cyrilzakka/clinical-trials huggingface dataset:
Oral Health Care in Autism Spectrum Disorder

Persons with autism spectrum disorder (ASD) are characterized by impairments in social interactions, speech and communication, restricted patterns of behaviour, and unusual sensory sensitivities. There are not many studies available reporting oral health status, dental care needs and oral health care protocol for persons with an ASD.

Despite the fact that there appears to be no known ASD specific dental and oral manifestations, there are consistent reports that persons with ASD exhibit significantly poorer oral health epidemiological profile when compared to their neurotypical counterparts. In addition to that, it has been reported that persons with ASD to substantial extent have a special health care needs and are almost twice as likely to have unmet oral health care needs as their typically developing peers regardless socioeconomic and cultural background. All these oral health related problems might arise because of ASD related challenging behaviors such as communication limitations, personal neglect, self-injurious behaviors, dietary habits, effects of medications, resistance to receiving dental care, hyposensitivity to pain, and possible avoidance of social contact. Frequently overlooked but very important reason is the lack of oral care providers who are willing to serve this population. As a results, oral health problems and unmet oral health needs transfer from childhood to adult period in persons with ASD.The broad, long-term objective of the investigator's proposed research is to describe the oral health status, oral health related behaviors, oral care delivery pattern, limitations of routine dental treatment and requirements for use general anaesthesia for oral health care of patients with ASD. Oral health status, pattern of oral health care delivery, dental treatment needs met in routine dental treatment and general anaesthesia will be analysed retrospectively on 52 participants with diagnosed ASD who were treated and monitored at the Paediatric Dentistry Department, Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad during 5 years (2013-2018) observation period. Conditions assessed will include, dental caries, missed teeth, filled teeth (DMFT index), restorations, bruxism, delayed eruption/missing teeth, oral infection, injuries, general health status, dental treatment acceptance (Frankle scale), dental treatment attendance, routine dental treatment and general anaesthesia dental treatment assessment.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Diagnosis of a autism spectrum disorder not confirmed by a physician
Dexmedetomidine for Prevention of Chronic Postoperative Pain

Chronic postoperative pain (CPSP) is common symptom in patients after surgery, seriously affected the quality of life. Accumulating evidences have demonstrated dexmedetomidine can improve chronic pain. However, the prevention of dexmedetomidine on CPSP remain uncertain.

Chronic postoperative pain (CPSP) is defined as pain persisting at least 3 months after surgery. It is most common in patients who undergoing breast or thoracic surgery. Dexmedetomidine, a adrenergic α2 agonists, can alleviate the postoperative pain 24 h after surgery. In our study, patients were randomly assigned to one of the two group to receive 0.5mg/kg/h infusion dexmedetomidine (Group D, n=57) or normal saline (Group C, n=57). The pain scales were evaluated day 1, day 2, day 3, month 3, month 6 after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been 18 to 65 yr old, and been scheduled for breast or thoracic surgery.

Exclusion Criteria:

* Patients with limitations of self-expression or visual dysfunction or having emergency surgery, a severe psychiatric illness, or chronic pain problems in the chest area for longer than 2 months before the surgery,or patients who could not provide informed consent were excluded.
* Pregnant women and prisoners were also excluded.
Effect of Intravenous Dexamethasone on Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery

The use of dexamethasone, administered either systemically or perineurally, as an adjunct to peripheral or neuraxial regional blocks, is currently one of the hottest topics in the field of regional anesthesia.

A large number of clinical studies have investigated this off-label application of dexamethasone in recent years, with many reporting enhanced sensory block and/or improved postoperative analgesia following either intravenous (i.v.) or perineural dexamethasone. Dexamethasone is potent, selective glucocorticoid having minimal mineralocorticoid action. Systemic anti-inflammatory and immunosuppressive properties may be responsible for the prolongation of analgesia when administered intravenously. Various studies proved the efficacy of steroids for the prolongation of the effects of regional nerve blocks. We decided to conduct the present study to evaluate the effects of intravenous (IV) dexamethasone on the subarachnoid block.

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists score I-III,
* Patients undergoing lower abdominal surgery under hyperbaric bupivacaine spinal anesthesia

Exclusion Criteria:

* History of allergy to amide LAs or dexamethasone,
* Presence of a preexisting lower limb neurological deficit
* Chronic use of corticosteroids.
A Study To Assess the Safety of Extended Release Alprazolam for the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks

The purpose of this study is to assess the long-term safety and tolerability of alprazolam extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will also be evaluated.

Due to recruitment difficulties in this adolescent population, the clinical program for alprazolam XR was cancelled and this study was terminated on 1 September 2004. There were no safety concerns that led to this decision.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet one of the following 6 diagnoses: a. A current diagnosis of panic disorder with or without agoraphobia; b. Generalized anxiety disorder with a history of at least one panic attack in the course of their illness; c. Social anxiety disorder (social phobia) with a history of at least one panic attack in the course of their illness; d. Separation anxiety with a history of at least one panic attack in the course of their illness; e. Posttraumatic stress disorder with a history of at least one panic attack in the course of their illness; f. Anxiety not otherwise specified with a history of at least one panic attack in the course of their illness.
* Educational level, intelligence, or other mental condition in the subject and/or his/her parent(s) are judged by the investigator to be sufficient to permit adequate informed consent/assent to be obtained, and for study procedures to be complied with.

Exclusion Criteria:

* Current (in the past 6 months) diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence.
* Current (in the past 3 months) diagnosis of alcohol and/or substance abuse.
* Primary diagnosis of conduct disorder, oppositional defiant disorder, or Attention Deficit Hyperactivity Disorder.
* Any current or past history of schizophrenia or psychosis; bipolar disorder or cyclothymia; dementia, delirium or other organic brain disease; an eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder.
* A Childhood Depression Rating Scale, Revised score \>35.
Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

The purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (GFL) with or without bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer, histologically or cytologically confirmed
* Age 18 or greater
* Adequate hematologic function (ANC \> 1500, hemoglobin \> 10 g/dl, platelet count \> 100,000)
* Adequate hepatic parameters (bilirubin \< 2.0, Alk. Phos \< 5 times normal, ALT \< 5 times normal)
* Adequate renal function (creatinine \< 2.0)
* Performance status ECOG 0-2
* 0-2 prior lines of chemotherapy for metastatic colorectal cancer are allowed. Prior 5-FU/LV or capecitabine allowed either in the adjuvant setting, or in the metastatic setting or both.
* Absence of other serious concurrent medical illnesses
* Evaluable or measurable disease for phase I; measurable disease only for phase II

Exclusion Criteria:

* Histologies other than adenocarcinoma
* Previous grade 4 toxicity to 5-FU +/- LV or capecitabine
* Uncontrolled brain metastases
* Chronic diarrhea (greater than five bowel movements per day)
* Previous chemotherapy or radiation therapy less than 4 weeks prior to study day 1 (less than 6 weeks for chemotherapy with Mitomycin or nitrosoureas)
* Major surgery within 2 weeks before study entry
* Known allergic sensitivity to leucovorin
* Prior exposure to IFN-γ
* Previous hematopoietic growth factor (e.g. epoetin alfa or darbepoietin less than 2 weeks prior to study day 1)
* Pregnancy or breast feeding. Women of child-bearing potential must have a negative pregnancy test before the first dose.
* Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
* Inability to provide written and informed consent
* Uncontrolled hypertension
* History of deep venous thrombosis or CVA
* Prior exposure to bevacizumab
* Proteinuria \> 500 mg/24 hr
Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension

Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event and statins through their vasculoprotective effect might be of value in the treatment armamentarium of PAH related to SSc.

The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.

Background: Pulmonary arterial hypertension (PAH) is an acknowledged devastating complication of systemic sclerosis (SSc); difficult to manage with a poor prognosis.

Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event.

Statins, through their pleotropic effects might be of value in the treatment armamentarium of PAH related to SSc.

Objectives: The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.

Methods: Forty SSc patients fulfilling the ACR criteria for the classification of SSc diagnosis and having PAH were recruited.

All SSc patients underwent transthoracic echocardiography and the six minute walk test (SMWT).

Patients were randomized into 2 groups; the first group (n = 23) were assigned to receive 40mg of rosuvastatin and the second group (n = 23) received placebo for 6 months.

The levels of endothelial dysfunction and inflammatory markers were assayed at baseline and after 6 months of therapy. Outcome measures assessed included exercise capacity (SMWT), MPAP, WHO functional class change, tolerability and safety.

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association (NYHA) class III
* A mean pulmonary artery pressure (mPAP) of \> 30mmHg at rest

Exclusion Criteria:

* Smoking
* Diabetes mellitus
* Hypercholesterolemia
* Hypertension
* Cardiac insufficiency
* Coexisting hepatic and renal diseases
* Use of drugs known to interact with statins.
* Patients with severe interstitial lung fibrosis
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung

This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.

Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal.

A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.

Eligibility Criteria:
Inclusion Criteria:

1. Over 21 years of age;
2. Capable and willing to give informed consent;
3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
4. Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy

Exclusion Criteria:

1. Medical contraindication to bronchoscopy as assessed by the investigator
2. Presence of uncorrectable bleeding disorders
3. Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker
4. Patients with the target lesion having endobronchial involvement seen on chest CT
5. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,
6. Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;
7. Uncontrolled or irreversible coagulopathy;
8. Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure;
9. CT scan done greater than 28 days before the bronchoscopy procedure.
Lesser Poland Cracovian Heart Failure Registry

The goal of Lesser Poland Cracovian Heart Failure Registry (LECRA-HF) is to expand the knowledge about acute heart failure (AHF) and its long-term prognosis.

The main questions are:

* assessment of long-term prognosis of AHF and its determinants
* determination of the optimal AHF treatment methods
* assessment of indications for invasive coronary arteries diagnostics and revascularization and their long-term effects
* analysis of the particular HF subtypes (HFimpEF, HFpEF, HFsnEF, HFrEF, HFmrEF)

LECRA-HF is a registry of patients with acute heart failure (AHF) hospitalized in the Department of Coronary Disease and Heart Failure, John Paul II Hospital in Krakow, Jagiellonian University Medical College. So far, a small population of patients has been included in similar registries conducted in the Polish population. This did not allow to draw reliable conclusions about this diverse group of patients.

As part of the LECRA-HF registry, a comprehensive analysis of the clinical characteristics of patients is planned, taking into account their medical history, anthropometric measurements, results of electrocardiographic, imaging and laboratory tests, as well as the treatment used during the index hospitalization and after discharge. Their long-term prognosis will also be analyzed. LECRA-HF is a continuous registry, updated annually until 2026.

The data collected in the LECRA-HF will be used to distinguish and describe relatively new subtypes of HF (HFimpEF, HFsnEF) as well as to properly characterize that difficult and very diverse population with a serious long-term prognosis.

Eligibility Criteria:
Inclusion Criteria:

* hospitalization due to acute heart failure
* \> 18 years of age

Exclusion Criteria:

* inability to give informed consent to participate in the registry
Human Metabolic Dynamics at Rest and During Aerobic Exercise Under Normobaric Normoxic and Moderate Hypoxic Conditions

The aim is to define in detail metabolic pathways at rest and during aerobic exercise in normal and healthy men and women under normobaric normoxic and moderate hypoxic conditions, using metabolomics technologies based on minimally invasive sampling relying on gas chromatography and mass spectrometry.


Eligibility Criteria:
Inclusion criteria:

* approval and written, informed consent
* healthy adults of varying fitness levels (age \>18 years to 75 years)

Exclusion criteria:

* chronic illness requiring any medication
* pregnancy
* limitations regarding functioning in the hypoxic chamber
* inability to follow simple instructions
* relevant or severe abnormalities in medical history, physical examination, ECG routine laboratory parameters from blood and urine
Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care

Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. This randomized controlled trial aims to evaluate the effectiveness and processes of the ReDS-guided heart failure management program in primary care settings for patients with heart failure.

Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. Our newly developed ReDS-guided heart failure management program, led by nurses, incorporates algorithms for a follow-up schedule, diuretic adjustments, and symptom monitoring.

The specific aims of the study are:

1. To examine whether the program decreases the number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death in patients with heart failure.
2. To evaluate the intervention processes and explore barriers to and facilitators for the implementation of the program.

This is a multicentre 1:1 randomised controlled clinical trial with a 6-month follow-up. Study participants will be patients with diagnosed with heart failure. The primary outcome will be the total number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisation, and all-cause death at 3 months. Secondary outcomes will include health-related quality of life, self-care behaviour, and healthcare cost. Throughout the randomised controlled trial, a process evaluation will be conducted to assess the fidelity, dose, and reach of the intervention program. Additionally, we will explore both barriers and facilitators for program implementation among study patients and healthcare professionals.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, there is no upper age limit
* Diagnosed with heart failure regardless of left ventricular ejection fraction
* Having New York Heart Association (NYHA) Class III/IV irrespective of prior hospitalisation for heart failure, or NYHA II with a history of at least one hospitalisation for heart failure within the previous 12 months
* Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) within 12 months: (a) ≥450 pg/ml for patients under 50 years; (b) ≥900 pg/ml for patients aged 50-75 years; (c) ≥1800 pg/ml for patients over 75 years.

Exclusion Criteria:

* NYHA I
* Life expectancy \<6 months
* Physical characteristics that prevented use of the ReDS (body mass index \< 22 or \>39, and height less than 155 cm or higher than 195 cm)
* Implantation of a left ventricular assist device or cardiac transplantation.
Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients

This study evaluate either Toripalimab or combined with chemotherapy as neoadjuvant treatment for patients with head and neck squamous cell carcinoma. Participants in arm A receive Toripalimab, in arm B receive Toripalimab plus PC (paclitaxel and carboplatin), arm C with Toripalimab plus modified TPF(paclitaxel and cisplatin and 5-fu).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed pathologic or cytologic diagnosis of squamous cell carcinoma of head and neck;
* Resectable or potentially resectable lesion;
* ECOG PS 0-1;
* Age \>18 years old;
* At least one target lesion according to RECIST 1.1;
* Proper function of the cardiovascular system, liver, kidney and bone marrow for receiving chemotherapy and surgery;

Exclusion Criteria:

* Distant metastasis;
* Second malignancy within 5 years;
* Nasopharyngeal carcinoma;
* Active autoimmune diseases;
* HIV infected;
* Required prednisone dose \>=10mg daily;
* Heart attack within 6 months;
* Stroke within 6 months;
* Other conditions that investigators consider the patients are not suitable for PD-1antibody;
Smoking Study With Behavioral Therapy for Hypertensive Patients

In total, 260 patients with pre- and stage I hypertension, who are regular smokers, will be randomized to: varenicline alone or varenicline plus behavioral therapy. Patients in both conditions will receive varenicline (titrated to a maximal dose of 1.0 mg twice daily) for 12 weeks along with standard smoking cessation therapy and regular carbon monoxide (CO) and cotinine monitoring. A significantly higher proportion of behavioral therapy patients are expected to achieve and maintain long durations of abstinence than patients receiving varenicline alone. Clinic and 24-hour blood pressure (BP) and heart rate (HR) will be primary clinical outcomes. The investigators expect that BP and HR will decrease more among behavioral therapy than non-behavioral therapy patients and reductions in smoking may mediate decreases in these indices.


Eligibility Criteria:
Inclusion Criteria:

* regular smokers, with no period of abstinence exceeding 3 months in past year
* expired CO of at least 8 ppm
* self-reported desire to stop smoking
* at least 18 years of age
* resting systolic BP of 120-160 mmHg and/or diastolic BP of 80-100 mmHg but otherwise in good health (see exclusion criteria)
* if on antihypertensive medication, have not changed medications during the previous month and do not intend to change in the next 3 months
* English speaking

Exclusion Criteria:

* receipt of smoking cessation treatment (behavioral or pharmacological) in the past month
* serious or unstable medical disease within the past 6 months, including myocardial infarction, cancer, congestive heart failure, kidney failure, stroke, or seizures
* evidence or history of allergic reactions contraindicating varenicline use or clinically significant laboratory or electrocardiographic (ECG) abnormalities
* breastfeeding, pregnant or not using effective contraception if a woman of childbearing potential
* arm circumference of \>42 cm, which precludes accurate BP monitoring
* serious psychiatric illness in past 6 months (e.g., schizophrenia, psychosis, suicide risk, drug or alcohol dependence other than nicotine)
* use of tobacco containing products other than cigarettes in past month and do not agree to abstain from use of these products during study participation
* ongoing use of any of the following medications: nicotine replacement therapies, monoamine oxidase inhibitors, antipsychotics, mood stabilizers, or naltrexone
* in recovery for pathological gambling