cyrilzakka/clinical-trials huggingface dataset:
Altered Neural Pain Empathic Reactivity in NSSI Adolescents

Nonsuicidal self-injury (NSSI) is defined as direct, deliberate bodily harm without suicidal intention. In recent years, growing evidence suggests that NSSI has become a worldwide public health issue. People with NSSI behaviors, especially adolescents, commonly exhibit emotion-related and interpersonal problems. Pain empathy represents an essential basal domain of socio-emotional processing and refers to the ability to empathize, connect and share with others' pain. However, altered empathic processing has not been systematically examined in adolescents with NSSI. To this end, the current functional magnetic resonance imaging (fMRI) study will recruit one group of NSSI adolescents (n=40) and one healthy control (HC) group (n=40), to compare their neural activity regarding pain empathy processing, which is measured by blood oxygenation level-dependent (BOLD) fMRI. The investigators included conditions of physical pain empathy (stimuli depicting noxious stimulation to the limbs) and affective pain empathy (stimuli depicting faces expressing pain) as well as corresponding control stimuli. The investigators hypothesize that compared to HC, NSSI adolescents show increased empathic reactivity to physical pain stimuli in salience and arousal related brain regions but decreased empathic reactivity to affective pain empathic stimuli.


Eligibility Criteria:
Inclusion Criteria:

* 15-18 years
* right-handed
* normal or corrected normal visual acuity
* meet the proposed DSM-5 frequency criteria (e.g., ≥5 days of NSSI behaviors in the past year)

Exclusion Criteria:

* diagnosis of borderline personality disorder, major depressive disorder, other
* psychiatric disorders, etc.
* high suicidal risk
* recent use of medications that can affect neural activity
* have received or are receiving Dialectical Behavior Therapy (DBT) other treatment for emotional problems within the past 6 months
* have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning)
Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With Type 2 Diabetes Mellitus (DM)

The purpose of this study is to assess the impact of home-delivered Medical Nutrition Therapy on clinical outcomes for persons with diabetes. The primary outcomes of this studies include A1c (A1C), blood glucose, blood pressure, Body Mass Index, lipid levels and other measures of disease progression and management as well as costs of medical care provided throughout the intervention period.

Data collected as a result of this project will be evaluated in aggregate to demonstrate the potential impacts on health and medical costs available through this type of intervention, with long-term goals of reducing disability and deaths due to chronic disease.

Eligibility Criteria:
Inclusion Criteria:

1. African-American subjects
2. Males or females 65 - 85 years of age
3. Body mass index (BMI) equal to or greater than 30 kg/m2
4. Fasting blood glucose less than 300 mg/dL and HbA1c less than 9.0%
5. Ability to understand and be willing to adhere to the study protocol
6. A known history of type 2 diabetes mellitus greater than 3 months, receiving either diet alone or oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).

Exclusion Criteria:

1. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state.
2. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine greater than 3.0 mg/dL.
3. Mental condition rendering the subject unable to understand the scope of the study.
InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation.

As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly interested in patients with Bone and Joint Infections (BJI). These patients are treated with antibiotics having significant consequences on their intestinal flora, causing intestinal discomfort, which can be manifested by diarrhea.

MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI). The objective of this study is to follow patients with treated BJI in order to characterize intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota Transplantation (aFMT) intervention.

To do this, patients will be monitored according to the current CRIOAc recommendations, with the aim of taking biological samples from patients at the same time as scheduled visits, routine monitoring patients. Only one additional consultation will be carried out 15 days after stopping the antibiotics in order to better evaluate the dysbiosis evolution.

Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up consultations over a period of 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Consenting subjects with BJI (native or material related BJI) at participating sites who are being treated with antibiotics as part of their standard treatment procedure will be enrolled
* The subject is willing, able to understand and comply to the protocol requirement
* More than 18-years-old
* Subject is suspected for implanted or native BJI and is eligible for antibiotics treatment
* Subject signed Inform Consent Form

Exclusion Criteria:

* Pregnancy
* Severe disease with a life expectancy \< 3 months
* Antibiotherapy in the 14 days before inclusion in the study
* Patient non-affiliated to health care system
* Patient under the power of law
* Guardianship, curators patients
Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies

Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers, may potentially have a delay in the adjuvant therapy when faced with this complication.

Studies performed in this groups of patients report a readmission rate of 17-21% for dehydration.

Loperamide has been shown to significantly decrease the daily volume of weight of stool in these patients.

The purpose of this study is to establish whether loperamide given at 4mg three times daily for 14 days from day of discharge empirically decreases 30 days readmission rate for dehydration.

The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the readmission rates, that severity of dehydration will be decreased.


Eligibility Criteria:
Inclusion Criteria:

1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
2. Males or females, age 18 and older at the time of study screening;
3. American Society of Anesthesiologists (ASA) Class I-III (Appendix III) undergoing elective surgery

Exclusion Criteria:

1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
2. American Society of Anesthesiologists (ASA) Class IV or V; emergency surgeries
3. Children \<18
4. Pregnant patients
5. Patients who have intra-abdominal sepsis or partial or intermittent bowel obstruction or enteritis
6. Patients who are on long term steroids, opioids or antidiarrheals pre operatively
7. Patients who are administered pro kinetics eg. Metoclopramide
8. Patients with recurrent disease in their small bowel - Crohn's disease, or previous irradiated pelvis resulting in irradiation bowel disease
9. End ileostomies
WHEN DO WE HAVE to PERFORM CARDIAC MAGNETIC RESONANCE in PATIENTS REFERRED for PREMATURE VENTRICULAR COMPLEXES by THEIR CARDIOLOGISTS

Premature ventricular complexes (PVC) are a common entity affecting approximatively 20% of the general population. It can be discovered incidentally on electrocardiogram (ECG) or associated with symptoms with a wide spectrum from palpitations, chest pain, to syncope.

The initial and non invasive assessment includes holter ECG monitoring, a transthoracic echocardiography (TTE) and an exercise stress test to rule out structural heart disease (SHD), and referred to as benign or "idiopathic" ventricular arrhythmias (IVA).

However, these exams may fail to identify subtle myocardial abnormalities such as arrhythmogenic right ventricle dysplasia (ARVD), apical hypertrophic cardiomyopathy, healed myocarditis, ischemic or non-ischemic cardiomyopathies.

Cardiac magnetic resonance (CMR) imaging is the gold standard modality to assess regional and global ventricular function. It is also a unique modality to non-invasively detect myocardial edema, myocardial fatty replacement, focal and diffuse fibrosis and could potentially identify SHD in patients with PVC.

However, the role of CMR is uncertain, recommended in case of atypical presentation or when the initial assessment can't exclude a cardiomyopathy (recommendations class IIa).

This study sought to determine whether and when CMR can be performed to provide diagnosis or prognostic information complementary to initial assessment in patients referred for PVC by their cardiologists.


Eligibility Criteria:
Inclusion Criteria:

* patients with PVC who have performed ECG, Holter ECG and a CMR

Exclusion Criteria:

* patient showing opposition tu use his personal data for the reseach,
* patient unable to express his opposition,
* patient deprived of liberty,
* patient with language issues (speaking or writing French)
Ingestion of Lipids and Changes in Cerebral Blood Flow of People With Obesity

This study aims to determine changes in cerebral blood flow of people with obesity after the ingestion of fat.


Eligibility Criteria:
Inclusion Criteria:

* Live in Ribeirão Preto, São Paulo - Brazil.
* Regular menses.
* Weight inferior than 120 Kg and body mass index (BMI) between 30 and 40 kg/m2, for the group with obesity.
* BMI between 18,5 and 24,9 kg/m2, for the group without obesity.

Exclusion Criteria:

* High blood pressure, diabetes, glucose intolerance or impaired fasting glycemia, metabolic syndrome, hypothyroidism and any kidney, liver, heart or neurologic disease.
* Psychiatric disorders, alcoholism, smoking or illicit drug abuse.
* Pregnancy or desire to be pregnant
* Use of medications, excluding contraceptives.
* Contraindication for magnetic resonance imaging.
* Be in treatment for obesity.
Observational Study on Metabolism and Psychopathology in Transsexual Patients

Gender identity disorders (also known as transsexualism) is defined as a condition in which a person with apparently normal somatic sexual differentiation is convinced that he or she is actually a member of the other sex. Most patients therefore undergo so called cross-sex hormone treatment. Treatment protocols follow international consensus statements but vary considerably between different centres and countries since no prospective and controlled trials are available on this subject and recommendations are mainly based on retrospective data analysis and experience of the individual centres. Applying high doses of testosterone to biological females and vice versa high doses of estradiol to biological males definitely impacts myriads of body functions, from which it has to be assumed that only a minority has already been elucidated so far. Especially in male-to-female-transsexuals there seems to be an increased risk for the development of mood disorders and cardiometabolic comorbidities. In this multi-center observational study we want to investigate, if there is any difference with regard to these outcomes, according to the varying standards of cross-sex hormone treatment between the different centers. Different outcome measures described below will be assessed each time during routine visits at the different centers.


Eligibility Criteria:
Inclusion criteria

* Patients with the diagnosis gender identity disorder (ICD-10: F64.0), who have given written informed consent following adequate oral and written information.

General Exclusion criteria

* Patients below the age of 18
* Legally incompetent patients
* Prior intake of cross-sex hormones
* Missing written informed consent
* Intersexuality
The Impact of Lifestyle Behaviors on In Vitro Fertilization (IVF) Outcome

Many women undergoing in vitro fertilization (IVF) ask their doctor if there are any behaviors they should avoid, or any behaviors they should emphasize during their IVF cycle. This study examines the effects of health habits surrounding exercise, smoking, alcohol, sleep, caffeine, herbal medications, acupuncture, and diet on pregnancy rates during IVF cycles. The purpose of this study is to determine if lifestyle behaviors have a significant impact on pregnancy rates during treatment with IVF.

This is an observational study conducted at a private academically-affiliated infertility clinic and includes 118 women ages 44 and below scheduled to undergo IVF treatment. All subjects were asked to complete a health history survey at the time of enrollment and a daily survey during each day of their IVF cycle. The primary outcome is clinical pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

* Female Boston IVF infertility patient undergoing IVF treatment
* Age 18-44 years
* Able to read, understand and sign the informed consent in English
* Willing and able to comply with study requirements
* Must be well versed in using a personal computer and the internet and must have access to an internet-connected computer seven days per week
SPECT/CT in Endocrine and Neuroendocrine Tumors

The value of fusion of functional and anatomical data has been described using several fusion techniques for various nuclear medicine procedures and morphologic imaging modalities (SPECT-CT, SPECT-MRI, Coincidence-CT). We hypothesize that NM -CT data has advantages over the data obtained using separately performed NM study and conventional anatomic imaging as CT. We hypothesize that more accurate localization of the radio-isotope activity on NM images will improve diagnostic accuracy and will have an impact on patient management:

Improved accuracy of NM study will improve tumor localization, the evaluation of the extent of disease and the post therapy follow up.

It will direct other diagnostic procedures to lesions otherwise undetected, or exclude the need for more invasive procedures. It can also guide invasive procedures and radiation-therapy planning, thus improving therapy results and avoiding unnecessary treatment-related side effects.

The value of fusion of functional and anatomical data has been described using several fusion techniques for various nuclear medicine procedures and morphologic imaging modalities (SPECT-CT, SPECT-MRI, Coincidence-CT). We hypothesize that NM -CT data has advantages over the data obtained using separately performed NM study and conventional anatomic imaging as CT. We hypothesize that more accurate localization of the radio-isotope activity on NM images will improve diagnostic accuracy and will have an impact on patient management:

Improved accuracy of NM study will improve tumor localization, the evaluation of the extent of disease and the post therapy follow up.

It will direct other diagnostic procedures to lesions otherwise undetected, or exclude the need for more invasive procedures. It can also guide invasive procedures and radiation-therapy planning, thus improving therapy results and avoiding unnecessary treatment-related side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patient referred for NM scintigraphy to assess the presence of endocrine or neuroendocrine tumors.
* Patient signed informed consent

Exclusion Criteria:

* The study will not be performed in pregnant or lactating women.
* Patient will not be able or willing to tolerate the scan until its completion.
Individual and Environmental Risk Factors for Unscheduled Hospitalizations of Elderly People

The elderly are weakened by the accumulation of chronic diseases. Their acute decompensation often leads to unscheduled hospitalization, which constitutes a breach of care with often serious consequences in terms of morbidity and mortality. Few studies have identified all the risk factors for unscheduled hospitalization in the very elderly. This project deals with the impact of air pollution on the very elderly as a source of physiological decompensations leading to unscheduled hospitalizations, in association with other individual and environmental risk factors. It complements the Rieho cohort that followed 973 elderly people on the same objective and enriches it with the use of sensors measuring the peri-individual atmospheric environment.

In order to facilitate the perspective and scientific valorization of these data, the experimental design and population characteristics reproduce those of the RIEHO cohort (Coordinator P Aegerter), which aims to identify individual and environmental risk factors for unscheduled hospitalization of the elderly and included 973 people over 80 years of age with a 2-year follow-up, closed in early 2017. Indeed, the workforce mobilized in the Rieho-C study is undersized to measure an association between air quality and a major health impact (hospitalization or death), this objective can only be achieved by adding Rieho-C data to those of Rieho.

Eligibility Criteria:
Inclusion Criteria:

* Person over 80 years of age consulting in the geriatrics department of Ste-Périne Hospital (Gerontology Consultations, Dr A Hiance- Delahaye, Head of Department Pr J Ankri. Paris XVI), for a standardised geriatric assessment, for any reason, if it does not result in immediate or foreseeable hospitalisation within 2 weeks,
* Living at home or in a residence,
* Subject living in Ile-de-France,
* Subject speaking French; this study requires minimal participation of subjects (wearing sensors, qualitative interview) that does not appear compatible with comprehension problems,
* MMSE Score ≥ 15
* ADL score ≥ 3
* Affiliated with a health insurance plan or eligible,
* Person who has signed an informed and written consent.

Exclusion Criteria:

* Subject whose state of health requires hospitalization within two weeks,
* Subject under guardianship or curatorship,
* Subject living in collective housing (retirement home) or entering an institution within 2 weeks,
* Abundant thoracic hair causing poor contact of the ECG electrodes of the physiological sensor,
* Rejection of patient's contact information, refuses to answer questionnaires and follow-up visits, or refuses to wear sensors, Impossibility, during the initial assessment, to establish at least telephone contact with the caregiver when he or she organizes the home visit,
* Subject already included in the study.
Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis

The purpose of the trial is to compare the effects of intra-dialytic low-frequency electrical muscle stimulation and intra-dialytic cycling, with usual care haemodialysis without exercise training.

End stage renal disease is associated with reduced functional capacity. Dynamic exercise training i.e. cycling, performed between dialysis sessions or during dialysis (intra-dialytic) can be effective in improving functional capacity and quality of life. However, many patients are unable to engage in intra-dialytic cycling due to limiting comorbidities. Other exercise modalities should be considered. Low-frequency electrical muscle stimulation of the quadriceps is well tolerated and may improve functional capacity in clinical populations.

The trial is a longitudinal, randomised controlled trial. Participants will be randomly allocated to 10 weeks of 1) intra-dialytic low-frequency electrical muscle stimulation, 2) intra-dialytic cycling, or 3) usual care haemodialysis without exercise training. Outcomes will be assessed at baseline and 10 weeks by assessors blinded to group allocation.

Eligibility Criteria:
Inclusion Criteria:

1. On haemodialysis for at least 3months
2. On 3 times 4 hours of dialysis per week
3. Urea reduction rate of at least 65% during the three months before enrolment
4. Age 18 years or older
5. Able to complete the exercise test and exercise training
6. Able to provide informed consent
7. Life expectancy of more than 6 months according to clinical assessment

Exclusion Criteria:

1. Clinically significant valvular insufficiency
2. Clinically significant dysrythmia
3. Uncontrolled blood pressure: systolic \> 160, diastolic \>95 during the months before enrolment
4. Excessive fluid accumulation between dialysis sessions (\>3 liters), more than twice pulmonary edema over 3 months before enrolment deemed to be due to excess fluid intake
5. Haemoglobin unstable and below 9.0
6. Ischemic cardiac event or intervention in the last 3 months
7. Clinically significant, still active inflammatory or malignant process
8. Pacemaker or cardiac device (contraindicated for bioelectrical impedance)
9. Planned kidney transplant during study period.
Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery

The MostCare system, thanks to the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy), provides new hemodynamic parameters of the cardiovascular system. The PRAM method is a noncalibrated pulse contour method which requires only an arterial line (radial or femoral). This method has been validated in various clinical conditions. Among the collected parameters, some are well known and used daily care in Intensive Care Unit (ICU), i.e. cardiac output (CO), arterial pressure, heart rate, stroke volume (SV). Others such as arterial elastance (Ea) or dicrotic pressure are more recent and merit further investigation to determine their interest in clinical practice. To date, it is rarely used to adapt therapies, mostly because of a lack of knowledge regarding the evolution of these parameters.

The aim of this study is to analyze the relationship between the evolution of Arterial Elastance and fluid responsiveness after a 250 mL fluid challenge of crystalloids in 5 minutes in patients with either septic shock or in the postoperative course of a major vascular surgery.

Patients will be considered fluid responders if an increase \>10% of the stroke volume is observed .


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years
* Septic shock (according to Sepsis-3 definition) or patients who underwent elective or emergent abdominal aortic surgery
* Invasive blood pressure (radial or femoral) and Mostcare monitoring
* Stroke volume between 20 and 50 mL/beat on the Mostcare system
* Indication for a fluid challenge: hypotension (Mean arterial pressure under 65mmHg) or oliguria (urine flow rate \< 0,5mL/kg/h for more than 12h), mottling, hyperlactatemia \> 2 mmol/l

Exclusion Criteria:

* Age \<18 years
* Cardiac arrhythmia
* Arterial wave form distortion
* Inappropriate identification of the dicrotic notch for any reason
* Refuse to consent to the study