cyrilzakka/clinical-trials huggingface dataset:
Parkinson's Disease Biomarker Study

The primary objective of this study is to determine whether data acquired from a remote monitoring approach can reliably identify and track motor symptoms in prodromal PD and clinical PD.

The study is a one-year longitudinal biomarker study recruiting idiopathic RBD patients, Parkinson's Disease patient and healthy controls. All participants receive a smartphone with the Roche PD Mobile Application, complete a number of active tests daily and their movements will be remotely monitored. Participants will undergo additional neurological exams and DaT-SPECT and MRI imaging in the study.

A second objective of this study will be to validate an immunohistochemistry skin biopsy assay for the detection of pathological alpha-synuclein diagnostic of PD, in the peripheral nerves of the skin.


Eligibility Criteria:
Inclusion Criteria:

* signed consent form, male or female over age 40, ability to follow protocol, additional group-specific inclusion criteria

Exclusion Criteria:

* participation in interventional clinical study within 3 months of screening, moderate to severe depression in judgement of the investigator, any concomitant disease, condition or treatment which may interfer with the conduct of study (determined by investigator), additional group-specific exclusion criteria
Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea

To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12\~23 months

To compare the Vero cell-derived inactivated Japanese encephalitis(JE) vaccine 'KD-287(JEIMMUGEN INJ.)' with the mouse brain-derived inactivated JE vaccine in terms of the immunogenicity and safety, in Korean healthy children aged 12\~23 months

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged 12-23 months
* Written informed consent

Exclusion Criteria:

* History of documented HIV
* Known or suspected impairment of immunologic function
* History of serious chronic disease
* Received any JE vaccine prior to enrollment
Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.

The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).


Eligibility Criteria:
Inclusion Criteria:

* Subject is Caucasian.
* Current healthy smoker as judged by the Principal Investigator.
* Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.
Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction

The objective of this project is the non-invasive prenatal detection of placenta-limited aneuploidies, in patients whose fetuses have a intrauterine growth restriction below 3rd percentile, in parallel with an amniocentesis.

This study will allow the chromosomal study of the placenta in pregnant women whose genetic prenatal diagnosis, made by amniocentesis, does not allow exploring the placental causes of fetal RCIU.

Placental chromosomal aneuploidies will be detected by high-throughput whole genome sequencing of non-cellular DNA present in maternal plasma during pregnancy.

The study of the cfDNA will be carried out from a blood sample with the automated solution VERISEQ NIPT (Illumina) using the software illumina VeriSeq v2, allowing the detection of all chromosomal abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old,
* treated in the DDIANE fetal medicine centre at the Bordeaux University Hospital,
* having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound),
* from 16 weeks of amenorrhea or more,
* accepting an Invasive Prenatal Diagnosis by amniocentesis with array comparative genomic hybridization

Exclusion Criteria:

Childbearing women who:

* do not accept a non-invasive prenatal diagnosis (amniocentesis)
* have a fetus with non-isolated IUGR (associated with other ultrasound signs)
* do not consent to participate in the research protocol
Optimization of Insomnia Treatment in Primary Care

The primary objective of this pragmatic clinical trial is to evaluate the efficacy, feasibility, and adaptability of pharmacological and non-pharmacological treatments for insomnia disorder, delivered in primary care clinics. The second objective is to evaluate the efficacy of a sequential (stepped care) approach for persistent insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over
* Meeting criteria for insomnia disorder
* Registered patient at one of the primary care clinics participating in the study
* Fluent in French
* Computer and internet access

Exclusion Criteria:

* Unstable or untreated psychiatric disorder
* Lifetime psychotic or bipolar disorder
* Current suicide risk
* Progressive or unstable medical disorder
* Untreated sleep disorder other than insomnia
* Use of medication altering sleep
* Irregular or atypical sleep-wake schedule
* Current or planned pregnancy
Use of DNAse in Neutrophilic Asthma

In this pilot protocol, the researchers look to determine benefits from use of nebulized rh-DNase for 4 weeks in patients with neutrophilic asthma.

Patients with asthma of a non-Th2 phenotype have few advanced therapeutic options if their asthma remains poorly controlled despite adherence to guideline-based therapy. Currently, no targeted biologic therapies are available for neutrophilic asthma. The role of Recombinant human deoxyriboneuclease (rhDNase) has not been investigated in refractory asthma. rhDNase cleaves extracellular DNA released by neutrophils and other granulocytes, thereby reducing the viscosity of mucus. It is known that patients with asthma have higher levels of extracellular DNA than normals; however, these levels are lower than DNA levels found in the sputum of patients with cystic fibrosis. The benefits of rhDNase in cystic fibrosis have been well described. In these patients, use of daily nebulized rhDNase has shown improvement in lung function and reduction in exacerbations. Very little is known about DNAse use in asthmatics. Case reports have shown benefit when used in acute asthma exacerbations, but there are no data on its use as a therapy for neutrophilic asthma.

Eligibility Criteria:
Inclusion Criteria:

* i. Able to read and sign an Informed Consent Form (ICF)
* ii. At least Age 18
* iii. Diagnosis of Asthma with previous source documentation of PC 20 ≤ 16 mg/dl measured by FEV1 and/or reversibility with albuterol of ≥12% in FEV1
* iv. pre-bronchodilator Forced Vital Capacity (FVC) less than 85% predicted AND Serum total MMP9 ≥ 1800 (cut off determined by previous clinical investigation- Medimmune) OR serum IL-8\> 20 pg/ml OR Sputum extracellular DNA ≥ 3.8 µg/mL OR Sputum Neutrophils \> 40%

Exclusion Criteria:

* i. Pregnancy
* ii. Current smoker, smoking within the past year or pack/year history ≥ 10
* iii. Respiratory infection within past 6 weeks
* iv. Antibiotics within the past 4 weeks
* v. Active lung disease other than asthma
* vi. Cancer within the past 5 years (excluding basal cell skin cancer)
* vii. Chronic infection due to HIV, HBV, or HCV
* viii. Hematologic or autoimmune disease
* ix. Unable to safely undergo bronchoscopy as determined by primary or study doctor.
Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis

Randomized, double-blind, placebo-controlled Phase IIa clinical study, assessing safety, tolerability, pharmacodynamic effects and pharmacokinetics of temelimab, administered at three different dose levels (18 mg/kg or 36 mg/kg or 54 mg/kg).

In this study temelimab is administered subsequently to rituximab therapy, i.e. no co-administration of rituximab and temelimab is done in this study.


Eligibility Criteria:
Main Inclusion Criteria:

* Current diagnosis of RMS, based on McDonald 2017 criteria
* Having received treatment with rituximab, as per local clinical routine for at least 12 months prior to the Screening Visit
* Having received their last dose of rituximab not more than 8 weeks and not less than 4 weeks before Randomization (Study Day 1)
* Having expanded disability status scale (EDSS) 2.5 - 5.5 inclusive at Screening
* Present clinical worsening in one or more neurological domains as assessed by EDSS, ambulatory function as assessed by 6MWT or T25FW, cognitive functioning as assessed by SDMT or increased need of walking aids or pharmacological/procedures for bowel and bladder functions over the last year.

Main Exclusion Criteria:

* Current diagnosis of primary progressive MS (PPMS)
* Any disease other than MS (e.g. myelitis and /or bilateral optic neuritis) that could better explain the patient's signs and symptoms
* Usage of any of the following medications prior to the Screening visit:

  * Any usage of interferon beta, glatiramer acetate, IV immunoglobulin (IVIG), dimethyl fumarate or teriflunomide within 12 months prior to Screening,
  * Any history of exposure to mitoxantrone, cladribine, alemtuzumab, cyclophosphamide, systemic cytotoxic therapy, total lymphoid irradiation, and/or bone marrow transplantation at any time,
  * Any usage of natalizumab within 24 months prior to Screening,
  * Any usage of highly potent immune modulating therapy, such as: ocrelizumab, ofatumumab, fingolimod, siponimod, ozanimod or anti-cytokine therapy, plasmapheresis or azathioprine within 12 months prior to Screening,
  * Any usage of any experimental treatment if not washed out for ≥ 5 half-lives or ≥ 12 months (whichever is longer), except rituximab which is allowed before the study.
* CTCAE Grade 2 or greater lymphopenia
* Any major medical or psychiatric disorder that would affect the capacity of the patient to fulfill the requirements of the study
* History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4)
* Any history of cancer with the exceptions of basal cell carcinoma and/or carcinoma in situ of the cervix, and only if successfully treated by complete surgical resection, with documented clean margins and any medically unstable condition as determined by the investigator
* Pregnant or breastfeeding women
An Observational Study of Patients With Endometriosis to Evaluate the Usefulness of the MEDL Score, a New Method for Evaluating Endometriosis Using MRI

The purpose of this study is to confirm the reproducibility that the MEDL score can be evaluated by Magnetic Resonance Imaging (MRI) in the similar way as laparoscopy, the gold standard for the evaluation of the disease state of endometriosis, in order to establish the MEDL score, a new evaluation index for endometriosis using MRI. Approximately 70-90 patients with endometriosis diagnosed by imaging and who are candidates for fertility-preserving surgery will be recruited retrospectively or prospectively, and the disease status of endometriosis will be evaluated using preoperative MR images, laparoscopic surgery videos, etc. The relationship between the condition and clinical symptoms, such as pain, is also considered.


Eligibility Criteria:
Inclusion Criteria:

* Patients who consent to use their data in this study
* Patients with endometriosis diagnosed by transvaginal ultrasound (TVUS) and/or MRI
* Patients undergoing fertility-preserving surgery
* Patients with pain due to endometriosis
* Patients with endometriotic lesions other than ovarian cysts confirmed by MRI (concomitant ovarian cysts can be recruited)
* Patients with the following patient clinical information (TVUS is not mandatory when archived data is used)

Patient clinical information: Preoperative MR images, videos of laparoscopic surgery, pathological evaluation of endometriosis, videos of preoperative TVUS, pain information related to endometriosis, information about infertility before surgery, information on QOL, information on postoperative recurrence, information on surgical difficulty, operating time, length of hospital stay for surgical operation, age, history of treatment (drugs, surgery), anamnesis and complication, history of endometriosis, age at menarche, menstrual cycle, date of surgery, date of MR image acquisition, operative procedure and history of pregnancy and childbirth.

Exclusion Criteria:

* Patients who had surgery for endometriosis prior to the surgery included in this study
* Patients deemed inappropriate by the principal investigator
* Patients who obtained their voluntary consent but later withdrew their consent
Surveillance Study of NovoRapid® for New Drug Re-examination

This study is conducted in Asia. The aim of this study is to observe the safety and efficacy of insulin aspart (NovoRapid®) administered via vial and three different devices.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)
Duration of ANtibiotic Therapy for CEllulitis

Cellulitis is among the most common infections leading to hospitalization, yet the optimal duration of therapy remains ill defined. Pragmatically, Dutch guidelines advise 10-14 days of antibiotics, which is the current standard of care. Recently it has been shown that antibiotic treatment for pneumonia and urinary tract infections can safely and significantly be shortened. Importantly, in an outpatient setting, treatment of uncomplicated cellulitis with 5 days of antibiotics was as effective as 10 days. We hypothesize that there is no difference in outcomes when patients hospitalized with cellulitis are treated with either a short-course (6 days) or standard-course (12 days) of antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to receive intravenous antibiotics for cellulitis/erysipelas
* 18 years of age or older
* Capable of giving written informed consent, able to comply with study requirements and restrictions

Exclusion Criteria:

* Allergy for flucloxacillin, other beta-lactam antibiotics or one of the additives, or flucloxacillin induced hepatitis or liver enzyme disorders.
* Concurrent use of antibiotics for other indications
* Alternative diagnosis accounting for the clinical presentation.
* All cases involving any of the following complicating factors:

  * Use of antibiotics with Gram-positive activity for more than 4 days in the past 7 days
  * Intensive care unit admission during the last 7 days
  * Severe peripheral arterial disease (Fontaine IV)
  * Severe cellulitis necessitating surgical debridement or fascial biopsy
  * Necrotizing fasciitis
  * Periorbital or perirectal involvement
  * Surgery
  * Life expectancy less than one month
  * Risk factors associated with Gram-negative pathogens as a causative agent:

    * Chronic or macerated infra-malleolar ulcers, or infra-malleolar ulcers with previous antibiotic treatment, in patients with diabetes mellitus.
    * Neutropenia
    * Cirrhosis (Child-Pugh class B or C)
    * Intravenous drug use
    * Human or animal bite
    * Skin laceration acquired in fresh or salt open water
    * Fish fin or bone injuries
OsteoCrete in Filling Bone Voids in Participants With Bone Voids or Defects

This trial studies the side effects of OsteoCrete in filling bone voids in participants with bone voids or defects. OsteoCrete may eliminate the need for further surgery and the removal of healthy bone.

PRIMARY OBJECTIVES:

I. To assess the safety of the device, which for the purpose of this study is defined as the compound injected into bone.

SECONDARY OBJECTIVES:

I. To determine the rate of absorption and bone ingrowth.

OUTLINE:

Participants receive OsteoCrete intraoperatively to fill voids that occur in bones during surgery or to augment screw fixation.

After completion of study treatment, participants are followed for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of a diagnosis as evidenced by one or more clinical features consistent with one or more of the following criteria:

  * Bone void created during surgery.
  * Lucency noted on x-ray preoperatively.
* Written informed consent (and assent when applicable) obtained from subject or subject?s legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
* Creatinine greater than 1.3.
* Presence of active bone infection.
mTOR Inhibitors: the Lesions Induced by Papillomavirus for Transplant Patients.

The injuries induced by Human Papillomavirus (HPV) (anogenital condyloma mainly) are more frequent among transplanted patients due to their immunosuppression. These injuries are benign but they have a negative impact on the patients' quality of life. The initial treatment is topical and then surgical. The injuries can relapse, especially among transplanted patients.

The modification of the immunosuppressant treatment with a switch to mTOR inhibitors (mammalian Target Of Rapamycin) has shown its efficacy in preventing the recurrence of squamous cell carcinomas or treating Kaposi's disease.

By analogy, this therapeutic strategy can be sometimes put forward to transplanted patients with HPV-induced injuries.

The principal objective of this study is to describe the evolution of HPV-induced lesions in solid organ transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (Age ≥ 18 years)
* Transplanted patient (any organ), having developed HPV-induced lesions after transplantation
* Patient followed or having been followed at Edouard Herriot Hospital (HEH)
* Patient having been informed and not having objected to participating in the study

Exclusion Criteria:

* Transplanted patient without HPV-induced lesions
Educational Interventions for Patients With DCIS

The purpose of this study is to determine whether adding an educational intervention, in the form of a decision board, which outlines the risks and benefits of treatment options for DCIS, at the time of the first surgical consultation will improve decision making for women with DCIS.

* The decision board explains the risks and benefits of mastectomy, excision and radiation, excision, radiation, and tamoxifen, excision alone, and excision without radiation and tamoxifen for women with DCIS.
* Patients will receive a decision board to take home for review. Two fifteen-minute telephone interviews will be conducted, one approximately one week after enrollment and one 2 months after enrollment.
* In the phone interviews, patients will asked to complete a brief survey. This survey will ask abou DCIS in general, the patient's treatment decisions, their feelings, as well as their experience with the decision board.
* This study will take about 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will include women over the age of 25 with newly-diagnosed DCIS who are candidates for breast conserving therapy.
* Pathologic confirmation of DCIS without evidence of invasive breast cancer and mammograms showing a single suspicious focus without mammographic or clinical evidence of multicentricity.
* Patients that have not made a decision regarding management of DCIS
* Eligible for radiotherapy to breast
* Oral and written knowledge of English

Exclusion Criteria:

* Patients that have undergone mastectomy
* History of prior radiotherapy to the breast, scleroderma or systemic lupus erythematosus
* Clinically palpable disease in the axilla or contralateral breast cancer
* Co-morbidities that would render them ineligible for general anesthesia
Determination of Amifostine Levels During Radiation Therapy

Currently, there are no published methods for easily determining the level of amifostine in the blood or saliva. A method has been developed within the Department of Radiation Oncology by Drs. Douglas Spitz and Gurminder Sidhu, within the Spitz Lab. This method has been tested using both animal sampling and expired blood (obtained from DeGowin blood center) mixed with amifostine.

If the method proves successful, it could then be used as a tool to quantify blood and salivary amifostine levels and possibly correlate them to treatment efficacy or limiting adverse events using amifostine. A better method of treatment, either increasing the efficacy of amifostine or reducing its unwanted side effects, could then be developed.

Currently, there are no published methods for easily determining the level of amifostine in the blood or saliva. A method has been developed within the Department of Radiation Oncology by Drs. Douglas Spitz and Gurminder Sidhu, within the Spitz Lab. This method has been tested using both animal sampling and expired blood (obtained from DeGowin blood center) mixed with amifostine.

If the method proves successful, it could then be used as a tool to quantify blood and salivary amifostine levels and possibly correlate them to treatment efficacy or limiting adverse events using amifostine. A better method of treatment, either increasing the efficacy of amifostine or reducing its unwanted side effects, could then be developed.

Amifostine is an FDA-approved medication that protects the lining of the mucous membranes of the head and neck when radiation treatments are given. Normally, amifostine is injected into a vein causing side effects of nausea, vomiting and low blood pressure. The amifostine can reduce radiation side effects but does not remove them completely.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign a written informed consent document.
* Receiving radiation treatment at University of Iowa Hospitals and Clinics.
* Voluntarily elected to receive amifostine during treatment

Exclusion Criteria:

* none