cyrilzakka/clinical-trials huggingface dataset:
Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients

There are some orthodontics treatments that perform risk movements ,and a bone dehiscence may be expected. In that cases mucogingival surgery , such as connective tissue grafts, is necessary prior to tooth movement.

The connective tissue graft in combination with coronal advanced flap is still considered the gold standard , although the use of porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects.

Most of the studies report clinical results after a connective tissue graft and there is no evidence about the type of attachment obtained after the graft is performed, a few articles have shown histological results. But, as a rule , a histological study is only performed under exceptional circumstances such as a dental fracture, untreatable decay, tooth extraction for orthodontic reasons, or other reasons.

Most of the techniques results in the formation of a long junctional epithelium and connective tissue attachment with fibers parallel to the root surface. Animals studies have shown a shorter epithelium and a larger new cementum formation after the use of the collagen matrix.

The purpose of this study is to confirm that periodontal regeneration happens after mucogingival surgery The principal outcome is compare the millimeters of new attachment create after a connective tissue graft and after the use of a porcine collagen matrix in teeth that have to been extracted (because of the orthodontic planing treatment) after mucogingival surgery .

The secondary outcomes are:

1. length of new cementum (histometry results)
2. length of the junctional epithelium (histometry results)
3. length of connective tissue attachment (histometry results)
4. complete root coverage (clinical results)
5. width of keratinized tissue

Eligibility Criteria:
Inclusion Criteria:

* Patient in orthodontic treatment ,who needs mucogingival surgery in both hemi arcade and later the tooth adjacent to the graft should be extracted because of the orthodontic planing treatment .
* The patient must be 18 years or older
* Patient shows sufficient plaque control (FMPS \< 20%).
* The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent

Exclusion Criteria:

* General contraindications for dental and/or surgical treatment are present.
* The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
* Untreated periodontal conditions
* Patients not willing to participate
Impact of Genetic Polymorphism on Drug-Drug Interactions Involving CYP2D6

CYP2D6 is characterized by a huge variability in the general population, mainly because of genetic polymorphism and drug-drug interactions (DDIs). CYP2D6 genotype is known to have an impact on the extent of DDIs. Indeed several studies have pointed out differential DDIs extent according to CYP2D6 genotype. The terms phenoconversion and phenotype switch are both used to describe the phenomenon by which a given subject changes his phenotype to another due external influence such as DDIs. When given a sufficiently strong CYP2D6 inhibitor, the phenotype of an individual with no mutant allele (extensive metabolizer, EM) of CYP2D6 can be modified to a poor metabolizer (PM) phenotype. This vulnerability is also thought to be dependent on CYP2D6 genotype. Various combinations of alleles predict an EM genotype, which represents about 60 to 70% of the general population. The aim of the study is to determine whether the presence of genetic mutation in CYP2D6 has an impact on DDIs involving the CYP2D6 enzyme. Our interest focuses on CYP2D6 EM carriers of two fully functional alleles and carriers of one non-functional and one functional allele. In order to elucidate this question, CYP2D6 activity will be measured on healthy volunteers by administration of single low doses of dextromethorphan and tramadol in presence or not of duloxetine and paroxetine, two known CYP2D6 inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Age 18-60 years
* Body Mass Index 18-27
* Understanding of French language and able to give a written inform consent
* CYP2D6 genotype : combination of two fully-functional (normal activity) alleles or of one fully-functional and one non-functional allele (null activity), according to table 1, without gene multiplication

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Any pathologies, use of drugs or food that may affect CYP2D6 activity
* Regular smokers of \>5 cigarettes/day
* Renal or hepatic impairment
* Medical history of chronic alcoholism or abuse of psychoactive drugs, including opiate addiction
* Liver transplantation
* Sensitivity to any of the drugs used
* Alteration of hepatic tests more than 2x normal
* Glomerular filtration rate \< 60 ml/min/1.73m2
A Comparison of Silicone Hydrogel Contact Lenses: AIR OPTIX® COLORS Versus AIR OPTIX® AQUA

The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses.

Eligible participants were randomized at Visit 1 (Screening) to receive 1 of the 2 investigational products (1:1 assignment). Between Visit 1 and Visit 2, participants wore their habitual AIR OPTIX® AQUA lenses. Investigational products were dispensed at Visit 2 (Baseline), after which participants were asked to return for 2 additional visits: Visit 3 (Day 14) and Visit 4 (Day 28).

Eligibility Criteria:
Inclusion Criteria:

* Visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity ≥ 20/25 in each eye.
* Manifest cylinder less than or equal to 0.75 diopter (D) (within the previous year) in each eye.
* Successful wear of AIR OPTIX® AQUA soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Willing to sign an Informed Consent form. If under legal age of consent, legally authorized representative must also sign an Informed Consent form.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
* Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
* Monovision, monocular (only one eye with functional vision), or fit with only one lens.
* History of intolerance or hypersensitivity to any component of the test articles.
* Use of any over-the-counter (OTC) or prescribed topical ocular medications within previous 7 days (excluding rewetting drops).
* Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications, and any corneal infiltrates.
* Current or history of ocular infection, severe inflammation, or disease within previous 6 months.
* Any systemic disease that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
* Ocular or intra-ocular surgery within the previous 12 months (excluding placement of punctal plugs).
* Use of medications contributing to dry eye or ocular irritation unless on a stable dosing regimen for a minimum of 30 days prior to study entry and able to remain on stable regimen throughout the study.
* Participation in any investigational clinical study within previous 30 days.
* Other protocol-specified exclusion criteria may apply.
Management of Dry Eye Disease After Cataract Surgery With Topical Hyaluronic Acid and Gingko Biloba

Cataract surgery is one of the main causes of Dry Eye Disease (DED). This paper aimed at evaluating the prevalence of iatrogenic DED on a population of patients without DED receiving cataract surgery, and the impact of an eyedrop containing hyaluronic acid and gingko biloba (HA-GB, Trium free eyedrops, Sooft srl, Italy).

In this phase-IV trial we enrolled 40 patients with no DED. Patients were seen at baseline, day 1, week 1 and week 4. At each visit patients received Ocular Surface Disease Index (OSDI) questionnaire, Anterior segment ophthalmoscopy with grading of conjunctival hyperemia, fluorescein tear break-up time (TBUT), grading of fluorescein corneal staining (epithelial damage); adherence and tolerability using a visual analogue scale were checked at week 1 and 4.

At day 0 patients underwent cataract surgery (2.4 mm temporal incision) and were randomized to standard postoperative care (control group) or standard postoperative care + HA-GB given three times a day for 4 weeks (HA-GB group).


Eligibility Criteria:
Inclusion criteria were:

* At least 18 years old Cataract requiring surgery
* TBUT of 7" or more in both eyes.

Exclusion criteria were:

* BUT of 6 seconds or less in one or both eyes
* Corneal staining of grade 2 or more using Oxford scale in one or both eyes
* Presence of corneal neuropathy (Cochet-Bonnet esthesiometry less than 50 mm) in one or both eyes
* Contact lens wear less than 30 days before surgery
* Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
* Autoimmune diseases
* Past or active ocular surface diseases (any corneal disease, cicatricial conjunctivitis, ocular surface burns, keratinization of the eyelid margin, Sjogren syndrome, corneal trauma)
* pregnant and lactating women pediatric patients or adolescents under 18 years
* ocular or general factors predisposing the patient to an increased risk for intraoperative complications, according to investigator's evaluation. These include (but are not limited to) pseudoexfoliation capsulae, complete cataract, iridodonesis, previous eye surgery, previous eye trauma, history of complicated cataract surgery in the fellow eye, benign prostatic hyperplasia under treatment.
Punch Trabeculectomy Versus Classic Trabeculectomy

Bleb failure is reduced with Punch trabeculectomy procedure. Wide sclerostomy during surgery is wanted but controllable. This can be done with single securing suture, releasable sutures and topical intraoperative mitomycin-c. Average IOP without fluctuation (risk factor) can protect the optic nerve.

This is a prospective randomized study. Patients had uncontrolled glaucoma on maximum tolerated medical therapy including acetazolamide tablets were enrolled in this clinical trial and were randomized to tight flap technique group (group A) and loose flap technique group(group B). Randomization assigned 40 patients to group A and 40 patients to do group B. A total of 80 patients were enrolled in the Study between 2012 and 2014.

During trabeculectomy, Trabecular meshwork and scleral lamellae were excised made an opening with the kelly scleral punch 1.0 mm 3-5 bites. At 12 o'clock 10/0 nylon monofilament stitch was used to close the apex of triangular scleral flap tightly and two releasable stitches were used at the sides of triangular scleral flap in group A. Fig-1 At 12 o'clock 10/0 nylon monofilament stitch was used to secure the edges of the flap at the apex of and two-four releasable stitches were used at the sides of triangular scleral flap in group B. The intraocular pressure and bleb morphology were followed for one year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary open-angle glaucoma
* Clinical diagnosis of pigmentary glaucoma
* Clinical diagnosis of Pseudophakic glaucoma

Exclusion Criteria:

* high risk factors for failed trabeculectomy must be present e.g. previous failed trabeculectomy surgery and active intraocular infection/ inflammation.
* Clinical diagnosis of aphakic glaucoma was excluded.
* Clinical diagnosis of glaucoma with previous ocular incisional surgery (except for clear cornea cataract surgery) were excluded.
Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line

Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and response complete not confirmed.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue.
3. Follicular lymphoma patients previously treated with the combination of rituximab and chemotherapy (R-CHOP, R-CVP, R-fludarabine), having received rituximab maintenance, refractory to a first line (excluding radiotherapy) or relapsed after having achieved any response to previous treatment.
4. ECOG ≤ 2.
5. Signed written informed consent

Exclusion Criteria:

1. Clinical suspicion or documentation of histological transformation.
2. Patients with hypersensitivity to rituximab.
3. Prior autologous or allogeneic transplant.
4. CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis).
5. Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA).
6. HCV infection. HIV infection or other conditions of severe immunosuppression.
7. Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated.
8. Congestive heart failure\> NYHA grade 1.
9. Impaired renal function (creatinine\> 1.5 x Upper Limit of Normal, ULN) or creatinine clearance \<50 ml / h, not related to lymphoma.
10. Impaired liver function (bilirubin, AST / ALT or GGT\> 2 x ULN) were not related to lymphoma.
11. Women who are nursing or pregnant.
12. Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma.
13. Severe acute or chronic infection in activity.
14. Any other concurrent medical or psychological comorbidity that might interfere with participation in this study.
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea

Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South Korea.

Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal clinical care in South Korea.


Eligibility Criteria:
Inclusion Criteria:

1. Participants with congenital hemophilia B (FIX level ≤5%)
2. Participant or the participant's legally authorized representative has provided signed informed consent.
3. Participant is indicated for treatment according to the RIXUBIS Korean product leaflet.

Exclusion Criteria:

1. Participants with known hypersensitivity or presence of any contraindication to RIXUBIS or its excipients including hamster protein
2. Participants with Disseminated Intravascular Coagulation (DIC)
3. Participants with signs of fibrinolysis
COVID-19 Bivalent Booster Megastudy

This megastudy is a massive randomized controlled trial. By randomizing participants to 10 different intervention conditions simultaneously, the investigators will be able to compare the effectiveness of different interventions to one another and to a control group (in which individuals will only receive the usual communications from their partner organization) to identify which interventions significantly increase vaccination rates. Pharmacy customers will be randomly assigned to receive one of the interventions designed by team scientists to encourage vaccination or to a control group. The baseline intervention will be based on the top-performing SMS intervention identified in the investigators previous megastudies on encouraging vaccination (Milkman et al., 2021b, 2022). Pharmacy customers will receive SMS messages conveying that a COVID booster vaccine is reserved or waiting for them at the pharmacy. Additional behavioral science messaging strategies will be tested by building off of this baseline intervention.


Eligibility Criteria:
Inclusion Criteria:

• Patient of a large retail pharmacy that has opted into receving SMS messages from the pharmacy and has received their primary COVID vaccination series.

Exclusion Criteria:

* The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message
* The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message.
Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients

Qlaris Phase 2 clinical study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle glaucoma (OAG) and/or ocular hypertension (OHT) patients.

Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day once daily evening (QPM) dosing, followed by 14-day twice daily (BID) dosing of an investigational product (IP), QLS-111, or vehicle as concomitant therapy with monotherapy latanoprost a PGA treatment that is administered QPM. Both eyes (OU) will be dosed. The study is comprised of seven (7) visits and approximately 28 days of IP dosing.

Eligibility Criteria:
Inclusion Criteria:

* 12 years or older
* Able and willing provide signed informed consent (assent)
* mild to moderate OAG or OHT in at least one eye and current or previous treatment with PGA. Exhibits decrease (i.e., \>20% from reported pre- treatment) in intraocular pressure (IOP). Patient is willing to continue latanoprost throughout the study.
* IOP ≥19 mmHg at 08:00 hour (H) at qualification visits prior to randomization

Exclusion Criteria:

* History of active ocular disease other than mild to moderate OAG/OHT
* Nonresponse to and/or noncompliant with PGA treatment
* Use of other topical ocular medications with exception of the PGA which the patient will use throughout the study
* Moderate to severe glaucomatous damage in either eye
* Previous glaucoma intraocular surgery in either eye (e.g., trabeculectomy, tubes, cyclodestructive procedures, diode) with exception of selective laser trabeculoplasty (SLT) if done less than 12 months from screening, trabecular meshwork minimally invasive glaucoma surgery (MIGS) when combined with cataract surgery and done less than 12 months from screening.
* significant ocular trauma, or intraocular surgery (e.g., cataract extraction/intraocular lens insertion) or extensive retinal laser treatment, refractive surgery in either eye.
* Ocular infection, inflammation (e.g., uveitis), moderate to severe blepharitis/meibomitis and/or severe keratoconjunctivitis sicca in either eye at screening, history of herpes simplex keratitis, in either eye.
* Clinically significant retinal disease in either eye
* Clinically significant systemic or psychiatric disease
* Participation in any investigational study within 30 days prior to screening
* Pregnant or lactating
Clinical Pharmacy for Patients with a PICC Line

Clinical pharmacy is a patient-centered discipline and improves significantly the safety of drug management. Regarding medications, clinical pharmacy is efficient. The investigator hypothesize that clinical pharmacy applied to medical devices could be as effective as in the medication field.

The main objective of this study is to assess the effectiveness of clinical pharmacy activities during entire care pathways of patients implanted with a PICC line, in preventing complications.

This is a preliminary, before-after, monocentric and prospective study. The study will begin with an observational period and will be followed by an experimental intervention period. Sixty-nine adult patients in each period will be included. During the observational phase, no clinical pharmacy activities will be performed. During the interventional phase, clinical pharmacists will be active during the entire patients' care pathways.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient, age equal to or older than 18 years old
* Patient capable of giving free and informed consent
* Patient insured by the Social Security System
* Patient living at home
* Patient with a PICC line prescription
* Patient whose discharge prescription should contain drugs and MDs
* Patient for home discharge implanted with a PICC line
* Patient reachable by phone

Exclusion Criteria:

* Under aged patient, age under 18 years old
* Uninsured patient by the Social Security System
* Patient not living at home :
* Institutionalized patient
* Patient living in a home for elderly dependent persons
* Nursing home resident
* Home-hospitalized patient
* Patient deprived of liberty by a judicial or administrative decision
* Patient under guardianship, curatorship or safeguard of justice
* Patient unreachable by phone
* Pregnant or breastfeeding women
Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia (PRISCA)

The main objective is to determine the effectiveness of a program which consists of multidisciplinary, intensive and individualized interventions, carried out by a group of health professionals (psychiatrist, psychologist, mental health nurse, primary care doctors, pharmacist), during six-month, to improve the global cardiovascular risk (CVR) in patients with schizophrenia. Secondarily, will be analyzed the effectiveness of this program on improving the control in four selected cardiovascular risk factors: hypertension, hypercholesterolemia, hyperglycaemia and smoking, after 6 months Methods: randomized study with parallel assignment in two groups: control and intervention group, six-month follow-up. The eligible patients will be 130 adult (≥18 years) outpatients with a current diagnosis of schizophrenia who follow-up by health mental network in Catalonia, who presents at least bad control in one of the four selected cardiovascular risk factors. The intervention group will receive a multidisciplinary and individualized approach (psychoeducational, recommendations of life style and diet, medication adherence and changes in pharmacological strategy, depending on the individual needs assessing after cardiovascular risk screening. The control group will follow the standard management according to the primary care professionals' team.

Main measurements: the global CVR at baseline and at six-month follow-up through Framingham tables calibrated for the Catalan population (Registre Gironí del Cor, REGICOR). Secondary measures: they will be determined, at baseline and at six-month follow-up, four cardiovascular risk factors as well: hypertension, hypercholesterolemia, hyperglycaemia and smoking, according with the latest recommendations of the Program of preventive activities and health promotion (PAPPS) of the Spanish Society of Family and Community Medicine. Other measures: anthropometric parameters. Functional Assessment Screening Tool (FAST) and quality of life (EQ-5D).


Eligibility Criteria:
Inclusion Criteria:

adults (≥18 years of age), outpatient, current diagnostic of schizophrenia, follow-up by mental health network in Catalonia, signed informed consent.

Exclusion Criteria:

other severe mental illnesses different from schizophrenia, patients with intellectual disabilities or clinical acute psychotic relapse