cyrilzakka/clinical-trials huggingface dataset:
Innovative OSA Screening in Head and Neck Cancer Patients with the Apneal App

Obstructive sleep apnea syndrome is a common but often underdiagnosed condition, with significant impacts on quality of life, such as fatigue, attention disorders, and an increased risk of heart attack or stroke. Structural changes in the head and neck region appear to contribute to the onset or worsening of this condition.

To improve patients' quality of life, early diagnosis is essential. Currently, diagnosis relies on expensive devices, often associated with long waiting times. To address these challenges, an innovative solution is proposed: a smartphone application enabling a simple and accessible diagnosis. This application is currently under validation and has not yet been commercialized.

The purpose of the study is to determine whether this smartphone application can be used in clinical practice for patients with a head and neck lesion to diagnose sleep apnea syndrome and to assess its progression during the medical care. This study is for patients who present a head and neck lesion currently under evaluation in our department at Caen University Hospital.

This research will be integrated into routine follow-up for a period of six months.

The medical device used in this study, Apneal, is a smartphone application currently undergoing validation for the rapid diagnosis of sleep apnea syndrome. Its use is simple: the smartphone is placed in airplane mode and secured to the chest overnight. Using the phone's built-in sensors, respiratory sleep data is collected and analyzed.

As part of the initial assessment, a dedicated sleep consultation is included, during which a few questionnaires are completed, followed by an overnight sleep recording using the Apneal application. This will be conducted at the beginning of the care during the assessment phase and again six months after the completion of any potential treatment.

Depending on the results, if they are inconclusive, an additional sleep recording may be required using a ventilatory polygraphy device.

This study involves only two overnight recordings with a smartphone secured to the chest, which we will set up during the consultation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing diagnostic workup for a lesion suspected to be a head and neck cancer, followed by confirmation of the malignant nature of the lesion. The following locations will be included: the nasopharynx, nasal cavities, sinuses, oral cavity, oropharynx, hypopharynx, larynx, and parotid gland.
* The collection of the informed consent signature is required.
* The patient must be affiliated with the social security system.

Exclusion Criteria:

* Minor patients, or those under judicial protection, guardianship, or curators.
* Lack of confirmation of the malignant nature of the lesion.
* Diagnosis of metastatic cancer.
* Known history of obstructive sleep apnea syndrome (OSAS) or previously treated head and neck cancer.
Treatment of West Nile Virus With MGAWN1

This study will test a drug called MGAWN1 for the treatment of West Nile infections.

The objective of this study is to evaluate the safety, efficacy, and pharmacokinetics of MGAWN1 in subjects with West Nile Fever or a syndrome compatible with West Nile Neuroinvasive Disease (WNND) \[encephalitis, meningitis, or acute flaccid paralysis\]. Subjects can be enrolled based on a syndrome compatible with WNND, and do not need documented West Nile virus infection.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent
2. Be \>=18 years of age at the time of enrollment
3. Have West Nile Fever defined as:

   1. temperature \>38°C, headache, AND
   2. positive diagnostic test for WNV Ribonucleic acid or Immunoglobulin M with serum or cerebrospinal fluid (CSF)

   OR have West Nile Neuroinvasive Disease (includes neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis), defined as:

   • West Nile encephalitis (must meet criteria a and b below)
   1. Encephalopathy (depressed or altered level of consciousness, lethargy, or personality change lasting 24 hours)
   2. CSF pleocytosis \>=5 cells/mm\^3

      AND/OR

      • West Nile meningitis (must meet criteria c and d)
   3. Clinical signs of meningeal inflammation, including nuchal rigidity, Kernig or Brudzinski sign, photophobia, or phonophobia
   4. CSF pleocytosis \>=5 cells/mm\^3

      AND/OR

      • Acute flaccid paralysis (must meet criteria e and f)
   5. Acute onset of limb weakness with marked progression over 48 hours
   6. Two or more of the following conditions:

      * asymmetry to weakness
      * areflexia or hyporeflexia of affected limb(s)
      * absence of pain, paresthesia, or numbness in affected limb(s)
      * CSF pleocytosis \>=5 cells/mm\^3
      * CSF elevated protein levels (4.5 g/L)
      * electrodiagnostic studies consistent with an anterior horn cell process
      * or abnormal increased signal in the anterior gray matter as documented by spinal cord magnetic resonance imaging
4. Have epidemiological factors consistent with West Nile Virus infection (must meet criterion a or b below):

   1. Appropriate time of year for West Nile Virus transmission in region
   2. Travel history to a region where West Nile Virus is active
5. Develop signs and/or symptoms within 14 days before study enrollment.
6. If female of childbearing potential or male and in a sexual relationship with a female of childbearing potential, agree (or have partner agree) to practice abstinence or use 2 of the following methods of contraception for 120 days (approximately 4 months) after study drug administration:

   1. Oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches
   2. An intrauterine device
   3. Barrier contraception (condom) with a spermicide (i.e., female subject ensures use by male partner\[s\])
   4. Any other equivalent method of contraception (as judged by the investigator)
COVID-19-Related Health and Practices Among Dental Hygienists

As dental practices reopen their practices during a global pandemic, the risk of 2019 novel coronavirus (COVID-19) infection that dental hygienists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. These findings could be used to describe the prevalence and incidence of COVID-19 among dental hygienists, determine what infection control steps dental hygienists take over time, describe dental hygienists' employment during the COVID-19 pandemic, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.


Eligibility Criteria:
Inclusion Criteria:

* Dental hygienist
* Licensed in the United States
* 18 years of age or older

Exclusion Criteria:

* Not employed as a dental hygienist as of March 1, 2020
Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be one treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 20 through 24 and a twice daily dose of lopinavir/ritonavir 400 mg/100 mg (two 200 mg/50 mg tablets per dose) on Days 9 through 24. Pitavastatin will be administered under fasting conditions in the morning and lopinavir/ritonavir will be administered under fasting conditions in the morning and evening.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female volunteer aged 18 to 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive.
* Subject has normal hematology, serum chemistry, and urinalysis test results
* Subject is able and willing to abstain from alcohol, grapefruit, caffeine, or caffeine containing products for 4 days before Day 1 until after completion of this study.
* Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug.

Exclusion Criteria:

* Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.
* Subject has had a previous allergy or intolerance to treatment with pitavastatin or lopinavir/ritonavir.
* Subject has a history of drug or alcohol abuse.
* Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.
RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope

We will conduct a randomized trial comparing the success rate and time to intubation using the RIFL vs. the fiberoptic bronchoscope, as the latter is commonly held to be the gold standard of difficult airway devices. Specifically, we wish to compare the of intubation between the two devices in patients with potentially difficult airways as defined by an oropharyngeal class 3-4, BMI greater than 35, or in patients with a history of difficult intubation using direct laryngoscopy.

Patients who require general anesthesia with endotracheal intubation will be identified the night prior to their surgery based upon the examination documented in their preoperative history and physical. If their body mass index achieves a calculated score of 35 or greater or they have an oropharyngeal class 4 airway then they will qualify to participate.

After written informed consent is obtained, The intubation method would be randomized as one of two groups: intubation via use of the fiberoptic bronchoscope or the RIFL. The intubation attempt will be terminated if the SpO2 \<90, HR\<50, there is traumatic injury, or time \> 100sec. If terminated, the patient will be mask ventilated and the attending anesthesiologist would determine the subsequent technique that will be used for airway management.

Eligibility Criteria:
Inclusion Criteria:

Patients with known or suspected difficult airways defined as:

* patients with an oropharyngeal score of 3 or 4
* patients whose body mass index calculates greater to or equal to 35

Exclusion Criteria:

* Patients who necessitate an awake fiberoptic intubation or a rapid sequence intubation.
Comparison of Two Needles (ProCore vs EchoTip) for the Diagnosis of Pancreatic Solid Mass Under EUS

The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS) for the diagnostic of solid pancreatic masses is 70% on average in the current literature with 22 gauge needles. There is a wide variability of this rate across studies (from 38 to 92%). In case of negativity of the biopsy, the risk of missing a pancreatic cancer whose prognosis is severe and extensive treatment, remains important. To improve the sensitivity of EUS echo endoscopy, several methods were used. A new needle (Echo Tip ® HD ProCore ™) has received CE Mark in the field of EUS. This instrument combines the comfortable and handy size of 22 Gauge and innovative design (window lateralized bevel) with in vitro studies obtaining core biopsy. In addition, a single pass through the tumor is achieved with this hand against several (2-3 minimum) with the current hardware. The theoretical goal is to have a tissue material more abundant during the sampling, without increasing morbidity and increase the diagnostic accuracy. A preliminary prospective study with this material has shown interesting results (increase the diagnostic accuracy of 15%).

To determine the diagnostic gain with this new hand, it seemed essential to propose a prospective comparative study (22 gauge needle ProCore ™ versus the old EchoTip ® 22-Gauge) randomized (randomization of the order of the needles) in crossover (on the same lesion) in samples of pancreatic solid tumors. The caliber of 22 gauge is the gauge most often used for punctures under ultrasound endoscopy, resulting in less morbidity. Puncture by the 2 needles on the same injury can limit the effect of variability between patients and thereby have a better power for the investigators study without increasing the risk of complications (the needle ProCore ™ does not require that one pass through the tumor). The study of pancreatic solid tumors is one that poses the biggest diagnostic problem still present in the investigators daily practice. The aim of this study is to compare the diagnostic accuracy of the needle ProCore™ versus EchoTip® in etiological cyto histological diagnostic for pancreatic solid tumors under EUS.


Eligibility Criteria:
Inclusion Criteria:

* Solid tumor of the pancreas (\<50% share or anechoic fluid) to receive a biopsy under endoscopic ultrasonography (EUS)

Exclusion Criteria:

* Contraindications to the achievement of an upper gastrointestinal endoscopy
* Haemorrhagic disease, disorder of hemostasis and coagulation (PT \<60%, CaT\> 40 sec. and platelets \<60000/mm3)
* Pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging)
* Pregnant or lactating
A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy

The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy via a newly developed limb cryocompression device in healthy subjects and cancer patients. The limb cryocompression device will be tested for its safety in delivering limb cryocompression and efficacy in improving the preservation of peripheral nerves during chemotherapy.

The study consists of two parts. The first part of the study will consist of up to 18 healthy subjects to assess safety and tolerability of the new limb cryocompression device. The occurrence or lack of core hypothermia will be studied. The second part of the study will consist of 15 cancer patients recruited from the National University Hospital. Patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy. Cryocompression of the limbs will be administered using cooling wraps attached to a cooling device. The limbs will be cooled from the digits to the elbow/knee.

Eligibility Criteria:
Inclusion Criteria:

1. For healthy subjects:

   * Age 21-80 years
   * Signed informed consent from patient or legal representative
   * No history of neuropathy
   * ECOG 0
   * No history of hospitalization in the past 6 months
2. For cancer patients:

   * Age 21- 80 years
   * Signed informed consent from patient or legal representative
   * Scheduled to receive weekly paclitaxel chemotherapy
   * Patients may receive other chemotherapy drugs alongside taxane e.g. Platinum/Herceptin.

Exclusion Criteria:

1. For healthy subjects:

   * Open skin wound or ulcers of the limbs
   * History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
   * Pregnant women
2. For cancer patients:

   * Open skin wound or ulcers of the limbs
   * History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
   * Pregnant women
Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels

The purpose of the study is to test the clinical efficacy of oral Vitamin D3 on Wound Healing in patients with Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels After Endonasal Endoscopic Sinus Surgery


Eligibility Criteria:
Inclusion Criteria:

* 1. Clinical diagnosis of Chronic Rhinosinusitis with nasal polyps 2. Be 18-60 years old of Chinese people and of either sex，the Han nationality 3. Vitamin D level of less than 30 ng/ml

Exclusion Criteria:

* 1. Women must not be pregnant, breast feeding 2. Chronic oral corticosteroid therapy 3. History of physician-diagnosed nephrolithiasis 4. Chronic diseases（ diabetes，Hypertension，renal insufficiency, severe liver disease） 5.prior surgeries of the paranasal sinuses 6. With an upper respiratory tract infection within 4 weeks of entering the study
Responses to Colloid Infusions

In situations such as dehydration, illness and surgery, fluid 'drips' are given to patients to keep them hydrated. Different fluids stay in the circulation for different lengths of time. For example, some types of fluid remain in the circulation for a short time which means patients would need to be given more fluid to achieve the desired effects. Giving a lot of fluid to sick patients can in itself cause problems, for example, it can affect the way the bowels work and delay the patient's recovery from illness. In these situations the investigators use specialized fluids called colloids, that are designed to stay in the circulation for longer. This means a smaller amount of fluid needs to be used and less problems are likely to occur. There are two different types of colloids that are commonly used, but the investigators do not know which of them is better. The purpose of this study is to investigate which of the two different colloids (one is called Gelofusin and the other is called Voluven) works better in patients who undergo surgery. Knowing which of the two fluids works best in patients will help us improve the care of surgical patients. The investigators hypothesis is that the fluid that has the larger size of molecules as part of the solution will work better during surgery.

To study the responses of patients to 1 litre infusions of Gelofusine (succinylated gelatine 40g/L) and Voluven (6% hydroxyethyl starch in 0.9% saline) over 1 h intraoperatively. In particular, the extent and time course of the effects of the two infusions on haematocrit, serum albumin, serum biochemistry, plasma expanding capacity and the resultant urinary responses will be measured

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-60 years undergoing elective laparoscopic cholecystectomy for proven gallstone disease.
* BMI of 20-26 kg/m2
* Able to give voluntary written informed consent to participate in the study
* Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures
* (Females of child bearing age will be offered a pregnancy test)

Exclusion Criteria:

* Patients with a known history of allergic reaction to the colloid infusions
* Patients with acute cholecystitis or the systemic inflammatory response syndrome
* Patients with a serum bilirubin \> 25 μmol/l
* Females who are pregnant or refuse to have a pregnancy test
* Patients with a haemoglobin \< 10 g/l
* Patients with a history of acute pancreatitis
* Patients likely to undergo common bile duct exploration
* Patients with renal impairment, ischaemic heart disease, cardiac failure and chronic restrictive airways disease
Goal-directed Therapy in Neurosurgery.

The purpose of the study is to assess feasibility of future large randomised controled study aimed on assessment of effect of goal-directed therapy on incidence of complications in neurosurgery compared to standard care.

Patients undergoing neurosurgical operations are at risk of inadequate intravascular volume for several reasons. The appropriate fluid management in neurosurgery is a challenge. Goal-directed therapy has been shown to improve the outcome of patients undergoing major surgery. Current knowledge regarding effect of fluid management on patient-orientated outcomes in neurosurgery is limited.

This study is designed as a pilot study with two parallel groups. Patients scheduled to planned brain surgery at the University Hospital Brno will be screened whether they meet the inclusion criteria. After obtaining informed consent, the patient will be randomized to one of the study arms.

In one arm (STANDARD) standard monitoring of vital signs will be introduced. During the operation, perioperative fluid therapy and administration of vasoactive agents will depend entirely at the discretion of the attending anaesthetist. Postoperative therapy will be fully controlled and will depend on the decision of the attending physician. In the second arm (GDT), a non-invasive hemodynamic monitor STARLINK™SV will be introduced in addition to standard monitoring. In this arm, basal infusion with crystalloid balanced solution will be initiated. Additional boluses of fluids will be administered based on haemodynamic monitoring. The primary outcome of the study is a proportion of patients with serious adverse event (SAE). Incidence of SAEs will be compared between study groups. SAE will be defined as unsatisfactory brain tissue relaxation at the end of operation and any intervention for brain oedema postoperatively.

The secondary outcome is to compare proportion of patients with postoperative complications in both groups and length of ICU and hospital stay.

This study will enroll 34 patients in total, 17 in each group. After completion of enrolment of patients the statistical analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* age at least 18 years
* anticipated duration of surgery at least 2 hours
* signed written consent form
* American Society of Anesthesiologists (ASA) classification \< 4.

Exclusion Criteria:

* unavailability of hemodynamic monitor
* emergency operation
* ASA ≥4
* sitting operating position and awake craniotomy
* awake craniotomy
* serious cardiorespiratory disorder
* cardiac arrythmia
* obesity with BMI above 35 kg/m2
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)

The purpose of this study is to investigate the effectiveness and safety of the regimen including high dose rifampicin for individualized duration (3 months after Culture Conversion) for the treatment of drug-sensitive pulmonary tuberculosis.


Eligibility Criteria:
Inclusion Criteria:

* Documented positivity by sputum Xpert MTB/RIF assay
* Administration of current tuberculosis therapy (if any) for no more than 7 days (≤7) at the time of enrolment.

Exclusion Criteria:

* Negative on Xpert MTB/RIF assay
* Resistance to rifampicin as detected by an Xpert MTB/RIF assay
* Known resistance to isoniazid, rifampicin, or pyrazinamide
* HIV positive
* Cancer patient on anti-cancer chemotherapy
* Uncontrolled DM
* Chronic hepatitis, liver cirrhosis
* Any contraindications of drugs to be used