cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Safety and Efficacy of CLL1 CAR-T in Patients With R/R AML

This is an open label, phase I study to assess the safety and efficacy of CLL1 CAR-T in patients with relapsed and refractory acute myeloid leukemia


Eligibility Criteria:
Inclusion Criteria:

1. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
2. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
3. The expression of CLL1 in AML blast is positive ;
4. The patient has recovered from the toxicity of previous treatment;
5. ECOG score ≤ 2 and expected survival period is not less than 3 months;
6. Adequate organ function defined as:

   AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%;
7. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;
8. From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia;
2. History or presence of a CNS disorder;
3. HBsAg or HBcAb are positive; HCV 、HIV and Syphilis antibody are positive, CMV DNA in peripheral blood is more than≥500 copies /mL;
4. History of severe hypersensitivity reaction;
5. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;
6. History of organ transplant surgery;
7. Required systemic application of immunosuppressive or other drugs;
8. Auto-SCT within the 3 months before enrollment;
9. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES));
10. Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ;
11. Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management;
12. Live vaccine received within the ≤ 4 weeks before enrollment;
13. Persons with serious mental illness;
14. History of major surgical operations four weeks before enrollment;
15. History of alcoholism or substance abuse;
16. Was identified by the investigators as unsuitable to participate in the study
Improving Substance Abuse Counseling Adherence Using Web-based Videoconferencing

This research is being done to compare the effectiveness of standard on-site, in-person counseling with Internet web-based videoconferencing (e-therapy) in drug-dependent patients in opioid-agonist treatment programs. The study is looking to see if there are any differences in satisfaction or in treatment outcome if counseling sessions are given by e-therapy compared to standard, in-person counseling given in the clinic. The e-therapy happens in real time- it works very much like standard therapy in the clinic except that the patient is in his or her own home (or other convenient location outside the clinic) and talks to and sees the therapist through an Internet connection on the computer (the therapist will usually be at the clinic).

This study will be the first to evaluate the efficacy of an accredited and currently available, Internet web-based videoconferencing platform to deliver routine schedules of counseling in an opioid agonist treatment program. It has outstanding potential to help determine transportability of this technology to other treatment programs by demonstrating the benefits of integration of web-based therapy with on-site services to expand the continuum of care.

Eligibility Criteria:
Inclusion Criteria:

* Access to a computer with Internet capability
* Full adherence to their routine counseling schedule over the previous 30-days
* Negative urine specimens over the previous 30-days
* Patient at ATS for 90 days

Exclusion Criteria:

* No access to a computer with Internet capability
Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke

To examine the association of subclinical hypothyroidism and risk of myocardial infarction and stroke in a large prospective cohort of post-menopausal women.

BACKGROUND:

Cardiovascular disease, including myocardial infarction (MI) and stroke, is the leading cause of death for women in the United States. Subclinical hypothyroidism (SCH), in which thyroid hormone levels are in the normal range but thyroid stimulating hormone (TSH) is elevated, has been linked to abnormal lipid profiles, atherosclerosis, and MI. The literature is scant however, and the evidence constrained by small studies, many of cross-sectional design. Both the US Preventive Services Task Force and the Institute of Medicine recently concluded that current data are insufficient to inform clinical decision-making about the need for screening or treatment for SCH.

DESIGN NARRATIVE:

This is a case-cohort study within the 93,676-member Observational Study of the Women's Health Initiative, including 800 women who have experienced an MI, 750 with thrombotic/embolic stroke, and a randomly selected subcohort of 3,200 women density-matched for age, race/ethnicity, and clinical center. Participants have extensive baseline demographic, health, behavioral, and physical exam data and stored serum available. The investigators will measure TSH and thyroid hormone levels in order to identify SCH at entry. Follow-up includes annual health status updates and a physical exam in the third year; \>=5 years have passed since enrollment for all women. Thus, using new laboratory studies and existing Women's Health Initiative (WHI) data, they will be able to answer these primary research questions: Among women without a history of thyroid disease, MI, or stroke: 1) Is subclinical hypothyroidism at baseline independently associated with risk of MI? 2) Is subclinical hypothyroidism at baseline independently associated with risk of ischemic stroke? 3) What form of association best describes the relationship between TSH, as a continuous measure, and risk of MI and stroke? 4) What are the population correlates (i.e., race/ethnicity, body mass index (BMI), hormone therapy, comorbidity) of SCH? This information - currently unavailable for middle-aged and older women - is germane to public health and health care policy to define the burden of illness associated with SCH, and to quantify the benefits and costs of eventual population screening and treatment

Eligibility Criteria:
No eligibility criteria
Determination of Blood Tumor Cells

Magnetic nanoparticles coated with anti-EpCAM or anti-CD52 antibodies will be tested ex-vivo in patients blood .

Magnetic nanoparticles, coated with epithelial cell adhesion molecule (EpCAM)-antibodies are designed to interact with epithelial tumor cells. Aim of this study is to see if circulating tumor cells (EpCAM as marker)can be removed out of the blood with the help of these particles. Patients suffering from prostate, colon, lung or pancreatic cancer will be asked to test their blood.

Similarly, magnetic nanoparticles will be coated with antibodies, directed against non-solid tumors in the blood such as lymphoma or leukemia (CD52 as marker).

Eligibility Criteria:
Inclusion Criteria:

Epithelial cell cancer, advanced stage Non-solid tumors (lymphoma, leukemia)

Exclusion Criteria:

Inability to understand the language of the center (German)
Reverse Phototherapy With Super Light-emitting Diode(Super-LED) for Hyperbilirubinemia in Term and Late Preterm Infants

The aim of this study is to compare the efficacy of super-LED reverse phototherapy with the fluorescent reverse phototherapy in term and late preterm newborns.

This is a randomized controlled clinical trial with hospitalized infants in the Professor Fernando Figueira Medicine Institute(IMIP), who require phototherapy as an indication of the medical team. Following the sample calculation, 144 patients will be randomized according to gestational age (350/7-376/7 or 380/7-416/7 weeks) to receive super-LED reverse phototherapy or fluorescent reverse phototherapy with spectral irradiance of 8-12 microwatts/cm2/nm.The bilirubin will be determined by micromethod with bilirubinometer, after blood collection in heparinized capillary until bilirubin reaches level that indicates suspension of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Newborns in the maternity Professor Fernando Figueira Medicine Institute(IMIP)
* Gestational age between 350/7 and 416/7 weeks
* Birth weight greater than 2200g
* Absence of congenital malformations
* indication of phototherapy after 48 hours of life
* Terms of consent signed by parent or guardian

Exclusion Criteria:

* Total Bilirubin level indicative of phototherapy intensive or exchange transfusion
* RH incompatibility hemolytic disease
* Mother's refusal to continue to participate in the study
* Unavailability of the two types of phototherapy equipment for randomization
* Mother or newborn who received phenobarbital
Impacts of Touch-massage on the Experience of Patients With Chronic Pain: a Mixed Study.

The main purpose of this study is to evaluate the impacts of Toucher-Massage on the experience of patients with chronic pain. The study takes place in two rehabilitation internal medicine services of the University Hospitals of Geneva at 2 inpatients units with 78 participants (39 per group).

This is a monocentric study with a design of non-randomized cluster trial with an exploratory qualitative part. The treatment is assigned to one of two care units and subjects are allocated to the care unit not according to a randomization process but based on administrative basis.

The main purpose of this study is to evaluate the impacts of Toucher-Massage (TM) on the experience of patients with chronic pain hospitalized in two rehabilitation internal medicine services.

The main objective is to measure the effects of TM on the global impression of change of the perception of pain.

The secondary objectives are:

1. Measure the effects on

   1. the severity and impact of pain
   2. anxiety/depression
   3. caregiver-patient interaction
2. Explore the experiences of patients benefiting from TM
3. Explore perceptions, resistance, barriers and facilitators regarding the proposed interventions with the health care teams of the units.

The population is patients suffering from chronic pain in two units of the internal medicine rehabilitation service at Beau-Séjour. The two units are similar in terms of care intake and populations cared for.

The required sample size is 78 participants (39 per group)

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized for a minimum of two weeks
* Suffering from chronic pain for more than 3 months
* Having sufficient command of French in reading, writing or speaking

Exclusion Criteria:

* Documented cognitive impairments, and jeopardizing their ability to discern
* Diagnosed with cancer that does interfere with foot massage (extremities metastases)
* Dermatological conditions that interfere with foot massage
* Suffering from major polyneuropathy
* Taking anticoagulants or bleeding disorders
* Being pregnant
* Having a pacemaker
MicrOwave and laSer ablaTion Study (MOST Study)

To validate the safety and efficacy of microwave versus laser ablation of the great saphenous vein in patients with varicose veins of lower extremities

A prospective, multicenter, randomized, controlled clinical trial to validate the safety and efficacy of microwave versus laser ablation of the great saphenous vein in patients with varicose veins of lower extremities

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older, not older than 80 years, male or female
2. Patients clinically diagnosed as primary great saphenous vein insufficiency with reflux lasting \> 0.5 seconds on duplex ultrasound
3. Patients with CEAP grade C2-C6
4. Patients who voluntarily participate in this trial, understand all the risks and benefits described in the informed consent document, and sign the written informed consent form

Exclusion Criteria:

1. Patients with diameter of target lesion vein \< 2 mm or \> 15 mm
2. Patients with previous surgical treatment on the target lesion or patients with acute thrombosis
3. Patients with deep vein thrombosis and superficial vein thrombosis
4. Patients with acute systemic infectious diseases
5. Patients with severe liver and kidney dysfunction (ALT \> 3 times the upper limit of normal value; creatinine \> 225 umol /L)
6. Patients with known uncorrectable bleeding or severe coagulopathy
7. Patients with anesthesia contraindications
8. Patients with poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) and diabetes mellitus (fasting glucose ≥ 10.0 mmol / L)
9. Patients with non-primary varicose veins caused by post-deep vein thrombosis syndrome, KT syndrome (Klippel-Trenaunay syndrome), arteriovenous fistula, etc.
10. Patients with other diseases that may cause difficulty in conducting the trial or evaluation, such as mental illness, AIDS, malignant tumors, liver disease, cardiac insufficiency, etc. or patients whose life expectancy is less than 1 year
11. Pregnant, lactating women, or those planning on becoming pregnant during the trial
12. Patients who have participated in clinical trials of other drugs or medical devices in the past 3 months
13. Patients considered unsuitable for inclusion by investigators for other reasons
Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction

The objective of the present study will be to evaluate the efficacy of photobiomodulation (PBM) with LED in pain control, facial edema, paresthesia, bone repair and quality of life arising after maxillar surgical disjunction (MSD). A randomized, double-blind, placebo-controlled clinical trial involving 72 participants aged 18 to 45 years, who search the Service of Oral Maxillofacial Surgery and Traumatology of the Mandaqui Hospital Complex to undergo MSD, attend to the eligibility criteria and agree to participate. Surgeries will be conducted by three oral maxillofacial surgeons who will perform all surgical procedures, two examiners (who will perform pre and post-surgical evaluations, blinded to the experimental group) and another researcher who will perform the LED application. Before the surgeries, facial measures, radiographic examinations, tests of facial and oral sensitivity and the evaluation of the level of anxiety of all the participants will be carried out. Immediately after the surgeries, the participant will be inserted into the placebo group or the LED group, according to block randomization defined previously. In the LED group, the participants will receive PBM with an extraoral device (660 and 850 nm with 6J per point) and an intraoral one (660 nm with 2J per point) and in the control group the participants will be attended in the same way, but with the LED devices kept off. The applications will be in the immediate postoperative period, 1, 2, 7, 14, 30, 60, 90 and 120 days after the end of the surgeries, when the evaluations will also be performed. Facial measurements, extra and intraoral sensitivity, pain and bone repair will be evaluated. Secondarily, the data regarding the occurrence of headache; otalgia; nausea; bruise; nasolacrimation; epistaxis; dysphagia; systemic and superficial temperature in the operated region; use of analgesics and anti-inflammatories; anxiety and impact of oral health on the participants' quality of life will be computed.


Eligibility Criteria:
Inclusion Criteria:

* Transverse maxillary deficiency ˃ of 5 mm with bilateral posterior crossbite and indication for surgical maxillary disjunction.
* Agree to participate in the study after reading and signing the Term of Consent for Participation in Clinical Research.

Exclusion Criteria:

* Transverse maxilla deficiency, with unilateral posterior crossbite.
* Local or systemic alterations that contraindicate surgical intervention or hinder the postoperative period.
* Smokers.
* Display photo sensitivity history.
* Possess systemic diseases, chronic pain or neurological and psychiatric disorders.
* Have been using anti-inflammatories, analgesics or bisphosphonates in the past 15 days.
* Pregnant.
* Breastfeeding.
* Participants who present any type of complication during surgery (hemorrhage, operative difficulty), as these cases will not be in the expected pattern for these surgeries. These data will not be part of the statistical analysis but will be described and discussed, as well as possible adverse effects.
Safety and Feasibility of Early Active Rehabilitation in Children After Concussion

It has been suggested that activity immediately following concussion is detrimental to recovery and may lead to long term impairments. The animal model has shown that exercise too soon can lead to neurometabolic energy imbalances within the brain. However, there is also evidence to suggest that prolonged inactivity has negative consequences that may contribute to prolongation of symptoms. Determining the ideal timeframe in which to initiate an active rehabilitation protocol for patients who are slow to recovery is an important factor in concussion management.


Eligibility Criteria:
Inclusion Criteria:

* referred to the mTBI clinic of the MCH for atypical recovery (defined as the presence of symptoms with little improvement at 10 days post-injury preventing them from entering standard return to activities protocols)

Exclusion Criteria:

* co-morbidity preventing children from participating in intervention
Prevention of Severe Acute Graft-versus-host Disease in Adult Patients Using a daGOAT Model

To evaluate the efficacy and safety of ruxolitinib for prophylactic therapy of adult patients who are predicted to have a high risk for developing severe acute graftversus-host disease (aGVHD) by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model.

This study aims to prospectively evaluate the use of the daGOAT model in real-world clinical settings at the Institute of Hematology, Chinese Academy of Medical Sciences (IHCAMS).

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be \> 16 years of age;
2. Patients receiving human leukocyte antigen mismatched and non-cord blood allogeneic hematopoietic stem cell transplantation;
3. Patients who can take oral medication;
4. Patients have to sign an informed consent form before the start of the research procedure.

Exclusion Criteria:

1. Tandem transplantation or multiple transplantations;
2. Patients who are allergic to or cannot tolerate ruxolitinib ;
3. Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements ;
4. Patients who are pregnant or cannot take appropriate contraceptive measures during treatment;
5. Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.
Does Choice Improve the Pain Relief Derived From a Brief Intervention

This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience.

This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience. Participants will be randomized to one of three conditions: 1) a 4-minute pain psychoeducation recording, 2) a 4-minute mindfulness recording, or 3) choice. In the choice condition, participants will be able to choose which recoding (i.e., pain psychoeducation or mindfulness) they would like to listen to.

Eligibility Criteria:
Inclusion Criteria:

* Receiving pain treatment at Tallahassee Orthopedic Center
* Understanding English instructions fluently
* Being 18 years of age or older

Exclusion Criteria:

* Unable to consent because of physical or mental incapacity.
rTMS in Overactive Bladder

Overactive bladder (OAB) imposes a significant quality of life, mental health, and economic burdens. OAB with or without Urgency incontinence is associated with depression, sexual dysfunction, and limitation of social interactions and physical activities, which significantly affects quality of life.

Non-invasive neuromodulation with repetitive transcranial magnetic stimulation (rTMS) can be used in research settings to investigate responses to focal regional brain activation. In the clinical setting, rTMS normalizes brain activity with associated clinical benefits in conditions such as refractory depression. rTMS has been studied for effects on lower urinary tract symptoms (LUTS) in bladder pain and neurogenic lower urinary tract symptoms (LUTS) populations.

Unlike many standard of care OAB interventions, the safety of rTMS is well-reported, including for use in elderly populations and those with cognitive impairment. Functional magnetic resonance imaging (fMRI) to evaluate neuroplasticity is emerging as an essential tool to define OAB phenotypes; however, phenotyping studies guided by mechanistic data are lacking. The effects of central neuromodulation on regions involved OAB mechanisms and associated physiological and clinical responses are unknown. This study will be the first to report neuroplasticity, physiologic, and clinical effects of central neuromodulation with rTMS in adults with OAB.

This prospective trial will enroll eligible adults with OAB recruited from Urology and urogynecology clinics. Subjects have a baseline evaluation with questionnaires, clinical data, and fMRI to assess brain activity during urinary urgency. All subjects receive the intervention: 5 daily sessions of rTMS to regions of interest. Electromyography will assess pelvic floor muscle activity at rest during rTMS. Following the intervention, an evaluation with questionnaires, clinical data, and fMRI is repeated.

Eligibility Criteria:
Inclusion Criteria:

* Females \& Males
* 40 to 80 years old
* 3 months of OAB symptoms without active urinary tract infection currently
* Bladder diary:

  * Mean voids/24 hours ≥ 8.0
  * Mean urgency episodes/24 hours ≥ 3.0
* Montreal Cognitive Assessment (MoCA) score \>10

Exclusion Criteria:

* Pregnant, nursing, or self-report of planning to become pregnant.
* Contraindication to MRI or to the Rapid2 Magstim Device as listed in the operator manual
* Qmax \< 10 ml/s in males on uroflow
* \< 20th percentile on Liverpool nomogram
* Postvoid residual volume ≥ 200 mL, suprapubic or indwelling catheter
* Personal or immediate family history of seizure disorder
* Taking (bupropion) Wellbutrin or heavy alcohol use
* Parkinson's disease, Multiple sclerosis, spinal cord injury
* Intracranial lesions and hemorrhagic stroke within the last 12 months
* History of interstitial cystitis, pelvic radiation, bladder augmentation
* Intradetrusor botulinum toxin injections within 6 months
* Pelvic floor therapy within 2 months.
* Active/on-mode Sacral nerve stimulator (eligible if turned off)
* Incarcerated patients