cyrilzakka/clinical-trials huggingface dataset:
Pregabalin Premedication for Conscious Sedation

Conscious sedation is usually required during flexible bronchoscopy. Sedation should be done without causing respiratory depression or loss of consciousness. The present study was designed to evaluate the advantage of pregabalin pre-medication on reducing sedatives and respiratory depression for patients undergoing flexible bronchoscopy with dexmedetomidine and midazolam.

Seventy patients undergoing elective flexible bronchoscopy were randomly divided into two equal groups, 35 patients each. All patients received premedication one hour before the procedure. PG group received 150 mg pregabalin and C group received placebo. All patients sedated to achieve optimum working conditions. Intra-operative respiratory rate and post procedure patients' and pulmonologists' satisfaction were compared in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 21 and 65 years old American Society of Anaesthesiologists physical status II or III scheduled for elective flexible bronchoscopy

Exclusion Criteria:

* Patients with known allergy to any drug used in the study, chronic use of analgesics and/or sedatives, substance abuse, sleep apnea, renal or hepatic dysfunction, and psychiatric disorders.
Follow-up Pilot Study After a First Stroke

This is a randomized follow-up study after discharge from a stroke unit after a first stroke. The patients are randomized either to follow-up at a special out-patient stroke unit or with their general practitioners. The hypothesis is that follow-up with specialists is superior to follow-up with general practitioners. Endpoints are mortality, recurrent stroke and handicap measured with different scales.


Eligibility Criteria:
Inclusion Criteria:

* first stroke (ischemic or hemorrhagic)
* age below 85 years
* living at home before the stroke

Exclusion Criteria:

* modified Rankin scale 5 points
* other severe disease
* expected survival less than one year
* severe dementia
* drug or alcohol abuse
Comparing Two Mandibular Positioning Techniques for Dental Sleep Appliances

This is a prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.

Obstructive sleep apnea is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom-made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. Current methodology within dentistry is to position the mandible based on the person's maximum ability to position their mandible forward as the starting point and then slowly move the bottom jaw forward as necessary. Recent literature has shown that different mandibular positioning techniques may require less protrusion, less titrations, and potentially decreased side effects compared with the traditional protrusive techniques. One of the most promising techniques involves the use of speech to determine mandibular position. This technique would not require that a patient place their jaw outside of their normal functional range and could potentially decrease the face pain/jaw joint problems commonly associated with the use of oral sleep appliances for the treatment of obstructive sleep apnea. The use of speech as the determinant for where to position the mandible is important for muscular balance. Minimal research has been done in this area, with most studies being either retrospective or confounded by other variables. This will be the first prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.

Eligibility Criteria:
Inclusion Criteria:

Patient diagnosed with obstructive sleep apnea, and

* Prescription/order for a dental sleep appliance
* 18 years or older
* Treatment planned in accordance with AADSM treatment guidelines

Exclusion Criteria:

* There are no separate exclusion criteria
Drug Use Investigation for Arepanrix® (H1N1)

This post-marketing surveillance study is designed to collect safety information such as post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1) Intramuscular Injection.

The following items will be investigated as priority investigation items. \<Priority investigation items\>

1. Allergic reactions
2. Anaphylaxis


Eligibility Criteria:
Inclusion Criteria:

* Subjects who receive Arepanrix® intramuscular injection for the first time

Exclusion Criteria:

* Not applicable
Liver Fibrosis and Gut Microbiota in Patients With Psoriasis Vulgaris and Rheumatoid Arthritis on Methotrexate

While methotrexate (MTX) remains a treatment of choice for patients with rheumatoid arthritis (RA), psoriasis (PsO) and psoriatic arthritis (PsA), long-term MTX use has been shown to be associated with liver fibrosis and cirrhosis in these patients. In addition, gut dysbiosis has been found to be associated with liver fibrosis and cirrhosis via the gut-liver axis, underscoring the potential role of gut microbiota and bacterial translocation in the pathogenesis of chronic liver diseases in these patients.

In this study, we aim to assess the prevalence of advanced liver fibrosis or cirrhosis among these patients on MTX treatment compared to those without, using transient elastography. We also aim to identify the possible risk factor(s) for advanced liver fibrosis or cirrhosis among them. Further, we aim to characterize the difference in fecal microbiota patterns among these three groups of patients.

Using a cross-sectional, prospective cohort design, this study will enroll approximately 600 eligible patients, including 300 patients with PsO/PsA and 300 patients with RA, to examine the following hypotheses:

1. Patients on higher cumulative dose of MTX will have higher prevalence of advanced liver fibrosis or cirrhosis compared to those on lower cumulative dose of MTX;
2. Patients with MTX use will have higher prevalence of advanced liver fibrosis or cirrhosis compared to those without MTX use;
3. The fecal microbiota composition will be different between patients with and without MTX treatment; and
4. The fecal microbiota composition will be different between patients with and without advanced fibrosis/cirrhosis while on MTX treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 85 years
* Have regular follow up in Dermatology/ Rheumatology clinics of Queen Mary Hospital
* Diagnosed with PsO/PsA or RA
* Chinese ethnicity

Exclusion Criteria:

* Age below 18 years or above 85 years
* Known decompensated cirrhosis
* Pregnancy or breastfeeding
* Unstable medical illness or active infection
* Unable to provide written consent
* Unable to adhere to the protocol
* Unable to read and/or write Chinese language
* On anticoagulant/ antiplatelet treatment
* Abnormal platelet count \<150
* Known disease/condition with prolonged INR/bleeding tendency
The Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging

The study was planned to include patients with bladder tumors attending the Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, from 09/2024 to 12/2025. Patient demographics will be collected, patients will be monitored for medical history and co-morbidities, co-morbid medications or treatments, vital signs, and cystoscopy will be performed. Patients meeting the inclusion criteria will be included in this study. Patients will receive PET/MR imaging after bladder instillation of \[68Ga\] NOTA-DNA multivalent SGC8 injection to assess the effectiveness of bladder tumor imaging and to evaluate the safety of \[68Ga\] NOTA-DNA multivalent SGC8.

The primary study was the ability of gallium \[68Ga\] NOTA-DNA multivalent SGC8 injection to provide tumor-specific imaging of bladder tumor patients of different genders, with a compliance rate of more than 80% when compared to the gold standard TUR pathology. To study the safety of gallium\[68Ga\] NOTA-DNA multivalent SGC8 injection; to assess the correlation between gallium\[68Ga\] NOTA-DNA multivalent SGC8 imaging ability and clinical parameters; to study the ability of gallium \[68Ga\]NOTA-DNA multivalent SGC8 to differentiate between bladder tumor foci and inflammatory foci; to explore the gallium \[68Ga\]NOTA- DNA multivalent SGC8 target PTK7 receptor protein expression in bladder tumors and the correlation between tumor differentiation and malignancy.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary enrolment with signed informed consent
2. Age \>18 years, \<85 years
3. Cystoscopic diagnosis of bladder tumour with imaging and pathology reports not required
4. Willingness and ability to follow trial protocol requirements.

Exclusion Criteria:

1. Pregnancy, breastfeeding, severe hepatic, renal insufficiency and children
2. Hypersensitivity to the test drug, allergy or allergy to multiple drugs
Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men

The purpose of this study is to learn if lifestyle changes and counseling along with standard medical care, compared to standard medical care alone, can prevent heart problems and diabetes in men who are receiving ADT for prostate cancer treatment.

Prostate cancer is a very treatable cancer but those treatments can have long-lasting effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used along with other treatments like radiation and has been shown to improve survival. However, ADT can have negative effects especially on the heart and metabolism (the body's system for using and storing energy).

Participation in this study will last for up to 12 months. The study is looking at two different approaches to treating men who are undergoing ADT:

1. Staying Strong \& Healthy Intervention + Usual Care
2. Usual Care

All participants will have blood drawn and be asked questions about how they are feeling during their participation. The men in the Staying Strong \& Healthy Intervention group will also take part in a diet and exercise program and receive counseling from a member of the study team.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with prostate cancer
* Starting or have started ADT (oral or injection) for prostate cancer treatment within the last 3 months
* Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the man's dosage is every six months and he has been off ADT for more than six he is eligible);
* Able to speak and read in English or Spanish
* Reachable consistently by telephone
* Able to travel to KUMC

Exclusion Criteria:

* Not diagnosed with prostate cancer
* Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
* Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
* Not able to speak and read in English or Spanish
* Not reachable consistently by telephone
* Not able to travel to the study site for data collection
Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis

Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.


Eligibility Criteria:
Inclusion Criteria:

* patients age 50 or older who present with symptomatic primary osteoarthritis of the knee
* daily pain for the previous 3 months
* analgesics usage at least once a week
* less than 30 minutes of morning stiffness
* WOMAC score of ≤ 75 in the target knee
* Brandt Radiographic Grading Scale of Osteoarthritis grade 1 and 2

Exclusion Criteria:

* evidence of secondary knee osteoarthritis
* severe osteoarthritis (Joint space width - JSW \< 2 mm)
* prior intra articular injections within the previous one year prior to inclusion
* patients with clinically significant systemic disease
Exercise and Ectopic Fat Deposition

Excess ectopic fat deposition is associated with development of cardiovascular and metabolic diseases. This study investigates how lifestyle interventions can have an effect on different sites of ectopic fat deposition and cardiovascular or metabolic factors. Moreover, the clinical and economic value of exercise to supplement a hypocaloric diet is investigated.

Endocrinologists of the University Hospital of Antwerp, Belgium, will be recruiting women during consultations. Also, recruitment posters will be used in the University Hospital of Antwerp and the University of Antwerp. Potential participants meeting all a priori set inclusion and exclusion criteria will be randomized by minimization method to a hypocaloric diet group (usual care) or a group of hypocaloric diet combined with physical fitness training. Both groups will undergo an intake procedure in which personal goals are set and barriers to changes in behavior will be discussed. Ectopic fat deposition will be measured by imaging techniques after three and six months of intervention. Based on the known relationship between ectopic fat and cardiovascular outcomes, the short term study results will then be extrapolated to an estimation of the reduction of cardiovascular events.

The following clinical outcomes will be presented: change in ectopic fat in the abdomen (visceral fat), the liver (intra hepatic lipids), skeletal muscle (intra myocellular lipids), heart (epicardial fat) after a dietary or combined (diet+physical activity) intervention. The impact of supervised exercise in addition to diet will be expressed in projected healthcare costs and quality adjusted life years.

protocol of the study was published, Hens et al. (physioscience 2017; 13: 80-87)

Eligibility Criteria:
Inclusion Criteria:

* Participants should be willing to undergo a weight loss intervention and body weight must be stable during the past six months.
* There will be no upper eligibility criterion for body mass index (BMI) but BMI should be at least 27 kg/m².

Exclusion Criteria:

* Individuals who have a clinical history of type 2 diabetes, prediabetes (with use of medication), or hypothyroidism will be excluded.
* when postmenopausal; Premenopausal state will be verified by hormonal data (follicle-stimulation hormone (FSH) \< 25 mU/ml and estradiol \> 20 pg/ml).
* Subjects will not be allowed when pregnancy is planned
* when physical activity is not possible due to problems of the musculoskeletal system
* when changes in medication (e.g. beta blockers) are advised by an endocrinologist.
* when smoking
* when drinking more than two alcoholic consumptions/day or binge drinking (self-reported)
* when taking medication that influences body weight or metabolism (e.g. tricyclic antidepressants)
* Since all participants will undergo medical imaging, exclusion criteria related to MRI and CT scans are also applicable.
The Efficacy and Safety of Electronic Cigarettes: a 5-year Follow-up Study

The main aim of this multicentric 5-year follow-up study is to evaluate for the first time the long-term efficacy and safety (in terms of smoking-related serious diseases requiring hospitalization) of e-cigarette smoking, comparing its health effects with those of traditional cigarette smoking and mixed electronic and traditional cigarette smoking.

The study will also permit to evaluate, over a 5-year follow-up, the self-reported quality of life, and the reported adverse events according to current and past smoking habit.

Finally, the study will also explore the long-term adherence to e-cigarette smoking and its efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking.


Eligibility Criteria:
Inclusion Criteria:

* resident into the Abruzzo and Lazio Region
* aged between 30 and 75 years;
* smoker of e-cigarettes (inhaling at least 50 puffs per week) containing nicotine since six or more months (E-cigarettes only Group);
* smoker of at least one traditional cigarette per day since six or more months (Traditional cigarettes only Group);
* smoker of both electronic and traditional cigarettes (at least one per day) since six or more months (Mixed Group).

Exclusion Criteria:

* illicit drug use,
* breastfeeding or pregnancy,
* major depression or other psychiatric conditions,
* severe allergies,
* active antihypertensive medication,
* angina pectoris,
* past episodes of major cardiovascular diseases (myocardial infarction, stroke/TIA, congestive heart failure, COPD, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia.
Transcranial Doppler Using Wearable Ultrasound Patch

The main objective of this research is to measure the Doppler signal by the ultrasonic patch. Blood flow measurement is critical for vasospasm, stroke, and embolism monitoring on patients in the ICU or understanding the neurovascular coupling on different subjects. Currently, A conventional transcranial Doppler (TCD) probe is widely used for these applications. A headset design must be applied and fixed on the participants to obtain stable blood flow spectra. However, the TCD headset is operator dependent. The operator needs to be a trained expert and hold the ultrasound probe to get accurate blood flow velocity information. The stretchable and wearable non-invasive ultrasonic patch can not only free the operator's hands but can also provide long-term continuous monitoring, which is not possible by using the current operator-dependent ultrasound machine. The device can be conformal to the skin and attached to the skin surface.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent.
* In relatively good health with no serious medical conditions.

Exclusion Criteria:

* Inability to sign the informed consent.
* History of the following conditions: Heart attack, low blood pressure, aortic stenosis/carotid artery stenosis (also known as heart valve disease), glaucoma (a group of eye conditions that damage the optic nerve) or retinopathy (a disease of the eye retina).
Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania

The aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in Tanzania. The investigators will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called STOP-NCDs) and; (b) Assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized STOP-NCDs strategy. The investigators will select and/or adapt intervention components making up the optimized STOP-NCDs strategy. Using a hybrid clinical-effectiveness implementation design, the investigators will conduct a study in 2 sequential phases: 1) A clinical-effectiveness phase in which the investigators evaluate the effect of our combined strategies (task-sharing and WelTel) versus Usual Care, on rates of systolic BP reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of CVD risks and prevention, and, other features of health provider NCD prevention activities. 2) A post-implementation phase in which the investigators use the RE-AIM framework to evaluate changes in the adoption and maintenance of our combined strategies in participating iCHF health facilities across Kilimanjaro region. The investigators will use the WelTel communication and Patient Management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. It allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. Deployment of WelTel will allow for integration of NCD prevention targeted health services to all adult iCHF members across differing life stages and NCD risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change.


Eligibility Criteria:
Inclusion Criteria:

* All adults with uncontrolled HTN who receive care through iCHF membership and are able to provide informed consent.

Exclusion Criteria:

* Adults with controlled HTN or those without a diagnosis of HTN
* Unable or unwilling to provide informed consent
To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer

The cyclotron production model of Tc-99m pertechnetate (CPERT) has received significant validation in the independent expert review conducted by Natural Resources Canada (NRCan) in the follow up to the Chalk River crisis. The University of Alberta's Edmonton PET Centre and the Edmonton Radiopharmaceutical Centre is a cyclotron / radiopharmacy unit, providing a safe, cost effective, unsubsidized, and reliable supply of radiopharmaceuticals to hospitals and clinics in Edmonton and northern Alberta. A Phase I study is proposed to show safety of CPERT as well as comparability with generator-produced Tc-99m pertechnetate (GPERT) in subjects with well differentiated thyroid carcinoma post-thyroidectomy and prior to planned I-131 Iodide treatment.

Patients who have had a thyroidectomy for cancer routinely have a Tc-99m Pertechnetate (GPERT) scan at the Cross Cancer Institute to check for thyroid tissue remnants prior to radioactive iodine therapy. The first 10 subjects will receive a CPERT whole body scan, and and 20 subsequent case-matched controls (2 for each CPERT subject, matched for age and gender) will receive a GPERT whole body scan. CPERT safety will be assessed by pre-injection and post-imaging collection of vital signs and blood samples (haematology and biochemistry). Adverse event collection will be done for both CPERT and GPERT subjects. The whole body biodistribution pattern of CPERT will be qualitatively compared to GPERT by two independent and blinded Nuclear Medicine physicians.

Eligibility Criteria:
Inclusion Criteria:

* If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
* Have confirmed well differentiated thyroid cancer, post-thyroidectomy and pre-RAI
* Biochemical parameters as measured are required to be within 5 times the normal limits for age
* white blood cell count (WCB) \> 3.0/µL
* absolute neutrophil count (ANC) \> 1.5/µL
* Platelets \> 75,000/µL
* Hemoglobin \> 10 g/dL
* Able and willing to follow instructions and comply with the protocol
* Provide written informed consent prior to participation in the study
* Karnofsky Performance Scale score of 50 - 100

Exclusion Criteria:

* Nursing or pregnant females
* Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the pre-treatment scan
* White blood cell count (WCB \< 3.0/µL)
* absolute neutrophil count (ANC) \< 1.5/µL
* Platelets \< 75,000/µL
* Haemoglobin \< 10 g/dL
* unable and unwilling to follow instructions and comply with the protocol
* unable or unwilling to provide written informed consent prior to participation in the study
* Karnofsky Performance Scale score \<50