cyrilzakka/clinical-trials huggingface dataset:
A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study

The goal of this prospective cohort study is to evaluate the clinical performance of a new generation of customized CAD/CAM pre-fabricated root-analog dental implants over a 36-month period. The main questions it aims to answer are:

1. Are these novel implants safe, effective, and clinically viable for 36 months?
2. Do these drilling-free implants result in better post-operative outcomes compared to traditional implant techniques? Twelve patients receiving these customized implants immediately after tooth extraction will undergo clinical and radiographic examinations at 12, 24, and 36 months after prosthesis installation. The study will assess peri-implant tissue health, post-operative comfort, bone preservation, tissue integration, and implant survival rates.


Eligibility Criteria:
Inclusion Criteria:

* Received a personalized dental implant using the iDENTICAL Dental Implant System during the previous interventional phase;
* Completed the 12-month follow-up period after implant placement in the previous interventional phase;
* Available for follow-up evaluations during the 36 months of the observational study.

Exclusion Criteria:

* Occurrence of serious complications (implant loss, infection, etc.) during the previous interventional phase;
* Development of uncontrolled medical conditions during the follow-up period;
* Inability to attend scheduled follow-up visits;
* Refusal to participate in the observational study.
Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage

So far the evaluation of scar treatment was based on subjective criteria. The patient groups were divided into treated versus non-treated.

In this study we use patients undergoing ear reconstruction with autologous rib cartilage. The thoracic scar of harvesting the rib cartilage is routinely reopened after 3 month during second stage of reconstruction. Therefore we have a ideal model of clinical, physiological and histological scar evaluation in a homologous patient group.

All patients randomly treat one half of the scar with a silicone gel (Dermatix). The other half is untreated as an internal control.


Eligibility Criteria:
Inclusion Criteria:

* patients with high grade microtia requiring a reconstruction with autologous rib cartilage

Exclusion Criteria:

* diabetes mellitus
* vascular disease
* known allergic reaction to silicone
Early Post-marketing Study of Eliquis (Apixaban)

The primary objective of the study is to identify and describe any suspected (AEs) in all patients with NVAF treated with Apixaban, as a request of the National Center of Pharmacovigilance (CNFV) in Mexico.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period

Exclusion Criteria:

* Subjects who received Apixaban as part of a clinical trial
* Subjects who received Apixaban for any indication other than local approval (ie, to reduce the risk of stroke and systemic embolism in patients with NVAF)
Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization

It is known that volumetric response of leiomyomas following uterine artery embolization correlates well with patients clinical outcome. The aim of this study is to assess diffusion -and perfusion weighted MRI for the prediction of volumetric response following uterine artery embolization in patients with symptomatic leiomyomas.


Eligibility Criteria:
Inclusion Criteria:

* women with symptomatic leiomyomas

Exclusion Criteria:

* women with known contra-indications for MRI (cardiac pacemaker, cochlear implants, claustrophobic patients)
* women with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR \< 30 mL/min)
Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM)

To search for a Maximum Tolerated Dose (MTD) for the combination of daratumumab and induction chemotherapy with Idarubicin and cytarabine in patients with Acute Myeloblastic Leukemia (AML) of poor prognosis


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 60 ans
* Poor prognosis AML defined according to the following criteria:1. For first-line AML:intermediate or unfavorable risk according to ELN 2022 2.for Relapsed AML:regardless of the ELN risk group
* ECOG \<= 2
* Patient eligible for intensive chemotherapy
* Who provide their written informed consent
* Liver workup: transaminases \< 3x normal, bilirubin \< 1.5 X normal
* Creatinine clearance \> 60ml/mn
* LVEF \>= 50%.

Exclusion Criteria:

* Patients with FLT3 ITD or TKD mutation
* Patients with tuberculosis
* Patients with documented active infection with COVID 19
* Patients with hereditary fructose intolerance (HFI)
* Uncontrolled infection
* Active or past infection with Hep B, C or HIV+
* Not Affiliated with French social security system or no beneficiary from such system
* Pregnant women or patients who cannot take contraception ( contraceptive pill, abstinence, unauthorised IUD) in case of fertility. A patient who cannot continue contraception for at least 6 months after the last injection of DARATUMUMAB is not eligible for inclusion.
* Breastfeeding women
* Minors
* Adults under guardianship, curatorship or safeguard of justice
* Hypersensitivity to any of the active ingredients or excipients
* Patients with significant cardiovascular pathology including any of the following: myocardial infarction within 6 months prior to study entry, unstabilized coronary artery disease, uncontrolled hypertension, congestive heart failure.
* Patient with disease requiring systemic immunosuppressive therapy (such as high-dose steroids defined as ≥ 10mg prednisone or equivalent per day) within 4 weeks prior to the 1st scheduled dose of study treatment with the exception of dermocorticoids
A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD

The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design.

This dose-escalation study will examine HLD100 in 24 subjects.

The subjects (n=24) will be tested with HLD100 in ascending doses from 10mg up to 40mg.

This study will be divided into several phases: Screening, Active Treatment and Follow-Up. All visits have a 2 day window to allow for scheduling.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of ADHD as defined by DSM-5 criteria with confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
* Subjects must demonstrate mild-to-moderate impairment of ADHD symptoms and function per the following at screening (V1) and/or baseline (V2):

  * ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in total score and ≥24 at Baseline;
  * CGI-S score ≥4;
* Subject body weight must be ≥20 kg.
* Subject must be considered clinically appropriate for treatment with amphetamine and HLD100, including prior treatment experience with an amphetamine product, and ability to swallow treatment capsules.

Exclusion Criteria:

* History of, or current, medical condition or laboratory result which, in the opinion of the investigator, unfavorably alters the risk-benefit of study participation, may jeopardize subject safety, or may interfere with the satisfactory completion of the study and study-related procedures.
* Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug.
* History of seizure disorder (except febrile seizures prior to age 5 and with last occurrence at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM-5 criteria).
* History of psychosis, bipolar disorder, anorexia nervosa, bulimia, or suicide attempt. Current depression, anxiety, conduct/behavior disorder, substance use disorder, or other psychiatric condition which, in the investigator's opinion, may jeopardize subject safety or may interfere with the satisfactory completion of the study and study-related procedures.
* Active suicidal ideation as evidenced by an ideation score of 2 or greater on the C-SSRS.
* History of severe allergic reaction or intolerance to amphetamine.
Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty

To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma


Eligibility Criteria:
Inclusion Criteria:

* Open angle Glaucoma

Exclusion Criteria:

* Active corneal inflammation or edema
* Choroidal detachment, effusion, choroiditis
Speed Manipulated Adaptive Rehabilitation Therapy Bike for Parkinson's Disease

Parkinson's disease (PD) is a progressive neurological disorder that results in slowness of movement, muscle stiffness, tremor, and postural instability. These symptoms significantly affect PD patients' quality of life, independence, and functional performance. There is currently no cure for PD, but symptoms can be treated with levodopa or deep brain stimulation surgery. Exercise-based rehabilitation has similar beneficial effects to surgical and pharmacological management without the potential negative side effects. Cycling-based interventions have been shown to increases motor function and mobility in individuals with PD. Specifically, benefits are greater when cycling cadence (revolutions per minute, RPM) is 30% greater than a self-selected pace.

Although high cadence cycling improves motor function in individuals with PD, there is significant heterogeneity in individual responses. To maximize the treatment effects and minimize the heterogeneity of high-cadence cycling, it is important to determine patient-specific settings. Previous studies have shown that higher variability (entropy) of cadence leads to greater improvement in motor function. The entropy of cadence calculation will be utilized to understand how patient-specific settings can drive improvements. The purpose of this study is to determine patient-specific settings and measure the effects of high cadence stationary (i.e. dynamic) cycling on functional performance in individuals with PD. Volunteers with Parkinson's disease will complete 12 cycling sessions over a 1-month period and measures of motor function, quality of life, functional performance, mood and exercise readiness will be collected.

Potential participants will be prescreened with the ACSM pre-participation questionnaire over the phone or in person. Those who qualify will be asked to visit the research lab and sign the informed consent. Participants will be randomized into one of two groups: 1) patients-specific adaptive dynamic cycling or 2) non-adaptive dynamic cycling. Both groups will participate in a total of 12 sessions, each session consisting of 5 minutes of warm-up, 30 minutes of the main exercise, and 5 minutes of the cool-down period. For the patient-specific adaptive dynamic cycling group, the optimization process will be done after the 3rd, 6th, and 9th sessions. The optimization procedure is based on sample entropy of cadence calculation from the previous session's cycling performance. After optimization, participants will receive specific settings for the next session. For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* 50-79 years of age
* no contraindications to exercise including cardiovascular disease or stroke

Exclusion Criteria:

* one or more major signs/symptoms of cardiovascular or pulmonary disease
Quality of Life (QOL), Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome

1. Characterize the quality of life of young children with CVS (i.e., psychological, social, physical, school functioning) and the impact of the child's illness on the parent's and family's quality of life (i.e., emotional, social, cognitive functioning, communication, worry, daily activities and family relationships).
2. Assess symptoms of depression, anxiety, ADHD and behavioral problems in what our preliminary data suggests is a psychiatrically vulnerable population.
3. Evaluate the associations between quality of life and psychiatric symptoms and the frequency and intensity of CVS attacks.
4. Use the data generated from this study to develop a psychosocial intervention targeted at young children with CVS and their families who evidence risk for functional disability, with the aim of intervening as early as possible to limit the psychological and social morbidity experienced by children with CVS and their and families.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CVS

Exclusion Criteria:

* Children and parents who are not English speaking
* Youth with significant developmental delay, mental retardation, psychotic symptoms, or other significant mental impairments and those with other major medical disorders such as IDDM, congenital heart disease, cystic fibrosis, etc.
GPED Regimen for Relapsed/Refractory or Advanced ENKTCL

The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients (ENKTCL).

Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL, hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.
* refractory or relapsed after initial remission, or stage III-IV de novo patients
* PET/CT or CT/MRI with at least one objectively evaluable lesion.
* General status ECOG score 0-3 points.
* The laboratory test within 1 week before enrollment meets the following conditions:
* Blood routine: Hb\>80g/L, PLT\>50×10e9/L.
* Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal.
* Renal function: Cr is normal.
* Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
* Sign the informed consent form

Exclusion Criteria:

* Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.
* Significant organ dysfunction Pregnant and lactating women.
* Those who were known to be allergic to drugs in the study regimen.
* Patients with other tumors who require surgery or chemotherapy within 6 months.
* Other experimental drugs are being used.
Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix (NanoDx-CoV-19)

Phase 1:

25 patients with a PCR-based diagnosis of Covid-19 will be be included to give 500 microliters of saliva and a 3 ml sample of blood for proteomic analysis; a drop of blood will also be put in a device connected to a silica matrix to perform spectrometric analyses. 25 patients with a non-Covid-19 respiratory infection will be included for the same samples. The proteomic analyses will be performed from classicaly draught blood, blood drop on silica, and saliva, to search for discriminating profiles between Covid-19 and non-Covid-19.

Phase 2:

150 patients with a suspected Covid-19 will be included at the same time than the Covid-19PCR is performed ; they will have a sample of saliva and of a drop of blood for proteomic analysis, whose results will be matched with PCR results.

Phase 1: derivation analyses 25 patients with a PCR-based diagnosis of Covid-19 will be be included to give 500 microliters of saliva and a 3 ml sample of blood for proteomic analysis; a drop of blood will also be put in a device connected to a silica matrix to perform spectrometric analyses. 25 patients with a non-Covid-19 respiratory infection will be included for the same samples. The proteomic analyses will be performed from classicaly draught blood, blood drop on silica, and saliva, to search for discriminating profiles between Covid-19 and non-Covid-19.

Phase 2: confirmation analyses 150 patients with a suspected Covid-19 will be included at the same time than the Covid-19PCR is performed ; they will have a sample of saliva and of a drop of blood for proteomic analysis, whose results will be matched with PCR results.

Eligibility Criteria:
phase 1:

Inclusion Criteria for group 1:

* positive Covid-19 PCR
* clinical signs evocative of Covid-19

Exclusion Criteria for group 1:

* asymptomatic Covid-19 infection

Inclusion Criteria for group 1:

* negative Covid-19 PCR
* acute respiratory infection

Exclusion Criteria for group 1:

* none

Phase 2

Inclusion Criteria:

* suspicion of Covid-19
* sample for Covid-19 PCR planned or performed the same day
* admission ot emergency room exclusion criteria:
* past known Covid-19
A Study of RC48-ADC Combined With Cadonilimab（AK104）in the Treatment of HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma

This study will evaluate the efficacy and safety of RC48-ADC combined with AK104 in HER2-expression locally advanced or metastatic urothelial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary agreement to provide written informed consent.
* Male or female, Age ≥ 18 years.
* Predicted survival ≥ 6 month.
* Histologically and/or cytologically confirmed locally advanced or metastatic urothelial carcinoma (including urothelial carcinoma originating in the renal pelvis, ureter, bladder, or urethra).
* Pior not received systemic therapy, and can not tolerant cisplatin or refuse chemotherapy.
* HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Have at least one evaluable lesion (RECIST 1.1 criteria)
* Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment.
* Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
* Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

* Has received other antitumor therapy before planned start of trial treatment.
* Previously received allogeneic stem cell or parenchymal organ transplantation;
* Previously or currently suffering from congenital or acquired immunodeficiency diseases;
* known or suspected to have a history of allergies to similar drugs such as RC48-ADC and anti-PD-1, or has a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or is allergic to excipients of the study drug.
* Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
* Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
* NYHA Class III or IV heart failure.
* Suffering from active infection requiring systemic treatment.
* Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;
* Required systemic treatment with glucocorticoid (\>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to enter the trial.
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Pregnancy or lactation.
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease

The aim of the present study is an evaluation, whether an immobilization of the upper extremity by means of a positioning splint can help to reduce the incidence of local complications after transbrachial puncture for peripheral arterial interventions, or not.

Increasing numbers of peripheral arterial interventions are performed via transbrachial access leading to a higher number of local complications at the puncture site. Patients are demonstrating complications, such as hematoma, false aneurysm, secondary hemorrhage and arterial stenosis or occlusion.

Due to not standardized post-interventional procedure regarding to immobilization a higher risk for local puncture site complication can occur. Usually, a compression bandage its applied to the brachial puncture site. Within this randomized study, patients randomized to the study group will receive an additional splint for 24 hours to ensure an immobilization of the affected arm.

Following the removal of the compression dressing, and the splint in the study group, a duplex ultrasound its performed in order to detect local alterations and pathologies of the brachial artery.

This examination is repeated for each patient in the course of an outpatient control six weeks post-interventionally. Pathologies are documented and treated if necessary.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients suffering from peripheral arterial occlusive disease with indicated interventions via an transbrachial access (puncture of the left or right brachial artery)
* age \> 18 years
* approval to participate

Exclusion Criteria:

* unability or refusal to participate
* dialysis patients/AV-fistula interventions
* usage of closure devices
Ultrasound Guided Axillary Versus Jugular Central Venous Catheterization

The main intention of this study is to compare two ultrasound-guided central venous catheterization procedures namely: real-time, ultrasound-guided, in plane axillary vein catheterization and real-time, ultrasound-guided, out of plane jugular vein catheterization in terms of venipuncture, catheterization success, early mechanical complication and catheter-related infection rate in mechanically ventilated patients admitted to the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* mechanically ventilated intensive care patients with clinical indications for central venous line placement

Exclusion Criteria:

* trauma and hematoma at the catheterization site
* major blood coagulation disorders coincided with active bleeding
* anatomical abnormalities at the catheterization site
* infection at the catheterization site
* age less than 18 years
* lack of patients or closest relatives consent