cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Two Nasal Products Based on Diluted Seawater in the Treatment of Upper Respiratory Infections/Conditions

The goal of this interventional clinical trial is to test the safety and efficacy of two medical devices in subjects aged from 3 months old for the treatment of colds, rhinitis, sinusitis, and other upper respiratory infections/conditions for 7 days.

The main endpoint is a symptom score evaluation. Severity is evaluated using the Jackson scale, which includes 8 symptoms (nasal discharge, nasal congestion, sneezing, sore throat, cough, headache, discomfort, chills) rated as absent, mild, moderate, or severe by the physician/investigator, on Day 0, immediately after the first use, on Day 3, and on Day 7.

The clinical evaluation is also conducted by the ENT specialist using the CGI (Clinical Global Impression - 7-point scale) on Day 0, immediately after the first use, on Day 3, and on Day 7, and by patients using the PGI (Patient Global Impression - 7-point scale) every day.

Concomitant treatments, number and timing of daily use, and tolerance (adverse effects) will also be studied.

Eligibility Criteria:
Inclusion Criteria:

* Autonomous adult, or minor with the consent of their legal representative
* Adults and children from 3 months old
* Ability of the patient (for adults) or their legal representative (for children) to follow the instructions for product use
* Having signed a free and informed consent to participate in the study expressed by the patient (for adults) or by their legal representative (for children) after being informed by the doctor.
* Person with an upper respiratory tract infection (cold, rhinitis, rhinopharyngitis...) with symptoms of nasal congestion and nasal discharge of moderate to severe intensity (Jackson derived score (nasal congestion + nasal discharge) ≥ 4 on Day 0).
* Persons with symptoms that started no more than 48 hours before the first visit

Exclusion Criteria:

* Person not showing cold symptoms, particularly no nasal congestion (chronic dry rhinitis, or Jackson derived score (nasal congestion + nasal discharge) \&amp;lt; 4 on Day 0).
* Person undergoing treatment with a cortisone derivative, mucolytic, or medication containing pseudoephedrine or a similar product acting on nasal congestion or having used such a product within the 3 days preceding inclusion.
* Person having used a nasal wash product within the 3 days preceding inclusion.
* Person whose ability to use the product daily and complete the daily follow-up diary is in doubt.
* Person refusing to sign the informed consent form prior to the study.
* Person participating or having participated in any other clinical study within the 30 days preceding the study.
* Person participating in any other clinical study.
Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis

The goal of this study is to establish parameters of gastric myoelectrical activity and heart rate variability in healthy human subjects and compare and contrast them to those with gastroparesis and functional dyspepsia, at baseline and following taVNS.

This is a prospective pilot study assessing the relationship of electrogastrography and heart rate variability, with transauricular stimulation of the vagal nerve in healthy subjects compared to gastroparesis and functional dyspepsia patients. The investigators plan to recruit a total of 60 patients: 20 healthy volunteers, 20 gastroparesis, and 20 functional dyspepsia patients. Participants will undergo two testing sessions in which electrogastrography (EGG) and heart rate variability (HRV) will be measured using electrodes following transauricular vagal nerve stimulation (tAVNS) at various frequencies.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female.
2. Age 18-85 years.
3. Healthy volunteer or established diagnosis of idiopathic, diabetic, or postsurgical gastroparesis and functional dyspepsia.
4. Patient is capable of giving informed consent.
5. Patient is on stable doses of other medications for gastroparesis or functional dyspepsia for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals).

Exclusion Criteria:

1. Any diagnosis of systemic autonomic dysfunction.
2. Use of narcotic, anticholinergic, cholinergic, or promotility medications in preceding 2 weeks of study.
3. Enteric feeding tubes.
4. Parenteral nutrition.
5. Severe disease flare requiring hospitalization or ER visits within 3 months of study.
6. Untreated depression or suicidal thoughts.
7. Pregnant/breastfeeding women.
8. History of gastric pacemaker implantation.
9. Implantable electronic devices (i.e. cardiac pacemakers)
10. Extrinsic myopathy/neuropathy
11. Vagal nerve injury.
12. High risk cardiac arrhythmias (high grade AV block, atrial fibrillation, atrial flutter).
13. GERD.
14. History of dumping syndrome.
15. History of rapid gastric emptying.
16. Severe allergy to skin adhesives.
17. Concurrent enrollment in other clinical trials.
A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-109 in healthy male subjects.

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-109 compared with AD-1091 in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy male volunteers at the time of screening visit

Exclusion Criteria:

* Patients with Medical history increasing the risk of bleeding
Developement of Stroke Prognosis Predictive Precision Medicine Based on a Digital Twin

The purpose of this study is to realize customized precision medicine for stroke patients and the visual digitization of patient medical information required in the era of digital transformation.

This study will collect large-scale, high-quality clinical data and daily life exercise pattern data covering the subacute to chronic stages of stroke patients. Based on this, we will use artificial intelligence analysis technology to predict the functional status of stroke patients in the chronic stage after their disability is fixed. We aim to develop the next generation of personalized digital twins by creating a prognostic prediction model.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 20 years of age with a history of stroke onset between 2018.01.01 to 2023.07.31.
* Patients who exist rehabilitation medical evaluation after stroke onset
* Patients who voluntarily decide to participate in this study

Exclusion Criteria:

* Those who have severe internal diseases such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc. and are in poor overall condition.
* Those who have impaired ability to consent (MMSE score less than 10 points) and not accompanied by a care-giver.
* In any other cases where the researcher determines that participation in this study is not appropriate.
Evaluation of Ridge Dimensional Changes After Immediate Implantation and Efficacy of This Procedure

1. Evaluation of dimensional changes in alveolar ridge following immediate implantation compared to delayed implantation
2. evaluation of the effect of gap dimensions between socket walls and dental implant in implant stability

24 hopeless single root teeth will be selected. The horizontal and vertical measurements will be assessed in 12socket after immediate implantation and filling the gape with DFDBA.

Horizontal dimensions (bucco-lingual) of alveolar ridge will be measured at 1,3 and 7 mm using caliper and CBCT , and vertical ridge dimensions at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ) will be determined using a periodontal probe from the line connecting the two adjacent CEJs ,and dimensional changes will be measured after 3 months following implant insertion with the same device during the second stage surgery.

The vertical and horizontal dimensions between the implant and alveolar crest and between the crest and base of the gap will be measured at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ).

The primary and secondary stability will be measured using Osstell at baseline and 3-month later.

Twelve sockets will heal without grafting materials, soft and hard tissue measurements including horizontal and vertical ridge dimensions will be determined. All the measurement will be assessed using caliper and CBCT at the time of extraction and 3-month later at the time of implant insertion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hopeless single root tooth and willing for dental implants
* Having no systemic disease

Exclusion Criteria:

* Fail to osseointegrate
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease

At present, no drug therapy has been proven to delay the progression of Parkinson's disease (PD). rTMS, as a non-invasive neuromodulation method, can regulate Slow-wave sleep (SWS). SWS is recognized closely related to neurodegeneration. However, there has been no clinical studies on if rTMS could delay the progression of PD by regulating SWS.

The main purpose of this study is to explore the changes of SWS in non-rapid eye movement (NREM) sleep period in PD patients by using rTMS, and the relationship with potential improvements of SWS and motor symptom delay. The study aims to find a potential new treatment strategy to delay the neurodegenerative process in PD patients by modulating SWS by rTMS.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the clinically definite or clinically probable PD according to the MDS 2015 version.
2. Chinese Han population (three generations), age greater than or equal to 50 years old, less than or equal to 80 years old, male or female.
3. Hoehn-Yahr stages 1-4.
4. The dose of levodopa drug therapy was stable three weeks before enrollment and during the follow-up period.
5. Right-handed.
6. The patient signed a written informed consent.

Exclusion Criteria:

1. Any form of Parkinsonism other than primary PD.
2. Those who have received neurosurgical intervention or stereotaxic brain surgery for PD, or have previously received TMS treatment.
3. Cognitive dysfunction (MMSE ≤ 24 points) or those who cannot cooperate with the scale score.
4. Persons with mental disabilities.
5. Pregnant women.
6. There are contraindications for rTMS treatment.
7. There are contraindications for MRI examination.
8. Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; BMI\>=30.
9. Patients who are addicted to alcohol, taking SSRIs, TCAs, sedative hypnotics, histamine antagonists and other drugs and food that may affect NREM and REM sleep structure.
10. Those who are unwilling to participate in the study or unable to sign the informed consent form; and other circumstances that the researcher considers inappropriate to participate in the study.

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Impact of Periodontal Treatment on Gastric Helicobacter Pylori Eradication

The efficacy of conventional systemic antibiotic therapy for eradication of gastric H. pylori has been seriously challenged by antibiotic resistance. Identification of alternative therapeutic strategies might help to overcome the limitation. The investigators' aim was to examine the effect of adjunct periodontal therapy, on gastric H. pylori eradication rate.


Eligibility Criteria:
Inclusion Criteria:

* tested positive for H. pylori both in gastric biopsy specimens and dental plaque samples

Exclusion Criteria:

The patients who had treatment with following medications within 6 months before the clinical protocol:

* had antibiotics
* had Proton pump inhibitor (PPI),
* had H2 blockers, and
* took bismuth derivatives
* had previous eradication therapy, or
* had previous periodontal therapy
* Edentulous patient
* Diabetic patients
* pregnant patients
The Effect of Screen Time on Recovery From Concussion

This study will prospectively examine the effect of screen time on recovery from concussion. Patients 12 to 25 years of age presenting to the ED with a concussion will be randomized to allow for screen time as tolerated or to abstain from screen time for the first 48 hours of recovery. The amount of screen time use and duration of concussive symptoms will be assessed through daily surveys and a daily post-concussive symptom score (PCSS).


Eligibility Criteria:
Inclusion Criteria:

* Individuals presenting to the emergency department with a traumatic head injury sustained in the last 24 hours and diagnosed concussion as defined by Acute Concussion Evaluation tool (ACE-ED)
* Between 12 and 25.99 years of age
* English-speaking
* Subject (and parent/guardian when applicable) is able and willing to provide informed consent and assent
* pregnant women,

Exclusion Criteria:

* individuals who have a Glasgow Coma Scale score of 13 or less;
* have brain abnormalities on imaging;
* have severe preexisting neurological conditions;
* a concussion diagnosed within the last 2 weeks;
* have significant developmental delay;
* are intoxicated;
* require neurosurgical intervention, intubation, or hospital admission
* individuals who do not meet the age criteria;
* non-English speaking;
* prisoners;
* unable or unwilling to provide informed consent;
* Are under the age of 18 and do not have a parent/guardian with them who is willing and able to consent.
Single Dose Study of PF-05230907 in Healthy Japanese Subjects

The purpose of this study is the following:

* To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.
* To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
* To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
* To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male of females
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs) and \<120 kg (265 lbs).
* Japanese subjects who have four biologic Japanese grandparents born in Japan.

Exclusion Criteria:

* Pregnant or nursing females.
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism

The biological diagnosis of the primary hyperparathyroidism is now facilitated by the reliability of the balance of phosphate and calcium and the dosage of parathyroid hormone (PTH).

This diagnosis of preoperative localization is important as surgery are now targeted to the responsible lesion.

The "gold standard" for this localization is the cervical ultrasound exploring the usual sites of adenomas and a MIBI scintigraphy (the parathyroid adenoma significantly concentrating this cell marker).

However, the diagnosis of preoperative localization remains a subject of discussion as to the most appropriate tests. Indeed, the morphological diagnosis is performed at the ultrasound stage in more than half the cases. It is the new performance of this morphological examination that makes it possible to obtain these results.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary hyperparathyroidism with surgery indication
* Age \> 18yo

Exclusion Criteria:

* surgical contraindication
* medical treatment by cinacalcet
* non sporadic hyperparathyroidism
* Age \<18yo
* Protected by the law
Are You Sitting Down: Cognitive Exectutive Function Task Comparison Between Seated and Standing Positions

The aim of this trial has been to explore the effects of self-positioning on cognitive performance in the work environment using a standardized cognitive test battery to evaluate executive function under two conditions: sitting and standing.

The aim of this trial has been to explore the effects of self-positioning on cognitive performance in the work environment using a standardized cognitive test battery to evaluate executive function under two conditions: sitting and standing.

Methods: This counterbalanced controlled trial involved 17 men (mean age +/-SD: 29.8 +/- 5.5) all with a science background and graduate degrees. The participants were accustomed to working in an open environment and none of whom currently using standing desks. We used a modified version of the CNS Vital Signs (CNSVS) test battery to assess cognitive executive function (CEF) in two typical work positions - standing and seated. Participants were randomly assigned to a standing or seated position to begin the testing procedure. Upon completion of the first test round they were instructed to rest for 10 min. in a dark room with no distractions before commencing the second round of testing positioned in the alternate fashion. The main outcome measure was a CNSVS score in each of the six CEF domains in the two different work positions

Eligibility Criteria:
Inclusion Criteria:

* male
* computer savvy
* advanced education degree

Exclusion Criteria:

* ADD
* on any medication
* currently a person who uses a standing desk
Body Composition in Infants and Children

This study will test a new method for measuring body fat and muscle in infants and children: QMR.


Eligibility Criteria:
Inclusion Criteria:

* healthy child
* weighing between 0 and 110 pounds

Exclusion Criteria:

* child has condition that may affect growth or bone development
* child has chronic disease
* child has disorder of carbohydrate metabolism
* child takes medication that could affect bone density
* child has any type of nonremovable metal
Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds

To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Nasopharyngeal RT-PCR positive SARS-CoV-2 patient
2. Age 20-50 years
3. BMI 18-28 kg/m2
4. Informed consent

Exclusion Criteria:

1. Symptoms: Cough, fever, shortness of breath
2. O2 saturation by pulse-oximeter below 94%
3. Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
4. Arrhythmias and/or history of arrythmia
5. Psoriasis and/or history of psoriasis
6. Neuropathy or myopathy and/or history of these
7. Hypoglycemia and/or history of hypoglycemia
8. Pre-existing hepatic disease
9. Pre-existing renal disease
10. Use of antacids within 1 week
11. Use of antibiotics within 1 week
12. Pregnancy
13. RT-PCR performed \>3 days prior to enrollment
DePuy Global Unite Shoulder System

To collect medium to long-term survivorship implant outcomes on the DePuy Global Unite Shoulder System


Eligibility Criteria:
Inclusion Criteria:

* Patient greater than 18 years of age and skeletally mature
* Patient qualifies for primary or revision total or reverse shoulder arthroplasty based on diagnosis of investigator of osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, un-united humeral head fractures, irreducible 3- and 4- part proximal humeral fracture, avascular necrosis, or gross rotator cuff deficiency.
* Patient is willing and able to provide written informed consent and to complete scheduled follow up visits/evaluations/questionnaires

Exclusion Criteria:

* Patient has one of the following compromise the affected limb; a significant injury to the upper brachial plexus, paralysis of the axillary nerve, or a neuromuscular disease compromising the affected limb
* Patient has a known or suspected infection
* Patient is known to be pregnant
* Patient has a sensitivity or allergic reaction to one or more of the implanted materials
* Patient is unwilling or unable to provide consent or comply with follow up visits
A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)

The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European Union (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic breast cancer in the first-line treatment setting. The hypothesis to be tested in this study is that the efficacy (ORR) of PF-05280014 is similar to trastuzumab-EU.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of breast cancer.
* Presence of metastatic disease.
* Documentation of HER2 gene amplification or overexpression.
* Available tumor tissue for central review of HER2 status.
* At least 1 measurable lesion as defined by RECIST 1.1.
* Eastern Cooperative Oncology Group status of 0 to 2.
* Left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan.

Exclusion Criteria:

* Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment (except endocrine therapy) and within 1 year before randomization.
* Prior systemic therapy for metastatic disease (except endocrine therapy).
* Prior cumulative dose of doxorubicin of \>400 mg/m2, epirubicin dose \>800 mg/m\^2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m\^2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m\^2 of doxorubicin.
* Inflammatory breast cancer.
* Active uncontrolled or symptomatic central nervous system metastases.