cyrilzakka/clinical-trials huggingface dataset:
Dental Biofilm Control During Orthodontic Treatment

Orthodontic appliances can affect changes in the relationships of members of the oral microbiome. Microbiome imbalance can result in oral infections and complicate treatment. The focus is on the microbiological profile of dental biofilm and its control. The effects of metals released by corrosion of alloys for oral use on the microbiome and the extent to which they modify the effectiveness of gingivitis therapy by mechanical and chemical control of biofilm will be investigated. Early and late colonizers of the tooth surface will be analyzed. The condition of gingiva will be assessed, and the results will show the specifics of biofilm and gingiva exposed and unexposed, and differences in the response of individual bacteria to therapy. Molecular biology techniques will be used to quantify the total bacterial biomass (16s rRNA) and the proportion of specific bacterial species within the dental biofilm.

The aim is:

* to determine the clinical characteristics of gingiva of subjects not exposed to metals of dental alloys and exposed to metals
* characterization of microbiome of dental biofilm in subjects not exposed to metals of dental alloys and exposed to metals and to determine changes in the structure of dental biofilm due to exposure to metals
* examine the extent to which environmental influences modify the effectiveness of treatment of gingivitis by mechanical removal of biofilm and chemical control (chlorhexidine digluconate mouthwash (CHX))
* to examine the behavior of bacteria of early and late colonizers of dental biofilm after chemical control
* to analyze biofilm on metal and non-metal appliance
* to explore patient reported outcome measures Study design is a randomized controlled trial with 4 parallel groups: (I) fixed metal orthodontic appliance with regular oral hygiene, (II) fixed metal orthodontic appliance with CHX, (III) non-metal fixed orthodontic appliance with regular oral hygiene, and (IV) non-metal orthodontic appliance with CHX.

Eligibility Criteria:
Inclusion Criteria:

* malocclusion with moderate or great need for orthodontic treatment (Index of Orthodontic Treatment Need grades \>=3)

Exclusion Criteria:

* neurodevelopmental disorders
* intellectual disability
* oligodontia
* congenital craniofacial anomalies
* orofacial clefts
Ocular Response Analyzer Assessment of Intraocular Pressure and Corneal Biomechanical Properties in Myopic and Anisometropic Patients Under Atropine Treatment

Our study has three parts has three parts, and the main aim of the study is to find out if corneal hysteresis was associated with myopia or even a predictor of myopia poor control predictor:

* Part 1 of our study: patients with anisomeropia whose spherical equivalent refraction as measured by cycloplegic autorefraction between the two eyes differ greater than 1.5 D.
* Part 2 of our study: Minus spherical equivalent refraction as measured by cycloplegic autorefraction.
* Part 3 of our study: patients with minus spherical equivalent refraction as measured by cycloplegic autorefraction who are under regular atropine for the treatment of myopia;patients who are prescribed with atropine treatment are in need of myopia control instead of for research interest


Eligibility Criteria:
Inclusion Criteria:

1. Normal ocular health other than myopia or anisometropia
2. In good general health with no history of prematurity or cardiac or significant respiratory diseases
3. No allergy to atropine, tropicamide, proparacaine, and benzalkonium chloride
4. No previous or current use of contact lenses, bifocals, progressive addition lenses
5. No amblyopia or manifest strabismus, including intermittent tropia

Exclusion Criteria:

1. presence of keratoconus or other corneal disease
2. previous eye drops usage except Atropine
3. major ocular surgery history (including refractive surgery, scleral buckle, glaucoma filtering, cornea transplant, cataract and vitreoretinal surgery)
4. presence of other ocular conditions such as glaucoma, uveitis, or other ocular inflammatory or vitreoretinal diseases.
Geographic Atrophy and Intravitreal Ranibizumab Injections

Given the aging population who will be affected by wet AMD and lack of effective GA treatment, it is crucial to assess the safety profile of repeated ranibizumab injections in AMD patients with GA, particularly the possible risk of GA development and enlargement. This potential adverse effect has significant implication in the discussions with patients regarding the risks and benefits of AMD treatment and injection frequency. While monthly injections provide slight improvement of visual acuity at 2 years (Martin et al., 2012), the risk of GA enlargement may offset this benefit in visual acuity.

Previous studies assessed the association between intravitreal ranibizumab injections and de novo GA development in injection-naïve eyes (Martin et al, 2012, Querques et al., 2012., Grunwald et al., 2014), rather than GA enlargement in patients with preexisting GA. To the best of the investigators knowledge, there has been no prospective study assessing the association between intravitreal ranibizumab injections and rate of GA progression in patients with pre-existing GA. There is also no prospective study comparing the morphological features of GA between patients who are receiving intravitreal injections and those who are not, nor the concordance of GA enlargement rate between the 2 eyes among patients receiving and not receiving treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years old
* Patients with pre-existing GA secondary to AMD NOT requiring intravitreal injections (i.e. Dry AMD)
* Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and are treatment-naïve patients
* Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and have received previous intravitreal injections.
* Able to maintain steady fixation in foveal and parafoveal area for fundus imaging Geographic atrophy (GA), both foveal-sparing and foveal GA. Foveal-sparing GA is defined as no GA within 250μm of the centre (Sunness et al. 1999)
* Area of GA can be imaged in its entirety and is not contiguous with areas of peripapillary atrophy
* Adequate media clarity for quality fundus images

Exclusion Criteria:

* Inability to undergo study procedures (e.g. contraindications to intravitreal injections) or attend follow-up visits CNV attributable to other causes than AMD
* Active intraocular inflammation
* Any other retinopathy, including diabetic retinopathy, retinal venous occlusion, epiretinal membrane
Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients

This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.


Eligibility Criteria:
Inclusion criteria:

* Recipients of any race, 18 years or older
* Recipients of primary de novo orthotopic liver transplant from a deceased donor
* Recipients of a kidney with a cold ischemia time \< 30 hours
* HCV-negative recipients

Exclusion criteria:

* Prior organ/cellular transplant or multiple organ transplant
* MELD-score \> 35
* HCC \> Milan criteria
* Donor age \< 12 years
* Cold ischemia \> 15 hours
* Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) or drugs with QT-prolonging properties

Other protocol-defined inclusion/exclusion criteria may apply
Comparing Mentalization-based Treatment And A Dialectical Behavior Therapy-inspired Treatment On The Utilization Of Services And The Dropout Rate In A Clinical Adult Population With A Cluster B Personality Disorder

Cluster B personality disorders (borderline, narcissistic, antisocial and/or histrionic) are an important clinical consideration because of their high prevalence and associated morbidity. Although many studies examine borderline personality disorder, few of them explore cluster B personality disorders as a whole. In clinical practice, personality disorders are frequently comorbid. Patients who receive services in specialized clinics for these disorders often have a complex diagnosis that include many cluster B personality disorders. Therefore, our study globally examines patients with cluster B personality disorders even though borderline personality disorder is empirically the most studied psychopathology. Previous data suggests that borderline personality disorder has a prevalence of 2% in the general population, of 25% in the clinical psychiatric population and of 15% in all visits to the emergency room. Furthermore, it is associated with social costs estimated from 15,000$ to 50,000$ USD per patient per year. In Quebec, this psychopathology is associated with an increased mortality rate compared to the general population, totaling a loss of nine years for women and 13 years for men of life expectancy. Other studies suggest that borderline personality disorder is often comorbid with other personality disorders, including those in cluster B. The population with comorbid personality disorders have a worse prognosis and a lower chance of reaching symptomatic remission, which is the reason why it is crucial to better understand and study patients with cluster B personality disorders.

The study compares the effectiveness of two psychotherapies for borderline personality disorder, mentalization-based therapy and a modified version of Linehan's dialectical behavior therapy, in a retrospective naturalistic study of patients with at least one cluster B personality disorder who have undergone either treatment. The scarcity of data on cluster B personality disorders and on the comparison between MBT and DBT further highlights the necessity of a naturalistic study like ours to examine both aspects and bring research closer to the clinical setting. Based on clinical observations, the investigators believe that there will be no statistically significant difference between either treatment.


Eligibility Criteria:
Inclusion Criteria:

* Meet the general criteria for a personality disorder
* Be diagnosed with at least one cluster B personality disorder
* Be admitted to the Service of personality and relational disorders and referred to mentalization-based treatment or a treatment inspired from dialectical behavior therapy

Exclusion Criteria:

* None
Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.

Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and associated with an increased risk of stroke and death. Within the first two years after pacemaker implantation almost half of the patients are diagnosed with AF. Studies have indicated that an increased amount of stimulation from the pacemaker in the atria is associated with an increased amount of AF.

The aim of the present study is to test the hypothesis that a reduction of stimulation from the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.


Eligibility Criteria:
Inclusion Criteria:

* Sick sinus syndrome with and without AV block and indication for first-time implantation of a DDD pacemaker: symptomatic sinus pauses (\>2 sec) or bradycardia with or without paroxysmal AF.
* Age ≥18 years.
* Patient informed consent.

Exclusion Criteria:

* Permanent or persisting (\>7 days) AF prior to implantation.
* Persisting symptomatic sinus bradycardia and/or chronotropic incompetence where DDD-pacing at a frequency of \>40 bpm is indicated (verified with long term ECG monitoring).
* Life expectancy \<2 years.
* Participation in another interventional research study.
* Indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT).
* Pregnancy.
Effects of Somnage® in the Management on Sleep and Mood in Cancer Patients

The aim of this placebo-controlled randomized study is to evaluate the effects of Melatonin 1mg/Zn 30% VNR/Mg 100% VNR (food supplement) in the management on sleep quality and mood alteration in cancer patients

The main objective of this study is to evaluate the activity of a food supplement, made of Melatonin, Zinc and Magnesium on sleep quality in cancer patients, compared to placebo.

Secondary objectives are to evaluate the activity of Melatonin, Zinc and Magnesium on the quality of life, on the fatigue and on the mood alteration in cancer patients.

The study will also assess the safety of the food supplement under investigation.

In two small subgroups, on voluntary basis, some additional assessments will be done (arm band, nutritional change diary, DXA in one group and activity tracker in another group)

Eligibility Criteria:
Inclusion Criteria:

1. Male and Females aged between 18 and 75 years (included)
2. Pittsburgh Sleep Quality Index (PSQI) score ≥ 5
3. Diagnosed for breast, lung or colon-rectal cancer
4. Metastatic first chemotherapy line
5. Planned duration of chemotherapy treatment at least 63 days
6. Negative to pregnancy test
7. Patients able to swallow

Exclusion Criteria:

1. Known hypersensitivity reaction to Melatonin, Zinc or Magnesium or any components of the product
2. Known current drug or alcohol abuse.
3. Use of other investigational drug(s) within 30 days before study entry or during the study
4. Clinically significant findings on physical examination or presence of known clinically significant disease that would interfere with study evaluation
5. Patients treated with benzodiazepines, hypnotic, anticonvulsant, antipsychotic or antidepressant drugs in the two months before screening visit
6. Patients receiving or planned to receive warfarin
7. Chronic treatment with steroids with daily dose over 10 mg prednisone or equivalent product
8. Brain metastases
Omega-3 Fatty Acids and Muscle Protein Synthesis

The purpose of this study is to determine whether omega-3 fatty acid supplementation influences muscle protein synthesis rates in young and older adults.

Loss of muscle mass is a normal consequence of aging. The decline in muscle mass is estimated to be 0.2-0.5% per year from 60 years old onwards in healthy subjects with the decline worsened by chronic illness, poor appetite and diet, and reduced physical activity in the elderly. Increased morbidity is demonstrable with as little as a 5% loss of muscle mass - therefore, treatments that can prevent or slow the progression of muscle loss with aging are much desired.

A major cause for loss of muscle mass in advanced age appears to be an impaired ability to stimulate the synthesis of muscle protein in response to increased levels of amino acids (the building blocks of proteins) and insulin as occurs after eating because of low-grade inflammation and insulin resistance in muscle of old persons. We propose that long-chain omega-3 polyunsaturated fatty acids (fish oil) slow the loss of muscle mass because fish oil has anti-inflammatory properties and increases the sensitivity of muscle protein synthesis to insulin and amino acids. We will test this by studying the effect of fish oil supplementation on the muscle protein synthesis process in young and older adults.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \< 30 kg/m2;
* Age 18-45 yr; or
* Age 65-85 yr

Exclusion Criteria:

* Those taking medications known to affect substrate metabolism or medications that may confound the findings from our study (synthetic steroids, glucocorticoids etc.);
* Those with evidence of significant organ system dysfunction (e.g. diabetes mellitis, cirrhosis, hypo- or hyperthyroidism; hypertension);
* Body mass index \> 30 kg/m2
* Age \<18 yr, 45-65 yr or \> 85 yr
* Those performing \>1.5h of exercise/wk
PDS*Plus and Wound Infections After Laparotomy

The aim of this study is to ascertain if the use of PDS plus® reduces the number of wound infections and incisional hernia after midline and transverse laparotomy comparing to polyglactin suture.

All patients are treated using clinical pathways (CP) to standardise surgical procedures in our high volume centre. Part of the clinical process management was the standardisation of wound incision and abdominal wall closure.

Wound closure is achieved using continuous absorbable loop suture. The suture length to incision length ratio is at least 4:1. The running sutures are 1 cm apart and at least 1.5 cm from the wound edge. In the first time period , the CP step for fascia closure foresees a triclosan-coated PDS 910 loop suture (PDS plus®, Ethicon GmbH, Norderstedt, Germany). In the second time period the CP step will be altered to the use of PDS loop suture (PDS II®, Ethicon GmbH, Norderstedt, Germany). The CP- step is changed every 100 patients to cluster-randomize the patients. The primary outcome is the number of wound infections. Together with this the number of incisional hernia will be recorded. Patients demographic and disease as well as procedure related data are collected in a clinical information system (ISHmed on SAP platform, GSD, Berlin, Germany) prospectively. Risk factors for poor wound healing, such as operation time, patients age, sex, body mass index, blood loss, peritonitis, antibiotics, and performance level classified according to the American Society of Anesthesiologists (ASA), are collected prospectively to compare the two groups.

Eligibility Criteria:
Inclusion Criteria:

* surgical pathologies accessed via midline or transverse abdominal incision
* primary fascial closure

Exclusion Criteria:

* pregnancy
* age under 18 years
* open abdominal treatment
* known hypersensitivity against PDS/Triclosan
CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia

The purpose of this research study is to test whether giving T-cells (type of white blood cell that are also known as immune cells) that have been specially processed in the laboratory will help chronic lymphocytic leukemia (CLL) patients' immune system return to normal faster after chemotherapy. This research study will also look into the ability of the lab to process the T-cells for infusion and the side effects of giving T-cells to patients with chronic lymphocytic leukemia (CLL).

Single arm, multi-center trial to evaluate the efficacy of administering CD3/CD28 stimulated T cells to chronic lymphocytic leukemia (CLL) patients following treatment with fludarabine or alemtuzumab based chemo- immunotherapy. All patients will undergo an apheresis to collect peripheral blood mononuclear cells (PBMCs) for generation of expanded T cells post- chemo-immunotherapy. Those subjects who achieve a complete or partial response to the chemoimmunotherapy based regimen will receive an infusion of 1.0 x 1010 (+/- 20%) activated autologous T cells expanded from the collected apheresis unit. Prior to T-cell infusion, at Day +30, +60, and +365 after T cell infusion, blood draws will be performed to assess immune reconstitution and immune function as compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow.
* Patients with Rai stage III-IV - OR - Patients with Rai stage 0-II
* Zubrod performance status of 0-3
* Prior treatment with fludarabine or alemtuzumab based regimens.
* No untreated or uncontrolled life-threatening infection
* Women of childbearing potential must have a negative serum pregnancy test and agree to use a medically accepted form of contraception from the time of initial screening through completion of the study
* No active CNS disease
* Negative tests for HIV antibodies, Hepatitis B surface antigen, and hepatitis C antibodies.

Exclusion Criteria:

* Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 months prior to registration
* History of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g.

idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment
Arterial Hypertension Related to PARP Inhibitors (ArteRIB)

Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce.

The objective was to investigate reports of hypertension related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, and fluzoparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of hypertension AE related to PARPi.

Eligibility Criteria:
Inclusion Criteria:

* case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
* patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib, pamiparib, fluzoparib (none).

Exclusion Criteria:

-chronology not compatible between the PARPi and adverse event
Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis

This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used biologics.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist and presence of moderate to severe psoriasis symptoms according to physician's judgement at time of recruitment.
* Participant starting any approved treatment for psoriasis and physician's decision must be reached prior to recruitment in the study.
* Participant willing to continue with study documentation after cessation of therapy.

Exclusion Criteria:

* Unwillingness or inability to comply with study requirements.
* Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in a post-market observational study (PMOS) or Registry is acceptable.