatase, the last treatment must be started for more than 3 months.
* Musculoskeletal pain appearing or increased under AA:
* Overall pain score of QCD ≥3 (on a scale of 0 to 10)
* Pain on at least 2 sites
* Pain for at least 3 months
* History of radiotherapy and / or adjuvant chemotherapy authorized
* Patients may have received tamoxifen
* Patient affiliated to a social security system
* Patient mastering the French language and able to complete the evaluation questionnaires
* Free and Informed Consent

Exclusion Criteria:

* Patients who have already undergone treatment in auriculotherapy for the same indication
* Patient benefiting at the same time from a PNCAVT (acupuncture or homeopathy) for musculoskeletal pain
* Wearing hearing aids hindering the placement of semi-permanent needles (ASP)
* Wearing of a valve prosthesis
* Patient under guardianship or unable to give informed consent
* Patient unable to undergo medical follow-up for geographical, social or psychopathological reasons
Validity and Reliability of the Modified Delirium Diagnostic Tool - Provisional (DDT-Pro) (Thai Version) in Peri-operative Fragility Hip Fracture Patient

Nowadays, the number of hip fracture patients is increasing. As Thailand enters into an aging society, hip fractures are becoming more common. They are typically treated with surgery. Complications, such as urinary tract infections, pressure sores, and acute confusion, are often observed. These various complications contribute to an increased rate of illness and death.

Delirium is a common problem among hip fracture patients. Currently, diagnosis is typically made using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), which is a standard tool. However, utilizing it effectively requires expertise. Additionally, other tools such as the Confusion Assessment Method (CAM) and the Memorial Delirium Assessment Scale (MDAS) are available. Nonetheless, training is necessary for their proper use, and they may be more suitable for specific patient groups.

The Delirium Diagnostic Tool-Provisional (DDT-Pro) is another tool created to aid in diagnosing delirium. Unlike other tools, it does not require specialized training. It can assess the main symptoms of delirium, including cognitive ability, higher-level thinking skills, and the sleep-wake cycle. This tool has been utilized in foreign countries such as Spain. The tool was found to have good accuracy and reliability and is useful in aiding the diagnosis of delirium. However, it has never been translated and tested for use in elderly Thai patients with fragility hip fractures.

Inclusion criteria

* Patients older than 65 years
* Had a hip fracture within 7 days before receiving treatment at Siriraj Hospital
* Received surgical treatment for a hip fracture

Exclusion criteria

* Unable to communicate in Thai
* Was diagnosed with cancer before or during treatment for a hip fracture
* Have a history of schizophrenia
* Patients infected with COVID-19

Primary outcomes include:

Validity: Conducting concurrent validity to examine the relationship between the Thai version of DDT-Pro and the Thai version of DSM-V using the 95% confidence interval (CI) for the AUC statistic.

Reliability: Determining the internal consistency of the tool through Cronbach's Alpha with a 95% confidence level, and assessing inter-rater reliability using the 95% CI for Kappa statistic.

Secondary outcomes include:

Prevalence of delirium in patients undergoing surgery for fragility hip fractures

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 65 years
* Hip fracture within a period of 7 days
* Receiving treatment at Siriraj Hospital and who have undergone surgical treatment for the hip fracture.

Exclusion Criteria:

* Unable to communicate in Thai
* Was diagnosed with cancer before or during treatment for a hip fracture
* Have a history of schizophrenia
* Patients infected with COVID-19
The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux

The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules oral suspension, once daily (QD), in infants with gastroesophageal reflux symptoms during a 4-week treatment period.

This study will be conducted by approximately 20 investigative sites in the U.S. and Poland. Participants who qualify will be randomized in equal proportions to receive either lansoprazole Pediatric Suspension (0.2-0.3 mg/kg/day in infants \<10 weeks of age or 1.0-1.5 mg/kg/day in infants \>10 weeks of age) or Placebo. This study consists of three periods: Pretreatment Period of 7-14 days, Double-Blind Treatment Period of 4 weeks (Dosing), and the Post-Treatment Period of 30 days (Follow-Up).

Eligibility Criteria:
Inclusion Criteria:

* At least 7 days post-surgery at the time of Screening (Study Visit 1) with no anticipated need for surgery during the study.
* Experiencing symptoms of gastroesophageal reflux disease (regurgitation, vomiting or "spitting up," fussing/irritability, feeding refusal, crying during feeding, arching back, poor weight gain, or extraesophageal manifestations) or endoscopy proven reflux disease.
* Must continue to have reflux symptoms during the Pretreatment Period despite reducing or eliminating exposure to tobacco smoke, using one positioning and feeding strategy the last 7 days as documented in the Daily Diary.
* The infant exhibited crying, fussing, or irritability during or within 1 hour of feeding in \>25% of all feedings during the last 4 days of the Pretreatment Period as documented in the Daily Diary.

Exclusion Criteria:

* Body weight \<2.0 kilogram at Dosing Day 1 of the Double-Blind Treatment Period.
* Unstable, congenital or acquired, clinically significant disease of any major organ system (cardiovascular, respiratory, renal, hepatic, metabolic, etc.), including suspected and/or documented culture-proven sepsis.
* Coexisting esophageal disease (e.g., eosinophilic esophagitis, viral, bacterial or fungal infection) or caustic or physiochemical trauma to the esophagus.
* Any congenital anomaly of the upper gastric intestinal tract that might interfere with gastrointestinal motility, pH, absorption, or active or known history of necrotizing enterocolitis that has been surgically corrected.
* Use of a proton pump inhibitor within 30 days prior to Dosing Day 1.
* Use of H2 Blockers (i.e. Zantac) within 7 days prior to Dosing Day 1.
* Allergy to proton pump inhibitors (i.e. Prilosec, Prevacid).
* Use of prokinetics (e.g., metoclopramide) unless on a stable dose for at least 3 days prior to entering the Pretreatment Period.
* Unable to obtain stable drug levels after continuous treatment with required drugs including theophylline derivatives, digoxin, phenytoin, phenobarbital, or carbamazepine within the 7 days prior to Dosing Day 1.
* Clinically Significant abnormalities in clinical laboratory values.
Trial to Assess the Efficacy of Malaria Vaccine PfCS 102

Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum. The main outcome will be the length of time between artificial challenge and development of blood stage parasitaemia detected by microscopy performed twice a day.


Eligibility Criteria:
Inclusion Criteria:

* resident in or near Lausanne;
* age \>18 and \<45 years;
* written informed consent;
* \>10/12 correct responses to the questionnaire of understanding.

Exclusion Criteria:

* history of malaria; possible exposure to malaria within the previous 6 months;
* positive serology for PfCS102by ELISA;
* history of severe reactions or allergy to mosquito bites, artemether/lumefantrine (Riamet®) or vaccines;
* pregnant or lactating female;
* any confirmed or suspected immunodeficient condition;
* seropostivity for HIV;
* chronic or active neurological, gastrointestinal, cardio-vascular or respiratory disease;
* hemoglobinopathies;
* history of \>2 hospitalisations for invasive bacterial infections;
* requirement of any chronic medication;
* suspected or known current alcohol or illegal drug abuse (excluding cannabis);
* any other significant finding which, in the opinion of the investigator, would significantly increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study;
* a body mass index \< 18kg/m2 or \> 32 kg/m2;
* evidence of past or present psychiatric condition;
* seropositivity for HIV, hepatitis C or B (other than HBs Ab);
* 10-year risk of coronary heart disease \<10%;
* any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis.
EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge

To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin bridge.


Eligibility Criteria:
Inclusion Criteria:

* Taking anticoagulants
* Written informed consent

Exclusion Criteria:

* Platelets count less than 50000/μl
* PT-INR more than 2.6
* ASA more than 3
* Severe bleeding tendency
Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.

Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.

Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks).

Approximately 1200 participants will be enrolled at approximately 250 centers globally.

All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
* Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
* Either out-patients or residents of an assisted-living facility or a skilled nursing home
* Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
* Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
* Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
* Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline

Exclusion Criteria:

* Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
* Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
* Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline
Different Techniques for Emergency Cricothyroidotomy

This educational study will examine two different techniques for training emergency residents and staff on achieving a surgical airway (called a cricothyroidotomy).

Introduction: In patients that cannot be intubated or ventilated by conventional means an emergency cricothyroidotomy is a potentially life saving intervention that is the common final pathway of difficult airway algorithms. Significant debate surrounds the ideal method of performing an emergency cricothyroidotomy. The literature remains divided between the open (surgical) and closed (wire assisted, or Seldinger) techniques. We feel that these two methods are not mutually exclusive and are proposing a novel "incision first" modification to the traditional Seldinger closed technique. Making a small (1 cm) incision prior needle insertion could facilitate localization of landmarks and may improve speed or success rate of the closed Seldinger procedure.

Introduction: In patients that cannot be intubated or ventilated by conventional means an emergency cricothyroidotomy is a potentially life saving intervention that is the common final pathway of difficult airway algorithms. Significant debate surrounds the ideal method of performing an emergency cricothyroidotomy. The literature remains divided between the open (surgical) and closed (wire assisted, or Seldinger) techniques. We feel that these two methods are not mutually exclusive and are proposing a novel "incision first" modification to the traditional Seldinger closed technique. Making a small (1 cm) incision prior needle insertion could facilitate localization of landmarks and may improve speed or success rate of the closed Seldinger procedure.

Methods: Using concealed allocation, this randomized controlled cross-over trial will be performed in a laboratory setting. Outcome assessment will be blinded. Both staff and resident emergency physicians will be included in this trial. We will use a well-validated swine trachea model for this study.

Results: Results will be collected using standardized Case Report Forms (CRF) and independently entered into a pre-constructed Microsoft ACCESS database. The primary outcome will be time to procedure completion. Secondary outcomes will be proportion of successful cricothyroidotomy, complications and ease of procedure and ability to increase clinical confidence using this model. Paired t-tests and Fisher's exact test will be used to compare the outcomes and due to multiple statistical tests, a correction will be used to adjust for multiple tests (p \< 0.025) to indicate significance.

Conclusions: This study will assess and evaluate both the incision first model and closed Seldinger cricothyroidotomy techniques. We will discuss the merits of each technique and the effectiveness of the model.

Eligibility Criteria:
Inclusion Criteria:

All staff and residents presenting to a airway lab for Informed verbal consent.

Exclusion Criteria:

Non-physicians
Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates

The primary aim of the work is to compare the efficacy of Sugammadex and neostigmine in reversing rocuronium-induced muscle relaxation to reach complete recovery of neuromuscular block (TOF ratio≥ 0.9) in preterm neonates.

The secondary aim is to evaluate the safety of using Sugammadex in preterm neonates and to detect any complications that may occur in this age group.


Eligibility Criteria:
Inclusion Criteria:

* preterm neonates
* scheduled for elective inguinal hernia repair

Exclusion Criteria:

* drug hypersensitivity
* patient is with any diseases affecting the neuromuscular junction
* Patients with family history of malignant hyperthermia
Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure \[msDBP\] ≥ 95 mmHg and \< 110 mmHg and mean sitting systolic blood pressure \[msSBP\] ≥ 140 mmHg ). This study was conducted to support registration of the fixed-dose combination of aliskiren and amlodipine for the treatment of hypertension in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Patients with essential hypertension (msDBP ≥ 95 mmHg and \< 110 mmHg and msSBP ≥140 mmHg )
* Outpatients

Exclusion Criteria:

* Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
* History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers
* History or evidence of a secondary hypertension

Other protocol-defined inclusion/exclusion criteria applied