cyrilzakka/clinical-trials huggingface dataset:
Exercise and Therapeutic Exposure

The proposed project seeks to demonstrate that a brief bout of aerobic exercise can improve a particular type of therapeutic learning among victimins of interpersonal violence with or without posttraumatic stress disorder (PTSD).

The proposed study has one aim:

Specific Aim: To examine the effects of acute exercise on the consolidation of therapeutic safety learning. It is hypothesized that participants who engage in 30-min of moderate-intensity aerobic exercise following the first session of imaginal exposure will show larger between-session (visit 2 to 3) reductions in heart rate and anxiety during imaginal exposure to trauma narratives compared to participants who engage in light-intensity exercise.

Eligibility Criteria:
Inclusion Criteria:

* Experience of interpersonal violence
* English speaking
* Medically healthy

Exclusion Criteria:

* Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease and as assessed via the Physical Activity Readiness Questionnaire (PAR-Q), which probes into participants' history of heart conditions, chest pain, dizziness, loss of consciousness, bone/joint problems, and medication history). Participants would not be excluded if they report this condition being "controlled" or "addressed" through medication or lifestyle change, such as regular exercise.
* Major medical disorders (such as cancer, AIDS)
* Psychotic disorders
* Intellectual disabilities
* Developmental disorders
* Active substance use disorders
* Pregnancy or probably pregnancy
* Body mass index greater than or equal to 35
* Daily cannabis use
* History of any cardiac disease
* Inability to provide informed consent
* Physical disabilities that prohibit task performance (such as deafness or blindness)
* Self-reported history of loss of consciousness (greater than 30 minutes)
Losartan in Decompensated Heart Failure

The dual blockade of the renin-angiotensin-aldosterone system with an angiotensin-converting enzyme inhibitor and an angiotensin-receptor blocker used together in heart failure patients has been demonstrated to be beneficial. However, the dual inhibition has not been studied during heart failure decompensation or even when low cardiac output is present.

The objective of this study was to assess the effects of add-on therapy with angiotensin receptor blocker on plasma B-type natriuretic peptide levels and hemodynamic measurements in heart failure patients with low cardiac output during hospitalization for decompensation.

This was a randomized, double-blind, placebo-controlled clinical trial.

The inclusion criteria were hospitalization for decompensated heart failure defined by worsening of symptoms until fatigue or dyspnea at rest, low cardiac output defined by the clinical-hemodynamic profile, dobutamine dependence, and ejection fraction \< 0.45, spontaneous breathing and receiving angiotensin-converting enzyme inhibitors. The patients could have jugular ingurgitation, lower limbs edema, ascites and rales. Dobutamine dependence was defined by infusion for more than 15 days or an unsuccessful attempt of withdrawal.

The exclusion criteria were serum creatinine \> 3.0 mg/dL, serum potassium \> 6.0 mEq/L, systolic blood pressure \< 70 mm Hg, aortic stenosis, and acute coronary syndrome in the previous 2 months. The patients were randomly assigned by permuted block of 4, stratified by sex, to losartan or placebo.

The endpoints were change in B-type natriuretic peptide levels, cardiac index, pulmonary wedge capillary pressure, systemic vascular resistance, and successful withdrawal of dobutamine.

Eligibility Criteria:
Inclusion Criteria:

* hospitalization for decompensated heart failure
* dobutamine dependence
* ejection fraction \< 0.45
* taking angiotensin-converting enzyme inhibitor

Exclusion Criteria:

* serum creatinine \> 3.0 mg/dL
* serum potassium \> 6.0 mEq/L
* systolic blood pressure \< 70 mm Hg
* aortic stenosis
* acute coronary syndrome in the previous 2 months
Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor

'Supervised exercise to PRomote Infiltration of NK-cells into the Tumor? The objective of this feasibility study is to 1) study trial feasibility in terms of patient enrollment and the percentage of tumor biopsies that can be examined successfully, and 2) generate preliminary data on the potential effects of exercise on immune function assessed in the tumor and in blood.

This is a multicenter randomized controlled feasibility trial, in which 20 women with breast cancer scheduled for neoadjuvant 2 or 3 weekly AC-T(H) chemotherapy will be randomized into a combined aerobic and resistance exercise intervention group or a usual care (no exercise) control group, during the first 6 weeks (2 or 3 cycles) of chemotherapy. Patients from the control group will receive care as usual and are requested to maintain their usual daily physical activities. In order to limit contamination (increase of exercise in the control group), non-participation and prevent dropout, the control group will be offered the same 6-week exercise intervention after the tumor biopsy has been taken after 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* stage I-III breast cancer
* scheduled for neoadjuvant chemotherapy with 2 or 3-weekly Adriamycin/Cyclofosfamide, followed by Paclitaxel weekly +/- trastuzumab
* willing to undergo an additional ultrasound guided biopsy
* ECOG-performance score ≤ 2 (able to perform basic activities of daily living such as walking or biking)

Exclusion Criteria:

* addition of immuno- or targeted therapy at start of neoadjuvant chemotherapy
* currently participating in structured vigorous aerobic exercise and/or resistance exercise

(≥2 days per week).

* cognitive disorder or severe emotional instability
* presence of other disabling co-morbidity that might hamper physical exercise e.g. heart failure (NYHA classes 3 and 4), chronic obstructive pulmonary disease (COPD, gold 3 and 4), orthopaedic conditions and neurological disorders (e.g., hernia, paresis, amputation, active rheumatoid arthritis);
* immunosuppressive medication (e.g. corticosteroids (other than used as part of standard chemotherapy premedication protocol), cyclosporine)
* immunodeficiency (primary or secondary)
* impossibility to perform an ultrasound-guided biopsy of the tumor
Real-time Attended Home-polysomnography Through Telematic Data Transmission

The purpose of this study is to develop an efficient home-based polysomnography device, which allows, through GPRS,continuous real-time monitoring from the sleep lab based in the hospital, in order to decrease the failure rate of home-based recordings.


Eligibility Criteria:
Inclusion Criteria:

* clinical suspicion of OSA
* 18 y old

Exclusion Criteria:

* restrictive respiratory disorders
* distance home-hospital exceeding 30 Km.
Belimumab in Patients With Systemic Lupus Erythematosus

The BeliLES-GEAS project pretends to obtain an extensive data registry of patients with systemic lupus erythematosus (SLE).

The main objective is to create a national SLE patients registry treated with belimumab to describe effectiveness and safety of intravenous (IV) or subcutaneous (SC) belimumab in patients with active SLE treated in the Spanish departments of Internal Medicine in a real-life setting. This research project aspires to cover the vast majority (if not the whole) of SLE patients treated with belimumab in all of the Spanish Departments of Internal Medicine.

The goal of BeliLES-GEAS registry is to create an observational, non-randomized, non-controlled, national multicenter prospective and retrospective cohort with the aim to explore the real performance, with its lights and shadows, of Belimumab, either IV or SC, in a real-world population of lupus patients.

The intention is to perform a longer-term follow up, so that the measure of hard outcomes, such as improvement in mortality, could be feasible, but also reliable data regarding the safety profile could be recorded.

In order to achieve that, the following variables will be included: individual criteria as part of 2019 EULAR/ACR, SLICC or ACR 1997 classification criteria, gender, age at diagnosis, age at symptoms onset, duration of the disease, age at first Belimumab administration, mean time of follow-up prior to, and from Belimumab administration, complete medical history including other systemic autoimmune diseases, type/s of organ/systems affected by SLE, prior immunosuppressants received, number of flares 2 years prior Belimumab onset, number of medical visits, number of days of sick leave, type of disease, treatment and laboratory data. As a measure of damage, Systemic Lupus International Collaborating Clinics-Damage Index (SLICC-DI) score will be calculated at baseline and at 12, 18, 24 months and yearly of follow-up. All centers will be requested to provide the SLICC-DI calculated annually of the last five years before the initiation of belimumab, when available.

The efficacy will be evaluated as time to reach any of the definition of remission included in the DORIS (definitions of remission in SLE) consensus, or LLDAs (lupus low disease activity state). Regarding the safety of Belimumab in real-world setting, it will be defined and evaluated by documenting adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Fulfillment of the 2019 EULAR/ACR classification criteria for SLE, SLICC classification criteria, 1997 American College of Rheumatology (ACR) revised criteria for SLE or patients with only 3 criteria but SLE diagnosed according to the clinical judgment of the treating physician.
2. Age of 18 years or more.
3. Having received at least one dose of intravenous or subcutaneous belimumab according the physician criteria regardless the clinical/immunological response.
4. Signed informed consent.

Exclusion Criteria:

1) Negative from the patient to participate in the study.
Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)

The purpose of this study is to evaluate the use of aromatherapy to reduce nausea, vomiting, and the use of anti-emetic in cancer survivors undergoing moderate to highly emetogenic chemotherapy regimens.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Able to read and speak English or Spanish
3. Able to and willing to give informed consent
4. Currently undergoing moderate and high emetogenic chemotherapy (adjuvant or neoadjuvant)
5. Receiving three or more remaining cycles of chemotherapy
6. Symptoms of nausea or vomiting after the first chemotherapy infusion

Exclusion Criteria:

1. Unable or unwilling to give informed consent
2. Sensitivity to essential oils\*
3. Olfactory disorders
4. Receiving chemotherapy for the first time
5. Undergoing low emetogenic chemotherapy regimens
6. Patients with hormone-sensitive cancers
7. Timely request of treating provider
Search for Predictors of Therapeutic Response in Ovarian Carcinoma

In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).


Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer of the ovary, peritoneum or of the fallopian tube
* Stage III or IV
* Cancer of serous histology
* Patients of any chemotherapy naive
* Patients should receive treatment with chemotherapy for first line by Taxol- Carboplatin. Avastin is authorized in concomitant.
* An initial surgery or through authorized
* Patients who signed informed consent
* Patients over the age of 18 years

Exclusion Criteria:

* Patients being treated for another cancer chemotherapy and / or hormone therapy
* Patients receiving other chemotherapy Taxol-carboplatin associated or not to avastin
* Patients under guardianship
* Previous history of pelvic radiotherapy
* History of malignancy blood
Biomarkers in Predicting Response to Rituximab Treatment in Samples From Patients With Indolent Follicular Lymphoma

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in predicting response to rituximab treatment in samples from patients with indolent follicular lymphoma.

OBJECTIVES:

Primary

* Genotype the full cohort of samples available from the RESORT clinical trial (ECOG-E4402) for FCGR3A 158V/F in parallel to independently verify results.
* Correlate the FCGR3A 158V/F polymorphisms to response, response duration, and time to rituximab resistance.

Secondary

* Quantify copy number variation in FCGR3A in this cohort.

OUTLINE: Archived DNA samples isolate from peripheral blood mononuclear cells and from formalin-fixed paraffin-embedded tissue samples are analyzed for FCGR3A 158V/F polymorphisms using different complementary genotyping methods. Assay results are reviewed and compared with patients' outcome data.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with indolent follicular lymphoma
* Treated on RESORT trial (ECOG-E4402) comprising rituximab monotherapy and then randomized to rituximab maintenance therapy or retreatment with rituximab upon disease relapse

  * Blood and tissue samples from patients available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
The Effect of Isosorbide Diesters Based Moisturizer on Skin Health

The overall objective of this study is to assess how a natural ingredient, isosorbide diesters (IDEAS), works in association with colloidal oatmeal for eczema.

The topical therapy of eczema largely focuses on the use of topical medications but there is demand for topical moisturizers and ingredients that can reduce the need for topical steroids. The goal of this study is to assess the use of a natural ingredient, isosorbide diesters (IDEAS), for eczema and if it can reduce the need for the use of topical steroids.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 or over
* Subjects with a diagnosis of mild to moderate eczema with a SCORAD between 1-50.

Exclusion Criteria:

* Individuals who have a known allergy to isosorbide diesters.
* Individuals who have solely hand and/or foot eczema without evidence of eczema anywhere else on their body.
* Individuals who have been on topical calcineurin inhibitors or crisaborole to the predetermined areas within two weeks of initiation of participation or unwilling to undergo a washout period.
* Subjects with an ongoing secondary infection of the skin.
* Subjects who are on systemic therapy or who need systemic therapy at the discretion of the investigator. Systemic therapies include cyclosporine, systemic steroids, methotrexate, and dupilumab. Subjects who have been on cyclosporine, systemic steroids, or methotrexate in the month prior to initiation of study intervention or are unwilling to undergo a washout period. Subjects who have been on dupilumab in two months prior to initiation of study intervention or are unwilling to undergo a washout period.
* Subjects with a diagnosis of Scabies.
* Pregnant women
* Prisoners
Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension

The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.


Eligibility Criteria:
Inclusion Criteria:

* Untreated bilateral newly diagnosed patients with primary open angle glaucoma

Exclusion Criteria:

* Any ocular hypertension other than chronic open angle glaucoma
A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)

This single site study will examine plasma and alveolar compartment (AC) levels of posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal infection rates will be assessed following transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo lung transplantation
* Able to take oral/nasogastric medication
* Females of childbearing potential, males, and the sexual partners of males must use an effective method of birth control during this study and for 6 weeks after completing the study.

Exclusion Criteria:

* Severe liver disease
* Current use of cytochrome P-450 (CYP)-3A4 inhibitors including terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days before transplant
* Treatment with posaconazole within 14 days before transplant
* Breastfeeding
Laminaria and Misoprostol Before Operative Hysteroscopy

Laminaria and Misoprostol before Operative Hysteroscopy

The use of laminaria versus laminaria plus misoprostol was compared before operative hysteroscopy in nulliparous women to assess the efficacy of both methods in cervical dilatation.

Eligibility Criteria:
Inclusion Criteria: nullipara

* need hystroscopic intervention

Exclusion Criteria: previous pregnancy

cervical lesion

contraindication to misoprostol

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Kinetics of Urinary Excretion of Gadolinium Contrast Agents Used in MRI Examinations

This is a single-center cohort study aimed to describe the urinary excretion kinetics of gadolinium contrast agents (Gd-CAs). Patients with a prescription for injected MRI are invited to participate in the study. If they agree, blood and urine samples are collected before Gd-CAs injection, and urine samples are collected between 0- and two-and-a-half-hours post-injection of Gd-CAs.

The contrast agents used in MRI to characterize certain lesions contain a chemical element from the rare earth family: Gadolinium (Gd). Gd, in its isolated form, is toxic in humans, but it can still be used in the form of complex molecules such as gadolinium contrast agents (Gd-CAs), which retain its contrast power while greatly minimizing its toxicity.

The MRI is performed rapidly after the injection of Gd-CAs, and these compounds are eliminated by the urinary route in the first urine following the examination. After elimination, and in view of their very high stability, these compounds follow the path of wastewater via sewage treatment plants. However, the processes currently used in these plants do not retain them, and they remain present in the purified water discharged into rivers.

Work carried out at the Laboratoire Interdisciplinaire des Environnements Continentaux (LIEC) at the University of Lorraine has demonstrated the bioaccumulation of these compounds in freshwater organisms. Gd-CAs then follow the classic pathway of continental waters. It should be noted that the quantity of Gd released as a result of MRI activities has been estimated on average at 1 injection per 1 g of Gd used.

In order to prevent future environmental disorders, recovery of all or part of the Gd-CAs immediately after MRI by urine collection is undoubtedly the most effective approach.

The aim of this project is to assess the feasibility of such an approach, and to propose a protocol applicable to MRI involving the injection of gadolinium contrast agents for urine collection.

This project is part of the "Rare Earths" theme of LabEx R21. It will examine the possibility of recycling gadolinium as an element or as Gd-CAs.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* over 18 years of age
* with a prescription for MRI with gadolinium-based contrast agents (Gd-CAs) injection validated by a radiologist
* affiliated with a health insurance plan
* have signed an informed consent form

Exclusion Criteria:

* Patients:
* with known allergy to gadolinium-based contrast agents (Gd-CAs)
* with known severe renal impairment (GFR \< 30 mL/min)
* on dialysis
* with urinary incontinence
* with an ongoing urinary tract infection
* under hydric or hydrosodic restriction
* unable to urinate independently
* Protected persons (under guardianship, curatorship or safeguard of justice)
* Pregnant or breast-feeding women
Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment in Adult Patients

Orthodontic treatment with fixed appliances can be necessary to correct malocclusions in adolescence or adulthood. It its known that orthodontic treatment induces aseptic pseudo-inflammatory reactions. However, studies could show that an increase of certain inflammatory cytokines during orthodontic treatment correlated with a higher risk of root resorption. Moreover, it has been shown that orthodontic treatment leads to a dysbiosis of the oral microbiome especially during the first 3 months of the orthodontic treatment. This could be a potential risk factor as the inflammation of periodontitis during an orthodontic treatment could favor root resorption and progressive destruction of the periodontal apparatus.

Probiotics are already used successfully as an adjuvant therapy in the treatment of periodontitis to improve clinical parameters and to reduce local inflammation. However, there are only a few studies that investigated the influence of probiotics during an orthodontic treatment.

Therefore, the aim of our study is to investigate if the daily intake of lozenges containing probiotics versus placebo lozenges during the first 3 months of orthodontic treatment with fixed appliances can improve clinical parameters, reduce local inflammation, systemic inflammation and prevent a dysbiosis of the oral microbiome.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older) with fixed appliances undergoing orthodontic treatment.
* Signed declaration of consent by the patient

Exclusion Criteria:

* • Systemic or metabolic disease that are related to gingivitis or (e.g. diabetes) or could possibly influence the oral microbiome

  • obesity:
* body mass index (BMI) \> 30 kg/m² (weight and height will be measured)

  • Eating disorder or underweight
* BMI \< 18,5 kg/m² (weight and height will be measured)

  * Above-average consumption of milk products: \> 3 portions/day = \>1,2 liters of milk or 1200g yoghurt/day (daily dose recommended by the german society for nutrition = 1-3 portions of milk products)
  * allergy to ingredients of the lozenges
  * intake of antibiotics or dietary supplementation (probiotics, vitamin C/D) in the last 6 months or during the study
  * regular use of antibacterial mouth wash
  * pregnancy
  * smoking
  * retraction of the declaration of consent by the patient