cyrilzakka/clinical-trials huggingface dataset:
Lithium Clearance in Patients With High Risk of Acute Kidney Injury

Renal lithium clearance is hypothesized to be a useful indicator of renal tubular function.

In this study lithium clearance will be monitored in patients with sepsis associated acute kidney injury and in healthy controls.

Lithium is almost completely reabsorbed in the proximal tubule in parallel with sodium and water. What is not reabsorbed here is assumed to be fully excreted in urine, giving a reasonably accurate measurement of sodium reabsorption in the proximal tubule. Endogenous lithium clearance will be measured by inductively coupled plasma mass spectrometry (ICP-MS). The Gomez equations will be applied to calculate efferent arteriolar resistance, afferent arteriolar resistance, glomerular hydrostatic pressure, glomerular filtration pressure, and glomerular oncotic pressure. N-acetyl-β-D glucosaminidase (NAG) and NGAL, markers of tubular injury, will be measured by a spectrophotometric method using a commercially available kit. Routine blood and urine analyses will be performed at the Diagnostic Clinic Laboratory, University Hospital of North Norway, Tromsø.

Eligibility Criteria:
Inclusion criteria sepsis associated acute kidney injury:

* Sepsis diagnosed or suspected
* Age \>18 years

Inclusion Criteria healthy controls:

* Previously healthy individuals
* Age \>18 years

Exclusion Criteria:

Oliguria or renal impairment due to other causes than sepsis. Pregnancy or breast-feeding.
Micro Array Analysis in Preeclampsia

Preeclampsia is a frequent pathology. His etiology is doubtful.

Targets :

The study target is to identify a risk of preeclampsia group obtained with transcriptom analysis from circulating peripheric cells.

Design:

Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC).

The study of the transcriptional history of peripheral blood cells of 2patients groups:

* A patient group with a preeclampsia before 34 SA
* A patient group with a normal pregnancy paired on main confusion factors. Blood sampling will be collected at the diagnosis and 8 weeks after delivery.

Results and perspectives

* Obtain a transcriptionnal signature of preeclampsia
* To identify new mechanism of the disease
* Identification of a specific transcriptom analysis with the comparison after delivery For long-term, the target is to identify risk patient in order to conduct easily preventive clinical trials in preeclamsia (primary prevention) and to consider a specific follow-up for risk patients.


Eligibility Criteria:
Inclusion Criteria:

* A prééclampsie (blood pressure superior to 140 mmHg and to 90 mmHg) and at least a cross of protein in the strip and/or more of 300mg / 24h after 20 LIMITED COMPANIES and before 34 limited companies.
* An informed consent signed by the patient will necessarily have to be obtained.
* Woman having been taken care during the pregnancy or at the time of the childbirth(delivery) by one of the participating teams to the current project.
* Caucasian Patient
* Wait primigeste and nullipare

Exclusion Criteria:

* Major Patient protected by the law.
* Patient deprived of freedom for administrative or judicial reasons.
* Patient not benefiting from a national insurance scheme.
* Refusal of the patient to participate in the study.
* Not Caucasian Patient
* Multipare Wait
* Multiple Pregnancy
* Existence of foetal deformation explaining a delay of growth or a foetal death in utero.
* Age 18 years and \> 40 years.
* Absence of written consent or impossibility to receive the written consent (language or understanding).
Trial of the Effect of Low-Molecular-Weight Heparin (LMWH) Versus Warfarin on Mortality in the Long-Term Treatment of Proximal Deep Vein Thrombosis (DVT) (Main LITE Study)

The purpose of this study is to assess the long-term treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus the standard care use of intravenous heparin followed by oral warfarin sodium.

The accepted treatment for acute deep vein thrombosis (DVT) is initial continuous intravenous heparin followed by long-term oral anticoagulant therapy. Improvements in the methods of clinical trials and the use of accurate objective tests to detect venous thromboembolism have made it possible to perform a series of randomized trials to evaluate various treatments of venous thromboembolism.

The specific objectives of the Main LITE Study are:

* to determine if low-molecular-weight heparin, given subcutaneously once daily without laboratory monitoring, is more effective than adjusted oral warfarin sodium in the reduction of mortality rate.
* to determine if such a low-molecular-weight heparin therapy is more cost-effective than present standard care methods.
* to determine the incidence of Factor V Leiden and Prothrombin 20210A mutant genetic abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Patients having a first or recurrent episode of acute proximal vein thrombosis

Exclusion Criteria:

* Presence of familial bleeding diathesis or presence of active bleeding contraindicating anticoagulant therapy
* Receiving therapeutic heparin or therapeutic low-molecular-weight heparin for more than 48 hours or have already been on warfarin for more than 2 days for the treatment of proximal deep vein thrombosis
* Receiving long-term warfarin treatment
* Females who are pregnant
* Known allergy to heparin, warfarin sodium, or bisulfites
* History of heparin-associated thrombocytopenia
* Severe malignant hypertension
* Hepatic encephalopathy
* Severe renal failure
* Inability to attend follow-up due to geographic inaccessibility
* Inability or refusal to give informed consent
* Recent neurological or opthalmic surgery (within the previous 14 days)
* Pulmonary embolism requiring thrombolytic therapy, surgical thrombectomy, or vena cava interruption
* Life expectancy of less than 3 months
* Taking ASA prior to randomization and unable to discontinue this medication during the 84 day study treatment period
A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers

This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers and/or healthy female volunteers of non-childbearing potential who are 18 to 55 years of age;
* Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Clinically significant infections within the past 3 months
HIIT for Inflammatory Rheumatic Disease: Man vs Machine

The purpose of this study is to compare two modes of delivering high-intensity interval training (HIIT) in a population with inflammatory rheumatic disease over 10 weeks. One group will recieved HIIT supervised by a healthcare professional, the other group will perform self-monitored HITT with guidance by a smarthpone application.

People with inflammatory rheumatic diseases (IRS) such as rheumatoid arthritis (RA), spondyloarthritis (SpA) and systemic lupus erythematosus (SLE) have been shown to have reduced cardiovascular fitness and quality of life than the general population. Cardiovascular health is the single most important factor of total mortality. It has been shown previously that individuals with IRS tolerate both endurance training, resulting in improvement in function and cardiovascular health while also having a positive effect on disease activity measured through inflammation, pain, joint health and fatigue. In recent years, studies have also been conducted that demonstrate both the safety and effect of aerobic 4x4min high-intensity interval training (HIIT) for patients with IRS.

This study will involve an intervention period consisting of 20 HIIT sessions. Participants are randomized into one of two training groups. One group will perform HIIT under the supervision of a healthcare professional. The other group will perform the same HIIT training with identical instructions, however they will be self-monitored with the aid and guidance of a mobilephone application.

The purpose of the intervention is to increase maximum oxygen uptake and improve quality of life. The intervention period will consist of 2 weekly sessions lasting approximately 35 minutes performed on non-consecutive days. The endurance training will consist of 4 intervals of 4 minutes duration, separated by a 3-4 minute active break and follows the principle of intensive aerobic interval training. Before and after the training period, identical testing (approximately 30-40 min) will be performed by both intervention groups. The testing will include measurements of work economy and maximal oxygen uptake in an endurance test. Additionally, quality of life questionnaires will be obtained.

Eligibility Criteria:
Inclusion Criteria:

- Inflammatory rheumatic disease

Exclusion Criteria:

* Inability to complete the testing procedures
* Pregancy
* Not able to perform exercise intervention
* Planed surgeries or other plans during initial exercise intervention period than directly will effect the testing or training.
* Access to a smartphone
* Less than 80% compliance of planned training sessions
Emotion Regulation in Trait Schizotypy

Our aim is to compare state anger and state emotion regulation strategies in healthy individuals with high trait schizotypy and to look at differences of induced anger, negative emotions, decrease of positive emotions and aggressive behaviour after anger induction. Our further aim is to compare conditions where an instruction to suppress or reappraise emotions is given with a control condition with no instruction.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 58 years,
* good command of German language

Exclusion Criteria:

* present or past psychiatric or neurological illness,
* ongoing treatment with psychiatric drugs,
* constant consume of heroin or hallucinogenic drugs,
* alcohol dependence,
* cannabis consume two weeks before testing.
Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit for a Severe Bacterial Infection

The aim of this study is to assess patient's quality of life 5 to 10 years after a severe bacterial infection with hospitalization in a intensive unit care. The population is derived from the DIABACT III study. The investigators will include every patient still alive. To evaluate our question, patients and their parents will answer quality of life questionnaires. The investigators will also have telephone interviews with the parents to know somatic and psychological effects on their child.

The investigators will see if quality of life and sequelae differ depending on various studied factors.

The aim of this study is to assess patient's quality of life 5 to 10 years after hospitalization in intensive car unit for a severe bacterial infection. The population is derived from DIABACT III study, and includes all patients still alive.

To evaluate their quality of life, patients and parents will answer specific questionnaries. The Pediatric Quality of Life inventory (PedSQL) has various versions for children depending on their age, adults and parents. The investigators will get physical, emotional, social and academic scores.

To assess somatic and psychological effect after the severe bacterial infection, the investigators will have telephone interviews with the parents, with many questions about organs disorders, specialized medical follow-up, medication, need physical or material assistance, financial and psychological family impact... The investigators will examine data from DIABACT III study to assess determinants of the quality of life for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Every patients from DIABACT III study still alive at the beginning of this study

Exclusion Criteria:

* Patients who did not respond to the questionnaire
* Inability to contact the patient and family
* No fixed postal address
A Study of LY900014 in Participants With Type 2 Diabetes on Insulin Injection Therapy

The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female participants with Type 2 Diabetes Mellitus (T2DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
* Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
* Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study
* Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
* Have venous access sufficient to allow for blood sampling
* Have provided written consent and are willing to follow study procedures and commit to the study duration

Exclusion Criteria:

* Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
* Have previously completed or withdrawn from this study
* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
* Had blood loss of more than 500 milliliters (mL) within the last month
* Are treated with a continuous subcutaneous insulin infusion (insulin pump)
Comparative Study of the VeraCept Low-Dose Intrauterine Copper Contraceptive vs. the TCu380 Copper IUD

The purpose of this study is to evaluate the safety and effectiveness of the VeraCept Low Dose Intrauterine Copper Contraceptive compared to the standard T shaped copper IUD, the TCu380.

This is a prospective, randomized, subject-blinded, two arm controlled study of the Safety, Feasibility and Effectiveness of the VeraCept low-dose intrauterine copper contraceptive as compared to a concurrently controlled, commercially available standard copper "T" IUD (TCu380).

Eligibility Criteria:
Inclusion Criteria:

* Adult females ages 18 to 42 (pre-menopausal)
* Have had at least one child (parous) and currently seeking long acting reversible contraception
* Normal uterine cavity as determined by ultrasound
* Willing to sign informed consent
* Able and willing to comply with study assessment schedule

Exclusion Criteria:

* Post menopausal
* Pregnant (at time of enrollment)
* Known anatomical abnormalities of uterus, cervix and/or fallopian tubes
* Diagnosed or in treatment for cancer
* Untreated acute cervicitis
* In treatment for active Pelvic Inflammatory Disease
* Unexplained uterine bleeding or menometrorrhagia
* Known allergy to copper (Wilson's Disease) or imaging contrast media
* Unsuitable for study participation in the opinion of the Principal Investigator
To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder.

This is a randomized, double-blind, placebo-controlled pilot study aiming to evaluate the effects of NMRA-335140 on symptoms of major depression in adults with Bipolar (BP) II disorder. The study design consists of a Screening Period (up to 28 days), a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo), and a 6-week Safety Follow-up Period.


Eligibility Criteria:
Inclusion Criteria:

1. Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of BP II disorder with a current major depressive episode (MDE), without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID-5-CT) at screening (this may be a first or recurrent episode).
2. Participant's current MDE and lifetime history of hypomanic episodes must be confirmed by independent assessment.
3. The symptoms of the current MDE have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit.
4. Have a MADRS total score of 25 or higher at Screening and Baseline.
5. A change in MADRS total score between Screening and Baseline of ≤20%.

Exclusion Criteria:

1. Have failed 2 or more courses of antidepressant (adequate dose and duration, i.e., minimum 6 weeks) or mood stabilizer/antipsychotic treatment (each or in combination) for treatment of depressive symptoms in the current MDE.
2. Have currently or in the past year any of the following DSM-5-TR disorders: bipolar episodes with mixed features (including the current MDE), bipolar II with rapid cycling pattern (4 or more distinct mood episodes during a 12-month period). Participants with comorbid generalized anxiety disorder, social anxiety disorder, simple phobias, panic disorder, for whom bipolar II MDE is considered the primary diagnosis are not excluded.
3. Have a lifetime diagnosis of bipolar I disorder (manic episode schizophrenia, schizoaffective disorder, schizophreniform disorder, anorexia nervosa, bulimia nervosa, cluster B personality disorder, post-traumatic stress disorder (PTSD), or obsessive- compulsive disorder.
4. Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine).
5. Are actively suicidal (e.g., any suicide attempts within the past 12 months) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) (score of "YES" on suicidal ideation Item 4 or 5 within 3 months prior to Visit 1 \[screening\]) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients

This pilot study focuses on the persistence of central nervous system (CNS) immune activation that has been observed in the presence of 'effective' combination antiretroviral therapy (cART). Attention to this issue is based on the fear that chronic CNS immunoactivation can cause indolent brain injury that will eventually compromise brain function as patients survive for years on treatment. A leading hypothesis explaining this continued immunoactivation is that viral replication continues within the brain at a level too low for detection in cerebrospinal fluid (CSF), yet sufficient to stimulate local immunoactivation. Based on this hypothesis, we propose to use augmented treatment with raltegravir to test whether additional suppression of this hypothesized CNS HIV-1 replication will reduce continued CNS immunoactivation.


Eligibility Criteria:
Inclusion Criteria:

* Capacity to provide informed consent.
* Documented HIV-1 infection.
* History of continuous cART treatment (with at least three drugs) for at least 2 years.
* Documentation of 'undetectable' plasma HIV-1 RNA for at least 1 year.
* HIV-1 RNA \<50 copies/mL in plasma and CSF at screening visit.

Exclusion Criteria:

* Contraindication to LP (suspicion of CNS mass lesion, bleeding diathesis, etc.).
* Prior experience with raltegravir or contraindication to raltegravir treatment, including medication interactions that might compromise ongoing antiretroviral therapy or treatment of other conditions.
* Active opportunistic infections or neurological diseases.
* Other conditions or treatments likely to interfere with treatment or evaluation.
* Hemoglobin \< 10 Gm/dL.
* Pregnant or anticipating pregnancy during study.
* Active substance abuse.
* Subjects taking rifampin, phenytoin, Phenobarbital or other drugs that accelerate raltegravir metabolism and might decrease its tissue concentrations.
The Segmental Distribution of Hypersensitivity in Patients With Chronic Subacromial Pain Syndrome

This study aimed to determine the distribution of pain sensitivity according to body segments in patients with central sensitization associated with chronic subacromial pain syndrome (SPS).This cross-sectional study included patients with chronic SPS and central sensitization (patient group) and the same number of healthy participants as controls. The presence of central sensitization was determined using the Central Sensitization Inventory. To determine the segmental distribution of pain sensitivity, pressure pain threshold measurements were performed bilaterally from the shoulder, forearm, and leg.

Shoulder pain is a common musculoskeletal pain condition in the general population, with a prevalence that has doubled in all age groups over the past 40 years, reaching 22%-30%. Despite treatment, at least 40% of patients report incomplete improvement in pain severity and duration of symptoms, which are the two main determinants of treatment response. There is convincing evidence that the persistence of pain in these patients is due to peripheral or central sensitization mechanisms. Central sensitization refers to pain hypersensitivity mainly resulting from amplifying central nervous system signals and reduced activity of central inhibitory pathways. The clinical presence of central sensitization is determined by examining specific pain characteristics or evaluating changes in pain threshold. The objective manifestation of central sensitization is a decreased pressure-pain threshold (PPT) (hypersensitivity). In previous studies using PPT measurement, pain sensitivity was detected in the shoulder and remote joints in patients with subacromial pain syndrome (SPS), which was considered as evidence of central sensitization. However, these studies did not show how pain sensitivity differs according to body segment in patients with SPS. Hypersensitivity that develops due to chronic shoulder pain would exacerbate the perception of pain caused by other musculoskeletal diseases or trauma. Therefore, it may be important for clinicians to determine how pain sensitivity varies by body segment in patients with SPS

Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with chronic (≥ 3 months) unilateral SPS according to clinical examination (the Hawkins-Kennedy test and the painful arc test) and/or imaging.
* To be scored ≥ 40 on CSI

Exclusion Criteria:

i) Bilateral shoulder pain syndrome, ii) History ofshoulder surgery, iii) Osteoarthritis of the glenohumeral joint on direct radiography, v)concomitant diseases with the potential risk of development of central/peripheral sensitization \[diseases specified in CSI part B, vi) symptomatic lateral/central spinal stenosis, myelopathy, or radiculopathy, vii) history of centrally acting drug use (e.g.,pregabalin, gabapentin, amitriptyline, duloxetine, and opioid) viii) alcohol/substance abuse.