cyrilzakka/clinical-trials huggingface dataset:
Stannous Fluoride and Gingivitis

8-week study using stannous fluoride toothpaste on subjects with gingivitis ("unhealthy") and without gingivitis ("healthy"). Gingivitis index will be performed at BL, Week 4 and Week 8. A number of biological samples will be collected at each timepoint.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older;
* Provide written informed consent and receive a signed copy of consent;
* Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study;
* Agree not to participate in any other oral care studies for the duration of this study;
* Agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products;
* Agree to return for all scheduled visits and follow study procedures;
* Have at least 16 natural teeth;
* Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.

For Unhealthy Group:

* Have at least 20 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and
* Have a minimum of 3 sampling sites with bleeding and pocket depth \>/=3mm but not deeper than 4mm at the Screening visit.

For Healthy Group:

* Have a maximum of 3 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and
* No pockets deeper than 2mm.

Exclusion Criteria:

* Self-reported pregnancy or the intent to become pregnant anytime during the course of the study;
* Inability to comply with study procedures;
* Rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
* Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;
* Fixed orthodontic appliances or attachments for aligner treatment;
* Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
* Having taken antibiotics or used anti-gingivitis/anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
* Needing an antibiotic prophylaxis prior to dental visits;
* Presenting with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or
* Having any condition or disease, as determined by the Investigator/Designee which could be expected to interfere with examination procedures or with the subject's safe completion of the study.
Determinants of Functional Capacity in Children With Asthma

The primary aim of this study is to compare the respiratory function, respiratory muscle strength, functional capacity, and lower extremity strength of children with asthma and healthy children in the same age group. The secondary aim of our study is to determine the determinants of functional capacity in children with asthma.


Eligibility Criteria:
Asthma Group Inclusion Criteria:

* Being between the ages of 6-17
* Being diagnosed with asthma
* Able to walk, cooperate and clinically stable
* Being a volunteer to participate in the study
* To be able to speak, read, understand, and cooperate in Turkish

Asthma Group Exclusion Criteria:

* History of previous lung or liver transplant
* Having an acute exacerbation and/or a history of hospitalization in the last 1 month
* Having diagnosed orthopedic problems affecting mobility or a history of musculoskeletal surgery

Control Group Inclusion Criteria:

* Being between the ages of 6-17
* To be able to speak, read, understand, and cooperate in Turkish
* Being a volunteer to participate in the study

Control Group Exclusion Criteria:

* Having a diagnosed vision, hearing, or neurological disease that may affect balance
* Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic disease or pathological condition that would affect assessments
* Resting saturation below 90% during exercise tests
The Value of EMDR in the Treatment of Tinnitus

A prospective, randomized, controlled, clinical trial with blind evaluator that uses TRT and EMDR as a treatment for tinnitus.

Patients with subjective, chronic, non-pulsatile tinnitus will be randomized in two treatment groups: TRT and CBT versus TRT and EMDR. Evaluations will take place at baseline before therapy starts, at the end of the treatment, after 3 months (10 treatment sessions) and 3 months after therapy ends. The Tinnitus Functional Index (TFI) will be used as the primary outcome measurement. Secondary outcome measurements will be the Visual Analogue Scale of Loudness (VAS), Tinnitus Questionnaire (TQ), Hospital Anxiety and Depression Scale (HADS), Hyperacusis Questionnaire (HQ), psychoacoustic measurements and Event-related potentials (ERP). The objective is to evaluate whether the bimodal therapy TRT and EMDR can provide faster and/or more relief from the annoyance experienced in chronic tinnitus patients' daily lives compared to the bimodal therapy TRT and CBT.

Eligibility Criteria:
Inclusion Criteria:

* Tinnitus type: chronic, subjective, non - pulsatile tinnitus
* Duration of tinnitus = more than 3 months
* Minimum age of the patient is 18 years old - maximum age is 75 years old
* Tinnitus Functional Index (TFI) score ≥ 25 - \< 90
* Stable use of medication during therapy

Exclusion Criteria:

* HADS - score: anxiety and depression-subscores \> 15
* HQ - score \> 40
* Objective, pulsatile tinnitus
* Active middle ear pathology
* Neurological and psychiatry co-morbidity for which currently psychotherapy is ongoing
* Psychosis, schizophrenia, epilepsy
* Pregnancy
Influence of the COVId-19 Pandemic on STRESS, and Screening Procedures (COVISTRESS Screening)

Coronavirus has caused containment of more than a third of the world's population. Some countries have used a major screening strategy. Screening procedures, such as waiting (or resulting) for the test, can be stressful and can attract the most stressed people. However, there is currently no data on the relationship between stress and screening for SARS-CoV2

This is an observational study by REDCap questionnaire® via a flyer deposited in the waiting room of the COVID screening centres. No incentive to complete the questionnaire will be made. The self-survey will assess stress and its relationship to SARS-CoV2 screening procedures, socio-demographic factors or lifestyle habits. This Screening questionnaire includes 31 questions.

Eligibility Criteria:
Inclusion Criteria:

* All volunteers who are screened

Exclusion Criteria:

* None
Salivary Immunoglobulin A (sIgA) Normal Range Study

Salivary Immunoglobulin A (sIgA) is a marker of immune system activity. Typically, sIgA is determined by an ELISA test in which samples have to be sent to a specialized laboratory for testing. Investigators have developed a new instrument that is small, portable, and easy to use. This instrument is available for consumers to purchase and test their own sIgA at home.


Eligibility Criteria:
Inclusion Criteria:

* Adults committed to attend the session and follow the instructions described in Experimental Design will be included.

Exclusion Criteria:

* Participant with mouth infection or oral disease
A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605

A phase 3 study to evaluate efficacy and safety of HCP1401

A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605

Eligibility Criteria:
Inclusion Criteria:

* Hypertension patient who satisfied below condition at Visit 1.

  * patient who takes antihypertensive drug

    * 140mmHg \<= sitSBP \<= 200mmHg
  * patient who doesn't take antihypertensive drug

    * 160mmHg \<= sitSBP \<= 200mmHg
    * 140mmHg \<= sitSBP \<= 200mmHg at Visit 2

Exclusion Criteria:

* Patient who have received 4 or more antihypertensive drug
* Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1
* Patient with sitDBP \>= 120mmHg at Visit 2
* Patient with secondary hypertension
A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease

The purpose of this study is to determine whether ticagrelor is effective in reducing the number of days of pain, intensity of pain, and reducing the use of analgesics due to sickle cell disease

This is a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, study evaluating 2 doses of ticagrelor in 90 patients aged 18 to 30 years, with sickle cell disease (SCD). Patients will be randomised to double-blind double-dummy treatment period in a 1:1:1 ratio (30 to each treatment group) to receive ticagrelor 10 mg twice daily (bid), or ticagrelor 45 mg bid, or placebo bid to determine the frequency of days with pain using an electronic diary (eDiary) every day. Approximately 180 patients will be enrolled. Patient will be followed for safety assessment during and after 2 weeks of treatment completion.

During the 16 week treatment period, patients will complete a daily eDiary concerning daily pain intensity, pain location, use of analgesics and absence from school or work. At the end of the study patients will be asked to rate the change in their sickle cell pain compared to the start of treatment. Platelet aggregation will be measured and reported as P2Y12 reaction units (PRU) pre-dose and 2 hours post-dose at week 4 and week 5 after treatment start. Pharmacokinetic (PK) parameters will be measured at 2 hours post-dose at week 4, and pre-dose and at 2 hours post-dose at week 5. Biomarkers will be assessed pre-dose at week 4, week 5 and week 8. During the study, patients will be evaluated for adverse events (AEs) including bleeding and vaso-occlusive crisis (VOC).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed medical history or diagnosis of homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β0) by HPLC
* If treated with hydroxyurea, the dose must have been stable for 3 months

Exclusion Criteria:

* History of transient ischaemic attack or clinically overt cerebrovascular accident
* Moderate or severe hepatic impairment
* Treatment with chronic red blood cell transfusion therapy
* Pre-dominate cause of pain is not sickle cell disease related
* Chronic treatment with anticoagulants or antiplatelet drugs.
The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients

Spirulina, a widely used food supplement, improves the lipid profile and glycemic control in people living with diabetes, suggesting that it could have some effects on insulin sensitivity. Since HIV-infected patients develop metabolic abnormalities due to the virus and/or to antiretroviral (ARV) drugs, the investigators therefore proposed to evaluate the effect that spirulina can have on HIV/HAART-associated insulin resistance

Even though antiretroviral therapy (ART) has dramatically improved the health of people living with HIV/AIDS, the prospect of maintaining patients long term on ART can be severely restricted by the development of serious long term effects in their metabolism. These abnormalities include dyslipidemia, lipodystrophy and disorders of glucose metabolism with insulin resistance believed to be the underlying pathophysiological mechanism.

Spirulina, has recently drawn attention on its cholesterol and blood pressure lowering effects, including improvement of glycaemic control in diabetics subjects, suggesting it can have some effects on insulin sensitivity.

The aim of this three month, experimental, prospective, randomised trial was to evaluate the effect of Spirulina on HIV/HAART-associated insulin resistance on 33 subjects. Primary outcome was change in insulin sensitivity during the trial, over two time periods; t=0 and t=12 weeks. The second objective was to compare between the two groups, the percentage of subjects who improved insulin sensitivity by the end of the study.

Recruitment started in October 2008 and the trial ended in February 2009.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV infection
* Accepted to participate in the study

Exclusion Criteria:

* Acute intercurrent infection
* Treatment that modifies glucose or lipid profile
* Pregnancy
* Known diabetic patient
* Chronic renal failure with calculated creatinine clearance \< 60ml/min
Multi-domain Psychoeducation Self-management Program for Adults With MDD in Singapore

This is a single-centre, two-arm, unblinded pilot randomised controlled trial study on 60 participants (30 in each arm) from the community mental health service (CMHS) centre within a social service agency in Singapore based on inclusion criteria. The study will examine the effects of a 5-sessions of Multi-domain Psychoeducation Self-management Programme and treatment-as-usual) over 5 weeks or control (treatment-as-usual) group.

This is a single-centre, two-arm, unblinded pilot randomised controlled trial study. A total of 60 participants (30 in each arm) will be conveniently recruited from the community mental health service (CMHS) centre within a social service agency in Singapore based on inclusion criteria. Block randomisation with a block size of two will be used to randomise participants into the intervention (5-sessions of Multi-domain Psychoeducation Self-management Programme and treatment-as-usual) over 5 weeks or control (treatment-as-usual) group. Primary outcomes measures which include self-management competence, self-efficacy to manage emotions, mental health quality of life and depressive symptoms severity, will be collected at three timepoints: (T1) baseline, (T2) immediately post-intervention and (T3) three months post-intervention. Quantitative data will be analysed using the Statistical Package for Social Sciences (SPSS) software using non-parametric tests. Secondary outcomes include the feasibility and acceptability of the MPSP. Feasibility of the intervention will be evaluated using pre-defined recruitment, attendance and follow-up rates. Acceptability of the intervention will be evaluated using a semi-structured interview guide based on the Theoretical Framework of Acceptability, immediately post-intervention (T2) or not more than a week from the last session. Data for acceptability will be transcribed verbatim and thematically analysed based on Braun and Clarke's thematic analysis guideline.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with Major Depressive Disorder
* Community-dwelling adults aged 21 to 80 years old
* Singaporean or permanent residents
* Literate in the English language
* Willing to be video or audio-recorded during the qualitative interview sessions for acceptability of intervention

Exclusion Criteria:

* Clinically diagnosed with maternal depression
* Clinically diagnosed with cognitive impairment/ intellectual disability
* Pregnant women
* Currently institutionalised in a long-term care facility
* Currently attending other psychoeducation self-management programmes
* Those who do not agree to the audio or video recording.
A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg

14-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic, intractable pain in the foot and/or lower leg for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects with indwelling devices that may pose an increased risk of infection
8. Subjects currently has an active infection
9. Subject has participated in another clinical investigation within 30 days
10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
11. Subject has been diagnosed with cancer in the past 2 years.
Assessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients

The purpose of this study is to determine the efficacy of oral L-Citrulline on endothelial function and vasodilation in patients with coronary artery disease(CAD) by evaluating the brachial artery diameter in the antecubital area by ultrasonography.

Before prescribing the drug or placebo, the patients were evaluated via the ultrasound machine equipped. The brachial artery diameter in the antecubital area was measured by the ultrasound and was recorded. Then blood pressure cuff was attached on the arm and dilated 50mmhg above the systolic pressure and for 5 minutes remained the same level to induce ischemia at distal tissues until the occurrence of compensatory vasodilatation. Then the brachial artery diameter (as an estimation of FMD) was measured and recorded. After 4 minutes of administration of 2 puffs of nitroglycerin spray, the brachial artery diameter (as an estimation of NMD) was measured.

After 15 days treatment with the L-Citrulline or the placebo, the patients underwent the ultrasonography again and the above assessments were done.

Improvement of FMD to NMD ratio (before L-Citrulline prescription) to FMD to NMD ratio (after L-Citrulline prescription) is determined as "improvement of flow mediated dilation to nitroglycerin dependent vasodilation" evaluate.

Eligibility Criteria:
Inclusion Criteria:

* history of documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio less than 1

Exclusion Criteria:

* no documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio equal /more than 1
Improving College Students' Mental Help-Seeking Intention During the COVID-19 Pandemic

This study aimed at testing the effectiveness of a longitudinal intervention in increasing college students' intention to seek mental help during the pandemic.

This study aimed at testing the effectiveness of a longitudinal intervention in increasing college students' intention to seek mental help during the pandemic.

A four-armed randomized controlled experiment was conducted to compare two self-persuasion methods against two control conditions. Assessments took place at baseline (T0), post-first treatment (T1), post-second treatment (six weeks, T2), and ten-week follow-up (T3).

The results showed that the intervention significantly increased students' help-seeking intention, attitude, and efficacy at different time points. It also reduced mental help-seeking-related stigma after the first task.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Full-time undergraduate students
* Had more than a moderate amount of mental distress

Exclusion Criteria:

* Under 18 years old
* Not full-time undergraduate students
* Had less than a moderate amount of mental distress
Hepatitis C Virus (HCV) Positive Liver Grafts in HCV Negative Recipients

To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV sero-negative liver recipients who are currently listed.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18 and older
* Active on the transplant list
* Donor organ with Antibody and nucleic acid test (NAT) positive for HCV
* Graft with F2 fibrosis or less at time of explant
* HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
* Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject

Exclusion Criteria:

* Participants co-infected with HIV
* Donor previously treated with a non-structural protein 5A (NS5a) containing regimen (if treatment history of donor known)
* Known allergies or hypersensitivity to direct acting antiviral drug (DAA) or ribavirin (RBV)
* Pregnancy and/or actively breastfeeding