cyrilzakka/clinical-trials huggingface dataset:
Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System

Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System

Prospective, multi-center study to evaluate the clinical outcome of posterior stabilized design of LCS® Complete Mobile-Bearing Total Knee System. No comparison group. 12 month enrollment, 12 month post-operative evaluation. Follow-up intervals: Pre-op, 3 month, 6 month, and 12 month.

Eligibility Criteria:
Inclusion Criteria:

* M/F
* 18-80
* Diagnosis of osteoarthritis, rheumatoid , post-traumatic, inflammatory, juvenile arthritis.
* Skeletally mature, sufficient bone stock to seat and support prosthesis
* Willing/able return for follow-up.
* Subject is willing and able to provide informed patient consent for participation in the study

Exclusion Criteria:

* History of recent/active joint sepsis, charcot neuropathy, psycho-social disorders, prior knee arthroplasty on affected site, metabolic disorders of calcified tissue
* Communicable diseases that may limit follow-up
* Medical-legal or workers compensation claims.
Evaluation of a Clinical Decision Support System for Fungal Infections

Invasive fungal infections are serious and frequent diseases in our hospitals, especially in intensive care units. In accordance with the institutional recommendations, it is necessary to have a clinical decision support system to support the clinicians in a rapid and optimal prescription of antifungals for invasive fungal diseases. This clinical decision support system will benefit patients but also clinicians who will gain in medical efficiency. It will also have an ethical dimension since it will guarantee optimal antifungal treatments for all patients. The purpose of the research is to define the percentage of concordance between the medical prescription and the recommendation of the clinical decision support system.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving antifungal therapy for the treatment of invasive fungal disease

Exclusion Criteria:

* Patients not receiving antifungal therapy for the treatment of invasive fungal disease
Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study

Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a home-based, self-directed walking program can have similar benefits in women with an MBC diagnosis. The primary objective is to evaluate whether engagement in physical activity will reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study participants and measuring changes between baseline, 3 months and 6 months in additional quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30 patients. Findings from this study will provide preliminary data for a grant application to test the physical activity intervention in a randomized controlled trial (RCT) in a large sample of women with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 21 or older
* Metastatic breast cancer (MBC) diagnosis - Stage IV
* Receiving treatment regimen for MBC, but no more than 3 previous chemotherapy or biologic regimens
* Approval from the treating clinician to engage in moderate-intensity physical activity.
* Patient-assessed ability to walk and engage in moderate physical activity
* Proficient in English.
* IRB approved signed written informed consent.
* Willing and able to do all study requirements.

Exclusion Criteria:

* One or more significant medical conditions or other issues that in the physician's judgment preclude participation in the walking intervention.
* No more than 3 prior chemotherapy regimens.
Botswana Diarrheal Diseases Study

The goals of this study are to:

1. determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers.

   * analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers.
   * comparison to rates among infants born to HIV uninfected mothers.
2. link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to provide independent informed consent.
* Subject is able to complete a questionnaire as part of her enrollment visit and agrees to complete follow-up questionnaires monthly.
* Subject presents symptoms of acute diarrhea: at least 3 loose stools during 24 hours as reported by mother; persistent diarrhea: an episode of diarrhea lasting 14 days; recurrent diarrhea: a new episode of diarrhea after an interval of at least two diarrhea-free days.

For HIV-infected subjects:

* Mother: HIV antibody is detected by dual HIV-1 ELISA and confirmed by western blot. Infant: HIV antigen is detected by PCR on 2 samples during the follow-up period, or on 1 sample followed by the death of the infant.

Exclusion Criteria:

* Subject cannot provide legal independent informed consent.
Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI

Postoperative pain is an ideal model for study on acute pain changing into chronic pain. The functional imaging of magnetic resonance can reflect the extent and character of pain exactly and the structural imaging of it can be a sign of the change. By analyzing fMRI results of participants with acute pain and following them up for three months, the investigators expect to find objective indicators for acute pain changing into chronic pain and give preventive analgesia for people with high risk of chronic pain.

The day before surgery, evaluate and choose patients according to inclusion and exclusion criteria. Use the same anaesthesia and management and record information needed by the case report format. Patients are examined by fMRI on their brains during the first week after surgery. Follow up the patients after surgery for three months to find out whether they have chronic pain. The NRS, DN4, ID pain and QLQ-C30 are used for each patient.

Eligibility Criteria:
Inclusion Criteria:

* junior high school degree or above
* can be communicated in mandarin normally
* selective operation of mastectomy with or without axillary lymph node dissection
* similar operation method and incision size
* BMI between 18 and 30
* ASA grade I-II；informed consent

Exclusion Criteria:

* with brain disease or with brain disease history
* Opioid allergy
* with claustrophobia
* with history of chronic pain
* with psychological or emotional problems
* Serious hearing or visual impairment
* those who refuse to participant in this study
Uncertainty Analysis of Computational Model to Simulate Neurostimulation Caused by Gradient Fields in MRI

The aim of this research project is to quantify the uncertainty of current state-of-the art anatomical phantoms and computational models for predicting neurostimulation induced by time-varying magnetic fields (so-called gradient fields) within the context of magnetic resonance imaging (MRI) scanners. For this purpose stimulation thresholds will be measured in a volunteer study. The measurements will provide valuable data for the development and validation of future models.

The study does not investigate any health related interventions, neither a therapy nor medical device. The study aims to provoke peripheral nerve stimulation from time varying magnetic (so-called "gradient") fields in volunteers in order to measure gradient threshold levels in different configurations (different gradient coil units, different positions and postures). The experiments will provide new data regarding the interaction of gradient fields and function of the peripheral nervous system. These measurements are of general interest to quantify associated modeling uncertainties and validate current or future computational modeling techniques.

The experiments will use an MR scanner to generate the gradient fields used to induce stimulation. In normal mode the maximum gradient field allowed by the manufacturer may lead to peripheral nerve stimulation in approximately 50% of subjects. However, depending on the position and posture it may induce PNS in even fewer than 50% of subjects. Therefore, for the purpose of measuring stimulation thresholds it is necessary to operate the gradient units in experimental mode (with respect to the gradient field) as described in IEC 60601-2-33, i.e. the gradient limits set by the manufacturer will be disabled. As described in the standard, the gradient field will be increased slowly from non-stimulating levels until the volunteer perceives first stimulation sensations, at which point the gradient field will be stopped. This protocol does not lead to an increased risk of cardiac muscle stimulation compared to the normal mode, but only an increased likelihood of PNS with non-painful sensations in the skin, e.g. tingling, twitching or poking. PNS is not considered a health concern. The radio-frequency (RF) field will remain switched off, i.e. there is no risk of heating (the scanner will not acquire images in this mode).

Eligibility Criteria:
Inclusion Criteria:

* healthy adult volunteers (six female and six male)

Exclusion Criteria:

* pregnant woman
* metallic implants or a history of neurological or cardiovascular diseases
* children and persons who are not able to follow the instructions will be excluded, due to a higher risk and lack of direct benefits from participation
The IBD-FITT Study - Moderate-intensity Exercise for IBD Patients With Moderate Disease Activity

The investigators aim to investigate whether exercise therapy during 12 weeks including a lesson on general healthy lifestyle in adult patients with a moderately active disease is more effective, compared to control patients only receiving a lesson on general healthy lifestyle recommendations. The three main categories of outcomes are 1) health-related quality of life, 2) general health status of the patients 3) explorative outcomes. The primary outcome is health-related quality of life, the secondary outcome is general health status measured by waist circumference, disease activity scores, blood pressure, and blood lipids, and the third outcome are explorative outcomes (none-disease specific quality of life scores, biomarkers of C-reactive protein, fecal calprotectin and immunology markers including interleukins).

The investigators will apply a superior trial design in this randomized clinical trial with two arms, intervention and comparison. In both the intervention and comparison arm, the patients will receive the proper and usual medical treatment decided by their responsible physician and changes in the medical treatment is allowed at all times.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderately active Crohn's disease or ulcerative colitis are defined by fulfilling all the following five criteria:

  1. Well-characterized Crohn's disease or ulcerative colitis (physician assessment) i. Fulfilling standard clinical, endoscopic, radiologic, and histological criteria
  2. A minimum of one-year disease duration from the time of diagnosis of Crohn's disease or ulcerative colitis to inclusion into the trial
  3. Any of the following pharmacological treatments in a period of three months prior to inclusion:

     i. Usage of 5-Aminosalicylic acid (5-ASA) ii. Usage of corticosteroids iii. Immunomodulators usage: Azathioprine (AZA), 6-mercaptopurine (6-MP), Methotrexate (MTX) iv. Biologics usage: Anti-TNFα (Infliximab, Adalimumab, Golimumab), Ustekinumab or Anti-integrin (Vedolizumab)
  4. Disease activity defined by clinical disease score:

     i. Harvey Bradshaw Index (HBI) 27 \> 5 ii. Simple Clinical Colitis Activity Index (SCCAI) 29 \> 5
  5. Marker for gastrointestinal inflammation:

     i. Fecal calprotectin (FC) \> 200 mg/g

     Exclusion Criteria:
* 1. A language barrier that prohibits the exercise instructors/supervisors to give sufficient or safe instructions during the intervention or at the general health lesson.

  2. Known heart condition that prevents them to actively participate safely in the exercise intervention.

  3. Known pregnancy or planned pregnancy. 4. Disabling musculoskeletal injuries that prevent them to actively participate in the exercise intervention.

  5. Severe disease activity manifested clinically and with the need for urgent change in treatment evaluated by the responsible physician.
Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations

Stereotactic radiosurgery is a well established treatment option for arteriovenous malformations (AVMs). The potential complications related to radiosurgery are well documented and are predominately related to radiation effects to the surrounding brain parenchyma. These risks increase with larger lesions, requiring a concommitant reduction in the amount of radiation that can be delivered. This reduction in radiation dose decreases the efficacy of treatment. The broad, long-term objectives of this proposal are 1) to determine the role of fractionated stereotactic radiosurgery in the treatment of large (\>10cc) AVMs; 2) to evaluate the complication rates related to fractionating these doses compared to conventional stereotactic treatment 3) to evaluate the success rate of treating large AVMs with this protocol.

This research project will involve performing a preoperative MRI and angiogram on patients harboring an AVM to determine the feasibility of treating the lesion with gamma knife radiosurgery. Patient with lesions greater than 10 cc will be studied.

Each patient will have a Magnetic resonance angiography (MRA) with gadolinium and an angiogram immediately before each radiation treatment. If there is a contraindication for MRI examination (pacemaker or any other implanted ferromagnetic material), a CT angiogram will be obtained instead. Each treatment will be spaced at least 3 months apart. Follow-up MRIs or CT scans will be obtained at 6 month intervals. A follow-up angiogram will be obtained when there is radiographic evidence of complete occlusion based on the MRI images, or at 3 years after the procedure, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* All patients age 18 or older
* Inpatients and outpatients, referred for radiosurgical treatment of an arteriovenous malformation
* Patients with lesions greater than 10 cc, who are currently symptomatic from the AVM (hemorrhage, seizure, or ischemia from steal phenomenon)

Exclusion Criteria:

* Patients without symptoms related to AVM
Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia

B-acute lymphoblastic leukaemia (ALL) is the most common childhood malignancy. Despite enhancement of childhood B-ALL outcome, relapses remain difficult to treat. Several studies in adult acute myeloid leukaemia have shown that proliferation of immunosuppressive cells -particularly T regulatory (Treg) cells and deficient natural killer (NK) cells- was associated with poor response to chemotherapy. However, few studies have been done on childhood ALL and none on relapse of B-ALL. Moreover, a newly described immunosuppressive B cells subset (Breg cells) seems to have a role in oncogenesis in mice model, but its significance has never been evaluated in human cancers. The purpose of this study is to prospectively evaluate the immune status of children newly diagnosed with first relapse of B-cell ALL, and to compare results with those of children treated for B-ALL in complete remission. Classic lymphocytic phenotype, proportions of immunosuppressive cells (Treg cells, deficient NK cells, Cytotoxic T-lymphocyte-associated protein 4 and/or Programmed T cell death 1) and thymopoiesis will be evaluated. The investigators assume that increase of immunosuppressive cells proportions could be associated with B-ALL relapse.


Eligibility Criteria:
1. Inclusion Criteria for relapse Group :

   * Children aged from 1 to 18 years at the time of first B-ALL relapse diagnosis
   * Obtention of oral and written consent of the parents
   * Parents affiliated with the social security system
2. Inclusion Criteria for control Group :

   * Children aged from 1 to 18 years enrolled into FRALLE or EORTC treatment protocols, treated for B-ALL and who are in complete molecular remission
   * Obtention of oral and written consent of the parents
   * Parents affiliated with the social security system
3. Exclusion criteria for control Group are the same as for relapsed Group :

   * Children with hematologic syndrome predisposing to hematologic neoplasia (such as Fanconi's anaemia, Diamond Blackfan anaemia ...) or acute leukemia secondary to previous treatment, or who have had allogenic hematopoietic stem cell transplantation before relapse
Analyzes of Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)

Clinical evaluation of vaccines against respiratory viruses is currently based on the analysis of systemic immune responses, whereas respiratory immunity is the first line of defense against respiratory pathogens. In addition to secretory immunoglobulin A (IgA) in mucosal fluids which are essential to neutralize the pathogens at mucosal surfaces, tissue-resident memory immune cells have been shown to be crucial in protection. Furthermore, memory immune cells in blood able to migrate to airway tissues also play a crucial role. Airway immune responses have not been studied a lot due to the lack of a standardized methodology to evaluate them in humans.

The goal of this study is to develop a methodology to collect and analyze nasal tissue-resident memory T and B cells and to evaluate peripheral memory T and B cells expressing airway homing markers in healthy volunteers. Three devices for nasal cell sampling will be compared. Tissue-resident and peripheral memory immune responses will be determined using flow cytometry and correlated with humoral and cellular responses, as well as with gene expression at mucosal and systemic levels. .

Eligibility Criteria:
Inclusion Criteria:

* Affiliated to the Social Security System
* Signed informed consent form

Exclusion Criteria:

* History of recurrent nosebleeds or systemic hemorrhages
* Previous injury or surgery which modified nasal cavity (e.g. deviated nasal septum)
* Individuals receiving anticoagulant therapy
* Individuals who experienced a severe respiratory infection leading to hospitalization in the last 6 months
* Individuals who received an antibiotic therapy for respiratory infection or any other infection in the last 6 months
* Immunocompromised individuals, or individuals taking immunosuppressed therapy or having a pathology (chronic infection, auto-immune disease) which could impact on immunity based on investigator's opinion
* Unstable chronic pathology
* People deprived of liberty or hospitalized without any consent
* People under guardianship (authorship or curators)
* Individuals who received a vaccine (any vaccine) in the last 30 days
* Pregnant or breast-feeding people
* Individuals experiencing respiratory infection symptoms. Inclusion will be postponed up to 7 days after the symptom resolution
Three-dimensional Study on the Structural Destruction of Pelvic Anatomy in Cervical Cancer

Cervical cancer is one of the most prevalent malignancies in female .To the younger patients, radical hysterectomy which is a standard operation during the earlier and middle therapy stage as well as more effective technique like radiotherapy and chemotherapy give them a longer life expectancy. However, the operation destroys patients' normal pelvic anatomy, nutrient supplements and internal secretion so that postoperative pelvic floor functional dysfunction has a destructive effect for their life. There are tremendous studies on clinical symptoms while few on anatomical changes and the relationship between pelvic floor symptoms and the dysfunction. Two-dimensional Magnetic Resonance Imaging(MRI), transperineal ultrasonography， Urodynamic examination and anorectal manometry are frequently used in the fine-structure varies and pelvic floor function. Now three-dimensional MRI has more advantages in fine change of Pelvic anatomical and space position，as well as clearly showing the relationships between the change and space with the pelvic floor function. Based on an eight-year-study on three-dimensional MRI, we can analyze the postoperational anatomical changes and the relationship between the changes and the dysfunction by combined anatomic parameters which are measured on static-dynamic three- dimensional model with clinical symptoms, transperineal ultrasonography,urodynamic examination and anorectal manometry. We expect our study could provide scientific basis for on protective and repaired measures of pelvic floor.


Eligibility Criteria:
Inclusion Criteria： ①Patients diagnosed as FIGO stage IA2、IB1、IIA1 cervical cancer ; ②Patients diagnosed as FIGO stage IB2、IIA2 cervical cancer, eligible for RH after neoadjuvant chemotherapy; ③Patients diagnosed as FIGO stage IIA endometrial carcinoma; ④Patients didn't have pelvic organ prolapse and urinary incontinence; ⑤Ability to hold Valsalva for dynamic MRI; ⑥Patients aged 20-70 years; ⑦Patients undergone RH surgery; ⑧Informed consent was signed.

Exclusion Criteria：

①With MRI or urodynamic examination contraindication; ②Previously undergone POP or SUI surgery; ③BMI\>30 With serious postoperative complications.
Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder

The primary aim of this pilot study is to test the efficacy of the selective serotonin re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD) in an open clinical trial.

A secondary aim is to determine whether treatment with escitalopram increases plasma allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are correlated with treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Current DSM-IV TR PTSD and a score \> 40 on the CAPS, as a result of a traumatic event that occurred at least 6 months prior to evaluation.

Exclusion Criteria:

* Lifetime history of bipolar or any psychiatric disorder with psychotic features.
* Prominent suicidal or homicidal ideation.
* History of alcohol abuse/dependence within the past 3 months.
* History of drug abuse/dependence within the past 6 months.
* Subjects who plan to start a new form of psychotherapy during the protocol.
* History of sleep apnea, neurological disorder and/or current systemic illness affecting central nervous system function.
* History of myocardial infarction in the past year.
* Subjects on antipsychotic medications, systemic steroid medication, antidepressants, mood stabilizers, antianxiety medication, or benzodiazepines within the past 2 weeks.
* Use of Citalopram or Escitalopram within the past 6 months.