louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06621433: Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession
Official title: Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effectiveness of using titanium prepared platelet rich fibrin with coronally advanced flap in the treatment of type-2 Cairo gingival recession.


Eligibility criteria: Inclusion Criteria:

* Gingival recession type 2 according to Cairo et al (2011).
* Adequate amount of Attached Gingiva (AG) (2 mm≤ AG).
* Good oral hygiene (full mouth bleeding score and O'Leary index less than ≤10 % after complete phase I therapy)
* Clinically thick gingival biotype (1mm \&lt; gingival thickness).
* Anterior esthetic zone.

Exclusion Criteria:

* Patients with gingival recession types 1 and 3 according to Cairo et al.
* Inadequate amount of attached gingiva (AG \&lt; 2 mm).
* Uncooperative patients.
* Smoking more than 10 cigarettes per day.
* Patients with known systemic conditions or taking medications that may affect soft tissue healing.
* Pregnant and lactating women.
* Patients with parafunctional habits.

Primary outcomes:
measure: Probing depth
timeFrame: up to 6 months
measure: Clinical attachment loss
timeFrame: up to 6 months
measure: Recession width (RW)
timeFrame: up to 6 months
measure: Recession height (RH)
timeFrame: up to 6 months
measure: Width of keratinized gingiva (KT)
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT03702933: D-serine in Schizophrenia
Official title: The Effects of Add-On D-serine Pharmacotherapy in Chronic Treatment Resistant Schizophrenia Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: schizophrenia patients that do not respond to their treatments

Brief summary: This study will assess the effects of D-serine adjuvant treatment to the ongoing pharmacological treatment of schizophrenia patients that are resistant to treatments.


Eligibility criteria: Inclusion Criteria:

* DSM-5 Schizophrenia criteria, able and willing to give informed consent, and comply to study procedure, adequate contraception, post-menopausal or abstinent, PANSS Total Score equal or greater than 70, score of 4 or greater on two psychotic items

Exclusion Criteria:

* clinically significant, uncontrollable or unstable medical condition, mental retardation or severe organic brain syndrome, significant risk of suicide or violent behavior

Primary outcomes:
measure: PANSS Total Score
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Herzog Hospital
Study officials:
affiliation: Herzog Hospital
name: Uriel Heresco-Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00168233: Impact of HIV and Its Treatment on Reverse Cholesterol Transport
Official title: Impact of HIV Infection and Treatment With Highly Active Antiretroviral Therapy on Reverse Cholesterol Transport
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Treatment Naive
HIV
Lead sponsor: The Alfred
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2005-09-15
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected patients naive to ARV therapy

Brief summary: To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on individual steps of reverse cholesterol transport, endothelial function and intima-media thickness in HIV patients.


Eligibility criteria: Inclusion Criteria:

* Male patients with HIV infection (3 groups of 50 patients each)
* HIV infected patients, naïve to ARV therapy and not likely to need to commence therapy for the duration of follow-up (12 months)
* HIV-infected patients, PI naïve, initiating therapy with PI-containing HAART (ARV naïve or NNRTI experienced changing to PI regimen)
* HIV-infected patients naïve to ARV therapy, initiating NNRTI-containing regimen

Exclusion criteria

* Treatment with any form of lipid lowering drugs, including fish oils.
* Body Mass Index greater than 27.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital and Baker Heart Research Institute
state: Victoria
Study officials:
affiliation: Baker Heart Research Institute, Commercial Road, Melbourne
name: Dmitri Sviridov, Dr
role: STUDY_DIRECTOR
affiliation: Alfred Hospital, Melbourne, Vic 3004
name: Jennifer Hoy, A/Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04982133: Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification
Official title: Randomised Trial Weight Gain in Extremely Premature Infant: Targeted Versus Adjusted Fortification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Very Low Birth Weight Infant
Feeding, Breast
Food, Fortified
Keywords: preterm
nutrition
human milk fortified
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.

Detailed description: 1. Study design This is an interventional, randomized, controlled study.
2. Description of the study The very premature newborn will be identified by daily evaluation of the infants admitted for consultation in the income book.

   Informed consent will be requested from the infant´s father, mother or legal guardian between the fifth and tenth day of life.

   Fortification will be done according to the randomization group.
3. Outline of the study design

   * Excel calculation sheet of individualized supplementation according to the composition of breast milk in the target fortification group. Methodology of analysis of breast milk in FOSS analyzer.
   * In the adjusted fortification group, urea concentration levels will be kept between 19-30 mg / dL
   * Fenton curves or https://www.growthcalculator.org/ will be used for Z-scores calculation.
   * Growth speed calculation: Weight gain: (1000x ln \[Final weight / Initial weight\]) / number of days.

     4 Duration of the study for each participant The duration of participation in the study and the fortification intervention period will be a maximum of 132 days.

Eligibility criteria: Inclusion Criteria:

1. Preterm infants born \<1000 g of birth weight that are fed with breast milk or donated milk.
2. Written informed consent signed by the mother, father or legal guardian.
3. To tolerate enteral feeding, at least 100mL / kg / day.

Exclusion Criteria:

1. Non-premature or premature patients weighing ≥ 1000 gr.
2. Patients with major malformations.
3. Patients with diagnosed chromosomal diseases or of high diagnostic suspicion.
4. Patients with short bowel syndrome or any surgery on the gastrointestinal tract.

Primary outcomes:
measure: Growth rate 28 days after the start of fortification and birth
timeFrame: 28 days
Secondary outcomes:
measure: Mineralization differences between both fortication methods
timeFrame: Until 36 weeks of postmenstrual age (EPM) or at discharge
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: University Hospital La Paz
Study officials:
affiliation: La Paz University Hospital
name: MARTA CABRERA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05695833: Nd:YAG Laser and Radiofrequency in Treatment of Fingernail Psoriasis
Official title: Comparative Study Between Long Pulsed Nd:YAG Laser and Radiofrequency in Treatment of Fingernail Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nail Psoriasis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the effect of Radiofrequency to long pulsed Nd:YAG 1064 nm laser in treatment of fingernail psoriasis.


Eligibility criteria: Inclusion Criteria:

* Nail Psoriasis

Exclusion Criteria:

* Manual workers

Primary outcomes:
measure: Targeted Nail Psoriasis Severity Index (tNAPSI) score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00688233: Effect of the Innovated Seifi's Functional Appliance on Skeletal and Dentoalveolar Changes of Class II/ 1, Deep Bite
Official title: Phase 1 Effect of the Innovated Seifi's Functional Appliance on the Skeletal and Dentoalveolar Changes of Class II/Division 1, Deep Bite Cases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Orthodontic Appliance Design
Retrognathism
Malocclusion, Angle Class II
Deepbite
Keywords: Seifi's Functional, Class II/1, Mandibular Retrognathism
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-06-02
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: For improving the appearance of protruded upper front teeth when lower front teeth may touch palatal mucosa or have proximity to that; the innovated Seifi's Functional Appliance may be used.

Detailed description: Records will be obtained for each patient by the same operator before treatment and at the end of treatment. The appliance in this study is designed by Prof. Seifi and will be constructed by a well trained technician in the orthodontic laboratory of shahid Beheshti School of dentistry under the supervision of the operator. The appliance consists of a jack screw in the midpalatal region plus two Adams' clasps on the upper 1st molars and four Kimia clasps on the buccal embrasure of the upper deciduous molars or premolars. For the mandibular portion there is an incisal clasp and incisors are capped by acrylic.

The participants will be advised to use the appliance 24 hours per day except for meal times and when brushing the teeth or reading Farsi or English in class room.

Each patient will pay his/her first recall visit to the orthodontic department one week after the appliance delivery and will be instructed to turn the maxillary expansion jack screw 1:4 turn twice a week to achieve coordination of the upper and lower arches in the transverse dimension. The patients will be evaluated over one month intervals and necessary adjustments were made.

All cephalometric records, before and after treatment, will be coded and analyzed by a second party and the ultimate results and evaluations will be made.

Eligibility criteria: Inclusion Criteria:

* Age between 8 - 12 years old
* Class Π division 1 malocclusion (ANB\>4)
* Increased over jet (\>4mm)
* Increased overbite (\>4mm)

Exclusion Criteria:

* History of previous orthodontic treatment
* Evidence of craniofacial syndromes

Primary outcomes:
measure: Overjet and Overbite
timeFrame: 2-6 month depending on the amount of OJ and OB and the patient compliances
Secondary outcomes:
measure: sagittal and vertical cephalometric measurements
timeFrame: before-after
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Dental School, Shahid Beheshti Medical Sciences University
Study officials:
affiliation: Shahid Beheshti Medical Sciences University
name: Massoud Seifi, DDS, MSD
role: STUDY_CHAIR
References:
Clinical trial NCT05174533: Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia
Official title: Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: schizophrenia
cardiovascular disorders
prevalence
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged of 40 and more with schizophrenia

Brief summary: Schizophrenia is a psychiatric disorder, affecting 600,000 patients in France. Patients with schizophrenia have life expectancy decrease from 10 to 20 years because of cardiovascular death. Cardiovascular risk factors are numerous: inadequate diet, smoking, alcohol consumption, diabetes, obesity. Primary prevention of cardiovascular risk in patients suffering from schizophrenia is difficult because of understaff in general practitioners and psychiatrists.

Detailed description: The aim of the study is to describe prevalence of cardiovascular disorders in patients aged 40 and more with schizophrenia.

Eligibility criteria: Inclusion Criteria:

* male or female
* aged of 40 and more
* with schizophrenia
* agreeing to participate in the study

Primary outcomes:
measure: QRS morphology
timeFrame: Day 0
Secondary outcomes:
measure: cardiac rhythm
timeFrame: Day 0
Other outcomes:
Locations:
city: Prémontré
country: France
facility: Epsmd de l'Aisne
state: Grand-Est
Study officials:
References:
Clinical trial NCT02176733: Trial of Cyclosporine in the Acute Phase of Leber Hereditary Optic Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Leber Hereditary Optic Neuropathy
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-06-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Leber Hereditary Optic Neuropathy is a genetic disorder caused by maternal transmission of mitochondrial DesoxiroboNucleid Acid mutations. It is manifested by a rapidly progressive blindness, profound, due to atrophic optic nerve. The visual loss is primarily unilateral bilateralisation taking place in the vast majority of cases in weeks or months. The neuro-cardio-protective properties of cyclosporine (and its analogs specifically targeting the anti-apoptotic mechanisms) are particularly promising.

The investigators hypothesis is that cyclosporine may limit apoptosis during the acute phase of the disease process and would limit the loss of visual acuity and improve the visual prognosis of these patients.


Eligibility criteria: Inclusion Criteria:

* patient with the mutation confirmed by molecular analysis
* patient with a recent loss of monocular vision (≤ 6 months)
* voluntarily Patient Consent

Exclusion Criteria:

* patient who have not given their written and informed consent signed
* against indication of cyclosporine
* no drug compliance to previous inclusion
* no national health insurance affiliation
* pregnant women or lactating
* women who could become pregnant during the study period and with no contraception
* private patients of their liberty by judicial or administrative decision, or patients under supervision

Primary outcomes:
measure: Measurement of visual acuity with Monoyer, Early Treatment Diabetic Retinopathy Study and Parinaud scales
timeFrame: at 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
citation: Leruez S, Verny C, Bonneau D, Procaccio V, Lenaers G, Amati-Bonneau P, Reynier P, Scherer C, Prundean A, Orssaud C, Zanlonghi X, Rougier MB, Tilikete C, Milea D. Cyclosporine A does not prevent second-eye involvement in Leber's hereditary optic neuropathy. Orphanet J Rare Dis. 2018 Feb 17;13(1):33. doi: 10.1186/s13023-018-0773-y.
Clinical trial NCT00201851: Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Official title: Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Asian
Premenopausal
Women
Oophorectomy
Lead sponsor: International Breast Cancer Research Foundation
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 740
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.


Eligibility criteria: Inclusion Criteria:

* Open for accrual in Asia only
* Female age 18-50,
* premenopausal with regular cycles (\>25-35 in length)
* fine-needle aspiration diagnosis
* Stage II-IIIA hormone receptor positive invasive breast cancer
* No prior radiation or chemotherapy
* Must be surgical candidate for bilateral oophorectomy

Primary outcomes:
measure: Disease-free Survival
timeFrame: two- to three-year accrual and initial two or more years of follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: National Institute of Oncology
city: Cebu
country: Philippines
facility: Vicente Soto Memorial Medical Center
city: Manila
country: Philippines
facility: East Avenue Medical Center
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Manila
country: Philippines
facility: Rizal
city: Manila
country: Philippines
facility: Santo Toma Hospital
city: Danang
country: Vietnam
facility: Danang General
city: Hanoi
country: Vietnam
facility: Hospital K, National Cancer Institute
city: Hue
country: Vietnam
facility: Hue Central
Study officials:
affiliation: International Breast Cancer Research Foundation
name: Richard R. Love, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hade EM, Young GS, Love RR. Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival. Trials. 2019 Aug 23;20(1):527. doi: 10.1186/s13063-019-3632-9.
Clinical trial NCT02232451: Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique
Official title: Comparison of Loop-tip Cook Medical® Wire vs Traditional Endoscopic Technique Cannulation in the Prevention of Post-ercp Pancreatitis and Biliary Tree Access in High-risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications of Surgical and Medical Care: General Terms
Keywords: loop
ERCP
cannulation
biliary
wire
Lead sponsor: Azienda Ospedaliera San Paolo
Sponsor class: OTHER
First posted: 2014-09-05
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.

Detailed description: Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access with contrast injection even if results are conflicting. The aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in PEP high-risk patients.

Type of study: Multicentric, prospective and randomized trial

Patients: PEP high-risk patients underwent ERCP for benign biliary pathology

Number of patients: 320 patients (160 for each group)

Aim:

Primary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.

Eligibility criteria: Inclusion Criteria:

* high risk patients for post-ERCP pancreatitis

Exclusion Criteria:

* age \< 18 yrs
* allergy to the contrast medium
* previous surgery
* neoplastic bilio-pancreatic disease
* previous EBS

Primary outcomes:
measure: The evaluation of the incidence of PEP
timeFrame: loop20216
Secondary outcomes:
measure: The evaluation of CBD percentage cannulation.
timeFrame: loop20216
Other outcomes:
Locations:
Study officials:
affiliation: Hospital San Paolo
name: Enzo Masci, MD
role: STUDY_DIRECTOR
References: