cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting

This study will assess the effects of adalimumab treatment in moderate to severe Hidradenitis Suppurativa (HS) patients in the real world setting. The objectives of this study are to estimate the effectiveness of adalimumab treatment on disease severity, to estimate the impact of adalimumab treatment on patients' quality of life, psychological effect, work productivity and healthcare resource utilization and to describe treatment practices over the study period.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of moderate to severe Hidradenitis Suppurativa
* The decision to treat with adalimumab (Humira) is made by the physician in accordance with the local label (Summary of Product Characteristics; product label) prior to any decision to approach the participant to participate in this study
* Participants willing to be involved in the study and to sign patient authorization form to use and disclose personal health information (or informed consent, where applicable)

Exclusion Criteria:

* Participants in a clinical interventional study
* Participants treated with adalimumab prior to baseline visit
Restoration of Vision After Stroke

Occipital stroke is associated with homonymous visual field defects (occurring on one side of the visual field). Despite spontaneous recovery, some degree of defect is often permanent. Currently, no treatment exists for such visual field defects.The purpose of this study is to test the efficacy of a type of electrical brain stimulation method, transcranial alternating current stimulation, in reducing these type of visual field defects in their chronic stage.


Eligibility Criteria:
Inclusion Criteria:

* Occipital ischemic or hemorrhagic stroke 6 months or older
* Hemianopia or quadrantanopia demonstrated by standard automated perimetry
* Visual field defect is stable across baseline
* Presence of residual vision and detectable gradual transition between the the intact and absolutely blind parts of the visual field
* Best corrected visual acuity for at least one eye better or equal to 0.4

Exclusion Criteria:

* Eye or central nervous system disease that interferes with the study
* Cardiac pacemaker
* Other metallic devices or implants precluding participation in MRI scans
* Pregnancy or lactation period
* Epileptic seizures in the past 10 years
* Use of antiepileptic or sedative drugs
* Expected low compliance due to substance abuse
* Known active malignancy
Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema

The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids.

Chronic hand eczema (CHE)is a distressing disease that poses difficult problems for dermatologists. CHE leads to considerable work-absenteeism, disability and exclusion from labour market. Conventional treatments, including highly potent topical steroids, yield often unsatisfactory results. This study investigates the efficacy and safety of oral alitretinoin, a retinoid, in patients who have not responded to avoidance of causative factors, such as contact allergens and skin irritants, non-medicated skin care and highly potent topical steroids. Eligible patients are randomly assigned to receive alitretinoin or a placebo.

Eligibility Criteria:
Inclusion Criteria:

* all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis
* rated as severe by the physician
* unresponsive to highly potent topical corticosteroids, such as clobetasol

Exclusion Criteria:

* patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants
* patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances
* patients with psoriasis lesions
* active fungal, bacterial or viral infections of the hands
* female patients who are pregnant or breastfeeding
* female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception
Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)

To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or who are not candidates for conventional surgery.

The Mi-thos® study is a single-arm, prospective, safety and performance clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Severe mitral regurgitation ≥ 3+;
* Patients with an STS score \>8 or who have been evaluated by a cardiothoracic surgeon as high risk for conventional surgery or who cannot tolerate conventional open-heart surgery;
* Age ≥ 65 years old;
* Life expectancy \> 12 months;
* Patients sign an informed consent form.

Exclusion Criteria:

* Previous cardiac mitral valve surgery;
* Active infections requiring antibiotic therapy;
* Clinically significant untreated Coronary Artery Disease (CAD);
* Pulmonary hypertension （Pulmonary systolic pressure \> 70 mmHg）;
* Patients with severe right heart failure;
* Left ventricular ejection fraction \<25%;
* Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
* Dialysis patient;
* Patients with severe coagulopathy;
* Patients with contraindications to anticoagulant drugs;
* Patients with stroke or transient ischemic within 30 days;
* Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;
* Patients who require surgery or interventional therapy for other valvular lesions;
* Patients with severe macrovascular disease requiring surgical treatment;
* Patients with more than 70% of carotid stenosis;
* To be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products;
* Patients with severe neurological disorders affecting cognitive ability;
* Life expectancy \< 12 months;
* Patients with severe thoracic deformities.
Optimizing Tracheal Intubation Outcomes and Neonatal Safety

The purpose of the study is to assess the impact of a personalized intubation planning tool, the Personalized INtubation Safety (PINS) Bundle on intubation procedural safety and clinical outcomes among patients intubated in the neonatal intensive care unit (NICU) setting.

Tracheal intubation (TI) in the neonatal intensive care unit (NICU) is frequently complicated by adverse safety outcomes such as adverse tracheal intubation associated events, multiple TI attempts, and oxygen desaturation. Investigators have developed, refined, and tested a Personalized INtubation Safety (PINS) Bundle that targets a prospective and individualized approach to TI planning and management. The Prospective Intubation Safety (PINS) Bundle addresses 5 core evidence-based domains that are individualized to the patient to develop a prospective, personalized and comprehensive multidisciplinary TI plan: (1) patient risk assessment; (2) treatment threshold for intubation; (3) premedication (promoting paralytic medication); (4) equipment (promoting video laryngoscope); (5) provider selection and escalation plan.

This is a pragmatic stepped wedge cluster randomized trial of NICU patients who are intubated across 8 participating hospitals to determine if the PINS Bundle, compared to no PINS Bundle, reduces the incidence of adverse tracheal intubation associated events.

The primary objective of this study is to determine the effectiveness of the PINS Bundle to decrease adverse TI safety events. The secondary objectives are 1) to evaluate if the impact of the PINS Bundle on adverse TI safety events varies based on provider skill, and 2) to determine the impact of the PINS Bundle on NICU clinical outcomes of extubation failure, duration of intubation, NICU mortality, and intraventricular hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

Infants undergoing tracheal intubation in the neonatal intensive care unit (NICU)

Exclusion Criteria:

Endotracheal tube exchanges, as this represents a distinct procedure.
EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses

Craniostenosis is a congenital disorder caused by early fusion of the cranial sutures between the skull bones, resulting in orbito-naso-frontal deformities. The damage is primarily aesthetic, but intracranial hypertension may also be observed.

The treatment of craniostenosis involves surgery, to restore harmonious growth between the skull bones and the brain, and proper development of the latter.

There are various surgical techniques for correction, based on remodeling of the upper forehead and the orbito-naso-frontal band (BONF). However, BONF reshaping is difficult to tailor to each individual child. In most cases, the surgeon performs the reshaping "freehand", without a template. The result is therefore subject to the surgeon's experience and judgment.

A surgical instrument (template) has been developed to guide the surgeon in the ideal reshaping of the BONF in patients with anterior craniostenosis (anterior plagiocephaly and trigonocephaly), according to each child's specific morphology.

The aim of EPBONF research is to evaluate the benefits of using this template on the symmetry and angle of the BONF.


Eligibility Criteria:
Inclusion Criteria:

* Children with anterior craniostenosis (organic trigonocephaly or anterior plagiocephaly), aged 4 to 24 months
* Procedure performed at Besançon University Hospital
* Written consent from both parents, or from one parent if there is only one, indicating that they have understood the purpose and procedures of the study, and that they agree to their child's participation in the study and to the study's requirements and restrictions.
* Affiliation with a French social security scheme or beneficiary of such a scheme.
* Pre-operative computed tomography scan and cone beam to measure the fronto zygomatic distance and naso-frontal angle in trigonocephaly, and to calculate the frontal process of the zygoma symmetry defect in organic anterior plagiocephaly.

Exclusion Criteria:

* Legal incapacity or limited legal capacity of parent(s)
* Subject is in the exclusion period of another study or is on the "national volunteer list".
Assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects

The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study-specific procedures
* Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
* Post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (FSH) levels in the laboratory defined post-menopausal range
* Irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation
* Volunteers must have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg
* Volunteers must be able to understand and be willing to comply with study procedures, restrictions and requirements
* Healthy male and non-fertile female volunteers ages 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

* Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the absorption, distribution, metabolism, and excretion of drugs
* Current smokers, those who have smoked or used nicotine products within the previous 3 months from the date of screening (Visit 1)
* Plasma donation within 1 month of screening or any blood donation/blood loss \>500 mL during the 3 months prior to screening or intention to donate blood or blood products during the study or within 3 months after the completion of the study
* Positive screen for drugs of abuse, or cotinine (nicotine level above 400 ng/mL), at screening or admission and/or positive alcohol test at admission
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
The Right to be Forgotten in the AYA Population: Patients' Experience and Perspectives (Diritto All'Oblio)

Cancer survivors experience a form of social discrimination that is described in numerous areas such as private life, educational and work paths and the achievement of personal goals. Starting from this scenario, more and more national legislative initiatives are emerging to reconcognize the right to be forgotten, defined as the right not to have to report one's, resolved, oncological disease in contact with institutions such as insurance companies, banks or others. The issue of the right to be forgotten is current and new, primarily in the AYA (adolescents and young adults) population. The purpose of this study is to explore and describe the experience of adolescents and young adults affected by previous oncological disease with respect to the issue of the right to be forgotten. In particular, focusing on:

* awareness (knowledge of the issue);
* significance attributed and subjective perception;
* implications/fallouts perceived or experienced on one's present and future history.

Cancer survivors experience a form of social discrimination that is described in numerous areas such as private life, educational and work paths and the achievement of personal goals. Starting from this scenario, more and more national legislative initiatives are emerging to reconcognize the right to be forgotten, defined as the right not to have to report one's, resolved, oncological disease in contact with institutions such as insurance companies, banks or others. The issue of the right to be forgotten is current and new, primarily in the AYA (adolescents and young adults) population. The purpose of this study is to explore and describe the experience of adolescents and young adults affected by previous oncological disease with respect to the issue of the right to be forgotten. In particular, focusing on:

* awareness (knowledge of the issue);
* significance attributed and subjective perception;
* implications/fallouts perceived or experienced on one's present and future history.

Eligibility Criteria:
Inclusion Criteria:

* Age at diagnosis between (or equal to) 15 and 39 years;
* patients not in active phase of treatment;
* at least 5 years elapsed since diagnosis;
* comprehension and written expressive ability of the Italian language.
* subscription informed consent to the study.

Exclusion Criteria: NA
Telephone Intervention for Pain Study (TIPS)

Treatments teaching people how to manage pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these treatments delivered over the telephone can benefit persons with multiple sclerosis, spinal cord injury or an acquired amputation. Specifically, we want to determine if these treatments can help reduce the negative consequences that pain often causes in terms of a person's mood, daily activities, and enjoyment of life. We are also interested in finding out if these treatments decrease a person's pain.


Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnosis of acquired amputation (AMP), multiple sclerosis (MS), or spinal cord injury (SCI) confirmed by participants' primary care physicians
* Average pain intensity in the past month of greater than 3 on 0-10 numeric rating scale;
* Pain is either worse or started since the onset of the disability;
* Pain of at least six months duration, with pain reportedly present greater than or equal to half of the days in the past six months;
* Read, write and understand English;
* Must be able to communicate over the phone (i.e., must be verbal);
* Age 18 years or older.

Exclusion Criteria:

* Cognitive impairment defined as one or more errors on the Six-Item screener (Callahan et al., 2002).
* Current or previous participation in a psychological treatment for pain (obtained via self-report).
* Current participation in a psychological treatment for any reason on a regular basis(obtained via self-report).
Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes

A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system commercially available in Germany \& Holland.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with type 1 or type 2 diabetes mellitus
* Age between 18 and 75 years.
* Patients with stable blood glucose in judgment of the investigator.
* Subjects receive intensive insulin therapy (Multiple Daily Injection defined as at least two insulin injections per day)
* Patients perform blood glucose self measurements on a routine basis
* Patients must have experience in self measurement blood glucose for at least 6 months.

Exclusion Criteria:

* Patients with unstable blood glucose in judgment of the investigator.
* Patient has been diagnosed with progressive / serious diseases that in judgment of the investigator preclude successful completion of the observational period.
* Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study.
* Subject without legal capacity.
* Blood donation within the last 30 days.
* Known pregnancy.
* Subject has already participated in the study.
Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.

This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.

Eligibility Criteria:
Inclusion criteria:

* Women aged 20-45 years in 28 to 32 weeks of pregnancy
* Positive HBsAg and HBeAg
* Serum viral load above 6 log10 IU/mL

Exclusion criteria:

* Major systemic disease of the mother or fetus
* Positive anti-HIV or anti-HCV
* Under treatment of antiviral therapy
* Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
* Pregnant woman whose amniocentesis reveals any genetic abnormality
Depression And Bipolar Disorder

This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.


Eligibility Criteria:
Inclusion

* Patients must provide written and informed consent.
* Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks.

Exclusion

* Patients must not be suicidal.
* Patients must not have a history of non-response to antidepressant treatment.
* Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry.
* Patients must not have had epilepsy or hypothyroidism.
Effects of Music Therapy in Controlling Symptoms in Patients With AML and Undergoing HSCT

The goal of this clinical trial is to test passive music therapy in patients receiving induction chemotherapy for an acute myeloblastic leukemia or undergoing an hematopoietic stem cell transplantation. The main questions it aims to answer are:

- Can music therapy control physical and psychological symptoms and improve the mood and quality of life of these patients?

Participants will be randomly assigned to the control and experimental group. Patients included in both groups will complete weekly mood and quality of life questionnaires. Those included in the experimental group will also complete daily symptom burden questionnaires before and after listening to a music therapy session.

Researchers will confirm if the experimental group improves their symptoms after the music therapy session and will compare both groups to see if there are differences in mood and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old.
* Patients receiving induction chemotherapy for a newly diagnosed acute myeloblastic leukemia (except for acute promyelocytic leukemia).
* Patients undergoing autologous or allogeneic stem cell transplantation.
* Being able to understand and read Spanish properly.
* Basic computer skills.

Exclusion Criteria:

* Moderate-severe hearing impairment (unilateral or bilateral).
* Past history of psychiatric disorders.
* Performance status: ECOG ≥ 3.
Evaluation of On-Couch CBCT Image Quality

This is a prospective, single-arm, single-site study designed to generate data describing the image quality and applicability/useability of a high-performance, on-couch CBCT imaging technology (HyperSight) in patients receiving radiation treatment for cancer on a C-arm linear accelerator (TrueBeam).


Eligibility Criteria:
Inclusion Criteria:

* Patient age is ≥ 18 years old.
* Patient has a diagnosis of primary or metastatic cancer, including but not limited to tumors arising from or involving the head/neck, lungs, liver, pancreas, prostate, urinary bladder, rectum, cervix or uterus.
* A previous (standard-of-care) decision was made to treat the patient with radiation therapy using a Varian TrueBeam treatment system.
* A previous (standard-of-care) decision was made to treat the patient with a radiation dose of at least 20 Gy in at least 5 fractions, one fraction per day on consecutive days, Monday to Friday.
* Patient is willing and able to provide informed consent to participate in the study.

Exclusion Criteria:

* Patient is pregnant or has plans for pregnancy during the period of treatment.
* Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response").