cyrilzakka/clinical-trials huggingface dataset:
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.

Cilta-cel (JNJ-68284528/LCAR-B38M chimeric antigen receptor T-cells \[CAR-T\]) is an autologous CAR-T therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. There will be no treatment administered during the study and the data obtained from this study will help to assess whether there will be long-term cilta-cel-related toxicities. The study will consist of 2 phases: within the first 5 years after receiving the last dose of cilta-cel and Year 6 to 15 years after last dose of cilta-cel. Safety evaluations will include a review of adverse events, laboratory test results, and physical examination findings (including neurological examination). The duration of the study is up to 15 years after last dose of cilta-cel and participants will be followed at least once per year.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
* Participants who have provided informed consent for this study
Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation

Speech is a privileged means of communication for humans: its trouble can thus prove being extremely handicapping. Standard speech therapy is limited in some cases by the lack of sensory feedback available to the patient (hearing, surgery, neural damage, etc.).

The present study aims at quantify the contribution of the tongue articulatory visual feedback offered by ultrasound echography to speech trouble rehabilitation.

Two complementary populations will be studied : 30 adults with buccopharyngeal surgery, and 10 childrens with important speech troubles due to central nervous system damage.

The principle is to conduct standard speech therapy sessions, alternating series of sessions with the use of visual feedback and sessions without visual feedback.

The progress will be regularly measured by means of standard batteries of speech articulation tests.


Eligibility Criteria:
Inclusion Criteria:

* Articulatory troubles needing speech therapy
* French mother tongue
* Adult patients \[18 ≥ age \< 80 years\] who underwent buccopharyngeal surgery after cancer diagnostic OR children \[8 ≥ age \< 18 years\] suffering from central nervous system damage

Exclusion Criteria:

* Incapacity to easily understand the speech therapist instructions
* People protected by the law
* People deprived from freedom by judiciary decision
* Potential allergy to the water-based conducting gel used to ensure good skin - probe contact
* Overweight if large fatty mass under chin
* Major edema under chin limiting echogenicity
* Non corrected vision or hearing problems
* For the adults: central or peripheral neural damage
* History of Ear, Nose, and Throat surgery or radiotherapy
* For the adults: isolated articulatory trouble, former articulatory trouble not treated, disfluency
* Massive orofacial dyspraxia
* Posture trouble
* Motor problem in upper limbs
Get Social Media and Risk-Reduction Training

This study examines the implementation of the TodaysBaby™ mobile safe sleep intervention program in US hospitals. The main aims of this study are to examine: 1) differences in program penetration and the equity of penetration according to income and race/ethnicity; 2) differences in feasibility, acceptability, sustainability and fidelity top the intervention; and 3) the effectiveness of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Must speak English or Spanish
* Must live in the United States
* Must have given birth to a healthy, term infants (37 weeks or greater) and be discharged within 7 days of birth
* Must plan to care for infant and live in the same household as infant after birth
* Must enroll in the TodaysBaby program by the time their infant is 7 days of age

Exclusion Criteria:

* A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, such as supine infant sleep positioning.
Dispersion Stability

To assess the acute efficacy of ablation of the most stable VX1 areas (levels 2 and 3) in terms of the rate of acute AF termination.

Identify the spatial distribution of dispersion stability levels based on VX1. Document the rate of adverse events. To assess the long-term efficacy of ablation of the most stable VX1 areas in terms of the absence of documented arrhythmias during a 12-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older candidates with Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter):

   * AF duration of ≥ 3 months and ≤ 5 years or
   * 1 effective cardioversion followed by AF recurrence lasting ≥ 3 months
2. Continuous anticoagulation with warfarin (INR 2-3) or NOAC for \> 4 weeks prior to ablation
3. Patients must be able and willing to provide written informed consent to participate in the clinical trial
4. Maximum of 50% of patients (13 patients) in persistent AF \< 12 months (\>30% of long-standing persistent AF ≥ 12 months)
5. Being affiliated to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

1. Paroxysmal and short-standing persistent AF \< 3 months
2. Severe obesity (BMI \> 45)
3. LA thrombus on Transesophageal Echocardiography (TEE) prior to procedure
4. Contraindications to anticoagulation (heparin, warfarin or NOAC)
5. Patients who are or may potentially be pregnant
6. Any cardiac surgery within the past 2 months (60 days) (includes PCI)
7. Myocardial infarction within the past 2 months (60 days)
8. History of blood clotting or bleeding abnormalities
9. Documented thromboembolic event (including TIA) within the past 12 months (365 days)
10. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
11. Unstable angina within the past month
12. Acute illness or active systemic infection or sepsis (including COVID 19)
13. Enrollment in an investigational study evaluating another device, biologic, or drug
14. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
15. Life expectancy or other disease processes likely to limit survival to less than 12 monthsLife expectancy or other disease processes likely to limit survival to less than 12 months
16. Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)
17. Patient protected (guardianship or curatorship), or deprived of liberty by a judicial or administrative decision;
18. Person subject to a safeguard measure.
Postural Analysis of Patients Receiving Rehabilitation Program

This is a study for evaluation of posture of patients with neurological disease in rehabilitation department.

In this study, we evaluate the static posture stability of the patient, such as during sitting, standing and dynamic posture stability of the patient, such as during walking, time-up-and-go test.

Eligibility Criteria:
Inclusion Criteria:

* Patient with physical disability followed-up in rehabilitation department

Exclusion Criteria:

* Patients with congitive impairment that can't complete the evalaution well
* Patients with uncontrolled comorbidity diseases
* Attended other study in recent 3 months
Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure

A number of 100 patients with pulmonary hypertension associated with the left Heart failure scheduled for elective pulmonary arterial denervation (PADN) are randomized 1:1 to either PADN or control group.

Heart failure patients must have completed the right heart catheterization. All the patients accepted the optimal medical therapies,including diuretics, Nitrate esters, β-blockers, ACE inhibitors or receptor blocker aldosterone antagonists and/or digoxin).The patients of pulmonary hypertension are defined into two groups: "passive" pulmonary hypertension(mPAP≥25 mmHg, PCWP\>15 mmHg and pulmonary vascular resistance\<3 woods unit) increase due to backward transmission of increased left ventricular filling pressure, "reactive" pulmonary hypertension (mPAP≥25 mmHg, PCWP\>15 mmHg and pulmonary vascular resistance \>3 woods unit) increase in resistance due to either pulmonary vasoconstriction or structural changes in the pulmonary vasculature.

All the "reactive" pulmonary hypertension patients are eligible for the randomized study in PADN group or control group according to the computer generated random table.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18yr
* "Reactive"Pulmonary Hypertension in Left Heart Failure: mPAP≥25 mmHg, PCWP\>15 mmHg and pulmonary vascular resistance (PVR) \[The PVR =(mPAP-PCWP)/ carbon monoxide\]\>3.0 woods unit
* Voluntary acceptance of all follow-up assessment of program requirements.

Exclusion Criteria:

* WHO group I, III, IV, V pulmonary artery hypertension
* Severe Renal dysfunction (Ccr\<30 ml/min)
* Blood platelet count\<100,000/L
* Expected life span\<12-month
* In pregnancy
* Systematical inflammation
* Malignant cancer(s)
* Tricuspid valve stenosis, Supra-pulmonary valve stenosis
* Allergic to studied drugs or metal materials
Personalized Quantum Sonotherapy in Regional Anesthesia

The objetive of the study is to evaluate the effect of personalized quantum sonotherapy on the level of anxiety and pain in outpatients schedule for orthopedic surgery under regional anesthesia in a second level center. The investigators believed that personalized quantum sonotherapy could reduce the levels of anxiety and pain before and after surgery evaluated through hemodynamic variables and scales for pain (analogous visual scale) and anxiety (STAI Spielberger anxious state questionnaire).


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective orthopedic ambulatory surgery under regional anesthesia
* Age between 18 and 60 years.
* Patients with anesthetic risk ASA 1 and 2.
* Patients without contraindications for the administration of opioids and benzodiazepines.
* Patients living in the metropolitan area who have a telephone line and can be contacted by telephone within the first 48 hours through calls at 24 and 48 hours after surgery, made by the researchers at the number previously reported by the patient.
* Patients with an adequate level of understanding, who are able to communicate by telephone and understand a numerical scale.
* Patients who agree to participate in the work.

Exclusion Criteria:

* Patients with auditory and cognitive problems.
* Patients requiring general anesthesia at some time during the intraoperative period.
* Patients with morbid obesity.
* Patients consuming anxiolytics in the last month.
* Patients whose start of surgery is after 45 minutes of the blockade.
Synergies Between Exercise and Abacus in Childhood.

This study investigates the synergistic effects of physical exercise and abacus training on enhancing academic performance and well-being in children. It aims to establish a comprehensive educational framework that leverages the cognitive benefits of both physical activity and mental math skills. Research indicates that regular physical exercise not only contributes to better physical health but also significantly enhances cognitive functions such as memory, attention, and problem-solving abilities. Studies have shown that active children tend to perform better academically due to improved brain function and increased focus. Simultaneously, abacus training has been recognized for its role in developing mathematical skills and cognitive abilities. It promotes visual-spatial reasoning and enhances memory retention, which can lead to better performance in mathematics and related subjects.

By integrating these two methods, seeks to provide children with a holistic approach to learning, fostering not only academic success but also emotional and psychological resilience. Preliminary findings suggest that children engaged in combined physical and cognitive training programs show notable improvements in their academic outcomes and overall well-being compared to those who participate in traditional learning environments. The project emphasizes the importance of creating educational strategies that prioritize comprehensive child development, suggesting that a balanced approach involving both physical exercise and cognitive training tools like the abacus can lead to significant benefits in children's learning experiences.


Eligibility Criteria:
Inclusion Criteria:

* School-aged children, ages 6-7.
* Students who are able to engage in moderate-intensity physical activity without medical restrictions and are able to handle the abacus.
* Students who can regularly participate in the intervention program sessions and follow-up assessments.
* Voluntary participation, with informed consent signed by parents or legal guardians.

Exclusion Criteria:

* Children with health conditions that prevent them from safely engaging in physical activity or using the abacus (e.g., heart disease, severe respiratory problems, motor disabilities that limit physical activity).
* Students with severe cognitive or learning disabilities that may significantly interfere with the use of the abacus or the ability to equitably benefit from the intervention.
* Children who are unable to commit to continued participation in the program, whether for personal or logistical reasons.
* Students who are involved in other extracurricular or school programs focused on cognitive or physical training, to avoid overlapping effects of other interventions.
Direct Current Neuromuscular Electrical Stimulation for Treatment of Peripheral Neuropathy

This study will compare two methods of electrical stimulation (alternating current and direct current) as an adjunctive therapy to treating peripheral neuropathy. Both types of electrical stimulation have been used in clinical practice for physical therapy, however direct current stimulation is much less common and there is less known about their impact on physical therapy outcomes. The aim of this project is to show the efficacy of a novel device, the Neubie direct current device, compared to traditional TENS unit, in clinical physical therapy treatment of neuropathy. Outcomes measured will include three methods of two-point discrimination, vibration sense, pain, and score on the modified Toronto Clinical Neuropathy scale.

To determine the efficacy of direct current electrical stimulation (the Neubie device) on long-term symptoms and severity of neuropathy, participants will enroll in a 6-week treatment regimen at one of 9 Hands On Physical Therapy associated clinic sites listed included in application. The first session will consist of an EMG/NCS evaluation to determine severity of neuropathy and to rule out polyneuropathy, which will serve as baseline (and a within subject control) for the intervention.

Participants will then undergo a specialized neuropathy protocol that includes traditional PT therapy for neuropathy, as well as treatment with the Neubie (or traditional e-stim) both during PT exercises and as additional treatment after sessions. Subjects receive an evaluation session that includes an Electrodiagnostic Study, pain assessment, evaluation of two-point discrimination, and vibration sense.

The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min foot bath session with the Neubie and 15-min of various physical therapy exercises.

The control group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min footbath with TENS and 15-min of various physical therapy exercises.

At the end of the 12 sessions of treatment, subjects receive a final evaluation session that includes an Electrodiagnostic Study, pain assessment, evaluation of two-point discrimination, and vibration sense.

Participants will receive 12 treatments over 6 weeks. EMG/NCS and a neuropathy pain questionnaire will be measured at both the initial evaluation and at the completion of the final session, and will provide both quantitative and qualitative data on the severity of neuropathy symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Must have a minimum score of 1 on the modified Toronto Clinical Neuropathy Score
* Must be able to attend weekly sessions for the 6 week period of the study (no extended travel)
* Must be at least 18 years old.

Exclusion Criteria:

* Currently pregnant
* Cardiac pacemaker
* Active or recent cancer in the lower limbs
* Active or recent blood clots in the lower limbs
* History of epilepsy
* No open wounds
Mass Balance Study of [14C]-Orvepitant Oral Solution in Healthy Male Subjects

This is a single centre, open-label, non-randomised study to assess the mass balance recovery, absorption, metabolism, and excretion of a single oral dose of \[14C\]-orvepitant in healthy male subjects. It is planned to enrol 6 subjects. Each subject will receive a single dose of 30 mg \[14C\] orvepitant containing not more than (NMT) 3.7 megabecquerel (MBq) \[14C\], administered as an oral solution in the fasted state. Subjects will be admitted in the evening on the day prior to \[14C\]-orvepitant administration and will be dosed in the morning following an overnight fast. It is planned that subjects will remain resident in the clinical unit until 168 hours post-dose (Day 8) when they will be discharged from the clinical unit. Through the resident period samples (blood, urine, faeces) will be collected and analysed for mass balance, total radioactivity, orvepitant levels. Metabolite profiling and ID will also be performed.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy males
* Aged 30 to 65 years inclusive at the time of signing informed consent.
* Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening.
* Must provide written informed consent.
* Must agree to adhere to the contraception requirements

Key Exclusion Criteria:

* History of any drug or alcohol abuse in the past 2 years.
* Regular alcohol consumption \>21 units per week.
* Current smokers and those who have smoked within the last 12 months.
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
* Clinically significant abnormal clinical chemistry, haematology, or urinalysis as judged by the Investigator.
* Subjects with a presence of any of the following at screening: bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \>1.5 × the upper limit of normal.
* Confirmed positive drugs of abuse test result.
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
* Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of \<80 mL/min using the Cockcroft-Gault equation.
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, or GI disease, neurological or psychiatric disorder, as judged by the Investigator.
Mobile Goal-setting Intervention to Improve Vegetable Intake Among Young College Students

This study used a two-group pre-posttest experimental design. After completing a background survey, participants used their smartphones to uploaded photos and/or descriptions of their meals to an online platform for three days. In addition, those in the intervention group were asked to use a checklist to count the number of times they ate red/orange vegetables and to set a goal to eat one more time the next day. The dependent variable was a measure of eating behavior-an estimate (number of times/day) of red/orange vegetable intake on that day based on review of uploaded photos and descriptions. Those in the intervention group, who were asked to use a checklist to count their red/orange vegetable intake and set a goal to eat one more the next day, improved their vegetable intake.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and above
* Undergraduate at the university
* Currently lived in a dorm
* Owned a smartphone
* Had internet access on their smartphone

Exclusion Criteria:

* Already part of a study to change their eating behaviors
Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management

To see if nurse guided web based cognitive behavioral therapy (CBT) will show pain improvement in patients with all types of pain complaints.

The primary objective of this application is to test the feasibility of a care model where clinic nurses play a vital role in promoting the adoption of web-based CBT in the ambulatory medical setting. Participants (n=60) in the primary care and rheumatology clinics will be randomized to one of 2 arms: (1) 6 regular telephone contacts, vs. (2) 6 computer generated email reminders (control arm) over an 8-week period. To enhance participants' motivation to engage in the web-based CBT, nurses will use motivational interviewing technique. The investigators will use outcome measures including the number of completed web-based learning modules, amount of time spent by the nurses on study-related and non-study related phone calls, health care use, and clinical variables. Our proposed line of research is significant because it will potentially make CBT, a significantly underutilized treatment modality, potentially more affordable and accessible. If nurse guided web-based CBT can be shown to be effective and implementable, Wake Baptist Health System can potentially leverage web-based CBT as one component in a multidisciplinary pain management program to prospective employers in North Carolina. Wake Baptist may also develop its own web-based CBT for commercial use.

Eligibility Criteria:
Inclusion Criteria: -

1. patients at the primary care or rheumatology clinic with daily pain for 6 months or longer affecting the low back, neck, hip, knee or widespread pain;
2. at least moderate in average pain severity, defined as a weekly average pain severity score of 5 or greater 24;
3. at least 18 years of age;
4. reliable phone (landline or cell), and
5. have home computer with reliable internet access.

Exclusion Criteria:

1. planned elective surgery during the study period;
2. very severe symptoms of depression (i.e., The eight-item Patient Health Questionnaire depression scale (PHQ8) score of ≥ 20);
3. ongoing unresolved disability claims;
4. inflammatory arthritis (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis, etc.);
5. cancer-related musculoskeletal pain;
6. history of bipolar disorder or schizophrenia; and
7. takes daily opioid for more than one year.