cyrilzakka/clinical-trials huggingface dataset:
The Effect of Cysteine, Tryptophan and Tyrosine Supplements on Breast Milk

The purpose of this project is to study the effect of dietary supplementation with a natural health product (NHP) with a focus on its effects on its levels in breast milk.

The effect of oral cysteine on its levels in breast milk and plasma will be measured in breast feeding mothers.

The investigators will not be studying tryptophan and tyrosine in this study. The title is an overview title left over from other past studies (but the investigators are only assessing cysteine at this time).

Eligibility Criteria:
Inclusion Criteria:

* Subjects would be healthy mothers who are breastfeeding at the moment, but plan to stop at the time of study
* The subject, as reported, should be in a good health
* The subject is not taking any medication
* The subject is not taking any investigational medicinal product within 8 weeks prior to dosing
* The subject does not have any known hypersensitivity to components in the proposed treatment
* The subject does not have a history of severe drug allergy or drug hypersensitivity

Other general medical requirements for inclusion:

* Age 18 to 45
* BMI 19 to 40 (kg/m2)
* Resting pulse between 45 and 100 bpm
* Systolic blood pressure between 91 and 139 mmHg (inclusive)
* Diastolic blood pressure between 51 and 90 mmHg (inclusive)
* Orthostatic blood pressure change \<20 mmHg (based on the difference between supine and standing (1 minute) systolic blood pressure)
* The subject is in good health based on their report and answer to general health questionnaire

Exclusion Criteria:

* The subject has taken any investigational medicinal product within 8 weeks prior to dosing
* The subject is pregnant (based upon urine pregnancy test at time of screening and day of supplement intake)
* The subject has known hypersensitivity to components in the proposed treatment or to related compounds
* The subject has a history of severe drug allergy or drug hypersensitivity involving an anaphylactic reaction i.e. shortness of breath and/or reduced blood pressure
* Subjects who are smoking more than one package of cigarette per day will be excluded from the study
* The subject decides to breastfeed the infant on the study day
Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder

Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and brainstem.

Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so-called "reward system".

A strong link was found between these two disorders and therefore the investigators believe that RBD is associated with impaired reward system.

The main objective of this study is to evaluate differences in brain activation between PD patients with and without RBD.

The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment.

Type of study: Prospective, case control study.

Number of centers: 2 (Clermont-Ferrand and Vichy)

Patients :

The study will be performed in 75 subjects (25 PD patients with RBD, 25 PD patients without RBD and 25 healthy volunteers, age-and sex-matched without any contraindications to perform an MRI)

Study Performance :

During the first visit (J0, inclusion visit, 3 hours), each subject will perform a clinical and neurological examination (MDS-Unified Parkinson Disease Rating scale (MDS-UPDRS)) and neuropsychological assessment (depression by the Beck Depression Inventory (BDI); apathy by the Lille Apathy Rating Scale (LARS), impulsivity by the Urgency, lack of Premeditation, lack of Perseverance, Sensation Seeking scale (UPPS)) Eligible patients will be welcomed in a subsequent visit at the MRI department for the functional MRI (J0+1week, 1 hour). This session will be of about 45 minutes. The reward system was explored using an experimental task during functional Magnetic Resonance Imaging (fMRI). The name of this task is the"monetary incentive delay task".

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease (UK Parkinson's Disease Society Brain Bank Criteria)
* men or women 45 to 80 years old
* diagnosis of RBD made with polysomnographic recording

Exclusion Criteria:

* Previous history of psychosis or psychiatric disease
* History of stroke or vascular lesion on MRI.
* pregnant women
A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus

The purpose of this trial is to evaluate the effect of a single PPC-5650 dose in a human pain model including multimodal (mechanical, thermal, electrical, chemical) stimulations of the esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent before any study specific procedures
* Able to read and understand Danish.
* Healthy i.e. no history of chronic or recurrent pain rewarding diseases
* Able to co-operate and tolerate the experimental procedures (as assessed in the training visit)
* No over the counter medication 24h before the three visits
* No medications in the study period
* BMI 18.5-35.0
* Caucasian
* No symptoms of Gastroesophageal reflux disease
* All men must use a safe method of contraception during the study period

Exclusion Criteria:

* Any clinically relevant abnormal values from the laboratory tests on hematology, clinical chemistry, and/or urine analyses, as judged by the investigator.
* Participation in any other clinical trial within three months prior to the training day.
* Alcohol or drug abuse.
* Mental illnesses
* Allergic to the active ingredient in the investigational medicinal product
Remote Ischemic Preconditioning Mechanism Study

This research is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not relieve all types of pain or may relieve pain only at doses that produce side effects and potential complications.

Although Remote Ischemic Preconditioning (RIPC) appears promising, there remain several unanswered questions about how it works. This research trial will help determine how RIPC may activate the bodies natural pain control system. The goals of this study are to see if RIPC has any effect 1) on a small area of skin that will be expose to a small amount of UV- B radiation (a mild sunburn), 2) on acute thermal heat temperatures that will be applied to skin, and 3) on the sunburn-like sensation to light touch after putting capsaicin cream (the active ingredient in hot chili peppers) on skin.

Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to three times. This procedure causes the body to increase its natural pain relief system that may help to decrease the amount of postsurgical pain.

The purpose of this pilot study is to determine whether RIPC effects peripheral sensitization, central sensitization or both and determine effect size since there is no data regarding the presumed effect. These issues cannot be easily sorted out in patients experiencing postoperative pain and hypersensitivity, since surgery affects both components. In order to address this purpose the investigators will examine, in healthy volunteers, the effect of RIPC on a manipulation which generates hypersensitivity by an exclusive peripheral mechanism (ultraviolet B (UV-B) burn) and a manipulation which generates hypersensitivity by an exclusive central mechanism (topical capsaicin). Understanding the sites at which RIPC reduces the amplification of pain after injury will be useful in determining where it would be most logically applied clinically and in guiding preclinical mechanistic studies.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers of both sexes ASA 1 or II classification
* between the ages of 18-55
* weighing less than 250 pounds
* without chronic pain
* not taking analgesics
* off caffeine for 2 days.

Exclusion Criteria:

* pregnancy
* allergy to capsaicin
* lower extremity vascular insufficiency
* active treatment for DVT
* severe thigh pain
* taking psychotropic medications, including anti-depressants.
Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion

The are 2 principal goals in this study:

1. To measure plasma copeptin levels in healthy subjects and to correlate them with plasma AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states.
2. To measure plasma copeptin concentrations in patients with chronic renal failure under the same conditions described above, in order to characterize the impact of renal function on circulating copeptin levels in correlation to plasma AVP and urine osmolality.


Eligibility Criteria:
Inclusion Criteria:

* chronic renal failure grade I through IV
* healthy age-matched controls

Exclusion Criteria:

* chronic renal failure grade V
* heart failure
* liver disease
* nephrotic syndrome
* anemia (hemoglobin level \< 100 g/L)
* uncontrolled hypertension (systolic BP \> 160 mmHg; diastolic BP \> 95 mm Hg)
* coexisting severe disease
* known thyroid disease
* known hypocortisolism
* known hypercortisolism
* known diabetes insipidus
* pregnancy
* lactation
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)

This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.


Eligibility Criteria:
Inclusion criteria:

* Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening.
* Documented presence of abnormal alanine aminotransferase (ALT) (1.3 - 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease.

Exclusion criteria:

* Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.
Impact of a Multidisciplinary Assessment in Day Hospitalization Versus Standard Care on the Deployment of Supportive Oncology Care Recommended by the Personalized Post-cancer Plan in Patients at the End of Initial Treatment for Gynecological Ovarian and Endometrial Cancer Endometrial Cancer

This project proposes a structuring of supportive oncology care for the recovery phase after gynecological cancer (ovarian/trope/peritoneum or endometrium). Patients will be divided into three groups based on the identification of oncological support care needs. Patients with supportive oncology care needs will be randomized into two groups: the experimental group, receiving a personalized post-cancer plan with a multidisciplinary assessment of supportive oncology care needs in a day hospital and coordinated follow-up by the referring study nurse, and the control group, receiving a personalized post-cancer plan without a day hospital. Randomization will be stratified according to tumor location (ovary vs. endometrium), use of supportive oncology care during treatment, and treatment center. Patients with no need for supportive oncology care will be followed in an observational cohort. The main objective is to identify and manage the supportive oncology care needs of patients in remission from endometrial or ovarian cancer to improve their quality of life and post-treatment follow-up. A medico-economic analysis will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years
* Patients in remission from first-line treatment of endometrial or ovarian/tumor/peritoneal cancer.
* Patient who has completed her initial treatment; patients on maintenance therapy are eligible.
* Fluency in French
* Patient with access to a telephone line
* Patient affiliated to a social security scheme
* Signature of informed consent prior to any specific study procedure

Exclusion Criteria:

* Any associated medical or psychiatric condition that could compromise the patient's ability to participate in the study
* Patient with locoregional or metastatic recurrence
* Patient deprived of liberty, under guardianship or curatorship
* Simultaneous participation in a therapeutic clinical trial
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.


Eligibility Criteria:
Inclusion Criteria:

* between 1 and 12 months old
* having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
* whose parent(s) signed the informed consent form

Exclusion Criteria:

* Infants mainly or exclusively breastfed,
* Infants having a weight at inclusion \< 2500g,
* Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
* Infants fed an amino acid based formula
* Infants who had an anaphylactic reaction in the past,
Prospective Single-center Study About the Use of ctDNA in the Management of Patients With Tumors of the Gastrointestinal Tract

This study will evaluate the use of ctDNA in the clinical management of patients with tumors of the gastrointestinal tract.

This is a a prospective observational single-center study; it is a spontaneous study, not sponsored by pharmaceutical companies, and does not involve the use of experimental drugs. The study involves a collection of data, carried out while protecting the anonymity and personal information of individual patients suffering from neoplasms of the gastrointestinal tract, the execution of peripheral blood samples and the collection of faecal material at pre-determined times -points. Circulating biomarkers (as ctDNA) will be evaluated in these samples, in order to optimize both the diagnostic and therapeutic processes of patients with tumors of the gastrointestinal tract.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* PS ECOG \<2;
* Histological diagnosis of gastrointestinal cancer: esophageal, gastric, intestinal, pancreatic, biliary tract neoplasms;
* Radiological evidence of resectable/locally advanced/metastatic disease on the date of signing the written informed consent;
* Adequate organ and function;
* Availability of tumor histological material.

Exclusion Criteria:

* No histological diagnosis of neoplasia of the gastrointestinal tract.
* No written informed consent.
Screening and Treatment of SAHS in Patients With Acute Ischemic Stroke

Ischemic stroke is a kind of common disease with great harm. In acute stage of stroke there is sharply increasing morbidity of sleep apnea hypopnea syndrome. Our suppose that treatment with noninvasive ventilation for patients with acute ischemic stroke should improve the functional prognosis（measuring with 90d modified Rankin score）.

In acute state of ischemic stroke，if patients with sleep apnea hypopnea syndrome may need additional respiratory management such bi-level positive airway pressure.We supposed the patients with stroke can take benefit of functional recovery form bi-level positive airway pressure. We choose the patients who suffered ischemic stroke in 48 hours ，then evaluate the respiratory status. Stroke patients who were diagnosed as sleep apnea hypopnea syndrome will accept additional treatment with bi-level positive airway pressure for 7 night（per night 6 hours）.Then the modified Rankin scale score and NIHSS will be recorded at 30 days and 90 days after stroke.

Eligibility Criteria:
Inclusion Criteria:

* ischeic stroke onset within 48 hours , NIHSS:4-15

Exclusion Criteria:

* mRs\>2 before onset of enrollment severe hepatic renal insufficiency cancer in reached an advanced stage
Text Reminders to Immunize in a Managed Care Organization

The purpose of the study is to evaluate the effectiveness of a managed care-based HPV vaccination reminder/recall system using a randomized controlled trial (RCT) across diverse practices and patient populations. The trial will measure the effectiveness of text messaging reminder/recall on (a) improving initiation and (b) completion rate of the HPV vaccine series; (c) decreasing the time between vaccine doses; and (d) improving rates of preventive visits for adolescents

The hypotheses are that text-messaged reminders to parents of adolescents will result in improved rates of HPV vaccine series initiation, HPV vaccine series completion, will decrease the intervals between vaccine doses and will improve rates of preventive care among adolescents. Parents receiving specific text-messaged reminders about services (i.e. HPV vaccination, well child care visits) for which their adolescent is due will be compared to a control group of parents receiving general health tips through text messages.

The study setting is western New York State and the Southern Tier of New York State (15 counties total). Investigators will work with the Monroe Plan for Medical Care, an IPA-model managed care organization (MCO) that serves Medicaid managed care and SCHIP enrollees. The MCO will conduct regular reviews of insurance claims data and the New York State Immunization Information System of adolescents ages 11-\<16 years. Parents (all over 18 years of age) of adolescents will receive the texted messages on their phones.

There are no enrollment restrictions based upon race or ethnic origin. The inclusion criteria are that the adolescents are a) enrolled in Medicaid or SCHIP through the Monroe Plan, b) have been enrolled greater than 6 months with the Monroe Plan (in order to have sufficient claims data to determine whether they are due for a well child care visit or recommended immunizations), c) the Monroe Plan has received their consent to send preventive care text messages, d) their child attend a primary care practice that has agreed to participate and d) they are between the ages of 11-\<16 years at the start of the study.

The key independent measure is group allocation (intervention vs. control); an intention-to-treat strategy will be used to assess the effectiveness of text messaging reminders. Key outcome measures will be: 1) receipt of 0, 1, 2 or 3 doses of HPV vaccine 2) interval (in days) between doses and 3) having a preventive visit in the 6 month period.

Eligibility Criteria:
Inclusion Criteria:

* 11-\<18 years
* Member of MCO for \>6 months
* Opted in to receive texted reminders from MCO

Exclusion Criteria:
Attitudes and Feelings of Doctors Caring for Their Colleagues: a Qualitative Study in Picardy

The sick doctor is a patient apart. His right of prescription and his knowledge of semiology easily lead him to self-medication.

The sick doctor is a patient apart. His right of prescription and his knowledge of semiology easily lead him to self-medication. Several factors linked to his profession may also lead to a delay in care: overworking with schedules that are not compatible to organize follow-up, poor access to prevention or occupational medicine for liberal doctors but also modesty And ashamed of being sick (and especially unfit to heal). Specialized centers and specific training courses concerning burnout, addictions and psychiatric pathologies of doctors are currently emerging.

To look after a colleague also seems to imply certain specificities like the sharing of knowledge or the medical vocabulary. The physician-patient relationship may seem easier, but it can also lead to confusion of roles and create ambiguity. In this case, the doctor may feel too close to the doctor-patient to maintain his objectivity and to treat him properly. In the same way, the relationship of trust can be altered by sharing medical knowledge, communication techniques or confidence building which can thus lose their effectiveness.

This physician-caregiver relationship has already been the subject of some qualitative research demonstrating the difficulty from the point of view of the treated. The feelings and attitudes of the doctor caring for his colleague remains a field very little studied. The research hypothesis is that there are specificities to this relationship.

Eligibility Criteria:
Inclusion Criteria:

* Practicing general practitioners, registered with the Order, caring for or having treated other doctors whatever their specialties

Exclusion Criteria:

* No
Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

Research Hypothesis: Ipilimumab (an antibody that blocks negative signals to T cells) administered alone or in combination with a pancreatic cancer vaccine (allogeneic pancreatic tumor cells transfected with a GM-CSF gene), has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.

Primary Objective: To determine the safety profile of ipilimumab alone or in combination with a pancreatic cancer vaccine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.

Secondary Objectives:

* To estimate overall survival (OS) which will serve as the primary efficacy signal.
* To explore an association of T cell responses and immunological responses with OS in patients receiving treatment.
* To estimate overall response rate (ORR), immune related best overall response rate (irBOR), progression free survival (PFS), and duration of response in patients receiving treatment.
* To explore an association between immune-related adverse events (IRAEs) and ORR.
* To measure tumor marker kinetics (CA 19-9) in patients receiving treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Documented cancer of the pancreas who have failed (or are not candidates for) standard therapy
2. ECOG Performance Status of 0 to 1
3. Adequate organ function as defined by study-specified laboratory tests
4. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
5. Signed informed consent form
6. Willing and able to comply with study procedures

Exclusion Criteria:

1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
2. Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
3. Systemically active steroids
4. Another investigational product within 28 days prior to receiving study drug
5. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
6. Infection with HIV, hepatitis B or C at screening
7. Pregnant or lactating
8. Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures