cyrilzakka/clinical-trials huggingface dataset:
Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal

Over time, many different types of manual and electric toothbrushes have been produced. A systematic review has shown that some electric toothbrushes are more effective at removing bacterial plaque than manual toothbrushes. A new U-shaped electric toothbrush with silicone bristles has recently been produced that has a fully automatic and simultaneous action on both arches. However, its efficacy in removing bacterial plaque is not clear at the moment, as no randomized study has been published on this type of toothbrush.

The aim of this study is to compare the efficacy in terms of bacterial plaque removal in a single use of a new automatic U-shaped electric toothbrush, compared with the usual home toothbrushing procedure, a conventional electric toothbrush, and negative control (no toothbrushing) in a group of volunteer students of the School of Dentistry of the University of Florence, Italy.

Primary endpoint will be the difference in "full mouth plaque score" between before and after brushing. Secondary endpoints will be feeling of "clean mouth" evaluated on a VAS (Visual Analogue Scale) scale from 0 to 10 where 0 indicates no feeling of clean mouth and 10 maximum feeling of clean mouth.

This study will be a monocentric, randomized, controlled, superiority, cross-over study, with blind examiner and 4 therapies (U-shaped electric toothbrush, usual home toothbrushing procedure, conventional electric toothbrush, no toothbrushing), carried out in a single session with an interval of one week between the 4 therapies.

Study population will be students of the School of Dentistry who are healthy volunteers. Number of patients to be enrolled: 22. Inclusion criteria: age between 18 and 30 years; no fixed orthodontic appliance; presence of at least 20 teeth; Full mouth plaque score (FMPS) above 40%.

Exclusion criteria: subjects with manual disabilities to perform normal oral hygiene maneuvers; subjects allergic to silicone.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 30 years;
* no fixed orthodontic equipment;
* presence of at least 20 teeth;
* Full mouth plaque score (FMPS) above 40%.

Exclusion Criteria:

* Subjects with manual disabilities to perform normal oral hygiene maneuvers;
* Subjects allergic to silicone
The Glycemic Response Elicited by Beta-glucans of Different Physical Properties and Form

The ability of oat β-glucan to lower postprandial glycemic responses has been attributed to the viscosity of the solution in which the fibre is solubilized. To our knowledge, no studies have investigated the effect of β-glucan solutions on glycemic response when concentration, and thus viscosity, is varied by changing the solution volume but not the β-glucan dose. Therefore, the investigators will test the effects of altering β-glucan solution viscosity by altering solution volume at a fixed amount of β-glucan fibre.

The ability of β-glucan to lower postprandial glycemic responses has been attributed to the viscosity of the solution in which the fibre is solubilized. It has been demonstrated that the viscosity of a β-glucan solution increases with the molecular weight (MW) of β-glucan polymers, as well as the dose or concentration (C) of those polymers in solution. Numerous studies have shown that glycemic response-lowering is strengthened when the C of a β-glucan solution of fixed liquid volume is increased by increasing β-glucan dose. However, the C of a β-glucan solution depends on not only the amount of fibre present but also on the solution volume. To our knowledge, no studies have investigated the effect of β-glucan solutions on glycemic response when C, and thus viscosity, is varied by changing the solution volume but not the β-glucan dose. Therefore, the investigators will test the effects of altering β-glucan solution viscosity by altering solution volume at a fixed amount of β-glucan fibre. Knowing how to incorporate β-glucan into solution so that its physiological benefits are preserved will assist in the development of β-glucan-containing functional foods.

Eligibility Criteria:
Inclusion Criteria:

* healthy men and women

Exclusion Criteria:

* BMI greater than or equal to 35
* known to have diabetes, HIV, hepatitis or a heart condition
* use of medications or having a condition which may harm the subjects
* use of medication which may affect the study results
18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Diffuse Large B-cell Lymphoma

The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of diffuse large B-cell lymphoma can predict disease progression

In this study investigators develop a prognostic model based on 18F-FDG PET/CT and test its ability for prognostic value in patients with DLBCL. PET/CT scans evaluation using the liver SUVmax as reference. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold (1.6 fold of liver SUVmax) or new 18F-FDG avid lesions. 18F-FDG PET/CT-based prognostic model includes PET/CT image, dominant clinical and pathological prognostic factors to predicting disease progression during chemotherapy or survival in DLBCL.

Eligibility Criteria:
Inclusion Criteria:

1. newly diagnosed DLBCL;
2. treated using an anthracycline-containing regimen with or without rituximab;
3. minimal follow-up at 6 months after the completion of first-line treatment;
4. complete medical history and clinicopathological data

Exclusion Criteria:

1. secondary malignant disease;
2. serious infection or inflammation (e.g., HIV);
3. primary central nervous system lymphoma;
4. hepatic or renal dysfunction.
STOP (Shared Decision Making To Treat Or Prevent) HIV in Justice Populations

This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.

This study will be done in two phases. Phase 1 the R61 portion of the project will be a Pilot Study, and Phase 2 the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.

The focus of this registration is the pilot study. In Year 1 (R61; Aim 1) the intervention of the patient choice menu of options of PrEP/ART and SUD treatment services for justice involved people who use drugs (PWUD) to supplement established peer navigation (PN +PC) will be developed and pilot tested in Western Connecticut only (Fairfield, Litchfield, Southern New Haven Counties).

Implementation procedures for this study include needs assessment survey and focus groups consisting of CAB members and PNs to assess the types of services available in their community, as well as gaps in services and ideas of how services can be improved. These needs assessment surveys and focus groups will occur 3 times throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* able to provide written informed consent in English or Spanish;
* living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);
* Those with current justice involvement (with in the past 6 months) (e.g., prison, jail, community supervision);
* willing to have HIV testing to determine negative or positive status;
* persons with HIV who report not currently taking ART and have a viral load \>200 copies/mL in past 6 months OR persons who test negative for HIV who report not taking PrEP that meet CDC PrEP eligibility criteria in past 6 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and;
* have a current DSM-5 SUD (opioid and/or stimulant).

Implementation portion/CAB members:

* able to provide written informed consent in English or Spanish;
* working with persons with a history of justice involvement and substance use in the areas targeted for this project

PN Participants:

* able to provide written informed consent in English or Spanish;
* be employed at a project research site as a Patient Navigator

Exclusion Criteria:

* severe medical or psychiatric disability making participation unsafe;
* unable to provide consent.
* persons self-reporting pregnancy

Implementation portion/CAB members:

* persons self-reporting pregnancy
Testing the Effectiveness of Behavioral Text Messages to Promote Attendance at HMRE Sessions

The University of Florida offers relationship education programs named ELEVATE, for couples, and Smart Steps, for couples in stepfamilies, in Citrus, Duval, Manatee, Palm Beach, and Santa Rosa counties. Each workshop comprises 4 2.5-hour long sessions. The STREAMS evaluation will examine whether text messages informed by behavioral insight theory can improve couples' attendance at relationship skills education group sessions, and if so, which kinds of messages are most effective

The University of Florida operates the SMART program, which will offer four relationship education programs, each targeting a different population: (1) Relationship Smarts PLUS, for high school youth; (2) Before You Tie the Knot, for couples interested in marriage; (3) ELEVATE, for couples, and (4) Smart Steps, for couples in stepfamilies. All programming is offered through the University of Florida's IFAS Extension service in Citrus, Duval, Manatee, Palm Beach, and Santa Rosa counties.

The STREAMS evaluation will test text messaging strategies with couples enrolled in ELEVATE and Smart Steps. It will examine whether text messages informed by behavioral insight theory can improve couples' attendance at relationship skills education group sessions, and if so, which kinds of messages are most effective. ACF staff have noted that among the most common technical assistance requests from HMRE grantees are help with improving participation. Even if relationship skills sessions are offered in a convenient location where adults receive other services and even if programs offer transportation, child care and other assistance to facilitate regular program attendance, achieving consistent participation in these voluntary programs can be challenging. The University of Florida study will help address these challenges by examining whether text messages based on behavioral theories can work as a simple, practical strategy for improving program participation in group sessions. More broadly, the site will also add to the large and growing effort across the federal government to study the use of behavioral interventions or "nudges" to improve social programs.

Eligibility Criteria:
Inclusion Criteria:

* Couple
* Both partners consent to receive text messages

Exclusion Criteria:

* Single Adults
* Either Partner or both do not consent to receive text messages
Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain

A controlled and randomized clinical trial will be conducted, in which scores on dependent variable measures will be compared before and after the intervention, both in the experimental group (EG) (individuals who will attend the in an aquatic program based on the back school) and in the control group (CG) (individuals who will not attend the in an aquatic program based on the back school). The experimental procedure will follow the recommendations of the CONSORT and TidIER guidelines. The study protocol will be approved by the Research Ethics Committee of the University of Vigo. This study will be conducted under the Declaration of Helsinki (2013 version). Participants will sign a written informed consent after being informed of the benefits and risks of the research. Participants in the EG will participate in an aquatic program based on the back school. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports centre. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totalling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus and the other two will have a theoretical focus.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age.
* With non-specific low back pain for at least three months, with pain intensity (30-70 on a VAS).

Exclusion Criteria:

* History of cancer, spine infection, rheumatologic diseases, history of spine fracture, history of trauma, red flag signs including unwanted weight loss (exceeding 10 percent of the total body weight) in the past six months and fever, history of psychological disease and history of spine surgery, radiculopathy, anatomical and congenital disturbance.
* Missing more than two Back School sessions.
* Not being able to attend the measurement sessions.
a Study in Subjects With Otoferlin Mutation-related Hearing Loss Using RNA Base-eDiting Therapy(SOUND)

The purpose of the study is to determine whether HG205 as CRISPR/Cas13 RNA base-editing therapy is safe and effective for the treatment of hearing loss caused by p.Q829X mutation in OTOF gene.


Eligibility Criteria:
Inclusion Criteria:

* Male or females between 1 and 16 years of age at the time the subject/parent/legal guardian signs the informed consent form.
* Willing to adhere to the protocol as evidenced by written informed consent or parental permission and subject assent.
* Molecular diagnosis of biallelic mutations in the OTOF gene with at least one mutation being p.Q829X through collected blood samples at screening;
* Based on auditory brainstem response (ABR), clinically diagnosed sensorineural hearing loss (SNHL) with the following hearing thresholds: severe (65 dB ≤ hearing threshold \< 80 dB) or profound (80 dB ≤ hearing threshold \< 95 dB) or complete (hearing threshold ≥ 95 dB) hearing loss in both ears.
* Acceptable hematology, clinical chemistry, and urine laboratory parameters.

Exclusion Criteria:

* Pre-existing other hearing-loss conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints or complications of surgery.
* Presence of cochlear implants in the study ear.
* Complicating systemic diseases or clinically significant abnormal baseline laboratory values.
* Complicating systemic diseases would include those in which the disease itself, or the treatment for the disease, can alter hearing function.
* Prior participation in clinical study with an investigational drug within the past six months.
* Prior gene therapy treatments.
* Any condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation.
The Use of Aromatherapy for Symptom Management

The purpose of this pilot study is to introduce the use of aromatherapy/essential oils to medical oncology patients at Central DuPage Hospital to assess their perceived effectiveness to relieve symptoms of nausea or vomiting and/or anxiety.

Peppermint oil will be used for nausea/vomiting and lavender oil will be used for anxiety. This study will involve administration of aromatherapy to a convenience sample of patients, who will then be asked to complete a brief questionnaire. The questionnaire will involve a simple likert scale to measure efficacy (in the opinion of the patient) and simple multiple-choice questions to determine patients' likeliness to use aromatherapy again.


Eligibility Criteria:
Inclusion Criteria:

* Adult hospitalized medical oncology patients admitted to Central DuPage Hospital.
* Age 18 years or greater.
* Able to understand and speak English.
* Women of non-childbearing potential or with childbearing potential with a negative pregnancy test documented during the hospital stay.
* Able to understand concept of aromatherapy for treatment of distressing symptoms.

Exclusion Criteria:

* Prisoners.
* Non-English speaking patients.
* Under the age of 18.
* Unable to comprehend the concept of aromatherapy.
* Severe cognitive impairment.
* Not experiencing the symptoms of nausea, vomiting or anxiety.
* Women with child-bearing potential who have not had a negative pregnancy test during the hospital stay.
* Patients with known allergy to lavender or peppermint.
The Combination of PSMA-PET/MR and p2PSA in Early Diagnosis of Prostate Cancer

This is a single center prospective non-randomized controlled study.

The goal of this clinical trial is to figure out whether the combination of PSMA-PET/MR and PHI could add values to each method alone. The main questions it aims to answer are:

* Compare the diagnostic value of the combination with each alone and set up a diagnostic model.
* Compare the diagnostic value of PSMA-PET/MR+PHI to mpMRI+PHI.
* Evaluate the diagnostic value the combination of PHI and PSMA-PET/MR in suspected PCA patients.

Patients will experience mpMRI or PSMA-PET/MR and their blood samples will be used to test PSA and p2PSA. Prostate biopsy will be the golden standard.


Eligibility Criteria:
Inclusion Criteria:

1. Preoperative clinical judgment of suspected early prostate cancer (according to NCCN guidelines): meet PSA ≤ 20ng/ml and clinical stage\<T3, while meeting one of the following criteria:

   ① Digital rectal examination revealed suspicious nodules of the prostate;

   ② Transrectal prostate ultrasound or MRI found suspicious lesions;

   ③ PSA\>10 ng/ml；

   ④ PSA 4\~10ng/ml, f/t PSA suspicious or PSAD value suspicious;
2. Aged between 18 and 85 years;
3. Generally in good health, able to tolerate and cooperate with research interventions, such as prostate biopsy and radical prostatectomy Etc;
4. Provide a signed and dated informed consent form;
5. Commit to complying with research procedures and cooperate in the implementation of the entire process of research.

Exclusion Criteria:

1. Preoperative clinical characteristics of suspected high-risk prostate cancer (according to NCCN guidelines): meet PSA\>20 ng/ml or clinical stage ≥ T3;
2. Have received any treatment (endocrine therapy, radiotherapy, chemotherapy, prostate resection, etc.)
3. Have had prostatitis (infectious or non infectious) 3 months before the examination
4. Taking 5a reductase inhibitors
5. Previously diagnosed with prostate cancer
6. In the acute infection period and fever period;
7. Have a hypertensive crisis;
8. In the period of decompensation due to cardiac insufficiency;
9. Diseases with a tendency to severe bleeding;
10. In diabetes, blood sugar is unstable;
11. Have severe internal and external hemorrhoids, perianal or rectal lesions;
12. Combined with other systemic malignant tumors;
13. Implantation of functional electronic devices and various stimulators such as cardiac pacemakers, cochlear implants, and cardiac stents in vivo, with implants made of ferromagnetic materials (such as iron, cobalt, nickel, etc.);
14. A perfusion device implanted in the body, such as insulin or other perfusion pumps;
15. Have a history of surgery within the past 3 months, especially organ transplantation, heart and kidney surgery;
16. People with claustrophobia.
Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures

Intramedullary nailing is the standard treatment of trochanteric fractures. Mechanical failure such as cut-out and cut-through are associated with high rates of revision surgery, functional impairment and mortality. Augmentation of the implant have shown encouraging results in reducing the number of mechanical failures. The aim of the study was to evaluate the rate of mechanical failure of the cement augmented screws of TFNA nails.

A descriptive, retrospective, multi-operator, single-centre study was performed at our level 1 trauma centre. Patients were included if they were \> 65 years of age, presented with a trochanteric fracture treated with an augmented TFNA nail. The primary outcome was fixation failure rate (cut-out or cut-through) at 3 and 6 postoperative months. Secondary endpoints were intraoperative data, clinical scores, and radiographic analysis.


Eligibility Criteria:
Inclusion Criteria:

* \> 65 years of age
* a trochanteric fracture that occurred through a low-energy mechanism
* an augmented TFNA nail

Exclusion Criteria:

* pathological fracture
* open fracture
* hips with pre-existing deformities other than osteoarthritis
* a history of hip surgery
* an insufficient quantity of injected cement (\< 3 mL).
Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users

The aim of the present pilot study is to evaluate the effect of antiperspirant to treat residual limb hyperhidrosis with the emphasis on the utility of the iodine-starch test to identify the location of the sweating.

Many persons with lower limb amputation report that they have major problems with sweating (hyperhidrosis) on the stump in connection with prosthetic use. Despite the frequency and the negative effect of sweating for prosthetic users, there is a lack of evidence on how the sweating should be examined and treated. In the dermatological literature, the guidelines recommend the use of topical antiperspirants such as aluminum chloride as first-line treatment. No studies have previously been published evaluating the effect of antiperspirant on prosthetic users.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years,
2. used a prosthetic for at least 1 year,
3. HDSS score of ≥ 2,
4. use the prosthetic daily and be able to walk for a minimum of 10 minutes.

Exclusion Criteria:

1. Open wounds on the stump,
2. Known sensitivity or allergy to iodine and/or starch,
3. Known sensitivity to antiperspirant.
Observational Study on Levemir® in Obese Diabetic Patients

This study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients. A local extension will be conducted in Slovenia in order to reach the planned 400 patients for the sub-analysis of Slovenian patients.

Included in the study is a retrospective part to evaluate the weight progress since initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD) and/or bolus insulin therapy. Retrospective data will be collected at baseline and at approximately 6 and 12 months before starting insulin detemir therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus (Type 1 or type 2)
* BMI greater than 27 kg/m\^2, or more than 3 kg weight increase since start of insulin therapy

Exclusion Criteria:

* Subjects currently being treated with insulin detemir
* Subjects who were previously enrolled in this study;
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months Female patients will be reminded to use adequate contraceptive during the study, where is relevant.