cyrilzakka/clinical-trials huggingface dataset:
The Prediction of Hemorrhage Transformation by Cerebral Autoregulation in AIS Patient After Endovascular Thrombectomy

This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcome.

Patients: patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT.

dCA Examination: dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT.

The objectives of the study were as follows: The changes of cerebral hemodynamics and parameters of dCA in different time periods after EVT were analyzed. So as to determine the correlation between hemodynamics and dCA change and HT and clinical outcome after EVT and to explore the predictors of HT and adverse clinical outcomes.

Part of the data from March 2022 to March 2022 was obtained, but it was still need more data and need a one-year follow-up of the data. Therefore, this is a 4 years prospective cohort study.

The objectives of the study were as follows: This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcomes. To explore the predictors of HT and adverse clinical outcomes.

A. To enroll 300 cases of patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT.

B. dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT.

C. The computed tomography was performed to distinguish if the patients have HT within 7 days after EVT.

D. Utilizing the modified Rankin Scale (mRS), the clinical prognosis was assessed 3 months and 1 year after stroke. The outcomes were dichotomized according to the mRS score: favorable outcome (mRS ≤ 2) and unfavorable outcome (mRS: 3-6). During the telephone call follow-up, the clinician was unaware of any pertinent clinical or dCA information while examining each mRS score.

E. All tests are non-invasive.

Eligibility Criteria:
Inclusion Criteria:

* (i) age ≥18 years; (ii) complete recanalization of the affected MCA (thrombolysis in cerebral infarction grade 2b or 3); and (iii) sufficient temporal windows to obtain ﬂow signals for the MCA.

Exclusion Criteria:

* (i) inability to perform dCA after EVT due to restlessness; (ii) re-occlusion of the culprit MCA after EVT; and (iii) other conditions such as low cerebral blood ﬂow caused by severe heart disease.
PK Assessment of Tacrolimus Exposure Before and After a Switch From Twice Daily Immediate-release (Prograf®) to Once-daily Prolonged Release Tacrolimus (Envarsus®)

Tools have been developed in our unit to calculate the inter-dose AUC (Area Under Curve) of immunosuppressive drugs (ISD) based on a limited number of blood concentrations (i.e., blood samples) using Bayesian methods. Since 2005, we have implemented these tools in an expert system and made them available to the transplant community through our very successful ISBA (Immunosuppressive drugs Bayesian dose Adjustment) website.

Briefly, we first need to develop a population pharmacokinetic model using rich pharmacokinetic (PK) profiles (about 10 samples per patient over the dosing interval). The model developed can then be used for inference of ISD PK parameters in new patients using Bayesian estimation. Bayes' theorem is based on conditional probability: individual PK parameters are estimated based on the known PK parameters in the population (mean and distribution), given the dose and concentrations observed in a patient. Our previous studies have shown that a limited sampling strategy (LSS) based on 3 samples collected within the first 3 hours after drug intake can estimate adequately the interdose AUC of ISD. In the present study, the AUC0-24h and the recommended dose will be calculated using Bayesian estimators previously developed using PK data from the clinical trials run by Veloxis, and proposed to the clinicians via a dedicated website comparable with ISBA.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥ 18 year-old) male and female patients
2. Recipient of a single kidney or liver allograft
3. Patient transplanted for more than 2 weeks and less than 1 year at enrolment
4. Patient with stable Prograf® dose, defined by the following criteria:

   * Criterion 1: unchanged Prograf® dose for at least one week; if not, apply criterion #2
   * Criterion 2: unchanged Prograf® dose since the last two therapeutic drug monitorings (TDM)
5. Patient for whom the decision is made to switch from Prograf® to Envarsus®
6. Written informed consent obtained prior to any study-related procedure
7. Patient with tacrolimus C0 between 4 and 12 µg/L at V1
8. Patient with hematocrit \> 27% at V1

Exclusion Criteria:

1. Patient presenting any contra-indication to tacrolimus according to the summary of product characteristics (SmPC) of Envarsus®
2. Recipient of any transplanted organ other than kidney or liver
3. Patient treated by Prograf® for less than 7 days at enrolment
4. Patient previously treated by any other investigational agent if it is not stopped at least 7 days prior to enrolment
5. Pregnant or lactating woman (based on declaration)
6. Patient under judicial protection
7. Patient incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol.
Rilpivirine in Virologically Suppressed Adolescents

To describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from EFV to RPV in virologically suppressed adolescents

Study Procedures:

At screening, the informed consent process will be provided to participant, or participant legally acceptable representatives before any study procedure. Only adolescents who know their HIV status will be asked to give assent.

Twenty adolescents followed at HIV-NAT and the Department of Pediatrics, Faculty of Medicine, Chulalongkorn University will be asked to participate in the PK sub study. Participant who are enrolled in the PK substudy will be asked to take RPV in the morning after breakfast and then commence the PK evaluations after this witnessed dose. After the PK study at week 4, Participant will be followed with the other 80 adolescents until the end of the study. Participant will be asked to provide a small hair sample for RPV concentrations at weeks 4, 12, 24, and 48 after switching. This is an option therefore participant can refuse to provide their hair samples at any visits. HIV RNA levels will be performed at baseline, week 12, 24 and 48 visits. If the HIV-RNA at any visits is between \>50 copies/ml, the HIV-RNA test will be repeated within 4-8 weeks with adherence improvement counseling. At any visit, if HIV-RNA is ≥1000 copies/ml, genotypic resistance testing will be performed. Modification of treatment both for resistance and safety consideration will be subject to the site principal investigator's decision.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected adolescents aged 12-18 years;
* Body weight \>25 kilograms;
* Currently treated with stable EFV-based HAART (EFV plus two nucleoside or nucleotide reverse transcriptase inhibitors \[N(t)RTI\]) for \>3 months prior to enrollment;
* Plasma HIV RNA \<50 copies/ml within the last 12 months;
* ALT \<200 IU/L within the last 12 months;
* Caregivers give written informed consent and adolescents who know their HIV status (i.e., have been fully disclosed to) give assent

Exclusion Criteria:

* Has evidence of NNRTI-associated resistance mutation(s) from previous genotypic resistance testing;
* Currently has PI(s) in the HAART regimen;
* Has currently active HIV-related infection(s), (The subject can be enrolled after the infection is under controlled);
* Has significant medical problem(s) that would compromise study results (in the site principal investigator's opinion);
* Pregnancy (postpartum women are allowed);
* Concomitant treatment with drugs known to effect the PK of RPV (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin, omeprazole, esomeprazole, lansoprazole, erythromycin, clarithromycin, azithromycin, roxithromycin)
Effects of Intranasal Oxytocin on Striatal Functional Connectivity

To investigate whether 40 IU of intranasal oxytocin treatment can influence the resting-state functional connectivity in healthy males.

In a double-blind, between-subject, placebo controlled design, investigators plan to investigate the effects of oxytocin treatment on resting-state functional connectivity.

Subject will receive either intranasal oxytocin or placebo administration and go through a seven-minute resting-state scan in MRI scanner to test whether oxytocin changes functional connectivity in the brain. Trait anxiety and mood questionnaires will be administered as control variables.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* with MRI Contraindications
Repair of Articular Osteochondral Defect

Background: Matrix-associated autologous chondrocyte implantation (MACI) has been recently used to treat cartilage defects. The investigators had previously developed a biphasic osteochondral composite as the construct for chondrocyte implantation. The investigators further conducted this feasibility study of such device to treat patients with osteochondral lesion of the knee joints.

Methods: Ten patients with symptomatic isolated osteochondritis at the femoral condyle were treated by replacing the pathological tissue with autologous chondrocyte-laden biphasic cylindrical plug of DL-poly-lactide-co-glycolide, with its lower body impregnated with -tricalcium phosphate as the osseous phase. The osteochondral lesion was drilled to fashion a pit of identical size and shape as the plug. The chondrocyte-laden plug was press-fit to fill the pit. Outcome of repair was examined by KOOS scale at 3, 6 and 12 months postoperatively, and tissue sample was collected with second-look arthroscopic needle-biopsy at 12 months. The primary outcome parameter was the postoperative change of KOOS; and the secondary outcome parameter was the regeneration of cancellous bone and hyaline cartilage at the repair site.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 \~ 60 years
* Articular cartilage defect of the knee
* Diagnosis by X-ray and/or MRI, Arthroscopy
* Confined area: diameter \< 3 cm
* Full layer cartilage damage

Exclusion Criteria:

* Pregnancy
* Nonunion of fracture around the knee
* Diffuse degenerative arthropathy of the knee
* Diffuse cartilage pathology due to
* Rheumatism: rheumatoid, psoriatic, ...
* Metabolic disorder: gouty, hemorrhagic, ...
* Stiff knee from any reason
* Flexion \< 130˚
* Extension loss \> 20˚
Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients

Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.

Multicentric Randomized Controlled Trial

Primary Objective:

To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term treatment efficacy and patient compliance

Secondary Objectives:

To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with NIV


Eligibility Criteria:
Inclusion Criteria:

* COPD patient already treated by NIV requiring therapy assessment in their routine care Follow-Up or
* COPD patient requiring de Novo NIV therapy according to routine care rules (NIV\<12h)
* Patient requiring NIV therapy by S9 VPAP ST +/- oxygen therapy
* Patient willing to participate to the study
* Patient or attendant able to complete patient passport and to come to Follow-Up visits.

Exclusion Criteria:

* NIV therapy Failure during screening phase (intolerance, patient refusal, significant leaks, significant AHI or Oxymetry events)
* Hospitalization conducting to NIV discontinuation for at least 1 week during the screening phase
Genetics of Differences of Sex Development and Hypospadias

This study seeks to identify genetic causes of conditions that affect the gonads and genitals, and to study the impact on families of receiving genetic results.

This study seeks to understand the genetic causes of conditions that affect the development of the genitals, such as differences of sex development (DSD) and hypospadias, and the impact on families of receiving genetic results. The investigators are recruiting individuals with DSD and/or hypospadias without a clear genetic cause along with their family members for our research study. The investigators will collect samples for genetic studies. The investigators will review the clinical record for history, labs and physical exam information. The investigators will also build a tissue bank of blood, urine, and discarded tissues from surgeries. The investigators will return results of genetic testing to parents/guardians of children with DSD/hypospadias and have them complete questionnaires to assess the impact of receiving these results.

Eligibility Criteria:
Inclusion Criteria:

* Genital or gonadal abnormalities as evidenced by physical examination or imaging (including but not limited to hypospadias, microphallus, clitoromegaly, ambiguous genitalia), with no cause identified by standard clinical evaluation

Exclusion Criteria:

* Inability to provide informed consent
EX-PRESS® P-50 and EX-PRESS® P-200

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term clinical performance and safety outcomes for EX-PRESS Glaucoma Filtration Devices Models P-50 and P-200.

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify patient charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Patients meeting the eligibility criteria who have a minimum of 5 years of follow-up data since the implantation of the P-50 or P-200 device will be enrolled, including patients whose 5-year standard of care visit is scheduled during the study enrollment period.

The overall study duration is expected to be approximately 7 months.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved informed consent form authorizing data collection prior to the review of any medical records;
* Implanted (one eye or both) with the EXPRESS P-50 or EXPRESS P-200 device per indications for use for at least 5 years;
* Have a minimum of 5 years of recorded follow-up data;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Enrolled in any clinical trial within the last 5 years;
* At the time of implantation:

  1. Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
  2. Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
  3. Diagnosed with angle-closure glaucoma.
* Other protocol-defined exclusion criteria may apply.
Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers

The aim of this study is to compare the effectiveness of three public health intervention strategies to reduce weight excess and obesity prevalence among teenagers within the frame of a public health program aiming at promoting healthy eating and physical activity behaviors.

A cluster randomised trial implemented in 24 high and technical schools including 20 000 fifth-former aims, on a three-year period, at evaluating the effectiveness of three strategies, combined or not, according a 2\*2\*2 factorial plan, concerning the promotion of healthy dietary and physical activity behaviours: to develop individual skills by individual and collective education, to propose favourable environment, to screen and care for subjects at risk of weight excess. Main outcomes are improvement of knowledge, attitudes and behaviours, mean body mass index (BMI) change, proportion of obese children according to international standards after two years of follow-up, and finally psychological and sociological factors which are facilitators or barriers to such actions. The evidence of the effectiveness of one or the other of the strategies will help to define interventions framework for medical, educative and economic sector actors.

Eligibility Criteria:
Inclusion Criteria:

* Being student in the included public high school in Region of Lorraine (East of France) whatever the age

Exclusion Criteria:

* None
Post-Marketing Surveillance Study of OTEZLA

To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients with Psoriasis vulgaris that is with an inadequate response to topical therapies and Psoriasis arthropathica

1. Planned registration period 2 years
2. Planned surveillance period for 4 years from 6 months after launch


Eligibility Criteria:
Inclusion Criteria:

- Patients who have received a diagnosis of either of the following diseases and have received OTEZLA for the first time will be included in this survey.

* Psoriasis vulgaris that is with an inadequate response to topical therapies
* Psoriasis arthropathica

Exclusion Criteria:

* N/A
Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors

multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.

Multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.

The primary objective of this study is to evaluate the detection rate of PSMA PET/CT, defined as the ratio of PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one PSMA-positive lesion.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with mCRPC or advanced/metastatic solid tumors;
2. Male or Female, aged \>18 years;
3. Written informed consent;
4. Relapse or progression of disease on CT scan and / or MRI;
5. If female of childbearing potential, highly effective birth control methods according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials" (2014_09_15 section 4.1) are mandatory, beginning at the screening visit and continuing until 6 months following last 68Ga-PSMA PET/CT.
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

1. Pregnancy / Nursing;
2. Participation in another clinical trial with any investigational agents within 30 days prior to study entry
3. Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent.
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study.
5. inability to remain still for the entire duration of the exam
Elderly With Hip Fracture and Perioperative Hemoglobin and Perfusion Index Levels

The overall aim of the study is to investigate the time difference in the diagnosing of anemia among elderly with hip fracture, between measurements with standard blood samples and non-invasive SpHb-measuring. Another aim is to investigate the relationship between perfusion index and prolong perioperative anemia and the potential impact on perioperative complications.

Immediately after admission and diagnosis of a hip fracture the patients will be monitored with Masimo SpHb. The Patients will be continuously measured until the third day after surgery. The Monitors Hb and PI data but not the SpO2% will be blinded to all participating healthcare personnel.The first three postopertive days the patiens will daily be examined to determined it they have developed delirium.

All perioperativ complications in that period will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Primary hip fracture requiring surgery
* Patients able to give informed consent
* Patients who are able to undergo the Hospitals standardized fast track
* Perioperative care regimen for hip fracture including are pre operative placed epidural

Exclusion Criteria:

* Patients who can not co-operate to have a sensor attach to the finger continuous for 4 days.
* Patients who has allergy to the bandage that is used to attach the sensor.
Iron Status and Lung Function in Pediatric Asthma

Iron has a variable role regarding asthma and respiratory function. In addition, iron deficiency may affect spirometry results in asthmatic children. So, we aimed to assess the effect of ion status on lung function in childhood asthma

This cross-sectional study included fifty asthmatic children in the age group of 6-16 years. Asthmatic patients were classified according to their complete blood count and iron profile into 2 groups: group 1; asthmatic children without iron deficiency anemia (IDA), group 2; asthmatic children with IDA. All patients underwent full history taking, clinical examination, laboratory investigations, asthma control test, and pulmonary function tests.

Pulmonary function testing was performed using standardized spirometry. Lung function was measured by forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, and maximal mid-expiratory flow (MMEF 25-75%) of FVC. both patients' groups are compared.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of bronchial asthma: The diagnosis of bronchial asthma in the studied children was based on clinical examination The diagnosis of iron deficiency anemia was supported by criteria provided and updated by the World Health Organization

Exclusion Criteria:

* chronic lung diseases other than asthma Severe systemic illnesses such as liver, renal diseases, and nutritional disorders
MIRA Registry Study

The purpose of the MIRA Surgical System Registry is to accumulate and evaluate real world evidence experience as part of post-market surveillance using the MIRA Surgical System.

The studies primary goals are to:

* To evaluate the performance of the MIRA Surgical System
* To evaluate the Device Safety profile


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery using the MIRA Surgical System
* Subject is able to provide informed consent
* Subject is available for post operative follow up visit through 30 days

Exclusion Criteria:

* Has or is participating in another clinical trial which may confound study results
* In the opinion of the investigator, patient is not likely to complete post-operative care and/or return for standard follow-up.
Addressing Diabetes Together

Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP) into WellConnect.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older
* Diagnosis of diabetes
* enrolled in the DSMP or DPP

Exclusion Criteria:

* unable to provide consent
Rasch-analysis of Clinical Severity in FSHD

The purpose of this study is to make a standardized and scalable Rasch-built clinical severity scale to help in finding genetic and environmental modifiers of disease in Facioscapulohumeral muscular dystrophy (FSHD).


Eligibility Criteria:
Inclusion Criteria:

* Genetic confirmation of FSHD (either FSHD-1 or FSHD-2)

Exclusion Criteria:

* Do not understand English
* Unable to provide informed consent