cyrilzakka/clinical-trials huggingface dataset:
Depression Return to Work Intervention

This study is a randomized controlled trial to test the effectiveness of a mobile app-based program aimed to help individuals with unemployment-related emotional distress return to work.

This study will compare two different approaches to reducing unemployment-related emotional distress. Participants will be involved in the study for a total of 22 weeks. During the first 6 weeks, participants will complete activities relating to either the mobile-app based program or the self-guided job-seeking program. The study team will follow up with participants at 8 weeks after the program is completed and at 16 weeks after the program is completed. Participants will also be asked to complete questionnaires before starting the program, during the program, after they complete the program, and at the follow-up visits. The questionnaires will be about the participant's mood, job seeking behavior, and related emotional experiences.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Currently unemployed and actively searching for work
* Prior to unemployment, were employed full-time (35 hours per week or more) for at least 1 year
* Prior to unemployment, received an individual highest salary of $100,000 or less
* Owns an iPhone or Android Phone
* Willing and able to provide informed consent
* Has a minimum depression score according to the PROMIS depression scale
* Able to communicate in English (verbal and written)

Exclusion Criteria:

* Current moderate or severe alcohol/substance use disorders
* Current symptoms of mania or psychosis
* Currently employed, retired, or a full or part-time student
Nurse-Led Telemedicine Versus In-Person Lactation Support for Breastfeeding Initiation of Low-Birth-Weight Infants

Breastfeeding initiation among mothers of low birth weight (LBW) infants is crucial for neonatal health but poses significant challenges. This randomized controlled trial aims to compare the effectiveness of nursing-led telemedicine lactation support versus in-person lactation support on breastfeeding initiation rates in mothers of LBW infants. The study will utilize validated tools such as the LATCH scoring system, the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), and the State-Trait Anxiety Inventory (STAI) to assess outcomes. By evaluating these two modalities, the research seeks to inform best practices for lactation support, particularly in settings where in-person care is limited.

Breastfeeding offers unparalleled health benefits for infants and mothers, including optimal nutrition, immune protection, and enhanced bonding. These benefits are especially critical for low-birth-weight infants, who are at increased risk for morbidity and mortality. Despite the recognized importance, mothers of low birth weight (LBW) infants often face barriers to initiating and maintaining breastfeeding due to factors such as neonatal intensive care unit (NICU) admissions, maternal stress, and lack of specialized support.

Telemedicine in Lactation Support Telemedicine has emerged as a promising avenue for delivering healthcare services, including lactation support. It offers increased accessibility and convenience, particularly for mothers who may face challenges attending in-person consultations. While telemedicine has been successfully implemented in various healthcare domains, its effectiveness compared to traditional in-person lactation support requires further investigation, particularly among mothers of LBW infants.

Nurses play a pivotal role in providing education, emotional support, and practical assistance to breastfeeding mothers.Understanding how nursing interventions can be optimized in telemedicine versus in-person settings is essential for enhancing breastfeeding initiation.

Objectives

* To compare breastfeeding initiation rates between mothers receiving telemedicine lactation support and those receiving in-person support.
* To assess changes in breastfeeding self-efficacy using the BSES-SF.
* To evaluate maternal satisfaction with the mode of lactation support received.
* To measure maternal anxiety and stress levels using the STAI.
* To monitor infant growth parameters up to 3 months postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Mothers aged ≥18 years.
* Mothers of infants with a birth weight \<2,500 grams.
* Mothers intend to breastfeed.
* Access to a smartphone, tablet, or computer with internet capability for the telemedicine group.

Exclusion Criteria:

* Infants with congenital anomalies affecting feeding.
* Mothers with medical conditions contraindicating breastfeeding.
* Non-English-speaking mothers (due to resource limitations).
High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy

The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.

This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach without further substrate modification.

This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. This study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation.

Approximately 300 subjects at up to 20 sites worldwide will be enrolled.

Subjects will be followed until they complete their 12-month visit. Clinical Investigation visits will occur at Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months. Endpoints will be analyzed when all subjects have completed their 12-month follow up visits.

Eligibility Criteria:
Inclusion Criteria:

1. Documented atrial fibrillation with planned endocardial ablation procedure
2. Age 18 years or older
3. Able and willing to provide written informed consent prior to any clinical investigation related procedure
4. Able and willing to complete all required study procedures through 12 months

Exclusion Criteria:

1. Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration
2. Previous ablation or surgery in the left atria
3. Implanted left atrial appendage occluder
4. Implanted mitral or tricuspid valve replacement
5. Implanted cardiac defibrillator (ICD)
6. Participation in another clinical investigation that may confound the results of this study
7. Pregnant or nursing
8. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
9. Life expectancy less than 12 months
Does the "TOOKIE Vest" Reduce Line Fall Out Rate in Children?

The objective of the trial is to assess whether the TOOKIE vest is an effective intervention in reducing line fall out. All oncology patients with a tunneled central line will be approached to participate in this study. Following informed consent they will be issued with a TOOKIE vest.

All oncology patients with a tunneled central line will be approached to participate in this study. Following informed consent they will be issued with a TOOKIE vest. Lines will be studied for the duration they are in situ. This will vary depending on the underlying diagnosis and treatment regime. One hundred central line insertions for oncology patients will be prospectively identified and be given the "TOOKIE Vest" to wear. Data will be collated for each group regarding age, gender, diagnosis, type of central access inserted, duration of line, reason for removal, in cases of infection the infected organism will be documented, date of each fall out.

Eligibility Criteria:
Inclusion Criteria:

* Any child receiving treatment for malignancy at Royal Manchester Children's Hospital
* Patients with a tunnelled central line inserted for treatment of their malignancy

Exclusion Criteria:

• Any child having a portacath inserted as their mode of central access
EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients

Continuous measurement of breathing patterns, heart rate, restlessness and cough in sleep using EarlySense ES 16 device. Predicting worsening in COPD patients' condition using the above parameters.

Study's participants are CHF, COPD and Pneumonia patients or patients who are otherwise hospitalized in internal medicine department. During the study the patients' breathing patterns, heart rate, restlessness and cough in sleep will be measured by the EarlySense ES 16 device, which is placed in the patients' bed.

Patients' clinical status are followed. The patient's clinical condition is followed and analyzed in comparison to the EarlySense system output in order to determine the capability of the EarlySense system to predict COPD, CHF or Pneumonia deteriorations.

Eligibility Criteria:
Inclusion Criteria:

* CHF, COPD and Pneumonia Patients or control group non respiratory patients
* 18 years old and up
* Able to perform spirometry test or connect to ECG, respiratory belt, SPO2
* Willing to sign consent form
* Home close to Tel Aviv

Exclusion Criteria:

* hospitalization within the passing year
Smoking Treatment of Prisoners

The purpose of this study is to determine the efficacy of a 10-week smoking cessation therapy combined with NicoDerm CQ for smoking cessation among female prisoners.

This is a randomized controlled trial utilizing a wait-list control group to examine 10-week group therapy and nicotine replacement compared to wait-list for smoking cessation among female prisoners.

Eligibility Criteria:
Inclusion Criteria:

* 1) current smoker and (2) seeking group treatment to quit smoking.

Exclusion Criteria:

* (1) non-english speaking, (2) housed in segregation, (3) presence of active, severe mental illness as defined by active psychosis, manic episode, or imminently suicidal/homicidal, (4) mental retardation such that they cannot provide informed consent, and (5) due to be released or transferred to another facility within the next year.
Interaction of the Cognitive and Sensory-cognitive Tasks With Postural Stability in Individuals With Stability Disorders

The aim of this study is to describe the interaction of the cognitive and visual-cognitive task with postural stability in patients suffering by cerebellar ataxia. Investigators will measure changes in postural stability parameters and in secondary task performance, which should show the ability of the patients to manage the dualtask situations.

The aim of this research will be to describe the interaction between cognitive and cognitive sensory tasks and stability in patients whose disease impairs the ability to maintain a stable upright position, for example in patients with cerebellar syndromes. And further compare this interaction with a control group of healthy probands. This interaction will be investigated in variously demanding postural situations (eg. standing on both lower limbs, with the exclusion of visual control, with reduced proprioceptive input from the patch).

Patient stability will be quantified using a stabilometric examination on the Kistler platform (Kistler Instrumente AG, Switzerland). investigators will quantify the performance of patients in secondary tasks using parameters such as response time to response and success in assigned tests.

The expected number of probands is 20 individuals in both groups. Study will objectify postural stability by means of a static stabilometric examination on the Kistler platform, the recording length of each postural situation will be 30 s. Four different demands of postural tasks were chosen - a bipedal stand, a bipedal stand with the exclusion of visual control, a stand on a foam pad and a stand on a foam pad with the exclusion of visual control. To evaluate postural deviations, investigators chose the following CoP parameters: stabilogram curve length and stabilogram area. During the stabilometric measurement, the number of touches of the guardrail will also be recorded, or the number of falls or touches with a lightened limb of the pad or the other limb during the measurement. Testing will take place in the Neurological Laboratory of the Department of Neurology, 2nd Faculty of Medicine, Charles University in Prague and FN Motol.

Gradually, two types of secondary task will be added to the postural tasks, with visual input (modified Stroop test) and a purely cognitive task (Backward counting test). At first, probands will be acquainted with what types of tasks await them during the experiment and will be able to train each of them in two trial experiments. This will be followed by testing trials in random order (cognitive tests in single-task situations, namely sitting in a chair, single task postural tasks and dual-task situations).

Eligibility Criteria:
Inclusion Criteria:

* 3 Hz tremor in in frequency analysis (posturografy)
* stability disorder caused by cerebellar disorders in diagnose

Exclusion Criteria:

* lower than high school education
* vestibular disorders
* ankle instability
* other specific stability disorders
* unability to stand for 30s
Title Endovascular Treatment of Superior Cave Syndromes Reaching the Trifurcation: a Single-Center Case Series

Superior vena cava syndrome (SCS) is caused by obstruction of blood flow in the superior vena cava, which allows venous return from the upper half of the body to the heart.

The causes are most often oncological, but can also be benign (coagulopathy, Behçet) or iatrogenic (catheterisation, PAC).

The surgical management of superior vena cava syndromes (SCS) involves the use of innovative endovascular techniques, which have become the therapy of first choice for symptomatic patients, whether the occlusion occurs in a benign or malignant context. For occlusive lesions involving the trifurcation, there are several surgical approaches and strategies, but very little data on their efficacy. In particular, Y-stenting has been described in several case reports as a means of treating the SCS and keeping the two jugulo-subclavian veins (VJSC) patent. This innovative technique has been used for several years by the vascular surgery team at Hôpital Louis Pradel.

The aim of our study is to assess the feasibility and medium-term efficacy of innovative endovascular treatments for SCS involving the trifurcation.


Eligibility Criteria:
Inclusion Criteria:

* All patients treated by endovascular surgery (stenting) at Hospices Civils de Lyon between March 2019 and July 2023 for superior cave syndrome

Exclusion Criteria:

* Minor patients
* Patients unable to give consent
* Patients unable to understand French
* Patients with lesions not reaching the trifurcation (elective involvement of the superior vena cava)
Drug-Drug Interaction of SHR1459 With a Strong CYP3A Index Inducer (Rifampicin)

This drug-drug interaction (DDI) study had been designed to investigate the effect of a strong CYP 3A index fan-inducer rifampicin on the pharmacokinetics of SHR1459 in Chinese healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Body weight ≥50 kg for male and≥ 45 kg for female, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
5. In females, documented surgical sterilization, postmenopausal status for at least 1 year (follicle stimulating hormone \[FSH\] \> 40 mIU/mL serum at Screening), or agreement to use an approved form of contraception
6. In males, agreement to avoid sperm donation for 3 months days after the dose of SHR1459
7. Liver function test results must be below the upper limit of normal.
8. Participants must agree to refrain from donation of whole blood and other blood products from 90 days prior to screening.
9. Heart rate ≥60 bpm.
10. GFR≥90 mL/min/1.73m2.

Exclusion Criteria:

1. Loss of more than 400 mL blood during the 3 months before the trial (eg, as a blood donor)
2. Allergic constitution;
3. History of drug use, or drug abuse screening positive;
4. Alcoholic or often drinkers;
5. A smoker with 5 cigarettes per day for more than 90 days;
6. Positive serology for hepatitis B surface antigen (HBsAg) and HCV (healthy participants), anti-treponema pallidum virus (TP), or antihuman immunodeficiency virus (HIV) Type 1 and Type 2 (all subjects)
7. Use of any drugs or substances known to be inhibitors or inducers of CYP3A within 90 days from the first dose or 5 half-lives, if known, of the drugs or substances, whichever is greater, prior to SHR1459 administration and during the study.
8. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
9. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
10. Use of grapefruit or marmalade in 2 weeks prior to admission to the clinical unit, as reported by the subject.
11. Major surgery within 6 months before screening.
12. Woman in breastfeeding and pregnancy and with egg donation plan, and man with sperm donation plan in 6 months after follow-up in the trial.
Public Health Impact of Unilateral Spatial Neglect

This multi-center project aims to quantify the socio-medical costs associated with Unilateral Spatial Neglect (USN) resulting from acquired brain injury (stroke) and to measure the effects of USN rehabilitation on functional autonomy, quality of life and psychological well-being of patients affected by this syndrome, considering the repercussions on a psychological level and on the quality of life of caregivers.

To this end, the experimenters will administer to right brain-injured patients - with (Experimental Group) or without (Control Group) USN - who undertook a rehabilitation process, a series of questionnaires: Activities of daily living (ADL), Barthel Index; Instrumental activities of daily living scale (I-ADL:), the Health Related Quality of Life questionnaire (EQ-5D-5L), the Geriatric Depression Scale (GDS), and the State-Trait Anxiety Inventory (STAI-Y). The aforementioned tests will be administered before the start of the rehabilitation (baseline) and after one month, 3, 6 and 12 months after the end of the rehabilitation. The impact of USN and its treatment on the psycho-physical well-being of the caregiver will be measured through the Caregiver Burden Inventory questionnaire, which will be administered with the same timing (baseline, 1-3-6-12 months after rehabilitation). The costs of USN will be surveyed through an ad-hoc questionnaire, which includes a version intended for patients and one for caregivers, in order to identify the resources consumed due to the disease and the expenses taken during the observation period, to be estimated subsequently in monetary terms (€).


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years;
* right brain injury due to stroke (of ischemic or hemorrhagic origin);
* Disease duration ≥ 10 days;
* Participation to a rehabilitation program;

For stroke patients with USN:

- clinical diagnosis of USN, placed by the specialist of reference, on the basis of clinical indicators and the results obtained by the patient in the routine neuropsychological evaluation (by means of a battery of standardized psychometric tests calibrated in the Italian population).

Exclusion Criteria:

* Other brain disorders
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit

This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.

Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea USPI, which recommends a dose of 2 mg aflibercept (0.05 mL) administered by IVT injection. Only subjects already under IVT Eylea treatment and hence familiar with the IVT procedure were eligible for the study. Administration of the study treatment was embedded into their routine treatment scheme.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 50 years of age at baseline
* Patients diagnosed with nAMD (uni- or bilateral)
* Patients already under IVT Eylea treatment (last injection of the induction period or maintenance phase)
* Willing and able to comply with all study procedures, and be likely to complete the study
* Signed informed consent must be obtained before any assessment is performed

Exclusion Criteria:

* Active, suspected or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye at baseline, which is of clinical significance according to the investigator's judgment, such as active infections of the anterior segment; this includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or autoimmune associated uveitis or endophthalmitis
* Any uncontrolled ocular hypertension or glaucoma in the study eye (defined as IOP ≥ 26 mmHg, despite treatment with anti-glaucomatous medication)
* History of a medical, ocular or non-ocular condition, that in the judgment of the investigator, would preclude a safe administration of investigational product
* Visual acuity Score (VAS) worse than 20/200 on a Snellen chart, the generally accepted level of legal blindness
* Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening
* Systemic treatment with long-acting corticosteroids (more than 10 mg prednisolone equivalent) within 3 months prior to screening Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol
* Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation (approved or investigational) in the study eye any time during the past 3 months
* Receipt of any systemic anti-VEGF within the last 6 months prior to enrollment
* Uncontrolled hypertension (defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening)
* Participants who do not comply with the local COVID-19 regulations of the study site