cyrilzakka/clinical-trials huggingface dataset:
Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide

Approximately 30 adults will participate in this study at the International Diabetes Center (IDC). The IDC is the only site conducting this study.

Length of participation can range from two to three months which will include four to seven clinic visits.

The purpose of this study is to use a Continuous Glucose Monitoring (CGM) system to determine the characteristics of glucose control and patterns of food intake before exenatide is started, during the start and adjustment of exenatide and during exenatide treatment.

The long-term purpose of this study is to determine to what extent continuous glucose monitoring improves or alters clinical decision making for patients treated with exenatide. And, the study will also compare CGM to conventional self-monitored blood glucose methods.

The study will also compare subjects' changes, if any, in nutrient intake such as energy, protein, fat and carbohydrate during the course of the study through interpretation/analysis of self-reported food intake.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (if of child-bearing age must practice appropriate birth control such as tubal ligation, oral contraceptives, abstinence or vasectomized partner during the duration of the study)
* Previously diagnosed with type 2 diabetes
* Age 21 and older
* Treated with metformin, a sulfonylurea, a thiazolidinedione, a combination or metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione (approved FDA indications)
* HbA1c 7.1-11%, unless subject has been using exenatide prior to study; in that case, there is no restriction on HbA1c level.
* Willing to give informed consent
* Motivated and capable of following the protocol and instructions provided by the healthcare professional
* Available for the study on the scheduled visit days
* Access to telephone communications

Exclusion Criteria:

* Under 21 years of age
* Pregnancy
* Creatinine clearance \<30 ml/min (using MDRD formula)
* Known gastrointestinal disease
* Without diabetes or known type 1 diabetes
* Unable to follow the study protocol
* Unable to read and write in English
* Allergy to adhesives
* Any concomitant medical condition that would likely affect the evaluation of CGM device performance as determined by the investigator such as dermatological conditions or myxedema.
Cystatin c and Beta 2 Microglobulin in Thalassemic Children.

Beta thalassemia has many complications on many systems as the renal system.So early detection of renal impairment is required in those children to decrease complications of this nephropathy.

Thalassemia syndromes are the most common single gene disorders worldwide especially in developing countries. The use of regular and frequent blood transfusions in patients with beta thalassemia major has improved patients' life spans and quality of life, but can lead to chronic iron overload. Many factors contribute to the functional abnormalities found in beta thalassemia patients such as decreased red cell life span, rapid iron turnover, tissue deposition of excess iron and also, specific iron chelators can affect kidneys. The success in management of patients of beta thalassemia has led to chronic hemosiderosis in different organs like liver and heart and long-term complications in other organs like pancreas and kidneys have recently been studied. The evidence of proximal tubular damage has been observed in beta thalassemia patients. Also, low-molecular-weight proteinuria has been found in almost all patients. Unlike other organs, it is unclear whether kidney damage results solely from intravascular haemolysis, chronic transfusion or as a complication of iron chelation therapy. Although the early identification of patients at high risk of renal impairment is of great importance as it may allow specific measures to be taken to delay renal impairment, there are limited studies about renal dysfunction in pediatric thalassemic patients. Thus, in this study we will use different measurements for early detection of renal impairment even if the patients have no symptoms to handle with the disease in its reversible stage before being irreversible. Beside the usual investigations of renal function we will measure cystatin c and beta2 microglobulin as early markers of renal impairment.

Eligibility Criteria:
Inclusion Criteria:

* Children with beta thalassemia from the age of 1 year to 18 years.

Exclusion Criteria:

* Children who have other hematological or chronic disease.
Protein Quality on Appetite Control, Reward-driven Eating, & Subsequent Food Intake

To determine whether the consumption of a beef-rich lunch improves appetite control, satiety, and energy intake regulation while reducing food reward and food cravings compared to the consumption of a soy-rich lunch when matched for macronutrients and fiber content or when match for serving size. The mechanisms of action surrounding the differential responses of beef versus soy proteins were also explored.

A randomized, crossover design, acute study was completed in 21 healthy adults (age 23 ±1 y; BMI: 23.8 ± 0.6 kg/m2) to compare 400 kcal lunch meals varying in protein quality. Two separate comparisons were performed. The first comparison consisted of macronutrient and fiber-matched lunches which varied in protein quality: 24 g beef protein vs. 24 g soy protein. The second comparison matched serving size only: 1 serving of beef (24 g protein with 0 g fiber) vs. 1 serving of soy (14 g protein; 5 g fiber). For each treatment, the participants completed 2 testing days per lunch treatment. During the "Appetite Assessment Days," each participant reported to the lab to consume one of the lunch meals. Pre and 7-h post-lunch appetite and cravings questionnaires were completed throughout each testing day along with plasma, hormonal responses, and plasma amino acid concentrations through repeated blood sampling. Ad libitum dinner energy intake was also measured. During the "Reward Assessment Days," the participants reported to our facility to again consume one of the lunch meals. Pre and post-lunch neural responses to food stimuli, through functional magnetic resonance imaging (fMRI), occurred followed by ad libitum consumption of a lunch dessert.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-30 y
* Normal to Overweight (BMI: 18-29.9 kg/m2)
* No metabolic, psychological, or neurological diseases/conditions
* Not currently/previously on a weight loss or other special diet (in the past 6 months)
* Not a vegetarian
* Right-handed (necessary for the fMRI analyses)
* Not pregnant
* Meets the MU-Brain Imaging Center Screening Criteria
* Have not given blood (for the American Red Cross in the past 6 months)

Exclusion Criteria:

* Age \>30 y and \<18y
* Under Weight or Obese (BMI: \<18 kg/m2 or \>29.9 kg/m2)
* Clinically diagnosed with diabetes (Type I or Type II), having an eating disorder, or having any other metabolic, psychological, or neurological diseases/conditions that would influence the study outcomes.
* Currently/previously on a weight loss or other special diet (in the past 6 months)
* Left-handed
* Claustrophobic (≥ 2 past bouts of claustrophobia when exposure to small spaces)
* Do not meet the fMRI criteria established by the MU-BIC (regarding metal implants, etc.)
* Pregnant
* Does not meeting the MU-Brain Imaging Center screening criteria
* Have given blood (for the American Red Cross) in the past 6 months or plan to give blood in the following 6 months
Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma

Objectives: Transoral Laser Microsurgery (TLM) is widely used in for treating T1/T2 glottic cancers. Hyaluronic acid (HA) is a safe and commonly-used injectable in vocal cord augmentation. We report on the results of our single-blinded, randomized-controlled trial (RCT) investigating the impact of intra-operative HA injection on voice outcomes in early glottic cancer.

Methods: Patients with T1/T2 glottic cancers were randomized to the treatment group (n=14) receiving HA injection to the unaffected cord during TLM; or the control group, receiving no injection (n=16). All patients had a Voice Handicap Index-10 (VHI-10) questionnaire and a Maximum Phonation Time (MPT) measurement preoperatively and at 3, 12 and 24 months post-operatively. Mean change in VHI-10 and MPT, between pre-operative and post-operative time points, and between the time points, were compared. Survival estimates were also calculated.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* 18 years of age or older with a biopsy-proven T1a, T1b or T2 glottic SCC
* Lesion amenable to CO2 TLM resection.

Exclusion Criteria:

* Previous radiotherapy to the head and neck.
* Palpable, or radiographic, pathological lymphadenopathy.
* Allergy, or sensitivity, to HA or components of the injectable.
* Neurological disorder affecting phonation, such as multiple sclerosis or stroke.
Low-load Blood Flow Restriction Training in COPD

Peripheral muscle weakness is a predominant problem in patients with COPD and treated using exercise training in pulmonary rehabilitation. Despite pulmonary rehabilitation being an effective intervention, muscle strength impairment is a persisting problem in COPD patients. Patients have problems to tolerate the high training loads, which are necessary to develop strength. Low-load blood flow restriction training (LL-BFRT) might therefore be an option to enhance muscular response of patients with COPD to strength training. Up to now, no studies investigating LL-BFRT in respiratory diseases are available.

The primary outcome of this randomized pilot study is knee extensor muscle strength. Secondary, the study will evaluate if LL-BFRT is well tolerated and feasible in COPD patients attending outpatient pulmonary rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed COPD according to GOLD-guidelines
* Assigned to outpatient pulmonary rehabilitation by the treating physician

Exclusion Criteria:

* Physical or intellectual impairment precluding informed consent or protocol adherence
* Non-German speaking (precluding informed consent)
* Acute or recent (within the last 6 weeks) exacerbation of COPD
* Attending a pulmonary rehabilitation program within the last 3 months
* Pregnant patients
* History of thromboembolic event in the lower extremity
* Diagnosis of polyneuropathy
* Resting systolic blood pressure \<100 mmHg
Optimizing the Diagnosis of Acute Appendicitis

Aim of the study: to identify the signs of acute appendicitis delta signs - clinical, laboratory or ultrasound signs, whose change (delta) would allow to identify or deny the diagnosis of acute appendicitis without a computed tomography examination and thus to lower computed tomography rates.

This study consists of two parts:

* In the first part investigators enroll all patients (except pregnant) that are refered to Vilnius University Hospital Santaros clinics with suspected acute appendicitis in order to get cohort data. All patient get primary clinical evaluation, laboratory tests (WBC, CRP) an ultrasound examination.
* After primary evaluation if final diagnosis could not be made, and investigator still suspect acute appendicitis, participant is included in to randomised study part.
* Randomised sudy part has two arms: control and observation groups.
* Control group get the traditional diagnostic path - is refered to CT scan examination.
* Observation group get repeated evaluation after 8-12 hours and only than is diagnosis stays unclear, patient gets a CT scan.
* All patient are contacted after 30 days after visit to our hospital, to get information about their health status and possible additional visits to other hospitals or operations.

Eligibility Criteria:
Inclusion Criteria:

* Patient with the symptoms of acute appendicitis: pain in the right lower quadrant, pain migration from epigastrium to right lower quadrant, nausea, rebound pain, elevated temperature.

Exclusion Criteria for randomized part:

* Pregnant patient.

Inclusion Criteria for randomized part:

* After primary clinical, laboratory and ultrasound examination diagnosis of acute appendicitis could not be confirmed or excluded.
* No other gynecological, urological ir gastroenterological pathology is confirmed.

Exclusion Criteria for randomized part:

* Clinical symptoms lasts for longer than 48 hours
* Signs of peritonitis
Social Network Approach for Increasing Testing Coverage Among Men Who Have Sex With Men

HIV testing is essential in shortening the time to identify a new infection, the first 90 of the UNAIDS 90-90-90 targets. However, over one-third of the men who have sex with men (MSM) had never been tested for HIV; even if they did, one-fifth had their tests done more than a year ago. Assortative mixing pattern observed in the HIV-positive MSM group shaped the transmission dynamics and could be leveraged for intervention. Barriers to access HIV testing services could, on the other hand, be hurdled by self-tests. A network approach for intervention could therefore be promising in delivering effective HIV self-tests. To experiment with such an approach, a 2-phase study was conceptualised incorporating actual network-based referred HIV self-tests and an agent-based simulation evaluating its impact. Sixty-four MSM would be recruited as seeds for promoting HIV self-tests within their network and those being referred could refer their friends for the same after passing online training. To facilitate the process, an online platform would be developed offering information, collecting informed consent, requesting HIV self-test kits, returning results, performing online training, and referring peers. Participants could opt to receive self-tests by delivery or to conduct it on-site with staff assistance. A hotline with video conferencing support would be maintained to assist those who self-test at home. They could also choose between blood and oral fluid tests. Two user interfaces, namely gamification and neumorphism, would be randomly assigned. Primary outcomes to measure are number and proportion of MSM who had never or not tested within 12 months and the associating factors, and usability of the two user interfaces. Data collected in the empirical study would be used for parameterising the agent-based simulation to evaluate the impact of the approach in increasing testing coverage and shortening time to diagnosis. Its economic assessment would also be performed to cost each new infection to be identified. The approach could be feasible and effective to be adopted for future broader implementation for peer-led HIV self-test kit or HIV prevention message distribution.


Eligibility Criteria:
Inclusion Criteria:

* male
* had sex with another male in the preceding year
* able to communicate in written Chinese or English
* normally resided in Hong Kong

Exclusion Criteria:

* prisoners
* having mental illnesses that informed consent cannot be obtained
The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis

The main aim of the project is to establish inter-rater reliability, internal variability and variability of results got in two different ways of the Nine Hole Peg Test administered according to the new Czech extended version manual in patients with multiple sclerosis.

At least 30 patients with multiple sclerosis will be tested by Nine Hole Peg Test according to new Czech manual for this test. The testing will take place in one session. Video of patients' performance will be obtained.

The inter-rater reliability, internal variability and variability of results got in two different ways will be established.

Eligibility Criteria:
Inclusion Criteria:

* outpatients with clinically definite multiple sclerosis
* Czech language as a mother tongue
* age from 20 to 65 years
* clinically stable disease (more than 30 days since the last attack of the disease)
* Expanded Disability Status Scale (EDSS) score between 1.5-8.0

Exclusion Criteria:

* inability to complete the test attempt of the Nine Hole Peg Test
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to complete complete testing
* failure to sign Informed consent for the patient and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague
The Impact of Melatonin Lotion on Sleep and Mental Health

The purpose of this study is to examine the effect that melatonin lotion has on sleep quality, the nervous system, and mental health. Melatonin is a hormone secreted by the brain that regulates sleep and might improve depression and anxiety symptoms. The goal is to determine whether melatonin in lotion form is an effective treatment for young adults with inadequate sleep and might improve mental health. Participants will fill out surveys, wear an actigraph (a wrist-worn device that measures sleep), wear a heart rate monitor (a strap worn around one's chest), and provide nightly saliva samples during treatment weeks. In one of the two treatment weeks, participants will receive a lotion that contains melatonin. During the other week they will receive a control treatment that will be lotion with no melatonin, and there will be a week in between with no treatment at all.

All participants will receive a melatonin lotion and a placebo lotion in a randomized crossover design. Participants will receive equipment and supplies on a Monday and will begin the assigned treatment that night, by self-applying premeasured lotion 1 hour before bedtime. During the two treatment weeks, participants will wear ActiGraph GT3X-BT accelerometers (ActiGraph, Pensacola, FL) at all times except when bathing or submerged in water. They will wear Polar H10 heart rate monitor chest straps (Polar Electro, Kempele, Finland) from one hour prior to bedtime until after a 5 min sitting period after waking. Three times daily they will be asked 1-item mood/anxiety questions ("How ___ do you feel right now?") through REDCap software. Participants will check any experienced side effects off a checklist once daily. Participants will collect a passive drool sample daily at bedtime and store in their home freezer until returning the samples to the laboratory. Treatment will occur for seven nights, with a return of equipment and saliva samples as well as confirmation of actigraphy and HRV readings the following Monday. After a seven day washout period to reduce any carryover effects, equipment and supplies will be supplied the next Monday and the participant will begin the other assigned treatment (active or placebo) that night in a crossover design. At three timepoints (pre-treatment, at the end of the melatonin treatment week, and at the end of the placebo week), participants will answer the following surveys online via REDCap: PROMIS short forms for anxiety, depression, sleep quality, and sleep-related impairment.

Eligibility Criteria:
Inclusion Criteria:

* a T score ≥ 48 on the sleep disturbance short form Patient-Reported Outcomes Measurement Information System (PROMIS) measure, and
* a T score ≥ 55 on the anxiety or depression short form PROMIS measures (mild symptoms or more)

Exclusion Criteria:

* currently using antidepressant, anti-anxiety, or sleep medication including melatonin
* are pregnant
* have allergies/sensitivities to scented lotion
* are unwilling to commit to keeping a similar bedtime (± 1 hour) during treatment weeks.
Masked Hypertension in Patients With Obstructive Sleep Apnoea

Assessment of the possible difference in masked hypertension prevalence when it is evaluated by automated office blood pressure measurement (AOBPM) instead of office blood pressure measurement (OBPM) in patients with obstructive sleep apnoea.

Rationale:

Obstructive sleep apnoea is characterized by repetitive closure of upper airways leading to apnoea (complete airflow cessation) or hypopnoea (airflow limitation \> 50%+ blood oxygen desaturation \> 4%). It is considered to be an important risk factor for arterial hypertension. In these patients is highly prevalent nocturnal hypertension (NH) and also masked hypertension (MH). Ambulatory blood pressure monitoring (ABPM) is considered to be a gold standard for the diagnosis of NH and MH. Results of ABPM are compared with office blood pressure measurement which could be falsely elevated in some patients (white coat effect). For this reason, automatic office blood pressure measurement was developed. Nowadays some devices like BpTRU were developed. This was validated on some patient groups but robust data for patients with obstructive sleep apnoea are missing.

Process:

Patient with ronchopathy and suspected obstructive sleep apnoea undergo automated office blood pressure monitoring followed by office blood pressure monitoring at the Department of Exercise Medicine and Cardiovascular Rehabilitation. After education, ambulatory blood pressure monitor will be provided to patients for the following 24 hours. In the same night, respiratory polygraphy will be performed in the Sleep Laboratory, Department of Respiratory Medicine, University Hospital Olomouc. All data will be statistically evaluated after completion of the target number of subjects. Patients without obstructive sleep apnoea (apnoea-hypopnoea index \< 5) will not be included in statistical evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnoea syndrome

Exclusion Criteria:

* Non- compliance of patients with blood pressure monitoring
Rijavithi Viral and Mycobacterium PCR Arrays in CNS Infection Study

This study of neurotropic viral infection and Tuberculous CNS infection is the comprehensive investigation of CSF PCR arrays (Hybrydiaztion technique,Sybergreen and Taqman real time PCR arrays of CSF ) in suspected cases of viral CNS infection, Tuberculous CNS infection in both AIDS and non AIDS patients.

Patients with clinical viral encephalitis and all meningoencephalitis including all patients with HIV/AIDS CSF and non AIDS will be banked and test for RNA and DNA viral sequence by Real time PCR arrays and IS6110 gene of Mycobacterium tuberculosis. Clinical data and final diagnosis will be used to analyze the result of this PCR arrays technique compared to clinical gold standard criteria.


Eligibility Criteria:
Inclusion Criteria:

1. AGE MORE THAN 15 YRS
2. ABLE TO INFORM CONSENT BY THEMSELF OR THEIR PARENT
3. SUSPECTED CNS VIRAL INFECTION

Exclusion Criteria:

1. UNABLE/CONTRAINDICATED FOR LUMBAR PUNCTURE OR CSF COLLECTION
2. WITHDRAW CONSENT
3. SUSPECTED SEVERE OR VILURENT VIRAL INFECTION SUCH AS H5N1/SARS INFECTION