cyrilzakka/clinical-trials huggingface dataset:
High Intensity Body-weight Circuit Training Feasibility and Efficacy for in Middle Aged Persons With Type 2 Diabetes

This research study proposes to quantify the efficacy of the novel high intensity body-weight circuit (HIBC) training intervention on metabolic profile, body composition, and health related fitness exercise in middle aged persons with type-2 diabetes (T2DM). This research project is extremely relevant to public health, in that prevalence of T2DM continues to rise on a national and global scale, placing a heavy economic cost on both the healthcare industry and the individual patient in an age-dependent fashion. Results of this study may provide an effective and appealing alternative exercise intervention for cardiometabolic disease management in adults with T2DM, and have significant clinical and public health applications.


Eligibility Criteria:
Inclusion Criteria:

* Recent diagnosed of type 2 diabetes (T2DM) (within a year) \* HbA1c of 6% or higher

  * Non-insulin dependent
  * No medicinal treatment
  * Not currently undergoing a physical activity program in the last six months
  * Received written medical clearance from overseeing physician

Exclusion Criteria:

* Those who have undergone any revascularization procedure

  * Diagnosed with or symptomatic of any renal, pulmonary, or cardiovascular disease (CVD)
  * Diagnosed cognitive dysfunction
  * Current smoker
The Effect of ICON Treatment on WPL With Patients After Fixed Orthodontic Appliances

The aim of this study is to determine the effect of ICON on White spot lesions compared to CPP-ACPF plus.

The participants were categorized to either group (group1) receiving ICON treatment method (Icon, DMG, Germany), or (group 2) who shall be receiving CPP-ACPF treatment method (Tooth Mousse plus).

Eligibility Criteria:
Inclusion Criteria:

* permanent dentition, in good general health and without systemic diseases, who had received fixed orthodontic treatment.

Exclusion Criteria:

* Patients with primary dentition, enamel hypoplasia, dental fluorosis or tetracycline pigmentation and carious cavity were excluded.
Effects of Coffee Consumption on Health Among Adults

The purpose of this study is to research the changes of typical thermal processing food intervention on health outcome, metabolites, and gut microbiota, in order to explore the molecular mechanism of interaction between maillard reaction associated hazards and complex food matrix, and provide scientific basis and reference model for combining food nutrition and safety protection.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking, non-occupational exposed healthy volunteers, 18.5\<BMI\<30 kg/m\^2, were screened. If the evaluation of disease history, blood biochemistry and blood routine was normal, the volunteers were considered healthy.

Exclusion Criteria:

* The main exclusion criteria included people with high exposure to cold and fever, recent drug intake (including dietary supplement intake), alcohol intake, vegetarians, pregnancy, high-temperature processed meat and beverages such as coffee and milk tea.
Study to Determine if AZD0284 is Effective and Safe in Treating Plaque Psoriasis

The Sponsor is developing the study drug, AZD0284, for the potential treatment of Plaque psoriasis. Psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. The severity of the disease varies, but in many cases it can have a major impact on their quality of life if not adequately treated.

The purpose of the study is to determine the short term safety, pharmacodynamic and clinical effect of AZD0284 in patients with psoriasis.

This is a randomised, double-blind, placebo-controlled, multi-centre, parallel group Phase 1b study, designed to evaluate the pharmacodynamic effects, clinical efficacy and safety of AZD0284 compared with placebo as measured by the relative change from baseline in Psoriasis Area Severity Index (PASI score), other disease assessments of involved body surface area (BSA), static physicians global assessment score (sPGA), pruritis and biomarkers associated with the mechanism of disease and AZD0284. Disease activity will be assessed throughout the study as will changes in skin biopsy biomarkers. The study population will be comprised of patients with moderate to severe plaque psoriasis as defined by PASI score, BSA and sPGA.

Following completion of screening assessments and meeting all eligibility criteria, patients will be randomised to receive AZD0284 or placebo for 4 weeks of treatment followed by a 4 week follow up period

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent prior to any study specific procedures.
* At least 6 months documented history with a diagnosis of moderate to severe plaque psoriasis as defined by the Psoriasis Area and Severity Index (PASI), psoriasis Body Surface Area (BSA) and static Physician Global Assessment (sPGA).

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
* History and/or presence of tuberculosis, hepatitis, HIV. Other opportunistic infections within 6 months of the study.
* Clinically significant laboratory abnormalities.
* Clinically important abnormalities in rhythm, conduction or morphology of the digital Electrocardiogram (ECG) as considered by the Investigator may interfere with the interpretation of study data.
* Current treatment or treatment for psoriasis with biological therapies within 6 months of study.
* Efficacy and safety failure of biologic therapies targeting the IL-17 and IL12/23 pathway at any time.
* Current treatment or history of treatment for psoriasis with non-biological systemic medications within 4 weeks of Day 1
Neuralized1 and RGS14 Genes

Autism is a broad spectrum neurodevelopmental disease. Some individuals with ADS by high cognitive functions are diagnosed with High Functioning Autism (HFA). In some studies, it has been shown that NEURL1 gene increases learning and memory and RGS14 gene is suppressed them. We aimed to evaluate the differences between the expression levels of these genes between ASD, HFA and healthy controls and the role of these genes in the pathogenesis of ASD. Patients with 20 ASD and 20 HFA, and 20 healthy controls compatible with patient ages were included in this study. Expression of NEURL-1 and RGS14 genes was evaluated by quantitative Real Time PCR (qRT-PCR).

ASD is a neurological disease starting in the early stages of life and is characterized by cognitive and behavioral disorders (Ansel et al., 2008;Alvares et al., 2020). It is considered that the etiology of ASD stems from genetic, epigenetic and environmental factors; however, it has not yet been definitively clarified(Ito et al., 2017).

we aimed to evaluate the differences between the expression levels of these genes between ASD, HFA and healthy controls and the role of these genes in the pathogenesis of ASD.

Method:

Patients with ASD (n=20) and HFA (n=20), and healthy controls (n=20) compatible with patient ages were included in this study. Clinical evaluations of the patients were made and classification was made in accordance with DSM-IV diagnostic criteria.

High Pure RNA Isolation Kit (Roche Diagnostic, Version 12, Germany) was used for RNA isolation. cDNA synthesis was performed from these RNAs with the ranscriptor High Fidelity cDNA Synthesis Kit (Roche Diagnostics, GmbH, Mannheim).

qRT-PCR was performed using the LightCycler®480 Real Time Ready Assay Master Probe Kit (Roche Diagnostics, GmbH, Mannheim).The incubation was made with the PCR device program for 10 minutes at 95oC for 45 cycles, for 10 sec at 95oC, and for 60 sec at 60oC. The Ct values were obtained from the Light Cycler 480 Software Program, and both genes were analyzed separately. The comparative CT method (2-ΔΔCT) was used to determine the relative quantification of target genes, normalized to a housekeeping gene (β-actin).

Statisticaly:

The results of the experiments were evaluated using R 3.1.1 (www.r-project.org). and Chi-Square Tests, Mann-Whitney U-Test, Kruskal-Wallis H-Tests. The P\<0.05 level was taken as significant.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed ASD or HFA patient,
* Being between the ages of 2-16.

Exclusion Criteria:

* To use medicine,
* Have a other syndromic illness,
* Being younger than 2 years old or over 16 years old.
MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging

MRI 3D UTE Hyper-Cones \& ZTE for PET/MR lung attenuation correction \& for lung diagnostic imaging

The primary objective is to clinically test the feasibility of 3D UTE Hyper-Cones \& ZTE in capturing lung density of patients with lung diseases at reasonable clinical imaging times compared to standard MR lung protocols (LAVA-Flex, PROPELLER). Secondly, we want to investigate if Hyper-Cones \& ZTE can be used for lung imaging such as vessels and air-pathways, oncological patients, lung nodules and lung infiltration \& parenchyma pathophysiology such as chronic obstructive pulmonary disease.

Eligibility Criteria:
Inclusion Criteria:

* informed consent and signature
* clinical PET/CT planned and performed at Wagi site in Schlieren
* male or female patients
* from 18 to 80 years of age.

Exclusion Criteria:

- same exclusion criteria as for the clinical PET/CT exam (i.e. pregnant women).

Additional exclusion criteria:

- standard exclusion criteria for clinical MRI (evaluated by clinical standard determined by MRI questionnaire).
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* Between 18 to 65 years old

Exclusion Criteria:

* Patients in need of multiple organ transplants
Effect of an Investigational Lozenge (Biofresh® 4plus) Versus Placebo Control on Oral Malodor (Intra-Oral Halitosis)

This study is designed to evaluate the effect of an investigational lozenge with the enzyme polyphenol oxidase and green coffee extract in reducing and controlling intra-oral halitosis following immediate use and daily use of the lozenge over a one-week period.

This randomized, placebo controlled, double-blind, crossover study will use gas chromatography (GC) and oral microbial measurements to evaluate the reduction and control of intra-oral halitosis by an investigational lozenge containing the enzyme polyphenol oxidase and green coffee extract compared to a placebo control lozenge. A one-week washout period will precede the first crossover period and a one-week washout period will be implemented between periods 1 and 2. The study will consist of five study visits: Screening Visit, Period 1 Baseline Visit, Crossover Period 1 Day 8 Visit, Period 2 Baseline Visit, Crossover Period 2 Day 8 Visit.

Eligibility Criteria:
To be eligible for study participation, subjects must meet the following criteria:

Inclusion criteria:

1. Generally healthy males and females ≥18 years of age.
2. Able to read, sign and receive a copy of the signed informed consent form.
3. Have an average OralChroma™ reading ≥ 125 ppb hydrogen sulfide (H2S gas), volatile sulfur compound (VSC), based on 2 VSC measurements at Screening (Visit 1) and Baseline (Visit each 2 and 4), at least 12 hours after eating or drinking or oral hygiene.
4. Difference of the hydrogen sulfide gas readings is ≤ 500 ppb following the two mouth air samples for each VSC measurement for Screening (Visit 1) and Baseline (Visits 2 and 4).
5. Intra-oral cause of bad breath (non-systemic origin) as determined by health history or exam.
6. Have at least 18 natural teeth.
7. Agree to abstain from eating, drinking, breath mints, chewing gum, and any oral hygiene for at least 12 hours prior to evaluation of oral malodor at Screening, Baseline and Day 8 visits.
8. Agree to avoid drinking alcohol beverages and eating spicy foods, garlic and onions, cabbage, spices, cauliflower, and radishes (sulfur compounds) 48 hours prior to each study visit.
9. Agree to refrain from tongue brushing/cleaning for the duration of the study.
10. Adequate oral hygiene and no signs of oral neglect.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

1. History of allergy or significant adverse effects following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
2. History of allergies to ingredients in the test product.
3. Self-reported as pregnant or nursing.
4. Self-reported serious medical conditions.
5. Based on history and clinical exam: advanced and/or untreated periodontitis, frank caries, and mucosal diseases.
6. Antibiotic or anti-inflammatory medication within 30 days of screening visit.
The Effects of Stretching Versus Static and Dynamic Cupping on Lumbar Range of Motion

The objective of this study is to fill gaps in the literature regarding the effectiveness of cupping therapy on lumbar stiffness. Participants will be recruited from the University of South Carolina and from local clinics in Columbia, South Carolina. Individuals will be classified based on lumbar range of motion limitations, and then they will be equally dispersed into three treatment groups via stratified randomization. These groups include dynamic cupping, static cupping, or stretching. All participants will be assessed prior to selected treatment to obtain baseline values for four measures: back range of motion (BROM), pain pressure threshold (PPT), active straight leg raise (ASLR), and numeric pain rating scale (NPRS). Participants will be given each measure directly after treatment, followed by a follow-up measurement 24 hours after treatment.

Cupping therapy has become recently popular in Western culture due to affordability, lack of invasiveness, and low risk of adverse effects. However, there is insufficient evidence of the effectiveness on this treatment technique on decreasing pain and increasing range of motion. This project aims to help fill the gaps by using a larger sample size and clear methodology.

The aims of the study include to determine if both static and dynamic cupping therapy have a greater effect on BROM, PPT, ASLR, and NRPS as compared to stretching, and if any changes made are maintained to a different degree over a 24 hour period based on treatment. Additional aims of the study include to determine if there is a difference between type of cupping (static vs dynamic) on these four measures. By performing this study, scientific knowledge of cupping therapy will be improved and expanded, thus impacting how it is used in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, 50 degrees or less of lumbar flexion

Exclusion Criteria:

* Cancer, organ failure, collagen disorders, deep vein thrombosis, pacemakers, bleeding disorders, recent fever
A Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)

The purpose of this study is to determine if LY03005 is effective and safe in improve MADRS score, as compared to placebo (no medicine) in participants with Major Depressive Disorder (MDD)

The study consisted of two periods: a screening period of 1 week and a double-blind treatment period (8 weeks). After the screening period, 588 enrolled subjects were randomized into one of 3 study groups in the 1:1:1 ratio, 2 LY03005 treatment groups with different dose or 1 placebo group. Subjects were given investigatory drug or placebo according to the protocol, followed up at the end of 1, 2, 4 6, and 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 to 65 years subjects from outpatients;
2. Subjects currently meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for MDD with either single or recurrent episodes (296.2/296.3) without psychotic characteristics;
3. Subjects has a total score of the Montgomery- Åsberg Depression Scale (MADRS) ≥26 points at screening;
4. Subjects has a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening

Exclusion Criteria:

1. Allergic or known to be allergic to venlafaxine and desvenlafaxine;
2. Subjects with MDD who were not responsive to the previous venlafaxine treatment with sufficient amount and duration and to at least two different mechanisms of action antidepressants with adequate amount and duration in the past;
3. There is a clear suicide attempt or behavior and score of the 10th item (suicidal ideation) in MADRS scale is 4 points or greater;
4. Pregnant or lactating women,women who have a planned pregnancy in the near future;
5. Subjects meet the diagnostic criteria for other psychotic disorders(except for MDD) in DSM-5, such as Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Obsessive-Compulsive and related Disorders, post-traumatic stress disorder, separation disorders, anorexia nervosa or bulimia and personality disorder;
6. Subjects who meet the diagnostic criteria for substance or alcohol abuse (excluding nicotine or caffeine) 6 months prior to the screening;
7. MDD secondary to other mental illnesses or physical illnesses;
8. Those with a history of seizures (except for convulsions caused by febrile seizures in children).
Taste Test of a New Formulation of Sildenafil (Revatio)

taste of formulation

taste test None

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* History of hypersensitivity to test compounds or excipients.
Validity and Feasibility of Newborn Bed Monitoring Device - a Clinical Pilot Study

The aim of this clinical pilot study is to evaluate the validity, acceptability and usability of the newborn bed monitoring device among newborns, parents and healthcare professionals in hospital environment. The specific aims for the study are to:

1. validate the following infant parameters collected with the bed monitoring device: heart rate, breathing rate, movements.
2. evaluate the feasibility on detecting awake, REM and non-REM sleep stages
3. collect data on environmental factors from the infant sleep environment
4. explore how parents and healthcare professionals perceive the acceptability and usability of the bed monitoring device
5. describe the key requirements for the bed monitoring device to be implemented in the newborn care path

The participating newborns will be sleeping on the bed monitoring device for two hours and the measurements of the device will be compared with the reference device (golden standard). The acceptability and usability will be assessed by parents and healthcare professionals by fulfilling a questionnaire and participating in interviews.


Eligibility Criteria:
Inclusion Criteria for newborns:

* received informed consent from both parents/guardians
* newborn is treated in the Ward of families and newborns
* newborn is having normal health status without ongoing additional treatments. No exclusion criteria

Inclusion criteria for parents:

* being a parent of newborn participating in the study with bed monitoring device
* being able to participate in Finnish. No exclusion criteria

Inclusion criteria for healthcare professionals:

* being a healthcare professional working with newborns
* being able to participate in Finnish. No exclusion criteria
Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth

The aim of the study is to clinically evaluate the shade matching and clinical performance of the Universal shade composites Omnichroma and GC Essentia versus the multi shade composite Filtek Z350XT in restoring cervical lesions of anterior teeth.


Eligibility Criteria:
Inclusion Criteria:

* Class V carious lesions in anterior teeth
* Vital upper or lower anterior teeth with no signs of irreversible pulpitis and necrosis.
* Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Exclusion Criteria:

* Deep carious defects ( Close to pulp, less than 1 mm distance)
* Periapical pathology or signs of pulpal pathology
* Endodontically treated teeth
* Tooth hypersensitivity
* Possible prosthodontic restoration of teeth
* Heavy occlusion and occlusal contacts or history of bruxism
* Severe periodontal affection
* Lesions in premolars and molars
* Posterior teeth
Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care.

Oxaliplatin: 130mg/m2 given on day 1 by intravenous injection; and Docetaxel: 60mg/m2 given on day 1 by intravenous injection

Cycles are repeated every 21 days until disease progression, unacceptable toxicity or subject's withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic or locoregionally recurrent SCCHN deemed incurable by local therapy
* Measureable disease
* No prior use of palliative chemo after the SCCHN is deemed incurable by local therapy
* No prior treatment with oxaliplatin or docetaxel
* 18 years of age or older
* ECOG Performance status 0-1
* ANC 1,500/mcl or greater
* Adequate renal function
* Adequate liver function
* Recovered from acute and late effects of any prior treatment with a minimum of 4 weeks from the last session to enrollment in the study
* Patient or their legal representative must be able to read, understand, and provide informed consent
* Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication

Exclusion Criteria:

* Patients with an active documented infection or with a fever (38.5 degrees celsius or higher) within 3 days of the first scheduled dose of study treatment
* Patients with active CNS metastases
* Hypercalcemia related to SCCHN
* History of prior malignancy with the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia or localized prostate cancer
* Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel or to other drugs formulated with polysorbate 90
* Patients receiving concurrent investigational therapy or investigational therapy less than 30 days from first scheduled dose of study therapy
* Peripheral neuropathy grade 2 or higher
* Any medical condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
* History of allogeneic transplant
* Known HIV or Hepatitis B or C (active, previously treated or both)
Bioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation

Primary objective for this study is to demonstrate bioequivalence between Japanese commercial tablet and Japanese commercial image liquid formulation. Secondary objective for this study is to estimate the food effect for Japanese commercial image liquid formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease