cyrilzakka/clinical-trials huggingface dataset:
Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa Mental

Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neural correlates of self-recognition in Anorexia Nervosa. Patients are hypothesized to activate the self-recognition network when seeing images of a fatter body shape than their own.

Patients suffering from Anorexia Nervosa and control subjects (matched by age and study level) are recruited in medical care facilities in Lille's Metropolis. They are asked to identify their body shape when being presented with 3 different stimuli, i.e.real (RBS), estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to identify modifications in the self body-recognition network.

Eligibility Criteria:
Inclusion Criteria:

* Providing informed, dated and signed consent (for minors, consent must be signed by both parents)
* With medical insurance
* With normal vision
* Only for the AN Group : Diagnosis of Anorexia Nervosa (AN) restrictive for at least one year and with a Body Masse index (BMI) between 14 and 18
* Only for the control Group : BMI between 18 and 25 and without any psychiatric disorder

Exclusion Criteria:

* Pregnant or breast-feeding women
* With antecedent or current neurologic disease
* With antecedent or current ophthalmologic disease
* Contraindication for IRMf
Dynamic Neural Mechanisms of Audiovisual Speech Perception

Understanding speech is one of the most important functions of the human brain. We use information from both the auditory modality (the voice the of person we are talking to) and the visual modality (the facial movements of the person we are talking to) to understand speech. We will use intracranial encephalography to study the organization and operation of the brain during audiovisual speech perception.


Eligibility Criteria:
Inclusion Criteria:

* must be undergoing neurosurgery for the treatment of a brain disorder

Exclusion Criteria:

* must have corrected-to-normal vision and hearing
Nasotracheal Intubation in Critically Ill.

The aim of this prospective randomized trail is to compare nasotracheal versus orotracheal intubation in critically ill patients. We aim to study:

* required sedation depth
* rate of spontaneous breathing
* extend and possibility of physiotherapy
* vasopressor and sedative drug doses

Participants are randomized 1:1 to receive either nasotracheal or orotracheal intubation.

In the intensive care unit endotracheal intubation and consecutive mechanical ventilation are required for different surgical procedures, examinations and interventions in the ICU or due to respiratory insufficiency. Commonly, intubation is performed orotracheally by direct laryngoscopy after preoxygenation and administration of narcotics and a muscle relaxant. When using this technique sedation is often necessary for tolerance of the orotracheal tube. To avoid the adverse side effects of sedation and mechanical ventilation as for example hypotension, barotrauma, ventilator associated pneumonia, etc., intubation via a nasotracheal approach might be favorable. Retrospective data show that nasotracheal intubation is associated with fewer sedatives, vasopressors, and a higher rate of spontaneous breathing. As there is a paucity of data concerning the use of nasotracheal intubation in the intensive care setting the investigators aim to compare the use of orotracheal and nasotracheal tubes in a prospective randomized trial, using sedation depth as primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patients requiring tracheal intubation during their intensive care stay.

Exclusion Criteria:

* orotracheal or nasotracheal route of intubation technically not possible (e.g. confirmed indication for awake fiberoptic intubation due to expected difficult airway)
* tracheal intubation indicated for deep sedation (e.g. treatment of elevated intracranial pressure)
* thrombocytopenia \< 50/nl or other risk factors for bleeding
* pregnant or breastfeeding women
* denial of consent
Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV

The purpose of this study is to see if individuals with HIV-infection, particularly those with increased belly fat, have abnormalities in the renin angiotensin aldosterone axis. Renin, angiotensin, and aldosterone are hormones that regulate salt and water balance in the body, and they may also have effects on sugar metabolism and cardiovascular health. There is some evidence that individuals with HIV-associated abdominal fat accumulation may have increased aldosterone, which may contribute to abnormalities in sugar metabolism and increased cardiovascular disease seen in HIV. The purpose of this study is the measure renin, angiotensin, and aldosterone activity, as well as other hormonal axes, in people with and without HIV infection, and with and without increased belly fat. The investigators hypothesize that aldosterone will be increased in HIV-infected individuals compared to those without HIV-infection, and that aldosterone will be further increased in HIV-infected individuals with increased abdominal fat compared to those without abdominal fat accumulation.


Eligibility Criteria:
Inclusion Criteria:

1. Stable use of antiretroviral therapy for at least 3 months (HIV group)
2. Age ≥ 18 and ≤ 65 years of age

Exclusion Criteria:

1. Antihypertensive use, including angiotensin converting enzyme inhibitors or angiotensin II receptor blocker use, diuretics, beta-blockers, calcium-channel blockers, potassium supplements, and spironolactone; and/or blood pressure (BP) \>140/90 at screen
2. Current or recent steroid use within last 2 months.
3. Known diabetes and/or use of antidiabetic medications
4. Creatinine \> 1.5 mg/dL
5. Potassium (K) \> 5.5 mEq/L
6. Hemoglobin (Hgb) \< 11.0 mg/dL
7. Alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN)
8. Thyroid disease/abnormal thyroid stimulating hormone (TSH)
9. Significant electrocardiographic abnormalities at screen such as heart block or ischemia
10. History of congestive heart failure, stroke, myocardial infarction, or known coronary artery disease (CAD)
11. For women: Pregnant or actively seeking pregnancy, or breastfeeding
12. Estrogen, progestational derivative, growth hormone (GH), growth hormone releasing hormone (GHRH) or ketoconazole use within 3 months.
13. Current viral, bacterial or other infections (excluding HIV)
14. Current cigarette smoker/use of nicotine (patch/gum) or current active substance abuse
Study to Evaluate the Performance of a Sustained Vacuum System

The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21 years or older;
* Undergoing mastectomy (uni or bilateral), axillary node resection, or inguinal node resection;
* Capable of providing informed consent.

Exclusion Criteria:

* Pregnant or lactating females;
* Patients on steroids or other immune modulators known to impact healing;
* Patients who are likely to not complete the study;
* Patients who, in the opinion of the investigator, are unlikely to comply with the protocol;
* Patients who have participated in this trial previously and who were withdrawn;
* Patients with known allergies to contacting materials (i.e. latex, metal, etc.);
* Patients who received neoadjuvant chemotherapy or radiotherapy within the last 3 weeks.
Concentration-Volume Relationship in Infraclavicular Block

This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomized into three groups. Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups

Although ultrasound guided infraclavicular nerve block is routinely used to provide anesthesia for almost all of the upper extremity surgeries, optimal volume and concentration of locak anesthetic to be administered is still a subject of debate. This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomly allocated into three groups. 81 patients (27 in each group) are planned to be enrolled in this study due to a power analysis performed (G-power ver 3.1). Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups Researchers who perform the block and assess the block quality and onset will be blinded to patients' groups. Patients will also be blinded to groups they are assigned.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for upper extremity surgery with infraclavicular nerve block

Exclusion Criteria:

* Patient Refusal
* Patients younger than 18
* Patients with known local anesthetic allergies
* Patients with a BMI\>30
* Diabetic Patients
* Uncooperated Patients
* Patients with coagulopathy or recieving anticoagulant therapy
* Skin infection on injection site
* Patients diagnosed with sepsis or bacteremia
* Physiologic and emotional lability
* Surgeries that are expected to last longer than 3 hours
Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib

This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by age, gender, and body weight to assess the effect of hepatic impairment on the pharmacokinetics of alectinib.


Eligibility Criteria:
Inclusion Criteria:

All Participants

* Body mass index between 18 to 35 kilograms per square meter (kg/m\^2) inclusive and weight greater than (\>) 50 kilograms (kg)
* Female participants must be surgically sterile or post-menopausal
* Male participants and their partners of child-bearing potential must be willing to use 2 effective methods of contraception, one of which must be a barrier method

Participants with Hepatic Impairment

- Documented chronic stable liver disease (Child-Pugh Class A, B or C)

Exclusion Criteria:

All Participants

* Pregnant or lactating women, males with female partners who are pregnant or lactating, or women of child bearing potential
* Positive test for drugs of abuse or alcohol
* Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to study drug administration
* History of hypersensitivity to any of the additives in the alectinib formulation
* Participants under judicial supervision, guardianship, or curatorship
* History of severe drug-related allergic reactions or drug-induced hepatotoxicity

Healthy Participants

* Use of any medications (prescription or over-the-counter), within 2 weeks or 5 half-lives (whichever longer) prior to study drug administration
* Use of any herbal supplements or any metabolic inducers within 4 weeks, or 5 half-lives (whichever is longer) prior to study drug administration

Participants with Hepatic Impairment

* Positive screening test for human immunodeficiency virus (HIV)
* History of liver transplantation
* Hepatocellular carcinoma or acute liver disease
* Severe ascites at screening or admission to the clinic
* Recent history (past 2 years) or current severe hepatic encephalopathy (Grade 3 or higher)
* Any evidence of progressive liver disease within the last 4 weeks
* Presence of surgically created or transjugular intrahepatic portal systemic shunts
A Trial of the Safety and Efficacy of Single-Dose Administration of ANB-010 in Subjects With Hemophilia A

The goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of ANB-010 in subjects with hemophilia A. The study will have a dose-escalation design with elements of phase I/II seamless adaptive design.

The study will be conducted in 2 stages:

Stage 1: pilot efficacy and safety study of different doses to select a potentially therapeutic dose for further study.

Stage 2: study of the efficacy and safety of ANB-010 at the selected potentially therapeutic dose.

The stage 1 design is typical of phase I clinical trials with a modified "3+3" design and dose escalation. Three subjects are to be sequentially included in each cohort, each of whom will recieved a pre-specified cohort dose of ANB-010 as a single inravenous infusion.

Subjects will be monitored for dose-limiting toxicity (DLT) events for 4 weeks after the drug infusion. The decision concerning dose escalation will be made at the Independent Data Monitoring Committee (IDMC) meetings.

At the second stage the main study period will include 6 subjects who will receive ANB-010 at the optimal dose selected based on the results of stage 1 data analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Male subjects aged ≥18 years at the time of signing the informed consent form.

3. Established diagnosis of hemophilia A with a documented history of endogenous FVIII activity ≤1% AND ≤2% at screening.

4. Therapy with FVIII concentrates for at least 150 exposure days.

Exclusion Criteria:

1. History of use of any gene therapy product.
2. Use of emicizumab within less than 6 months before the date of signing the ICF.
3. The presence of other blood or hematopoietic disorders other than hemophilia A.
4. Presence of AAV6 antibodies detected by ELISA.
5. BMI \<16 kg/m² or ≥35 kg/m².
6. Diagnosis of HIV infection.
7. HBV infection.
8. HCV infection.
9. Any active systemic infections or recurrent infections requiring systemic therapy at screening.
10. Any other disorders associated with severe immunodeficiency.
11. Relevant hepatic disorders or conditions that can be a symptom of existing liver disorder.
12. Malignancies with remission duration of less than 5 years at the time of signing the ICF, except for cured basal cell carcinoma.
Social Media and Breastfeeding Self Efficacy

This study aimed to determine the effect of breastfeeding support on women's breastfeeding self-efficacy via social media. This study was conducted maternity unit at a state hospital in Turkey. Education and consulting about breastfeeding were given via WhatsApp application to women in the intervention group. Women in the control group receive only routine breastfeeding training.

The research was conducted as a randomized controlled trial. The stratified and permutation block randomization methods were used in the study. The personal information form and BSES-SF were administered to women in the hospital before the intervention. Breastfeeding education and counseling were provided via social media (WhatsApp) to support women for breastfeeding and to ensure the continuity of breastfeeding in the postpartum period. Breastfeeding education was given to women in the first four weeks after discharge from the hospital. The control group received the routine breastfeeding postpartum educational training given to all women by healthcare personnel as part of the hospital procedures. Except for routine breastfeeding training, no intervention was applied to the control group.

Eligibility Criteria:
Inclusion Criteria:

* being primipara
* being 18 years of age or older
* using the WhatsApp social media application
* having a newborn with a weight of 2500 grams and above
* agreeing to participate in the study

Exclusion Criteria:

* being multiparity
* having a physical or mental health problem that would prevent breastfeeding
* preterm labor (before 37 weeks)
* difficult labor
* either mother or baby having a health problem after birth
* mother's substance use (drug, smoking or alcohol)
Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in the Context of Suspicion of COVID-19 Infection

In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients.

The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The analysis of VOC can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.

Moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of SARS-CoV-2 infection with a specificity greater than 90%; this olfactory signature corresponds to VOCs detectable by the flair of dogs (Nosaïs-Covid19 study).

Validation of the diagnostic value of VOC analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a SARS-CoV-2 infection warrants the performance of this clinical study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients

   * Patents anaged at the Foch Hospital for suspected COVID-19 and any other patient whose management requires diagnosis of SARS-CoV-2 infection
   * Patients aged 18 or over;
   * Patients Fluent in French ;
   * Patients with a signed consent form;
   * Patients with a health insurance plan.
2. Healthy volunteers

   * Foch Hospital staff asymptomatic for SARS-CoV-2 infection;
   * Aged 18 yor over;
   * Fluent in french;
   * with a signed consent form;
   * With a health insurance plan.

Exclusion Criteria:

* Pregnant woman
* Patient deprived of liberty by judicial or administrative decision
Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda

The main aim of this study is to test the primary hypothesis that the addition of intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will reduce malaria prevalence among pregnant women when compared to routine antenatal cares services alone.

More specifically, the primary objective is to understand the effect of ISTp in a context where routine antenatal care does not include malaria chemoprohylaxis and whether this intervention is protective against malaria during pregnancy. The secondary objective is to determine whether this intervention results in an improvement in other key maternal and newborn health outcomes including maternal anemia, low birth weight and prematurity. The third objective is to determine the feasibility, effectiveness and acceptability of ISTp among women who receive ISTp and among health workers who deliver this intervention.

This study will establish if testing and treating pregnant women is effective, feasible and whether it adds an additional burden to the work already being undertaken by facility-based health workers who provide antenatal care services. It is expected that the study will result in information to develop appropriate approaches that can be implemented in Rwanda in the prevention of malaria in pregnancy in addition to the use of preventive measures such as insecticide treated mosquito nets (ITNs) and case management. This information may potentially also be used by other countries with similar patterns of malaria transmission.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women age 18 or older who have their first ANC visit during the study recruitment period
* Willing to participate

Exclusion Criteria:

* • Pregnant women below the age of 18

  * Not willing to participate
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.

The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Advanced biopsy-proven metastatic non-small cell lung cancer
* Somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy
* Prior treatment with osimertinib with response followed by disease progression
* No prior first or second generation EGFR inhibitor treatment (gefitinib, afatinib, erlotinib)
* Archival tissue available from a tumor biopsy done after disease progression on osimertinib or willing to undergo a tumor biopsy or liquid biopsy after disease progression on osimertinib prior to study initiation
* Measurable (RECIST 1.1) indicator lesion not previously irradiated
* Karnofsky performance status (KPS) \>/= 70%
* Age \>/= 18 years old
* Ability to swallow oral medication
* Adequate organ function

  * AST, ALT \</= 3 x ULN
  * Total bilirubin \</= 1.5x ULN
  * Creatinine \</= 1.5x ULN OR calculated creatinine clearance \>/= 60ml/min
  * Absolute neutrophil count (ANC) \>/= 1000 cells/mm3
  * Hemoglobin\>/=8.0 g/dL
  * Platelets \>/=75,000/mm3

Exclusion Criteria:

* Pregnant or lactating women
* Any radiotherapy within 1 week of starting treatment on protocol.
* Any major surgery within 1 weeks of starting treatment on protocol.
* Any evidence of active clinically significant interstitial lung disease
* Continue to have unresolved \> grade 1 toxicity from any previous treatment Treatment
* Patients with a known mechanism of resistance to osimertinib that will clearly not respond to dacomitinib therapy (i.e. known MET amplification, ALK fusion, RET fusion).
* Symptomatic brain metastases or leptomeningeal disease requiring escalating doses of steroids
Online Psychological Support Group for Patients With Heart Failure and Depression

Heart failure is a chronic disease, being the second cause of death in Brazil. Currently, it is estimated that 6.4 million Brazilians suffer from this disease. The higher number of rehospitalization, lower survival of these individuals. There are recommendations from Societies of Cardiology for the inclusion of effective self-care for patients with chronic HF, intend greater control of symptoms, greater adherence to treatment and, consequently, decrease of rehospitalization. One of the pillars of self-care's education for chronic patients recommended by the Health Ministry is the management of the patient's emotional aspects. These have been undertreated in most studies. The prevalence of depression among patients with HF is high and ranges from 41% to 72%, and the assessment with the BDI-II, which is the gold standard used, is 67%. Patients with HF and depression have greater difficulty in adhering to treatment and poor maintenance of self-care. Also, they present 4 times more risk of rehospitalization/mortality. Faced with this problem, this project was designed, proposing an online psychological support group for patients with heart failure and depression, primarily aimed at improving self-care, adherence and secondarily at reducing the rates of depression and readmission.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with heart failure
* Age between 18 and 79 years B)
* After hospital discharge
* Depression (BDI-II score above 14 points)
* Acceptance of the Term of Consent;

Exclusion Criteria:

* Patients with dementia
* Communication barriers
* Octogenarians
* People unable to access the internet for the intervention
* Who declined to participate;