cyrilzakka/clinical-trials huggingface dataset:
Induction Chemotherapy and Immunotherapy Combined Radiotherapy With or Without Concurrent Chemotherapy for Stage III-IVa NPC

The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus immunotherapy with concurrent chemoradiotherapy (CCRT) or RT alone in patients with stage III-IVa nasopharyngeal carcinoma(NPC), in order to confirm the value of Immunotherapy and concurrent chemotherapy in NPC patients.

Patients Patients with stage III-Iva(except T3N0M0) non-keratinizing NPC (UICC/AJCC 8th edition) are randomly assigned to receive immunotherapy and induction chemotherapy plus CCRT or RT alone. Patients in both groups receive Anti-PD-1 Antibody, gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. The immunotherapy and induction chemotherapy plus CCRT group receive cisplatin 80-100 mg/m² every 3 weeks for 2 cycles, concurrently with intensity-modulated radiotherapy (IMRT). IMRT is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor. Our primary endpoint is failure-free survival(FFS). Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
* Tumor staged as III-Iva(except T3N0M0) (according to the 8th AJCC edition).
* No evidence of distant metastasis (M0).
* Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
* Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
* Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN.
* Adequate renal function: creatinine clearance ≥ 60 ml/min.
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

* WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
* Age \> 65 or \< 18.
* Treatment with palliative intent.
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
* Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
* History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
* Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study

Despite experts' recommendations, the consumption of Fresh frozen plasma (FFP) is very heterogeneous among French cardiac surgery centers. This probably reflects heterogeneous practices that are not characterized and whose outcomes on morbidity and mortality are not documented.

The principal objective of the study is to describe transfusional strategies of FFP in patients undergoing cardiac surgery. The other objectives are: to assess the conformity of FFP transfusion or lack of transfusion to current French authorities' recommendations, to describe the post-operative mortality and morbidity and to assess the prognostic role of FFP on mortality and morbidity. Prognostic analyses will take into account other prognostic factors of mortality and morbidity.

1500 patients undergoing cardiac surgery and presenting with a serious bleeding (or transfused with FFP without bleeding) will be included in the study.

Background

Fresh frozen plasma (FFP) transfusions recommendations are essentially based on experts' opinions. However, disparity in consumption of FFP by cardiac surgery centers in France probably reflects heterogeneous practices that are not well characterized. Furthermore, health outcomes of these strategies on morbidity and mortality are not documented.

Objectives

Primary: to describe transfusional strategies of FFP in patients undergoing cardiac surgery and either presenting a serious bleeding during pre, per or post-operative periods or transfused by FFP without a serious bleeding.

Secondary:

* To estimate the conformity of transfusion or lack of transfusion of FFP to French authorities recommendations.
* To describe the post-operative mortality and morbidity.
* To evaluate the prognostic role of FFP transfusion on mortality and morbidity

Study design

Prospective prognostic cohort study, with an exhaustive recruitment in participating cardiac surgery centers during the study period.

Eligibility criteria

Centers: 16 French cardiac surgery centers.

Patients:

* Coronary artery bypass grafting (CABG), valvular replacement, surgery for thoracic aorta aneurysm or dissection, heart graft.
* Serious bleeding or FFP transfusion during pre, per or post-operative period.
* Patient's consent for collecting medical data

Analysis

Descriptive analysis of transfusional strategies according to patients' characteristics, type of surgery and circumstances of transfusions.

Conformity to French authorities' current recommendations. Multivariate analysis of the prognostic role of FFP transfusion on 30-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery bypass grafting (CABG), valvular replacement, surgery for thoracic aorta aneurysm or dissection, heart graft.
* Serious bleeding or FFP transfusion during pre, per or post-operative periods.
* Patient's consent for collecting medical data

Exclusion Criteria:

* Congenital heart disease
A Study of MK-8033 in Patients With Advanced Solid Tumors (MK-8033-001)

This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK-8033.

Parts A and B of the study will determine the maximum tolerated dose (MTD) and RP2D. Part C of the study will be a single panel crossover study to determine the effect of omeprazole, a gastric pH modifier, on the pharmacokinetics of MK-8033.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be at least 18 years of age, with adequate organ function, and an Eastern Cooperative Oncology Group (ECOG) performance of \<2
* Patient must be willing to undergo pre-study and post-dose tumor biopsy and have tumor accessible for biopsy (Waived during Parts A and C)

Exclusion Criteria:

* Patient is currently using bisphosphonate therapy or has received this therapy in past 6 months
* Patient has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of study participation
* Patient has history of cardiac disease
* Patient with a primary central nervous system tumor
* Patient has a known psychiatric or substance abuse disorder
* Patient is pregnant or breastfeeding, or expecting to conceive during the study
* Patient is known to be Human Immunodeficiency Virus (HIV) positive and the HIV infection is not well controlled
* Patient has received therapy with a Proton-Pump Inhibitor, Histamine2-Receptor antagonist or antacid within one week of study participation (Part B only)
Transthoracic Echocardiography of Ventricular Function of Parturients in Labor

This echocardiography study will characterize heart structure and function during labor. Imaging of the heart during the stress of labor could increase detection of subclinical cardiovascular disease using advanced imaging techniques. Cardiac serum biomarkers and complication rates will also be measured and compared between patients with and without evidence of cardiovascular disease on echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* All healthy parturients 18 years of age or older with estimated gestation greater than or equal to 37 weeks who are expected to deliver during their hospitalization.
* During the echocardiographic exam, the patient must be in active labor with cervical dilation between 6-10 cm and contractions that are spaced less than 5 minutes apart.

Exclusion Criteria:

* Known functional or structural heart disease
* Previously diagnosed pulmonary hypertension.
* Comorbid disease other than diet controlled gestational diabetes, uncomplicated obesity, mild asthma and euthyroid patients with a history of hypo or hyperthyroidism.
* Parturients endorsing active use of non-prescription mind-altering drugs including cocaine, methamphetamine, or ketamine.
* Other non-inclusion criteria include inability to tolerate left lateral positioning either symptomatically or by fetal heart rate monitoring, suspected hypo-or hypercoagulable states that was not previously diagnosed, hemodynamic instability requiring \>2 L crystalloid administration within 1 hour time frame after epidural placement or vasopressor administration of \>15 mg ephedrine or \>300 mcg phenylephrine administration within 1 hour after epidural placement.
123I-BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients

The aim of this multi-center study is to determine the applicability of BMIPP to diagnosing cardiac disease and to predicting the outcome of patients on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:Adult hemodialysis patients with one or more of the following 10 risk factors for coronary heart disease

* Hypertension
* Diabetes mellitus
* Hyperlipidemia
* Obliterative arteriosclerosis in the lower extremities
* Smoker
* Family history of juvenile coronary artery disease
* History of ischemic stroke
* History of heart failure requiring hospitalization
* Within 3 months after initiation of hemodialysis therapy
* Dialysis hypotension

Exclusion Criteria:Hemodialysis patients who meet any one of the following conditions will be excluded.

* Peritoneal dialysis
* Severe valvular disorder requiring treatment
* Diagnosis of hypertrophic cardiomyopathy(HCM) or dilated cardiomyopathy(DCM) before start of dialysis
* History of revascularization(PCI, CABG) or prior diagnosis of myocardial infarction
* Hypersensitivity to BMIPP or its analogue
* Judged unsuitable for the study for any other reasons by physicians.
Prevention of Recurrent Hepatitis B After Liver Transplantation

Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage. Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it may be possible to tailor the preventive therapy according to the risk. The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.


Eligibility Criteria:
Inclusion criteria: adult patients listed for liver or liver-kidney transplant for hepatitis B.

Exclusion criteria: patients with contraindications to use of prophylactic antiviral therapy.
MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY

This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as fully anonymized data sets, derived from original clinical records on appropriately informed subjects.

This is a patient-outcomes Registry for subjects of any age who are provided in routine clinical practice with one or more MED-EL hearing devices. The Registry aims to collect data for hypothesis generation on subject device use, auditory performance, quality of life and health-related utilities, across different types of implantable and non-implantable hearing devices from MED-EL company. Subjects will be evaluated with a set of standardized tests and questionnaires prior to implantation or prior to initial device activation (baseline) and at follow-up intervals according to the clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* For children and adults receiving an implant: Subjects submitted or planned to be submitted to unilateral or bilateral implantation, using simultaneous or sequential procedures.
* For children and adults receiving a non-implantable device: Subjects submitted or planned to be submitted to unilateral or bilateral treatment with a non-implantable device from MED-EL.
* Unilateral, bilateral or bimodal users (children and adults) of cochlear implants (CIs), electric-acoustic devices, bone conduction implants, middle ear implants or any other implantable or non-implantable hearing solution from MED-EL.
* Signed written informed consent for data collection for Registry purposes.

Exclusion Criteria:

* Lack of compliance with any inclusion criteria.
* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the Registry procedures
Effect of Physical Rehabilitation in Patients With Parkinson's Disease

This is a prospective study. The aim of this study is to investigate the effect of exercise retraining on cardiorespiratory parameters, postural balance, sociopsychological variables, and cognitive function in subjects with Parkinson's disease.

There will be two measurement sessions, one pre-intervention and one post-intervention (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and assessing cognitive function).

this is a 12-week prospective study with the theme that I wish to develop in this context entitled "the effect of exercise retraining on cardiorespiratory parameters, postural balance, sociopsychological variables, and cognitive function in subjects with Parkinson's disease".

There will be two measurement sessions, one pre-intervention and one post-intervention (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and assessing cognitive function).

The recruited subjects will be randomly assigned to two groups: a control group and an experimental group. The subjects will be invited to attend the program three times per week.

The control group will engage in an endurance training program, while the experimental group will participate in a combined endurance training and cognitive training program

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's disease according to the Movement Disorder Society (MDS) 2015 criteria.
* Mild to moderate stage according to the Hoehn and Yahr scale.
* No hearing or visual impairments that could hinder the integration and implementation of the rehabilitation protocol.
* Has the ability to communicate and walk.
* Patient has been stable on treatment for 3 months.

Exclusion Criteria:

* A contraindication to engaging in cardiovascular physical activity
* A Montreal Cognitive Assessment score (MoCA ) of less than 24.
* A current psychiatric disorder that could make it difficult or dangerous to adhere to the research protocol.
* Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program.
* Treatment with sedative medications
Small Particle Steroids in Refractory Asthma

The purpose of this study is to determine whether an inhaled steroid with a small particle size can be an additional treatment option in patients with refractory eosinophilic asthma.

We have identified a group of patients with refractory asthma who have ongoing eosinophilic airway inflammation despite high dose inhaled corticosteroids.

Traditional inhaled steroids have a relatively proximal airway distribution which may lead to inadequate treatment of the distal airways.

We aim to demonstrate that a steroid inhaler with a smaller particle size which targets the distal airways can be a useful additional treatment option in this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* ACQ \>1.5 or a requirement for oral steroids twice a year or more
* High dose inhaled steroid (\>1000mcg BDP or equivalent)
* Treatment with or unsuccessful trial of:

  * long-acting beta agonist
  * leukotriene antagonist
* Sputum eosinophil count \>3% despite high dose inhaled steroid or \>2% with serum eosinophils \>0.4x10exp9/l
* Clinical response to 2 weeks of oral prednisolone: (any one)

  * reduction in ACQ by 0.5 or more
  * increase in FEV1 by 200ml
  * normalisation of exhaled nitric oxide or reduction of \>25ppb

Exclusion Criteria:

* Current smoker, or ex-smoker for \<12 months
* Current treatment with an extrafine steroid inhaler
* Respiratory infection within the last 4 weeks
* Pregnancy or lactation
* Poor compliance with usual asthma medication
* Clinical diagnosis of significant bronchiectasis
* Use of a medication which may interact with ciclesonide:

  * ketoconazole or itraconazole
  * ritonavir, nelfinavir
Intraoperative Pain After Infiltration Technique Using Artpharma Versus Artinibsa in Children

The aim of this study is to assess Intraoperative pain for extraction of Maxillary primary molars using Artpharma Versus Artinibsa in children during infiltration technique.

Articaine is used for pain control Like other local anesthetic drugs, articaine causes a temporary and completely reversible state of anesthesia (loss of sensation) during (dental) procedures.This local anesthesia was first synthesized by Rusching in 1969, and carried to the market in Germany by Hoechst AG, a life-sciences German company, under the brand name Ultracain ,it entered clinical practice in Germany in 1976. The name was changed in 1984, the year it was released in Canada. It then entered the United Kingdom in 1998, the United States in 2000 and Australia in 2005. At this time, articaine is available as a 4% solution containing 1:100, 000 or 1:200, 000 adrenaline. Articaine has been widely used in dental surgery.It started to use carticaine around 1977.In dentistry has been investigated widely. Articaine is a unique amide LA in that it contains a thiophene, instead of a benzene ring.The thiophene ring allows greater lipid solubility and effectiveness as a greater portion of an administered dose can enter neurons

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-9 years.
* Children with maxillary primary molars indicated for extraction.

Exclusion Criteria:

* Children with medical conditions.
* Uncooperative children.
* Parents or guardians who refuse participating in the study.
Use Surveillance Technology to Reduce Elder Abuse Recidivism

The project is to build multi-sector and multi-institutional partnerships to test the feasibility, acceptability, and efficacy of a pilot surveillance camera intervention (N=10) to reduce the frequency and severity of abuse, exploitation, and neglect in community older adults.

This a feasibility investigation that aims to conduct an 8-week pilot RCT (N=10 total) to test the potential effectiveness of a surveillance intervention to reduce frequency and severity of elder abuse among older populations. Eligible participants will be recruited from community-dwelling populations in which an older adult victim has experienced elder abuse (abuse, exploitation, neglect) according to New Jersey APS referrals or our screening. With informed written consent, participants will be evenly randomized into one of three conditions: camera, mock camera, and control (usual care).

Primary outcomes are elder abuse cases including psychological, physical, sexual abuse, financial exploitations, caregiver neglect, and self-neglect measured by 83 items. For psychological and physical abuse, we use eight items and ten items from a modified Conflict Tactics Scale (CTS).46-53. Sexual abuse will be assessed by a question asking about experiences of being touched in private areas when unwanted. Financial exploitation will be assessed by the 17-item Financial Exploitation Scale, adapted from Conrad et al in a study funded by the Department of Justice.54 Caregiver neglect will be assessed by 20 items of unmet needs in key activities of daily living among individuals living with at least one person.35,55 Self-neglect was assessed by a widely used and validated measurement56,57.The measurement was reviewed by a community advisory board of over 20 community organizations led by a geriatrician and has shown good contend, convergent58, and predictive validity59.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 60 or older;
2. Community-living;
3. Individuals identified by New Jersey APS as potentially at risk of elder abuse; OR Individuals who have experienced abuse, exploitation, or neglect within the last 3 months (assessed by any "present" or "yes" response to elder abuse questions on the screener).

Exclusion Criteria:

1. Live in institutional and/or residential facilities;
2. Have plans to move for the next 3 months;
3. Unable to understand and provide written consent. Capacity to consent will be determined by a score of at least 24 on the Mini-mental state examination;
4. Have impairment in eating, dressing, bathing, walking, transferring, grooming, bladder control, or toileting. These will be determined by any "present" or "positive" item on the Activities of Daily Living (ADLs).
Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

The study seeks primarily to determine whether modulation of systemic and testicular sex steroids balance by aromatase inhibitors will positively affect the metabolic health and spermatogenesis of men with Klinefelter syndrome (KFS) as compared to the current state of the art for each issue.

Secondary objectives of this study are (i) to unravel the heterogeneity of the reproductive and metabolic phenotype of men with KFS by performing a multi-omic analysis in a large cohort at baseline; (ii) to evaluate the efficacy of semaglutide-induced weight loss to achieve metabolic and reproductive benefit in men with Klinefelter syndrome as compared to standard testosterone replacement; (ii) to assess whether addition of hCG to aromatase inhibitors further increases intratesticular testosterone and promotes spermatogenesis in men with KFS.


Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of Klinefelter syndrome (47,XXY or mosaicism)

Design 1:

* Age range: 16-40 years old
* Intention to become parent or interest in fertility preservation
* Confirmed azoospermia (lack of spermatozoids) after centrifugation of one semen sample

Design 2:

* Age range: 18-65 years old
* No interest in fertility or fertility preservation
* Hypogonadism at diagnosis or after wash-out of testosterone replacement therapy
* High metabolic risk defined as overweight (BMI 25-28 kg/m2) and insulin resistance (HOMA-IR \> 2.6)

Exclusion Criteria:

* Contraindications to testosterone-rising therapies (prostate or breast cancer, PSA \> 4 µg/l, active liver disease, symptomatic heart disease)
* Decreased life expectancy due to terminal disease
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study (language problems, severe psychological or mental disorders)