cyrilzakka/clinical-trials huggingface dataset:
Allogenic Cord Blood Transfusion in Patients With Autism

Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress.

The possible reason for ASD is neural hypoperfusion and immune deregulation. The Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. In this study, the safety and efficacy of hUCB-MNCs infusion will be evaluated in patients with Autism.

Autism Spectrum Disorders (ASD) are heterogeneous neuro-developed disorders. Autism is the most common disorder of the diseases characterized by dysfunctions in response social interaction and communication, as well as the presence of repetitive and stereotyped behaviors. Recent reports of a sharp increase in the number of children with autism. The exact etiology of autism remains unclear. Compliance, the definition of effective treatments for autism is particularly difficult.

Although it has been understood, it can be a question of immune dysregulation. Examination of the inflammatory cytokines, dysfunction of the immune system and the immune system. The Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. The Our study suggest that infusion of cord blood mononuclear cells will affect Autism.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis: autistic type disorder (ASD).
* Systemic speech underdevelopment
* The presence of attention deficit hyperactivity disorder as a comorbid state
* Cognitive impairment

Exclusion Criteria:

* organic pathology of the brain according to CT, MRI
* the presence of the following diseases in history: heart failure in the stage of decompensation, stroke in history less than 1 year ago, blood diseases;
* decompensation of chronic and endocrinological diseases;
* acute respiratory viral and bacterial infections, period less than 1 month after the acute phase.
* HIV infection, hepatitis B and C.
* oncological diseases, chemotherapy in the anamnesis;
* tuberculosis.
* Severe form of intellectual disability.
* Cerebral palsy.
* epilepsy.
Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy for Locally Advanced Pancreatic Adenocarcinoma

The study is a prospective and observational cohort study. The purpose is to to investigate the safety and efficacy of nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy versus nab-paclitaxel and gemcitabine alone for locally advanced pancreatic adenocarcinoma (PDAC)

We will prospectively collect 100 patients who receive nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy or nab-paclitaxel and gemcitabine alone. Data will be stored in a private database. The process of data collection will be supervised and regular data examination will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18-75 years;
2. histologically or cytologically proven diagnosis of pancreatic adenocarcinoma;
3. treatment-naive locally advanced pancreatic cancer (locally advanced status was determined by our multidisciplinary team based on the National Comprehensive Cancer Network definitions);
4. no distant metastasis as defined by CT or MRI of the chest, abdomen and pelvis;
5. at least 1 measurable lesion based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST) 1.1;
6. an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
7. adequate hematological, liver, renal function:

   1. absolute neutrophil count≥1500 cell/mm3;
   2. platelet count≥100×109/L;
   3. hemoglobin concentration \>90 g/L;
   4. albumin≥30 g/L ;
   5. total bilirubin\<1.5 times the upper limit of normal;
   6. alanine aminotransferase and aspartate aminotransferase≤3 times the upper limit of normal;
   7. serum creatinine concentration\<1.5 times the upper limit of the normal range or less and creatinine clearance rate≥45 mL/min;
8. life expectancy of at least 3 months.

Exclusion Criteria:

1. with any other malignancy within the 5 years before enrolment;
2. with active infections (bacterial, viral, or fungal) requiring systematic treatment, with hepatitis B or C infection, or a history of HIV infection, or receiving immunosuppressive therapy;
3. with peripheral sensory neuropathy at a grade \>1;
4. with a history of allergy or hypersensitivity to the study drugs;
5. pregnant or breast feeding women, reproductive aged women who refused to take adequate contraceptive measures during the study.
Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts

The purpose of this study is to determine if patients with malignant middle cerebral artery infarction have a better clinical outcome after early decompressive surgery compared to standard medical management.

The Decompressive Craniectomy In MALignant middle cerebral artery infarction (DECIMAL) trial is a prospective, multicenter, randomized, open (single blind for the evaluation of the primary outcome measure) controlled study of the efficacy of decompressive craniectomy plus the standard medical therapy as compared with the standard medical therapy alone in patients with a malignant middle cerebral artery infarction. The study protocol is approved by a regional ethic committee (CCPPRB Hospital SAINT LOUIS, PARIS). The study is conducted in 13 stroke centers in France and is funded by the French Ministry of Health and the "ASSISTANCE PUBLIQUE- HOPITAUX DE PARIS". An independent Data Safety Monitoring Board (DSMB) monitors the safety, progress and ethics of the trial.

The aim of the trial is to determine if patients with malignant middle cerebral artery infarction have a better clinical outcome after early decompressive surgery compared to standard medical therapy alone.

Secondary objectives are to determine clinical or MRI based prognostic factors of better outcome after decompressive surgery.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and CT scan signs of complete infarction of the middle cerebral artery
* Onset of symptoms \< 30 hours to a possible surgical intervention (\< 24 hours for the inclusion and possibility to start treatment/surgery within 6 hours after randomisation)
* DWI infarct volume \> 145 cm3

Exclusion criteria:

* The patients having a neurological pre existing handicap (score of Rankin sup or equal in 2).
* Patients having an ischaemia lateral against significant.
* Patients having a haemorrhagic transformation(conversion) sup in 50 % of the territory of the infarct.
* Patients having a severe co-morbidity with a reduced life expectation.
* Patients having a severe cardio-respiratory co-morbidity.
* Patients having antecedent of DUROPLASTIE with transplant of dura mater or transplant of cornea.
* Patients having a thrombolyses in 24 last hours.
* Patients having a severe coagulopathies.
* Patients having one against indication in the general anesthetic.
* Patients for whom a medical follow-up is not possible.
* The pregnant women.
* The patients to whom the surgical operation cannot be realized within 6 hours following the randomisation.
Follow-up Study in French Practice to Evaluate Improvements in Walking and Pain Relief in Patients Treated With Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon

This study is part of the subordination for the renewal of the registration of the LUTONIXR035 or RANGERTM drug coated balloon catheter by the CNEDiMTS following the transmission of the results of a French study on quality of life (evaluation of pain relief and walking evaluation criteria) for patients treated for de novo lesions of the femoropopliteal artery above the knee by endovascular treatment with LUTONIXR035 or RANGERTM drug-coated balloon catheters.

In accordance with the HAS practical guide on the approval of medical devices in France (November 2017), the protocol for this study was submitted in advance to the HAS and its suggestions were taken into account when drafting the objectives relative to the population to be included.

A second exhaustive study will be conducted in parallel using SNDS data to complete the CNEDiMTS application in order to evaluate, in the context of this registration renewal, the interest of the technique by documenting limb preservation, overall survival, the rate of re-interventions and the number of stents implanted.


Eligibility Criteria:
Inclusion Criteria:

* patient having given express oral consent
* patient to be treated by endovascular procedure with a LUTONIXR035 or RANGER TM drug coated balloon catheter according to the recommendations of the ANSM dated 13/05/2019 1 and possible updates of these recommendations.

Exclusion Criteria:

* pregnant or likely to be pregnant (a pregnancy test may be carried out if necessary according to the centre's practice)
* adult unable to express consent
* patient whose follow-up is considered impossible by the investigator (comprehension problem, planned move, ...)

Per-intervention exclusion criteria

* patient considered to have failed endovascular treatment (presence of residual stenosis of more than 30% after surgery despite the possible use of a stent.
* Patient operated on but for whom the balloon was not used during the procedure
* Patient operated but for whom another balloon than those under study was finally used during the operation
Increasing Spontaneous Non-exercise Activity (The Sitting Study)

The purpose of the study is to see if one's liking and awareness of different types of activities is related to one's activity pattern.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary lifestyle

Exclusion Criteria:

* 5% weight loss within the past 2 months
* Active job or lifestyle
* Participation in an exercise program
* Pregnant and/or lactating
* Uncontrolled hypertension
* Alcohol or drug abuse
* Presence of acute illness
* Major limitation of physical movement
Phenotypic Characteristics of Superlean Individuals Including Gut Microbiome

The goal of this observational study is to build on our previous work to further characterise the phenotype of superlean individuals (BMI \< 18.5) when compared to normal BMI people (BMI 21.5 to 25). This will include characterising the body composition, food intake behaviour, circulating hormone levels, genetics and characteristics of the gut microbiota. The investigators expect to recruit up to 200 healthy superlean and control volunteers respectively,

The focus of this work is to characterise the phenotype and genotype of individuals who have low BMI ( \< 18.5) but are otherwise healthy and do not have eating disorders. The investigators term this group 'superlean' individuals. The study is observational and the investigators aim to establish a healthy superlean cohort,and use the combined metagenomic and metabolomic multi-omics analysis techniques, combined with imaging and physiological measurements, to focus on the correlation between gut microbiota characteristics and metabolism in superlean population. The investigators expect to recruit up to 200 healthy superlean and control volunteers (BMI 21.5 to 25) respectively, to explore the microbiota characteristics and differences between control and healthy superlean populations by measuring the basic physical indicators and metabolic parameters. This will include analyzing the postprandial hormonal changes, appetite differences, and changes in the gut microbiome and serum metabolome in the two groups of volunteers, establishing the relationship between the gut microbiota and the metabolite and metabolic phenotypes of the body, and exploring the gut microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Control group (21.5≤ BMI\<25), Superlean group (BMI≤18.5)
* Age between 25-40 years old

Exclusion Criteria:

* Having metabolic diseases or eating disorders
* Recent weight loss due to various disease causes
* Being treated for weight loss
* Having an infectious disease
* Pregnant and lactating women
* People with blood sickness, pathological hypo- or hypertension
* People suffering from claustrophobia
* No metal implants in the body
* Use of antibiotics, probiotics, oral laxatives, etc. within 8 weeks
Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

This is a pilot study on the impact of switching from cigarettes to Electronic Cigarettes (EC) on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting Chronic Obstructive Pulmonary Disease (COPD). The researchers hypothesize that the smokers who switch to EC completely or significantly will experience reduced COPD symptoms, risks of exacerbations, and decreased levels of oxidative stress and inflammation.

Smokers with COPD have a higher pack-year history and nicotine dependence compared to regular smokers as exemplified by the relatively large proportion of patients diagnosed with COPD that continue to smoke (95%).

This is a translational project which addresses the changing profile of tobacco product use in the United States (US) and the need for data regarding toxicity pathways for new nicotine products such as EC. In particular it focuses on critical scientific and clinically relevant gaps relating to oxidants in EC and their potential long-term cardiopulmonary effects. The study will obtain new information regarding the potential cardiopulmonary toxicity resulting from exposure to EC-derived oxidants that may lead to long-term disease development.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate COPD
* Smokes a popular brand of cigarette
* Willing to use an e-cigarette to reduce cigarette smoking down to 75% of their daily baseline cigarette use
* Ability to read, write and understand English
* Ability to provide informed consent and attend study visits

Exclusion Criteria:

* History of active, chronic drug abuse or alcohol abuse problems
* Actively changing smoking behavior
* Unwilling or unable to provide blood samples
* Pregnant, planning to become pregnant, or nursing
* Use of tobacco products other than cigarettes in the past 30 days
* Recent history (\< 6 months) of myocardial infarction (MI)
* Any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or drug therapy within the past year. Antiarrhythmic drugs include amiodarone, flecainide, IV ibutilide, IV lidocaine, procainamide, propafenone, quinidine, tocainide
* Hospitalization for heart failure (NY Heart Association III or IV) within the past year
* Uncontrolled hypertension
* Known allergy to vegetable glycerin and propylene glycol
* History of seizures or medications to prevent seizures
Registry of Subjects at Risk of Pancreatic Cancer

IRFARPC is a multicenter national registry designed to study the diagnosis and predisposing factors of subjects with an inherited increased risk for pancreatic cancer.

Pancreatic cancer is a devastating disease with a dismal prognosis. One of the ways to improve survival might be early detection.

Within years, many predisposing diseases or genetic conditions have been identified, thus screening/surveillance have been established worldwide.

A registry of subjects at risk of pancreatic cancer will has been built up to investigate the possibility of diagnosis pancreatic cancer, or one if its predisposing lesions.

Inclusion criteria will be adopted as "enrollment criteria". According to this, individuals \> 18 years old will be enrolled; their familiar history and/or genetic predisposition will be collected, as well as current or previous medical records/medications data. Thereafter, according to specific age-based criteria, those individuals initially enrolled will be will be considered for a "surveillance protocol" ("interventional follow-up criteria") and they will be submitted to Cholangio-Wirsung Magnetic Resonance or Pancreatic Endoultrasonography according to the pancreatologist's prescription at each participating center.

Individuals suffering from the following conditions will be enrolled:

familial pancreatic cancer; Peutz-Jeghers syndrome; a known BRCA-2, BRCA-1, PALB2, or p16 mutation with at least one first- or second-degree relative suffering from pancreatic cancer; hereditary pancreatitis; FAMMM syndrome; Lynch syndrome with at least one first- or second-degree relative suffering from pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria to enter the registry:

* individuals with at least two relatives suffering from pancreatic cancer, with at least 1 first-degree and until the third-degree
* subjects with known genetic mutation of BRCA2, BRCA1, p16, PALB2 with at least 1 first- or 2nd-degree relative suffering from pancreatic cancer
* subjects suffering from FAMMM Syndrome
* subjects suffering from Peutz-Jeghers Syndrome
* subjects suffering from PRSS-1- or CFTR- or SPINK-1- related pancreatitis
* subjects suffering from Lynch syndrome with at least 1 first- or 2nd-degree relative suffering from pancreatic cancer

Inclusion criteria to join the "radiologic follow-up":

* 45 years or 10 years younger than the youngest index case of pancreatic cancer in the family for familial cases
* 40 years or 5 years younger than the youngest index case of pancreatic cancer for subjects suffering from hereditary/genetic pancreatitis, Lynch syndrome, or carrying a known BRCA 1/2, PALB2, p16 genetic mutation with familiarity for pancreatic cancer
* 30 years for subjects suffering from FAMMM, Peutz-Jeghers syndrome

Exclusion Criteria:

- pregnancy
Change Trend of Effluent Eosinophil During Peritoneal Dialysis-Related Peritonitis

A multi-center prospective cohort study will be conducted to explore the change trend of eosinophil in peritoneal dialysis effluent during peritoneal dialysis-associated peritonitis, and to explore the relationship between eosinophil increase, peritonitis severity and antibiotic use. This study will provide evidence for routine eosinophil testing

A multi-center prospective cohort study will be conducted to explore the change trend of eosinophil in peritoneal dialysis effluent during peritoneal dialysis-associated peritonitis, and to explore the relationship between eosinophil increase, peritonitis severity and antibiotic use. In this study, 100 patients with peritoneal dialysis-associated peritonitis who meet the inclusion criteria will be selected. Demographic data, laboratory variables, peritoneal fluid cytology and bacterial culture will be collected within 24 hours of peritonitis (day 1). Peritoneal fluid cytology includes leukocyte classification and eosinophilic leukocyte count will be examined at day 3, 5, 7, 10, 14, 21, 30, 60 and 90 after peritonitis. All patients will be followed up for 90 days, and their peritonitis outcome will be recorded. The primary endpoint is the prevalence of eosinophil increase in peritoneal effluent, which is defined as \>100 eosinophils/mm\^3, or \>10% eosinophils of the total non-erythrocyte count. Secondary end points are peritonitis outcome at month 1 and 3 including transfer to hemodialysis , death.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as peritoneal dialysis-related peritonitis;
* Age\> 14 years
* Maintenance peritoneal dialysis due to end-stage renal failure ≥3 months
* Use of lactate glucose dialysate

Exclusion Criteria:

* Those who cannot be followed up regularly
* Reluctant to join this researcher
A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.

A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.


Eligibility Criteria:
Inclusion Criteria:

* Patient (male or female) ≥12 years of age
* ECOG (Eastern Cooperative Oncology Group) performance status ≤1
* Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.
* Patients must be willing and able to undergo study required biopsies.
* Presence of at least one measurable lesion according to RECIST v1.1.
* Documented MAPK pathway alteration

Exclusion Criteria:

* Prior treatment with ERK inhibitors.
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
* Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
* Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
* Patients with malignant disease other than that being treated in the study.
* Clinically significant cardiac disease.

Other protocol-defined exclusion criteria may apply.
A Study To Assess The Effect Of Linezolid On QTc Interval

The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG readings) which could predispose patients to ventricular arrhythmias. This study is conducted to satisfy this requirement.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between the ages of 21 and 55 years.
* Body mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \> 45 kg (99 lbs).
* An informed consent document signed and dated.

Exclusion Criteria:

* Evidence or history of clinically significant abnormality.
* 12-lead ECG demonstrating QTc \>450 msec at Screening.
* Receiving selective serotonin reuptake inhibitors (SSRIs) and/or sympathomimetic agents.
* Abnormal liver function tests.
* A positive urine drug screen, history of excessive alcohol and tobacco use.
Clinical Trial for Prostate Cancer

Phase III trial using an injectable for treatment of prostate cancer.


Eligibility Criteria: