cyrilzakka/clinical-trials huggingface dataset:
Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia

This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.

Probiotics has demonstrated to be effective in the management of anxiety and depression. Although these results are promising, more research is needed to explore the role of probiotics to improve physical, emotional and cognitive processes in different clinical populations that are associated with altered microbiome. Thus, the main aim of the present project is to explore whether the oral intake of probiotics might provide benefits to a group of patients with fibromyalgia.

The investigators expect to found significant differences between some physical, emotional and cognitive measures assessed pre- and post-treatment demonstrating the effects of microbiota on the Central Nervous System as well as its potential as a therapeutic tool for the treatment of Fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia syndrome diagnosis.
* No treatment with antibiotic.
* More than a year of diagnosis
* Agreement to participate in the study.

Exclusion Criteria:

* Severe physical disability.
* Malignancy.
* Pregnancy
* Psychiatric illnesses (eg, schizophrenia or substance abuse).
* Medication usage other than as-needed analgesics (excluding long-term narcotics).
Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (T2DM) treated with stable dose of metformin \> or = to 1500mg/day as monotherapy for at least 8 weeks
* Hemoglobin A1c (HbA1c) 7% to 10% at screening
* Body mass index (BMI) \< or = to 45 kg/m2

Exclusion Criteria:

* History of taking antihyperglycemic therapy other than metformin or metformin extended release (XR) during the 8 weeks prior to screening
* History of taking a dipeptidyl peptidase-4 (DPP-4) inhibitor or pramlintide during 12 weeks prior to screening
* History of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study
* History of prescription or over the counter weight loss medication during 3 months prior to screening
* Previous exposure to exenatide or any glucagon-like peptide-1 (GLP-1) receptor agonist during 6 months prior to screening
Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes

The implementation of a sensor of glycemia Enlite coupled with an insulin pump (Medtronic Minimed 640G) is a therapeutic option that Hospital of Mulhouse can propose to the children affected by type 1 diabetes. The glycemic rate detected by the sensor of continuous measure of the glycemia is visible in real time on the pump and then the rate can be normalized. The study will evaluate the impact of the continuous measurement of blood glucose on insulin pump on child quality of life with type 1 diabetes aged 2 to 13 years old.

The French High Health Authority recommends, for patient with type1 diabetes, a supervision of at least 4 tests a day in pre and post prandial with additional controls in circumstances of meal or of unusual physical activities.

Du to age, this control need supervision of an adult, in each place of children life (school, nursery, out-of-school center ...), according to their autonomy.

During several years, all the actors of educational care tried to improve the welcome of the children affected by handicap or by chronic disease.

Since 10 years, the team of pediatric diabetology of Mulhouse Hospital has developed a partnership with the department of Education by setting up every year in September of a training courses for voluntary teachers and all staff nursery.

These sessions are consisted of a formal time bringing knowledge on the disease, followed by exchanges and finally a practical time around manipulation of the readers of glycemia and pumps.

Alerts can be scheduled to warm an increase or an important reduction of blood glucose.

The study will evaluate the child quality of life, and also parents and staffs in preschool, school or in out-of-school center felt too.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment between September 15 to November 15, 2016
* Insulin-dependent Type 1 Diabetes with insulin pump
* From 2 to 13 years old
* Schooled to the nursery or primary school, seeing frequently a day-nursery or in an out-of-school center
* Treated at the hospital of Mulhouse, France

Exclusion Criteria:

* Opposition to study participation
* Patients who don't need sensor of measure of the continuous glycemia
Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty

Post operative pain (POP) is a major obstacle on the road to healing, despite the increasing interest in postoperative pain management and development of pain control modalities (1). Postoperative pain is still insufficiently treated with more than 50% of patients suffering from moderate to severe pain early after surgery .Pain after orthopedic surgery is considered especially difficult to manage. Approximately half of total knee or hip arthroplasty patients present with extreme pain immediately after surgery. Total knee and hip arthroplasty often results not only in severe perioperative pain and debilitation, but chronic pain, joint stiffness, and functional disability many months or even years following the procedure. Various modalities of treating orthopedic POP exist, but the optimal management of postoperative pain remains controversial with no clear consensus of the best method.We suggest that acupuncture can be an effective treatment for post operative pain after total knee or hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent, above 18 years of age, about to undergo total knee or hip arthroplasty

Exclusion Criteria:

* Known mental disease, active cancer disease, coagulopathy, Hepatitis B,C.
Testicular Vascular Evaluation in Patients Undergoing Inguinal Hernia Repair

Patients scheduled to undergo laparoscopic preperitoneal or open inguinal hernia repair will be evaluated by means of scrotal/testicular ecocolordoppler ultrasound investigation before and after surgery in order to rule out the potential impact of the surgical procedure on testicular arterial and venous blood flow

Patients scheduled to undergo laparoscopic preperitoneal or open inguinal hernia repair will be evaluated by means of scrotal/testicular ecocolordoppler ultrasound investigation before and after surgery in order to rule out the potential impact of the surgical procedure on testicular arterial and venous blood flow

Ecocolordoppler will evaluate:

1. testicular arterial flow (Peak Systolic Velocity Testicular Artery - End-Diastolic Velocity Testicular Artery - Resistive Index testicular Artery)
2. venous impaired outflow using varicocele classifications (DUBIN - scale 1-3; HIRSCH scale 1-5)
3. testicular volume

Eligibility Criteria:
Inclusion Criteria:

* Inguinal hernia with surgical indication for surgical repair

Exclusion Criteria:

* History of urologic surgery and/or radiotherapy
* Recurrence of inguinal hernia
Unravelling the Measles Paradox in Children

Measles is caused by measles virus (MeV). The disease is associated with lymphopenia and immune suppression, which is an important cause of measles-associated morbidity and mortality. Measles-induced immune suppression can last several years, whereas measles lymphopenia is usually resolved within two weeks. At the same time, measles induces lifelong immunity. This apparent contradiction, known as the 'measles paradox', was partially solved when investigators demonstrated that MeV infects and depletes pre-existing memory cells, thereby causing 'immune amnesia'. This model is supported by observations in animal models and clinical studies, but several questions remain to be addressed, like the duration of measles-induced amnesia and changes in the immune repertoire after measles. to address the immunological questions regarding MeV infection.

Measles is caused by measles virus (MeV). The disease is associated with lymphopenia and immune suppression, which is an important cause of measles-associated morbidity and mortality. Measles-induced immune suppression can last several years, whereas measles lymphopenia is usually resolved within two weeks. At the same time, measles induces lifelong immunity. This apparent contradiction, known as the 'measles paradox', was partially solved when investigators demonstrated that MeV infects and depletes pre-existing memory cells, thereby causing 'immune amnesia'. This model is supported by observations in animal models and clinical studies, but several questions remain to be addressed, like the duration of measles-induced amnesia and changes in the immune repertoire after measles. Recently, investigators have acquired permission to address these remaining questions in 18-25 years old adults (MEC-2024-0230). However, investigators have reservations about the feasibility of including enough participants between 18 and 25 years old that have not been vaccinated against or infected with MeV; it is possible that investigators will not reach sufficient inclusions to address the immunological questions regarding MeV infection in that protocol. Therefore, investigators propose to additionally study these questions in children in the age of 4 up to and including 17.

Eligibility Criteria:
Inclusion Criteria:

Group A

* Aged 4 - 17 years old
* Susceptible to measles
* No pre-existing immunity against measles (vaccination or earlier infection)

Group B

* Aged 4 - 17 years old
* Protected against measles due to vaccination or earlier infection

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Diagnosed chronic disease that lasted over 3 months
* Immune suppression (due to medication or underlying disease)
* Group A; Detectable MeV-antibodies in the T1 blood sample
Nanoscope System During Sacrospinofixation

Sacrospinofixation is one of the reference techniques for the treatment of vaginal prolapse. It consists of fixing a non-absorbable thread on the sacrosciatic ligament unilaterally or bilaterally to correct a urogenital prolapse.

The technical difficulty is linked to the fact that the approach to the sacrosciatic ligament is palpatory without visual control. However, if the thread is not well fixed in the ligament, there is a risk of this suture coming loose and therefore of recurrence of the prolapse. On the other hand, due to the vascular and nervous proximity (pudendal nerve), vascular complications such as hemorrhage and/or hematoma have been described by vascular lesion during the passage of the needle through this ligament. Nervous complications due to pinning of the pudendal nerve or its nerve branches have also been described, which can cause after-effects of pain or even chronic dyspareunia.

Clearly and precisely visualizing the sacrosciatic ligament and the vascular and nervous structures with a microcamera could make it possible to better correct the prolapse and limit recurrences, but also to avoid these serious and disabling complications.

The Nanoscope system, which can be used in routine practice as part of sacrospinofixation, could make it possible to obtain visibility of tissues under vision control. Thus the precise visualization of the sacrospinous ligament would allow an easier approach and therefore more precise surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* women over 18
* patient who benefited from anterior and/or posterior sacrospinofixation using the nanoscope system
* person having expressed his non-opposition

Exclusion Criteria:

* inability to understand the information given
* person deprived of liberty
* person under guardianship
Yonsei OCT (Optical Coherence Tomography) Registry for Evaluation of Efficacy and Safety of Coronary Stenting

Optical coherence tomography (OCT) has been recently studied for evaluation of coronary stenting. Because of high resolutions, several reports have shown that OCT is appropriate for evaluating neointimal tissue after coronary stent implantation. Also, the strut coverage and the characterization of neointimal tissue can be accurately evaluated. Furthermore, OCT-defined coverage of a stent strut was proposed to be related with clinical safety in drug-eluting stents-treated patients. Therefore, the investigators will evaluate the appropriateness of currently using coronary stents (e.g. Sirolimus eluting stent, Paclitaxel-eluting stent, Zotarolimus-eluting stent, Everolimus-eluting stent, Biolimus eluting stent, EPC(endothelial progenitor cell) Capture stent, etc) based on the findings of OCT. Additionally, the investigators will evaluate neointimal hyperplasia, malposition or strut coverage to decide the differences in the stent characteristics, the duration of antiplatelet use, and the differences according to the clinical presentations.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with coronary stents
2. Patients who will have coronary stents because of coronary artery stenosis

Exclusion Criteria:

1. Hemodynamically unstable patients
2. Ostial lesions that begin within 15 mm of the left main coronary artery
3. Lesions with diameter more than 4 mm
4. Patients with allergy to antiplatelet agent (asprin or clopidogrel)
5. Patients with hepatic dysfunction (Liver enzyme 3 times the upper limit of normal)
6. Pregnant and lactating patients
7. Patients with life expectancy less than 1 year
Prospective Evaluation of Complications of MidLine Catheters in the ICU

Midline catheters (MCs) are peripheral catheters inserted into a vein in the arm above the elbow crease, with the tip in the axillary vein. As such, they do not enter the central venous circulation and are therefore not considered central venous catheters.

The main complications associated with CM are accidental removal, leakage, subcutaneous diffusion and occlusion. Severe complications include deep vein thrombosis (DVT) and catheter-related bacteremia (CRB). There is very little data on the use of CMs in intensive care units (ICU).

Resuscitation patients are more likely to develop severe catheter-related complications such as deep vein thrombosis and catheter-related infections. While the use of CMs in patients appears to be associated with a low risk of complications, this may not be the case in resuscitation patients.

Investigator therefore proposes to conduct a prospective observational study to determine the frequency and type of complications associated with CMs when they are implanted and used in ICU. In addition, investigator will attempt to determine whether risk factors predictive of complications can be identified. In addition, this study will evaluate whether the use of CMs can reduce the duration of central venous catheter maintenance in the ICU and the risk of central venous catheter-related infections.


Eligibility Criteria:
Inclusion Criteria:

* ICU Hospitalization
* Indication for MidLine catheter placement during the stay

Exclusion Criteria:

* Minor or protected adult
* Pregnant woman
* Local contraindication to the placement of a CM

  * Local infection
  * Venous thrombosis
  * Existing arteriovenous fistula or vascular network to be protected for a fistula for chronic dialysis
  * Paralysis of the limb
* Need for administration of contraindicated solutions on the peripheral venous route:

  * Catecholamines: Noradrenaline, adrenaline (dose greater than 0.2µg/kg/min)
  * Total parenteral nutrition
  * Glucose solutions at a concentration \>20
  * Potassium at a concentration \>0.1mEq/ml
  * Vesicants
  * Fluids with pH \<5 or \>9
Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education

Experimental intervention:

Patient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition.

Control intervention:

Conventional Patient education by health care professionals. A paper-based patient questionnaire will be provided.

Noncompliance with immunosuppressive medications after organ transplantation is thought to be a leading cause of allograft rejection, graft loss, and death. Immunosuppressant medy to prevent graft rejection after lung transplantation.

Reported non-compliance rates with calcineurin inhibitors are ranging between 13 and 22 % after lung transplantation. Incidence of non-compliance increases over time after transplantation. Increased health care costs, decreased quality of life, and organ failure (incl. the need for re-do transplantation) are possible consequences of immunosuppressant noncompliance. Therefore, medication compliance defined as the extent to which a patient's medication taking behaviour coincides with the prescribed regimen, is a critical issue in transplantation. Repeated patient education is one option to overcome non-adherence and immunosuppressive medication non-compliance.

Immunosuppressive therapy is monitored by measurement of drug levels. Fluctuating drug levels increase the risk for rejection and drug toxicities. In addition, frequent dose adjustments, case management and frequent monitoring of drug levels are cost-intensive.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 6 months after lung transplantation (single, double or combined)
* Informed consent
* At least 10 trough levels analyzed in MHH reference lab in last 6 months
* \< 50% of calcineurin inhibitor trough levels in target range in last 6 months in outpatient clinic

Exclusion Criteria:

* Hospitalization during last 3 months
* BOS stage 3 (FEV1 \< 50% baseline)
* End stage kidney disease (GFR \<15 ml/min/1.73 m2 or renal replacement therapy)
* Oxygen requirement at rest
* Steroid pulse therapy (\>500 mg methylprednisolone per day) during the last 4 weeks
* Illiteracy
* Need for isolation (Colonization with multi. or pan resistant organisms, e.g. MRSA, B. cenocepacia)
* limited German language skills or other reasons which might impair patient communication or computer handling
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin ) in reducing symptoms and recurrence of acute HIV-related sinusitis.

Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy.

Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy.

Patients are randomized to receive either Traditional Chinese Medicine (acupuncture and herbal treatment) or conventional antibiotic therapy (Sudafed and Augmentin). Treatment continues for 8 weeks, followed by a 4 week washout, with final follow-up at week 12. Patients must undergo endoscopic nasal exam and CT scan of paranasal sinus prior to study entry and at week 12.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiviral medication.

Patients must have:

* HIV infection.
* CD4 count \>= 50 cells/mm3.
* Recurrent sinusitis.
* No active opportunistic infection.
* No disease progression.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active infection with fever \> 102 F.
* Neurological symptoms such as epidural abscess, subdural hematoma, meningitis, and dementia.
* Malignant neoplasm of nasal passages.
* Not expected to remain clinically stable for the next 6 months.
* Inability to comply with protocol requirements.
* Malabsorption or inability to take oral medication.
* Concurrent participation on another study where antibiotics will be used.

Concurrent Medication:

Excluded:

* Antibiotics other than Septra.

Concurrent Treatment:

Excluded:

* Chinese herbal medicine or acupuncture unless on that study arm.
* Surgical intervention that has abated symptoms.

Patients with the following prior condition are excluded:

History of allergic reaction to the study antibiotics.
Alzheimer Prevention Trials (APT) Webstudy

The goal of the Alzheimer Prevention Trials (APT) Webstudy is to accelerate enrollment for Alzheimer's disease (AD) clinical trials by identifying and tracking individuals who may be at higher risk for developing AD dementia.

The APT Webstudy will use web-based cognitive testing and questionnaires to generate a risk score which will be used to identify individuals who may be at an increased risk for developing AD dementia.

Individuals who join the APT Webstudy will register at https://www.aptwebstudy.org/, sign an electronic informed consent form (ICF), provide basic demographic information and participate in web-based cognitive testing. Participants will return the APT Webstudy quarterly (every 3 months) to complete the cognitive testing again.

Based on the risk score and changes identified in the cognitive testing results, participants will be invited to visit a partnering clinical trial site for an in-person visit with biomarker testing and clinical assessment.

The combined results of the web-based assessments, with the biomarker and clinical assessments, will allow an adaptive statistical algorithm to improve the selection of those at highest risk for developing AD.

To Join the APT Webstudy, please visit https://www.aptwebstudy.org/.

Eligibility Criteria:
Inclusion Criteria:

* male or female at least 50 years of age
* no evidence of dementia
* willing to participate in remote longitudinal cognitive testing and possible referral for biomarker assessment based on risk

Exclusion Criteria:

* N/A. Anyone can register for the APT Webstudy, however, only individuals identified using the risk algorithm will be referred for in-person biomarker assessments.