cyrilzakka/clinical-trials huggingface dataset:
CD7 CAR-T for Patients With r/r CD7+ T-ALL/T-LBL

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 3-70
2. Diagnosis of r/r T-ALL/LBL.
3. CD7 positive expression
4. Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
5. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) \< 3×upper limit of normal, Total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl
6. Left ventricular ejection fraction ≥ 50% .
7. Baseline oxygen saturation ≥ 92% on room air.
8. ECOG performance status of 0 to 2.
9. The estimated survival time is more than 3 months.
10. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Sujects with concomitant genetic syndromes associated with bone marrow failure states.
2. Sujects with some cardiac conditions will be excluded.
3. History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
4. History of malignancy other than non-melanoma skin cancer or carcinoma.
5. Primary immune deficiency.
6. Presence of uncontrolled infections.
7. Sujects with some anticancer therapy before CAR-T infusion will be excluded.
8. Active uncontrolled acute infections.
9. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
10. Subjects who are receiving systemic steroid therapy prior to screening.
11. Subjects with acute graft-versus-host disease (GvHD)
12. Having received live/attenuated vaccine within 4 weeks prior to screening.
13. History of allergy to any component of the cell therapy product.
14. Pregnant or breastfeeding women
15. Any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.
RADx-UP- Impact of Community Health Worker Deployment

The proposed project will implement and evaluate a brief Community Health Worker (CHW) intervention through the Albany Area Primary Health Care, a rural Federally Qualified Health Center (FQHC). The primary goal of this study is to maximize effective outreach, education, and communication through CHWs in order to facilitate improved COVID-19 vaccine confidence and uptake in underserved and vulnerable communities. CHWs will be deployed to the homes of adults with increased risk of morbidity and mortality (i.e., African Americans or Latinos with uncontrolled diabetes or prediabetes, age \<50 years, and non-COVID-19 vaccinated) in order to educate them about diabetes, COVID-19 and related vaccines. Health assessments, including blood glucose measurement, will be conducted on the indexed patient and offered to all other adult family members in the household (i.e., "bubble"). Adults with Type 2 diabetes likely live in households with other adults who have or are at increased risk for diabetes (i.e., prediabetes and obesity).1 It is expected that they will also share similar COVID-19 exposure risk. The specific aims are to: 1) Evaluate a community-driven education program to increase and enhance COVID-19 vaccine confidence and uptake in individuals with uncontrolled diabetes and their families (i.e., their "bubble") and 2) Evaluate a community-driven education program to improve diabetes self-management behaviors and related outcomes (e.g., blood glucose) in individuals with uncontrolled diabetes in rural, Southwest Georgia.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be between18 and 50 years
* Self-identify as African American/Black or Latino
* English speaking
* Have received care for uncontrolled diabetes (HbA1c \> 9%) or prediabetes diagnosis within one of the AAPHC 27 community sites
* Unvaccinated for Phase 1 (vaccinated for Phase 2)

Exclusion Criteria:

* Not meeting the Inclusion Criteria
* Enrolled in the parent RADx-UP Project PEACH study
* Unable or unwilling to provide informed consent to participate in the study (ie: incarcerated individuals and children)
* Individuals with a terminal cancer diagnosis, have chronic kidney disease (stage 4-5), pregnant women, and people with severe psychological disorders (i.e., dementia,suicide ideation)
An Open Label, Single Centre Mass Balance C14 Study in Patients With Acute Myeloid Leukaemia (AML)

The purpose of the study is to assess how AZD1152 is absorbed or excreted in and out of the body in patients with Acute Myeloid Leukaemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission. Or, patients with newly diagnosed AML who are not considered to be suitable for standard induction and consolidation chemotherapy
* Ability to stay in hospital for up to 9 days on the \[14C\] AZD1152 treatment cycle.
* Subjects who have relapsed \> 1 year following myeloablative therapy with allogeneic bone marrow or stem cell transplantation may be eligible if they have no or limited evidence of extensive graft-versus-host disease

Exclusion Criteria:

* QTc interval ≥470 ms calculated from a single ECG reading or a mean of 3 ECG readings using Fridericia's or Bazett's correction
* Administration of hydroxyurea to control peripheral blood counts is prohibited within 24 hours prior to first dose of study drug
* Any chemotherapy or radiotherapy within 14 days prior to starting the study (not including palliative radiotherapy at focal sites)
The Asthma Breathing Record Study

The study involves a new device, called 'N-Tidal C', which uses a method that has the potential to predict when asthma attacks are about to happen. The device works by accurately measuring an individual's exhaled CO2 waveform. A person has to breathe in and out through the mouthpiece at their normal relaxed rate of breathing. It does not need any extra effort and therefore has considerable benefits over current breathing tests which require significant patient effort.

People with more severe asthma suffer from frequent asthma attacks that require regular hospital admissions. These attacks are difficult to predict and can devastate the lives of patients. A new tool is needed that can help to predict when an asthma attack is going to happen. This would help people recognise an attack earlier and allow treatment to be started sooner. This study will evaluate a new breathing monitor, to see whether it can detect asthma attacks. The study tests a new device, called 'N-Tidal C', which uses a method that has the potential to predict when attacks are about to happen. The investigators have found that people with asthma breathe out a gas, called carbon dioxide (CO2), in a different way to healthy people. The pattern of breathing out CO2 (the waveform) changes further when patients are having an attack of their disease. If patients could monitor their CO2, they may recognise when their asthma is getting worse, and take earlier action to avoid attacks getting out of hand and going to hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, aged ≥7 years.
2. Confirmed clinician diagnosis of asthma by examination of medical records, and based on accepted national and/or international criteria e.g. BTS/SIGN, or GINA.
3. Moderate or Severe asthma (defined as BTS stage 2-5)
4. Poorly controlled asthma (defined as an ACQ score of ≥1)
5. Exacerbation prone asthma (defined as at least 1 asthma exacerbation requiring oral corticosteroid treatment in the last 12 months).
6. Providing written informed consent, or parental/guardian consent and participant assent in the case of a child

Exclusion Criteria:

1. Inability to understand or comply with study procedures and/or inability to give fully informed consent.
2. Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would affect spirometry and/or other measures of lung function or TBCO2 measurements (including Breathing Pattern Disorder or Chronic Obstructive Pulmonary Disease).
3. Smokers (current or ex-smokers) with a \>10 pack year history.
4. In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently (for example, difficulty holding the device, or long periods of absence/travel) throughout the study period.
ENDOCUR - Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults

Chronic diseases such as diabetes, cardiovascular diseases and cancer are a major burden on the Scottish population. Obesity and inflammation have strong links to these diseases. One of the mechanisms explaining the relationship between low-grade inflammation and excess weight is "endotoxaemia". We wish to study this phenomenon, when small components coming from our gut bacteria can pass into the bloodstream, raising the body's defences. Diet can modulate endotoxaemia. In this study, we propose to use curcumin, in a capsule form, to modulate endotoxaemia. Curcumin comes from turmeric, which is widely used as a spice. In this study, we want to test the effect of consuming curcumin extract to the composition of the gut microbiota, post-meal endotoxaemia, and inflammatory markers in blood.


Eligibility Criteria:
Inclusion Criteria:

- BMI \> 25 kg/m2.

Exclusion Criteria:

* having chronic inflammatory or autoimmune disease, gastrointestinal complaints or known biliary obstruction (past and present)
* use of anti-inflammatory drugs 2 weeks before the start of the study
* use of antibiotics during the 12 weeks preceding the trial
* pregnancy
* lactation
Effect of Inhaled Molecular Hydrogen on Recovery Process After Downhill Walking on the Treadmill

This study assesses the effect of molecular hydrogen inhalation in healthy males on muscle soreness, fatigue, oxidative stress, and inflammation following eccentric muscle contraction during downhill walking on the treadmill.

The main aim of this randomized, double-blind, placebo-controlled crossover study is to assess the effect of molecular hydrogen inhalation on recovery after downhill walking with an additional load of 15% of body mass on the treadmill with a negative slope of -15% at a speed of 6.5 km/h for 90 min. The study includes 12 participants, healthy males aged 20-35 years. The study consists of two experimental sessions, one using molecular hydrogen inhalation and the other using placebo inhalation. Randomization is performed using a computer random generator. Molecular hydrogen is colourless, odourless, and tasteless, so it cannot be distinguished from placebo by the human senses. The washout period between sessions is set at four weeks. One week before each session, participants are asked to follow diet and physical activity rules. Variables measured during the 48 h recovery are as follow: creatine kinase level, perceived muscle soreness, reactive strength index, malondialdehydes level, and interleukin-6 level. The following variables are also measured during exercise: heart rate, ventilation and gas exchange, and blood lactate level. Analysis of variance for repeated measures and Fisher's post hoc tests are used for statistical analysis. The significance level is set at 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Free of major diseases.
* Completed questionnaire Sudden Cardiovascular Death in Sport: Lausanne Recommendations.
* Signed informed consent.

Exclusion Criteria:

* Acute conditions contraindicating laboratory testing of sports performance.
* Hypertension.
* Dyslipoproteinaemia.
* Cardiorespiratory disease.
* Pharmacotherapy affecting heart rate.
* Musculoskeletal problems.
Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults

Too few clinicians are able and willing to help autistic patients. A recent review identified challenges to mental health service delivery in autism, including a lack of interventions designed for community implementation and limited workforce capacity. It has been argued that improving impairment in emotion regulation has the potential to improve a range of mental health difficulties in autistic people. In this clinical trial, the investigators are comparing two evidence-based interventions for emotion regulation, to determine if one created specifically for autistic people is clinically superior. The interventions will be implemented in the community, through partnering agencies.

This study will compare the effectiveness of two transdiagnostic interventions for autistic adolescents and young adults - an intervention in widespread use among non-autistic populations (The Unified Protocol; UP) versus an autism-specific intervention (The Emotion Awareness and Skills Enhancement Program; EASE). The UP and EASE are ideal comparators because they are structurally equivalent and transdiagnostic - both shown to improve mental health outcomes that stakeholders identify as important, such as depression, irritability, and anxiety. The investigators will partner with 10 different community clinics in Pennsylvania and Alabama to recruit participants and facilitate the interventions. Each clinic will be randomized to use either UP or EASE. The investigators will look at effectiveness of the treatments, as well as the feasibility, benefits and harms.

Eligibility Criteria:
Inclusion Criteria:

* professional diagnosis of ASD
* a score in the clinical range on the EDI-Reactivity or EDI-Dysphoria scale based on caregiver report or self-report
* communicative ability (verbal or nonverbal)
* Clinician judgment that person could meaningfully participate and potentially benefit
* A caregiver or other adult with consistent contact who can complete assessments
* Client must live in Alabama or Pennsylvania

Exclusion Criteria:

* acute psychosis
* imminent suicide/homicide threat
* intoxication
* mania
Effect of Obstetric Anesthesia and Delivery Mode On Neurodevelopmental And Behavioural Outcomes In A Population-Based Birth Cohort

The study aims to determine:

1. The association between Obstetric anesthesia events at delivery (such as mode of anesthesia, drugs given, desaturation and hypotension) on pediatric neurodevelopmental and behavioural outcomes.
2. Mode of delivery on pediatric neurodevelopmental and behavioural outcomes.
3. Effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes.
4. To determine if these would differ between very preterm, moderate preterm, late preterm and term infants.

The study team hypothesise that:

1. Adverse maternal events during anesthesia and labor analgesia may be associated with poorer neurodevelopmental outcomes in infants.
2. Delivery via a lower segment caesarean section (LSCS) combined with a general anesthetic during delivery may be associated with adverse pediatric neurodevelopmental and behavioural outcomes.
3. The use of labour epidural analgesia is associated with poorer neurodevelopmental and behavioural outcomes.
4. These differences may be more pronounced in preterm infants as compared to term infants.

The relationship between the mode of delivery, type of anesthesia received, maternal anesthetic events at delivery and its effects on pediatric neurodevelopment and behavioral outcomes remains poorly defined with previous work showing conflicting results. Furthermore, previous studies have failed to take into account the potential effect of other antepartum anesthetic events such as the type of anesthesia, hypotension or desaturation. Furthermore, majority have failed to stratify between the subsets of premature infants, who may inherently be more susceptible to neurodevelopmental insult.

The GUSTO study is well-placed to provide unique insight with regards to these domains, due to its comprehensive, sensitive and specific follow-up of pediatric neurocognitive development and in-depth maternal anesthetic delivery data. Hence, previously collected, existing data from the Growing Up in Singapore Towards healthy Outcomes (GUSTO) cohort study will be utilized for this study.

This will be supplemented by additional maternal anesthetic and delivery data which the investigators aim to collect via a retrospective chart review.

Eligibility Criteria:
Inclusion Criteria:

* All mothers and infants recruited into the GUSTO database from 2011 to 2016, who underwent neurodevelopmental follow-up will be included in the study.

Exclusion Criteria:

* Children who dropped out of the study before 18 months of age
* Children who had subsequent exposure to general anaesthesia/surgeries/sedatives
Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults

The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.

This study is designed to assess safety and immunogenicity of four dose formulations of cytomegalovirus (CMV) vaccine (0.5 μg gB content with aluminum phosphate (alum), 1.0 μg glycoprotein B (gB) content with alum, 2.0 μg gB content with alum, or 1.0 μg gB content (without alum) as compared with placebo in approximately 125 healthy CMV-seronegative volunteer participants between 18 and 40 years of age.

Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy adult female and male 18 to 40 years of age, inclusive;
2. Serologically confirmed to be CMV seronegative at screening;
3. Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator
4. Sign an informed consent document indicating understanding of the purpose and procedures required for the study and willingness to participate in the study

Exclusion Criteria:

1. History of or current clinically significant medical illness or any other illness that in the opinion of the investigator interferes with the interpretation of the study results
2. Clinically significant abnormal physical examination, vital signs, or clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as determined by the investigator
3. Previous receipt of any cytomegalovirus vaccine
4. History of allergic reactions or anaphylactic reaction to any vaccine component
5. Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine
6. Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS
7. Chronic administration (defined as more than 14 days in total) of immune-suppressive or other immune-modifying drug with six months prior to the product dose (for corticosteroids, this is defined as prednisone ≥20 mg/day or equivalent). Inhaled and topical steroids are allowed
8. Participation in another clinical study within 30 days or plans to participate in another treatment based clinical study during the conduct of the present study
9. Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
10. Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease
11. Are family members of study center staff
Behavioral Family Therapy and Type One Diabetes

Behavioral family therapy, specifically focused on insuring support for the primary caregiver of a child with type one diabetes mellitus and healthy family dynamics, may improve the child's glycemic control as measured by hemoglobin A1c level (HbA1c).

The success or failure of type 1 diabetes mellitus (T1D) management in children depends not only on access to care, diabetes technologies and diabetes education, but also on the abilities of the patient and his/her family to carry out complex demands. Recent data show that family dynamics play a critical role in determining glycemic control in pediatric patients with T1D. The investigators prior work (Loomba-Albrecht and Glaser, unpublished data) suggests that the strongest determinants of glycemic control are factors related to the primary caregiver's involvement in supportive relationships with others, either a spouse or other family members. This provides a potential therapeutic target to improve outcomes for children with T1D.

Eligibility Criteria:
Inclusion Criteria:

* age 2 to 17 years
* newly diagnosed (within the past 12 weeks) with T1D
* seeking care at UC Davis

Exclusion Criteria:

- Families will be excluded if the child has severe underlying psychiatric, behavioral or medical conditions which could independently affect parental marital stress
Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia

Fondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous thromboembolism in high risk medical patients. A relevant proportion of these patients have renal insufficiency and/or thrombocytopenia which represent independent risk factors for bleeding. The risk of bleeding may be increased when fondaparinux is administered to patients with a reduced renal function and/or low platelet count. A lower dose of fondaparinux, 1.5 mg daily, has been approved for patients with renal insufficiency defined by a creatinine clearance between 20 and 50 mL/min. However, to our knowledge, there are no clinical studies that have specifically evaluated prophylaxis with fondaparinux in acutely-ill medical patients with a moderate to severe thrombocytopenia. The scope of this study is to evaluate the safety of fondaparinux in high risk hospitalized medical patients with a moderate to severe thrombocytopeniada defined by a platelet count between 100,000/uL and 30,000/uL.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years;
* hospitalization in an Internal Medicine Unit and a Barbar score of 4 points or above
* Platelet count between 100,000/uL and 30,000/uL
* written informed consent

Exclusion Criteria:

* Active bleeding or bleeding within the previous 3 months;
* Known bleeding diathesis;
* Active gastroduodenal ulcer;
* Severe renal insufficiency defined by a creatinine clearance below 20 mL/min;
* Ongoing treatment with unfractionated heparin, low-moleculr-weight heparin, fondaparinux, or oral anticoagulants Trattamento in corso con eparina non
* Prophylaxis with unfractionated heparin, low-moleculr-weight heparin, or fondaparinux for more than 48 hours;
* double antiplatelet therapy or acetylsalicylic acid at daily doses above 165 mg;
* planned invasive procedure during the period of thromboprophylaxis;
* Hemoglobin values below 9 g/dL;
* AST or ALT above 2 times the uper limit of normal;
* pregnancy or breast feeding;
* life expectancy lower than 1 month