cyrilzakka/clinical-trials huggingface dataset:
Method of Early Diagnosis of Laryngopharyngeal Reflux

The investigator will issue a Patient Information Consent for the participant in the study. 1.Patients will be asked to complete the Reflux Symptom Index questionnaire.

Clinical survey, medical history. 2. Objective methods for assessing the patient's condition:

- examination of ENT organs. 3. Laboratory and instrumental research methods: Endoscopic laryngoscopy and video laryngoscopy, pH-metry, acoustic voice analysis.

4.Sociological method. 5. Subjective methods for assessing the condition of the larynx. 6. Аnalysis of the received data

The investigator will issue a Patient Information Consent for the participant in the study. 1.Patients will be asked to complete the Reflux Symptom Index questionnaire.

Clinical survey, medical history 2. Objective methods for assessing the patient's condition:

- examination of ENT organs: rhinoscopy, otoscopy, pharyngoscopy and laryngoscopy 3. Laboratory and instrumental research methods - Endoscopic laryngoscopy and video laryngoscopy. pH-metry: The collection of mucus from the laryngopharynx for the determination of acid-base values. Acoustic voice analysis: objective assessment of the voice condition 4.Sociological method: determination of lifestyle, nutrition, the presence or absence of bad habits.

5. Subjective methods for assessing the condition of the larynx - Questionnaires.

6. Аnalysis of the received data

Eligibility Criteria:
Inclusion Criteria:

* Patient's informed consent
* Age: 18-75 years old
* No serious somatic diseases.
* Patients with complaints of sore throat, coughing, burning sensation in the throat, coughing, frequent sore throat, difficulty swallowing, lump in the throat, foreign body feeling in the throat, voice changes, heartburn and belching.
* Diagnosis: Chronic pharyngitis
* Chronic laryngitis

Exclusion Criteria:

* Disagreement to participate in scientific research
* Age: under 18 and over 76
* Severe somatic diseases, organic lesions of the gastrointestinal tract and ENT organs
* Patients with pulmonary pathologies
* Patients with allergic manifestations (seasonal hay fever, asthma, etc.)
* With diagnoses: Acute respiratory diseases
* Patients with general neuralgic disorders
Availability of Vitamin D in Orange Juice

The purpose of this study was to determine whether vitamin D2 and vitamin D3 in orange juice are effective at raising vitamin D levels in the blood and if vitamin D2 and vitamin D3 in orange juice raised blood levels of 25(OH)D as well as vitamin D3 and vitamin D2 supplements.

This study should provide valuable information about the bioavailability of both vitamin D2 and vitamin D3 formulated in orange juice compared to vitamin D2 and vitamin D3 formulated in a pill and taken with water. It is anticipated based on our previous observation that the vitamin D2 and vitamin D3 in orange juice will be at least 50% more effective in raising the blood levels of 25(OH)D than when taken in pill form.

This study will evaluate the bioavailability and metabolism of vitamin D2 and vitamin D3 in combination in tablet form. The results should provide important information as to whether a physiologic dose of vitamin D2 has a negative effect on circulating levels of 25-hydroxyvitamin D2 \[25(OH)D2 \] and on 25-hydroxyvitamin D3 \[25(OH)D3\]. Results from this study have important implications for expanding the adequate intake (AI) recommendations for vitamin D2 and vitamin D3 for adults.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults of all races ages 18 years and older

Exclusion Criteria:

* Pregnant and lactating women
* History of chronic severe liver (as defined by liver function test greater than 2 times upper limit of normal)or kidney disease as defined by a serum creatinine \>2.5.
* History of taking a daily supplement that contains 400 or more IU vitamin D2 or vitamin D3 within the past month or taking a pharmacologic amount of vitamin D2 or one of the active vitamin D analogs including Zemplar (Paricalcitol), Dovonex (calcipotriol), Hectorol (vitamin D pro hormone)
* Subjects who are taking orally Dilantin or glucocorticoids.
* Exposure to a tanning bed or tanning on a beach for more than eight hours within the past month.
* Subjects who drink more than 2 glasses (16 oz) cups of milk a day.
* Known history of elevated calcium. (\> 10.5 mg% (mg/dl))
* History of intestinal malabsorption (i.e. Cystic Fibrosis, Fat malabsorption Syndrome, Crohn's Disease)
* Allergies to orange juice
* Any medical conditions in which it is not advisable to receive one 8 oz. glass of orange juice per day.
* Currently taking, or having taken less than one month prior to start of study, a prescription vitamin D
* Unwilling to consent to this trial
Clinical Trial for the Validation of AR Based Neuronavigation System

The goal of this clinical trial is to test augmented reality (AR) based neuronavigation system in surgeries for patients of brain neoplasm or cerebral vascular disease. The main questions it aims to answer are:

• AR based neuronavigation system can achieve accuracy that is not inferior to conventional intraoperative navigation system.

Participants will participate the study after informed consent. When participants undergo surgery for their brain tumor, we will set up 2 types of neuronavigation, conventional navigation system and developed AR based neuronavigation system. Surgeon will plan and conduct surgery based on only conventional navigation system, but 3D errors at several selected points between two types of navigation will be measured and analyzed.

Being developed AR navigation were reported in our following papers:

1. Dho YS, et al., Development of an inside-out augmented reality technique for neurosurgical navigation. Neurosurgical Focus. 2021 Aug 1;51(2):E21. (doi.org/10.3171/2021.5.FOCUS21184)
2. Moon HC, et al., Navigation of frameless fixation for gamma knife radiosurgery using fixed augmented reality. Scientific Reports. 2022 Mar 16;12(1):1-0. (doi.org/10.3171/2021.5.FOCUS21184)

This study aims to evaluate the accuracy of anatomical localization of a newly developed augmented reality-based neurosurgery navigation. After 3-dimensional (3D) modeling of the brain of a patient with brain tumor or cerebral vascular disease through 3D image segmentation extraction and modeling, the Augmented Reality (AR)-based navigation developed by this research team can be used with a commercially available visualization device, such as iPad, iPhone, and Hololens2, to evaluate the accuracy.

The AR-based navigation obtained approval from the Ministry of Food and Drug Safety of Republic of Korea (class 2 medical device) in February 2022. Through this clinical tria that compare accuracy with existing conventional intraoperative neuronavigation system, we will evaluate whether it shows equivalent performance to replace the existing navigation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years or older who underwent MRI or CT scan due to brain tumor or cerebrovascular disease
* Adult patients aged 18 years or older who need surgical treatment using navigation for brain tumor or cerebrovascular disease

Exclusion Criteria:

* Cases where application of navigation is not necessary according to the judgment of the researcher or surgeon
* When the patient or guardian does not agree
* Patients with anatomical deformation due to previous surgery or requiring emergency surgery
Naples Federico II Intensive Cardiac Care Unit Registry (Naples FED2-ICCU Registry)

This protocol proposes to prospectively evaluate current epidemiology, pharmacologic and invasive management and clinical outcomes of patients with acute cardiovascular diseases admitted at our ICCU.

This study is designed as a single-center, investigator-initiated prospective observational study. Our ICCU is located at the Department of "Scienze Cardiovascolari, Diagnostica per Immagini, e Rete Tempo Dipendente delle Emergenze Cardiovascolari" of the Azienda Ospedaliera Universitaria Federico II. All scientific activities are performed in the Department of Advanced Biomedical Sciences of the University of Naples Federico II.

This is a prospective observational study which does not include pharmacologic or invasive treatments different from daily and guideline-directed management, but only collects data of patients for research purposes, therefore no specific treatments or procedures are included in this research protocol.

The Clinical Trial Unit at the University of Naples "Federico II" will oversee all study procedures and data management. The study data will be anonymized and managed using REDCap electronic data capture, which is hosted at the University of Naples "Federico II".

Once the patient is admitted to our ICCU, the informed consent will be signed and all data will be collected: demographic, clinical, procedural, therapeutic, and outcome data.

Clinical outcomes will be assessed in the in-hospital period, at 30 days, at 1-year and at the longest available follow-up (telephone or follow-up visit).

Main clinical outcomes will be adjudicated by an independent clinical events committee (CEC).

Eligibility Criteria:
Inclusion Criteria:

1. Acute cardiovascular disease admitted at our ICCU
2. Age ≥18 years;
3. Written informed consent.

Exclusion Criteria:

1) Patients not providing consent to data collection
Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease

Sleep disorders (SDs) are one of the most frequent non-motor symptoms of Parkinson's disease (PD), usually increasing in frequency over the course of the disease and disability progression. SDs include nocturnal and diurnal manifestations such as insomnia, REM sleep behavior disorder, and excessive daytime sleepiness. The causes of SDs in PD are numerous, including the neurodegeneration process itself, which can disrupt the networks regulating the sleep-wake cycle and deplete a large number of cerebral amines possibly playing a role in the initiation and maintenance of sleep.

Sleep disorders (SDs) constitute the second most frequent complaint, affecting 64% of PD patients, ranging from 41.1% in naïve patients to 78.3% in complicated patients. SDs in PD are multifactorial and include nocturnal and diurnal manifestations. Reduced sleep efficiency and an increased number of awakenings characterize sleep in PD. These disturbances are linked, on one side, to PD motor (akinesia, rigidity, and dystonia) and autonomic symptoms (nocturia) and, on the other side, to the presence of concomitant SDs such as REM sleep behavior disorder (RBD), restless legs syndrome (RLS), or breathing disorders such as obstructive sleep apnea (OSA). Diurnal manifestations include excessive daytime sleepiness (EDS) and sudden sleep attacks, which could be a consequence of nocturnal sleep impairment or dopaminergic treatment or, more interestingly, to the neurodegenerative process of PD itself dysregulating the circadian sleep-wake rhythm.

Eligibility Criteria:
Inclusion Criteria:

* Elderly individuals aged 60 years or older, with a confirmed diagnosis of Parkinson's Disease.
* Cognitively and physically able to engage in the study.

Exclusion Criteria:

* Participants using sedative medications .
A German Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Type 2 Diabetes Patients.

This study is a German, prospective, multicenter, controlled, cluster-randomized, interventional comparative study evaluating the efficacy and benefits of integrated PDM care by measuring HbA1c levels in patients with Type 2 Diabetes. Patients will be randomized into two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.

Outcome of both studies (RD001732 and RD001231) will be integrated and additionally reported as PDM-ProValue study program (Integrated Personalized Diabetes Management) due to the high similarity in study characteristics, design and study results.

Eligibility Criteria:
Inclusion Criteria:

* Existence of a signed Informed Consent form (before any study procedure)
* Diagnosed Type 2 diabetes mellitus
* Age =18 years
* Insulin therapy for =6 months: BOT, SIT, CT or ICT
* HbA1c =7.5% within the last 6 weeks before study visit 1 (patient's inclusion)
* Longer-term diabetes care by the trial site (at least for the duration of the 12-month study participation)
* General practitioner is the primary practitioner in the diabetes care of the patient
* Insured by the statutory health insurance (GKV) as a statutory or voluntarily insured member or as a family co-insured member
* Willing and able to participate in the study and to follow the study procedures, among other things sufficient command of the German language, spoken and written

Exclusion Criteria:

* Diabetes treatment by insulin pump therapy (CSII)
* Experience with the use of special software for systematic processing of SMBG data, e.g. the Accu-Chek® Smart Pix System/Software, the Accu-Chek® 360° Software and/or the Diabetes Software DIABASS
* Presence of terminal renal failure / dialysis and/or a loss of sight or a tumor illness
* Chronic use of steroids in adrenal suppressant doses, of other immuno-modulatory drugs or chemotherapy
* Known alcohol, drug and medication abuse
* Known metabolic disorders and/or disorders or therapies that could lead to or have led to wrong measured results (e.g. with the blood glucose measurement)
* Existing pregnancy, breast-feeding or plan to become pregnant during study participation
* Physical illness and/or psychological disorder with the result that the patient cannot implement the medical treatment recommendations independently
* Dependency relationship to the sponsor or to the investigator, e.g. as a professional colleague or family member
Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma

Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL.

Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR.

Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL

An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age.
* Part 1: A confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL, or subjects who have not previously received systemic anticancer therapy for FL., and which requires treatment.
* Part 2: For subject with relapsed or refractory MZL:

Histologically confirmed MZL including splenic, nodal, and extranodal sub-types

1. Subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criterion #4;
2. Subjects with gastric mucosa-associated lymphoid tissue (MALT) lymphoma must be Helicobacter pylori (HP)-negative

   * Part 3: For subjects with FL: Pathologically confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL and which requires treatment per National Cancer Institute or ESMO clinical practice guidelines.
   * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
   * Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria:

* •A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or Qtc \>480 msec
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
* Breast feeding or pregnant
A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is \>500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
* HbA1c \>=7.0% and \<=10% at screening;
* BMI \>=25kg/m2 (\>23kg/m2 for Asians) and \<=45kg/m2 at screening;
* stable weight +/- 5% for at least 12 weeks prior to screening.

Exclusion Criteria:

* history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
* history of acute metabolic diabetic complications within the previous 6 months;
* evidence of clinically significant diabetic complications;
* known proliferative diabetic retinopathy;
* myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
* any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
* known hemoglobinopathy or chronic anemia;
* clinically significant gastrointestinal disease.
Discussion on Pulse Diagnosis and Heart Rhythm Variability of Patients With Chronic Insomnia

Discuss the objective assessment of patients with insomnia by pulse diagnosis, and measure by subjective questionnaire and physiological instruments.

In Taiwan, insomnia is a prevalent illness. Clinical symptoms of sleep disturbances are rather typical now that the epidemic has taken hold. Pulse diagnosis is an important diagnostic method for insomnia in traditional Chinese medicine(TCM). TCM pulse diagnosis is not yet a widely used clinical diagnostic method for illnesses, nevertheless. Clinical use and teaching should benefit greatly if pulse diagnosis or learning can be made more objective or data-based.

Eligibility Criteria:
Inclusion Criteria:

* aged 40-60 years
* Complaints of insomnia symptoms in the past month that lasted for at least one week, such as difficulty falling asleep, waking up easily in the middle of the night, unable to fall asleep after waking up, still not getting enough sleep after waking up in the morning
* The score of sleep disorder on the Pittsburgh Sleep Quality Scale was more than 5 points

Exclusion Criteria:

* History of psychiatric disorders
* History of sleep apnea or nocturnal myoclonus
* Center or neurodegenerative disease
* Cancer
* Melatonin or sleeping pills use in the past month
Dental Caries Prevention by a Natural Product

The objective is to conduct an RCT to evaluate the effectiveness of Licorice in comparison to standard caries preventive measures for the prevention of new carious lesions in high caries risk patients.

Research hypothesis (Null hypothesis):

The present clinical trial will be conducted to reject or accept the null hypothesis that using Licorice extract mouth wash in addition to standard preventive measures will not differ from using standard preventive measures alone in preventing incidence of new carious lesions.

PICOTS:

P: Population with high caries risk patients

I: Use of licorice.

I2: Use of chlorhexidine

C: Use of standard preventive measures (tooth brushing, tooth paste, interdental cleaning).

O.1: Primary outcome is incidence of new carious lesions

T: Time for measurement is 12 months

S: A Randomized controlled clinical trial (Parallel study)

Eligibility Criteria:
Inclusion Criteria:

* Patients with high caries risk,
* 18-25 years,
* Males or females,
* Medically free patients,
* Patients approving to participate in the study.

Exclusion Criteria:

* Patients who were on antibiotic therapy or corticosteroid therapy for 30 days before the examination,
* Patients had history of professional cleaning in the last 15 days,
* Patients with exposed pulp,
* Evidence of parafunctional habits,
* Patients with developmental dental anomalies,
* Patients undergoing or will start orthodontic treatment,
* Patients with removable prosthesis,
* Periapical Abscess or Fistula.
Effect of the Salbutamol on Mechanical Properties of Respiratory System

The aim of this study is to assess the bronchodilator response of salbutamol on respiratory mechanics of healthy individuals, smokers and COPD with varying degrees of airway obstruction.

Clinical evaluation will be conducted and anthropometric measurements, then the pulmonary function tests: forced oscillation technique (FOT), whole body plethysmography, spirometry and-administration of salbutamol aerosol for assessment of bronchodilator response. After 20 minutes, the individual will be evaluated again following the same sequence.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals, smokers and patients with chronic obstructive pulmonary disease.

Exclusion Criteria:

* healthy subjects: no history of smoking respiratory infection and disease respiratory
* smokers and chronic obstructive pulmonary disease patients: asthma and other respiratory diseases.