cyrilzakka/clinical-trials huggingface dataset:
Validating Accelerometers to Study Physical Activity of Toddlers

One way to assess impacts of nutrition supplements to health is to measure physical activity. Physical activity can be measured with small devices called "accelerometers". Before they can be used, the devices need to be validated in the population in question. Objectives of this study are to test accelerometers in field conditions and validate their use in 16-18 months old Malawian toddlers. This study does not have a pre-set hypothesis.

Accelerometers have not been validated in children under 2 years of age. In this study 50 toddlers from Lungwena will be recruited. The participants will wear an ActiGraph GT3X+ -accelerometer fitted on their waist with an elastic belt for 7 days. During the measuring, they will have two videotaped one-hour activity observations while wearing and additional accelerometer device fitted on their ankle. The output from the two devices will be compared to observed activity classified with CPAF-method.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent from at least one guardian
* age 16.00 months to 17.99 months
* availability during the period of the study

Exclusion Criteria:

* any guardian reported or observed illness that limits child's physical activity
* a condition reported by the guardian that limits child's activity co-operate in the study
* wasting (weight-for-height \< 2 SD)
* concurrent participation in any clinical trial with an intervention
A Study of PICOPREP in Patients Needed to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery.

The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery

Exclusion Criteria:

* Patients in which prescription of PICOPREP® is contraindicated
Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

As the licensed Pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the safety and the immune response of the new investigational pneumococcal protein vaccine is evaluated in healthy elderly population.

Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge during the study period (for 3 consecutive years starting from September 2004), to be used by Investigators according to national vaccination schedule/practice.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion criteria

* Subjects who the investigator believes will comply with the requirements of the protocol
* A male or female ≥ 65 years at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Use of any anticoagulants.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines.
* Previous vaccination against Streptococcus pneumoniae.
* Bacterial pneumonia within 3 years prior to 1st vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Current serious neurologic or mental disorders.
* Currently smoking \> 25 cigarettes per day.
* Inflammatory processes such as known chronic active infections
* All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
* History of administration of an experimental vaccine containing MPL or QS21.
* Acute disease at the time of enrolment.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator.
* History of chronic alcohol consumption and/or intravenous drug abuse.
Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

The validation of biomarkers allowing the discrimination of cognitive and behavioral disorders of psychiatric origin from those of neurodegenerative origin would facilitate diagnosis and improve patient management. Neurofilaments, which are markers of neuronal lysis, appear to be a promising biomarker. In a previous preliminary study, the investigators demonstrated significantly lower concentrations of neurofilaments in CSF of psychiatric patients compared to neurodegenerative diseases.

The main objective of this study is to validate the plasma assay of neurofilament light chain as a biomarker for the differential diagnosis of psychiatric or neurodegenerative cognitive impairment. Other biomarkers of interest (Tau, TDP-43, GFAP and UCH-L1) will also be analyzed.

A sub-part of this study will also focus on the retrospective analysis of the CSF/Plasma correlations of the different biomarkers mentioned above from tube bottom samples taken in routine care.

One hundred twenty participants will be included in this study

* 30 participants suffering from psychiatric disorders (bipolar disorder or schizophrenia) without cognitive impairment
* 30 participants suffering from psychiatric disorders (bipolar disorder or schizophrenia) with cognitive impairment
* 30 participants with a biological diagnosis of Alzheimer's disease
* 30 participants with frontotemporal dementia according to Rascosky's criteria

All the participants will perform cognitive, behavioral, and psychiatric evaluation and will be have blood sample taken.

Eligibility Criteria:
Inclusion Criteria:

* haven given written consent

Participants with psychiatric conditions:

* Schizophrenia (DSM-V criteria) with or without cognitive involution
* Bipolar disorder (DSM-V criteria) with or without cognitive involution

Participants with neurodegenerative disease:

* probable or definite FTD (Rascovsky criteria 2011)
* Biological Alzheimer's disease with typical CSF (NIA-AA 2011)

Exclusion Criteria:

* Uninterviewable patient and/or missing history
* History of recent or previous head trauma with loss of consciousness
* History of ischemic or hemorrhagic stroke
* Chronic alcoholism / chronic drug use
* Progressive somatic pathology / severe metabolic disorder / poorly controlled epilepsy
* Age \< 45 years
* Age \> 80 years
* Electroconvulsive therapy for less than 6 months
Incidence and Risk Factor of Hydroxychloroquine and Chloroquine Retinopathy

The purpose of this study is to evaluate the incidence and risk factor of toxic maculopathy who treated with hydroxychloroquine or chloroquine due to their autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus. Total 5-year of the study periods, the investigators will screen these patients by baseline examination (Fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test and multifocal electroretinography) and observe with same examination for every year.


Eligibility Criteria:
Inclusion Criteria:

* Patient who treated with HCQ or CQ due to autoimmune diseases such as RA, SLE
* Patient who did not previously diagnosed with HCQ/CQ toxic retinopathy

Exclusion Criteria:

* Aged less than 19 years
Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

Colorectal and pancreatobiliary cancers are the most common digestive cancers. Their incidence has particularly increased over the last few decades, leading to suspicion that environmental factors are involved. In addition, strategies for the therapeutic management of these cancers are evolving in the context of the development of immunotherapies.

Tumor microenvironment is a potential source of new diagnostic, prognostic and predictive markers and new therapeutic targets. The links between tumor microenvironment and modulation of the immune system in colorectal and pancreatobiliary cancers are poorly understood. Molecular classifications have been proposed for these cancers, but their link with immunity and response to treatment remains to be explored.

Objective : explore links between molecular subtypes, tumor microenvironment, host (immune system, pre-metastatic niche, intestinal microbiota, metabolism), and survival (prognostic value), response (predictive value) and tolerance (toxicities) to treatments in digestive cancers, in particular colorectal and pancreatobiliary cancers.

Method: Retrospective and prospective monocentric cohort study


Eligibility Criteria:
Inclusion Criteria:

* Colorectal or pancreatic adenocarcinoma or biliary tract adenocarcinoma
* Cytologically or histologically proven adenocarcinoma, regardless of stage and treatment
* Age ≥ 18 years old
* Diagnosed from 2015 onwards
* Signed Consent
* Affiliation to a social security scheme (including CMU (Universal health coverage))

Exclusion Criteria:

* Patient under guardianship, curatorship or safeguarding of justice
* Pregnant or breastfeeding woman
* Any medical, psychological or social situation that could prevent compliance with the protocol according to the investigator's assessment.
* Refusal to participate in the study
* Patient on AME (state medical assistance)
* Persons deprived of liberty by a judicial or administrative decision
* Persons under psychiatric care
Microbiome and Immunologic Analysis - Women With Endometriosis

The primary goal of this study is to assess differences in the microbiome between women with and without endometriosis.

A second goal of this study is to assess immunologic differences between the eutopic (within the uterus) and ectopic (outside of the uterus) endometrial tissue in women with endometriosis.

In order to investigate these areas of interest, 25 women with endometriosis and 25 women without endometriosis will be enrolled. All women will be undergoing a previously scheduled surgical procedure at which time presence or absence of endometriosis will be confirmed and specimens will be obtained.

Endometriosis is a chronic gynecologic condition where implants of endometrial glands and stroma are present outside of the uterus. It occurs in 6-10% of women of reproductive age and is characterized by dysmenorrhea, chronic pelvic pain, dyspareunia, or infertility. In addition to symptom burden, there are significant direct costs related to diagnosis and treatment of disease, as well as indirect costs related to absenteeism from school and work, loss of productivity, and unemployment. The estimated national economic burden in the United States related to these costs is approximately 78 billion dollars per year. While clinical signs and symptoms may be suggestive of endometriosis, the gold standard for diagnosis requires surgical confirmation of disease.

The pathogenesis of endometriosis is complex and likely multifactorial with genetic, epigenetic, environmental, and immunologic factors. An increasing number of studies have also suggested the role of the microbiome in human health and development of disease. This study aims to investigate possible differences in the microbiome and immunologic factors that could contribute to pathogenesis of this disease. Findings from this study could potentially contribute to the development of of a less invasive, non-surgical diagnostic test for endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* Females, age 18 years or older
* Undergoing laparoscopy (conventional or robotic) with or without hysterectomy for non-cancer indications and including women from two groups:
* Suspected endometriosis
* Elective salpingectomy or tubal ligation or abnormal uterine bleeding
* Understands study procedures
* Willing and able to provide signed informed consent

Exclusion Criteria:

* Postmenopausal
* Currently pregnant or lactating
* Prior hysterectomy or oophorectomy
* Undergoing hysterectomy via vaginal or abdominal approach
* Undergoing hysterectomy or laparoscopy for suspected malignancy
* Use of antibiotics within 2 weeks prior to surgery
* Use of hormone therapy for endometriosis or contraception within 4 weeks prior to surgery
* Diagnosis or treatment of vaginitis during the past 6 months prior to surgery
* Personal history of autoimmune or inflammatory disease
The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

The study will be a Prospective, Single-arm, Phase Ⅱ Clinical Study. This study intends to explore the efficacy and safety of Fuzuloparib combined with bevacizumab in the maintenance treatment of patients with platinum-sensitive ovarian cancer. The progression-free survival, OS, and safety were evaluated based on RECIST V1.1.

Due to the lack of effective predictive molecular markers in the maintenance treatment phase, it is difficult to assess the effectiveness of maintenance treatment. This project plans to collect blood and urine from subjects before maintenance treatment, during relapse, and for follow-up molecular marker exploration research.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with platinum-sensitive recurrent ovarian cancer confirmed by pathology or histology;
2. Patients who have previously received platinum-based chemotherapy and had a recurrence interval of \> 6 months before the last platinum-based chemotherapy;
3. Patients who have previously received bevacizumab and did not experience progression within 3 months during the use of bevacizumab;
4. Patients who have previously received PARP inhibitors and did not experience progression within 12 months during the use of PARP inhibitors;
5. The patient achieved a complete or partial response after the last platinum-based chemotherapy;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
7. The patient has a life expectancy of at least 3 months and sufficient organ function;
8. The patient has sufficient bone marrow reserves and organ function, including a creatinine clearance rate of 45 mL/min calculated using the standard Cockcroft and Gault formula;
9. The patient voluntarily agrees to participate in this study and signs an informed consent form.

Exclusion Criteria:

1. Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients and cannot swallow medication;
2. Patients who have undergone major surgery within 28 days prior to enrollment;
3. Patients with central nervous system metastases or a history of seizures within the past 12 months;
4. Uncontrolled hypertension: systolic blood pressure ≥180mmHg, diastolic blood pressure ≥90mmHg;
5. NYHA functional class ≥ III;
6. Patients with severe, uncontrolled systemic diseases;
7. Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study;
8. Pregnant or lactating patients, or patients who cannot guarantee effective contraception during the study treatment period;
9. Patients with poorly controlled neurological or psychiatric disorders or mental illness, poor compliance, and inability to cooperate or describe treatment response;
10. Patients judged by the investigator to be unsuitable for participation in this study.
Neonatal Resuscitation in Zambia

Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (W.H.O.) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.

Birth asphyxia (defined as "failure to initiate and sustain breathing at birth") has been identified by the World Health Organization (WHO) as the most frequent cause of early deaths worldwide, accounting for about 20% of neonatal mortality. Although prompt resuscitation after birth can prevent many of the deaths and reduce disabilities in survivors from birth asphyxia, the WHO has concluded that resuscitation is often not initiated or the methods used are inadequate or wrong. The Neonatal Resuscitation Program (NRP) has been universally accepted in the developed world but has had limited dissemination in many developing countries, including Zambia. The primary hypothesis of this study is that implementation of the combined Neonatal Resuscitation Program/WHO Essential Newborn Care (ENC) Program, compared to basic neonatal care education of health care providers (ENC only) will result in reduced neonatal 7-day mortality. This trial will be performed in two Zambian cities: Lusaka and Ndola. Training in data collection will be conducted in order to establish baseline data on mortality and asphyxia. Following this time period, all centers will receive the ENC training and continue to collect data for 7 months. The clinics will then receive NRP Training and collect data for a 12-month period.

The primary outcome will be a decrease in neonatal 7-day mortality following the NRP training when compared to the ENC-only time period. Secondary outcomes will include neonatal mortality due to perinatal asphyxia, mortality or hypoxic ischemic encephalopathy (HIE) at 7 days, need for advanced resuscitation, Apgar scores at 5 minutes, sustainability of the program, as well as providers' self efficacy, competence, and performance in neonatal resuscitation.

Eligibility Criteria:
Inclusion criteria:

* Live birth infants with birth weight ≥ 1500 g
* Infants who are born at participating health centers in Lusaka and Ndola, Zambia
* No lethal malformations

Exclusion criteria:

* Stillbirths
* Infants with suspected/confirmed lethal malformations (e.g. anencephaly, Trisomy 13 or 18, or cyanotic or left sided congenital heart disease that will not be repaired)
* Any infant who is transported/brought to the center after delivery
Effects of a Positive Slope Treadmill Training in Individuals After Stroke. (Hemislope)

The main objective of this study is to determine if a single session of treadmill training with a positive slope improves the kinematic parameters of the hip, knee and ankle on the paretic lower limb.

Secondarily we will quantify the efficiency of a such training on kinetic and functional parameters.

comparison between patients having a single session of treadmill training with slope and those having a single session of treadmill training with no slope

Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic patient
* capacity to walk during 20 minutes without technical assistance

Exclusion Criteria:

* patient with bilateral brain lesions
* previous orthopedic surgery
* pregnant woman
A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)

A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 1 or 2 diabetes mellitus.
* Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.

Exclusion Criteria:

* Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
* Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.
Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical DeviceS

assess the impact of the intervention of a clinical pharmacist expert in sterile medical devices


Eligibility Criteria:
Inclusion Criteria:

* - The patient must be a member or beneficiary of a health insurance plan.
* The patient is managed for scheduled surgery (full hospitalization or outpatient) in the UDG (Urology Digestive Gynecology) operating room.

Exclusion Criteria:

* - The subject is in a period of exclusion determined by a previous study.
* The subject is under judicial protection.
* The subject (or his/her legal representative) has expressed his/her opposition to participate in the study.
* The patient is undergoing emergency surgery in the UDG (Urology Digestive Gynecology) operating room.
* It is not possible to give informed information about the subject.

Translated with www.DeepL.com/Translator (free version)
Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with primary central nervous system lymphoma.

OBJECTIVES:

* Assess the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening primary central nervous system lymphoma.
* Describe response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.

Tumors are measured every 2 months for 6 months, every 3 months for 2 years, every 6 months for years 3 and 4, and then annually for years 5 and 6.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage I-IV primary central nervous system lymphoma for which no curative therapy exists
* Measurable tumor by MRI or CT scan
* Tumor must be greater than 2 cm in largest diameter

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC greater than 2,000/mm\^3
* Platelet count greater than 50,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal
* No hepatic insufficiency

Renal:

* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

* No cardiac insufficiency
* No hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for at least 4 weeks after study participation
* No serious infection requiring antibiotics, antifungals, or antivirals

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulatory agents (e.g., interferon or interleukin-2)

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No concurrent antineoplastic agent

Endocrine therapy:

* Concurrent corticosteroids allowed
* Must be on stable dose for at least 4 weeks prior to study entry

Radiotherapy:

* At least 8 weeks since prior radiotherapy and recovered

Surgery:

* Not specified

Other:

* No prior antineoplastons