cyrilzakka/clinical-trials huggingface dataset:
Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection

This is multicenter placebo-controlled study evaluating the safety and efficacy of AI at two dosage levels compared to placebo in CF patients with P. aeruginosa lung infection.

This is multicenter placebo-controlled study evaluating the safety and efficacy of a 14-day treatment of AI at two dosage levels as compared to placebo, given twice daily, in CF patients with P. aeruginosa lung infection, delivered by the eFlow investigational nebulizer.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to the performance of any study related procedures.
* 13 years of age and above.
* Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) or homozygosity for ΔF508 genetic mutation or heterozygosity for two well characterized mutations.
* Ability to perform pulmonary function tests.
* FEV1 ≥ 40% predicted at Visit 1 (Screening).
* SaO2 ≥ 90% at Visit 1 (Screening).
* P. aeruginosa present in sputum at Visit 1 (Screening).
* Ability to expectorate sputum on a daily basis.

Exclusion Criteria:

* Administration of any antibiotic with antipseudomonal activity by any route within 56 days prior to Visit 1 (Screening).
* Administration of any investigational drug or device within 28 days of Visit 1 (Screening) and within 6 half-lives of the investigational drug.
* Oral corticosteroids in doses exceeding 10 mg per day or 20 mg every other day.
* History of sputum culture or throat swab culture yielding B. cepacia in the previous two years.
* Current daily continuous oxygen supplementation or requirement for more than 2 L/min at night.
* Known local or systemic hypersensitivity to monobactam antibiotics.
* Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 7 days prior to Visit 1 (Screening).
* Changes in physiotherapy technique or schedule within 7 days prior to Visit 1 (Screening).
* History of lung transplantation.
* A chest radiograph at Visit 1 (Screening) or within the previous 90 days of Screening, with abnormalities indicating a significant acute finding (eg, lobar infiltrate and atelectasis, pneumothorax, or pleural effusion).
* Abnormal renal or hepatic function or serum chemistry at Visit 1 (Screening):

  * AST, ALT \> 2.5 times upper limit of normal range.
  * Creatinine \> 1.5 times upper limit of normal range.
* Positive pregnancy test. All women of childbearing potential will be tested.
* Female of childbearing potential who is lactating or is not practicing acceptable method of birth control (eg, hormonal or barrier methods, or IUD).
* Findings at Visit 1 (Screening) that, in the investigator's opinion, would compromise the safety of the patient or the quality of the study data.
Awbat Versus Biobrane in Partial Thickness Burns

• To determine if AWBAT, used in treating partial-thickness burns, would provide better healing, pain control, control of infection, shorter length of hospital stay, lower costs, and improved scarring and long term recovery when compared to Biobrane®.

Currently there is no "best covering" or a standard "approved care" for treating partial thickness burns. Several options are available; however, they all have shortcomings. The application of topical antimicrobial dressings is time consuming and the regular dressing changes often associated with pain. Homograft or cadaver skin is often unavailable or in great shortage for skin transplants. Biobrane®, a biosynthetic wound dressing constructed of a silicone film with a nylon fabric partially imbedded into the film, has been available and used at our institute for many years as a skin substitute. It has been shown to reduce pain and the number of necessary dressing changes, and significantly reduced healing time (1). Its main side effects, although rare, are the occasional occurrence of infections and allergic reactions to the material.

Recently, a new product, AWBAT, has been developed for the coverage of partial thickness burns. AWBAT is similar to Biobrane® in terms of silicone membrane thickness, the structure of nylon fabric that gives the dermal substitute its strength, and the use of collagen peptides on the inner side of the membrane. These peptides are used for the purpose of reacting with the fibrin in the wound in order to achieve good initial adherence and to accelerate re-epithelialization. The key novelties of AWBAT are the different pore size and modality of collagen peptide attachments. These two key modifications aim at a reduction of the above mentioned adverse reactions.

The purpose of this study is to compare AWBAT to Biobrane® for covering partial thickness-burn injuries. We wish to determine if AWBAT, used in treating partial-thickness burns, would provide better healing, pain control, control of infection, shorter length of hospital stay, and improved scarring and long term recovery when compared to Biobrane®.

Eligibility Criteria:
Inclusion Criteria:

* Partial thickness burns between 4% and 40% Total Body Surface Area(TBSA)
* Full thickness burns not to exceed 10% TBSA,
* Age as specified

Exclusion Criteria:

* Full thickness burns that require immediate excision and grafting
* Known allergic reaction against Biobrane
* Chemical and electrical burns
Preparing Family Caregivers to Make Medical Decisions for Their Loved Ones

The overarching goal of the project is to improve the process and experience of surrogate decision-making by family caregivers. Since feeling unprepared to make surrogate decisions is a major contributor to caregiver stress, the primary outcome is caregiver self-efficacy --i.e., caregivers' assessment of how well prepared they feel to serve effectively as a surrogate decision-maker. Through follow-on Renewal funding, we are now also qualitatively examining family caregivers' experience with surrogate decision-making.

The long-term goal is to help family caregivers of seriously ill patients be better prepared to serve as surrogate decision-makers when their loved ones can no longer make medical decisions for themselves. Research shows that family caregivers find surrogate decision-making highly stressful and emotionally burdensome, in part because they feel unprepared for surrogate decision-making. To date, no studies have determined which advance care planning (ACP) process best prepares caregivers for this role. The investigators' prior work shows that a computer-based decision aid can help patients make more informed decisions and communicate their wishes more effectively. The investigators now propose to determine if family caregivers of patients with life-threatening illnesses are better prepared for surrogate decision-making: 1) when they engage in a structured ACP process together with patients; and 2) when they use this online decision aid for ACP. This will be accomplished via a randomized, controlled trial with a 2 x 2 factorial design comprising 4 groups: Standard ACP/Patient Alone (Group 1), Decision Aid/Patient Alone (Group 2), Standard ACP/Patients and Caregivers Together (Group 3), and Decision Aid/Patients and Caregivers Together (Group 4).

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Diagnosis of kidney disease (e.g. chronic kidney disease, end stage renal disease ) OR advanced cancer (Stage IV disease or having an estimated survival of \<2 years) OR severe heart failure (e.g. New York Heart Assoc. Class III or Class IV) OR severe lung disease (e.g. Stage III or Stage IV COPD by modified GOLD Spirometric Classification, Idiopathic Pulmonary Fibrosis).
3. Able to read and understand English at an 8th grade level (word 26 on either blue or tan version of the WRAT-3 reading subtest)
4. Neuro-cognitively able to engage in ACP (Mini Mental State Exam (MMSE) score \>23)
5. No active suicidal ideations (i.e., score of 0 or 1 on item 9 of the BDI-II).

Exclusion Criteria:

* Failure on any of the above inclusion criteria.
Metobolomics in the Characterisation of HE

Hepatic encephalopathy is (HE) defined by the neurological and/or neuropsychological symptoms caused by an acute or chronic liver disease and/or a portosystemic shunt. Its pathophysiology is still debated, although the synergic role of hyperammonemia and inflammation is now admitted for years. Several additional mechanisms have been suspected, one of them being an altered permeability of the brain blood barrier (BBB). Nevertheless, many aspects remain poorly understood.

The rise of "-omics" techniques, and especially metabolomics, allowed to identify more precisely the different metabolic pathways that are involved in the pathophysiology of HE. Using a high flow chemistry technique and multivariate data analysis, metabolomics is an accurate way to understand the pathophysiology and pathogenesis of multifactorial diseases such as HE. Several studies have been published in cirrhosis. It has been suggested that serum metabolites at admission, as well as thyroxine, can predict advanced HE in patients without brain failure. In a cohort including more than 600 patients, a higher microbially-derived metabolites, together with a lower thyroxine level, were associated with further development of brain failure. In another study from the same team, serum and urinary metabolites were significantly different in hospitalised patients who had developed poor outcome or not. Another study conducted in the CANONIC cohort as also found changes in metabolites of patients with cirrhosis and acute-on-chronic liver failure (ACLF), revealing mitochondrial dysfunction in peripheral organs that may contribute to organ failures. Last, our team previously analysed plasma and cerebrospinal fluid (CSF) samples of patients with cirrhosis and HE hospitalised in intensive care unit (ICU), showing alteration in ammonia and amino-acids metabolism, and also in energy metabolism. However, in the latest study, ALCF grading was not available. As many of these patients were in a severe condition, one could hypothesize that the metabolomic changes observed in these patients may have been confounded by an ACLF profile. Therefore, the objective of this study is to characterize the metabolomic fingerprints of HE in patients with cirrhosis, using 4 different groups of patients: patients with or without HE, with or without ALCF.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years
* Patient with cirrhosis of any etiology
* Informed patient who does not object to participating in the study
* Patient affiliated to a social security scheme or entitled beneficiary

Exclusion Criteria:

* Pregnant or breast-feeding women
* Protected populations: under guardianship or trusteeship
* Previous liver transplant
* Patient on AME
A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm

This study is a single arm, non-randomized, open label, multiple doses phase I/II international, multicenter clinical trial to evaluate safety, tolerability, PK/PD, immunogenicity and preliminary efficacy in subjects with advanced malignant neoplasm. The study is consisted of two stages: dose escalation and clinical expansion.

Only Phase I has been submitted to US FDA,and the protocol number is still the same as 6MW3211-2021-CP101.The US title is : A Phase 1, First-in-Human (FIH), Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 6MW3211 in Patients with Advanced Malignancies .

Six cohorts are included in dose escalation stage, at doses of 0.3\~45 mg/kg, respectively. Safety, tolerability, and dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W), IV.

From the first study drug administration, some dosing cycles will be observed for phase I, initial tumor efficacy assessments will be performed at week 7, after that tumor efficacy assessment will be carry out for every 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 1. Men or women, age ≥18.
* 2.Subjects with advanced malignancy histopathologically and/or cytologically, with at least one evaluable tumor lesion.
* 3.ECOG PS is 0 or 1.
* 4.Survival expectation of at least 3 months.
* 5.Adequate organs and hematopoietic functions
* 6.Voluntarily signing of informed consent

Exclusion Criteria:

* 1.Subjects with brain metastases of clinically active central nervous system (CNS).
* 2.Subjects that require to take anticoagulants and/or aspirin.
* 3.Blood transfusion within 2 weeks prior to the first administration of study treatment.
* 4.Inadequately controlled body cavity effusions.
* 5.Subjects with active, or have a history and possible recurrence of autoimmune diseases .
* 6.Have uncontrolled systemic diseases.
* 7.Subjects who had received anticancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.
* 8.Subjects are known to have previously experienced severe allergic reactions to large molecular protein formulations/monoclonal antibodies.
* 9.Pregnant or lactating women.
Culture System for Isolating Circulating Tumor Cells

This culture system utilizes the special affinity difference of biomedical material coating for different cells to achieve the effect of isolating cancer cells from the blood sample. The coating of the system has the characteristic that to make the WBCs adhesion, but the cancer cells in the blood sample suspend in the culture medium, which achieves the effect of separating cancer cells from the blood. The supernatant with the cancer cells can further be isolated from the cultural system for related analysis and detection to achieve early diagnosis and screening.


Eligibility Criteria:
Inclusion Criteria:

1. Polycythemia patients are between the ages of 20 and 70.
2. Willing to sign the consent form under the informed consent.

Inclusion Criteria:

Exclusion Criteria:

1. Vulnerable Subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.
3D-printing and Acces to Tele Rehabilitation

This study will investigate whether 3D printing of orthoses (night splints and AFO/KAFO for walking, further named as dynamic AFO/KAFO) for the lower limbs can help to improve the limited accessibility to orthopaedic devices in developing countries. The 3D printed orthoses will be assessed for effectiveness, cost and feasibility. Measurement and manufacture of the orthoses is also supported remotely via video conferencing.

Specifically, the study is being conducted in 3 West African countries: Togo, Niger and Mali. A total of 4 orthopaedic centres are involved, whereby an equal number of patients are recruited everywhere.

There are 2 groups of patients, those who need a (knee) ankle-foot orthosis to move around (dynamic AFO/KAFO) and those who need a night splint to correct the ankle or knee position. All patients in the study will have a treatment route involving fitting a new traditional orthosis and a new 3D printed orthosis. The order of application of both treatments will be randomised in a crossover design. Patients will be measured at baseline after the first treatment period (3 weeks) and after the second treatment period (6 weeks). The primary outcome measures are different for both groups of patients: the walking speed when performing the 10-metre walk test in the patients wearing the dynamic AFO/KAFO, and the measured angle (of knee or ankle) in the patients wearing a night splint.

Eligibility Criteria:
Inclusion Criteria:

* Pathology: foot stance abnormality
* Both unilateral and bilateral orthoses are included
* Pathology: genu varum

Exclusion Criteria:

* Patient is already wearing a night splint
* The patient cannot stand upright
* The patient is pregnant
Mental Health of Professionals Working in Pediatric Intensive Care Units During the COVID-19 Pandemic

Health professionals are extremely exposed to psychosocial risks, as they experience, in general, high levels of stress, anxiety, fatigue and suffering, due to the nature and location of their work. As a result, the health and well being of these professionals can be significantly compromised. In outbreaks of serious infectious diseases and pandemics, these risks become amplified and the health team is at greater risk of falling ill, presenting changes in mental health and psychological trauma, while caring for infected patients and becoming potential contaminants in their family and community.

The objective is to study the mental health of professionals who work in Pediatric Intensive Care Units (PICUs) in Brazil, during and after the COVID-19 pandemic. The primary outcome will be the prevalence of burnout in the team involved with the care of critically ill children. Secondary outcomes such as anxiety, depression, quality of professional life, compassionate fatigue and post-traumatic stress disorder will be measured. Possible associations between demographic, work and coping variables (social support and resilience) with mental and emotional health outcomes will be investigated, in an exploratory character.

It is a multicenter, observational, longitudinal study, with a descriptive and exploratory analytical component. Data collection will be carried out through an electronic survey during and after the COVID-19 pandemic.

Health professionals are extremely exposed to psychosocial risks, as they experience, in general, high levels of stress, anxiety, fatigue and suffering, due to the nature and location of their work. As a result, the health and well being of these professionals can be significantly compromised. In outbreaks of serious infectious diseases and pandemics, these risks become amplified and the health team is at greater risk of falling ill, presenting changes in mental health and psychological trauma, while caring for infected patients and becoming potential contaminants in their family and community.

The objective is to study the mental health of professionals who work in Pediatric Intensive Care Units (PICUs) in Brazil, during and after the COVID-19 pandemic. The primary outcome will be the incidence of burnout in the team involved with the care of critically ill children. Secondary outcomes such as anxiety, depression, quality of professional life, compassionate fatigue and post-traumatic stress disorder will be measured. Possible associations between demographic, work and coping variables (social support and resilience) with mental and emotional health outcomes will be investigated, in an exploratory character.

It is a multicenter, observational, longitudinal study, with a descriptive and exploratory analytical component. Data collection will be carried out through an electronic survey during and after the COVID-19 pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants that signed informed consent form

Exclusion Criteria:

* Refused to sign informed consent form
Effectiveness of a Program With Aquatic Therapy in Patients With Parkinson's Disease Clinical Trial

The aim of this study is to determine the effect of an aquatic Ai Chi training program on the perception of pain, the maintenance of balance and the functional independence of patients with Parkinson's disease.

Fifteen patients diagnosed with Parkinson's disease (Hoehn and Yahr range: 1-3) participated in a program of Aquatic Ai Chi lasting ten weeks with sessions held twice weekly. These were compared to a group of 15 Parkinson patients (control group) who received therapy on dry land.

All study participants met the following inclusion criteria: individuals diagnosed with PD in stages 1 to 3 (Hoehn and Yahr Scale), older than 40 years, in the off phase (not medicated) and with a score greater or equal to 24 on the Mini-Mental State Examination Scale, without any medical contraindications and who accepted the study norms (regular assistance and active participation). The exclusion criteria were: individuals who did not comply with the above mentioned criteria, and the presence of articular and/or muscular lesions in the lower limbs affecting independent gait.

The procedure of randomization was performed for the overall sample using stratified randomization controlling for the Hoehn \& Yahr stage employing Excell software (Microsoft Excell 2013: Microsoft Corp. Redmond WA).

The participants received an initial assessment on dry land lasting 30-45 minutes, performed by a physiotherapist not involved in the study. Timetable norms were disclosed as well as recommendations regarding appropriate clothing for the activity. A baseline assessment was performed prior to commencing therapy. This was repeated upon completion of all sessions while a follow-up assessment took place one month later.

Eligibility Criteria:
Inclusion Criteria:

* individuals diagnosed with PD in stages 1 to 3 (Hoehn and Yahr Scale), older than 40 years, in the off phase (not medicated) and with a score greater or equal to 24 on the Mini-Mental State Examination Scale, without any medical contraindications and who accepted the study norms (regular assistance and active participation).

Exclusion Criteria:

* individuals who did not comply with the above mentioned criteria, and the presence of articular and/or muscular lesions in the lower limbs affecting independent gait.
Pharmacogenetics and Cardiovascular Events

To assess interactions between selected cardiovascular medications and genes in the incidence of heart attack, stroke, and atrial fibrillation, an irregular heartbeat.

BACKGROUND:

This complex study will collect additional genetic data for 3 ongoing case-control observational studies of drug-gene interactions in myocardial infarction, stroke, and new-onset atrial fibrillation. This study will add single nucleotide polymorphism (SNP) discovery for 16 of 36 candidate genes involving the renin-angiotensin system, sodium transport, adrenergic receptors, and G-proteins, and allow analysis of haplotype data.

The study was initiated in response to RFA HL-03-001, Ancillary Studies in Pharmacogenetics.

DESIGN NARRATIVE:

The primary aim of this study is to assess interactions between selected cardiovascular medications and the major candidate-gene variants or haplotypes on the incidence of myocardial infarction (MI), stroke and atrial fibrillation (AF). The candidate-gene sets-selected on the basis of biology, pharmacology, and information from genome-wide scans-include: (1) 10 genes in the renin-angiotensin system; (2) 10 genes involved in renal sodium transport; (3) 8 genes encoding alpha and beta adrenergic receptors; (4) 8 other genes, including G-proteins, estrogen receptors, and the alpha-1C subunit of the L-type calcium channel. The products of these genes represent the sites of action for many cardiovascular drugs: angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, all classes of diuretics, alpha blockers, beta-blockers, central alpha agonists, calcium antagonists, and estrogens. Both hypothesis-testing and hypothesis-generating analyses are planned. For selected single nucleotide polymorphisms (SNPs) studied in vitro or in small clinical populations, several specific drug-gene interactions are plausible, and these associations will be evaluated in an hypothesis-testing manner.

The study used data from previously funded case-control studies which are expected to produce 1053 MI cases, 565 stroke cases and 800 atrial fibrillation cases and 3249 matching controls from the enrollees of Group Health Cooperative. These patients will already have had chart abstractions, pharmacy database searches, telephone interviews and phlebotomy with specimen storage.

Eligibility Criteria:
No eligibility criteria