cyrilzakka/clinical-trials huggingface dataset:
An Observational Follow-up Study of 1st-Line Treatment With Herceptin (Trastuzumab) in Patients With Metastatic Breast Cancer (Post-HERMINE)

This is an observational follow-up study on the efficacy of 1st-line treatment with Herceptin (trastuzumab) in patients with metastatic breast cancer 7 years after initiation of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Female patient, \>/= 18 years of age
* Metastatic breast cancer
* 1st-line treatment with Herceptin initiated in 2002
* Included in pharmaco-epidemiologic HERMINE study

Exclusion Criteria:

* Patient died before scheduled follow-up visit (March 2005)
Blood-Flow Restriction Exercise Following a Knee Replacement

This study will determine the safety and efficacy of using blood-flow restriction exercise enhancement (B-FREE) to overcome persistent quadriceps muscle weakness that occurs following a total knee replacement (TKR).

This study aims to determine the safety and efficacy of using B-FREE to overcome persistent quadriceps muscle weakness that occurs following a TKR. We hypothesize that B-FREE can provide a safe training stimulus and offer a home-based program to restore quadriceps muscle strength and improve functional mobility. Specifically, subjects that have a TKR will perform B-FREE at home (light weights with resistance bands and walking) 3x/wk for 10 weeks. Quadriceps muscle strength, balance, and functional mobility will be assessed before and after the program. Changes in these variables will be compared to healthy age-matched uninjured controls.

Eligibility Criteria:
Inclusion Criteria

* 40-75 years of age
* Have had a unilateral TKA \> 6 months prior to participation (Arm 1)
* No previous history of knee injury/surgery (Arm 2)

Exclusion Criteria

* Are a smoker
* Have diabetes
* Have suffered a heart attack or stroke
* Have any cardiopulmonary disorders (hypertension discussed below)
* Have been diagnosed with any neurological disorders
* Have any implanted devices such as but not limited to a pacemaker or pain pump
* Uncontrolled (not medicated) Stage 1 hypertension or Stage 2 hypertension
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.

This study is a multi-center trial consisting of an open-label segment of up to 52 weeks, followed by a double-blind, placebo-controlled, randomized withdrawal segment. Subjects participating in the randomized-withdrawal segment will be randomized in a 1:1 ratio either to continue to receive AXS-05 or switch to placebo, for up to 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participation in Study AXS-05-AD-302 or Study AXS-05-AD-304.
* Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment.

Exclusion Criteria:

* Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
* Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone.
* Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being.
* Initiation of a new medication since enrolling in AXS-05-AD-302 or AXS-05-AD-304 which may pose a safety risk when taken concurrently with AXS-05.
Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures

The goal of this observational study is to measure in real practice the performance and safety of RTR+Membrane, a synthetic dental membrane for guided tissue regeneration in periodontal or dental implant surgery. The main question it aims to answer is to measure the post-operative wound healing several months after surgery. Participants will be followed after their dental surgery via clinical examination and radiological and photos images.

Participants are any adult patients with one of the 3 following dental treatments to be done with RTR+Membrane:

* post-extraction socket preservation,
* alveolar ridge augmentation,
* Guided Tissue Regeneration (GTR) during immediate implant placement.

Since it is a real-life evidence study in current practice, patients will be followed at their surgery and their follow-ups. Below are listed visits and type of data collected.

* V1 - Surgery: Demography, Medical history and concomitant treatments, Clinical/technical information (tooth extraction, surgery, membrane and grafting materials use), Clinical Exam, Photography, X-rays or Cone Beam Computed Tomography (CBCT)
* V2 - Early follow-up (including suture removal, if needed): Clinical Exam, Questionnaire, Photography
* V2bis - Early follow-up: Clinical Exam, Photography
* V3 - Late follow-up: Clinical Exam, Photography, X-rays or CBCT, Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult patient
* Patient with one of the 3 following dental treatments to be done with the study device: post-extraction socket preservation, alveolar ridge augmentation, or Guided Tissue Regeneration (GTR) during immediate implant placement.
* Patient affiliated or beneficiary of a social security system.
* Patient has signed his/her informed consent form.

Exclusion Criteria:

* Pregnancy or lactation
* Active tissue infection at the implant site
* Several dental treatments done simultaneously in non-contiguous dental zones
* Heavy smoker (\>10 cigarettes / day)
* Patient receiving long-term corticosteroid therapy, anti-rejection drugs, bisphosphonates, head \& neck radiotherapy or chemotherapy
* Patient with chronic infections (such as osteomyelitis) at the surgical site
* Patient with poorly controlled metabolic disorders (such as diabetes, osteomalacia, thyroid disorders)
* Patient with an auto-immune disease
* Patient under tutelage, vulnerable person, person without liberty, or unable to complete questionnaire independently
The Roles of Human Microbiome and Vitamin D in the Development of Childhood Allergic Diseases

A birth cohort study to evaluate the role of human microbiome and vitamin D in the development of allergic diseases in young child before one year of age.

Allergic diseases are chronic inflammatory disorders that frequently affect young infants before one year of age, and is the beginning of allergy march in later life. The prevalence is increasing in industrial world, Taiwan included. Genetic and environmental factors, such exposure to allergens and microbes, especially early in life, have a detrimental role in the development of allergic diseases, such as atopic dermatitis (AD), allergic rhinitis and asthma. Vitamin D has an important role in different allergic disease. Lower cord blood vitamin D status was observed in infants that developed eczema. Vitamin D binding protein (DBP) bound to vitamin D and regulated its metabolites in the circulation. Moreover, vitamin D receptors have been identified on nearly all cells of the immune system. It may contribute to maintenance of intestinal barrier function by preventing increased intestinal permeability, dysbiosis, inflammation, and a lack of immune tolerance in the gut.

Although aberrant interactions between gut microbes and the intestinal immune system have been implicated in this allergic disease, however, the causal effect of microbiota colonization of the gut and vitamin D that influence the development of allergic diseases, such as AD, in young infants is still unknown. The investigators plan to design a birth cohort study to evaluate the role of human microbiome and vitamin D in the development of allergic diseases in young child before one year of age.

In this study, the investigators will recruit mother-infant pairs in antenatal clinics in China Medical University Hospital and China Medical University Children's Hospital. Newborns who have been enrolled at birth are collected for meconium samples before discharged from nursery and eligible for follow-up visits, and collect their nasal and anal swab microbiome samples at 2 and 12 months follow-up visit. Parental questionnaires are collected at 6, and 12 months of age. All infants were assessed at birth, 2 and 6, and 12 months of age. Assessment included physical examination for allergic diseases. In addition, infants at 12 months of age were collected their 3cc of blood sample.

The investigators believe this longitudinal and prospective study, to follow-up infants from the date of birth until one years old, can answer the cause-effect relationships of microbiota and vitamin D in the development of allergic diseases, and design a microbiota-related preventive and treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

* All term newborn babies who are born in China Medical University Hospital. The term baby defines the maternal gestational age between 37 0/7 weeks to 41 6/7 weeks.

Exclusion Criteria:

* The exclusion criteria are prematurity newborn, congenital anomalies and cardiopulmonary failure need for resuscitation immediately after birth.
Transforming Hemodialysis-Related Vascular Access Education

The focus of this study is on vascular access for hemodialysis. This is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. Study participants will each be assigned to one of the 3 approaches: 1) "Education", in which participants will be given a video and brochure that provide information about the types of vascular access and what can be expected before and after the vascular access is placed, 2) "Education-Plus", in which participants will be given the video and brochure and will also have sessions by telehealth with a motivational interviewing coach to provide additional support around vascular access placement, and 3) "Usual Care", in which participants will have the usual education provided by their kidney doctor and clinic staff just as if they were not in the study. Participants in all 3 groups will be asked to complete questionnaires by telephone and may be invited to be interviewed about their experience with the study intervention at the end of the study. Study participation will last for about 12 months, with most of the study activities taking place during the first 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Nephrology visit for chronic kidney disease during the last 18 months
3. Most recent eGFR less than or equal to 20 ml/min/1.73 m2 or 2-year Kidney Failure Risk Equation score greater than 40%
4. Documentation in the medical record or confirmation from the treating nephrologist of a patient-nephrologist discussion about hemodialysis

Exclusion Criteria:

1. Planning for peritoneal dialysis, preemptive transplant, or conservative management of kidney failure
2. Previous placement of an AV access
3. Prior appointment with surgeon for AV access evaluation or creation
4. Cognitive dysfunction or severe visual impairment that prevents use of the education materials
5. Does not speak either English or Spanish
A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).


Eligibility Criteria:
Inclusion Criteria:

* Have confirmed diagnosis of CF
* Have an FEV1 greater than or equal to 60%
* Have oxygen saturation greater than or equal to 90% on room air
* Be clinically stable for at least 4 weeks prior to screening
* Be able to reproducibly perform spirometry maneuvers

Exclusion Criteria:

* Have clinically significant comorbidities
* Have changed their physiotherapy technique or schedule within 7 days prior to screening
* Using prior and concurrent medications according to protocol
An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola

The purpose of this study is to determine how safe and tolerable Brincidofovir (BCV) is when given for post exposure prophylaxis of Ebola virus disease.

The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD

Eligibility Criteria:
Inclusion Criteria:

* Individuals have high-risk exposure to Ebola Virus based on CDC definitions
* Must be able to ingest, absorb and tolerate oral medication
* As appropriate, must be willing to use adequate methods of contraception during the study and at least 6 months after their last dose of BCV

Exclusion Criteria:

-
Anxiety and Work Resilience Among Tertiary University Hospital Workers During the COVID-19 Outbreak: An Online Survey

For limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th.

Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7).

In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak.

As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed


Eligibility Criteria:
Inclusion Criteria:

* Employees of CHU Nîmes during COVID-19 pandemic
* Approved to participate

Exclusion Criteria:

• Participation refusal
The Application Value of STIC in the Diagnosis of Fetal Complex Congenital Heart Disease

The objective of this study is to use of STIC technology to assist the traditional echocardiography to diagnose the fetal congenital heart disease accurately and then to provide a basis for prenatal counseling.

This is a diagnostic test in Shanghai Xinhua hospital from Nov.2016 to Dec.2017. 265 Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography.Only gravidas who are willing to have complete pregnancy checks and finally delivery or abortion in the hospital are interviewed are eligible for the study. Study participants will be asked for their informed consent.We collect their fetal 2D echocardiography and STIC images every 4-6 weeks during pregnancy and 1 weeks after the baby giving birth we finish their neonatal echocardiography.

Eligibility Criteria:
Inclusion Criteria:

1. Gravida with singleton pregnancy taking fetal echocardiography.
2. No virus infection or drug use history, no harmful substances in the early pregnancy.
3. Complete pregnancy check in the hospital, and finally delivery or abortion in the hospital.
4. On the basis of informed consent，willing to cooperate with our group.

Exclusion Criteria:

1. Elderly pregnant women (\>35 years old)
2. Twin or multiple pregnancy
3. Pregnant women suffering from mental illness, can't take care of themselves.
4. Fetus diagnosed with other abnormalities (except congenital heart defects)
Mental and Cognitive Health and Physical Activity in the Perioperative Breast Cancer Setting

This study evaluates the complex relationships between mental health, cognitive function, and physical activity before surgery in patients with stage I-III breast cancer. Most patients with breast cancer experience declines in their mental health, with up to two-thirds of patients reporting symptoms of depression and anxiety. Cancer-related cognitive decline is even more prevalent; 75% of patients with breast cancer report varying degree of loss in mental acuity throughout their cancer experience. Both mental and cognitive health declines are pervasive, lasting anywhere from 5 years to decades after treatment completion. Not only are these declines detrimental to patients' quality of life, but they also increase the risk of cancer-related mortality. Maintaining sufficient levels of physical activity (PA) is important to both prevent breast cancer and improve health post-diagnosis. PA improves anxiety and depressive symptoms during and after treatment. Early intervention with PA prior to or during cancer treatment, or prehabilitation, can avoid or reduce the severity of treatment-related side effects, hospital length of stay, surgical complications, and care costs. Information gained in this study may help researchers learn more about the right time during treatment for delivering lifestyle programs to improve mental and cognitive health.


Eligibility Criteria:
Eligibility Criteria Patients:

* A physician-confirmed diagnosis of breast cancer (stage I-III)
* Female over the age of 18
* Scheduled to receive curative-intent breast surgery and chemotherapy (neoadjuvant or adjuvant)
* Able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document. Given documented mental and cognitive health declines after both neoadjuvant and adjuvant treatment regimens, the investigators are including both patient populations in this exploratory study. Patients of all baseline anxiety, depression, cognitive function, and physical activity levels are eligible to participate.

Eligibility Criteria Stakeholders:

* Healthcare personnel with a staked interest in patient care during chemotherapy, including but not limited to surgical oncologists, medical oncologists, physical and occupational therapists, nurses, patient navigators, dietitians, and exercise physiologists
* Able to understand and willing to sign an IRB-approved informed consent document
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy

Approximately a fourth of children with seizures do not respond adequately to available therapy. Ketogenic therapy has a long history as treatment for intractable epilepsy, but there is no agreement concerning how it works and what is the best way to administer it. This natural history study will collect data pertaining to both questions.

The basis of Ketogenic Therapy is an altered macronutrient intake. It is based on a ratio of fat: protein+carbohydrate in which protein intake is adequate and carbohydrate is minimal. On Ketogenic Therapy, the body metabolizes fat, producing ketones as an energy source for the brain. Induction of ketosis has been shown to correlate with the reduction of seizures observed with Ketogenic Therapy. A major challenge of Ketogenic Therapy in children is that the compounds provided to stop seizure activity are the same compounds provided for growth and development. The altered macronutrient ratio that is the basis of Ketogenic Therapy is also a potential risk factor for dyslipidemia and may adversely affect growth. The investigators will evaluate efficacy of Ketogenic Therapy by assessing seizures and requirements for antiepileptic drugs. The investigators will evaluate adverse effects of Ketogenic Therapy by assessing dyslipidemia and growth. The investigators will foster optimal daily administration of therapy with structured training programs for caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose physician has prescribed the ketogenic diet
* Patients with lab tests consistent with the ability to metabolize a high fat and low carbohydrate diet
* Patients that can be compliant with administration of the therapy and with record keeping.

Exclusion Criteria:

* Patients with lab tests consistent with the inability to metabolize a high fat and low carbohydrate diet
* Patients at risk of being non-compliant with administration of the therapy and with record keeping
Leflunomide Treatment for MEN1 Patients - the LUMEN1 Trial

Multiple endocrine neoplasia type 1 (MEN1) is an autosomal dominant disorder due to mutations in the tumor suppressor gene MEN1 with the corresponding gen product menin. MEN1 is characterized by the occurrence of parathyroid, pancreatic islet and anterior pituitary tumors which can release excessive amounts of hormones (= functional active tumors). Other tumors (e.g. carcinoid tumors, adrenocortical tumors, meningiomas, facial angiofibromas, collagenomas, lipomas) have also been described. There is no geno-phenotype correlation but the disease occurs after a second hit of the corresponding gene within the endocrine organ leading to an uncontrolled growth.

MEN1-patients have a decreased life expectancy, mainly due to pancreatic neuroendocrine tumors (pNETs) which are often multiple and more aggressive than in non-MEN1 patients. To date, no prophylactic treatment exists to prevent tumor development in this hereditary disease.

Leflunomide has been used as a treatment for rheumatoid arthritis for many years. It is a potent inhibitor of the dihydroorotate dehydrogenase (DHODH). According to some preclinical studies, leflunomide showed antineoplastic activities in several malignancies, including prostate, breast, bladder, multiple myeloma, leukemia, and lymphoma. A recent study identified an interaction between MEN1 mutation and DHODH inhibition. In this study, leflunomide selectively killed MEN1 deficient cells in vitro, prevented the occurrence of pancreatic tumor development in xenograft models and led to tumor regression / stabilisation in three MEN1 patients with advanced aggressive pancreatic neuroendocrine tumors.

Accordingly, leflunomide could be used as a new treatment option for patients with known MEN1 germline mutation and associated endocrine disease. The aim of this study is, therefore, to evaluate the antitumor effect of leflunomide treatment on MEN1-associated tumors in patients with known MEN1-syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years) patients with known pathogenic or likely pathogenic MEN1-germline mutation and at least 1 associated tumor lesion OR hormonal syndrome

Exclusion Criteria:

* uncontrolled arterial hypertension, defined as blood pressure \>160/100 mmHg
* Impaired kidney function, defined as creatinine clearance \<50ml/min
* Impaired liver function, defined as bilirubin or liver transaminases \>3 times upper normal range
* Cytopenia, defined as one or several of the following: hemogloin \<100 g/l, leucopenia \<2x109/l, thrombocytopenia \<100x109/l