cyrilzakka/clinical-trials huggingface dataset:
CART19 in Adult Patients With Minimal Residual Disease During Upfront Treatment for ALL

This is a single center, single arm, open-label phase 2 study to determine the efficacy of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART19" cells) in adults with minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic leukemia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with CD19+, B cell Acute Lymphoblastic Leukemia (B-ALL) who have 0.01%≤MRD\<10% during upfront treatment
2. Patients must be within 18 months of initial ALL diagnosis
3. Age ≥18 years
4. Adequate organ function defined as:

   1. Creatinine ≤ grade 2
   2. ALT/AST ≤3x upper limit of normal range for age
   3. Direct bilirubin ≤2.0 mg/dl
   4. Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia
   5. Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA
5. Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy.
6. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood
7. Adequate performance status defined as ECOG Performance Status 0 or 1
8. Provides written informed consent
9. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol

Exclusion Criteria:

1. Active, uncontrolled infection
2. Active hepatitis B or hepatitis C
3. HIV Infection
4. Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 2)
5. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment.
6. Pregnant or nursing (lactating) women
7. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
Predictors of Treatment Outcome for Smokers With and Without Schizophrenia

The primary purpose of this investigation is to determine the predictive value of task persistence as measured by a mirror tracing task. A secondary purpose is to evaluate differences in task persistence in smokers with or without schizophrenia. It is hypothesized that task persistence in smokers in both diagnostic categories (schizophrenia and no schizophrenia) will predict tobacco dependence treatment outcome at one and six months. It is also hypothesized that smokers with schizophrenia will show lower levels of task persistence after controlling for other motor skills than smokers without schizophrenia.

Please see brief summary above.

Eligibility Criteria:
Inclusion Criteria:

* Current smokers must be over the age of 18,
* Must fit into the diagnostic groups schizophrenia / schizoaffective disorder; or the non-schizophrenia group.
* Must smoke at least 10 cigarettes per day
* Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22.

Exclusion Criteria:

* Those unable to give informed consent.
* Psychotic disorders other than schizophrenia
Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry

In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will grow significantly and therefore, meticulous prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.

The study is a prospective multicenter evaluation of transcatheter aortic valve-in-valve implantations in Polish health centers.

Duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Failing surgically implanted aortic bioprosthetic valve (stented/stentless/homograft) demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
* Qualification for TAVI by decision of the local Heart Team
* Patient provided written informed consent
Internet-based Affect Focused Psychodynamic Therapy for Neuroticism: a Randomized Controlled Trial

The purpose of the study is to investigate if internet delivered affect-focused psychodynamic therapy (IPDT) leads to lowered levels of trait neuroticism compared to a wait-list control condition. The target group is adults (18+) who experience mild to moderate symptoms of anxiety and/or depression. The IPDT treatment consists of 8 modules that the participants will work with for 9 weeks, with therapist support. Participants will be recruited in Sweden with nationwide recruitment.

This study is a randomized controlled trial with the aim to investigate if IPDT leads to lowered levels of trait neuroticism. Participants will either be randomized to the treatment which is based on Affect Phobia Therapy or to a wait-list control. Participants will have weekly contact with a therapist who will provide feedback and support.

Primary outcome measure is trait neuroticism (measured on the 24-Item Neuroticism scale of the IPIP-NEO-120). Secondary outcome measures will include measures of anxiety, depression, quality of life, emotion regulation, and defense mechanism adaptiveness. Emotion regulation and short measure of anxiety and depressive symptoms will be collected weekly throughout the treatment period. Pre-treatment measurement, post-treatment measurement, weekly measure, and one-year follow up is planned to be collected through an online survey.

Eligibility Criteria:
Inclusion Criteria:

* Score 5 points or more on either the PHQ-9 or GAD-7
* 18 years or older
* Ability to speak, read and write in Swedish
* Have access to the internet and a smartphone, computer or other device

Exclusion Criteria:

* Severe psychiatric or somatic illness that makes participation difficult or impossible
* Ongoing addiction
* Acute suicidality
* Other ongoing psychological treatment
* Recent (within the latest month) changes in the dose of psychotropic medication or planned change of dose during the treatment weeks
Erector Spinae Plane Block Versus Local Wound Infiltration After Modified Radical Mastectomy

This randomized prospective double blinded study will aim to evaluate the postoperative analgesic effect of ultrasound guided Erector Spinae plane block and local wound infiltration (drain block) for patients scheduled for modified radical mastectomy surgery.

Breast cancer is the most commonly diagnosed cancer worldwide and it represents 1 in 4 cancers diagnosed among women globally. Modified Radical Mastectomy (MRM) is a commonly performed surgery for breast cancer and is associated with moderate-to-severe postoperative pain. Poor postoperative pain management can lead to increased chances of the development of chronic pain. Therefore, adequate postoperative pain management after breast cancer surgery is essential. Regional block for pain management has many advantages in such patients including provision of adequate analgesia, reduced need for opioids, decreased postoperative nausea \& vomiting and postoperative pulmonary complications. It also facilitates early ambulation. Thoracic Epidural (TE), paravertebral block (PVB), pectoral nerve I \& pectoral nerve II blocks, serratus anterior plane block and erector spinae plan block have been used with good results. In particular, the erector spinae has proven to reduce pain severity and opioid consumption in this group of patients. Further, in meta-analysis, the ESP block was shown to effectively alleviate postoperative pain severity and reduce opioid consumption. In ESP block, local anesthetic is deposited deep to the erector spinae muscle which results in blocking of the ventral and dorsal rami of multiple spinal nerves. The LA diffuses into the paravertebral space and cephalo-caudally and blocks the pain by action on dorsal rami, ventral rami, and lateral cutaneous branches of intercostal nerves. Also, in many situations, a superior postoperative analgesia yet avoiding the detrimental effects of opioids, can be extracted from a simple technique of wound instillation of local anesthetics through surgical drain which provide a satisfactory long opioid free postoperative analgesic period.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) physical status I-II
* scheduled for unilateral Modified radical mastectomy

Exclusion Criteria:

* Patient refusal.
* Patient with neurological deficit.
* Patient with bleeding disorders.
* Uncooperative patient.
* Infection at the block injection site.
* Patients with history of allergy to local anesthetics.
* Advanced hepatic, cardiac or renal failure.
* Chronic opioid consumption.
* Body mass index (BMI)≥ 30 kg m-2
* Chronic use of gabapentin or pregabalin
Effects Of Dry Needling On Mobility Among Children With Cerebral Palsy

This study explores the potential of dry needling as a treatment for spasticity in the foot among children with cerebral palsy (CP). Dry needling involves inserting fine needles into specific trigger points or tight muscles without injecting any substances, aiming to relieve pain, improve muscle function, and promote tissue healing. In CP-related foot spasticity, dry needling may target hypertonic muscles, inducing a local twitch response that helps release muscle tension, reduce spasticity, and enhance overall muscle function. The technique may also stimulate sensory nerves and trigger the release of endorphins, contributing to pain relief and muscle relaxation.

While dry needling has shown effectiveness in reducing spasticity and improving muscle function in adults with conditions such as post-stroke, there is limited research on its benefits for children with CP. This randomized controlled trial aims to address this gap by evaluating the impact of dry needling on spasticity, range of motion, and functional mobility in children with CP.

The study will be conducted at Bliss Center of Care and Therapy in Faisalabad, involving 38 participants aged 6 to 12 years, all diagnosed with spastic cerebral palsy and classified under the Gross Motor Function Classification System (GMFCS) levels I-II. Participants will be divided into two groups: an experimental group receiving dry needling therapy (DNT) and routine physical therapy (RPT) and a control group receiving RPT only. Critical exclusion criteria include recent interventions, bleeding disorders, fixed joint deformities, recent seizures, Botulinum Toxin injections, or contraindications to dry needling.

Outcomes will be measured using the Wartenberg Pendulum Test, Active and Passive Ankle Dorsiflexion Range of Motion, and the Timed Up and Go Test, which will be assessed before and after a 10-week intervention. Data will be analyzed using SPSS version 23.0 to determine the efficacy of dry needling in managing spasticity in children with CP.

Eligibility Criteria:
Inclusion Criteria:

* Age: 6 to 12 years old
* Walking ability at Gross Motor Function Classification System levels I to II
* Modified Modified Ashworth Scale (MAS) score higher than equal to 1 (score up to 2)
* Ability to understand and execute orders
* No ongoing rehabilitation intervention

Exclusion Criteria:

* Recent introduction of a new intervention in addition to previous treatments
* Presence of bleeding disorders or skin conditions
* Skin sensitivity issues
* History of seizures within the past six months
* Previous administration of BTX-A injection within the last 6 months
* Presence of
* contraindications to dry needling
* Lack of consent to participate in the study
Effects of Combined Training Protocol in Volleyball Players

The 12-week training will take place during the preparation period. At the beginning and end of the 12-week period, vertical jump test, 60 seconds countermovement jump (CMJ) test, change of direction (T-Agility) test, sprint test, YO-YO (level-1) test will be applied in terms of performance test. In terms of skill testing, service test and spiking test protocols will be applied. Players will perform plyometric (PL) or jump rope (JR) training with the same amount of total training time in each training session. Rating of perceived exertion (RPE) will be obtained using (CR6-20). All players will also complete the short form of the physical activity enjoyment scale (PACES).

There will be 12 weeks of training during the preparation period. Each daily training will start with a 10-minute standard warm-up consisting of running, dynamic stretching and sprinting with volleyball-specific technical movements integrated. After warm-up and Small Sided Games (2v2, 3v3, 4v4, 5v5), players will perform plyometric (PL) or jump rope (JR) training with the same amount of total training time in each training session. At the start of the 12-week period, the vertical jump and 60 second countermovement jump (CMJ) using a portable force plate (Smart Jump; Fusion Sport, Queensland, Australia), T-Agility change of direction and Sprint tests with timing gates (Smart Speed; Fusion Equipment, Brisbane, Australia) and Yo-Yo Intermittent Recovery Test Level 1 will be used for VO2max levels. Serve and Spiking Technical Skill Tests will be applied together with these. To minimise the negative effects of fatigue on psychological, physiological and performance responses, each training intervention will be performed at least 2 days apart. Rating of perceived exertion (RPE) will be obtained using the category ratio scale (CR6-20) to calculate the internal training load (ITL) immediately after the completion of each session. The scale will be introduced at baseline to familiarise players. All players will also complete the short form of the physical activity enjoyment scale (PACES). The scale consists of 8 items scored on a 1-7 Likert scale and has been validated as an indicator of Turkish youth's level of enjoyment of activity.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy
* Male volleyball athletes
* Willing to maintain the intervention for all sessions

Exclusion Criteria:

* Being under 18 years old
* Having a chronic disease
* Contraindications for exercise
Corticosteroid Therapy for Severe Community-Acquired Pneumonia

The purpose of the present study is to assess the efficacy of methylprednisolone as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (PSI 4-5).

The hypothesis of the study is that methylprednisolone can decrease the mortality of severe CAP without any significant side effects,with reduction of the time to clinical stability and failure rate of treatment.


Eligibility Criteria:
Inclusion Criteria:

* community-acquired pneumonia
* PSI score：4-5
* with at least one of following conditions：①CRP ≥150 mg/L,②oxygen index ≤250 , ③bilateral or multi-lober infiltrates in chest image,④ area of pulmonary infiltrates increase \>50% with 48 hous,⑤fever higher than 39℃ exceed 72 hours

Exclusion Criteria:

* nosocomial Pneumonia
* aspiration pneumonia
* acute burn injury
* gastrointestinal bleeding within the past three months
* uncontrolled diabetes mellitus
* pregnant or breast feeding
* a condition requiring treatment with greater than 0.5 mg/kg/d of prednison or its equivalent
* severe immunosuppression (human immunodeficiency virus infection, immunosuppressive conditions or medications)
* active tuberculosis
* preexisting medical condition with a life expectancy of less than 3 months
Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hypertension Patients

s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any hypertension treatment before or have received any of anti-hypertensive mono-therapy for the first four weeks of treatment. By increasing dose, s-amlodipine besylate 5 mg tablet will be administered for the last four weeks (4-8 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients 18 years and older.
* Hypertension patients have not received any anti-hypertensive treatment before ( ≥ 140 mmHg MSSBP \< 160 mmHg, ≥ 90 mmHg MSDBP \< 100mmHg).
* Hypertension patients controlled with single medicine.
* Patients giving written informed consent without being under any influence.

Exclusion Criteria:

* Pregnant patients, nursing mothers or female patients who have potential for childbearing and do not use any effective contraceptive method.
* Allergy or hypersensitivity to dihydropyridines.
* Patients receive more than one anti-hypertensive medicine.
* Patients with seconder hypertension.
* Patients with severe hypertension, myocardial infarction, NYHA stage 2-4 cardiac insufficiency, history of cerebrovascular disease, past ischemic attack, encephalopathy, underwent coronary artery bypass surgery or percutaneous coronary intervention, second or third degree heart block or symptomatic arrhythmia without pacemaker, clinically significant heart valve disease, potential life-threatening or symptomatic arrhythmia, simultaneous unstable angina pectoris, type I diabetes mellitus, atrial fibrillation until the last 12 months.
* Uncontrolled type II diabetes mellitus.
* Patients with significant liver disease (ALT, AST must be \> 2XULN in beginning, patients with esophageal varices, portacaval shunt).
* Patients with significant kidney disease (GFR \<60 ml/min according to Cockcroft-Gault formula).
* Patients with volume depletion.
* Patients with pancreas disease.
* Patients with gastrointestinal disease which may effect absorption.
* Drug/narcotic and alcohol abuse until the last 12 months.
* Patients with central nervous system disease and taking medicine for this reason.
* History of incompatibility with medical regimes or patients do not want to adhere the study protocol.
* Persons directly involved in the management of this protocol.
Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™

This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between 18 to 65 years of age
* Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined in the protocol
* Subjects diagnosed with CIS or RMS according to the revised McDonald criteria (2010)
* Treatment-naive subjects or subjects treated with Rebif® multi-dose injected by RebiSmart™ for no longer than 6 weeks prior to Baseline visit
* Subjects that are able to self-inject with RebiSmart™ (in the opinion of the physician)
* Subjects with Expanded Disability Status Scale (EDSS) score less than (\<) 6 (inclusive) at Baseline
* Signed informed consent and subject data collection form

Exclusion Criteria:

* Subjects experiencing a relapse within 30 days before Baseline
* Participation in other studies within 30 days before Baseline
* Received any MS therapy within 6 months prior to study enrolment (for example, other disease-modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif® multi-dose injected by RebiSmart™
* Any visual or physical impairment that precludes the subject from self-injecting the treatment using the RebiSmart™
* Pregnancy and breast-feeding
* Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure, as per investigator opinion
* Current or past (within the last 2 years) history of alcohol or drug abuse
* Have any contra-indications to treatment with interferon beta-1a according to Summary of Product Characteristics
Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy With Phacoemulsification to Treat Glaucoma and Cataract

It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.


Eligibility Criteria:
Inclusion Criteria:

* co-existing glaucoma and cataract
* glaucoma types ( open angle glaucoma,pseudoexfoliation syndrome, pigmentary glaucoma)
* eye with characteristic glaucoma changes (biomicroscopic,visual field) with IOP \>16mmHg on medication or without, or IOP\<16mmHg on 2 or more medications.
* uncontrolled IOP
* patients not tolerating antiglaucoma medications,
* patients with poor compliance
* progression in visual field

Exclusion Criteria:

* previous surgical glaucoma procedure
* previous cataract surgery
* visual function under 0,004
* closed angle glaucoma
* poorly controlled diabetes mellitus
* advanced AMD
* active inflammatory disease
* pregnancy
* mental disease or emotional instability, that could
Data Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Routine Care Procedures (GPS Study)

A prospective, multicenter, post-market, minimal risk, observational study designed to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical centers in the United States (US).

A prospective, multicenter, post-market, minimal risk, observational study designed to collect up to 60 PillCamTM SB3 CE procedures and subsequent DAE procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in up to 6 medical centers in the United States (US). The data will be collected from subjects who underwent standard of care (SOC) PillCamTM SB3 CE procedure and were referred to a subsequent SOC DAE. In addition, relevant surgical, endoscopic and histology reports as well as radiological data (such as CT, Magnetic Resonance Enterography (MRE) images and reports) may be collected retrospectively 6 months prior to enrollment and prospectively 3 months post enrollment, when applicable. In addition, up to 400 PillCamTM SB3 CE procedures data may be collected from subjects who underwent SB3 procedure (not necessarily followed by DAE) and abnormal SB findings were indicated in their CE report. Study duration is up to 3 years from initial Institutional Review Board (IRB) approval.

Collected data will include PillCamTM raw data, videos and reports, as well as DAE reports, videos and histology reports (when applicable). Demographic data will also be collected to provide a description of the study population characteristics and disposition. All the collected data will be de-identified by delegated and authorized sites' team members, in a manner that is untraceable by the sponsor. The data will be used by Medtronic Gastrointestinal research and development (R\&D) team in collaboration with third parties, including but not limited to external physicians and R\&D partners, as applicable, for development of an Artificial Intelligence (AI) software system to apply to endoscopy procedures, as well as for SB pathologies detection development and validation.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male and female subjects (≥18 years)
2. The subject underwent a SOC PillCamTM SB3 CE procedure and is referred to a subsequent DAE procedure(s), as part of the routine care or The subject underwent a SOC PillCamTM SB3 CE procedure (not necessarily followed by a DAE) and abnormal findings were indicated in the CE report (optional).
3. The subject received an explanation and understands the nature of the study and provided oral consent.

Exclusion Criteria:

1. The subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).