cyrilzakka/clinical-trials huggingface dataset:
Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout

The primary purpose of this study is to observe patients being treated with pegloticase in a standard healthcare setting in order to evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex related events. Additionally, serious adverse events associated with pegloticase therapy will be identified.

This was a Phase 4, multicenter, open-label, single-arm observational study of pegloticase 8 mg administered intravenously every 2 weeks in adult hyperuricemic patients with gout refractory to conventional therapy. Study duration is approximately 63 weeks, including 51 weeks of treatment and 12 weeks of follow-up.

The design of this study follows the FDA-approved Full Prescribing Information for the use of pegloticase and allows for capturing additional data related to the safety and efficacy of pegloticase within the standard healthcare setting.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18 years or more) with chronic gout refractory to conventional therapy, defined as patients who have failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose, or for whom these drugs are contraindicated.
* Patients who have made the decision, along with their treating physician, to begin treatment with KRYSTEXXA.
* Patients who are willing and able to give informed consent and adhere to visit/protocol schedules.

Exclusion Criteria:

* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Non-compensated congestive heart failure
* Pregnancy or breast feeding
* Prior treatment with pegloticase or another recombinant uricase
* Known allergy to urate oxidase
* Prior treatment or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug
* Recipient of an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation

This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM- mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU), compared with other three usual preventive measures which consist in the use of three different medical devices.

Non-Invasive Mechanical Ventilation (NIVM) has turned into a standard in the care of patients with acute respiratory failure. Defined as a support modality to the patient's spontaneous ventilation, it does not use invasive techniques to ventilate, working as an external device named interface or mask, avoiding so the complications associated to the invasive ventilation.

NIVM had been restricted to ICU and Pneumology services, but in the last years it has been extended to ER with good results and it is being also used in the pre-hospital attention and in the home care of chronic patient.

Often, the preferred interface is the oronasal, worst tolerated but associated to best treatment of the acute pathology. In most cases to avoid air leaks, its proper placement generates high pressure on the skin, being able to harm patient's tissues, so that this therapy as intervention for the acute patient has pressure ulcers -PU- as main iatrogenic effect - although 95% of the PU are considered as preventable-.

To diminish the pressure of the mask on the points of the face, nurses protect the most exposed zones with dressings of hydrogel-foam, polyurethane and/or hyperoxygenated fatty acids, trying to prevent PU.

Reviewed studies present a big variability in these practices as well as high dispersion of the results achieved.

Preventive measures are different and even none, as applying the mask or the interface directly could be the most effective treatment in the prevention of PU, avoiding not justified increase of fungible and other resources consumption.

The aim of this study is to test direct application of the mask or interface, as the most efficient intervention, compared with other three usual preventive measures which consist in the use of three different medical devices: autoadhesive polyurethane dressing (Allevyn Thin®), semi-permeable hydrogel-foams adhesive dressing (Askina Transorbent Border®) or hyperoxygenated fatty acids (Linovera®)

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years).
* Not tissue injury in face.
* Not structural deformation of the facial anatomy.

Exclusion Criteria:

* Rejects Informed Consent
Current Status of BTKi Treatment for CLL/SLL in China

BTKi has become the standard treatment regimen for CLL/SLL，there is a lack of large-scale real-world studies on the use status and related influencing factors of BTK inhibitors. Therefore, we plan to conduct this multicenter retrospective cross-sectional study to understand the current situation of BTK inhibitor treatment for CLL/SLL patients in China and the related influencing factors, and to explore more suitable treatment patterns based on this.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Patients with a confirmed diagnosis of CLL/SLL;
* Received BTK inhibitor treatment between February 2023 and February 2024.

Exclusion Criteria:

* Patients with other types of lymphoma;
* Cases deemed unsuitable for inclusion in this study by the investigators.
Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers

Buprenorphine, a treatment for opioid dependence, can be mixed with another drug, naloxone, to limit abuse potential. Parenteral administration (intravenous or intramuscular injection) of buprenorphine/naloxone causes withdrawal symptoms in opioid dependent individuals. However, naloxone does not cause withdrawal symptoms in non-dependent opioid abusers. This study will investigate whether naloxone decreases the opioid agonist effect from injected buprenorphine, hence decreasing the abuse potential of buprenorphine/naloxone, in non-dependent opioid abusers.

Naloxone has been combined with buprenorphine to decrease the parenteral abuse potential of buprenorphine in opioid dependent individuals through the mechanism of naloxone-precipitated withdrawal. While naloxone will not precipitate withdrawal in individuals who are not physically dependent on opioids, it is possible naloxone might attenuate buprenorphine's agonist effects, especially if administered parenterally. The purpose of this study is to assess the effect of sublingual (SL) and intramuscular (IM) buprenorphine and buprenorphine/naloxone in non-dependent opioid abusers.

Participants will stay on a research ward and will undergo challenge sessions twice per week. The following conditions will be tested: placebo; IM hydromorphone (2 and 4 mg; an opioid agonist positive control condition); SL buprenorphine (4, 8, and 16 mg); IM buprenorphine (4, 8, and 16 mg); SL buprenorphine/naloxone(4/1, 8/2, and 16/4 mg); and IM buprenorphine/naloxone (4/1, 8/2, and 16/4 mg). During challenge sessions, physiological status will be recorded continuously and tasks assessing psychomotor, subjective, and objective status will be performed repeatedly.

Eligibility Criteria:
Inclusion Criteria:

* Non-dependent opioid abuser
* Actively abusing opioids by injection

Exclusion Criteria:

* Opioid dependence
* Signs or symptoms of opioid withdrawal, once admitted to residential unit
Factors Affecting Early Adult Lung Function

Attainment of peak healthy lung function during the 18-26 yr window is a strong determinant of the rate of lung function decline during the later years of life. The attainment of a healthy peak lung function is mediated by pre and peri natal exposures ( in utero environment and nutrition) and exposure to environmental toxicants and nutrition during childhood and early adulthood. Towards this Indian birth cohorts, having collected comprehensive data on maternal nutrition and anthropometry can provide invaluable insight into the factors affecting lung function growth and their effect sizes in the Indian population. Therefore, in this observational study, the Investigator will be collecting data on lung function, current nutritional and environmental exposures and linking it to pre and peri natal data of the same participants in order to understand lung function growth and the reasons for an early decline in the Indian population, using a life course approach.

Introduction:

Attainment of peak healthy lung function during the 18-26 yr window is a strong determinant of the rate of lung function decline during the later years of life. The attainment of a healthy peak lung function is mediated by pre and peri natal exposures ( in utero environment and nutrition) and exposure to environmental toxicants and nutrition during childhood and early adulthood. Towards this Indian birth cohorts, having collected comprehensive data on maternal nutrition and anthropometry can provide invaluable insight into the factors affecting lung function growth and their effect sizes in the Indian population. Therefore, in this observational study, the Investigator will be collecting data on lung function, current nutritional and environmental exposures and linking it to pre and peri natal data of the same participants in order to understand lung function growth and the reasons for an early decline in the Indian population, using a life course approach.

Sampling:

F1 generation of previously registered Indian Birth Cohorts, having collected comprehensive data on maternal exposures, nutrition and anthropometry.

Techniques Employed:

Spirometry , Forced OscillationTechnique, Anthropometry, Questionnaire, Biochemical analysis of nutritional, immunomodulatory and inflammatory biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women
* 18-30 years
* Mothers registered in the birth cohort
* Able to perform IOS and Spirometry

Exclusion Criteria:

* Major systemic diseases like cardiac or renal problems
* Clinically significant anemia
* Bone deformity of chest or spine
* muscular weakness
* Otherwise unable to participate in spirometry
Sublingual Immunotherapy In Alternaria-Induced Rhinitis

Respiratory allergy due to Alternaria is a relevant clinical problem, and specific immunotherapy may represent a viable treatment option. Sublingual immunotherapy (SLIT) is safe and effective, but data for Alternaria are lacking. The study is aimed at assessing the efficacy of a standardized SLIT in patients sensitised to Alternaria, in a randomized, double blind, placebo controlled fashion.

Patients with rhinitis with/without intermittent asthma, and ascertained allergy to Alternaria are enrolled. After a baseline season, SLIT or matched placebo are given for 10 months. Symptoms and rescue medication intake are recorded on diary cards from June to October. Skin prick test, specific IgE and IgG4 and precipitins are measured at baseline and at the end of the study. Alternaria spore count is also performed. Primary outcome is the change in symptom score in the active vs placebo group. Secondary outcomes: changes in rescue medication intake, alternaria specific IgE and IgG4, skin prick test reactivity.


Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinitis
* Symptoms May-October
* Specific IgE to alternaria (skin test/radioallergosorbent \[RAST\] test)
* Age \>14

Exclusion Criteria:

* Sensitization to mites, parietaria, mugwort
* Pregnancy-lactation
* Malignancies
* Chronic systemic steroids
* Previous immunotherapy to alternaria
Comparison of Recurrence of Atrial Fibrillation Post Cryoballon Ablation During the 90-day Blanking Period-with and Without Anti-arrhythmic Drug Therapy

This study is being done to find out if patients taking Anti Arrhythmia Drugs (AADs) after cryoballoon ablation for atrial fibrillation, compared to patients who do not take Anti- Arrhythmic Drugs after an ablation affect Atrial Fibrillation from coming back. The study will also look at the side effects of the AADs.

Pulmonary vein isolation (PVI) is a cornerstone ablation strategy used in the management of paroxysmal atrial fibrillation (PAF), and it is a class IA indication for anti-arrhythmic drug (AAD) refractory symptomatic PAF. However, the consensus statements are vague about the utility of AAD management during the 90-day blanking window post-PVI. Moreover, there is no specific guidance to cryoballoon users on the usage of AADs during the 90-day blanking period that exists anywhere in the published literature. Simply, these studies have not been conducted with the cryoballoon procedure.

Eligibility Criteria:
Inclusion Criteria:

* Drug refractory and recurrent Paroxysmal Atrial Fibrillation
* The subject meets medical criteria for cryoballoon ablation to treat Paroxysmal AF
* Age 18 to 80 years
* The subject has a Cardiovascular Implantable Electronic Device (CIED) that captures AF episodes, such as an implantable loop recorder, pacemaker, or implantable cardioverter defibrillator (ICD) with a properly functioning atrial lead.

Exclusion Criteria:

* Use of any Anti- Arrhythmic Drugs for ventricular arrhythmias
* Ejection Fraction (EF)\<45%
* Prior A. Fib. ablation
* Pregnant women
Efficacy of a Non-invasive Device for Alleviation of Parkinson's Disease Symptoms

Investigation efficacy of a non-invasive wearable electrostimulator device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally and extracranially.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease
* H\&Y Stage \>= 2
* Existing bradykinesia symptoms
* Existence of one of the symptoms below
* Resting Tremor
* Rigidity
* Walking disorder

Exclusion Criteria:

* Cardiac Pacemaker
* Psychiatric diagnosis
* Irregular heart/respiration rate
* Pregnancy
* Alcohol consumption
* Cardiovascular disease history
* Wearing an electro-active prosthesis
* Brain surgery history
* Ongoing TENS/PENS therapy
An Internet-delivered Intervention for Parents of Children With ADHD

The aims of the present study is to investigate the efficacy of a co-designed individually-tailored Internet intervention for parents of children with ADHD.

Attention/deficit-hyperactivity disorder is a prevalent mental health problem in children with a significant impact on children, families and society. Despite the fact that evidence-based treatment exists, with pharmacologic and non-pharmacologic options available, a significant percentage of children do not have access to treatment. Behavioral parent training is recommended as first line treatment for children with ADHD, however, parents face numerous challenges in access, and even when they access BPT, dropout rates are high. Technology could improve access to evidence-based treatments and surpass existent gaps. For instance, Internet interventions are associated with moderate to large effect sizes for anxiety and depressive symptoms in adults.

Participants included in this study, namely parents of children diagnosed with ADHD (aged 6-11 years) will be randomized either to ADHDCoach intervention or Treatment as usual.

Eligibility Criteria:
Inclusion Criteria:

* Parent of a child diagnosed with ADHD
* Child aged between 5-11 years
* Have Internet access
* Have ability to read and write in Romanian
* No medication/ or stable dose of pharmacological treatment

Exclusion Criteria:

* Other ongoing psychological treatment or counselling for mental health problems (currently undergoing psychotherapy or participating in a parenting program for child ADHD)
* Recent (within the past 3 months) changes in the dose of medication
* Serious psychopathology requiring immediate clinical attention (e.g., severe depressive symptoms)
Percutaneous Mitral Valve Repair in Cardiogenic Shock: Mitra-Shock Study

Cardiogenic shock (CS) is a medical emergency and a frequent cause of death. CS can be complicated and/or precipitated by mitral regurgitation (MR). The efficacy of percutaneous treatment of MR in patients with cardiogenic shock is unknown. The aims of the study will be to analyse the efficacy of MitraClip therapy on early (30 days) and midterm mortality (6 months) as well as the predictors of outcomes. Investigators will also report the rate of periprocedural complications such as minor and major bleeding, vessel injury and Acute Kidney Injury (AKI).

It is a multicenter retrospective observational study on CE marked medical device (MitraClip® System). Retrospective time range: from 01/01/2012 to 01/01/2020


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old

Exclusion Criteria:

* multiorgan failure,
* VA-ECMO,
* inadequate peripheral access because of vascular disease,
* not suitable mitral valve anatomy.
Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy

This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.

Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to sign informed consent
* Age 50 or older at diagnosis
* Life expectancy greater than 10 years (excluding diagnosis of breast cancer).
* Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria).
* On histologic examination, the tumor must be DCIS or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either:

  1. sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or
  2. axillary dissection (minimum of six axillary nodes removed); and
  3. the axillary node(s) must be pathologically negative.
* The T stage must be Tis, T1, or T2. If T2, the tumor must be ≤ 3.0 cm in maximum diameter.
* Estrogen receptor positive tumor

Exclusion Criteria:

* Age \< 50 at diagnosis (regardless of histology)
* Pregnant or breast-feeding (if appropriate, patient must use birth control during the study)
* Active collagen-vascular disease
* Paget's disease of the breast
* History of DCIS or invasive breast cancer
* Prior breast or thoracic RT for any condition
* Multicentric carcinoma (DCIS or invasive)
* Synchronous bilateral invasive or non-invasive breast cancer
* Surgical margins that cannot be microscopically assessed or that are positive or close
* Positive axillary node(s)
* T stage of T2 with the tumor \> 3 cm in maximum diameter or a T stage \> 3
* Estrogen receptor negative tumor
A Single-arm Phase II Study of Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) to the Regional Nodes for Advanced Stage, Human Papilloma Virus (HPV) Positive, Oropharyngeal Cancer

To determine 2-year local (primary tumor site) control and toxicity rates in patients receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of the oropharynx.

To determine acute and long-term toxicity rates in patients receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of the oropharynx.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, stage IVa, p16-positive on immunohistochemistry Pathologic T1 or T2 disease, resected with negative margins ( 2mm) Pathologic N2a, N2b, or N2c disease ECOG Performance Status 0-1
* Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits - - - Ability to understand and the willingness to provide written informed consent

Exclusion Criteria

* Prior radiation therapy to the head and neck Prior chemotherapy within the past 5 years Presence of T3 or T4 disease Presence of close (2 mm) or positive margins PNI on TORS resection of the primary cancer Presence of N0 or N1 disease in neck dissection Presence of distant metastatic (M1) disease
* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection

This study evaluates the therapeutic value of: (i) simultaneous endoscopic visualization of the inner bladder using white light and blue light excitations and (ii) high resolution panoramic images of the bladder inner wall.

All participants will undergo fluorescence cystoscopy: the first half using first a reference medical device for fluorescence cystoscopy already on the market then using the innovative device specifically developped for the CyPaM2 project.

The other half will undergo fluorescence cystoscopy using first the innovative then the reference medical device.

An innovative medical device was developped by the CyPaM2 project's partners.This device is made of a hardware and of a software part: (i) an imager (light source and sensors) for simultaneous and colocalized visualisation of the bladder using white light and blue light for fluorescence excitation and (ii) a mosaicing software for automatic building of high-resolution panoramic images of the bladder inner wall. The medical device's qualitative (human engineering, images qualitty) and quantitative (medical examination and panoramic images building durations) specifications will be evaluated during the clinical trial in comparison with a reference medical device already on the market. The main goals are to achieve (i) better sensitivity of bladder cancers' cystocopic diagnosis and shorter medical examination durations thanks to the simultaneous visualization of the bladder inner wall with white and blue lights and (ii) better patients' follow up thanks to the high resolved panoramic images.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patient with suspicion of a bladder cancer or a suspected recurrence of a bladder cancer
* Cytological and bacteriological examination of urine culture negative
* Patient must be affiliated to a social security system
* Ability to provide written informed consent patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study

Exclusion Criteria:

* Age \< 18 years
* Bladder infection in progress and untreated
* Hemorrhage
* Urethral stenosis
* Contraindication for a cystoscopy examination
* Contraindication to administration of Hexvix (porphyria, hypersensitivity to hexylaminolévulinate or excipient of Hexvix (disodium phosphate dihydrate, potassium dihydrogen phosphate)
* Pregnant or breast feeding females
* Patients deprived of liberty or under supervision