cyrilzakka/clinical-trials huggingface dataset:
Use of Ozonized Water With Toothpaste and Mousse in Non Surgical Periodontal Therapy for Patients With Diabetes Mellitus Type 1: a Randomized Clinical Trial.

The aim of this study is to evaluate the efficacy of Peribioma Toothpaste and Mousse for home oral care in patients with Diabetes Mellitus Type 1.

Patients will undergo a professional oral hygiene procedure, followed by irrigation with ozonized water.

Patients will be randomly divided into two groups:

* Trial Group: patients will use Biorepair Peribioma Toothpaste and Mousse for home oral care
* Control Group: patients will use Biorepair Plus Parodontgel toothpaste for home oral care.

The variations of the following indices will be evaluated at the baseline, after 3 and 6 months: glycosylated hemoglobin (HbA1c) , Clinical Attachment Level (CAL), Plaque Index (PI), Probing Pocket Depth (PPD) and Bleeding on Probing (BoP).

The aim of this study is to evaluate the efficacy of Peribioma Toothpaste and Mousse for home oral care in patients with Diabetes Mellitus Type 1.

Patients who respond to eligibility criteria and that will sign the informed consent will undergo a professional oral hygiene procedure; then, ozonized water (aquolab) will be used to irrigate periodontal pockets for 1 minute.

Then, patients will be randomly divided into two groups:

* Trial Group: patients will use Biorepair Peribioma Toothpaste and Mousse for home oral care until the end of the study;
* Control Group: patients will use Biorepair Plus Parodontgel toothpaste for home oral care until the end of the study.

Changes in the following indices will be evaluated at the baseline, after 3 and 6 months: glycosylated hemoglobin (HbA1c) , Clinical Attachment Level (CAL), Plaque Index (PI), Probing Pocket Depth (PPD) and Bleeding on Probing (BoP).

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from Diabetes Mellitus Type 1
* adult patients
* patients who agreed to participate to the study and that signed the informed consent.

Exclusion Criteria:

* patients taking intravenous or oral Bisphosphonates at the study begin or in the previous 12 months
* patients with low compliance and motivation to participate
* pazienti irradiati alla testa o collo negli ultimi 12 mesi
* pregnant or breastfeeding women
* alcohol and drug abuse
* patients with psychiatric diseases
REGISTRY for the Use of a Software for Automatic Detection of the Evolution of Aneurysmal Volume and Graft Migration After EVAR (EndoVascular Aneurysm Repair)

The objective of this registry is to find and validate a correlation between morphological indicators such as volume sac evolution, graft migration or length between anatomical landmarks with aneurysm rupture risk or complications such as endoleaks requiring re-intervention... Secondary objectives are the validation of the reproducibility and accuracy of a dedicated fully automated software enabling Abdominal Aortic Aneurysm (AAA) segmentation to measure AAA diameter, volume evolution and growth over time, proximal and distal sealing zones analyze as well as device migration and integrity after EVAR on computed tomography angiography (CTA). This validation is in comparison with semi-automated analyse controlled by physician.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age
* Infra-renal Abdominal Aortic Aneurysm (AAA) treated with EVAR

  * ≥50mm
  * or ≥5mm increase in 6 months
  * or surviving Ruptured AAA
* legal capacity to make own decisions, informed of the nature of the registry, has signed non opposition form available for set-up and proper implementation of follow-up visits throughout the duration of the registry

Exclusion Criteria:

* Advancing Alzheimer's disease or socially dependent patient
* Opposition to the use of their data for this research
* Life expectancy supposed to be inferior to 2 years Pregnant female
Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)

The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.

This is a prospective open label, single center pilot trial that will evaluate regadenoson compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty eight subjects will be enrolled and get Adenoscan® administered via IV followed by Regadenoson IV.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective left heart catheterization
* Age ≥ 18 years (female not of child bearing potential)
* Able to provide written informed consent

Exclusion Criteria:

* Contraindications to administration of either Adenoscan® or Regadenoson
* High degree AV block, sick sinus syndrome without a functioning pacemaker
* Symptomatic bradycardia
* Recent STEMI (\< 5 days)
* Recent NSTEMI (\<5 days) if the peak CK is \> 1000 IU
* Dipyridamole use within 24 hours
* Adenoscan® is contraindicated (hypersensitivity to Adenoscan®, Regadenoson, or aminophylline
* Known severe bronchoconstrictive lung disease
Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)

The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Participants at least 20 years but under 65 years of age;
* Participants of American Society of Anesthesiologists (ASA) class 1-3;
* Participants scheduled for a surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of a neuromuscular blocking agent (NMBA) with an anticipated duration of surgery between 2 and 5 hours;
* Participants scheduled for a surgical procedure in supine position;
* Participants who had given written informed consent.

Exclusion Criteria:

* Participants in whom difficult intubation was expected because of anatomical malformations;
* Participants known or suspected to have neuromuscular disorders affecting NMB and/or significant renal dysfunction. In Germany, this also included serum creatinine and blood urea nitrogen outside local reference ranges;
* Participants known or suspected to have a (family) history of malignant hyperthermia;
* Participants known or suspected to have an allergy to medications used during general anesthesia;
* Participants receiving medication interfering with NMBAs, such as antibiotics, anticonvulsants and Mg\^2+; based on the dose and time of administration;
* Pregnant or lactating females;
* Female participants of childbearing potential not using any birth control or using only hormonal contraception as birth control;
* Participants who had already participated in trial CT 19.4.312, or in another trial with sugammadex;
* Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into CT 19.4.312.
Multimodal Program for Cancer Related Cachexia Prevention

The aim of the study is to evaluate the effectiveness of a multifactorial education and support program for the prevention of cancer-related cachexia syndrome, for patients and their family caregivers during anti-cancer treatment.

After being informed about the study and the need to nominate a family caregiver, all patients and their family caregiver giving written informed consent, they will undergo a 12-weeks multimodal program. Randomly they will divided into two groups (intervention and control). This 12-weeks multimodal program includes 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older
2. Participants must be diagnosed with solid tumour (stomach, colorectal, pancreas, breast, lung)
3. Participants needing chemotherapy/immunotherapy/hormone therapy/target therapy
4. Participants must be normal or pre cachectic as defined by the guidelines
5. Read and understand Greek or English

Exclusion Criteria:

1. Haematologic tumors
2. Parenteral Nutrition
3. ECOG Performance status \>2 or Karnofsky Performance Status \<60%
4. Participant who can not introduce a family caregiver
5. Participants in cachexia or refractory cachexia stage as defined by the guidelines below:

   * \>5% weight loss over the past 6 months (in absence of simple starvation); OR
   * BMI \<20 and any degree of weight loss \>2%; OR
   * Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men \<14.6 kg/m²; women \<11.4 kg/m²) and weight loss \>2%
6. Patients who use complementary therapies (ex-acupuncture)
Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals

The purpose of this study is to assess whether a boosting by cobicistat results in similar concentrations of darunavir in the brain compared to a boosting by ritonavir.

Cobicistat is a new pharmacokinetic enhancer or booster of the HIV protease inhibitor darunavir. Cobicistat is distinct from the conventional booster ritonavir in that cobicistat presents a more selective inhibition of the enzymes metabolizing drugs. In addition, cobicistat is a weaker inhibitor of the efflux drug transporters expressed at the level of the blood-brain barrier (i.e. P-glycoprotein (P-gp) and breast cancer resistance Protein (BCRP)). A weaker inhibition of these efflux transporters could possibly result in less darunavir entering the brain when boosted by cobicistat as compared to a boosting by ritonavir. Such a difference could potentially be critical in patients with HIV-associated neurocognitive disorders as sufficient drug levels are needed to efficiently inhibit HIV replication inside the brain.

The aim of this study is to determine whether the boosting of darunavir by cobicistat results effectively in lower darunavir concentrations in the CSF as compared to a boosting by ritonavir. The study will be performed in HIV infected patients presenting HIV associated neurocognitive disorders (HAND) and requiring a lumbar puncture for clinical reasons. In addition, the patients will be only eligible if the are treated or if they qualify for a darunavir/ritonavir (800/100 mg once daily) containing regimen. Darunavir concentrations will be measured simultaneously in the CSF and plasma (CSF/plasma ratio) first with the ritonavir boosting and subsequently with the cobicistat boosting.

Eligibility Criteria:
Inclusion Criteria:

* documented HIV infection
* presence of HIV associated neurocognitive disorders requiring a lumbar puncture for clinical reasons
* treatment or qualifying to be treated with a HIV therapy including darunavir/r (800/100 mg once daily)
* ability to comply with the study requirements
* informed consent

Exclusion Criteria:

* conditions which disrupt the blood-brain barrier and thereby impact the entry of drugs in the brain (meningitis, meningoencephalitis, multiple sclerosis, progressive multifocal leucoencephalopathy)
* co-medications inhibiting/inducing P-glycoprotein and BCRP
* co-medications inhibiting/inducing cytochrome P450 isoenzyme 3A4 (CYP3A4)
* non adherence to Treatment
* pregnancy
Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency

This trial is conducted in Europe and United States of America (USA). The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of catridecacog (recombinant factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent by subject's parents or subject's legally acceptable representative before any trial related activities. Trial related activities are any procedures that would not have been performed during the normal management of the subject
* Age 1 to less than 6 years old at the time of enrolment
* Congenital FXIII subunit-A deficiency previously documented by genotyping or evaluated by genotyping through blood sampling at screening visit
* Body weight at least 10 kg

Exclusion Criteria:

* Known antibodies to FXIII
* Hereditary or acquired coagulation disorder other than FXIII A-subunit congenital deficiency
* Platelet count (thrombocytes) of less than 50 × 10\^9/L (at screening visit)
* Previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus erythematosus
* Previous history of arterial or venous thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis
* Known or suspected allergy to trial product or related products
* Any surgical procedure in the 30 days prior to enrolment and any planned surgery during the trial period
* Any disease or condition which, judged by the Investigator, could imply a potential hazard to the subject or interfere with the trial participation or trial outcome including renal and/or liver dysfunction
Cleansing Device for the Treatment of Scalp and Hair Conditions

The objective of this study is to evaluate an improvement of scalp health after the use of an investigational off-label WaterPik and brush device aimed to massage and cleanse the scalp.

Seborrheic dermatitis and dandruff are skin conditions that present with common features and respond similarly to treatments. Dandruff involves flaking skin that can cause irritation and itching. Dandruff only involves the scalp, whereas seborrheic dermatitis can occur on the scalp, face, chest, and retro-auricular areas. Seborrheic dermatitis can also result in itching and flaking, as well as inflammation and erythema. Both dandruff and seborrheic dermatitis are known to be harmful to the scalp.

Despite shampoo and washing, one may still continue to have flaking and scale present on the scalp. There are numerous scalp massages and brushes on the consumer market. Waterpik® was FDA approved in 2018 to provide pressured water combined with a powered toothbrush for optimal plaque and particle removal when cleaning the mouth and teeth. Waterpik® now has several products on the market designed for oral health, pet care, and washing in the shower. The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health.

Through the investigational use of the off-label WaterPik® and brush device, the investigators propose the technique of massage and gentle water pressure will reduce seborrheic dermatitis and dandruff on the scalp.

Eligibility Criteria:
Inclusion Criteria:

* Participants must qualify for one of the following scalp conditions based on clinical opinion of a board-certified dermatologist: healthy scalp, dandruff, seborrheic dermatitis, or hair loss disease
* All Women of Child Bearing Potential must indicate use of two of the following contraceptive methods. The WaterPik device uses an ultrasonic technology which includes ultrasound. Unnecessary ultrasound is not recommended for pregnant women.

  * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
  * Intrauterine device (IUD)
  * Intraurerine hormone-releasing system (IUS)
  * Vasectomized partner
  * Sexual abstinence
  * Barrier method, such as a condom

Exclusion Criteria:

* Non-English speaking
* Exclusion related to pregnancy, lactation, or plans to become pregnant over the course of the study (based on self-report from the participant)
* Current clinical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements
T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant

RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce cytomegalovirus infection during the first year after a donor stem cell transplant.

PURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it works compared with standard therapy in treating patients at risk of cytomegalovirus infection after a donor stem cell transplant.

OBJECTIVES:

Primary

* To determine the frequency of cytomegalovirus (CMV) reactivation during the first year after allogeneic stem cell transplantation (ASCT) in patients at risk for CMV infection treated with adoptive transfer of selected CMV-specific cytotoxic T-lymphocytes.

Secondary

* To monitor CMV-specific immune reconstitution within the first year following ASCT in these patients.
* To determine the time to CMV reactivation in these patients.
* To evaluate the use of antiviral therapy in these patients.
* To determine the incidence of secondary CMV reactivation and CMV disease in patients treated with this regimen.
* To determine the incidence of acute and chronic graft-versus-host disease.

OUTLINE: This is a multicenter study. After undergoing an allogeneic peripheral blood stem cell transplantation (PBSCT) using an alemtuzumab-based conditioning regimen that also includes radiotherapy, patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive cytomegalovirus (CMV)-specific cytotoxic T-lymphocyte infusion on day 21-90 after allogeneic PBSCT.
* Arm II: Patients undergo standard follow-up care and receive standard antiviral therapy comprising ganciclovir IV or foscarnet sodium upon detection or confirmation of CMV reactivation.

Blood samples are collected to assess CMV viral load by quantitative PCR.

After completion of study therapy, patients are followed once a week for 100 days and then once a month for 1 year.

PROJECTED ACCRUAL: A total of 18 patients with sibling donors and 21 patients with unrelated donors are accrued for each arm, resulting in a total of 78 patients accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Planning allogeneic peripheral blood stem cell transplantation (PBSCT) using a conditioning regimen containing alemtuzumab and radiotherapy
* Sibling or matched unrelated donor available

  * Patients and donor matched for ≥ one of the following HLA alleles:

    * HLA-A\*0101
    * HLA\*0201
    * HLA-A\*1101
    * HLA-A\*2402
    * HLA-B\*0702
    * HLA-B\*0801
    * HLA-B\*3502
  * No donors whose stem cells have already been collected and cryopreserved prior to transplant
* Patient and donor must be CMV seropositive
* Stem cell harvests ≥ 4.0 x 10\^6 CD34 cells/kg

PATIENT CHARACTERISTICS:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior bone marrow transplantation
* No concurrent participation in another therapeutic transplantation study
INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE

Purpose:

To evaluate the influence of the nonsteroidal anti-inflammatory indomethacin on the brimonidine intraocular pressure (IOP) lowering effect.

Methods:

A randomized double-masked study was carried out. Patients medicated with timolol maleate 0,5% and needed complementary medication were random allocated into two groups: (a) brimonidine tartarate 0,15% and indomethacin 1% or (b) brimonidine tartarate and placebo (balanced saline solution). If patient's both eyes were eligible, they were allocated to the same group.

IOP was measured at two weeks, one month and two months after study beginning. The mean IOP of the eyes was used for analyzes, in the case of two eligible eyes. For statistical analyzes repeated measures analysis was used.


Eligibility Criteria:
Inclusion Criteria:

* primary open-angle glaucoma or ocular hypertension patients with the following criteria: 18 years of age or older, insufficient response to monotherapy with timolol maleate 0,5%, and adequate compliance in follow-up treatment

Exclusion Criteria:

* hypersensitivity to eyedrop solutions, insufficient compliance in follow-up treatment, pregnancy or childbearing potential.
Nepafenac 0.3% Two Study

The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.


Eligibility Criteria:
Inclusion Criteria:

* Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens;
* Patients who, in the opinion of the Investigator, would have improvement in best-corrected visual acuity after surgery;
* Able to understand and sign an informed consent;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit;
* Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit;
* History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye;
* Diabetic retinopathy in the operative eye;
* Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article;
* Other protocol-defined exclusion criteria may apply.