cyrilzakka/clinical-trials huggingface dataset:
The Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis

The objective of this trial is to determine the safety and effect on pulmonary function of 14 days of inhaled L-arginine versus placebo administered over a period of 14 days in a cohort of CF patients.

Despite the inflammatory nature of lung disease in CF, nitric oxide (NO) formation as well as the expression of NOS2 has been found to be decreased in CF airways. While the reasons for impaired airway NO formation remain incompletely understood, there is evidence that low NO formation contributes to lung pathophysiology in CF. Constitutive endogenous formation of Nitric oxide (NO) in airways is thought to play a role in neurotransmission, smooth muscle relaxation and bronchodilation. Previous animal experiments have shown that the addition of L-arginine, the precursor of enzymatic NO formation, resulted in a significantly greater relaxation of tracheas. There is also evidence that a single dose of inhaled L-arginine improves pulmonary function in CF. In this study we will assess the effect of L-arginine inhalation on lung function, nitric oxide formation, airway inflammation and bacterial infection in CF patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride concentration \> 60 mEq/L and/or two well characterized disease causing CFTR gene mutations
* 14 years of age and older at enrollment
* Clinically stable at enrollment
* Ability to comply with medication use, study visits and study procedures
* FEV1 % predicted \> 40% \< 80 % as calculated by reference equations

Exclusion Criteria:

* Respiratory culture positive for: B. cepacia complex within past year or at screening
* Use of systemic corticosteroids within 30 days of screening
* Use of intravenous antibiotics or oral quinolones within 14 days of screening
* History of biliary cirrhosis, portal hypertension, or splenomegaly
* Other major organ dysfunction
* History of lung transplantation or currently on lung transplant list
* Supplemental oxygen therapy
* Oxygen saturation \< 95 % on room air
* Positive pregnancy test at screening
* Investigational drug use within 30 days of screening
* History of alcohol, illicit drug or medication abuse within 1 year of screening
* Acute respiratory symptoms
* Inability to take any form of bronchodilator
* Wheezing at the time of study
Deep Sedation Instead of General Anaesthesia in Percutaneous Mitral Valve Repair Using the MitraClip® System

Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery. The PMVR procedure is typically performed under general anaesthesia, but the MitraClip® is also feasible in deep sedation.

The aim of this study is to investigate the safety of deep sedation in patients undergoing the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.

Percutaneous mitral valve repair (PMVR) with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair in patients who are at high risk and unsuitable for surgery.

The PMVR procedure, however, is typically performed under general anaesthesia. It has recently been shown in a first approach that performing the MitraClip® in deep sedation is feasible; however safety parameters and a direct comparison to general anaesthesia are still missing The aim of this study is to investigate the safety of deep sedation in patients undergoing the PMVR procedure and to evaluate how deep sedation in comparison to general anaesthesia influences procedural time and in-hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* severe mitral regurgitation
* PMVR using the MitraClip® system

Exclusion Criteria:

-
Special Use - Results Surveillance on Long-term Use With Wegovy®

The purpose of the study is to investigate the safety and effectiveness of Wegovy® in patients with obesity disease under real-world clinical practice in Japan. Participants will get Wegovy® as prescribed by the study doctor. The study will last for about 4 years. Participant will be in the study for about 2 years (104 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to initiate treatment with commercially available Wegovy® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
* Male or female, no age limitation
* Diagnosis of obesity disease; with either hypertension, dyslipidaemia or type 2 diabetes, insufficiently controlled with diet and exercise therapies, and should meet either of:

  1. Body mass index (BMI)\* greater than or equal to 27 kilograms per meter square (kg/m\^2) with two or more obesity-related comorbidities\*\*, or
  2. BMI\* greater than or equal to 35 kg/m\^2
* Participant who has never been exposed to Semaglutide or who started treatment with Wegovy® within the past 4 weeks at registration

  * BMI calculation will be based on height and body weight recorded in the enrolment form of electronic case report form (eCRF) at enrolment.

    * Definition of obesity-related comorbidities are in accordance with Japan Student Services Organization (JASSO) guideline 3: (1) impaired glucose tolerance, (2) dyslipidaemia, (3) hypertension, (4) hyper-uricemia/gout, (5) coronary artery disease, (6) cerebral infarction, (7) non-alcoholic fatty liver disease, (8) menstrual disorder/infertility, (9) obstructive sleep apnoea syndrome/obesity-hypoventilation syndrome, (10) locomotory disease or (11) obesity-related kidney disease.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to baseline (Visit 1)
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* A history of hypersensitivity to any ingredients of this drug
* Diabetic ketoacidosis, diabetic coma, pre-coma or type 1 diabetes mellitus \[The treatment with insulin is mandatory. It is not appropriate to use this drug\]
* In emergency cases such as severe infections and surgery in patients with type 2 diabetes \[It is desirable to control blood glucose with insulin; therefore, administration of this drug is not appropriate\]
* Pregnant or possibly pregnant female
* Female who plans to become pregnant within 2 months
Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients

A observational study is conducting at the First Affiliated Hospital of the Medical College of Zhejiang University from January 1, 2022 to January 1, 2024. Patients with severe sepsis and treatment with Ceftazidime-Avibactam will be enrolled.

Blood samples at different time points: 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time and the steady state concentration(more than 4 times drug administration) of drug administration will be collected to detect plasma drug concentrations of Ceftazidim-avibactam.

The investigators will collect the blood samples at different time points: 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time and the steady state concentration(more than 4 times drug administration) of drug administration from the patients receive treatment with Ceftazidime-Avibactam to detect plasma drug concentrations of Ceftazidime-avibactam. The collected specimens will be stored in a refrigerator at 0-8 °C, centrifuges within 24 hours (4 °C, 4000 r/min, 10 min), and the supernatant will be collected in an EP tube and stored at -80°C until subsequent analysis. Ultra-high performance liquid chromatography-mass spectrometry (UPLC-MS/MS) will be used to detect plasma drug concentrations of Ceftazidime-avibactam. According to the outcomes ,the investigators will analyze the following items,(1)T\>MIC,(2)Cmax/MIC,(3)AUC/MIC,(4)population pharmacokinetics.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe sepsis and treated with ceftazidime avibactam
* Age ≥ 18 years
* The patient or authorized persons agree and sign the informed consent
* The patient's hemoglobin is greater than 70g/l during blood collection

Exclusion Criteria:

* The expected length of ICU stay less than 48 hours,
* Pregnant woman,
* The blood sample is hemolysis.
Chidamide Plus R-CHOP in Elderly DLBCL

This is a prospective, single-arm, open-label phase II study of Chidamide in combination with R-CHOP in the treatment of de novo, elderly, high-risk diffuse large B cell lymphoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive
* Age 61-75 years
* ECOG 0,1,2
* Life expectancy\>6 months
* Informed consented
* IPI\>1

Exclusion Criteria:

* Chemotherapy before
* Stem cell transplantation before
* History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* Primary CNS lymphoma
* LVEF≤50%
* Lab at enrollment (Unless caused by lymphoma) Neutrophile\<1.5\*10\^9/L Platelet\<75\*10\^9/L ALT or AST \>2\*ULN,AKP or bilirubin \>1.5\*ULN Creatinine\>1.5\*ULN
* Other uncontrollable medical condition that may that may interfere the participation of the study
* Not able to comply to the protocol for mental or other unknown reasons
* Pregnant or lactation
* HIV infection
* If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
Impact of a Hospital Pharmacist's Intervention on FENO (Fractional Exhaled Nitric Oxide) in Asthmatic Patients

The impact of a pharmacist's intervention on asthma control has now been well demonstrated, but its effect on inflammatory markers of FENO (Fractional exhaled nitric oxide) in asthmatic patients has been little studied in the literature. The aim of this study is to investigate the impact of a pharmacist's intervention on FENO in patients seen in clinical practice by a pneumologist in a secondary university center.


Eligibility Criteria:
Inclusion Criteria:

* Adult asthmatics (definition of asthma: FEV1 \[forced expiratory volume in 1 second\] reversibility of at least 12% and 200 mL after 400 mcg of salbutamol and/or PC20M \[provocative concentration of methacholine causing a 20% fall in FEV1\]\<16 mg/mL)
* unchanged or increased dose of inhaled corticosteroids prescribed by the pneumologist at the visit
* FENO (fractional exhaled nitric oxide) \> or = 25 ppb

Exclusion Criteria:

* Treatment with oral corticosteroids to treat an asthma exacerbation within 4 weeks before the visit with the pneumologist

Exclusion Criteria during the study:

* Change of the dose of ICS (inhaled corticosteroids) during the follow-up of 3 months after the pharmacist's intervention
* Severe asthma exacerbation requiring oral corticosteroids within the 4 weeks before the follow-up visit (3 months after the pharmacist's intervention)
Prognostic Value of Residual Hypoventilation in Mechanically Ventilated Neuromuscular Patients

Different tools may be used to monitor the efficacy of home mechanical ventilation. Investigators aimed to compare the prognostic value of the different data obtained by capno-oxymetry in a mechanical ventilated neuromuscular disease's population.

Home mechanical ventilation (HMV) is used to treat hypoventilation, and its efficacy is mostly assessed by daytime blood gases and nocturnal oxymetry (SpO2). Transcutaneous CO2 measure (TcCO2) has shown higher sensitivity than SpO2 to detect hypoventilation in neuromuscular diseases (NMD) patients. No data exist on the prognostic value of these techniques to monitor mechanical ventilated NMD patients.

Basing on retrospective data review, investigators aimed to compare the prognostic value of the data obtained using different tools to assess residual hypoventilation in the cohort of ventilated NMD patients followed at our reference center.

Eligibility Criteria:
Inclusion Criteria:

* neuromuscular disease
* age ≥18 years
* mechanically ventilated
* capno-oxymetry performed between 2009 and 2011

Exclusion Criteria:

* Long-term oxygen therapy
Effective Iodide Therapy for Untreated Patients With Graves' Hyperthyroidism Avoiding Thionamide Drugs With Many Side Effects

As the drug treatment of Graves' hyperthyroidism, Plummer reported the effectiveness of excess iodide in 1923 and iodide was used as the therapy for Graves' hyperthyroidism starting from the 1930s. After the introduction of more potent antithyroid drug, thionamide, most thyroidologists preferred to use thionamide expecting potent antithyroid effect, but some careful thyroidologists continued to prescribe iodide in mild type Graves' hyperthyroidism. Recently, American and Europe Thyroid Association recommended methylmercaptoimidazole (MMI), one of the potent thionamide drugs, as the first-choice drug for Graves' hyperthyroidism. However, it became apparent that thionamide has serious side effects such as not only agranulocytosis, but also severe liver injury, MPO-ANCA related vasculitis and embryopathy in the pregnant women. In Japan, one patient died of thionamide-induced agranulocytosis every year. The incidence of side effects including minor side effect of drug eruption is more than 10%. We used to treat the patients with Graves' hyperthyroidism with MMI, as we reported in J Clin Endocrinol Metab 65:719, 1987. However, many side effects of thionamide prompted us to revive the treatment with classical KI in our outpatient clinic and found that KI was effective in the patients who showed side effects to thionamide, resulting in remission (reported in J Clin Endocrinol Metab 99:3995, 2014). Therefore, we began to treat the patients without serious complications such as heart failure or arrhythmia, with 100mg KI since 1996 and followed for 180 days. We were surprised to find that serum thyroid hormone level decreased in all the patients. Thionamide drugs were added only when euthyroidism could not be achieved by KI alone. Compared with thionamide, side effect of KI was almost none. Between 1996 and 2004, about 504 patients were treated with KI and a third of the patients were successfully treated with KI alone and other patients were also successfully treated with the combination of KI and thionamide, suggesting additive effect, or by radioactive iodine therapy. The long term prognosis of the patients initially treated with KI was almost the same as the patients initially treated with MMI. Our clinical experience suggested that patients with Graves' hyperthyroidism are also susceptible to excess iodide, as in the cases with Hashimoto thyroiditis, and this suppressive effect of excess iodide on the thyroid gland is a useful information for many patients suffering from Graves' hyperthyroidism and thionamide side effects.


Eligibility Criteria:
Inclusion Criteria: Untreated Graves' hyperthyroidism. (elevated serum free T4 and/or free T3 level, suppressed serum TSH level, positive anti-TSH receoptor antibody and high thyroidal radioactive iodine uptake -

Exclusion Criteria: dropped out patients within 180 days

-
Writing About Experiences and Health in Older Adults II

UCLA researchers looking for healthy older adults (aged 65+) to participate in a study investigating how writing about experiences can affect your brain and body.

Once a week for 6 weeks, participants will write about their experiences and fill out online questionnaires. Participants will also come to the UCLA campus to complete a neuroimaging session (fMRI), provide a blood spot sample, and fill out questionnaires 2 times: once prior to the 6-week writing period and once immediately after the 6-week writing period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults age 65 years and older

Exclusion Criteria:

1. current smokers
2. active, uncontrolled medical disorders
3. chronic infection (e.g., Hepatitis C, HIV)
4. use of certain medications (steroid use, opioid use)
5. psychiatric disorders (e.g., current major depression, bipolar disorder)
6. body mass index (BMI) greater than 35
7. left-handed
8. claustrophobic
9. metal in body

Other exclusion criteria may apply.
An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children

The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents. This study will also determine whether maraviroc is safe to use in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 2-18 years of age, treatment experienced for 6 months or longer with at least 2 ARV drug classes, with HIV-1 RNA ≥1,000 copies/mL

Exclusion Criteria:

* X4- or dual/mixed-tropic virus detected by the Trofile™ viral tropism assay
* Concomitant therapy with other investigational agents (other than experimental ARV agents available through pre-approval access programs)
* Known ≥Grade 3 of any of the following laboratory tests at Screening or within 30 days prior to Baseline Visit: Neutrophil count, hemoglobin, platelets, AST, ALT, and creatinine, lipase;
* Total bilirubin ≥Grade 3, unless ALL of the following are true: Current regimen includes atazanavir; ALT/AST \< 2.5 X ULN; No symptoms other than jaundice or icterus.
* Other laboratory values ≥Grade 3, must be reviewed by Pfizer.
Fall Risk Reduction in Multiple Sclerosis (FIRMS)

This study looks to see the effects of a home based exercise program on falls in people with MS.

The purposes of this project are four-fold: 1) to determine if a 6-month home-based targeted exercise program results in immediate and sustained reduction in falls risk and incidence ; 2) to identify the factors that contribute to a reduction in fall risk and incidence; 3) to determine if a decrease in physiological fall risk and/or fall incidence results in increased quality of life and participation in older adults with MS; and 4) to determine the association between cognition, environment and comorbidities on future falls and intervention efficacy.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria involve having an established definite diagnosis of MS
* Ability to walk 25 feet with or without aid
* Relapse free in the last 30 days
* Being ≥ 50 years of age
* Having fallen at least once in the past year
* Physician approval to engage in light physical activity
* Willingness and ability to attend the training sessions and testing sessions.

Exclusion Criteria:

* We will exclude all individuals with risk factors contra-indicative for undertaking strenuous exercise.
* During the initial phone contact with the project coordinator, participants will verbally respond to a health history questionnaire.
* Those individuals who are asymptomatic and meet no more than one risk factor threshold including family history of coronary heart disease, hypertension, high cholesterol, diabetes, obesity, and sedentary lifestyle will be considered at low risk and included for participation.
Telephone Counselling to Promote Physical Activity in Diabetes Mellitus People

The purpose of this study is to investigate the effects of phone counselling support as a strategy to increase physical activity in people with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus
* age between 18 and 80 years
* both sexes
* medical recommendation for physical activity
* ability to listen and answer questions
* have cell phone and/or residential
* be registered the Center for Family Health 03 in 2012
* People should also produce higher frequency than 75% stake in the proposed activities Diabetes Education Group and telephone counseling

Exclusion Criteria: People who do not attend the criteria for inclusion.

* did not have clinical diagnosis of type 2 diabetes mellitus
* did not have age between 18 and 80 years
* did not have medical recommendation for physical activity
* did not have ability to listen and answer questions
* did not have cell phone and/or residential
* do not be registered the Center for Family Health 03 in 2012
* People who did not participate in 75% of the activities of the Group proposed the Diabetes Education and telephone counseling
UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy

The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled in an ongoing \[C-11\]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.
2. Enrollment in the UAB-ADC amyloid-PET substudy under a separate IRB-approved research protocol. The amyloid-PET study does not have to have been completed prior to enrollment and participation in this tau-PET study.
3. Negative urine or serum hCG test within 2 days of \[F-18\]AV-1451 administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

Exclusion Criteria:

1. Meets any exclusion criteria for the UAB-ADC study.
2. Inability or contraindication for undergoing MRI and/or PET imaging
3. Inability to participate in the imaging studies due to severity of dementia
Tamoxifen Pharmacogenetics in Asian Breast Cancer Women

The clinical outcome of tamoxifen treatment in breast cancer patients may be influenced by the activity of cytochrome P450 enzymes involving in tamoxifen biotransformation.

The investigators investigated the prognostic and/or predictive value of genetic polymorphisms of enzymes involved in tamoxifen metabolism for the treatment outcome among Asian breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* incident breast cancer patients who underwent surgery

Exclusion Criteria:

* previous cancer history before breast cancer diagnosis
Dysport® Adult Upper Limb Spasticity

The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients - post stroke or brain injury
* Modified Ashworth Scale ≥ 2
* Ambulatory patients

Exclusion Criteria:

* Previous treatment with botulinum toxin of any type within 4 months prior to study entry for any condition
* Physiotherapy initiated less than 4 weeks before inclusion
* Previous surgery, alcohol, phenol in upper limb
* Neurological/neuromuscular disorders which may interfere with protocol evaluations