cyrilzakka/clinical-trials huggingface dataset:
IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation (TASMANIA)

The aim of this study is to assess humoral immune response in kidney transplant recipients after SARS-CoV-2 mRNA vaccine.

TASMANIA is a single-center prospective observational study with 1000 kidney transplant recipients from Institute for Clinical and Experimental Medicine (IKEM), Prague. The primary objective of the study is to assess humoral immune response to SARS-CoV-2 mRNA vaccines in SARS-CoV-2-naive kidney transplant recipients using immunochemiluminescent assay. As comparator several cohorts will be evaluated:

1. kidney transplant recipients with previous SARS-CoV-2 exposition verified by real-time reverse transcription polymerase chain reaction (RT-PCR)
2. kidney transplant recipients vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-CoV-2 previously exposed

The secondary objective is to determine clinical variables affecting antibody levels. SARS-CoV-2 anti S1/2 antibodies will be tested ≥ 15 days after the second dose of mRNA vaccines and in 3 months after the first blood sampling.

In subanalysis 50 kidney transplant recipients will be examined for a cell-mediated immune response after SARS-CoV-2 mRNA vaccine Enzyme Linked using Immuno Spot (ELISPOT) assay.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients
* Recipient age ≥ 18 years
* Written Informed Consent and Consent for Processing Personal Data
* Vaccination with two doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation.

Exclusion Criteria:

* Active SARS-CoV-2 infection.
* Patients that received anti-SARS-CoV-2 monoclonal antibodies.
* Active infection after vaccination
* Monoclonal antibodies treatment ahead of antibody or cellular immunity screening
A Reinforcement Approach to Improve Diabetes Management

The purpose of this project is to evaluate the efficacy of a behavioral economic intervention to improve self monitoring of blood glucose (SMBG) in adolescents and young adults with T1D. The intervention will reinforce patients for conducting SMBG, with escalating reinforcers provided when patients achieved sustained periods of testing at least 4 times/day at appropriate intervals. A 6-month trial will be conducted in which 60 patients will be randomized to: (1) standard care or (2) standard care plus the reinforcement intervention.


Eligibility Criteria:
Inclusion Criteria:

1. age 12-21 years old;
2. diagnosis of type 1 diabetes (T1D) \>12 months via ADA guidelines
3. receiving diabetes treatment at Yale Pediatric Diabetes Clinic and not meeting clinical care guidelines
4. SMBG user with clinical recommendations to test \>4 times/day and using a device that allows for remote uploading (e.g., Aviva, Contour, Freestyle, Lifescan, etc.; equipment for uploading will be provided);
5. access to a computer with internet for uploading and sending SMBG data;
6. access to a cell phone with text messaging capabilities and willing to text after SMBG testing and receive messages about reinforcement;
7. English speaking, able to read at \>5th grade level, and pass an informed consent quiz; and adequate knowledge of insulin dosing and dietary recommendations for managing T1D.

Exclusion Criteria:

1. have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) that would inhibit participation;
2. have a major visual impairment;
3. have a significant other medical condition that impacts diabetes management (e.g., asthma, rheumatoid arthritis, or other condition that requires steroid treatment);
4. plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched;
5. are participating in another clinical trial.
A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD

This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments.

The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819.

Study details include:

* The study duration will be up to 72 weeks
* The treatment duration will be up to 52 weeks
* A follow-up period of 20 weeks will be conducted
* The number of on-site visits will be 7 and the number of phone contacts will be 5


Eligibility Criteria:
Inclusion Criteria:

- Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study.

Exclusion Criteria:

* Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin
* Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status
* Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study
* Any situation that led to a permanent premature IMP discontinuation in parent trials

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Expanded Access to Fosigotifator

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Fosigotifator prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients

Objective: To investigate effects of home-based somatosensory stimulation associated with motor training on improvement in performance of the paretic upper extremity in patients in the chronic phase after stroke.

Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based rehabilitation. Subjects: Patients in the chronic phase (\> 6 months) after stroke. Interventions: Patients will be randomized to an active and a control group. In both groups, treatments will be performed at home, daily, over four weeks. Patients in the active group will be instructed to use a device that provides somatosensory stimulation in the form of electrical stimulation of the median nerve for two hours. Patients in the control group will also be instructed to use the device for two hours, and sham stimulation will be administered. In both groups, patients will be instructed to train activities with the paretic hand immediately after nerve stimulation.

Main measures: The primary outcome will be improvement in performance of the paretic hand evaluated by the Jebsen-Taylor test at end of treatment and four months after end of treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the interventions, assessed through a daily written log, and oral reports of the patients; 2) safety profile of the interventions.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years;
* single ischemic or hemorrhagic stroke in a cerebral hemisphere, documented by computed tomography (CT) or magnetic resonance imaging (MRI);
* stroke onset at least six months before;
* hand paresis with preserved ability to perform all tasks of the Jebsen-Taylor Test (JTT).

Exclusion Criteria:

* previous strokes;
* epilepsy and other neurological conditions;
* proprioceptive or tactile anesthesia;
* shoulder or hand pain;
* severe joint deformity;
* severe chronic disease;
* inability to give provide informed consent due to severe aphasia or cognitive impairment;
* left handedness before the stroke.
The Effect of Massage Therapy to Control Night Shift Related Stress

Background:

The sympathetic and parasympathetic branches (SNS and PNS) of the autonomic nervous system (ANS), keep our body in a state of balance, which can be disturbed in situations of uncontrolled stress. Sleep deprivation and specifically night shift is a source of stress with adverse consequences on sleep, wakefulness, eating patterns and cardio-vascular function. Furthermore, imbalanced autonomic profile is also associated with increased inflammation, a known risk factor for cardiac problems, diabetes, and cancer.

Parasympathetic stimulation can control the inflammatory reaction, leading research toward interventions which can stimulate the cholinergic pathway. Among these interventions, massage therapy has shown to stimulate the PNS and bring back the balance within the body's organs.

Objectives:

1. To assess the physiological effects of night shifts on the ANS profile and bio-markers of inflammation and stress in blood
2. To assess whether one session of massage therapy can revert the adverse effects of night shift via re-balancing these components.

Methods:

A pilot prospective randomized crossover trial with 10 healthy hospital staff is in progress:

Each participants will be their own control. All participants will be measured for their baseline characteristics and outcomes of interest on a regular working day as well as at the end of 2 nights of shift work. At the end of one shift they will be randomly assigned to receive a 30-minute-long "upper body massage", while at the end of the other shift they will receive a "reading intervention" which would serve as a control intervention. Randomization is done using a computer system that also verifies inclusion-exclusion criteria before allocating the intervention.

The autonomic profile is measured by spectral analysis of Heart Rate Variability (HRV) captured by a state-of-the-art machine which non-invasively records electrical signals from the body. The inflammatory markers in the blood are also measured using top-notch laboratory technology.

The results of the study will be reported by comparing the outcomes of each subject with their own baseline as well as comparing the two interventions for the effect of massage. Data will be pooled for all subjects in order to show the overall effect.

The final results of this study will be used to plan stress management intervention trials.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy hospital staff between the ages of 20 to 60 taking rotating night shifts on a regular basis.

Exclusion Criteria:

* Participants who are on anti-depressants or drugs that affect the cardiovascular system or the ANS.
* Any conditions or disorders that would affect the cardiovascular system or the activity of the ANS.
* Participants who smoke more than 10 cigarettes/day.
* Inability to provide consent.
* Inability to speak and/or understand English.
Effect of Strength Training and Protein Ingestion in Old Versus Very-old

From 3 interventiongroups in the project with ClinicalTrials.gov ID NCT02034760, namely:

HRTW: Heavy Strength Training x3/week \& 20g whey protein twice daily. LITW: Light Intensity Training x3-5/week \& 20g whey protein twice daily. WHEY: 20g whey protein twice daily.

15 subjects from each group will be recruited and tested after 3 months of intervention. Tests will include muscle cross sectional area (MRi), muscle biopsies (fiber types, size, cell- and capillary count), functional- and strength measurements, plasma lipids, HbA1c. Tests are to be compared with Project ID NCT01997320.

In- and exclusion criteria are listed in NCT02034760. Subjects will be randomized to interventions as described, and 15 subjects from each of the three groups will be tested after 12 weeks of intervention.

15 subjects are included in each group to account for an expected drop-out rate of 20%, and so 12 subjects are expected to complete each intervention. With this N an increase of around 11% in MRi-evaluated muscle size can be detected with a powerlevel of 80% and an alpha of 0.05 and use of reported SD.

Primary outcome is muscle size (MRi), and secondary outcomes are overall body composition (DXA), muscle strength, rate of force development, power, 30s chair stand, 400m gait speed, grip strength. Tertiary outcomes are habitual activitylevel (accelerometry), blood samples (HbA1c, cholesterols, creatinine), blood pressure, weight, BMI, wast- and hip circumference.

Results are to be compared with NCT01997320 and so a population of 65+ can be compared with a population of 83+. Both studies uses the same heavy strength training regimen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, independently living
* Age at least 65 years

Exclusion Criteria:

* Subjects dependent on help/nursing etc.
* Chronic medical diseases: Diabetes mellitus, clinical knee or hip osteoarthritis, other types of arthritis or connective tissue disorders, active cancer, renal diseases, severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, lactose or gluten intolerance, chronic inflammatory bowel diseases, non-treated hyper/hypothyroidism, dementia.
* Surgical diseases: Bone, muscle, tendon or joint injuries compromising participation in exercise regimens.
* Implanted magnetic devices incompatible with MRi-scanning.
* Weekly alcohol consumption \> 21 units (1 unit equals 4g of ethanol) for men and \> 14 for women.
* Medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40mg/day or if combined with subjective myalgia, ACE-inhibitors, Angiotensin II blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparing diuretics and loop diuretics.
* \>1 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation.
Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated, Adult Patients With Severe Gram-Negative Lower Respiratory Tract Infection

Antibacterial drugs are facing increasing limitations in terms of effectiveness due to emergence resistance. Improved antibacterial drug monitoring approaches are particularly needed in nosocomial infections occurring in ICU patients, including ventilator-associated pneumonia and ventilator-associated tracheobronchitis, where decreased susceptibility of the etiological organisms is observed worldwide and pharmacokinetic alterations frequently observed.

No routine drug monitoring is available for betalactams at the point of care in a useful time frame (i.e., within a few hours after having collected the blood specimens).

The purpose of this study is to compare MON4STRAT approach for reaching and maintaining a meropenem pre-determined PK-PD target when compared to conventional meropenem dose.


Eligibility Criteria:
Inclusion Criteria:

1. Males and non-pregnant, non-lactating females, 18 years of age or older
2. Currently intubated and mechanically-ventilated subjects in the ICU
3. Suspicion of lower respiratory tract infection
4. Presence of Gram-negative organism(s) by Gram stain OR by culture of pre-therapy respiratory specimen (eg, endotracheal aspirate \[ETA\], bronchoalveolar lavage \[BAL\], or mini-BAL) OR previous colonization 48 h before screening.
5. Initial empiric antimicrobial meropenem regimen
6. At least two risk factors for multidrug-resistant organisms
7. Provision of written informed consent by the subject or a family member or a close relative or waiver of consent.

Exclusion Criteria:

1. Subjects who have received antibiotic therapy for Gram-negative LRT infection for ≥ 36 hours at the time of randomization
2. Subjects with known or suspected type 1 hypersensitivity to beta-lactam and/or cephalosporin
3. Subjects taking valproic acid for a seizure disorder
4. Subjects who have had a left hemisphere stroke within five days and there is an increased risk of fatal brain oedema
5. Subjects who have cystic fibrosis, human immunodeficiency virus (HIV) infection with CD4 count \<100 cell/mm3 or invasive fungal infection of the lung
6. Neutropenia (ANC \< 103 neutrophils/mm3)
7. Bone marrow transplant.
8. Subjects who have been on mechanical ventilation for \>28 days
Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.


Eligibility Criteria:
Inclusion Criteria:

* IUGR defined as birth length and/or weight below the lower limit (\< P10) of the Lubchenco curves for the gestational age.
* Chronological age = 2-5 years
* HV below average for CA
* Insufficient catch-up growth (Height \< P3 for chronological age, according to Hernández)
* Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother
* Normal response to GH stimulation test (greater tan or equal to 10 ng/mL)
* Bone age (measured through Greulich and Pyle method) less than or equal to CA

Exclusion Criteria:

* Children born from multiple pregnancy
* Children with post-ischemic encephalopathy
* Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.)
* Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy)
* Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....)
* Nutritional disorders (celiac disease) or osteodystrophies
* Patients who receive or received any treatment (anabolic drugs, sex steroids, etc.) likely to interfere with GH effects
* Abnormal karyotype
* Neoplasms
* Previous or ongoing chemotherapy and/or irradiation
* Renal dysfunction, defined as serum creatinine \> 1 mg/dL
LIPAD - LRRK2 International Parkinson's Disease Study

The study aims to identify and systematically characterize Parkinson's patients with mutations in the LRRK2 gene. In about 90% of Parkinson's patients the cause of the disease is unclear. Based on current knowledge, it can be assumed that there are several causes and that the causes may be differ between patients; this makes research into the pathogenesis and possible therapies very difficult. In the case of monogenic Parkinson's diseases, which are due to changes in one gene (e.g. LRRK2), the function of the gene and possible disease mechanisms can be investigated. LRRK2-associated Parkinson's syndrome is clinically indistinguishable from idiopathic Parkinson's disease. It is inherited autosomal dominant, that means if one of the two gene copies is altered, the disease occurs. However, the disease does not occur in every mutation carrier, the penetrance is reduced and the mechanisms for that are still unclear. Ideally, knowledge of what influences penetrance could make it possible to exert targeted influence and prevent the disease. The comprehensive investigation of mechanisms of reduced penetrance but also of the effects of the mutation itself requires systematic investigations of as many affected persons as possible. We therefore aim to identify 4,000 people internationally, of them 1,500 with LRRK2-associated Parkinson's syndrome, 500 with LRRK2-mutations but without Parkinson's symptoms, 500 without mutations and without Parkinson's symptoms, 500 Parkinson patients with mutations in other genes than LRRK2 and 1,000 patients with idiopathic Parkinson's disease from the same populations. The participants will undergo a comprehensive survey on Parkinson's symptoms, concomitant diseases, environmental factors and medication and there is the possibility of more detailed genetic examinations. Participants will be asked to donate samples of blood, urine and household dust.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent is obtained from the participant.
* The participant is clinically diagnosed with Parkinson's disease or the individual is a family member of a participant with LRRK2 parkinsonism or is a member of a high risk population with an early PD onset.
* The participant is equal to or older than 18 years old.

Exclusion Criteria:

* Inability to provide informed consent.
* The participant is not suffering from Parkinson's disease or the individual is not a family member of a participant with LRRK2 parkinsonism or is not a member of a high risk population.
* The participant is younger than 18 years old.
* Previously enrolled in the study.
* Participant in custody.
Treatment of Periodontitis in Menopausal Patients

The goal of this clinical trial is to compare the effectiveness of polyunsaturated fatty acids (PUFAs) \[omega-3\] as an adjunctive treatment to scaling and root planing for menopausal women with periodontitis versus scaling and root alone as a non- surgical treatment .

. The main question it aims to answer is:

• to investigate the effect of systemic administration of Omega-3 fatty acids in addition to SRP on clinical periodontal parameters and GCF levels of osteocalcin and AST in menopausal women.

Participants will given \* a soft gelatin capsules containing PUFAs to be consumed directly once daily for 12 months along with non-surgical treatment (group2)

\*\* a soft gelatin capsules containing olive oil to be consumed directly once daily for 12 months along with non-surgical treatment (group1)

Researchers will compare group 1 to group 2 to see if PUFAs has an effect on clinical periodontal parameters and GCF levels of osteocalcin and AST in menopausal women. .

Menopause is typically accompanied by significant systemic and oral manifestations, including hormonal changes and increased susceptibility to periodontal disease, which may involve inflammatory biomarkers like aspartate aminotransferase (AST) and Osteocalcin in gingival crevicular fluid (GCF). The study aims to evaluate the effectiveness of regular inoculation of polyunsaturated fatty acids (PUFAs) as an adjunctive treatment for menopausal women's periodontitis.

Methods: Twenty elderly women with chronic periodontitis were split evenly into two groups by random assignment. Patients in group II (the research group) were given soft gelatin capsules containing PUFAs to be consumed directly once daily for 12 months, as opposed to the group I (the control group), who received soft gelatin capsules containing some olive oil (placebo). Scaling and root planning (SRP) were used to address periodontal disease in all cases.

At baseline, six and twelve months after treatment, clinical indicators and AST and Osteocalcin amounts in the GCF will be noted.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as; periodontitis patients
* presence of a minimum of 6 teeth in the mouth
* at least 3 periodontal sites with probing pocket depth more or equal to 5mm
* women experiencing menopause for at least a year

Exclusion Criteria:

* women suffering from any systemic disorder that might affect the periodontal tissues such as; Diabetes Mellitus, immune disorders,..
* anemic patients
* smokers
* patients taking NSAIDs, supplements, antibiotics regularly used mouthwashes within the last 3 months
* participants in any other clinical trials