cyrilzakka/clinical-trials huggingface dataset:
Olfactory and Trigeminal Functions in Patients With Multiple Sclerosis: Case-control Study

The sensation of smell is influenced by the somatosensory and chemesthetic sensati¬ons of the nose: for example, the cooling sensation of menthol or the prickle of carbon dioxide from carbonated drinks. These sensations are mediated in the nose by the trigeminal nerve and there is increasing evidence that trigeminal and olfactory functions are closely linked and potentially interdependent. In addition, trigeminal activation is crucial to the perception of nasal airflow. Some researchers speculate about the impact of trigeminal nerve on the entire olfactory sensation and about the presence of some specific "trigeminal cells" into the nose.Patients with Multiple sclerosis (MS) can suffer from quantitative olfactory disorders that generally are of light entity and do not interfere with daily life activities but it is important to underline that olfactory loss can be an onset sign of the MS. Considering the "trigeminal component" in the olfaction, because trigeminal nerve inflammation is quite common in MS patients due to central and peripheral inflammation, it could be possible that these patients suffer from changes in the quantitative, but more in the qualitative smell functions that are generally not identified because poorly investigated.

From a theoretically point of view pain in the trigeminal nerve increases the surrounding perception, including the perception of the odors. It has been shown that by using sweet food it is possible to reduce the level of pain; on the other side, sweet food in contrast to the bitter one was able to reduce the sensation of odor unpleasantness present with pain increase.

To date no studies have investigated the relationship between trigeminal inflammation, odors and pain in a cohort of patients with MS. This study aims at investigating the possible correlation between alteration in trigeminal functions and perception of odors using Sniffin' Stick Threshold, Detection and Identification test and quality smell questionnaire in a sample of healthy patients compared to MS patients.

Eligibility Criteria:
Inclusion Criteria:

Adult women (age 18 to 55) diagnosed with multiple sclerosis using the 2017 McDonald Criteria under treatment with Disease Modifying Therapy (DMTs) with or without trigeminal concerns, or newly diagnosed with MS

Exclusion Criteria:

* Chronic rhinosinusitis with and without nasal polyposis; current allergic rhinitis; other nasal issues that lead to olfactory dysfunction
* anamnestic COVID with incomplete recovery
* Neurodegenerative disorders (Parkinson, Alzheimer, Fronto-temporal Dementia, cognitive impairment and brain vascular diseases)
* History of stroke in the last three years
* Depression or any psychiatric condition
* intake of drugs with sedating side effects
* major health issues that might affect olfactory function (e.g., significant renal insufficiency, uncontrolled diabetes)
* Chronic alcoholism / drug abuse
* Severe head trauma
* Severe facial injuries
* Smoker over 20 cigarettes day or smoking from more than 15 years
Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer

This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old (including 18 and 75 years old);
* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
* Pathologically determined gastric or gastroesophageal junction adenocarcinoma;
* Advanced patients with radiographic confirmation of inoperable complete resection;
* No previous anti-tumor treatment for metastatic diseases;
* At least one measurable lesion according to RECIST version 1.1;
* Ability to take medications orally;
* No active bleeding;
* Adequate organ functions:

Absolute neutrophil count ≥2×109/L; Platelet ≥100×109/L; Hemoglobin ≥90g/L; WBC≥4×109/L Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN ； Serum creatinine (Cr) ≤1.5XULN；

• Have fully understood the study and voluntarily signed the informed consent;

Exclusion Criteria:

* Patients who had received any drug in the study protocol in the last year;
* Deficient mismatch repair (dMMR) or MSI-H detected by genetic test;
* HER2 positive（HER-2 3+, or HER-2 2+ and FISH+）;
* Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
* Patients with acute coronary syndromes (including myocardial infarction and unstable angina) received coronary angioplasty or stenting within 6 months before enrollment;
* Patients with massive pleural or peritoneal effusion requiring drainage;
* Patients with severe ECG abnormalities or heart diseases (such as cardiac insufficiency, myocardial infarction, angina pectoris) that affect clinical treatment;
* Severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
* Mental disorders or central nervous system diseases or brain metastases affecting clinical treatment;
* Patients with autoimmune diseases;
* Patients with grade 3 or higher bleeding within 4 weeks;
* Patients with a history of allergy to any drug, similar drug or vehicle in this study;
* Had a major surgical procedure (thoracotomy, or laparotomy , etc.) within 4 weeks prior to the first dose of study therapy;
* Patients with nonhealed wounds, ulcers, or fractures;
* Patients who required systemic corticosteroids (excluding temporary testing, prophylactic administration for anaphylaxis), or immunosuppressive agents or had received such agents within 14 days before enrollment;
* Pregnant or lactating women, or patients of childbearing age who refused contraception during the study period;
* Investigators believe that the patient has any other conditions that are not suitable for participating in the study.
Maternal Speech Decreases Pain Scores and Increases Oxytocin Levels in Preterm Infants During Painful Procedures

Preterm infants undergo early separation from parents and are exposed to frequent painful clinical procedures, with resultant short- and long-term effects on their neurodevelopment. We aimed to establish whether the mother's voice could provide an effective and safe analgesia for preterm infants and whether endogenous oxytocin (OXT) could be linked to pain modulation. Twenty preterm infants were exposed to three conditions-mother's live voice (speaking or singing) and standard care-in random order during a painful procedure. OXT levels (pg/mL) in saliva and plasma cortisol levels were quantified, and the Premature Infant Pain Profile (PIPP) was blindly coded by trained psychologists.

Preterm birth rates are continuously increasing in almost all countries, with 15 million premature infants being born every year worldwide1. Despite rapid advances in technology, the number of preterm-born children who show short- and long-term sequelae of prematurity, even before reaching school age, remains high. Around 40% of low birth weight preterm infants experience a complex spectrum of unfavourable neurodevelopmental outcomes when compared with their pairs at term. Thus, prematurity is of great concern for health policies in both low- and high-income countries. The impaired development of preterm infants is not only associated with medical factors, but it is also at least partly a consequence of the atypical early-life environment of these infants, including exposure to pain and separation from the primary caregivers.

The aim of the present work was first, to assess whether early closeness with parents during essential but painful clinical procedures could have a positive role in pain modulation in preterm infants, thus contributing to the universal right to pain relief. Second, we aimed to investigate the possible role of the oxytocinergic system in this putative pain modulation through maternal vocal contact.

In the present protocol, we introduce the effects of separation and early pain exposure as two environmental factors that are even more deleterious when concomitant, inducing short- and long-term problems in the preterm infant's development. We then suggest that there are protective effects of early closeness between parents and preterm infants in early care and, more specifically, of early vocal contact between parents and preterm infants during hospitalisation. Lastly, we discuss the role of oxytocin (OXT) as a crucial biomarker for attachment processes and in relation to brain inflammation due to stressful procedures for preterm infants in the neonatal intensive care unit (NICU).

Eligibility Criteria:
Inclusion Criteria:

* age \>29 weeks gestational age at birth,
* weight \>1000 g
* stable medical condition (absence of mechanical ventilation, no additional oxygen)

Exclusion Criteria:

For infants

* no specific pathological conditions
* no genetic abnormalities

For mothers

* history of substance abuse
* mental health problems
ECHO-012 Kosmos Bladder Clinical Validation Study

The goal of this clinical trial is to compare the Kosmos Automatic Bladder Volume to the manual annotated bladder volume in participants across gender (male and female), age (children ages 7-17 and adults 18-89), and BMI strata (low to normal and high BMI). The hypothesis it aims to evaluate is: The Pearson correlation coefficient between Kosmos estimated bladder volume and manually annotated bladder volume will yield more than 0.90.

Participants will:

* Have their full bladders scanned and bladder volume calculated using the Kosmos Ultrasound Diagnositic System by both a nurse and sonographer.
* Participants will void and measure their urine volume.
* Participants empty bladders will be scanned and bladder volume calculated using the Kosmos Ultrasound Diagnositic System again by both a nurse and sonographer.
* Three sonographers will manually annotate the pre- and post-void exam images for each patient to calculate the manually annotated bladder volume.


Eligibility Criteria:
Inclusion Criteria:

* Read and sign an English consent form, or assent form, in the case of a minor child
* Read and complete an English demographic and general health survey, or have an LAR complete it for them in the case of a minor child
* Give consent for participation, or assent in the case of a minor child
* Able and willing to comply with study requirements
* Follow fluid consumption requirements prior to the study visit
* Those aged 7 years through 89 years, healthy as well as individuals with pelvic region abnormalities (if applicable), including but not limited to:

  i) Bladder cancer ii) Thickened bladder wall iii) Bladder stones iv) Current bladder or urinary tract infection

Exclusion Criteria:

* Adults over 89 years old
* Children under the age of 7
* Persons who are pregnant
* Persons who report an empty bladder upon arrival at their scheduled study visit
* Children in foster care, as a foster parent may not legally consent for a foster child
* Those who cannot or refuse to sign their consent or assent (including those with an LAR willing to provide consent)
* Those who cannot provide informed consent or whose LAR cannot provide consent
* Those who cannot speak or read English
* Participants from ECHO-010 Bladder AI Training and Validation Data Collection Study
Safety and Efficacy Study of IPG Patient With Home Monitoring

The number of patients with implantable pulse generator (IPG) has steadily increased in Japan causing increment in number of in office follow-ups and greater burden on many hospitals.

The purpose of this multicenter randomized study is to demonstrate that BIOTRONIK Home Monitoring system reduces office follow-up visits without compromising patient safety.

Patients will be randomized into HM follow-up only (Group 1) or HM \& in-office follow-up (Group 2) and will be followed-up for 27 months.

Eligibility Criteria:
Inclusion Criteria:

* Indicated for IPG implantation under Japanese guidelines
* Implanted within the last 45 days or being considered for implant with a BIOTRONIK IPG with Home Monitoring
* Able to utilize HM system throughout the study
* Ability to give informed consent
* Geographically stable and able to return for follow-ups for 27 months
* Over 20 years old
* Patient able to understand and follow the procedure stated in protocol

Exclusion Criteria:

* Contraindicated for IPG under Japanese guidelines
* Patients who are currently included in another cardiac clinical study
* Patients with expected life period of less than two years
* Patients who might undergo heart transplantation in next two years.
Neurogenic Dysphonia/Dysphagia Registry

The Neurogenic Dysphonia/Dysphagia Registry is designed to be purely observational (i.e. non-interventional, exploratory). Patient data collected from the registry is expected to be consistent with any information which can be obtained during usual care of patients with dysphonia/dysphagia treated with vocal fold augmentation.

The Neurogenic Dysphonia/Dysphagia Registry is a 510K post-clearance multicenter, observational, open-label registry of the benefits and risks of management and outcomes of patients with neurogenic dysphonia/dysphagia who have received vocal fold augmentation (VFA).

Enrollment is open to all eligible patients meeting all of the inclusion and none of the exclusion criteria, with a target of 400 patients. Up to 100 sites in the US and abroad will be a part of the registry. Sites will provide retrospective data for active patients who have undergone VFA within the past 24 months at the site and also begin to prospectively enroll patients who are receiving VFA as a part of their usual care. Patients will be followed for up to five years prospectively, until lost to follow-up, or death.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females, ≥18 years of age
* Diagnosis of neurogenic dysphonia/dysphagia
* Under active treatment with VFA and follow-up care

Exclusion Criteria:

• Patients with:

* Vocal fold scar
* Laryngeal cancer defect
* Irradiation to the larynx
* Laryngeal trauma
* End-stage cancer
Diagnostic Value of Flexible Spectral Imaging Color Enhancement (FICE) Plus Probe-based Confocal Laser Endomicroscopy (pCLE) for Minimal Change Esophageal Reflux Disease (MERD) Diagnosis

Gastroesophageal reflux disease (GERD) patients without obvious mucosal break by endoscopy were examined by FICE, followed by confocal. Validity scores for MERD diagnosis were analyzed.

Thirty-six patients with suspected MERD (positive GerdQ but normal conventional endoscopy) and eighteen asymptomatic control were recruited. The new FICE (EPX-4450HD) was performed at non-magnified, x50, and x100 zoom levels. The criteria for positive FICE were; A) triangular indentation, B) punctuate erythema, C) villiform mucosa, or D) increased number of capillary vessel. At the same session, pCLE was applied to count the number of intrapapillary capillary loops (IPCLs) by using more than 5 IPCLs in 500x500 micron area as a criterion for MERD diagnosis. The validity scores of both modalities and interobserever agreement of pCLE interpretation was assessed.

Eligibility Criteria:
Inclusion Criteria:

1. age more than 18 year old
2. no PPI therapy in previous 2 weeks and
3. no esophageal tumor or stenosis or history of esophageal surgery.

Exclusion Criteria:

1. bleeding tendency including decompensated cirrhosis, chronic kidney disease
2. long term antiplatelets or anticoagulants,
3. pregnancy or
4. history of fluorescein allergy.
Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model

This study is designed to investigate the safety and causal prophylactic efficacy of KAF156 in healthy subjects using a controlled human malaria infection model.


Eligibility Criteria:
Inclusion Criteria:

- Healthy male subjects,aged 18 to 40 years of age included and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests

Exclusion Criteria:

* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
* Known history or current clinically significant ECG abnormalities or arrhythmias.
* Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, or other conditions which could interfere with the interpretation of the study results or compromise the health of the subjects.
* Sexually active males must use a condom during intercourse while taking drug and for al least 4 weeks after stopping study medication and should not father a child during this period.
* History of malaria or residence in a malaria-endemic area over a period of 6 months before study entry. - Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk or render the subject unable to meet requirements of the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.
Structured Home-based Exercise Versus Walking Advice in Claudication Patients: a Randomized-controlled Trial

A recent position paper calls for effective home-based exercise program for patients with peripheral artery disease (PAD) and claudication to be implemented in real-world care.

This randomized-controlled trial aims to test the effects on mobility, hemodynamics and cardiovascular outcomes of a structured home-based exercise program (SHB) compared to walking advice (WA) recommendation intended as usual care, in PAD patients.

Male and females PAD patients at Leriche-Fontaine's stage II and aged more than 60 years old will be enrolled. Patients will be randomized in SHB or WA groups.

Patients of SHB group will receive a prescription of a home-based walking program during serial testing sessions at the hospital. The program will include two 10-minute sessions/day (6 days/week) of intermittent walking (1-minute work and 1-minute rest while seated) at a prescribed speed converted into a walking cadence and followed at home using a metronome. Two follow-up visits (at weeks 8 and 16) will be performed to evaluate patient adherence and to update the exercise program by increasing the walking speed.

Patients randomized in WA group will receive the advice to walk as suggested by the guidelines. In particular, patients will be recommended to gather almost 30 minutes of walking at least 3 times per week; when they will face claudication pain, they will be allowed to rest and restart walking as soon as possible.

Outcome measures will be performed at the entry prior to randomization, at the end of exercise programs (6-month) and after 12-month follow up. Primary outcomes will be the pain-free walking distance and the 6-minute walking distance collected during the 6-minute walking test Secondary outcomes will include ankle-brachial index, quality of life, lower limb strength and long-term clinical outcomes including revascularization and mortality.


Eligibility Criteria:
Inclusion Criteria:

* male and females aged \> 60 years old
* peripheral artery disease at Leriche-Fontaine's stage 2a or 2b
* cognitive functioning to give informed consent identified by a Mini Mental Status Examination score ≥18/30.

Exclusion Criteria:

* peripheral artery disease at Leriche-Fontaine's stage 1
* peripheral artery disease at Leriche-Fontaine's stage 3 or more
* severe cardio-respiratory conditions (e.g. unstable angina; severe heart failure identified by New York Heart Association class III or IV)
* neurological or musculoskeletal conditions (e.g. above knee amputation) contraindicating or inhibiting exercise training.
* very good exercise capacity determined by a 6-minute walking distance \> 500 meters.
Safety Evaluation of Porous Silica in Men

The aim of the present study was to determine whether oral dosing, up to 9 grams/day, of porous silica administered as a food additive can be used safely in normal weight and obese male humans, without significant side effects on gastrointestinal function, bowel emptying habits, and biomarkers.

This single blinded safety study will consist of two study arms and include 10 males each (18-35 years). One arm will include participants with normal weight and one with obesity. After a placebo run-in period, all subjects will be given porous silica three times daily, with increasing dose up to 9 grams/day (Phase 1). Subjects with obesity continued the study with highest dose for additional 10 weeks (Phase 2).

The participants will have weekly contacts during with the representative for the study (PI or other research staff). Clinical examinations, and blood sampling will be performed day 1, 7, 14, and 21. Faeces and morning urinary sampling day 1, and 21. Information regarding eating habits, sleep patterns, living conditions and gastrointestinal health were obtained from written forms and orally. If gastrointestinal adverse events would occur after increased dosage, the study staff will adapt the dosage protocol to facilitate adherence.

Eligibility Criteria:
Inclusion Criteria:

Group - Normal weight subjects

* Age 18-35
* BMI 20-25

Group - Subject with obesity

* Age 18-35
* BMI 30-45

Exclusion Criteria:

* Chronic somatic diseases that may affect metabolic and/or intestinal function (e.g. diabetes, hypertension, dyslipidemia, Irritable Bowel Disease, gluten intolerance, pancreatic dysfunction, other causes of malabsorption, neoplastic disease,)
* Allergies with previous anaphylactic reactions
* Previous abdominal surgery
* Current or history of eating disorders
* Extreme or unusual diets such as Low Carb High Fat and vegetarian diets for the last year
* Psychiatric disorders (e.g. schizophrenia, and other diagnoses that may influence compliance)
* Drug or alcohol abuse
* Continuous oral pharmacological treatment and other types of pharmacological treatment that may influence the study
* Other conditions which the investigator considers could negatively affect the outcome of the study or study compliance