cyrilzakka/clinical-trials huggingface dataset:
Post STEMI Echo Registry

This is a prospective observational study of consecutive patients presenting with STEMI to the Prince of Wales Hospital over a 12-month period. All patients will receive standard of care including reperfusion and GDMT irrespective of study enrolment. Patient will be followed for 9 months after enrolled in this study. Point-of-care ultrasound (POCUS) using a hand-held ultrasound (Vscan, GE Healthcare) will be performed to assess baseline LVEF within 48 hours of admission. Patients with baseline moderate-to-severe LV dysfunction by visual POCUS assessment (i.e. LVEF \<40%) will be recruited for follow-up LVEF assessment at 3 months. Patients with persistent LVEF \<40% by POCUS will undergo formal echocardiography to confirm LVEF by either 2D area (Simpson's rule) and 3D volumetric measurements. In 9 month visit, patient's clinical data will be collected and no echo is needed during this visit.

This is a prospective observational study of consecutive patients presenting with STEMI to the Prince of Wales Hospital over a 12-month period. All patients will receive standard of care including reperfusion and GDMT irrespective of study enrolment. Patient will be followed for 9 months after enrolled in this study. Point-of-care ultrasound (POCUS) using a hand-held ultrasound (Vscan, GE Healthcare) will be performed to assess baseline LVEF within 48 hours of admission. Patients with baseline moderate-to-severe LV dysfunction by visual POCUS assessment (i.e. LVEF \<40%) will be recruited for follow-up LVEF assessment at 3 months. Patients with persistent LVEF \<40% by POCUS will undergo formal echocardiography to confirm LVEF by either 2D area (Simpson's rule) and 3D volumetric measurements. In 9 month visit, patient's clinical data will be collected and no echo is needed during this visit.

Categorical variables were presented in frequency tables and were compared using the Pearson Chi square test if all cell sizes were more than 5, or Fisher exact test if otherwise. Parametric and nonparametric continuous variables were expressed as mean ± SD and median (interquartile range) and were compared using the Student t test and Mann-Whitney U test, respectively. P\<0.05 was considered statistically significant. All statistical analyses were performed using SPSS version 24.0

Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years of age
2. STEMI (defined by symptoms of myocardial ischemia accompanied by persistent elevation of the ST segment on ECG and the subsequent rise of biomarkers of myocardial necrosis)
3. Ability to provide informed consent and to complete the study and required follow-up

Exclusion Criteria:

1. Pregnancy
2. Pre-existing ICD or CRT-D implantation
The Impact of Receptive Music Therapy in the ICU

The purpose of this study is to determine whether Music Therapy has an effect on pain, agitation, and vital signs of patients in the Intensive Care Unit (ICU) when compared to usual care. Music Therapy is an intervention provided to patients after a referral by a nurse or attending physician. Patients will be assigned to two groups. The intervention group will receive 1 30 minute music therapy intervention provided by a Board Certified Music Therapist (MT-BC). The music therapy intervention will consist of a relaxation experience with live music presented by the MT-BC on an acoustic guitar, and include improvised music and/or structured songs, created as an ongoing musical experience in response to the immediate needs of the patient. Vital signs, pain, and agitation are collected pre and post. Patients assigned to the control group will receive usual care for a patient in the ICU. Vital signs, pain, and agitation will be collected.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater
* On a Mechanical Ventilator

Exclusion Criteria:

* Airborne and Special Contact Isolation
* Non English or Spanish Speaking LARs
* Pregnant
* Prisoners
* Brain Dead
* Unstable bradycardia or hypotension
* Patients who have been referred to music therapy with a goal of stimulation.
Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma

The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus at different concentrations for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).

Kaposiform hemangioendothelioma (KHE) and tufted angiomas (TA) are rare vascular tumors, which are apparent predominantly in infancy or early childhood. Currently, no standard treatment regimens exist for KHE/TA. The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus at different concentrations for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).

Eligibility Criteria:
Inclusion Criteria:

* Children with superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)

Exclusion Criteria:

* Hypersensitivity to Tacrolimus Mucosal Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)
Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years

This study will evaluate the safety and immunogenicity of VAX161B \[STF2.HA5 H5N1\], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.

The purpose of this study is to test an investigational vaccine known as "VAX161B". VAX161B is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject will receive the VAX161B vaccine at one of five doses to see which does might be the best. VaxInnate want to find out how safe these vaccines are and how well they are tolerated by people who receive them. To measure how effective each type of vaccine is, VaxInnate will test the ability of the body to develop an immune response, which means how well the body recognizes and defends itself against the influenza virus.

Eligibility Criteria:
Inclusion Criteria:

* male or female aged 18 - 49 years inclusive
* give written informed consent to participate
* healthy, as determined by medical history, physical examination
* comprehension of the study requirements
* willing to provide multiple blood specimens collected by venipuncture.

Exclusion Criteria:

* Subjects who have a psychiatric illness, a chronic illness that would interfere with participation or interpretation of results
* clinically significant abnormal liver function tests
* positive serology for HBsAg or HCV antibodies
* impaired immune responses
* history of anaphylactic type reaction to injected vaccines
* history of drug or chemical abuse in the year prior to screening
* history of Guillain-Barré Syndrome
* history of chronic obstructive pulmonary disease or history of other lung disease
Human Sperm Epigenetics in Embryonic Development.

A total of 60 men (40 with a history of infertility and treatment with assisted reproduction and 20 infertile controls achieving conception naturally) will be asked to provide at least one semen sample each for conventional semen analysis including measurement of DNA-fragmentation and semen preparation with swim-up. The prepared semen sample will then analyzed by comprehensive microscopy analyses aiming at identifying distinct subpopulations of spermatozoa based on chromatin density and composition, mitochondrial and acrosome function and epigenetic markers. In addition, spermatozoa samples of selected individuals will be subjected to comprehensive analyses of the chromatin and RNA expression status using epigenomic approaches.

Hitherto male infertility has been defined by conventional semen analysis only, which mainly consists of determining concentration, progressive mobility and morphology of spermatozoa. However, the diagnostic accuracy of conventional semen analysis is poor and has very limited relationship with the outcome of assisted reproductive medicine. Preliminary data suggest that differences in chromatin density and epigenetic status of sperm may be more relevant, in particular with respect to the growth and differentiation of early embryos.

Chromatin density, morphology, mitochondrial status and epigenetic state in sperm of infertile men with disturbances of early embryo development in vitro will be compared with those of infertile men with normal embryo development and with fertile controls.

Primary outcome:

Features of chromatin density will be determined through staining of large numbers of spermatozoa. Differences in the staining results will be compared with known fertility outcome.

Secondary outcome:

Development of significant staining parameters towards the selection against sperm with reduced embryonic competence and/or in favor of sperm supporting embryonic development after assisted reproduction, thereby using flow cytometry and sorting (FACS) .

Eligibility Criteria:
Inclusion Criteria:

* Men with a history of infertility. Sperm concentration must be \>15 millions per ml.

Exclusion Criteria:

* No vulnerable persons will be invited to participate.
Observational Study on Costs and Caregiver Burden in Alzheimer's Disease

Objective of study is to assess the costs of care, objective and subjective caregiver burden and quality of life in relation to disease severity measured by cognitive function, ADL capabilities and presence of behavioral disturbances in Alzheimer's disease


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of possible or probable Alzheimer's disease, with or without vascular elements
* The primary caregiver can be identified
* The patient and his/her primary caregiver are both willing and able to participate in the study

Exclusion Criteria:

* Patient or caregiver affected by alcohol or narcotics to the extent that it interferes with the completion of the study
* Patient or caregiver does not understand English
* Patient and/ or caregiver is the physician or physician's staff
* Patient and/ or caregiver is a family member of the physician or physician's staff
A Study of Rapcabtagene Autoleucel in Systemic Lupus Erythematosus (SLE) Patients With Active, Refractory Lupus Nephritis (LN)

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) versus Standard of Care (SOC) in patients with systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN).

This is a Phase 2, adaptive, two-year, randomized, assessor-blinded, active controlled study:

* Part A: Participants suffering from systemic lupus erythematosus (SLE) with active, refractory LN will be randomized to Regimen 1, Regimen 2, or SOC.
* Part B: Participants suffering from SLE with active, refractory LN will be randomized to the selected regimen from Part A or SOC.

The study will consist of two periods:

* A screening period lasting up to 6 weeks, and
* A randomized treatment period and primary follow-up period lasting up to 104 weeks.

After end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.

Eligibility Criteria:
Key Inclusion Criteria:

* Men and women with SLE, aged \>= 18 years and =\< 65 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE at screening.
* Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of \>= 1:80 (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory.
* Active lupus nephritis without signs of significant chronicity
* SLEDAI-2K Criteria at screening: SLEDAI-2K score \>= 6 points (Gladman et al 2002, Touma et al 2011), excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome".
* Inadequate response at screening to at least two LN treatment regimens

Key Exclusion Criteria:

* Any acute, severe lupus related-flare at screening that needs immediate treatment other than pulse GCs and/or makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy
* Inadequate organ function during screening and prior to randomization
* History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants prior to randomization
* Human immunodeficiency virus (HIV) positivity at screening.
* Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening.
* Evidence of active or latent tuberculosis.
* Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening.
* Vaccination (including with live attenuated vaccines) not completed at least 6 weeks prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply.
Kids Obesity Prevention Program - Study (KOP)

Obesity and its associated comorbidities are becoming a key and rapidly growing public health problem. The cause of obesity is an imbalance between energy intake and energy expenditure in favor of the former. Childhood and adolescence are seen as critical time for its development. It is therefore crucial to provide both prevention and treatment actions already during childhood. The prevention and treatment weight-management programs in children focus on improving diet, eating behaviours, psychosocial aspects and increasing physical activity. One important basic requirement for any weight-management program is, that both children and their families are motivated and ready for change. Video games, including exergames, serious games or combined approaches offer additional chances in the treatment and prevention of obesity by approaching children in their environment and motivating them to deal with life-style topics.

The investigators developed a motion-controlled serious game for children aged between 9 and 12 years, addressing all the three core areas nutrition, physical activity, and psychosocial factors. In addition to the motion control, a tablet is used for knowledge-based and cognitive tasks. In comparison to other studies the nutrition part not only deals with the food pyramid but also with the energy density of foods and liquids and offers a self-reflexive diagnostic tool to analyse daily food intake. Moreover, psychological aspects, especially stress and stress-coping strategies are addressed e.g. by relaxation-exercises. The game consists of two sessions, having each a duration of about 35 minutes.

The aim of this study is to evaluate the program in a cluster-randomized controlled trial in a primary school setting in children aged 9 to 12 years. Therefore, six 4th grade classes of the same school will be randomly allocated to an intervention and a control group. The intervention group will play the game within two weeks, whereas the control group will receive basic information. At baseline, two weeks after baseline and at four weeks follow-up, measurements will be performed. The primary outcome of the study is the gain of knowledge (nutrition, psychosocial aspects) measured by a self-constructed questionnaires tailored specifically for the serious game. Secondary outcomes are the acceptance of the game, changes of nutrition behaviour, physical activity and intentions of the children to follow a healthy lifestyle, measured by mostly validated questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* all children which belong to the 4th graders of a primary school

Exclusion Criteria:

* children with massive linguistic difficulties will be excluded (after study participation; due to ethical reasons we can not do this ahead)
Study and Modulation of Immune Responses in Primary and Metastatic Colon Cancers

Colorectal cancer (CRC) is the 3rd most common cancer in France. Treatment of CRC relies primarily on surgical removal of the primary tumor and chemotherapy is the current standard of care for synchronous metastatic disease. Overall survival remains strongly correlated with the tumor stage at the time of surgery, from 90% at five years for localized disease (stages 1 and 2), to around 20% for metastatic forms of the disease (stage 4). Recent research in cancer highlights the role of the immune system in the development, evolution and fate of tumors. Understanding the nature of interactions between different immune cells infiltrating the tumor is important for the development of innovative therapies. Recently, the consensus molecular classification of CRC confirmed the importance of the immune response in CRC by showing that a "high immune response" is a good prognostic indicator for patients with this pathology. However, immunotherapies are effective for only a minority of patients with metastatic CRC. Indeed, anti Programmed cell Death 1 (anti-PD-1), -PD-L1 immune checkpoint blocking antibodies have only shown effectiveness in patients with microsatellite instability (MSI), which only represents 5% of metastatic CRCs.

Thus, the aim of this study is to better understand the role of the immune system on the development of CRC and its possible modulation to treat or prevent metastatic recurrences.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older
* Diagnosis of colorectal adenocarcinoma
* Scheduled resection of tumor and/or metastasis(es)

Exclusion Criteria:

* Patient's opposition to research
* Patients under guardianship
* The following situations

  1. Persons unable to understand and/or read the information leaflet
  2. Patient with one of the following functions: Investigator or co-investigator, research assistant, pharmacist, study coordinator or, having any involvement in the study
  3. Non-cooperative or potentially non-compliant person for the study and its procedures with foreseeable difficulties in regular follow-up over 5 years.
  4. Non-affiliation with a social security scheme, Couverture Médicale Universelle or any equivalent scheme.
* Pregnant or breast-feeding women.
* HIV-positive patients.
A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs

To evaluate the mechanism whereby thymopentin appears to retard the progressive immune suppression attributable to HIV infection.

Patients are randomized to receive subcutaneous thymopentin or placebo thrice weekly for 4 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Asymptomatic or minimally symptomatic HIV infection (no evidence of AIDS).
* CD4 count \<= 400 cells/mm3 within 6 weeks prior to study entry (CD4 count changed to 100 - 400 cells/mm3 per amendment).
* Tolerated the current nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known hypersensitivity to thymopentin or any component of the formulation.
* Significant chronic underlying medical illness that would impede study participation.
* Grade 2 or higher peripheral neuropathy related to nucleoside analog antiretroviral treatment.

Concurrent Medication:

Excluded:

* Any antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine.
* HIV vaccines or any investigational or non-FDA approved medication or immunomodulatory or experimental therapy within 30 days prior to study entry.

Patients with the following prior condition are excluded:

Abnormal chest x-ray consistent with active opportunistic infection within 6 weeks prior to study entry.

Prior Medication:

Excluded:

* Any prior antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine within 30 days prior to study entry.

Required:

* Current nucleoside analog antiretroviral treatment.

Required:

* Nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry.

Significant active alcohol or drug abuse sufficient to prevent study compliance.
A Kinematic Analysis of Motor Planning and Movement Execution of Children With Autism Spectrum Condition

Autism Spectrum Condition (ASC) is a behavioral syndrome characterized by a severe organizational disorder of thinking and major functions that regulate human adaptation. It is to be considered as a functional disorder, or of executive functions, whose dysfunction is expressed in the difficulty of making voluntary movements, sequentially coordinated with each other according to a purpose, and of initiating an action, planning and monitoring it by inhibiting inappropriate responses such as gesture perseveration. Literature studies suggest that, compared to children with typical development (TD) and regardless of cognitive status, children with ASC have pervasive motor dysfunction that results in universal difficulties in several aspects of motor function, including - (1) fine motricity, (2) some aspects of praxis while performing tasks based on imitation of sequences, (3) simultaneous coordination of both sides of the body during rhythmic tasks of the upper limbs, and́ (4) interpersonal coordination and synchrony. The hypothesis of the study is that by comparing these aspects in 2 groups of children with ASC and children with TD using A.I. systems, it will be possible to extract objective markers of motor deficits found in autism, facilitating the validation of measurements acquired with clinical scales. The objective of the study is to investigate the characteristics of manual motor planning and performance difficulties in children with ASC using kinematic measurements. 30 ASC children with medium-high functioning and 30 TD children, aged 7 to 13 years, IQ \> 80, in the absence of motor deficits due to another clinical condition, will be recruited. The protocol will take place in a single session during which children will be video-recorded performing simple and complex rhythmic upper limb actions with a social partner. The presence of characteristic fine motor behaviors, practice errors, perseverations, movement variability, and interpersonal synchrony will be observed. The study will involve the use of 3 tasks contained in NEPSY-II: Finger tapping, Visual-motor precision, and Imitation of manual motor sequences. The videos will be recorded simultaneously and the different angles will allow hand kinematics to be extracted and analyzed with A.I. algorithms to measure displacement, velocity, acceleration, frequency and any other kinematic parameters highlighted. Thus, it is expected to identify objective markers of motor deficits found in children with ASC.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism
* QI ≥ 80.

Exclusion Criteria:

* Motor deficits due to another clinical condition
STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic

STEP-COVID (Supporting the Transition to and Engagement in Parenthood during the COVID-19 pandemic) is a manualized group intervention for pregnant women during the COVID-19 pandemic designed to foster emotion regulation and reflective capacities in participants.

The program aims to (a) support mentalization in relation to oneself, motherhood and the relationship with the child to be born, (b) reduce isolation by allowing participants to exchange about the positive aspects and the challenges of pregnancy and motherhood with other women, (c) explore what pregnant women are going through in the context of the pandemic, (d) allow participants to repossess their experience of pregnancy in the current context of insecurity and fear, and (e) consider new ways of coping with stress and unpleasant emotions. The program is manualized and uses structured activities based on theoretical grounds and empirical research during which facilitators share information, animate reflective activities, and facilitate exchanges.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ages 18+ years
* Interested in reflecting about their experience of pregnancy and willing to attend weekly sessions in group setting.
* Must speak French as their first language

Exclusion Criteria:

* Severe psychiatric disorders (schizophrenia, bipolar disorder)
* Severe emotional dysregulation
* Current self-harm
* Not sure to keep the child
* High level of hostility