cyrilzakka/clinical-trials huggingface dataset:
Blinatumomab Maintenance After Allo-HSCT

To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia.

Blinatumomab is a novel immunological antibody based on BiTE. CD19 is a surface antigen expressed throughout the development of B lymphocytes, making it an ideal target for immunotherapy. Blinatumomab was approved by the FDA for the treatment of adults with relapsed/refractory cancers. Open-label, single-arm, multicenter phase II clinical study (BLAST study) , enrolling 116 adult patients with precursor B-ALL in complete hematologic remission after at least 3 doses of intense chemotherapy but persistently positive for Measurable Residual Disease (MRD) (MRD ≥10-3 ), which is the first ALL international multicenter clinical trial. In August 2022, China's National Medicines and Pharmaceutical Administration (NMPA) Approved Blinatumomab for the treatment of relapsed/refractory precursor B-cell ALL in adults.

Blinatumomab is mostly used for preemptive therapy after post-transplant MRD conversion, and fewer prospective studies have been conducted in the area of maintenance therapy. A prospective single-arm clinical study (NCT02807883) with Blinatumomab as maintenance therapy (up to 4 cycles) after allogeneic transplantation, concluded by MD Anderson in August 2021, had the primary endpoints of safety (acute graft-versus-host disease \[aGVHD\] and non-relapse mortality \[NRM\]) and the secondary endpoints of efficacy (PFS, OS, etc.), a total of 23 patients were enrolled in patients who received at least 1 cycle of Blinatumomab, the interval between transplantation and the first cycle of Blinatumomab use was 78 days (44-105), 57% of the patients completed 4 cycles of treatment, the median follow-up was 14.3 months, the 1-year NRM was 0%, the incidence of grade 3-4 aGVHD was 5%, the 1-year OS was 85%, and the 1-year PFS was 71%. There was a trend toward benefit in PFS and OS curves between the two groups. Although this study is an exploratory study, data from applied studies in the post-transplantation maintenance phase suggest that this immunotherapy may be termed as a new, better and safer option.

Therefore, the investigators conducted a multicenter, randomized, controlled study based on retrospective research to further explore and validate the safety and efficacy of Blinatumomab as a maintenance therapy after high-risk B-ALL allogeneic transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Age 16-65 years
2. Diagnosis with acute B-lymphoblastic leukemia (B-ALL) expressed CD19
3. High-risk group B-ALL
4. Have suitable hematopoietic stem cell donors
5. No dysfunction of vital organs

Exclusion Criteria:

1. CR/MRD negative before blinatumomab maintenance
2. Active hepatitis B
3. HIV-infected
4. Active infections; acute and chronic GVHD requiring systemic immunosuppressive therapy;
5. severe impairment of vital organ function
6. Those judged by the investigator to be unsuitable for participation in this trial.
Ultrasound Guided Pectoral Nerves Blockade for Persistent Pain After Breast Cancer Surgery

This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain after breast cancer surgery.

This study is in 2 parts: Part 1 is a description of the anatomy of the PECS block in pain free, unoperated patients using ultrasonography (non invasive). Part 2 is the administration of the block to patients that have persistent pain after breast cancer surgery. Before and after the block we will take a detailed pain history and do neurophysiological tests called quantitative sensory testing (QST). These tests assess the patients' ability to feel warmth, cold and test their thresholds for pain. The block is then administered using ultrasound guidance and 20mls of 0.25% bupivacaine is injected in the pectoral muscles on the side with pain. Thirty minutes after the block, the pain is re assessed and the QST is repeated.

Eligibility Criteria:
Inclusion Criteria:

* Female patients, aged 18 years or over, treated for breast cancer
* Patients with persistent pain in the breast after surgical treatment for breast cancer. Their pain score must be 4 or more on the numerical rating scale (NRS).

Exclusion Criteria:

* breast surgery within the last 12 months
* previous cosmetic surgery
* bilateral breast cancer (receiving bilateral intervention)
* pregnant or breast feeding
* neurological disease
* on-going treatment for severe mental illness or who abuse alcohol or drugs
* are unable to understand written or spoken Danish or English
* lack mental capacity to give informed consent or cooperate with the neurophysiological testing
* an allergy to amide local anaesthetics
* pacemaker in situ
* received treatment outside guidelines and recommendations from the Danish Breast Cancer Co-operative Group (DBCG)
A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age

Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.


Eligibility Criteria:
Inclusion Criteria:

* CHILDREN HAVE SYSTOLIC BLOOD PRESSURE AT A LEVEL =\>95th PERCENTILE FOR AGE/GENDER/HEIGHT
* CONSENT FROM PARENT(S)/GUARDIAN(S) MUST BE GRANTED

Exclusion Criteria:

* BLOOD PESSURE IS =\>5% HIGHER THAN 99th PERCENTILE FOR AGE
* SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON PHYSICAL EXAMINATION, AND LABORATORY AND OTHER ASSESSMENTS

Other protocol-defined inclusion/exclusion criteria will also apply.
Harnessing the Power of Technology: MOMBA for Postpartum Smoking

Through a smartphone platform, financial incentives for smoking abstinence in postpartum women can be delivered remotely, thus minimizing the need for participants to come to the office to receive traditional contingency management.

The specific aims of the proposal are:

1. To develop through a 15-month pilot study, a novel smartphone-based system, Momba Smoking, that can be used in further relapse prevention trials for postpartum smokers.
2. To determine, through a pilot randomized controlled trial, the potential feasibility, acceptability, and methodological parameters that are necessary to design a subsequent, appropriately powered, randomized controlled trial of the Momba Smoking smartphone-based system.
3. To advance discovery and understanding on the use of technology to translate smoking cessation interventions from clinical to community settings through the training of the next generation of scientists.

Eligibility Criteria:
Inclusion Criteria:

* Women who are over the age of 18
* Speak English
* Second or third trimester of pregnancy
* Smoking in the third trimester of pregnancy
* No complicating general medical or psychiatric conditions (including marijuana use).

Exclusion Criteria:

* Receiving other smoking cessation medication
* Planning to move out of New Haven in the next 15 months
* Actively suicidal, psychotic or unable to provide informed consent
Induction of Neutrophilic Traps ( NETs ) by the Environment and Infectious Inflammatory Lung Cystic Fibrosis

The study is defined in 3 stages of in vitro assays :

Phase 1 : Secretion of NETs in response to lung disease and their secretion of factors.

This is a transversal study in which we compare :

* Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of patients
* Producing NETs (DNA and proteases ) by purified neutrophils in the blood of patients and blood of control subjects

Phase 2: Mechanisms of activation of NETs secretory pathways . This phase will identify receptors (TLR ) involved in the secretion of NETs and analyze the involvement of dependent transduction pathways calcium and PKC . It will be performed on control blood neutrophils.

Phase 3: Analysis of cell death ( NETose )

This is a transversal study that will analyze :

the mode of cell death of neutrophils purified blood and sputum of patients and control blood neutrophils by flow cytometry and transmission electron microscopy .


Eligibility Criteria:
Inclusion Criteria:

Patients :

* Men or women over 18
* Patients with mucoviscidose in stable condition, i.e. not having presented an acute push of bronchopulmonary attack requiring a antibiothérapie or a hospitalization for treatment of its disease during the 2 previous weeks
* Signed consent

Volunteers :

* Men or women over 18
* Without respiratory antecedent nor known respiratory pathology
* Signed consent

Exclusion Criteria:

Patients :

* In exclusion period of an other study

Volunteers :

* In exclusion period of an other study
* Antibiotic treatment and/or anti-inflammatory drug (AINS or corticoids) in the 2 weeks before inclusion in the study
Establishment of Big Data Platform and Biobank for Colorectal Tubular Adenoma Lesions

Colorectal tubular adenoma is the most common precancerous lesion of colorectal cancer, and the point is that its precise prevention and treatment can reduce the incidence of colorectal cancer.However, the epidemiological characteristics of colorectal tubular adenoma in China are unclear, the rate of missed diagnosis by colonoscopy is high, and the existing diagnosis and treatment techniques are lack of unified quality control standards,which makes it difficult to diagnose and achieve accurate prevention and control. How to improve the precise prevention and treatment of colorectal tubular adenoma and reduce the incidence of colorectal cancer is a major clinical scientific problem that needs to be solved urgently. For this purpose, this study was conducted in colorectal guided by the needs of accurate prevention and treatment of tubular adenoma lesions,and a multi-center colorectal tubular adenoma data management platform and a high-risk population database covering a full range of data including demographic characteristics, lifestyle factors, clinical information, endoscopic data and pathological images were established, biological sample databases of patients with pathological changes and high-risk populations were established, and data quality control and sample quality control standards were formulated standards-based.

The pathological prediction model and accurate risk assessment system of colorectal tubular adenoma were constructed by the pathological database.


Eligibility Criteria:
Inclusion Criteria:

Voluntarily sign informed consent; Colorectal tubular adenoma was diagnosed according to JSGE clinical guidelines They are between 18 and 70 years old

Exclusion Criteria:

Refuse to sign the informed consent Patients who were judged by the investigator to be unsuitable for participation in this study.

The diagnosis is not tubular adenoma of colorectal or other adenomas according to JSGE clinical guidelines Age \< 18 or \> 70
Efficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence

The purpose of the study is to determine if cytidine 5'diphosphocholine (CDP-choline, a naturally occurring chemical in your body) has efficacy in reducing the methamphetamine craving of the subjects with methamphetamine dependence craving and helping them maintain the abstinence. In addition, investigators will measure the brain N-acetyl aspartate (a biologic marker for neuronal viability) level of participants to determine if brain deficits induced by methamphetamine may recover by taking CDP-choline.


Eligibility Criteria:
Inclusion Criteria:

* 19-60 year-old male or female
* Methamphetamine dependence diagnosed by DSM-IV
* Total cumulative dose for methamphetamine during the last two years: over 10 gram (over 200 shots of 0,05 mgram intravenous methamphetamine injection)
* Methamphetamine use in recent 4 weeks
* Subscale score of drug use in ASI: \>2

Exclusion Criteria:

* Significant current or past medical, neurological, or psychiatric co-morbidity including cardiovascular, renal, and endocrine disorder, as identified by medical history
* Lifetime axis I psychiatric disorders of bipolar disorder, schizophrenia, identified by SCID-IV
* Socially dysfunctional antisocial personality disorder
* Current alcohol or nicotine dependence identified by SCID-IV
* Taking psychotropic medication in recent two months
* Head trauma history with loss of consciousness or seizure
* Intelligence quotient \< 80
* Pregnant subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded. Female subjects who are of child-bearing potential will have to pass a urine pregnancy test before each visit.
* Any contraindication to an MR scan
Length of Effect of Extended Release Aspirin on Platelets in Patients With Diabetes and Heart Disease

This study is being conducted to evaluate the safety and the length of effect on platelet build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus and cardiovascular disease or multiple risk factors of developing cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-lactating, non-pregnant female subjects
* A history of Type 2 Diabetes and with history of at least one of the following: Coronary Artery Disease, Peripheral Vascular Disease, or Ischemic Stroke, along with at least 2 CVD risk factors (obese, smoker, ≥ 55 years of age, prior thrombotic event)

Exclusion Criteria:

* Sensitivity to aspirin or any NSAID (nonsteroidal antiinflammatory drug),
* Evidence of uncontrolled or unstable cardio- or cerebrovascular disorder,
* Presence of uncontrolled or chronic medical illness, GI disorder or surgery leading to impaired drug absorption, clinically significant abnormal baseline ECG, history of hepatitis, malignancy within the past five years, or HIV, history of alcohol or drug abuse.
Longitudinal Study of Chronic Postsurgical Pain in Children and Adolescents

Chronic postsurgical pain is defined as pain that develops or intensifies following a surgical procedure. After major surgery, around 20% of children and adolescents develop chronic postsurgical pain, and, as part of it, negative consequences on their quality of life. Emotion-related factors such as the variability of emotions, how emotions are regulated, and how well someone is able to differentiate between different emotions have in part been studied in other types of chronic pain. To date, no study examined emotion-related factors in the development and maintenance of chronic postsurgical pain. This observational study includes five assessment time points, one before and four after major surgery, with the goal to identify emotion-related factors that increase or decrease the risk for the development of chronic postsurgical pain.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged between 8 and 18 years
* Planned orthopedic surgery requiring in-patient care in one of the participating children's hospitals
* Able to read and understand German

Exclusion Criteria:

* Serious comorbid health condition (e.g., cancer, severe neurological impairment, chronic illness requiring daily medication)
* Prior major orthopedic surgery (e.g., prior spine surgery)
* Parent/caregiver and child not able to read and understand German
Sleep-Disordered Breathing and PAP in Perinatal Depression

The goal of this study is to understand the contribution of sleep-disordered breathing (SDB) to one of the most common and debilitating adverse pregnancy outcomes, perinatal depression. The study is a randomized trial to test the efficacy of positive airway pressure (PAP) on sleep and depression symptoms in perinatal women. Participants will be pregnant women with depression and sleep-disordered breathing. Participants will be randomly assigned to receive either PAP therapy (PAP group) or treatment as usual within obstetrics (TAU group). Mood and sleep assessments will be completed at baseline, after 1 week of enrollment, and monthly thereafter through 12 weeks postpartum. Cortisol will be measured using saliva collection at baseline and again 8 weeks later.


Eligibility Criteria:
Inclusion Criteria:

* 20-32 weeks gestation with a single, live fetus
* meet criteria for major depressive disorder per the Structured Clinical Interview for DSM-V (SCID)
* respiratory distress index (RDI; includes apneas, hypopneas, and respiratory effort-related arousals)≥5 per ambulatory assessment plus apnea symptoms (snoring, witnessed apnea, daytime sleepiness, sleep disturbance, snort arousals)
* stable dose (for ≥8 weeks) of a selective serotonin reuptake inhibitor (SSRI) OR free of all antidepressant medications past 4 weeks
* obstetrics care is at the University of Michigan, and the woman plans on delivering her baby at the University of Michigan

Exclusion Criteria:

* Diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V
* diagnosis of, or suspicion for, narcolepsy or REM behavior disorder
* current SDB treatment; medical conditions for which PAP is contraindicated (e.g., pneumothorax, pneumocephalus, recent trauma, recent surgery)
* evidence of risk for drowsy driving (excessive daytime sleepiness plus history of motor vehicle accident or near miss due to sleepiness, fatigue, or inattention in past 12 months).
Comparison of Intraoperative Volume Replacement Determined by the Plethysmograph Variability Index (PVI) With That Determined by the Delta PP in the Digestive, Gynecological, Urological, and Abdominal Surgery and Their Impact on the Length of Stay

An optimal intraoperative fluid replacement reduces the hospital stay, the admissions in the intensive care unit and the mortality rate after a major surgery.

Different criteria are used to guide the optimal vascular filling of a patient. Among the various monitoring for the last twenty years are parameters originating from the respiratory variations of the arterial pressure curves and the pulse oximetry.

On arterial curves, the Systolic Pressure Variation (SPV) is the difference between the maximum systolic pressure (DeltaUp) and the minimal one (DeltaDown).On the oxygen saturometry curves obtained with the Masimo Radical7, the plethysmographic variability index (PVI) corresponds to the formula (PImax-PImin/PImax X 100%) where PI corresponds to the quotient expressed in % between the pulsed infrared absorption signal and the continuous absorption signal.

It has been demonstrated that the dynamic indexes were better than the static indexes to determine the response to the vascular filling. A meta-analysis showed that the dynamic changes of the variables derived from the arterial pressure curve of patients under mechanic ventilation could predict the vascular filling responsiveness with a high specificity and sensibility. The same thing applies to the variables derived from the pulsed oxymetry curves.

Furthermore, monitoring and minimizing, through the vascular filling, the variations of the pulsated arterial pressure (delta PP) induced by the mechanic ventilation during a high risk surgery allows to reduce the postoperative complications and the hospital length of stay. This has not yet been proved for the non invasive parameters (IP and PVI).

The goal of this study is thus to compare a non invasive strategy (based on PVI) to an invasive strategy (based on the deltaPP) of perioperatory filling during abdomino-pelvic interventions (digestive, gynecologic, urologic), in order to test their equivalence and measure their impact in terms of hospital stay.

This record is linked to the NCT02709252 record and share the same cohort of patients.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal-pelvic surgery (digestive, gynecologic, urologic) with laparotomy or laparoscopy
* Surgery duration superior to 1 hour

Exclusion Criteria:

* ASA score of 4
* BMI \> 35
* supraventricular arrythmia (isolated extrasystoles excepted)
* cardiac insufficiency (F.E \< 25 %)
* severe peripheric vascular affections
* severe respiratory affections
* terminal renal insufficiency (creatine clear and \< 30 mL/min)
* gelatin allergies
The Impact Of Fascia Thickness on Chronic Low Back Pain

This study aimed to investigate the impact of lumbar perimuscular and subcutaneous zone thickness on pain, functionality, disability, and depression in individuals with chronic low back pain (CLBP).

This study investigates the role of the thoracolumbar fascia (TLF) in chronic low back pain (CLBP) persisting for more than one year. Specifically, the researchers aim to examine the relationships between various factors in individuals with CLBP, including the thickness of the perimuscular and subcutaneous regions in the lumbar and hamstring regions. The relationship with functional tests of the lower back and lower limbs will also be analysed. In addition, the intensity of the pain experienced by the participants, the extent to which the pain restricts their daily activities, and depression scores will be assessed. Through this analysis, the researchers aim to gain a deeper understanding of TLF's involvement in CLBP and its impact on the overall well-being of affected individuals.

Eligibility Criteria:
Inclusion Criteria:

* The absence of LBP in the last 12 months,
* A body mass index (BMI) of 18.5 to 30,
* An age between 30 and 50 years.

Exclusion Criteria:

* History of musculoskeletal diseases,
* a history of back and lower limb surgery,
* the use of anti-inflammatory drugs and steroids