cyrilzakka/clinical-trials huggingface dataset:
Physician Reimbursement Home Patients

This is an observational study using an online survey to solicit information from nephrologists who care for dialysis patients about the time and effort involved in providing care to home dialysis patients.

Physician reimbursement today for care of a home dialysis patient is a capitated reimbursement, defined by the age of the patient and their days on home dialysis. Due to the multiple advantages of home therapy, CMS is working on increasing home dialysis uptake; however, there is little to no data on the time and effort involved in providing care to home dialysis patients.

In this study, we will develop and distribute a survey to capture the components of home dialysis patient care and the perceived time and effort of nephrologists across the US to do so. This will provide data for CMS as they consider the adjustment of their policy values in physician reimbursement for home dialysis patient care, which is currently labeled as misvalued (Centers for Medicare and Medicaid Services, 2021).

Eligibility Criteria:
Inclusion Criteria:

* All nephrologists in the US who care for dialysis patients.

Exclusion Criteria:

* Nephrologists who have not cared for dialysis patients in the last year.
Study of BMN 349 Single Dose in (PiZZ) and (PiMZ) Adult Participants

The goal of this clinical trial is to assess the safety and tolerability of a single oral dose of BMN 349 in participants with PiZZ or PiMZ/MASH.

Primary outcome measures include incidence of any adverse events (including serious adverse events, dose limit toxicities, and adverse events of special interest), incidence of any laboratory test abnormalities, incidence of lung function test abnormalities and 12-lead ECG parameters.

Participants will receive a single dose of either BMN 349 or placebo and then monitored for safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have confirmation of PiZZ or PiMZ genotype
* Females and males, of any race, 18 to 64 years of age
* Nonsmokers, defined as not using tobacco or nicotine-containing products for at least 6 months prior to Screening

Exclusion Criteria:

* International normalized ratio (INR) \> 1.2
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \> 125 U/L
* Current or recent use of AAT augmentation therapy
* Participants with recent (last 3 months) diagnosis of pneumonia
A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma

The purpose of this study is to assess the safety and tolerability of a 6-week Inspiratory Muscle Training and cardiovascular exercise training program in children and adolescents with asthma.

To also determine the efficacy of inspiratory muscle training and exercise in increasing respiratory muscle strength and endurance, and to explore relationships between fitness interventions (inspiratory muscle training and exercise), exercise tolerance, airway closure and dyspnea scores.


Eligibility Criteria:
Inclusion Criteria:

* 10-17 years of age
* Clinician-diagnosed asthma
* Sedentary activity defined as having not participated in a sports team or formal activity (dance classes, gym membership, active hobby requiring physical activity) in the past 12 months or have a
* Body mass index (BMI) ≥85th percentile (adjusted for sex and age)
* Child must have a designated caregiver who expresses a commitment to encourage the participant to attend weekly clinic-based exercise and also complete additional home exercise.

Exclusion Criteria:

* Previous intubation for asthma,
* Forced expiratory volume in 1 second (FEV1) \< 50% of predicted at enrollment;
* Any major chronic illness that in the opinion of the PI would interfere with participation in the intervention or completion of the study procedures;
* Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI
* Currently active in sports, vigorous play or planned exercise more than 1 time per week on average over the past month
* Current Pregnancy as determined by urine pregnancy test.
* Parent/Caregiver unable to consent in English
Effect of Intranasal Anti-IgE Antibodies on IgE Production

In this study, participants will receive either intranasal anti-IgE-antibodies (n=5) or intranasal allergen (n=5) or intranasal placebo (n=5). Blood samples will be obtained before nasal administration of study drugs and 3, 5 and 8 weeks thereafter. In the serum samples, specific and total IgE levels will be assessed.

The intranasal challenge study will be performed over 8 weeks outside of the birch pollen season (November to January) as a randomized, double blind and placebo-controlled study. During a screening visit, 15 individuals will be recruited according to eligibility criteria. They will be randomized into 3 groups (i.n. administration of anti-IgE antibodies, Bet v 1 or placebo). Intranasal administration will take place on three consecutive days and serum samples will be taken 3, 5, and 8 weeks (+/- 4 days) after the treatment for analysis of total and specific IgE levels

Eligibility Criteria:
Inclusion Criteria:

birch pollen allergy

Exclusion Criteria:

history of anaphylaxis autoimmune diseases treatment with corticosteroids, antihistamines, immunosuppressant drugs, beta-blockers significant medical conditions pregnancy or lactation
Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification

The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.

The main endpoint is a symptom score derived from the Jackson scale: sum of 2 items relating to runny nose and nasal congestion (stuffy nose), with ratings of 0 to 3 for each (0: absent ; 1: mild; 2: moderate; 3: severe).

Eligibility Criteria:
Inclusion Criteria:

* Person with an upper respiratory condition (cold, rhinitis, nasopharyngitis ...) with symptoms of nasal congestion and intense runny nose moderate to severe (Jackson derived score ≥ 4)
* Ability of the patient (for adults) or their legal representative (for children) to follow the guidelines of the medical device
* have given their written informed consent

Exclusion Criteria:

* Patient with no cold symptoms, including no nasal congestion (chronic dry rhinitis...)
* Patient under treatment with cortisone derivative, mucolytic, or medication containing pseudoephedrine or related product acting on nasal congestion or having used such a product in the 3 days before inclusion
* Patient who used a nasal wash product in the 3 days before inclusion
* Patient allergic to seafood, or to any of the components of the products under study
* Vulnerable patient whose inclusion is not justified by the research objectives: woman pregnant, parturient, psychiatric patient, or adult subject to legal protection
* Patient participating or having participated in any other clinical study in the 30 days before the study.
Efficacy of Solifenacin or Mirabegron with Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder

To investigates the effects of solifenacin or mirabegron with local estrogen versus combination treatment with solifenacin and mirabegron in women with overactive bladder

Women with detrusor overactivity who were refractory to anti-muscarinics or mirabegron were enrolled for prospective study. Patients were divided into three groups: combined pharmacotherapy with solifenacin and mirabegron, solifenacin with vaginal estrogen cream and mirabegron with vaginal estrogen cream. Incontinence-related symptoms distress and impact on quality of life were evaluated by short form of Urinary Distress Inventory, (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score (OABSS). Objective outcomes include changes from baseline in episodes of daily micturition, urgency, urinary incontinence and nocturia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with anti-muscarinics were enrolled for prospective study.

Exclusion Criteria:

* Postvoid urine retention before treatment
* Women who had medical illness and contraindication for using solifenacin and mirabegron, such as narrow-angle glaucoma and hypertension
* Concerns for using estrogen include: Women with history of cerebrovascular disease; thromboembolic disorders; gallbladder disease; known or suspected breast carcinoma; estrogen-dependent neoplasm or undiagnosed abnormal genital bleeding.
The Effects of a Single Dose of Wild Blueberries on Mood and Cognition in Healthy Young Adults

This study aims to investigate whether consuming a drink containing powdered blueberries (equivalent to 150 g fresh fruit) can improve mood and cognition in healthy young adults. Blood biomarkers of inflammation and neurotransmitter turnover will be analyzed as well as responses to computer-based cognitive tasks designed to measure verbal memory, executive function, and emotional processing.

The present study will examine the psychological effects of a single dose of freeze-dried wild blueberries using a randomized, double-blind, placebo-controlled, counterbalanced, crossover design. A total of 30 healthy young adults will consume two drinks: one containing 22 g blueberry powder and the other containing 22 g matched placebo powder in counterbalanced order one week apart. The investigators will assess changes in transient mood, cognitive-emotional function, and serum biomarkers of inflammation, neuroplasticity, and monoamine metabolism from baseline to 2 hours post-ingestion.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 25 years of age
* Willingness to provide blood samples

Exclusion Criteria:

* Allergy to blueberries or any other Vaccinium species
* Diagnosis or symptoms of anxiety, depression, or other mental health conditions
* Any medically significant condition (e.g. anemia, gastrointestinal disorders, diabetes)
* Use of psychoactive medication or recreational drugs in the last two weeks
* Current use of medication that could interact with the intervention (e.g. antibiotics)
* Obesity or underweight
* Participation in other interventional studies in the last month
* Pregnancy or lactation
Simultaneous Corneal Wavefront-Guided Trans-PRK and Corneal Collagen Crosslinking After ICRS Implantation for Moderate Keratoconus

The investigators aim to investigate the effects of combined corneal wavefront-guided transepithelial photorefractive keratectomy (tPRK) and accelerated corneal collagen cross-linking (CXL) after intracorneal ring segment (ICRS) implantation in patients with moderate keratoconus. Medical records of 23 eyes of 23 patients undergoing combined tPRK and CXL after ICRS implantation were retrospectively analyzed. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), corneal indices based on Scheimpflug tomography, higher-order aberrations (HOAs), and corneal biomechanical properties were evaluated before and after ICRS implantation, and at 1, 3, and 6 months after combined tPRK and CXL. Corneal biomechanical properties were measured using the dynamic Scheimpflug analyzer at approximately the same time of day.

The investigators aim to investigate the effects of combined corneal wavefront-guided transepithelial photorefractive keratectomy (tPRK) and accelerated corneal collagen cross-linking (CXL) after intracorneal ring segment (ICRS) implantation in patients with moderate keratoconus. Medical records of 23 eyes of 23 patients undergoing combined tPRK and CXL after ICRS implantation were retrospectively analyzed. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), corneal indices based on Scheimpflug tomography, higher-order aberrations (HOAs), and corneal biomechanical properties were evaluated before and after ICRS implantation, and at 1, 3, and 6 months after combined tPRK and CXL. Corneal biomechanical properties were measured using the dynamic Scheimpflug analyzer at approximately the same time of day. The dynamic Scheimpflug analyzer automatically calculated corneal deformation amplitude, radius values, and maximal concave power when the cornea is deformed to its greatest curvature by the air puff. The deformation amplitude is defined as the maximum amplitude when the cornea is deformed to its greatest concave curvature and is influenced by corneal stiffness. The radius values represent the central concave curvature at the highest concavity (depressed to the highest concavity), while maximal concave power is the inverse radius of the curvature at the highest concavity.

Eligibility Criteria:
Inclusion Criteria:

* intolerant to contact lenses
* moderate keratoconus without apical scarring
* if progression had been noted over the previous 6 months
* All included patients underwent combined corneal wavefront-guided tPRK and CXL at least 1 month (average 2.7 ± 1.1 months; range 1 to 4 months) after ICRS implantation.

Exclusion Criteria:

* central or para-central corneal scarring
* central pachymetry \< 400 microns
* corneal endothelial cell density of less than 2000 cells/mm2
* systemic autoimmune disease
* a history of herpetic corneal disease
* pregnancy
* lactation
* severe dry eye syndrome
Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)

The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects greater than or equal to (\>=) 18 years of age at the time of informed consent who have RA satisfying American College of Rheumatology (ACR) criteria with a disease history of at least 6 months
* Subjects must have active disease, defined by \>=8 swollen joints (out of 66), \>=8 tender joints (out of 68) and CRP \>=10 milligram per liter (mg/L) and/or erythrocyte sedimentation rate (ESR) \>=28 millimeter per hour (mm/hr), despite treatment with MTX at a dose of \>=15 milligram per week (mg/week) for greater than (\>) 3 months
* Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

* Inflammatory joint disease other than RA
* Previous or concurrent treatment with any approved or investigational biological compound for RA, including but not restricted to any anti-TNFalpha agents, rituximab, abatacept, tocilizumab, interleukin-1 receptor antagonist (IL-1Ra) and belimumab
* Treatment with disease-modifying anti-rheumatic drug (DMARDs) other than MTX
* Participation in any interventional clinical trial within 1 month before study Day 1
* MTX dose \>25 mg/week, prednisone dose \>10 mg/day (or equivalent), or change in steroid or non-steroidal anti-inflammatory drug (NSAID) dosing regimen within 28 days before study Day 1
* Immunization with live vaccine or immunoglobulin (Ig) treatment within 28 days before study Day 1 or need for such treatment during the study (including follow-up)
* Any history or presence of active or latent tuberculosis, major infection requiring hospitalization or intravenous anti-infectives within 28 days before study Day 1
* Other major concurrent illness or organ dysfunction as specified in the protocol
* Serum IgG below 6 gram per liter (g/L)
* Known hypersensitivity to atacicept or to any of the components of the formulated atacicept
* Other protocol-defined exclusion criteria could apply
Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery

The objective of this international post-marketing surveillance study is to collect data on the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.


Eligibility Criteria:
Inclusion Criteria:

* In-patients with diagnosis of severe haemophilia A (FVIII \< 1%), heavily pretreated (\> 150 exposure days), without any history of inhibitors, a negative inhibitor test should be available, decision taken by the investigator to administer KOGENATE Bayer via continuous infusion during and after surgery.
Melatonin and Adiponectin in Hypertensive Kidney Transplant

Recently we have shown that melatonin secretion is impaired in rats with metabolic syndrome. We have also demonstrated that exogenic melatonin supplementation can improve blood pressure profile in nondipper patients.

The aim of this study is to find whether there is a difference between melatonin secretion in hypertensive kidney recipients versus "normal" hypertensive patients. Secondly, to ask if there is any correlation between melatonin secretion and adiponectin levels.


Eligibility Criteria:
Inclusion Criteria:

* hypertension
* kidney transplantation ( group 1)
* good renal function

Exclusion Criteria:

* diabetes mellitus
* cancer
* renal failure
Randomized Clinical Study Comparing Two Guided Surgery Techniques for Free-end Implant Placement

This is a randomized multicenter clinical study that compares two static guided surgery techniques in free-end partial edentulism.

The aim is to compare the accuracy obtained between dento-osseous supported and dento-mucosal supported surgical splints to place dental implants in posterior osseous ridges.


Eligibility Criteria:
Inclusion Criteria: All patients who come to one of the two clinics mentioned above with a posterior edentulous area from the second premolar onwards and in whom the placement of dental implants is not contraindicated.

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Exclusion Criteria: Patients with hypersensitivities or allergies that contraindicate the intervention, presence of orofacial neurological symptoms, patients treated with bisphosphonates, pregnant or breastfeeding women or with contraceptive treatment, signs of infection in the area to be operated, unconventional surgical requirements, or lack of collaboration would be excluded.

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Echocardiographic and Laboratory Findings in Hemodynamic Monitoring of Shocked Patients

Shocked patients require prompt and accurate assessment of their hemodynamic status to guide appropriate management. Echocardiography is a valuable tool for assessing cardiac function, while laboratory parameters such as mixed venous oxygen saturation and arterial blood lactate provide insights into tissue perfusion and oxygen metabolism. This study aims to compare echocardiographic findings, including cardiac index, speckle tracking parameters, and tissue Doppler indices, with laboratory findings in the evaluation of hemodynamic monitoring in shocked patients.

Shocked individuals necessitate expeditious and precise evaluation of their hemodynamic condition to direct appropriate treatment. The utilization of echocardiography is an invaluable method for appraising cardiac function, while the inclusion of laboratory parameters such as mixed venous oxygen saturation and arterial blood lactate offers valuable insights into tissue perfusion and oxygen metabolism. The primary objective of this study is to compare the echocardiographic discoveries, which encompass the assessment of cardiac index, speckle tracking parameters, and tissue Doppler indices, with the laboratory findings in the comprehensive assessment of hemodynamic monitoring in individuals experiencing shock. The purpose of this investigation is to delineate the correlation between echocardiographic and laboratory assessments in order to enhance our understanding of hemodynamic status in patients who are in a state of shock.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with shock based on clinical criteria (e.g., hypotension, signs of tissue hypoperfusion) requiring hemodynamic monitoring.
* Patients age \> 18 year old.

Exclusion Criteria:

* Patients with pre-existing cardiac conditions affecting echocardiographic parameters, those receiving mechanical circulatory support.
* Patients with contraindications to echocardiography or blood sampling.
Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition

A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as reference from birth to 1 year of age and a follow up period from 1 year to 5 years of age.

The primary objective of this clinical trial is to show that infants taking (from birth) either a formula with a low protein content (LoF) or breast milk will have an IGF-1 level, at 4 months, 25% lower to the IGF-1 measured in infants that received a high protein content formula (HiF).

The secondary objectives are: The hormonal profile; the Fat mass (FM) gain and the Lean mass (LM); the metabolomics and aminogramm during the first year of life.

Subjects are included in the study for a duration of 5 years. From birth to 4 months they are exclusively fed BF or FF. From 4 months of age they can start diversification, but they maintain the starter formulas until 12 months (the BF group will receive LoF). Subjects are then followed up until 5 years of age.

Eligibility Criteria:
Inclusion Criteria:

. Healthy newborn infant

* Full term infant (= 37 weeks gestation; = 42 weeks gestation)
* Birth weight = 2500 g and \< 4200 g
* Singleton birth
* Infant is = 7 days of age at the time of enrollment
* For the BF group: The infant's mother has elected to exclusively breastfeed her baby, from enrollment to 4 months of age For the FF groups: The infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
* Having obtained his/her or his/her legal representative's consent

Exclusion Criteria:

* Newborn whose mother's BMI was normal (\<20 or = 25) at start of pregnancy

  * Newborn whose mother had developed gestational diabetes during pregnancy
  * Newborn whose mother has diabetes of type-1 or type-2
  * Newborn whose mother smoked \> 5 cigarettes / day during pregnancy
  * Newborn whose mother had a drug dependence during pregnancy
  * Newborn whose mother has a chronic infectious disease
  * Newborn whose parents / caregivers cannot be expected to comply with treatment
  * Newborn currently participating in another clinical trial