cyrilzakka/clinical-trials huggingface dataset:
Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases

The present study will give information about the course over time in skeletal-related events (SRE) in prostate cancer patients with bone metastases treated with zoledronic acid 4 mg administered as a 15-minute infusion every 4 weeks for a maximum of 15 infusions. The protocol will enroll patients with recent diagnosis of bone metastases from prostate cancer who are hormone-refractory, hormone-naïve or still hormone-sensitive, that represent the entire population of prostate cancer patients


Eligibility Criteria:
Inclusion Criteria

* Patients aged ≥18 years
* Written informed consent
* Histologically-proven prostate carcinoma
* ECOG performance status ≤ 2
* Life expectancy \> 6 months
* Newly diagnosed (≤ 6 months prior to visit 1) bone metastases evidenced by bone scan or radiograph.
* Patients on androgen deprivation therapy (medical therapy with LHRH analogues + antiandrogens or surgical castration) or going to start it
* Patients with partners of childbearing potential should use a barrier method of contraception throughout the study

Exclusion Criteria

* Patients without a history of metastatic disease to the bone
* Prior treatment with bisphosphonates
* SREs prior to visit 2
* Prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to baseline
* Corrected (adjusted for serum albumin - see Appendix 5 for the calculation) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/l)
* Serum creatinine concentration \> 265 micromol/l (3.0 mg/dl) or a calculated creatinine clearance \< 30 ml/minute or serious underlying renal disease or prior renal transplantation
* History of other malignant neoplasm within previous five years with exception of non-melanomatous skin cancer which has been satisfactorily treated
* Other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future
* Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days
* Known hypersensitivity to zoledronic acid or other bisphosphonates
* History of noncompliance to medical regimens and patients who are considered potentially unreliable (for example drug or alchohol abusers) or incapable of giving informed consent as judged by the investigator
Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes

Our general aim is to investigate whether messenger RNA (mRNA) and/or microRNA (miRNA) expression profiles in white blood cells, predict metformin monotherapy efficacy in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (duration of diabetes of at least 2 years)
* age 40-70 yrs
* HbA1c \> 6.4 \< 9.0

Exclusion Criteria:

* insulin therapy
* contraindications to metformin use
Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea

Primary Endpoints:

•Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)

Secondary Endpoints: By polysomnography, reduction in:

* AHI with device on vs. off at 3 months, controlling for sleep position
* Oxygen desaturation index with device on vs. off
* Arousal index with device on vs. off
* Duration of snoring with device on vs. off
* Epworth Sleepiness Scale

Patient acceptance, in terms of:

* Refusal rate at screening
* Discontinuation rate during follow-up
* Daily compliance rate
* Device-related adverse events
* Serious adverse events

Please see summary above

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Diagnosis of OSA
3. AHI \> 10 on diagnostic PSG performed within last 3 months
4. Investigator believes that subject can benefit from OSA tx
5. Subject understands and is willing and able to comply with study requirements

Exclusion Criteria:

1. Use of any device that interferes with nasal/oral breathing
2. Persistent blockage of one or both nostrils
3. Any chronic sores or lesions on the inside/outside of the nose
4. Chronic use of nasal decongestants other than nasal steroids
5. Oxygen saturation \< 75% for \> 10% of the diag. PSG
6. Oxygen saturation \< 75% for \> 25% of the first 4 hours of the diag. PSG
7. Prior or near-miss motor vehicle accident due to sleepiness (last 12 mo.)
8. Current use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect neurocognitive function and/or alertness
9. History of allergic reaction to acrylic-based adhesives
10. Current acute upper respiratory inflammation/infection or perforation of the tympanic membrane
11. History of frequent and/or poorly treated severe nasal allergies or sinusitis
12. Narcolepsy, idiopathic hypersomnolence, chronic insomnia, RLS, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder
13. Current use of diurnal or nocturnal supplemental oxygen
14. History of CPAP use in the home for OSA tx
15. History of use of oral appliances for OSA tx
16. History of prior surgery for OSA
17. Currently working night or rotating shifts
18. Consumption of \> 10 caffeinated beverages per day
19. History of severe cardiovasc. disease, including NYHA Class III or IV heart failure, CAD with angina or MI/stroke in past 6 months
20. History of cardiac rhythm disturbance
21. Uncontrolled hypertension (SBP \> 180 or DBP \> 105 mm Hg)
22. Uncontrolled hypotension(SBP \< 80 or DBP \< 55 mm Hg
23. History of severe respiratory disorders or unstable respiratory disease
24. Any other serious, uncontrolled medical condition
25. Females of child bearing age who are pregnant or intending to become pregnant
26. Consumes more than 3 drinks of alcohol/day
27. Chronic neurologic disorders
28. Cancer, unless in remission for more than 1 year
29. Current psychiatric illness
30. Smokers whose habit interferes with the overnight PSG
31. Any known illicit drug usage
Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis

Open label study to evaluate the efficacy of CURE-EX device in the treatment of onychomycosis.

Each affected nail will be treated twice daily for 24-30 weeks. Efficacy will be evaluated by measuring the growth of healthy nail.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects diagnosed with clinical and mycological onychomycosis (by culture and smear).
2. Subjects did not receive topical antifungal treatment during the 14 days prior to commencing the study.
3. Subjects did not receive any systemic antifungal treatment during the 3 months prior to the start of the study.

Exclusion Criteria:

1. lunula infected with onychomycosis.
2. Pregnant or breast feeding female.
Effects of Hypoxia on Cognitive Performance

The goal of this clinical trial is to determine the effects of different hypoxia exposures (FiO2 = 11%, 13%, 15%, and 21%) on cognitive performance in healthy adults. The main questions it aims to answer are:

* What is the best hypoxia exposure to improve reaction time, anticipation, attention and memory tasks?
* Which hypoxia exposure causes the greatest detriments in cognitive function?

Participants will completed four trials in a single-blinded crossover randomised control trial. In the first session, individuals familiarised with the different cognitive tests and hypoxic exposures. In the next four experimental trials (separated by 1 week), participants arrived at the laboratory and rested in a seated for 10 min. The vital signs (i.e., SpO2, HR, blood pressure) and Lake Louise Score were recorded prior to mask placed and start with in one of the four conditions: a) PLA/NOR, b) FiO2=15%, c) FiO2=13% or FiO2=11%. In this hypoxic condition the participant will spend a total of 45 min, of which 30 min was at rest, and the other 15 min was performing the cognitive tasks (i.e., memory test, go/no-go test, eriksen flanker test, anticipation task and reaction time test).

Eligibility Criteria:
Inclusion Criteria:

* Physically active individuals ( \>150 min/week moderate physical activity or \>75 min/week vigorous physical activity)
* Non-smokers
* Individuals without serious and undiagnosed health problems

Exclusion Criteria:

* Pregnancy and/or breastfeeding
* Residing at an altitude of more than 1300 m
* Having been exposed to an altitude of more than 900 m in the last 8 months
* Having performed a study with hypoxia in the last 8 months
* Suffering from any of the following diseases/pathologies: diabetes, sleep apnoea, dyslexia, colour blindness, blurred vision, respiratory and/or neuromuscular diseases.
Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway

Social inequalities in the face of cancer are significant in all countries. They are characterized by higher mortality among people may be in the lower socioeconomic category. The care pathway may also be a source of inequality or accentuate inequalities. Socially vulnerable patients must be provided with appropriate care. It is therefore necessary to identify patients with such social vulnerabilities as early as possible and to take them into account throughout the care process. To meet this need, the DEFCO project ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") was designed and conducted by the Centre Hygée at the Lucien Neuwirth Cancer Institute (ICLN) in 2014 and 2015, in partnership with an industrial engineering research laboratory, the DISP ("Décision \& Information pour les Systèmes de Production"). Its objective was to develop a tool for systematic screening of social fragility, involving few caregivers and making it possible to identify patients most at risk of social maladjustment. The choice was made to develop a self-administered questionnaire using tablets connected to a neural network. Since its implementation, the deployment of the DEFCO project ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") tool at the Lucien Neuwirth Cancer Institute (ICLN) has required several training and awareness-raising activities to strengthen the motivation of the various stakeholders. These same actors have also implemented different strategies to optimize the functioning of the tool. Developed in a specialized institution, this tool must demonstrate, in this second stage of the project, it transferability and it possibilities of implementation in other structures. It is also necessary to evaluate it in terms of it is impact, particularly on the fluidity of care pathways and on the social consequences of the disease.

The aim of this study is to evaluate the implementation of the DEFCO ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") social fragility tracking tool over one year.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed for cancer (solid or hematological) since 15 days maximum
* Age over 18 years
* Affiliated with or entitled to a social security scheme

Exclusion Criteria:

* Refusal to participate
* Patient unable to understand the study process
* Patient with documented history of cognitive or psychiatric disorders.
* Patient under tutorship or curatorship
* Patient not understanding French
3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas

• three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. A 3.3 mm soft plastic paediatric naso-gastric suction catheter was then passed through the cervix into the uterine cavity without grasping the cervix.

The speculum was removed and a 5 MHz transvaginal 3D ultrasound probe inserted into the vagina (Voluson 730; KretzTechnik, Austria).

Eligibility Criteria:
Inclusion Criteria:

* • Women between 20 and 60 years with abnormal uterine bleeding in form of heavy menstrual bleeding, irregular and heavy menstrual bleeding) diagnosed on non-enhanced two-dimensional ultrasonography with submucous fibroids.

  * Absence of STD, PID, active vaginal bleeding.

Exclusion Criteria:

* Presence of general cause of abnormal uterine bleeding

  * History of drug use that can cause vaginal bleeding (anticoagulants, OCPs, HRT)
  * History of recent hormonal treatment
  * High risk of undergoing hysteroscopy
  * Vaginal, Vulval causes of bleeding
Diagnosing and Treating Low Blood Sugar Levels

Hypoglycemia is the term used to refer to lower than normal levels of blood sugar. This study will continue to research the causes of hypoglycemia.

Patients involved in the study will be admitted to the Clinical Center of the National Institutes of Health and undergo tests for evaluating blood sugar. Patients will be required to refrain from eating for a set period of time and will undergo blood tests for insulin levels and several other specific diagnostic tests related to insulin secretion. The patients will be under supervision and will be provided with appropriate medical and surgical attention as needed.

Study Description:

The purpose of this study is to gain knowledge and experience in the diagnosis and therapy of patients with fasting hypoglycemia due to diverse etiologies, such as insulinomas. Study subjects will be evaluated and treated for their particular condition according to standard care.

Objectives:

1. To understand the pathophysiology and various causes of hypoglycemia (e.g., insulinomas, MEN1, MEN2).
2. To identify new circulating biomarkers of insulinomas.
3. To create a repository of clinical data and samples for future research of insulinomas.

Endpoints: None

Eligibility Criteria:
* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Male, females ages \>= 18.
2. Patients with documented fasting blood glucose below 55 mg/dl.

4. Patients with biochemical evidence for insulinoma or other pancreatic neuroendocrine tumors.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Patients with significant cardiac disease will be excluded.
2. Subjects who are pregnant per self-report.
3. Medically unstable per the assessment of the PI.
A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-541468 Can Affect the Fate in the Body (Amount and Time of Presence in the Blood) of Rosuvastatin

A study in healthy male subjects to investigate whether administration of ACT-541468 can affect the fate in the body (amount and time of presence in the blood) of rosuvastatin


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in the local language prior to any study mandated procedure;
* Healthy male subjects aged 18 to 45 years (inclusive) at screening;
* Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening;
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Exclusion Criteria:

* Known allergic reactions or hypersensitivity to ACT-541468, rosuvastatin, any drug of the same classes, or any of their excipients;
* Any contraindication for rosuvastatin treatment;
* History or clinical evidence of myopathy;
* Asian or Indian-Asian ethnicity;
* Known hypersensitivity or allergy to natural rubber latex;
* Previous exposure to ACT-541468;
* Treatment with rosuvastatin within 3 months prior to screening;
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
A Cohort Study on Sleep Disorders During Pregnancy

The goal of this observational study is to: 1) determine the prevalence of sleep disorders in pregnancy and the early postpartum; 2) identify factors associated with sleep disturbance during pregnancy and the early postpartum; 3) describe the progression of sleep quality and quantity as gestational age; 4) determine if sleep is associated with adverse perinatal outcomes. Participants were asked to wear a forehead sleep recorder for 4 consecutive days and to complete a sleep questionnaire at ten timepoints: at 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, and 9 months pregnant and at 1 month, 2 months and 3 months postpartum.

There is a high incidence of sleep disturbances globally, especially among pregnant women. Long-term sleep disorders seriously affect the quality life of individuals, and it becomes undoubtedly an important public health problem. Studies have shown that sleep disorders during pregnancy can have short-term and long-term adverse effects on both mothers and their babies. In addition, sleep during pregnancy exhibits different characteristics at different stages. Most of the existing studies are based on the overall development trend to study sleep characteristics, ignoring potential individual differences. Based on the concept of precision medicine, this study intends to establish a cohort focusing on the sleep health of pregnant women, and carry out continuous home sleep monitoring of pregnant women from both subjective and objective perspectives. The aim of this study is, firstly, to explore the longitudinal change characteristics, potential classification and influencing factors of sleep during pregnancy; secondly, to analyze the differences in maternal and infant adverse outcomes among pregnant women with different sleep development trajectories. The final goal is to reveal the exposure window of maternal and infant adverse outcomes caused by sleep, thus improving the accuracy of outcome prediction, and promoting the development of accurate and personalized sleep management programs.

Eligibility Criteria:
Inclusion Criteria:

1. Gestation age ≤ 13 weeks + 6 days
2. 20 years old ≤ Age ≤ 40 years old
3. Singleton pregnancy
4. Give informed consent and able to participated

Exclusion Criteria:

1. Unmarried, divorced or widowed
2. Women who suffered severe physical or mental illness
3. Women who suffered death, abortion, stillbirth or neonatal death during the study
4. Women who are participating in other studies
5. Other reasons
Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids

The goal of this Registry Study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-Exablate treatment for their symptomatic fibroids.

This is an observational study only for all consented subjects who undergo an Exablate treatment. The Exablate procedure is a commercial treatment. The objective of this registry is to collect data about the effect of Exablate treatment on potential pregnancy occurrences in this population for two years post-treatment for purposes of labeling updates and overall safety data collection.

Eligibility Criteria:
Inclusion Criteria: - - Eligibility is as per the symptomatic fibroids device indication. - All registry-consented patients following the treatment of their fibroid(s) with the Exablate system. Exclusion Criteria: -
Health Improvement Project - Providence

This study will investigate whether phone-delivered mindfulness training is feasible and acceptable for persons living with HIV and whether it may help them improve adherence to medications and reduce risky sexual behaviors.

Two-thirds of people living with HIV show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. In this trial, the investigators will examine the utility of phone-delivered mindfulness training (MT) for people living with HIV. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents.

Fifty participants will be enrolled in this parallel-group randomized clinical trial (RCT). Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either MT or to health coaching intervention; both interventions will be administered during 8 weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Sub-optimal adherence to ART (Less than "always" taking ART medication and/or viral load \> 20 copies/mL);
* Psychological distress (PHQ-4 score ≥ 2);
* Recent risky sexual behavior (any unprotected sex OR \> 1 sexual partner over the past 6 months)
* Access to a telephone or cell phone

Exclusion Criteria:

* Unwilling or unable to provide informed consent
* Cognitive impairment
* Non-English speaking
* Low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them
* Enrolled in another behavioral trials
* Prior formal mindfulness training or have practiced of mindfulness or related mind-body techniques in the previous year
* Severe hearing impairment not allowing phone delivery
* Suicidal ideation
* Planning to move out of the area within the study period
* Clinic provider advising against recruitment in the study.
Care Pathway for Children With Autism Spectrum Disorder Included in the ELENA Cohort

Autism Spectrum Disorder (ASD) is lifelong neurodevelopmental disorder that affect social communication and interaction and includes limited and repetitive patterns of behavior (DSM 5). In France, national guidelines about practices recommends early and specific interventions but care pathway are not well described for ASD children. The national health insurance information system record demographic data, medical condition, and reimbursed drug over 98% of the French population. In addition, the ELENA cohort is a large cohort of children with ASD followed for 6 years. Data collected include clinical characteristics of children (IQ, severity of ASD...) and parents (educational level, professional status...).

The first objective of this project is to identify patterns of care trajectories using data from ELENA cohort matched to data from national health insurance information system. Secondary objectives are to examine the links between patterns of care trajectories and clinical characteristics, social environment of autistic children.


Eligibility Criteria:
Inclusion criteria:

- Included in ELENA Cohort

Exclusion criteria:

- Opposable to reuse data