cyrilzakka/clinical-trials huggingface dataset:
Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

This will be a pilot study of 9 patients undergoing standard-of-care clinically indicated carotid endarterectomy. The nine patients will receive an injection of Indocyanine green (ICG) at a dose of 0.25 mg/kg (maximum 25 mg) as an intravenous bolus.

Immediately following endarterectomy, the resected specimen will be immersed in normal saline. Ex vivo fluorescence reflectance imaging (FRI) and immunohistochemistry will be performed.

The investigators hypothesize that compared to controls, ICG-injected patients will demonstrate increased ex vivo and microscopic ICG fluorescence signal within areas of plaque.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients scheduled for elective carotid endarterectomy at Massachusetts General Hospital
* Age \> 18 years of age.
* Signed informed consent.

Exclusion criteria:

* Hemodynamic instability
* Any history of iodide allergy
* Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) \<50 ml/min/1.73 m2)
* Any history of liver failure
* Any history of bleeding diathesis
* Any history of cerebral vascular accident in the preceding 3 months
* Pregnant or lactating females.
* Hx of seafood allergy
Burst Optimized Stimulation Study

This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.

This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms.

Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.

Eligibility Criteria:
Inclusion Criteria:

* Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain;
* Subject has been exclusively using burst stimulation for at least three months;
* Subject is 18 years of age or older;
* Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation;
* Subject agrees not to add or increase pain-related medication from enrollment through the study duration;
* Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;

Exclusion Criteria:

* Subject is currently participating in a clinical investigation study that includes an active treatment arm;
* Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation;
* Subject has a non SJM neuromodulation device
Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk MDS Resistant or Relapsing After ESA Agents

Patients with low-risk MDS verifying the eligibility criteria may be included in the study.

Patients will receive the number of DFX tablets (Exjade, cp film-coated, 90mg or 360mg), in relation to their body weight to be closer to 3.5mg / kg / d for 12 months.

At one month and six months of treatment, the residual plasma levels of DFX will be measured in patients (sent to the Bordeaux laboratory of Biochemistry, Pr Molimard) to allow the dosage to be adjusted (plasma objective of 3 μM).

At inclusion (J1) and at 6 months of treatment, a dosage of NTBI and hepcidine will be performed.

If patients become transfusion-dependent (≥) 2 packed red cells (RBP) per 2-month period evaluated over 6 months, they will stop low-dose DFX and go out of protocol to receive DFX at 20mg / kg (according to EMEA authorization) for iron chelation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with MDS according to WHO 2008 criteria (refractory anemia with multilineage dysplasia, RA (refractory anemia), refractory anemia with ringed sideroblasts (RARS) including CMML-1 (chronic myelomonocytic leukemia) type 1 with \<10% blasts)
2. low risk (IPSS-R very low, low and intermediate)
3. in primary or secondary failure after erythropoiesis stimulating agents (ESAs), (either epoetins (≥60,000 units / week), or darbepoetin (≥250 μg / week), administered for at least 12 weeks, as defined by the IWG criteria 2006 (no erythroid response at 12 weeks, or more than 15g / l decrease in Hb after response to ESAs) PS: Patients with low transfusion of less than (\<) 4RBP assessed over 4 months (RBP administered for patients with Hb ≤ 9g / dl) will be accepted)
4. age ≥ 18 years
5. ECOG ≤2
6. informed consent dated and signed
7. affiliated to a social security scheme
8. Women and men of childbearing potential must have effective contraception throughout the duration of the study and up to 4 days after the last administration of deferasirox

Exclusion Criteria:

1. Transfusion dependent patient (≥) 2 red blood cells (RBP) per 2-month period evaluated over 4 months between M-4 and M0
2. Patients with high-risk MDS (based on IPSS-R) and patients with other hematologic and non-haematological malignancies who should not benefit from chelation therapy due to rapid progression of their disease
3. Ferritin \<200 ng / ml
4. Iron overload: ferritin\> 1000 ng / ml
5. Creatinine clearance according to MDRD ≤60 ml / min
6. 5q- deletion to karyotype
7. Patient eligible for allograft
8. Patient participating in another interventional clinical study or exclusion period from another study
9. History of cancer treated or untreated for less than 5 years, whether or not there are signs of relapse or metastases, with the exception of basocellular cancers.
10. Persons referred to in Articles L1121-5 to L1121-8 of the CSP: pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, can not not be included in clinical trials.
Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

RATIONALE: Beclomethasone dipropionate may be effective in preventing acute graft-versus-host disease in patients undergoing a stem cell transplant for hematologic cancer.

PURPOSE: This randomized phase II trial is studying how well beclomethasone dipropionate works in preventing acute graft-versus-host disease in patients undergoing a donor stem cell transplant for hematologic cancer.

PRIMARY OBJECTIVES:

I. Assess the efficacy of oral BDP for prevention of acute GVHD after allogeneic hematopoietic cell transplantation with myeloablative conditioning regimens.

OUTLINE:

Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral beclomethasone dipropionate 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.

ARM II: Patients receive oral placebo 4 times daily beginning at the start of the conditioning regimen and continuing through day 75 post-transplant. Patients also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Eligibility Criteria:
Inclusion

* Allogeneic HCT with marrow or growth-factor mobilized blood cells from an HLA-A, B, C, DRB1, and HLA-DQB1-allele matched or single-allele or antigen mismatched related or unrelated donor
* Use of myeloablative pre-transplant conditioning regimen with \> 800 cGy total body irradiation and cyclophosphamide, or high-dose busulfan and cyclophosphamide
* Use of methotrexate and tacrolimus for prevention of GVHD after allogeneic HCT
* Informed consent document signed

Exclusion

* Cord blood transplant recipients
* Use of T cell depletion or rabbit antithymocyte globulin to prevent acute GVHD
* Treatment with rabbit antithymocyte globulin or alemtuzumab within 3 months before the date of HCT
* Participation in another therapeutic trial where the primary endpoint is related to acute GVHD
* Hospitalization at the beginning of the pre-transplant conditioning regimen because of pre-existing medical complications
* Glucocorticoid treatment at prednisone-equivalent doses \> 0.2 mg/kg/day
* Known intolerance to BDP
* Anticipated inability to tolerate oral administration of study drug tablets for any reason during the first two weeks after HCT
* Body weight \< 35 kg (lower-dose formulations are not available for subjects with lower body weight)
* Pregnancy or breast feeding
* Women of child-bearing potential who are unwilling to use a reliable method of contraception
* Incarceration
Review of French Cases of Glutathione Synthetase Deficiency

The glutathione synthetase deficiency, inborn error of metabolism of autosomal recessive inheritance, is a rare disease (70 patients described in the world). The outcome of these patients and potential complications of this disease are not, to date, yet all known and described.


Eligibility Criteria:
Inclusion criteria:

* All patients followed in the French hospital centers the diagnosis of glutathione synthetase deficiency has been proven by assay of residual enzyme activity or identifying a mutation of the glutathione synthetase gene

Exclusion criteria:

* No formal proof of glutathione synthetase deficiency
Detection of Chlorhexidine in Tracheal Secretions After Routine Oral Care With Chlorhexidine Gluconate

Recent meta-analysis have suggested that the safety of oral care with chlorhexidine in patients under mechanical ventilation could be questionable. Whatever the hypothetical mechanisms involved (direct cellular toxicity, underdiagnosis of Ventilator-Associated Pneumonia), presence of chlorhexidine in tracheal secretions after routine oral care is the cornerstone of this potential side effect of the routine oral care with chlorhexidine gluconate. The DEMETER study assessing the medico-economical impact of the subglottic secretions drainage study (NCT02515617) provides the opportunity to perform this proof of concept study (detection of chlorhexidine in tracheal secretions after routine oral care with chlorhexidine gluconate) and to evaluate the impact of the subglottic secretion drainage on this potential detection of chlorhexidine.

This ancillary study will be performed in one of the centers participating to the DEMETER study.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Invasive mechanical ventilation (MV) delivered via an endotracheal tube and MV required more than 72 hours
* Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (SSD) will be available during the SSD period of the trial
* Information delivered

Exclusion Criteria:

* Previous inclusion in the study
* Patients moribund at the ICU admission
* Pregnant, parturient or breast-feeding woman
* Patient hospitalized without consent and/or deprived of liberty by court's decision
* Patient under guardianship or curators
* Lack of social insurance
* Concomitant inclusion in a trial on VAP prevention
* Patient with no comprehension of the French language
Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children

Study based in Southern Ethiopia Purpose - to explore if children in contact with adults with TB have positive acute reactants such as IFN-y and other cytokine responses; if these responses discriminate between high and low risk of disease progression and whether these could be incorporated into improved diagnostic approaches.

The study follows children in contact with TB. Those with positive TST will be offered chemoprophylaxis and all children will be followed for 2 years to describe IFN-y responses over time, identify symptoms of active TB and if these symptoms are associated with IFN-y and other cytokine responses.

Children with suspicion of TB attending health centres will also be investigated using routine diagnostic tests and IFN-y and other cytokines responses to evaluate if the latter could be used in improved diagnostic approaches.

Eligibility Criteria:
Inclusion Criteria:

- Children - 1 to 14 years old in contact with adults with smear positive TB

Or:

- Children with suspicion of TB admitted to the hospital for investigations

Exclusion Criteria:

- Residency \> 10 Km from recruitment center

Or:

- Patient severely to undergo diagnostic procedures.
A Study of the Effect of Fluvoxamine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a cross-over design. The anticipated time on study treatment is 40 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, 18-65 years of age inclusive
* Non-smokers
* Body mass index (BMI) between 18 and 30 mg/m2 inclusive
* Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception

Exclusion Criteria:

* Evidence of any active or chronic disease
* History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer History or presence of clinically significant psychiatric condition
* Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study
Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?

The investigators hypothesize that intensive acid suppression with a long acting high potency proton pump inhibitor (PPI) drug dexlansoprazole will lead to a greater decrease in levels of inflammatory mediators (compared to conventional PPIs) in the esophagus, which could potentially lead to decreased recurrence of intestinal metaplasia following endoscopic ablation.

Patients who achieve complete remission of intestinal metaplasia following ablation will be randomized (using concealed allocation, like the flip of a coin) to either intensive acid suppression with dexlansoprazole 60-90 mg/day or to symptom guided acid suppression with escalating doses of omeprazole (20-60 mg/day) for 6 months. Control of reflux will be assessed using 24 hour ambulatory pH monitoring. The need to escalate drug dosage at the 3 month visit will be determined by presence of excessive acid exposure on ambulatory pH monitoring. Biopsies of esophageal tissue will be obtained at baseline, then at 3 months and 6 months following randomization to measure changes in inflammatory biomarkers.

Eligibility Criteria:
Patients who have undergone ablation for Barrett's Esophagus (BE) and High Grade Dysplasia (HGD) or Low Grade Dysplasia (LGD) with Photodynamic Therapy (PDT)/Radiofrequency ablation and endoscopic mucosal resection who have no endoscopic and histologic evidence of specialized intestinal metaplasia on biopsies from the esophagus on two successive endoscopies post ablation will be offered enrollment in the study.

Inclusion criteria:

1. Absence of intestinal metaplasia on endoscopy (under Narrow Band Imaging) and on histology (from biopsies taken from gastroesophageal junction and distal esophagus) on two successive surveillance endoscopies.
2. Able to consent to study
3. Males and females age 18-90
4. Life expectancy of 5 years or greater.

Exclusion criteria:

1. Pregnancy
2. Inability to consent for the procedure
3. Anticoagulation therapy precluding performance of ambulatory pH monitoring and/or biopsies
4. Intolerance to proton pump inhibitors
5. Elevation in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), (liver enzymes), bilirubin or alkaline phosphatase more than five times the upper limit of normal.
Digital Treatment for Migraines - a Feasibility Study

An individualised internet-based treatment from a biopsychosocial perspective for patients with migraines in primary care has been developed within the Vastra Gotaland region in 2019. The treatment program is called Learning to live with migraines, and goes by the acronym "I am" (Internet Approach to Migraine). In a pilot study, the treatment programme and its feasibility in primary care will be evaluated. It is hoped that the intervention "I am" can educate patients about their illness and help the patient manage migraine attacks so that the likelihood of difficulty and frequency of migraine attacks does not increase, as well as provide an increased function and quality of life.

Purpose The overall purpose of the study is to evaluate in a pilot study the practical feasibility of a future randomized study to evaluate personalized digital biopsychosocial treatment method, "I am"- Learning to live with migraines in primary care.

Issues

Will a large or small percentage of individuals who are asked to participate in the study accept participation? Will the random advantage to the different groups make potential participants hesitant? Will measuring the effect be practicable? What investigative instruments are appropriate in this situation? Is a new investigative instrument to be built? Are the interventions reasonable to apply given the resources we can expect to have in a larger study? Will a large or small proportion of patients discontinue participation in the study for various reasons? How common are unforeseen problems (which may justify the exclusion of a patient or the negative/harmful effects of the intervention)? What change in endpoints is seen in the different groups?

Eligibility Criteria:
Inclusion Criteria:

* Women and men
* Age18 to 65
* Diagnosis migraine with (G43.0) or without aura (G43.1)
* 3-15 migraine days a month
* Access to computer/tablet or smartphone with bankid and internet connection

Exclusion Criteria:

* Ongoing malignant disease
* Other migraine diseases
* Moderate to severe psychiatric problems such as depression or anxiety disorder
* Neuropsychiatric conditions
* Psychosis disorders
* Addiction
* Personality disorders
* People who cannot read, speak or understand the Swedish language
* Ongoing psychological/psychotherapeutic treatment
Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

This research study is being done to find out if one of two drugs, ketamine or haloperidol, is better for treating agitation. Agitation is a state of extreme emotional disturbance where patients can become physically aggressive or violent, endangering themselves and those who are caring for them. Often chemical substances or severe mental illness is involved in this level of agitation. Specifically, the investigators are interested in studying agitation that is treated in the prehospital setting by paramedics. This study's hypothesis is that ketamine is superior to haloperidol for treatment of agitation in the prehospital environment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe agitation in the prehospital environment

Exclusion Criteria:

* Prisoners
* Persons known to be younger than 18 years old
* Persons suspected to be younger than 18 years old
* Obviously gravid women
* Persons with profound agitation
* Persons who are unable to be transported to the treating facility
Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study

This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550 mg three times a day in patients with IBS with diarrhea who respond to initial treatment of rifaximin 550 mg three times a day.

It is important in chronic conditions to have information about how a product that is intended for short course administration in order to confer prolonged benefit should be administered beyond the first cycle of use once symptoms reappear. This Phase 3 study will evaluate the efficacy and safety of repeat treatment with rifaximin 550 mg three times daily (TID) for 14 days in subjects with IBS-D who respond to an initial treatment course with rifaximin 550 mg TID for 14 days.

This study consists of several treatment phases outlined below:

Screening/Treatment 1 Phase. Subjects will receive single-blind placebo TID for 7-13 days and answer daily IBS symptom-related questions.

Treatment 2 Phase. Eligible subjects will receive open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders will continue into Maintenance Phase 1. Nonresponders will withdraw from the study.

Maintenance Phase 1. Subjects will continue the treatment-free follow-up period for up to 18 weeks until either: 1) they experience recurrence or 2) enrollment is met in the Treatment 3 Phase (Double Blind Repeat Treatment Phase). Subjects who do not meet recurrence criteria by the end of the Maintenance Phase 1 will withdraw from the study.

Treatment 3 Phase/ Double Blind Repeat Treatment Phase. Subjects who meet criteria for recurrence will be randomized 1:1 to receive either rifaximin 550 mg TID or placebo TID for 2 weeks with a 4-week treatment-free follow-up.

Primary efficacy analysis will be performed at the end of the Treatment 3 Phase (at Week 6 of the double-blind period).

Maintenance Phase 2. All subjects continued into an additional treatment-free follow-up period of up to 6 weeks (Maintenance Phase 2).

Treatment 4 Phase/Second Repeat Treatment Phase. Subjects will receive the same double-blind treatment as previously assigned in the Treatment 3 Phase for 2 weeks with a 4-week treatment-free follow-up.

A lactulose breath test sub-study will be conducted at select sites.

Eligibility Criteria:
Inclusion Criteria:

* IBS confirmed by Rome III diagnostic criteria.
* At least 18 years of age.
* Colonoscopy within the past 10 years to rule out inflammatory bowel disease; or flexible sigmoidoscopy if \< 50 years of age or previous colonoscopy \> 10 years prior.
* Willing to maintain a stable diet. including vitamins, supplements, and nutraceuticals.

Exclusion Criteria:

* Diabetes (Type 1 or 2).
* Lactose intolerance and not controlled by a lactose-free diet.
* Pregnant or planning to become pregnant or is lactating.
* History of HIV or hepatitis B or C.
* Participation in investigational study within past 30 days.
* Taking rifaximin or any other antibiotic within past 60 days.
* Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition.
* History of GI surgery.
Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease

This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic renal failure due to autosomal dominant polycystic kidney disease (ADPKD).

The investigators will assess the 18-month safety and potential efficacy of autologous MSCs as therapy for ADPKD. A total of 6 patients with ADPKD IV injection of high doses 2×106 of autologous mesenchymal stem cells / kg their weight, which will be derived from biopsies of their bone marrow. Assessments will be made at 1, 3, 6, 12 and 18 months after cell injection. Changes in GFR rate were evaluated by scan isotope.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* ADPKD symptoms
* ADPKD confirmed with sonography and genetic testing
* Patient's age between 18 - 60 years
* GFR GFR 25-60 mL/min/1.73 m2
* Ability to understand and willingness to sign consent from

Exclusion Criteria:

* Pregnancy or breastfeeding
* Associated Cardiovascular disease
* Diabetes requiring medical intervention
* Other systemic diseases involving the kidneys, such as cancer, autoimmune diseases, blood diseases, liver disease, etc.
* Hospitalization due to illness in the last two months
* Life expectancy of less than two years
* Any allergies to the ingredients used in the cell culture