cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Ultrasound (EUS) Intratumoral Injection of CAR-NK Cells in the Treatment of Advanced Pancreatic Cancer

This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of intratumoral NKG2D CAR-NK cell injection guided by endoscopic ultrasound in the treatment of locally advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. 18\~75 years old (including boundary value), both male and female.
2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinogenesis.
3. Recurrent or unresectable locally advanced pancreatic cancer. Patients with technically resectable tumors but are considered as unable to undergo surgical treatment due to medical comorbidities or the patient\&#39;s refusal of surgery are also eligible for enrollment.
4. ECOG PS score of 0-1.
5. At least 3 months of life expectancy at screening, as judged by the investigator.
6. Subject has adequate organ and bone marrow function. Laboratory screening results should be within the stable range described below, and there should be no ongoing supportive care (\&#34;jaundice relieve\&#34; therapy such as PTCD, ENBD, or bile duct stenting is allowed when pancreatic cancer invades the common bile duct). a) Blood biochemistry: serum creatinine ≤ 1.5×ULN, serum total bilirubin ≤ 2.0×ULN, and serum liver aminotransferase ≤ 3 ×ULN b) Blood tests: neutrophil count ≥ 1.5×109/L, platelet count ≥ 60×109/L, hemoglobin ≥ 8.0g/dL, lymphocyte count ≥ 0.4×109/L;
7. Childbearing status: not pregnant and, if of childbearing potential, willing to use effective contraception from the time of signing the informed consent form until 6 months after the last cell infusion (women of childbearing potential include premenopausal women and women within 2 years of postmenopausal time).
8. Subjects must sign a written informed consent form.
9. Subjects must be voluntary and able to comply with the scheduled treatment regimen, laboratory tests, follow-up, and other study requirements.

Exclusion Criteria:

1. Pregnant and lactating females.
2. Received any anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, or immunotherapy) for pancreatic cancer within 28 days prior to enrollment.
3. In the opinion of the investigator, the EUS technique poses undue risks to the subject, including but not limited to: - Previous EUS-FNA was technically deemed too difficult to perform; - Imaging showing multiple collateral vessels around or near the target tumor within the pancreas; - Presence of varicose veins near the target tumor. - If any of the above risk profiles become apparent after subject screening and/or enrollment, consideration should be given to withdrawal from the study prior to treatment.
4. History of malignancy within 5 years, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix.
5. Any other health condition by the judgment of the investigator would preclude participation in the study.
Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia

Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in healthy subjects and depressed patients. In this study, patients with treatment resistant negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI measures will be performed.


Eligibility Criteria:
Inclusion Criteria:

* schizophrenic patients with a negative syndrome. PANSS \> 40.

Exclusion Criteria:

* other psychiatric or neurologic diseases.
A Study of a Smartphone-based Intervention for Suicidal Inpatients

Suicide is the most common form of deadly violence. Indeed, since more than 40,000 people die by suicide each year, people are 2.5 times more likely to die by their own hand than someone else's. The four weeks after discharge from inpatient care is an especially dangerous period in terms of suicide risk, possibly because of poor post-discharge treatment adherence and poor treatment efficacy during a suicide crisis. To reduce suicide risk both in general and during the post-discharge period, interventions are needed that (1) are easily adhered to and (2) are effective during a suicide crisis. The goal of the study is to pilot-test a suite of five smartphone-based ecological momentary interventions (EMI) that can be easily used during a suicide crisis. Two target hopelessness, two target loneliness, and one targets negative automatic thoughts associated with hopelessness and loneliness. Although these interventions are new to the study of suicide, they are all grounded in decades of empirical work and adapted from effective interventions in areas relating to suicide.

Participants will be 20 inpatients (n = 10 each in treatment as usual \[TAU\] plus intervention and TAU plus assessment \[i.e., control\] groups) from the Massachusetts General Hospital Inpatient Psychiatric Service. The investigators hypothesize that those in the TAU plus intervention group will have lower levels of suicidal ideation during the inpatient and post-discharge period than those in the TAU plus assessment group.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include a recent (i.e., was included as the reason for admission) suicide attempt or serious suicidal ideation (i.e., ideation with at least 50% intent, assessed through either an explicit mention in the intake summary of intent greater than 50% or through this intent being inferred by clinical staff or in the notes \[for example, if the patient notes they wanted to die more than they did not want to die during the attempt or episode of suicidal ideation\]), English fluency, and access to an internet-capable smartphone (e.g., iPhone or Android).

Exclusion Criteria:

* Exclusion criteria include any factor that impairs the ability to effectively participate in the study (e.g., intellectual abilities that are too low to understand the study and/or consent process) or a diagnosis of any schizophrenia-spectrum or psychotic disorder.
* Additionally, patients who are on involuntary hospitalization status will be excluded.
The Use of Magnetic Endoscopic Imagers During Colonoscopy for Loop Recognition and Resolution

The purpose of this study is threefold. First, the ability of experienced colonoscopists to recognize the type of loop formed will be assessed and whether the use of the MEI improves this accuracy. Second, to determine which maneuvers are used for loop reduction and whether certain loops have set ways to reduce them. The third component will assess whether the colonoscopist thought that the imager helped or not.


Eligibility Criteria:
Inclusion Criteria:

* adults (18 years and older) undergoing colonoscopy

Exclusion Criteria:

* age less than 18 years old
* not willing to participate
* cardiac pacemaker
* internal cardiac defibrillator
* previous colonic surgery
Study on the Trajectories of Rehabilitation Compliance in Stroke Patients

To describe the general trajectories of rehabilitation compliance in first-onset stroke patients within 6 months, and to identify the heterogeneous development trajectory of different subgroups based on the mixed model of latent growth.To explore the predictors of different change tracks of rehabilitation compliance of stroke patients from the perspectives of biological, psychological and social factors, so as to provide the basis for formulating precise nursing intervention measures.

To describe the general trajectories of rehabilitation compliance in first-onset stroke patients within 6 months. To recruit first-onset stroke patients undergoing rehabilitation and collect the general data. Telephone follow-up at 2 weeks, 6 weeks, 8 weeks, 12 weeks and 24 weeks after the onset. Based on the biological-psychosocial medical model and literature, biological, psychological and sociological factors were screened. The patient rehabilitation adherence level in different periods was measured. Latent Growth Mixture Model (LGMM) was used to investigate the general trend of rehabilitation compliance in patients with first-episode stroke within 6 months. Latent Class Growth Analysis (LCGA) method in Latent Growth hybrid model was used to identify the track of heterogeneous change. Multivariate Logistic regression analysis was used to explore the predictors of different subgroups of change trajectories relative to other subgroups.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with stroke by CT or MR;

  * Patients with first onset (within 14 days of onset); ③ limb dysfunction (muscle strength ≤4); ④ Age: ≥18 years old; ⑤ Awareness (NIHSS consciousness level ≤1 point);

    * Informed consent of patients.

Exclusion Criteria:

* Patients with deep vein thrombosis;

  * fracture patients;

    * a history of severe cardiopulmonary dysfunction and craniocerebral trauma;

      * recurrent stroke during the study; ⑤patients with severe mental disorders; ⑥ Mixed aphasia patients.
Surveillance of AMR in DRC

This study addresses knowledge gaps regarding antimicrobial resistance (AMR) in sub-Saharan Africa, focusing on evaluating the feasibility of AMR surveillance and enhancing local research capacity. Conducted at a general referral hospital in semirural Kinshasa, DRC, the study will investigate bacterial infections, their resistance profiles, and related risk factors, including co-infections such as malaria.

Antimicrobial resistance (AMR) is a significant global health threat, but its full impact in many African regions is still poorly understood. In collaboration with the Kinshasa School of Public Health, the Institut National de la Recherche Biomédicale (INRB) of DRC, and the University of Oxford, this study will assess the feasibility of implementing AMR surveillance in a general referral hospital in semirural Kinshasa, where onsite microbiological testing is currently unavailable. A key objective is to strengthen local research capacity by training staff in patient identification and specimen collection for AMR surveillance. The study will include patients over six months of age with suspected bloodstream infections at the time of hospital admission who agree to participate and from whom informed consent has been obtained. The focus is on community-acquired infections, excluding patients with significant prior healthcare or antibiotic exposure. Blood samples will be analyzed at INRB to determine the bacterial cause of infections, evaluate antimicrobial resistance levels, and identify associated risk factors, including co-infection with Plasmodium falciparum. Study results will be shared promptly with the hospital team to aid in patient management. Participants will be followed up for 28 days post-admission.

Eligibility Criteria:
Patients older than six months who present with a clinically suspected bloodstream infection upon admission to the hospital, or who have been hospitalized for less than 48 hours, and provide written consent (or consent from their caregiver/legal guardian) to participate will be included. Patients with a significant history of healthcare exposure and those with any contraindications for phlebotomy as determined by the clinician's judgment, will be excluded.
Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss

The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.


Eligibility Criteria:
Inclusion Criteria:

* 5-20 weeks of gestation by ultrasound
* Miscarriage diagnosed by ultrasound
* Pregnancy tissue still present in utero, including an empty sac, and not completely expelled

Exclusion Criteria:

* Maternal age \< 18 years
* No visible pregnancy tissue on ultrasound
* Multiple fetal gestation (\> than singleton)
* Pregnancy was conceived using in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A) performed on the transferred embryo
* No microarray testing is planned on the product of conception
* Previous normal non-invasive prenatal testing (NIPT) or diagnostic testing (chorionic villous sampling or amniocentesis) in the current pregnancy
* Patient unable to provide consent
Direct Measurement of Leukemic Cell Turnover (Synthesis and Removal) in Patients With Chronic Lymphocytic Leukemia (CLL) Using Deuterated Water

Chronic lymphocytic leukemia. B-cell chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the Western Hemisphere, accounting for \~25% of all leukemia's. It represents a monoclonal expansion of small, long-lived, apparently slowly dividing CD5+ B cells. Because of the low proliferative index and a presumed uniform proliferative rate of B-CLL cells in vivo (a fact not yet tested or documented), B-CLL appears to be primarily a disease of accumulation rather than proliferation.

Chronic lymphocytic leukemia. B-cell chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the Western Hemisphere, accounting for \~25% of all leukemia's. It represents a monoclonal expansion of small, long-lived, apparently slowly dividing CD5+ B cells. Because of the low proliferative index and a presumed uniform proliferative rate of B-CLL cells in vivo (a fact not yet tested or documented), B-CLL appears to be primarily a disease of accumulation rather than proliferation.

B-CLL remains an incurable illness and there is no survival benefit to early intervention.

Therefore, patients with early stage disease are usually followed closely without initiating treatment. Patients with more extensive disease or progressive cytopenias are eventually treated with cytotoxic agents, with or without prednisone, or with nucleoside analogues that promote apoptosis in the leukemic cells. The clinical outcome of the disease is determined both by the profound dysregulation of the immune system that results in infection and autoimmunity and by leukemic infiltration and destruction of organs. Autoimmune phenomena are common and frequently directed against hematopoietic cells, resulting in autoimmune hemolytic anemia (10-25%) or immune thrombocytopenia.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age.
* Must meet the clinical and laboratory criteria for B-CLL (i.e., compatible clinical history and physical exam, presence of lymphocytosis, i.e., \>10,000 lymphocytes / mm3, evidence for a monoclonal population of CD5+/CD19+/CD23+ cells in the periphery that have dim surface membrane lg with L chain isotype restriction).
* All patients will be staged according to the system of Rai. Only new onset patients who are not receiving therapy will be entered into the heavy water leukemic cell turnover studies.

Exclusion Criteria:

* Patients hospitalized for an acute medical problem, related or not to their leukemia, within 4 weeks of enrollment.
* A history of a second malignancy involving the hematopoietic system, or the need for extensive chemotherapy for any second malignancy; patients with active immunologic disorders (e.g., HIV and AIDS), especially autoimmune problems (e.g., autoimmune hemolytic anemia of any cause other than B-CLL).
* Patients with impaired decision-making capabilities, e.g. dementia, psychosis, alcoholism, and illicit drug use will also be excluded.
Inflammasome Activation Via Circulating Metabolites

The clinical challenges confronting patients with HIV has shifted over the past 10 years from acquired immunodeficiency syndrome to chronic diseases including atherosclerosis, neurocognitive disorders, and osteoporosis. Chronic low grade inflammation and monocyte activation have been consistently associated with comorbidities in HIV patients. Indeed, recent studies indicate that inflammatory mediators including IL-6, IL-1, sCD14 and s CD163 produced by monocytes, but not T-cell activation, predict Non-AIDS-related events in virologically suppressed HIV-infected persons treated with combined antiretroviral therapy (cART), highlighting the important role of monocyte activation in the occurrence of comorbidities in cART-treated HIV infected patients. Yet, the underlying molecular pathways of persistent monocyte activation in cART treated HIV-infected patients remains incompletely characterized. Our preliminary results: 1/ establish a link between the activation of the inflammasome, the increased of pyrimidine-derived metabolites and the cardiovascular risk in a cohort of elderly patients; 2/ show that treated HIV-patients are characterized by increased soluble IL-1b or IL-18 in their blood suggesting that the inflammasome pathway is activated.

Objectives: In this study we will characterize the molecular pathways underlying persistent monocyte activation in treated HIV patients, through the implication of the activation of the inflammasome machinery: 1. Characterization of NOD like Receptor (NLR) expression in monocytes for IL-1b and IL-18 secretion (inflammasome activation); 2. Characterization of circulating metabolites that active the inflammasome machinery; 3. Evaluation of the link between the activation of the inflammasome, the increased of circulating metabolites and the non-AIDS related comorbidities.


Eligibility Criteria:
HIV patients :

Inclusion Criteria:

* Aged 18 years and above
* HIV-1 infected patients
* Enrolled in the CIADIS substudy of the ANRS CO3 Aquitaine cohort
* Patients receiving antiretroviral therapy
* HIV-1 RNA load below the detection limit of 40 copies/mL
* With a written and signed informed consent

Exclusion Criteria:

* HIV-2 or HIV-1/HIV-2 co-infection

Control patients :

Inclusion Criteria:

* Aged 18 years and above

Exclusion Criteria:

* HIV-1, HIV-2 or HIV-1/HIV-2 infection
Opioid Analgesic Reduction Study (OARS) - Pilot

The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.

A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and non-pregnant women who are at least 18 years of age, who are able to refrain from driving or operating heavy machinery while taking the study medication will be able to participate.
* Subjects who are English speaking and are able to provide consent will be considered.
* Subjects must be in generally good health and able to take ibuprofen, paracetamol (acetaminophen), and hydrocodone.

Exclusion Criteria:

Subjects who self-report the following history will be excluded from participating:

* Individual under the age of 18
* History of gastrointestinal bleeding and/or peptic ulcer
* History of renal disease (excluding kidney stones)
* History of hepatic disease
* History of bleeding disorder
* History of respiratory depression
* Any prior respiratory effect of an opioid or other anesthetic drug that required respiratory support postoperatively
* Active or untreated asthma
* History of known allergic reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia
* Currently taking any of the following medications:

  * CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression
  * CNS depressants.
* Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism
* History of drug or alcohol abuse (excludes marijuana use)
* Family history of drug or alcohol abuse in a first degree relative
* Has had one or more opioid prescription filled within the past 6 months
* Currently pregnant or lactating

Patients would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:

* Prior participation in this study
* Inability or refusal to provide informed consent
Effects of a Ketogenic Diet on PCOS Outcomes

The aim of the study is to investigate the effects of a low calorie Mediterranean ketogenic diet on Polycystic Ovary Syndrome (PCOS) related outcomes.

Fourteen overweight women with diagnosis of Polycystic Ovary Syndrome (PCOS) will undergo to a low calorie ketogenic Mediterranean diet with phyoextracts (KEMEPHY) for 12 week. Changes in body weight, body mass index (BMI), fat body mass (FBM), lean body mass (LBM), visceral adipose tissue (VAT), insulin, glucose, HOMA-IR, total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL(, triglycerides (TGs), total and free testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH); dehydroepiandrosterone sulfate (DHEAs), estradiol, progesterone, sex hormone binding globulin (SHBG) and Ferriman Gallwey score will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

diagnosis of PCOS according Rotterdam Criteria (at least 2 of 3 between

* oligo/anovulation
* hyperandrogenism
* clinical (hirsutism or less commonly male pattern alopecia) or biochemical (raised FAI or free testosterone) polycystic ovaries on ultrasound Other inclusion criteria
* fertile age (18-45 years);
* BMI\> 25 kg/m2,
* desire to lose weight;
* acceptance not to use contraceptives during the experimental period

Exclusion Criteria:

* pregnancy and lactation,
* hormonal therapy and/or insulin-sensitizers in the last 2 months,
* hepatic, renal and heart diseases
What is the Predictive Value of the Reflux Impact Scale

Gastric distress is a common phenomenon in our society. Heartburn and regurgitation occur daily in about 7% of the adult population,weekly 14-20% pf the adults and monthly in 34-44% of adults. The yearly prevalence of recurrent stomach complaints are frequent reason for consulting a primary care physician and are an important reason for using OTC medication. A good diagnosis is important as functional GERD with possible complications such as strictures and Barrett's esophagus or ulcer disease with life threatening complications such as bleeding \& perforations. The clinical diagnosis of reflux disease is mainly based on symptom evaluation. This, however, is hindered by the variety of complaints with different etiology. Treatment with a proton pump inhibitor can be used to confirm the diagnosis reflux disease. A major part of the patients with acid related stomach complaints indeed will experience symptom relief after starting PPI therapy. In this view, it is important to identify these patients who will react on treatment with PPI in quick, accurate, non-invasive and cheap manner. The Reflux Impact Scale (RIS) is validated, short, self explanatory questionnaire which asks for the presence \& impact of reflux symptoms. The RIS is developed for PCP to aid in the evaluation \& selection of these patient who will profit from treatment with PPI. The aim of this present study is to determine which questions of the RIS can be predictive for reaching treatment success with PPI. Treatment success is determined by asking for patients' satisfaction \& completion of the McMaster Overall Treatment Evaluation Heartburn questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients with symptoms of reflux disease and or regurgitation and/or retrosternal pain probably caused by acid during the previous 7 days and for which treatment with a PPI is started.

Exclusion Criteria:

* Use of PPI and/or H2-receptor antagonist in the month prior to participation in this study.
* Presence of alarm symptoms