cyrilzakka/clinical-trials huggingface dataset:
Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients

This within-patient study aimed to compare the satisfaction and oral health-related quality of life (OHRQoL) of edentulous maxillectomy patients with and without immediately loaded implant-supported obturator prostheses using single-piece compressive implants.

* Inclusion criteria:

  * Patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla.
  * Residual alveolar ridge quantity and quality as verified by cone beam computed tomography (CBCT), especially in the proposed implant sites.
* Exclusion Criteria:

  * Patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis.
  * Radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6 months)
  * Patients with local inflammation that may cause interference with implant placement.

All patients were informed about the detailed treatment plan and received a written informed consent to be signed.

II) Preparation of the patient for implant placement:

* Fabrication of maxillary obturator.
* Cone beam computed tomography (CBCT) was performed for all patients to accurately plan implant location, diameter, and angulation.

III) Surgical phase:

* Surgery was performed under local anaesthesia.
* All patients received single-piece compressive implants in the proper positions according to the case demands.
* The patients were prescribed systemic antibiotics for one week, anti-inflammatory, analgesic, and mouthwash.

IV) Prosthetic phase:

* Necks of placed implants bent up to 15 degrees to be parallel placed.
* The maxillary obturator was adjusted on the poured mode, and modified and access holes made above the abutment were finally relined in the patient's mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol.

IV) Evaluation:

* Patient Satisfaction Based on Visual Analog Scale (VAS)
* Oral health impact profile for edentulous patient (OHIP-EDENT)
* Obturator Functioning Scale

Eligibility Criteria:
Inclusion Criteria:

* Patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla.
* Residual alveolar ridge quantity and quality will be verified by cone beam computed tomography (CBCT) especially in the proposed implant sites.

Exclusion Criteria:

* Patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis.
* Radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6-months)
* Patients with local inflammation that may cause interference with implant placement.
Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)

The purpose of this study is to assess whether certain beverages can increase urinary citrate levels in healthy individuals with no history of kidney disease.

Higher urinary citrate levels have been shown to decrease one's risk of developing kidney stones. The study will compare apple cider vinegar, coconut water, diet citric soda and lemonade and determine which is superior at raising citrate levels. Research participants will consume two of the four drinks, each for 7 day periods, according to a prescribed regimen. Throughout the course of the study, participants will periodically provide blood draws for metabolic panels, as well as 24-hour urine samples to measure citrate levels. There will be 12 study arms, accounting for the permutations of two drinks for each patients out of four possibilities. 3 participants per arm is the goal, for a total of 36, but the recruitment aim is 50 participants, to account for dropout and noncompliance.

Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18-65 years old

Exclusion Criteria:

* History of peptic ulcer disease or gastroparesis
* Pregnant females
* History of chronic kidney disease
* History of urolithiasis
* Currently taking medications that interfere with urinary electrolyte excretion (thiazide and loop diuretics)javascript:document.
* History of Diabetes
Time to Clearance of Chlamydia Trachomatis and Neisseria Gonorrhoeae RNA After Treatment: a Prospective Cohort Study

The aim of this study is to evaluate the negativation time of chlamydial and gonococcal PCRs after treatment for urogenital, oropharyngeal and anal infections.


Eligibility Criteria:
Inclusion Criteria:

* - Patients attending the Trait d'Union department at the Nouvel Hôpital Civil for PrEP consultations, AES or HIV infection.
* Over 18 years of age
* Male or female
* Who have had an uncomplicated CT and/or NG infection treated with currently recommended therapies (Ceftriaxone 500mg DU for NG infections, Doxycycline 200mg per day for 1 week for rectal CT infections and Azithromycin 1g DU or Doxycycline 7 days for other CT infections).
* Subject affiliated to a social health insurance scheme
* Subject able to understand the aims and risks of the research and to give dated and signed informed consent

Exclusion Criteria:

* - Complicated CT and/or NG infections: epididymitis, prostatitis, upper genital infection, extra-genital involvement (keratoconjunctivitis, arthritis, skin involvement, Fiessinger-Leroy-reiter syndrome, Fitz-Hugh-Curtis syndrome).
* Interfering treatments and associated diseases: Severe immunosuppression (HIV infection with CD4 less than 200/mm3, chemotherapy in the last 6 months, active haemopathy, congenital immune deficiency, immunosuppressive treatment including corticosteroid therapy for more than 4 weeks or organ transplant.
* Impossibility of giving the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.).
* Subject under court protection
* Subject under guardianship or curatorship
Understanding Motivation in Parkinson's Patients Through Neurophysiology

The study aims to better understand motivation and value-based decision-making in Parkinson's patients through neurophysiology using Medtronic's Percept DBS device. By combining behavioral tasks with neural recordings, the study seeks to uncover how DBS affects motivation, particularly in relation to effort, reward, and timing.

Participants will perform reward-based decision-making tasks designed to assess both self-benefitting and prosocial motivation. The tasks will evaluate how effort and reward influence decision-making, as well as how proximity to a deadline impacts choices. These tasks will be conducted in both clinic and home settings.

Throughout the study, participants will remain on their regular dopaminergic medications. Each participant will complete sessions under two stimulation conditions: their usual DBS settings and with DBS turned off. Neural activity will be recorded using the Percept device, which enables real-time and chronic at-home data streaming. Additionally, participants will wear a device that captures movement, sleep, heart rate variability, and self-reported measures.

The primary outcomes are behavioral: changes in reaction time, acceptance rate, and success rate across different DBS conditions. The secondary outcomes focus on identifying neural oscillatory biomarkers time-locked to specific decision-making events. By linking brain activity to motivational behavior, this study aims to advance our understanding of non-motor symptoms in PD and inform the development of adaptive DBS algorithms targeting these symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Has Parkinson's Disease or Dystonia
* Has Medtronic Percept or RC+S DBS device implanted in either GPI or STN
* Has DBS device implanted either bilaterally or unilaterally
* Male or female
* More than 1 month post-DBS surgery

Exclusion Criteria:

* Severe cognitive impairments
* Has MOCA score below 20
* Pregnancy
* Age less than 18 years old
Prediction of Delivery Mode by Ultrasound-assessed Fetal Position in Nulliparous Women With Prolonged First Stage of Labor.

In the past years, numerous studies have been published on the use of ultrasound during labor, showing this is an effective, accurate and objective tool for the assessment of the fetal head position and station. Literature affirmed that traditional transvaginal digital examination is highly subjective and dependent on the operator's experience. On the contrary, the use of intrapartum suprapubic transabdominal ultrasound can improve accuracy in determination of fetal head position and the precise knowledge of the location of specific fetal head landmarks in relationship to maternal pelvis. Intrapartum ultrasound will assist obstetricians in the diagnosis of normal labor progression, suggesting when medical and or operative intervention should be taken in case of complications.


Eligibility Criteria:
Inclusion Criteria:

* nulliparous women
* Singleton pregnancy
* prolonged first stage of Labor
* average fetal weight
* gestational age at or beyond 37 weeks

Exclusion Criteria:

* IUFD
* malpresentation
Sodium Alendronate in Non Surgical Periodontal Therapy

In the past few years, studies have evaluated the effect of systemic use of sodium alendronate, especially in the treatment of structural bone defects caused by periodontal diseases. This study evaluated the effects of non-surgical periodontal treatment associated with the topical application of 1% sodium alendronate on clinical and topographical parameters. Chronic periodontitis patients were recruited for the present study and were monitored at 3 and 6 months after baseline examinations. A placebo gel was used as control.


Eligibility Criteria:
Inclusion Criteria:

* chronic periodontitis
* two contralateral teeth showing periodontal pocket depth ≥ 5mm, clinical attachment loss \> 3mm, proximal vertical bone defects, no prosthetic device, without caries lesions, proximal dental contact and lack of premature occlusal contact
* systemically healthy volunteers

Exclusion Criteria:

* need for antibiotic or systemic/local antibiotic use in the previous 3 months
* periodontal treatment in the previous 6 months
* pregnancy or lactation
* immunological disorders or imune suppressive treatments
* diabetes
* smoking
* orthodontic appliances or removable prosthesis
* osteoporosis
* known or suspected allergy to biphosphonates
* systemic use of biphosphonates
A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated

The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BI 3006337 in healthy male subjects following s.c. administration of single rising doses and multiple doses over 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \< 10 years, and have parents and grandparents who are Japanese
* Age of 18 to 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the start of injection of trial medication until 30 days after end of injection of trial medication:

  * Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration
  * Vasectomized (vasectomy at least 1 year prior to enrolment)
  * Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner
  * Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or PR outside the range of 50 to 90 bpm at screening visit
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Exploring Diroximel Fumarate Real-world Experience in Canada and Israel

The primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (RMS) treated with diroximel fumarate (DRF) in routine clinical practice. The secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence on treatment; to assess the effect of DRF on relapses; to assess the impact of DRF on cognition; to assess the impact of DRF on participant reported outcomes (PROs); to assess the impact of DRF on disability; to assess treatment satisfaction with DRF; to explore the real-world safety profile of DRF (i.e., gastrointestinal \[GI\] tolerability, lymphocyte dynamics, adverse events \[AEs\] leading to discontinuation, and serious adverse events \[SAEs\].


Eligibility Criteria:
Key Inclusion Criteria:

* Have a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the prescribing information.
* DRF prescribed and planned to be initiated within 60 days of enrollment or already initiated, with enrollment occurring no more than 7 days since the first dose.

Key Exclusion Criteria:

* History of gastric bypass or required use of feeding tubes.
* Current enrollment in any interventional study or in any study which may conflict with this study, per the discretion of the principal investigator (PI) and Biogen
* Have received prior treatment with DRF (more than 7 days before enrollment).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

This was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group multicenter study of orally administered lumacaftor in combination with ivacaftor in participants aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.

The study included a Screening Period (Day -28 through Day -1), a Treatment Period (Day 1 \[first dose of study drug\] to Week 24 ± 5 days), and a Safety Follow-up Visit (4 weeks ± 7 days after the Week 24 Visit).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF
* Homozygous for the F508del CFTR mutation
* Forced expiratory volume in 1 second (FEV1) greater than or equal to (\>=) 40 percent (%) and less than or equal to (=\<) 90% of predicted normal for age, sex, and height
* Willing to remain on a stable CF medication regimen through Week 24 or, if applicable, the Safety Follow up Visit

Exclusion Criteria:

* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose of study drug
* History of solid organ or hematological transplantation
* History of alcohol or drug abuse in the past year
* Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening
* Use of strong inhibitors, moderate inducers or strong inducers of Cytochrome P450 3A (CYP3A) within 14 days before Day 1 of dosing
Effects of Different Remineralization Agents on Molar Incisor Hypomineralization Defects: a Randomized Clinical Study

The aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish( Flúor protector), Clinpro™ White Varnish and pastes containing CPP-ACP in the remineralization of creamy-white and yellow brown defects in incisors and permanent first molars with Molar Incisor Hypomineralization (MIH) in schoolchildren 6-12 years-old in Mexico.

The study included 208 teeth with yellow-brown or creamy-white defects in children aged 6-12 years who were newly diagnosed with MIH with no substance loss or caries or prior restorative treatment. The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months. The evaluations will be made based on the ICDAS criteria and the measurements which were performed using the laser fluorescence method (DIAGNOdent, KaVo, Biberach, Germany) in the follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Children between 6 to 12 years
* They live in the selected study area
* Have at least one permanent incisor or molar with mild or moderate MIH (creamy white and/or yellow or brown opacities)
* That their parents authorize participation in the study through informed consent.
* No proven or suspected allergy and/or sensitivity to milk protein, as it is a component of the CPP-ACP product.

Exclusion Criteria:

* Defects in enamel development related to syndromes, dental fluorosis, amelogenesis imperfecta, dentinogenesis imperfecta.
* Presence of orthodontic appliances.
* Teeth with MIH with restorations, or severe MIH (affected enamel develops post-eruptive enamel breakdown), or carious lesions classified as score \>0 according to the ICDAS.
* Children who do not show cooperation in the use of remineralizing agents.
Long-Term Voclosporin Treatment in Adolescent Subjects with Lupus Nephritis

The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescents with active lupus nephritis.

This is a 12 month, prospective, multi-center, long-term, open-label extension study of voclosporin in addition to background standard of care with mycophenolate mofetil (MMF) and oral steroids.

Subjects completing participation and treatment with study drug (voclosporin/placebo) of the VOCAL Study (AUR-VCS-2020-03 ; NCT05288855) and meeting all eligibility criteria will continue to receive open-label treatment with voclosporin for approximately 12 months giving a total study treatment duration of 18 months from the start of VOCAL. Subjects completing treatment in Group 2 of the VOCAL study who were receiving placebo will switch to receive open-label voclosporin initially at the same number of capsules as was being administered at the End of Study (EOS) Visit in VOCAL.

All subjects will continue to receive background therapy of MMF and oral corticosteroids starting at the same dose as at completion of the VOCAL study. When clinically indicated, subjects are permitted to be titrated off oral corticosteroids.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from parent/guardian before any study-specific procedures are performed, if applicable per local regulations.
* Age-appropriate assent or informed consent from subject before any study-specific procedures are performed.
* Subjects who have completed 24 weeks of treatment with study drug (voclosporin/placebo) in the VOCAL study. Subjects who had a temporary interruption and were able to successfully re-start study drug will be allowed to enroll after Medical Monitor approval.
* In the opinion of the Investigator subject requires continued immunosuppressive therapy.
* Subject is willing to continue to take oral MMF for the duration of the study.

Exclusion Criteria:

* Currently taking or known need for any of the following medications during the study:

  * Cholestyramine or other drugs that may interfere with enterohepatic recirculation of MMF
  * Calcineurin inhibitors (CNIs) (e.g., cyclosporin and tacrolimus)
  * Strong CYP3A4/5 inhibitors and inducers (e.g., ketoconazole, rifampin, itraconazole, clarithromycin)
* Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
* A planned kidney transplant within study treatment period.
* Subjects with any medical condition which in the Investigator's judgement may be associated with increased risk to the subject or may interfere with study assessments or outcomes
Corneal WFG Versus AF Trans PRK in Myopic Patients With High Corneal HOA

compare the efficacy, safety and predictability of corneal wavefront guided (WFG) and aberration free ablation in single-step transepithelial photorefractive keratectomy (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs).

Objectives:to compare the efficacy, safety and predictability of corneal wavefront guided (WFG) and aberration free ablation in single-step transepithelial photorefractive keratectomy (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs).

Background: Corneal WFG and aberration free treatments have been proposed as methods to achieve better visual, refractive, and optical outcomes.

Methods: prospective case series was conducted in El-Hekma Eye-LASIK center, Menoufia governorate, Egypt during the period from January 2017 to December 2017. TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing either aberration free or corneal WFG patterns provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany). Uncorrected distance visual acuity (UDVA), manifest and cycloplegic refractions, best spectacle corrected distance visual acuity (CDVA), thorough slit lamp examination and corneal topography were assessed and repeated six months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Myopic patients with or without astigmatism

Exclusion Criteria:

* severe dry eye,
* blepharitis,
* corneal disease,
* contact lens warpage,
* cataract,
* uveitis
* posterior segment anomalies involving the macula or optic nerve
* systemic conditions; diabetes mellitus, connective tissue disease, pregnancy or nursing. Also, any patient who had previous ocular surgery including keratorefractive surgery was excluded