cyrilzakka/clinical-trials huggingface dataset:
High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes

In a series of double-blinded randomized cross-over acute studies, the investigators want to study the effects of naturally produced high-amylose barley (Lean-baking barley®) on the postprandial glucose-metabolism in subjects with and without type 2 diabetes (T2D).

The prevalence of T2D is increasing worldwide, primarily due to obesity, lack of physical activity and unhealthy diet. Therefore, it is of great important to evolve dietary products that counteracts this development.

Barley has shown some beneficial effects on postprandial blood glucose compared with wheat. A lowering of the postprandial glucose level reduces the risk of developing T2D and helps in the regulation of a pre-existing diabetes. However, barley is traditionally not used in bread-making in Denmark.

The elevation of postprandial glucose also depends on how fast the dietary products are degraded in the gastrointestinal tract.

The starch in barley consist of both fastly degraded amylopectin and slowly degraded amylose. Slow degradation is expected to lower postprandial glucose. By natural breeding techniques it has been possible for the investigators collaborative partners at the Universities of Aarhus and Copenhagen and PlantCarb ApS to make an natural organic high-amylose barley (Lean-baking barley®).

In a series of acute studies the investigators want to study the effects on the glycemic response to bread made with different flours (wheat, regular barley, Lean-baking barley® in subjects with T2D.

The investigators expect that Lean-baking barley® positively affect the postprandial glucose-metabolism more than wheat and regular barley and hereby acutely improves the glycemic regulation for both subjects with and without T2D.

Eligibility Criteria:
Inclusion Criteria for T2D group:

* T2D defined by standard Danish guidelines.
* HbA1c between 42-78 mmol/l.
* Treatment with drugs for hypertension and high cholesterol is allowed if the treatment dose is stable and does not demand changes during the study period.
* Participants are encouraged to maintain their present psychical activity level and their smoking and alcohol habits.

Exclusion Criteria:

* Type 1 diabetes
* Insulin demanding T2D
* Use of weekly administrated GLP-1 antagonist (e.g. ozempic, trulicity or byetta)
* Use of acarbose
* Significant cardiovascular, kidney, liver or endocrine comorbidity
* Significant psychiatric history
* Treatment with steroids
* Alcohol or drug abuse
* Pregnancy or breastfeeding
* Legally incompetent
An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation

1. To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions.
2. To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female adult smokers
* 18 to 55 years of age

Exclusion Criteria:

* Sensitivity to varenicline
* Illegal drug use
* Pregnant or nursing females
Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females

African American adolescent females seeking treatment for STIs are an underserved population at increased risk for HPV infection. While GARDASIL is an effective preventive vaccine, vaccination rates are low. Given the risk for HPV infection among this subgroup and the negative health effects associated with HPV, enhancing uptake of GARDASIL is necessary. The goal of this project is to promote GARDASIL vaccination through the development of a new multi-component, culturally-appropriate, interactive DVD.

We propose to recruit 280 unmarried African American adolescent females, 13-18 years of age, from participating clinic sites in Atlanta, Georgia. While seeking clinical services, adolescents will be contacted and invited to participate in the proposed study. Eligible adolescents will be required to provide written assent/consent prior to participation. Adolescents who are eligible and willing to participate in the project will complete a short survey on a laptop computer. The survey is designed to assess adolescents' risk taking and preventive behaviors. After they complete the survey, adolescents will be assigned at random to one of two groups. In one group, adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses. In the second group, adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. All adolescents are eligible to receive the GARDASIL vaccine at participating study clinics as part of their routine standard of care.

With the help of clinic staff, participant medical records will be reviewed over a 7 month period to assess vaccination rates. Vaccination rates from adolescents who received the interactive HPV/GARDASIL awareness DVD will be compared to the group of adolescents who received the healthy lifestyles DVD. It is hypothesized that study participants receiving the interactive DVD intervention that promotes HPV awareness will have higher vaccination rates over time.


Eligibility Criteria:
Inclusion Criteria:

* African American
* Female
* Age 13-18 years
* Seeking reproductive/STI services at participating clinic
* Ability to give written informed consent or assent

Exclusion Criteria:

* Pregnant
* Married
* Already received the HPV vaccine
Vascular Occlusion and Rheumatoid Arthritis

Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass resistance training alone. The investigators speculate this training strategy could be beneficial in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* female with rheumatoid arthritis
* Disease activity scores \> 2.6
* use of anti-TNF-alpha drugs for at least 8 weeks

Exclusion Criteria:

* BMD \< 20 kg/m2
* fibromyalgia
* cardiovascular disease
Feasibility of SBIRT-PN

Substance misuse is a common problem among HIV+ individuals. Research suggests that a Screening, Brief Intervention, and Treatment (SBIRT) model can be effective in reducing substance misuse in the general older adult population; however these findings have not been verified in the more vulnerable HIV+ older adult population. The present study seeks to address the problem of substance misuse in older HIV+ adults by piloting a SBIRT model for older HIV+ adults in a in a primary care setting. Individual reductions in alcohol and drug use can have significant effects on public health and safety when observed over a large population at risk for substance use problems. With wider dissemination statewide, a relatively low-cost intervention such as SBIRT could offer demonstrated benefits in this population.

The current project will pilot SBIRT with a peer navigator (SBIRT-PN) versus treatment at usual (TAU) to increase substance use treatment engagement among HIV-positive adults aged 50 years and older. The investigators will recruit patients from the Southern HIV and Alcohol Research Consortium (SHARC) HIV primary care clinic network.

In order to develop effective substance use intervention models for HIV care settings the specific aims of the current project are:

Aim1: Examine the feasibility of the SBIRT-PN model at the UF Health Infectious Disease-Medical Specialties Clinic. The investigators hypothesize that the SBIRT-PN model will demonstrate high feasibility within the UF Health Infectious Disease - Medical Specialties Clinic.

Aim2a: Assess the acceptability of SBIRT-PN. The investigators hypothesize that SBIRT-PN will demonstrate high acceptability among patients enrolled in this condition.

Aim2b: Assess the acceptability of SBIRT-PN among HIV-positive individuals by age cohort (younger vs older). The investigators hypothesize that SBIRT-PN will demonstrate higher acceptability among older HIV-positive patients enrolled in this condition.

Aim3: Assess influence of SBIRT-PN model on treatment engagement and substance use compared to enhanced treatment as usual (TAU).The investigators hypothesize that those in the SBIRT-PN condition will evidence greater treatment engagement and a reduction in substance use.

Eligibility Criteria:
Inclusion Criteria:

* Receiving care at an Infectious disease Medical Clinic
* HIV-positive (seropositive confirmed by medical records)
* have a substance misuse screening score indicating moderate or high risk.

Exclusion Criteria:

* lack fluency in English
* are unwilling to provide information for follow-up
* plan to leave the area within 6 months
* already have a referral to treatment from another provider
* unable to provide informed consent due to cognitive impairment.
Interest of the Induction With Target-controlled Inhalation of Sevoflurane on Spikes Wave Occurrence

Sevoflurane is widely used for induction of anaesthesia. Several studies showed EEG abnormalities during mask induction with sevoflurane. The aim of our study was to test the induction target concentration of sevoflurane on the spikes wave occurrence.


Eligibility Criteria:
Inclusion Criteria:

* programmed gynecological surgery
* ASA 1 or 2

Exclusion Criteria:

* arterial hypertension
* gastro-oesophageal reflux
* pregnancy
* diabetes
* obesity
* asthma
* tobacco
Silver Diamine Fluoride Application on Root Caries Fillings

The goal of this clinical trial is to learn the influence of prior silver diamine fluoride (SDF) application on root caries fillings.

The main questions to answer

1. Compare the success of fillings placed in dental root decay that have prior SDF application and those without prior SDF application;
2. Compare patient-based subjective evaluations on the two approaches mentioned above in treating root caries.

Participants will be allocated into two group

1. prior SDF application before receiving root caries fillings
2. directly receiving root caries fillings without any SDF application

The aim of the proposed study is to investigate the influence of prior SDF application on the restorative treatment of root caries.

The objectives of the study are to

1. Compare the success rate of restorations placed in root caries lesions that have prior SDF application and that of restorations placed without prior SDF application;
2. Compare patient-based subjective evaluations on the two different approaches mentioned-above in treating root caries lesions.

Hypotheses to be tested:

1. Prior SDF application increases the success rate of restorations placed in root caries;
2. Patient-based subjective evaluations of the treatment outcomes are better when SDF is applied to the root caries lesions prior to restoring the lesions.

Eligibility Criteria:
Inclusion Criteria:

* Older adults (aged 60 or above)
* At least one untreated decayed dental root

Exclusion Criteria:

* No self-care ability for basic daily activities
* Teeth with severe decay (cannot be filled)
* Teeth indicated for extraction
Bioavailability Study of K0706 in Healthy Subjects

This is single-center, single-dose, randomized, open-label, four-period, four sequence crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect for tablet formulation in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Willingness to provide written, informed consent for participation in the study in the compliance with the protocol requirements
2. Adult males or females aged between 18 and 55 years
3. Medically healthy on the basis of medical history and physical examination
4. Woman of childbearing potential must practice an acceptable method of birth control

Exclusion Criteria:

1. History of any major surgical or medical conditions within 4 weeks prior to dosing
2. History of blood transfusion and / or plasmapheresis within 4 weeks prior to dosing
3. Inability to swallow oral medication and / or difficulty to find peripheral access to veins or inability to undergo venipuncture
4. Any malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)
Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease

The coronavirus SARS-CoV-2 causing COVID-19 was pandemic since 2020. Vaccination is one of the most important measure to control the outbreak. The countries of the world started the vaccination since December, 2020. Taiwan started since March, 21st, 2021. Currently, Taiwanese people receive COVID-19 vaccination by either AZ or Moderna; Pfizer/BNT vaccine may import in the near future. The side effects post vaccination including injection site pain, fatigue, headache, myalgia, chills, arthralgia, fever, and so on. Incidence of side effects more frequent in young people than elders; more frequent in the first dose than second dose in AZ vaccine; more frequent in the second dose in Moderna or Pfizer/BNT vaccine. Taiwan V-watch is a system monitored by CDC for people proactive notification of side effects post COVID-19 vaccination. But it doesn't include the objective cardiovascular parameters, for example, heart rate, arrhythmia, blood pressure, central body temperature (ear temperature) and blood oxygen saturation level.

This study aims to monitor the physiologic and psychologic effects, and side effects before and after COVID-19 vaccination in patients at high cardiovascular risk, including hypertension, hyperlipidemia, and type 2 diabetes, and arrhythmia or coronary artery disease. The investigators arrange two weeks of continuous home BP/HR monitoring (7 days pre- and post-vaccination) for evaluation of physiologic effects post vaccination. Due to fever noted in some people post-vaccination, the investigators also measure ear temperature, pulse oximetry, and environmental temperature and humidity, for the reference of BP monitoring.

In conclusion, this study may provide important information of cardiovascular response and psychosocial effects after SARS-CoV-2 vaccination for proactive prevention of cardiovascular complications.


Eligibility Criteria:
Inclusion Criteria:

* People at high cardiovascular risk.
* Clinical diagnosis of hypertension
* Clinical diagnosis of hyperlipidemia
* Clinical diagnosis of type 2 diabetes
* Clinical diagnosis of arrhythmia
* Clinical diagnosis of coronary artery disease
* Patients at the cardiology clinic.

Exclusion Criteria:

* People who have been diagnosed by a doctor as unsuitable for vaccination.
* People with serious injuries or catastrophic illness, such as cancer patients.
* People who stay in bed for a long time and cannot take care of themselves.
To Advance the New Disability Evaluation System in Taiwan

Before 2007, the disability evaluation was based on the medical model in Taiwan. According to the People with Disabilities Rights Protection Act announced on 11 July 2007, the assessment of a person's eligibility for disability benefits has to be determined as suffering one of eight malfunction categories based on the International Classification of Functioning, Disability, and Health (ICF) framework. People with disabilities want to issue a disability identification and other welfare \& services need processes of evaluation \& assessment based on the ICF framework for the evaluation report and result of living need by the committee composed of professionals from medicine, social work, special education and employment counseling and evaluation.

In this year, investigators planed the project with the Taiwan Society of ICF to develop the evaluation form. The experts from various disciplines of the ICF Office convened internal integration meetings to reach a consensus for developed the ICF evaluation form, add the code of pain and sleep and the items from Short-Form 12 for quality of life to the questionnaire. The results were used to analysis other relevant factors affecting the disability evaluation. And then add the core set from World Health Organization to both physical and mental disorders linked coding group, compared the new disability evaluation system and evaluate the living need of people with disability to provide suggestion for core set.


Eligibility Criteria:
Inclusion Criteria:

* comply with a standard of the disability evaluation

Exclusion Criteria:

* no
To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies

This was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must fulfill all criteria in one of the following groups:

   * Impaired Glucose Tolerance (IGT) as diagnosed per protocol and not on an anti-diabetic medicine during the study
   * Diagnosis of Type 2 diabetes in stable treatment with metformin
   * Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day) in combination with a sulfonylurea
   * Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day), sulfonylurea and thiazolidinedione combination therapy
   * Diagnosis of Type 2 diabetes in stable treatment with at least two insulin injections a day with or without metformin
2. HbA1c between 6.5% and 8%, inclusive, at Screening; this criterion does not apply to the IGT group
3. Age from 18-74 years, inclusive, and of either sex

Exclusion Criteria:

1. Type 1 diabetes or diabetes that is a result of pancreatic injury or other secondary forms of diabetes
2. History or current findings of active pulmonary disease (e.g. tuberculosis, fungal diseases) as defined in the protocol:
3. Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven.
CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum

This study will be a single center, Phase 2, open-label trial to evaluate the safety and efficacy of 200mg CC-11050 administered twice daily taken with food for patients with moderate to severe ENL. The study will be performed in two steps: 1) to evaluate immediate effect in safety and efficacy of drug in 10 males with new or new recurrent episode ENL and, if found to be safe and effective by the DSMB and 2) if allowed by the DSMB, and approved by relevant study stakeholders, an additional 40 ENL patients will be enrolled for up to 52 weeks of treatment. A safety analysis will be conducted on all patients who have received at least one dose of study drug, and will include the frequency of all adverse events and laboratory abnormalities as well as frequency of dose interruptions, dose reductions and treatment discontinuation.


Eligibility Criteria:
Inclusion Criteria:

Study participants must satisfy the following criteria to be enrolled in the study:

1. Must be 18 -65 years old, weight \> 35kg for women and \>40kg for men at the time of signing the informed consent.
2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
3. Have signs or symptoms of new or new episode ENL. In Step one, participants must be male. In Step 2, participants can be either male or female.
4. Able to adhere to the study schedule and other protocol requirements.

Exclusion Criteria:

The presence of any of the following will exclude a participant from enrollment:

1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study.
2. Patients on continuous rifampicin will be excluded, however, If rifampicin is given only once a month as part of a multi-drug regimen, a minimum of 2-week washout period is required prior to administration of CC-11050
3. Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he were to participate in the study.
4. Any condition that confounds the ability to interpret data from the study (ie, HIV, chronic HepB, chronic HepC or TB patients under active treatment). Resolved TB patients will not be excluded from the study.
5. Stable and well managed patients with Diabetes and hypertension will not be excluded from the study.
6. Use of systemic corticosteroid or immunosuppressant therapy within 7 days of study medication initiation
7. Pregnant or nursing females.
Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered to Healthy Human Subjects

Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice and local legislation
* Age \>= 18 and \<= 45 years
* Broca \>= - 20 % and \<= + 20%
* Able to communicate well with the investigator and to comply with study requirements
* \> 10 elimination half lives present since last use of any investigational drug for that investigational drug
* Laboratory values within a clinically relevant reference range

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate, temperature, and EKG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
* Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial, (\< 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\< 1 months prior to administration or during trial)
* Smoker
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) \< one week prior to administration of study drug
* Blood donation or loss \> 400 mL (\< 1 month prior to administration or during the trial)
* Excessive physical activities (\< 5 days prior to administration or during the trial)
* Following specific laboratory findings: total white blood cell \>= 10 x 109/L, C-Reactive Protein \>= 4.5 mg/L, gamma-glutamyl-transferase \>= 25 U/L, aspartate transaminase \>= 16 U/L, alanine transaminase \>= 20 U/L any erythrocytes or \> 15 mg/dl protein on urine dipstick
* Any EKG value outside of the reference range of clinical relevance including, but not limited to QTcB \> 480 ms, PR interval \> 240 ms, QRS interval \> 110 ms
* History of any familial bleeding disorder
* Inability to comply with dietary regimen of study centre
* Inability to comply with investigator's instructions