cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Behavioural Psycho & Physiological Responses in People With ASD During a Blood Test in Routine Care Practice

The project is a prospective study designed to characterize behaviour and its psycho-physiological correlates of participants with ASD (children and adults) in comparison with subjects without ASD matched in age during blood test in common practice.

The project is a prospective study designed to characterize behaviour and its psycho-physiological correlates of participants with ASD (children and adults) in comparison with subjects without ASD matched in age during blood test in common practice.

The aim is to analyse in an automated and standardised way video recording during a blood test performed as part of routine follow-up care for people presenting ASD (children and adults), qualitative data (type of emotion) and quantitative (intensity)

1. Emotional facial reactions
2. Behavioural reactions (video recording of participants' movements)
3. Physiological reactions (wireless smart watch worn on the wrist)
4. Psychological reactions (self and hetero questionaires) to characterize the signs of pain and anxiety associated with this situation)

Eligibility Criteria:
Inclusion Criteria:

All participants :

* Person over 6 years of age
* Person who consent to participate in the study
* Membership of the social security scheme
* Person who not received analgesic treatment that may interfere with pain perception
* Person with medical prescription for blood sample

Participants with ASD :

* Person with ASD diagnosis
* If applicable, legal authority consent to participate in the study

Exclusion Criteria:

All participants :

* Person with unstabilized drug therapy
* Person with acute or chronic pain
* Person with pathology or receiving a treatment which can have an impact in modification of the pain
* Person with oculomotor and/or neuro-motor disorders
* Pregnant or breastfeeding woman
* Person with deprivation of liberty
* Person who no consent to participate in the study or no consent to realised video recording

Participants without ASD :

* Protected adult
* Person with ASD diagnosis
Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation

The purpose of this study is to see if ART-123 (recombinant human soluble thrombomodulin) decreases the number of people who die as a result of Disseminated Intravascular Coagulation (DIC) complication of sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Infection or suspected infection resulting in sepsis and DIC

Exclusion Criteria:

* Unable to provide informed consent, or lack of consent from an acceptable surrogate
* Subjects \< 18 years of age
* Known conditions that could confound the diagnosis of DIC due to sepsis
* Known conditions that increase the risk of bleeding
* Known medical condition associated with a hypercoagulable state
* Known or suspected severe liver disease
* History of solid organ (excluding uncomplicated kidney), bone marrow or stem cell transplantation
* Renal failure
Audiological Assessment of Recovered Covid 19 Subjects.

To assess the audiological profile in recovered covid 19 subjects in comparison with control group.

The outbreak of novel Severe Acute Respiratory Syndrome Corona virus type 2 (nSARS-CoV-2) infection in Wuhan, China in December 2019 has had impact on the world, resulting in over 2.2 million deaths globally The world envisioned sufferings of high proportions of losses in terms of health,finances and importantly, life.

The common symptoms including fever, cough, fatigue and gastrointestinal disorders have been well documented. Sensorineural hearing loss has been more commonly implicated in these patients although a few have exhibited conductive hearing loss. theViral upper respiratory tract infections have linked to new cases of otitis media. Although There is some controversy regarding the significance of viral species, but the human corona virus has been isolated from middle ear fluid and linked to otitis media in children. Most patients affected are asymptomatic or experience mild symptoms.

Various theories explaining the involvement of the ear following covid infection have been pos tulated, which include immune mediated damage,haematogenous spread, ischaemia theory, inflammation of auditory pathway components, presence of angiotensin converting enzyme receptors (ACE2) receptors in neurons and glial cell.

The hearing loss in COVID-19 could also be the consequence of therapy with chloroquine and hydroxychloroquine, which are part of clinical practice guidelines for COVID-19 treatment in several countries . These drugs are used for the treatment of malaria and some chronic inflammatory diseases as well. It is well known that these medications can induce hearing loss. Ototoxicity of chloroquine and hydroxy- chloroquine is the result of inner ear damage . The recommended dose of these drugs for COVID-19 treatment is higher than for malaria; therefore, ototoxic effect could be higher.Though many vaccines were intro- duced, the disease has hit second and third waves in many countries, elevating the number of infected individuals getting infected .

Some studies reported that the COVID-19 group had significantly poorerhearing thresholds at high frequencies. In addition, the amplitudes of transient evoked otoacoustic emissions ,in two of thesestudies were significantly lower for the COVID-19 group.

Eligibility Criteria:
Inclusion Criteria:

* Age 18_50

Exclusion Criteria:

1. History of previous ear symptoms, tympanic membrane perforations,ear trauma or ear surgeries
2. Evidence of systemic illness as Diabetes mellitus, Renal disease, patients received ototoxic drugs.
3. Evidence of neurologicl or psychiatric disease.
4. covid 19 Patients not maintaining saturation and requiring O2 support and intensive care unit patient.
Donation Network to Optimize Organ Recovery Study

This study consists in an cluster-randomized clinical trial involving near 60 Brazilian intensive care units (ICUs) with a high notification rate of potential donors of organs and tissues. ICUs will be randomized in a 1:1 ratio to manage potential organ donors through the use of a evidence-based checklist or to manage potential organ donors according usual care. The primary outcome is the rate of losses of potential donors due to cardiac arrest. Secondary outcome measures include number of effective organ donors and number of organs recovery per effective donor. The first subject was enrolled on June 20, 2018.


Eligibility Criteria:
Inclusion Criteria:

For ICUs:

* Adults ICUs reporting at least 10 potential valid donors (without clinical contraindications for donation) per year

For potential donor:

* Age of 14 years or older
* Suspected brain death after the first clinical test

Exclusion Criteria:

For ICUs:

* Coronary units, intermediate units, emergency services
* ICUs that use checklist for the management of the potential donors

For potential donors:

* Age \>90 years
* HIV
* Metastatic cancer
* Uncontrolled sepsis
* Acute hepatitis
* Malaria
* Acute viral infections
* Cryptococcal meningoencephalitis and prion diseases
* Active tuberculosis treated less than 2 months
* Colonization of the donor by bacteria without any option of antibiotic treatment
* History of breast tumor, melanoma, soft tissue sarcoma or hematologic neoplasia, WHO Group 3 primary tumors
Referrals for CLTI: Qualitative Study

The goal of this qualitative study is to explore the experiences of patients who have been diagnosed with chronic limb-threatening ischaemia (CLTI). The main questions it aims to answer are:

* What are the perceptions and experiences of patients between first symptom of CLTI and vascular surgery assessment
* What is important to patients during this process.

Participants will be interviewed and their words analysed using reflexive thematic analysis.

There are delays at every stage of the patient journey from developing chronic limb-threatening ischaemia (CLTI) to treatment, associated with poorer outcomes for patients. There is currently limited national and international guidance on how and when to refer patients with suspected CLTI to specialist vascular surgery services. The use of qualitative interviews will allow us explore perceptions and experiences of patients with CLTI being referred to vascular surgery services, and identify possible ways to improve the process via interviews. This study will provide novel information on patient experience, and together with other work provide a framework for improvement of the referral process for CLTI.

Eligibility Criteria:
Inclusion Criteria:

- CLTI diagnosed in the last year

Exclusion Criteria:

* Lacking capacity to consent to interview
* Potential to be violent
* Cognitive impairment
* Non-English speaking
Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN)With Alcohol in Unresectable Pancreatic Cancer: a Pilot Study

The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or unresectable pancreatic adenocarcinoma.

Hypotheses:

1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma.
2. Effective pain relief obtained from EUS-CPN will be related to better quality of life (QOL)


Eligibility Criteria:
Inclusion Criteria:

* A total of 20 consecutive subjects with locally advanced or unresectable pancreatic adenocarcinoma (stage II to IV) with pain (abdominal and/or back). Subjects with known or suspected unresectable pancreatic adenocarcinoma will be recruited for this study, as a diagnosis of unresectable pancreatic adenocarcinoma is often made during the endoscopic ultrasound (EUS) procedure.
* Subjects must have documented disease by computed tomography (CT), endoscopic retrograde cholangio-pancreatography (ERCP), or EUS.
* Subjects undergoing EUS for pancreatic cancer staging.
* Subjects undergoing pancreatic cancer surgery are eligible for study entry beginning 5 days after the operation if they have not had an intraoperative celiac plexus neurolysis.
* No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.

Subjects must not have a coagulopathy (platelet \<50,000, INR\>1.5, or bleeding disorder, or on blood thinners) Subjects with platelets below 50,000 will not be eligible to participate in this study due to the risk of bleeding. Patients will be asked to discontinue use of non-steroidals for 5 days prior to the procedure. Patients on plavix will be asked to discontinue use for 7 days prior to the procedure if they are clinically able to do so. Patients on coumadin or lovenox will also need to discontinue use prior to the procedure, but decisions regarding their management will be made on an individual basis as per our usual standards of care.

* Subjects must provide signed written informed consent.
* A baseline pain score is not required, however, subjects must be having pain that is requiring a stable dose of pain medication for control of pain.

Exclusion Criteria:

* Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical).
* Presence of an implanted epidural or intrathecal analgesic therapy. Subjects with psychiatric illness that affects their ability to assess quality of life or compliance with the protocol.
* Subjects with uncorrectable coagulopathy
* Subjects with an allergy to bupivacaine or alcohol.
* Presence of an aneurysm in the abdominal aorta, celiac trunk, or superior mesenteric artery.
Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

This observational prospective study will help to determine if an immune process similar to allograft rejection is responsible for the occurrence of an intrahepatic cholestasis of pregnancy (ICP).

If so, it would suggest the potential benefit of immunomodulatory therapeutics.

This observational study will include 322 pregnant women at delivery: 161 women diagnosed with an intrahepatic cholestasis of pregnancy, and 161 control women.

A blood test will be performed at delivery for each woman and each newborn, in order to measure several biological parameters involved in inflammation processes, allograft rejection and angiogenesis. Placenta will also be analysed. In particular, we will look for chronic inflammation in placenta.

Biological parameters and placental parameters will be compared between the two groups: cases with ICP and controls.

Eligibility Criteria:
Inclusion Criteria:

* Adult pregnant woman with singleton

For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP

Exclusion Criteria:

* Women under 18 years old
* Women under legal protection
* Gemellar pregnancies
* Delivery before 22 Weeks of gestation
* Medical termination of pregnancy
* Acute chorioamniotitis, in particular those due to the following pathogens: toxoplasmosis, rubella, CMV, herpes virus
* Premature rupture of membranes \<37SA
* Women infected by covid-19 in the month before delivery
Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia
* Must be an outpatient (not requiring hospitalization) now and for at least the past 8 weeks.
* Disease symptoms must meet a certain range as assessed by the clinician.
* Patient has experienced at least two episodes of clinical worsening of their condition. This could mean admission to a hospital or an emergency room visit. This could mean that a new medication was added, medication dose was increased, or medication was switched in order to better control symptoms of the condition.
* The patient must have an unsatisfactory response to their current medication or be experiencing negative effects of their current medication or not always take their current medication so that a change in current medication is desired.

Exclusion Criteria:

* Patients who are actively suicidal.
* Patients who are pregnant or nursing.
* Patients who have stopped past treatment with olanzapine because of adverse events, are treatment resistant or allergic to olanzapine, or have a condition which would prevent use of a long acting form of olanzapine.
* Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illness.
* Patients with Parkinson's disease, psychosis related to dementia or other related disorders.
The Clinical Impact of Selecting Acrosome Reacted Spermatozoa for ICSI

Presently spermatozoa for ICSI are selected based on morphology and motion, without determining if acrosome reaction (AR) had occurred during sperm preparation or not. Although not critical if the sperm is injected into the ooplasm, the occurrence of AR might might be an indicator of better spermatozoon quality and implantation potential, especially in severe OTA cases. It is impossible with conventional plain optic microscopy used in IVF units to determine in vivo (without fixation) if AR has occurred, and as a result spermatozoa are injected randomly. It is readily possible to distinguish AR+ from AR- spermatozoa using polarized light microscopy due to different bifriengance.

In this study the investigators seek to determine, by a prospective RCT, if selecting only acrosome reacted spermatozoa, in severe OTA cases, will improve the outcome of ICSI and the entire IVF process.

A prospective RCT to determine the effect of polscope based spermatozoa selection for ICSI.

Eligibility Criteria:
Inclusion Criteria:

* Female: normal uterine cavity and ovarian reserve. Male: TMC \< 1000000 cells.

Exclusion Criteria:

* Female: Abnormal uterine anatomy, low ovarian reserve, contributing egg factor, PGD.
A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)

The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).

This is a randomized open-label Phase 2 efficacy and safety study of two (2) subcutaneous (SQ) dosing schedules of decitabine in subjects with Low or Intermediate 1 Risk MDS. This study will be conducted in up to 6 study centers in the United States.

The primary efficacy outcome is the overall improvement rate. These two doses will be administered subcutaneously. The probability that one schedule is superior to the other will be estimated, and the level of toxicity for each schedule will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study:

1. Male or female patients age 18 years and older.
2. Patients must sign an institutional review board (IRB)-approved informed consent form, and understand the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment.
3. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. Adequate renal and hepatic function (creatinine \< 2 times upper limit of normal, total bilirubin of \< 2 times upper limit of normal, and AST and ALT ≤ 2 times upper limit of normal) unless proven to be related to disease infiltration.
5. Female patients need a negative serum or urine pregnancy test within 7 days prior to study drug administration (applies only if patient is of childbearing potential. Non-childbearing is defined as ≥ 1 year postmenopausal or surgically sterilized).
6. Women of childbearing potential and men must use contraception. Men and women must continue birth control for the duration of the study.
7. Patients with Low or Intermediate-1 Risk MDS by the International Prognostic Scoring System (IPSS) classification.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

1. Women who are pregnant or nursing.
2. Those who have received prior therapy with decitabine.
3. Prior therapy with azacitidine (Vidaza®).
4. Those who received growth factor support or lenalidomide in the 30 days prior to the first dose of decitabine.
5. Those who have received an investigational agent 30 days prior to the first dose of decitabine.
6. Patients with active, uncontrolled, systemic infection considered opportunistic, life threatening or clinically significant; or any severe, concurrent disease, which, in the judgment of the Investigator and after discussion with the Sponsor and Primary Investigator, would make the patient inappropriate for study entry.
An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen

The purpose of this study is to determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.

Adhesions are a common consequence of abdominal surgery. Trauma and emergency general surgery patients may require an open abdomen and undergo a series of abdominal operations, which may be increasingly complicated by the presence of adhesions. Adhesions appear soon after the initial operation and gradually mature within days. The effects of adhesion development on subsequent surgery may include: increased procedure time; difficulty differentiating, exposing, and accessing tissue planes; and increased risk of inadvertent enterotomy. Complications of adhesions include enteric obstruction and enterocutaneous fistulae. This study will determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the extent and severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.

Eligibility Criteria:
Inclusion Criteria:

* Trauma patients with open abdomen after initial laparotomy
* Emergency surgery patients with open abdomen after initial laparotomy
* Able to obtain consent from patient or LAR before any research initiated

Exclusion Criteria:

* Seprafilm application at initial laparotomy
* Patient is a prisoner
* Inability to obtain informed consent
* Consentable person does not speak English
Liposomal Amphotericin in Disseminated Leishmaniasis

Disseminated leishmaniasis (DL) is an emerging and severe form of leishmaniasis, with increasing prevalence in Bahia, Brasil. It is characterized by multiple acneiform, papular and ulcerated lesions localized on the face, chest, abdomen and extremities. The number of lesions ranges from 10 to hundreds, and mucosal disease has been documented in more than 40% of the cases.

DL is a hard to cure disease and therapeutic failure with pentavalent antimony has been documented in up to 70% of the cases caused by L. braziliensis in the endemic area of Corte de Pedra, Bahia. The majority of DL patients need several courses of antimony or the use of high dose of Amphotericin B desoxicolate to cure. Therefore DL patients are exposed to relevant drug toxicity, high morbidity due to a long lasting disease, with an important socio-economic impact. Our hypothesis is that liposomal Amphotericin B has a higher cure rate than historic cure rates of pentavalent antimony in the treatment of disseminated leishmaniasis.


Eligibility Criteria:
Inclusion Criteria:

* a) clinical diagnosis of Disseminated Leishmaniasis according to case definition; b) illness duration of less than three months, c) parasite identification by culture or polymerase chain reaction methods, d) no previous treatment for leishmaniasis.

Exclusion Criteria:

* a) immunodeficiency or antibodies to HIV, b) pregnancy or patients not willing or unable to use contraceptives during and 3 months after the end of therapy c) ALT, AST ≥3x normal reference values, creatinine and BUN ≥1.5x normal reference values, d) any evidence of serious underlying disease (cardiac, renal, hepatic, or pulmonary) including serious infection other than DL.
Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia

Multicentric evaluation of the reduction of unrelated cord blood transplantation (UCBT) toxicity by using reduced intensity conditioning (RIC) in patients with acute myeloid leukaemia.UCBT related mortality and morbidity were limiting factors for the development of this procedure in adults. Non myeloablative conditioning regimen showed promising results and prospective evaluation has to be developed to confirm these retrospective data.

Individual meta-analysis is planned to compare geno-identical transplantation with myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.

Eligibility Criteria:
Inclusion Criteria:

* Ages : 4 to 65
* De novo or secondary AML requiring allogeneic transplant
* No donor (related or unrelated) compatible 10/10
* Complete remission excepted CR1 with t(8;21) or inv (16) or t (15;17)
* Smouldering AML without progression
* Signed assent of recipient

Exclusion Criteria:

* If CR1: AML with with t(8;21) or inv (16) or t (15;17)
* Karnofsky \< 50% - Clearance of creatinin \< 40 ml/min
* Transaminases \> 8 N
* Previous autologous or allogeneic transplantation within 6 month prior to the study (except if tandem)
* total body irradiation contra-indicating 2 Gy TBI
* local irradiation contra-indicating 2 Gy TBI