cyrilzakka/clinical-trials huggingface dataset:
OXY-2: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models

Thirty-two healthy volunteers will be submitted to experimental pain and on the 2 study days receive Oxycodone 20 mg po vs. placebo. Half of the volunteers will be poor metabolizers according to CYP2D6 genotype and half will be extensive metabolizers (EM) and have an enzyme with normal function. The study hypothesis is that PM will experience less pain relief than EM.

Oxycodone is a semi-synthetic opioid with an analgesic effect in the postoperative pain management comparable to morphine. Oxycodone is N-demethylated by CYP2D6 to its active metabolite oxymorphone, a potent μ-receptor agonist. A genetic polymorphism divides a Caucasian population into two groups: 8% with an enzyme lacking activity, poor metabolizers (PM) and the rest with normal CYP2D6 activity, extensive metabolizers (EM).

Many different, single nucleotide polymorphisms (SNPs) are responsible for interindividual differences in the effect of opioids. Among these are the A118G SNP in the μ-receptor gene OPRM1 and the C3435T and G2677T/A SNPs in the MDR-1 gene of P-glycoprotein. P-glycoprotein is responsible for the absorption, excretion and transport of many drugs including opioids over the blood-brain barrier.

Electrical stimulation and cold pressor test are among the most well defined and evaluated human experimental pain models. The 32 volunteers will be submitted to the tests before and 1, 2, 3 and 4 hours after medicine intake.

To determine the plasma levels of Oxycodone and its metabolites blood will be drawn after each pain test. Also the CYP2D6 genotype and the above mentioned SNPs will be determined from the blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer age between 20 and 40 years.
* Healthy according to medical history and physical examination.
* Informed consent given.
* Phenotyped or genotyped as extensive or poor metabolizer of sparteine.
* Female: Use of safe contraception (IUD, gestagen injectiones or oral contraceptive) or negative u-HCG test.

Exclusion Criteria:

* Any known allergy or intolerance to oxycodone.
* Regularly drug therapy or medication (except contraceptives).
* Alcohol or medicine abuse.
Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging

Acute and chronic cognitive impairment (TBI and MCI) is one of the most common problems in the growing and aging society of the 21st century. At an individual level, not all brain structures are affected with the same rate. There are subcortical structures less involved (e.g., the cerebellum), and other more involved (e.g., the hippocampus) in the cognitive decline with age or following a traumatism. To pave the way for personalized precision medicine in the field of cognitive preservation and recovery, there is a need for testing the impact of individually tailored innovative non-invasive neuro-technologies. In this project, we aim at testing the benefit of non-invasively stimulating subcortical structures to boost resilience in supporting motor and non-motor memory.


Eligibility Criteria:
Inclusion Criteria:

TBI patients:

* Age ≥ 18 years
* Clinical diagnosis of TBI
* No history of other severe neurological or psychiatric disorders

Exclusion Criteria:

* Unable to consent

  * Severe neuropsychiatric (e.g., major depression, severe dementia) or unstable systemic diseases (e.g., severe progressive and unstable cancer, life threatening infectious diseases)
  * Severe sensory or cognitive impairment or musculoskeletal dysfunctions prohibiting to understand instructions or to perform the experimental tasks
  * Inability to follow or non-compliance with the procedures of the study
  * Contraindications for NIBS or MRI (1):

    * Electronic or ferromagnetic medical implants/device, non-MRI compatible metal implant
    * History of seizures
    * Medication that significantly interacts with NIBS being benzodiazepines, tricyclic antidepressants and antipsychotics
  * Regular use of narcotic drugs
  * Pregnancy
  * Request of not being informed in case of incidental findings
  * Concomitant participation in another trial involving probing of neuronal plasticity
Patients' Outcome With Severe or Fulminant Hepatic Insufficiency, Hospitalized in the Public Hospitals of Paris

The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris.

Severe, fulminating acute liver failure is a rare but serious disease. The overall prognosis has improved in recent years thanks to advances in medical management and liver transplantation.

However, the epidemiology of this disease in France, the survival with or without liver transplantation of these patients and the factors that can influence this survival are not well known.

The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris (APHP).

The data will come from the APHP Health Data Warehouse

Eligibility Criteria:
Inclusion Criteria:

* Age \> 15
* Severe liver failure or toxicants that may cause a liver failure Or
* (PR\<50% or INR \>1.5) And ALT \>250

Exclusion Criteria:

* Patients with underlying chronic liver disease
* Patients with the conditions given by this following ICD (International Classification of Diseases) : B18 - E831 - K70 - K715 - K717 - K730- K731 - K732 - 738 - K74 - K753 - K758 - K760 - K761
Enterobius Vermicularis and Bruxism in Children

Background. Bruxism is an involuntary, non-functional activity of the masticatory system, and is frequently seen in childhood. Bruxism has many aetiologies, like malocclusion, psychological factors, allergies and gastrointestinal disorders.

Aim. To investigate the relationship between Enterobius vermicularis infection and bruxism in children.

Bruxism has many aetiologies, like occlusal interferences, malocclusion, malnutrition, psychological factors, allergies and gastrointestinal disorders. Among these gastrointestinal disorders, are various intestinal parasitic infections.

Given the controversy surrounding the potential association between bruxism and intestinal parasitic infestations, both important health issues, this study sought to evaluate the relationship between E. vermicularis infection and bruxism in E. vermicularis-positive and E. vermicularis-negative 3-10-year-olds children with bruxism.

Eligibility Criteria:
Inclusion Criteria:

* Teeth-grinding at least once a week in the last 3 months before recruitment according to the criteria established by the American Academy of Sleep Medicine (AASM)
* Angle class I occlusion
* Mesial step occlusion according to flush terminal plane.

Exclusion Criteria:

* Treated with anti-helminthic drugs in the last 2 months before recruitment
* Drugs used that could affect the central nervous system and prevent sleep (sedatives, anti-depressants, neuroleptics, anti-muscarinics, selective serotonin re-uptake inhibitors)
* Sleep disorders (snoring, insomnia, obstructive sleep apnoea, restless leg syndrome, sleep-related epilepsy)
* Psychiatric or neurological disorders
* Upper respiratory system obstruction (last 15 days),
* Any systemic disease;
* Teeth erosion due to internal (reflux) or external (acidic drinks) factors
* Dermatological problems, associated with the use of BiteStrip (Up2dent, Inc., Pulheim, Germany);
* Unsuitable skin structure;
* Previously diagnosed and treated for bruxism;
* Angle class II or class III occlusion
Gut Microbiota in Major Depressive Disorders With and Without Rapid Eye Movement Behavior Disorder

The purpose of this study is to identify the variations in gut microbiota compositions between two subtypes of major depressive disorder.

Objective: To identify the variations in gut microbiota compositions between two subtypes of major depressive disorder (MDD), namely those with and without REM sleep behavior disorder (RBD). To correlate the microbiota composition with depressive severity and prodromal markers of α-synucleinopathy.

Design: Case-control study Setting: Established clinical cohorts consisting of patients with comorbid MDD+RBD and MDD only and a group of sexand age-matched healthy control Participants: Patients with comorbid MDD+RBD (n=55), patients with MDD only (n=55), and healthy control (n=55).

Main outcome measures: The abundance and composition of gut microbiota, severity of depressive symptoms, and prodromal markers of α-synucleinopathy.

Eligibility Criteria:
Inclusion Criteria:

1. Age-and sex-matched with MDD+RBD subjects;
2. Free of psychiatric disorders based on M.I.N.I.;
3. Without a personal history or a family history of RBD or neurodegenerative diseases (i.e. dementia and PD)
4. Free of RBD symptoms or RWSA by vPSG

Exclusion Criteria:

1. Presence of narcolepsy and other neurodegenerative diseases that may give rise to RBD and RWSA;
2. Severe psychiatric illness that could not permit a valid written informed consent or otherwise is not suitable for participating in a study;
3. Use of antibiotics within one month and the use of probiotics within three days prior to sample collection;
4. Pre-existing or post-operation of gastrointestinal diseases (e.g. inflammatory bowel disease, gastrointestinal cancer).
International Adoption and Stress Response Study

This study aims to provide information about the emotional and physiological responses of post-institutionalized children in both a stressful situation (immunization) and a play situation.

During the last decade, international adoptions have doubled in the United States. Because many of these infants and children have experienced institutionalization and poor caretaking before their adoption, international adoptees have special medical and emotional needs that must be met by both their parents and pediatricians. Currently, most clinical information about these children has focused on their physical health status so that protocols for evaluation and treatment can be established. Some systematic research has also focused on their overall developmental status including both cognitive and motor capabilities. These studies show that most of the children are developmentally delayed upon arrival to the U.S. Furthermore, follow-up studies have found international adoptees to score (on the average) significantly lower in cognitive functioning than their nonadopted peers even after spending substantial time in their adopting homes and falling mostly within the normal range. Not surprisingly, children's level of functioning at older ages is related to the length of time spent in institutional care.

These findings are consistent with an emerging literature on the lingering effects of early adversity on children's development. Potent adverse circumstances may include the unbuffered effects of poverty, experience in an institutional setting, physical or sexual abuse, and parental negligence Regardless of the source, children who are not protected from these disadvantageous situations demonstrate changes in their behavior as well as their biophysiological regulation.

Eligibility Criteria:
Inclusion Criteria:

* Infants less than 1 year old
* Adopted infants
* Control group of non-adopted infants

Exclusion Criteria:

* Children greater than 1 year old
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea

This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea.

This clinical trial will test a new wearable device for the diagnosis of Sleep Apnoea against Multi-channel polygraphy and Polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.
* patients between the age of 18 yo and 80 yo

Exclusion Criteria:

* who are not fluent in Spanish, or who have special communication needs.
* Known allergy to the adhesive dressing.
* patients with physical or mental impairments who would not be able to use the new technology on their own.
* patients with very loose/saggy skin in the neck area which would unavoidably result on AcuPebble swinging if moving the neck.
* patients with pacemakers or who have any type of implanted electronic device
The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients

The investigators multicenter randomized open-labelled study will investigate the efficacy of an everolimus based immunosuppression in reducing total native kidney volume in kidney recipients with autosomal dominant polycystic kidney disease compared to a calcineurin inhibitor-based immunosuppression.

Kidney graft recipients receiving a firs kidney graft (between 6 months and 5 years post-transplantation) will be randomized 1:1 to receive an everolimus based immunosuppression (in association with steroids and mycophenolate mofetil) or to continue their calcineurin inhibitor-based immunosuppression regimen. The primary objective will be the reduction of total native kidney volume after a 2-years treatment period.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 75 years-old
* recipients of a first kidney graft between 6 month and 5 years ago with a stable eGFR above 30 ml/min/1,73m2
* contraception for female recipients to avoid pregnancy
* valid health Insurance during the study period

Exclusion Criteria:

* signed informed consent not obtained
Methylation Effects of COV-19 Infection and Vaccinations

This is a retrospective non-randomized clinical study of 60 patients total to assess the effects of SARS-CoV-2 infection and the SARS-CoV-2 vaccination. This study will have 2 arms evaluating the epigenomes of patients pre and post-exposure to one of the interventions. The first arm of the study will analyze 40 patients' epigenomes whose DNA methylation was examined pre and post SARS-CoV-2 infection. The second arm of this study is analyzing 20 patients' epigenomes whose DNA methylation was examined pre and post-injection of the SARS-CoV-2 vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Subjects that are healthy individuals and of any sex, ethnicity, and anyone above the age of 18 years old.
Long-Term Supervised Treatment Interruption in HIV-Infected Patients

This trial is aimed at studying the safety of long term supervised treatment interruption in HIV infected patients with CD4 over 350/mm3 and plasma HIV RNA under 50 000/mL. Another aim of this study is to assess the immunological and virological factors associated with the duration of treatment interruption.

The limitations of the drugs used against HIV include their toxicity, their tolerability, their propensity to induce resistance when not taken with absolute regularity and their cost. Treatment interruption in patients receiving antiretroviral treatment in the setting of chronic infection are associated with viral rebound and rapid CD4 T cell decrease conducting to antiretroviral therapy restart.

In patients with high CD4+ cell counts (patients receiving treatment of chronic infection with controlled viremia and patients who are receiving HAART now in whom treatment would not have been started based on current guidelines), we evaluated the safety of long term supervised treatment interruption. Another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption (proviral HIV DNA at baseline and during follow-up, plasma HIV RNA at baseline and during follow-up, CD4 T cell and CD8 T cell HIV specific responses at baseline and after 12 months).

Eligibility Criteria:
Inclusion Criteria:

* Males and non pregnant females
* 18 years of age and older
* Who have confirmed laboratory diagnosis of HIV infection
* Started on first line antiretroviral treatment with CD4 over 350/mm3 and plasma HIV RNA below 50 000/mL
* Ongoing Antiretroviral therapy at inclusion with CD4 over 450/mm3 and plasma HIV RNA below 5000/mL

Exclusion Criteria:

* HBV-HIV co-infection receiving lamivudine therapy
* Ongoing immunotherapy including IL2, interferon or HIV specific vaccine
* Pregnancy or project of pregnancy
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

Objectives:

1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation.
3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Zubrod performance status 2 (See Appendix B).
* Life expectancy is not severely limited by concomitant illness.
* Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol.
* Serum creatinine \<1.5 mg/dL or Creatinine Clearance \>50 ml/min .
* Serum bilirubin 2.0 mg/dl, SGPT \<3 x upper limit of normal
* No evidence of chronic active hepatitis or cirrhosis.
* HIV-negative
* Patient is not pregnant
* Patient or guardian able to sign informed consent.

Exclusion Criteria:

* N/A
Resin Infiltratration on the Sealing of Proximal Early Caries

Material for caries prevention dont have better results compared with non-operatory interventions.

Two gruops will be compared. One using ICON and another gruop with non-operatory interventions consisted in hygiene instrutions and fluoride topical application. The caries progression will be evalueted with radiographic observation.

Eligibility Criteria:
Inclusion Criteria:

* Two early caries lesion in the same patient, lesion with the same radiolucencies images

Exclusion Criteria:

* Pregnancy, use of orthodontics appliences, use of drugs modified salivar flow, ausence of adjacent teeth
The Stronger at Home Study

Hip fracture is a major health problem facing older adults. Hip fractures result in higher mortality, morbidity, and costs than all other osteoporotic fractures combined. When returning home following hip fracture surgery, patients are at high risk of adverse outcomes (e.g., secondary fractures, institutionalisation, and death).

Objectives: This study aims to finalize and pilot test a new program of care including a user-friendly toolkit containing a home-based physiotherapy exercise and pain management program to help community-dwelling older adults recover after hip fractures.

Methods: This study will be two stages: First, finalizing the program. The investigators have created a self-explanatory toolkit that includes an illustrated exercise program based on a critical analysis of previous programs for hip fracture patients. The investigators will organize focus groups and conduct semi-structured interviews with patients, caregivers, policymakers, and healthcare providers to review the program and provide feedback.

Second, conducting a feasibility study. The investigators will pilot the program in a randomized trial with community-dwelling hip fracture patients and compare the intervention with conventional care.

Expected Outcomes: While the number of hip fracture survivors is increasing, they are becoming frailer, and their functional recovery has not improved, making this study timely and relevant. With the current focus on helping older adults "age in place," the proposed project addresses a vital health system challenge: helping older hip fracture patients access proper rehabilitation, so they can stay independent in their homes.


Eligibility Criteria:
Inclusion Criteria:

* hip fracture patients who are 65 years or older
* being discharged to home or retirement home .

Exclusion Criteria:

* participants with a terminal illness or significant contraindications preventing exercising (e.g. rapidly progressing neurological disease),
* live away more than 30 km from the centre of the city, and
* cannot sign the consent form and no proxy available to sign.
Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma

This is an open-label, phase Ib study evaluating the combination treatment of sintilimab and linperlisib in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (NKTCL).


Eligibility Criteria:
Key Inclusion Criteria:

1. Pathologically confirmed extranodal NKTCL.
2. Voluntary participation in the clinical study; fully understand the study, and have signed the written informed consent form.
3. Age ≥ 18 years.
4. Relapsed or refractory NKTCL after failure of at least one line of asparaginase-based chemotherapy or chemoradiotherapy regimen.
5. ECOG performance status: 0-2.
6. Estimated survival time ≥ 3 months.
7. At least one measurable lesion according to the Lugano 2014 lymphoma evaluation criteria.
8. Adequate organ and bone marrow function.

Key Exclusion Criteria:

1. Patients previously treated with PI3K inhibitors.
2. Patients with hemophagocytic syndrome.
3. Patients known to be allergic to any component of monoclonal antibodies.
4. Patients with a history of other malignancies within the past 5 years or concurrent malignancies (excluding basal cell carcinoma of the skin).
5. Patients with aggressive NK-cell leukemia or central nervous system involvement.
6. Patients who have participated in other drug clinical trials within 4 weeks prior to the start of this study or have received anti-tumor treatment within 4 weeks before the study initiation.
7. Patients with clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction) or patients who have undergone total gastrectomy.
8. Patients with a history of interstitial lung disease (except for asymptomatic interstitial lung disease caused by radiotherapy).
A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit

Patient with undifferentiated arthritis and the presence of anti-citruline (anti-CCP) antibodies are at high risk to develop RA. The presence of anti-CCP is associated with a higher rate of erosion and a higher risk of progressive and severe RA.

The investigators have demonstrated in the CIERA study that MTX/IFX combination therapy is superior to MTX alone to reduce MRI signs of synovitis and bone edema and is clinically more effective.

The immunopathogenesis of undifferentiated arthritis is poorly understood. However, synovial studies from patients with early arthritis suggest that UA and RA may share common immunopathogenic mechanisms. One biopsy study of asymptomatic joints in patients with early arthritis demonstrates synovitis in more than half of the joints samples with prominent T cell and macrophage infiltration, similar to Rheumatoid Arthritis (RA).

Thus intensive treatment with anti-TNF antibodies (infliximab) may have an impact on multiple immune mechanisms driving synovitis in undifferentiated arthritis and may influence the clinical outcome.

Recently, Methotrexate has been demonstrated to improve the course of undifferentiated arthritis and prevent the development of RA. Short regimen of more intensive therapy with Infliximab could alter the radiological, immunopathological and clinical outcome.

not necessary

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of UA Absence of American College of Rheumatology (ACR) criteria Active UA defined by a swollen joint count ≥ 1 and \< 4 Positive anti-CCP Disease duration \< 2 years DMARDs naive No chronic treatment with steroids (\> 3 months), if needed washout of 4 weeks NSAIDs stable

Exclusion Criteria:

Other rheumatic inflammatory diagnosis Contraindication to MRI (pace-maker, etc.) Congestive heart disease Active or latent tuberculosis