cyrilzakka/clinical-trials huggingface dataset:
Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study

Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.

Chronic Obstructive Pulmonary Disease (COPD) is the 4th leading cause of death in the United States. It is projected to be the leading cause of death by 2020. As many as 24 million Americans are estimated to suffer from impaired lung function. Of those more than 12 million were actually diagnosed with COPD, and over 118,000 deaths were attributed to COPD in 2004.

COPD has been linked with an increased risk for lung cancer. Both airway obstruction, defined by abnormal pulmonary function tests (PFTs), and CT scan diagnosed emphysema were shown to be independent risk factors for lung cancer.

Treatment for COPD includes cessation of environmental exposures (i.e. smoking), dampening the inflammatory response, symptoms control and, for a small subgroup, surgical approaches and lung transplant. Nevertheless, the effectiveness of these treatment options to change the natural history of this disease is very limited. Recent evidence suggests a new role for macrolides as immune-modulators in patients with COPD, although the mechanisms are not clearly determined.

The investigators hypothesize that in patients with COPD, treatment with azithromycin will show reduced inflammatory markers, transcription factors changes, and lung function changes consistent with reduced inflammation.

Eligibility Criteria:
* Key Inclusion Criteria: List primary criteria for study inclusion (i.e. do not need to enter entire list of inclusion criteria).

  1. Patient must be 50 years old or older.
  2. Patient must have a smoking history of at least 20 pack-years
  3. Patient must have stable COPD, GOLD 0, I and/or IIA.
  4. CT of chest with evidence of emphysema
* Key Exclusion Criteria: List primary criteria for study exclusion (i.e. do not need to enter entire list of inclusion criteria).

  1. FEV1 \< 70%.
  2. Exacerbations (defined as use of oral steroids or antibiotics) in the previous month.
  3. Cardiovascular Disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
  4. Diabetes mellitus
  5. Renal disease
  6. Liver disease
  7. Lung cancer
  8. ETOH use of more than \>6 beers \>4 mixed drinks daily
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 5 to less than 13 years of age
* Primary clinical diagnosis of ASD with symptoms of irritability
* ABC-I subscale score of ≥12 at Screening
* CGI-S score of ≥3 at Screening
* Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening
* Ability to swallow capsules

Exclusion Criteria:

* Has a primary psychiatric diagnosis other than ASD
* Reports suicidal ideation (Type 3, 4 or 5 on the Baseline/Screening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, and/or the Investigator assesses the patient to be a safety risk to him/herself or others
* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables
* History of a clinically significant cardiac disorder and/or abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) \> 460 msec at Screening
* Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening
* Has a history of uncontrolled/disruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate in study procedures
A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children

Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.


Eligibility Criteria:
Inclusion Criteria:

* Patients must complete the 16 Week double-blind efficacy study A1481131.

Exclusion Criteria:

* Any patient who did not complete Study A1481131.
The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Multiple Sclerosis

In this study the researchers want to investigate the effects of long-term transcutaneous electrical nerve stimulation on the cortical excitability of persons with multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Expanded Disability Status Scale (EDSS) scores between 2 and 6.5
* Stable MS (no relapse during the last 3 months before study onset)
* sensory impairment
* age: between 18 and 68 years old

Exclusion Criteria:

- Patients with other pathologies associated with peripheral and/or central sensory dysfunction or under psychotropic or antiepileptic medication
Effect of Massage on Hamstring Muscle Soreness

Delayed onset muscular soreness peaks in 24-48 hours after unaccustomed strenuous physical exercise. Therapists often provide manual massage with the hands to acutely relief the soreness. Alternatives to manual hand massage can be useful for therapists. Here the investigators examine the acute effect of a "massage roller" on DOMS in the hamstring muscles


Eligibility Criteria:
Inclusion Criteria:

* working age adults

Exclusion Criteria:

* blood pressure above 160/100
* disease of the cervical spine
Factors Associated With Posttransplant Cardiac Outcomes

Cardiovascular disease has become the leading cause of death early after liver transplantation (LT). The aging LT population is accompanied with the increasing prevalence of cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Furthermore, cirrhosis has been known to cause alterations in the systemic haemodynamic system and cardiac muscle dysfunction, systolic and/or diastolic, known as Cirrhotic cardiomyopathy (CCM). Hence, transthoracic echocardiography is required in all LT candidates for preprocedural evaluation and risk stratification. However, traditional echocardiographic indices of cardiac function have low sensitivity. It is unclear whether comprehensive echocardiographic multiparameters, including speckle tracking echocardiograph (STE) and tissue doppler imaging (TDI) can help improve preoperative risk stratification. Therefore, we sought to analyze the ability of clinical and comprehensive echocardiography variables to predict intraoperative and perioperative cardiac events and cardiac mortality in our LT patient experience up to early post-liver transplant.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* End-stage cirrhosis patients who will receive liver transplantation,
* Patients voluntarily take part in the study and write informed consent.

Exclusion Criteria:

* Decreased left ventricular systolic function (ejection fraction \<45%),
* Significant uncorrectable structural cardiac abnormalities (eg, symptomatic coronary heart disease, advanced cardiomyopathy, severe valvular disease, severe congenital heart disease, etc),
* Uncontrolled pulmonary hypertension defined as pulmonary arterial systolic pressure ≧ 35mm Hg at rest despite maximal medical management,
* Circulatory or respiratory system with a score of 4 based on the preoperative Organ Dysfunction (CLIF-SOFA) score,
* Second-time liver transplantation,
* Combined organ transplantation,
* Satisfactory quality echocardiography could not be obtained before operation.
Blood Biomarker Signature in Glioma

This is an exploratory, translational and non-interventional clinical study. The aim of this study is to identify a blood biomarker signature for glioma.

The identification of biomarkers (proteins, peptides and micro RNAs (miRNAs)) in the serum of patients with glioma would be a new, less invasive approach, which could help in the diagnosis of a glioma, and potentially help guide therapeutic decisions.

The investigators will investigate the existence of biomarker profiles, which can

* distinguish between low and high grade gliomas
* correlate with patient outcomes including response to treatment and survival
* indicate progression from a low to a high grade glioma.

In this study the investigators collect and analyse blood samples taken from patients with suspected newly diagnosed grade II/III glioma or glioblastoma multiforme (GBM). Blood samples will be collected before any surgical intervention (resection or biopsy) and at various follow-up time points until progression or death. Based on the known natural history of gliomas (described above), it is planned to follow patients with grade III/IV tumours, who receive treatment, for up to 3 years and those with grade II-III tumours, (irrespective of treatment) for up to 5 years. Ultimately, the investigators envisage the translation of our observations into the hospital setting to aid the distinction between glioma grade II and grade III/IV.

Eligibility Criteria:
Inclusion Criteria:

1. All patients with suspected newly diagnosed glioma (grade 2 or 3 or glioblastoma) with planned surgical intervention (resection or biopsy).
2. Patient aged 18 years or older
3. Patients have to be able to give informed consent

Exclusion Criteria:

1. Prior Radiotherapy to the central nervous system
2. Prior Chemotherapy within the last 5 years
3. Any prior central nervous system malignancy
Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Stable chronic renal disease patients receiving peritoneal dialysis for at least 16 weeks prior to the screening
* intact parathyroid hormone value ≥ 240 pg/mL at the screening
* Corrected serum calcium ≥ 8.4 mg/dL at the screening

Exclusion Criteria:

* Patients with primary hyperparathyroidism
* Patients who received cinacalcet within 2 weeks prior to the screening
* Patients who began to take or changed the dose/dosing regimen of active vitamin D/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
* Patients who underwent parathyroidectomy and/or parathyroid intervention
* Patients with uncontrolled hypertension and/or diabetes
* Patients with severe heart disorder
* Patients with severe hepatic disease
* Patients who take investigational drug in another clinical trial within 12 weeks prior to the screening
* Patients who have been judged ineligible to participate in the study by the investigator
Effects of Orange Oil Aromatherapy on the Pain and Anxiety

This randomized controlled experimental study was conducted prospectively with 80 patients with hematological malignancies were treated in the adult bone marrow transplant unit and adult hematology service of a private hospital between May 2021 and January 2022. Orange oil inhalation used in aromatherapy was applied to patients in the intervention group. Visual Analogue Scale and the State-Trait Anxiety Inventory used for data collection.

Introduction: Invasive interventions such as peripheral intravenous cannula and port needle placement, and blood collection are often required for both inpatient and outpatient follow-up patients with hematological malignancies and hematopoietic stem cell transplantation patients. This long and difficult treatment process causes anxiety and emotional disorders in most patients. Although invasive initiatives in the treatment and monitoring process are widely implemented, they lead to pain, anxiety and discomfort, which is often ignored. This study conducted to assess the effect of orange oil inhalation used in aromatherapy on pain and anxiety levels in invasive interventions to treat patients with hematological malignancies and hematopoietic stem cells transplantation.

Methods: This randomized controlled experimental study was conducted prospectively with 80 patients with hematological malignancies were treated in the adult bone marrow transplant unit and adult hematology service of a private hospital between May 2021 and January 2022. Orange oil inhalation used in aromatherapy was applied to patients in the intervention group. Visual Analogue Scale and the State-Trait Anxiety Inventory used for data collection.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old,
* without communication problems,
* without allergy and respiratory system problems,
* who agreed to participate in the study

Exclusion Criteria:

* severe hypotension
* other allergic complications that made it difficult for patients to continue the study
High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer

To describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in

A multi-center, randomised, double-blind, parallel-group phase III study to assess high dose esomeprazole Na i.v. treatment (bolus infusion of 80 mg followed by a continuous infusion of 8 mg per hour administered for 72 hours) for prevention of rebleeding

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Female or male aged =18 years and =70 years.
* Acute upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or such signs within the last 24 hours as judged by the investigator.
* One endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm in diameter, classified as Forrest Ia, Ib, IIa, or IIb. Photo documentation of the source of bleeding should be provided.
* Successful haemostasis (which is considered to have been established if bleeding has stopped and, if applicable, formerly bleeding vessels are flattened or cavitated) achieved by endoscopic treatment and confirmed by site staff.

Exclusion Criteria:

* Endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the investigator.
* Sign of multi PUB or concomitant other gastro bleeding from esophageal varices, reflux esophagitis, gastritis, Mallory Weiss rifts, ulcus simplex, Dieulafoy's lesion, colon, small bowel, or ulcer distal to the stom in Billroth-resected patients.
* Need for treatment during the first 7 days of the study with NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, acetyl salicylic acid (ASA) (including low dose) or clopidogrel.
* Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
* Chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned during the course of the study.
Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69

The aim of the study is to describe an immune activation profile of people at risk of insulin resistance based on a wide range of markers which will allow easy identification of patients at risk.


Eligibility Criteria:
Inclusion Criteria:

* The patient has been informed of the study, its objectives, constraints and the patient rights
* The patient must have given their free and informed consent and signed the consent form
* The patient is aged 55-69

Exclusion Criteria:

* The subject is participating in an interventional category 1 study
* The patient has participated in another category 1 interventional study in the last 3 months
* The patient is in a period of exclusion determined by a previous study
* The patient is under safeguard of justice or state guardianship
* The subject refuses to sign the consent
* The subject does not understand the information
Initial Clinical Presentation of Inflammatory Optic Neuritis Associated or Not With Autoantibodies Anti-Myelin-oligodendrocyte-glycoprotein

In eight ophthalmic units, the investigator will include all inflammatory optic neuritis (ON) during acute phase and rank them in two groups: 1/ ON with autoantibodies anti-myelin-oligodendrocyte-glycoprotein (ON MOG+) 2/ ON MOG-. The investigators will measure incidence of MOG-Ab in our prospective population of inflammatory ON. Then the investigator will compare clinical and radiological presentation of ON MOG+ versus ON MOG-.

Optic neuritis (ON) have a broad clinical spectrum ranging from a single episode (clinically isolated ON) to demyelinating diseases such as multiple sclerosis (MS), Chronic Relapsing Inflammatory Optic Neuritis (CRION), acute demyelination encephalomyelitis (ADEM), neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD). Myelin oligodendrocyte glycoprotein (MOG) is a myelin antigen exclusively expressed on the surface of oligodendrocytes and myelin in the central nervous system (CNS). MOG-Ab are associated with demyelinating diseases with a good specificity. Using cell-based assays, MOG-Ab were rarely found in healthy control and other neurological inflammatory disease. They were mostly identified in subgroups of NMO/NMOSD seronegative to auto antibodies against Aquaporin 4 (anti-AQP4): 8-39%, but also in MS (0-28%) ADEM and idiopathic ON. ON MOG + have a specific clinical presentation compare with ON associated with multiple sclerosis (SEP): older patient, less female preponderance, more often bilateral, more often optic disc swelling, worse initial visual loss, much more often recurrent with severe sequelae. ON MOG+ are more similar to ON associated with NMOSD AQP4+ which have some particularities: similar age, clear female preponderance, less optic disc swelling, more severe initial visual loss and visual sequelae. No prospective study has measured incidence of

MOG-Ab in population of Inflammatory ON. And no prospective study has ever compared ON MOG+ with all others inflammatory ON. The purpose of our study is to measure incidence of MOG-Ab in population of acute inflammatory ON. All consenting adults with suspicion of ON followed in the 8 ophthalmic units who participate will be screened. They will have, as usual, clinical follow-up, blood test with MOG-Ab research, encephalic and optic nerves MRI, and steroid treatment if necessary. At the end of the acute phase, all patients diagnosed with inflammatory ON will be included and rank in 2 groups: 1/ ON with MOG-Ab (ON MOG+) 2/ ON without MOG-Ab (ON MOG-). Clinical data will be register at this inclusion visit. There will be no additional visit and no intervention. After measuring incidence of MOG-Ab, the investigator will compare clinical and radiological data of ON MOG+ and ON MOG-.

Eligibility Criteria:
Inclusion Criteria:

* legally adult patient
* acute inflammatory optic neuritis
* consent

Exclusion Criteria:

* Patient under tutorship
Botulinum Toxin-A for Sialorrhoea Treatment in Asian Adults With Neurological Diseases

The efficacy of Botulinum toxin A (BoNT-A) in Asian population has not been properly studied and there is no literature available on the most efficacious dose of BoNT-A for sialorrhoea treatment. This research is aimed to find the dose of Dysport® that would be efficacious without treatment-related adverse events and the duration of effectiveness of the drug for sialorrhea treatment in Malaysian patients. The efficacy, safety, tolerability and adverse effects of three doses of Dysport®(50MU, 100MU and 200MU) are examined at 2,6,12 and 24 weeks post injection in this double-blinding, randomized trial.

Study Objectives:

To determine the efficacy, safety, tolerability and adverse effects of three doses of Dysport® (50MU, 100MU and 200MU) in the treatment of sialorrhoea in Asian patients with neurological disorders/diseases and to determine the most efficacious dose.

Study design:

Dose-ranging double blind pilot study.

Sample size:

At least 30 adult patients with various neurological disorders complicated with sialorrhoea including stroke, motor neurone disease, traumatic brain injury and Parkinsonism would be divided into 3 dosing groups.

Study method:

Patients who satisfy inclusion criteria and have given informed consent would be randomized into 3 equal groups given different total doses-50MU, 100MU, 200MU. The total dose will be divided equally and give to each of 4 salivary glands viz. the submandibular and parotid gland bilaterally. For example, if 200MU is to be given in total, 50MU would be given to each gland. Injections would be given via a 25G needle to each gland with ultrasound guidance for better needle placement. One site will be injected per gland.

Primary outcome measure The percentage reduction in the rate of saliva production (as measured by difference in mean weight of dental rolls per minute from baseline) for each of the groups given different doses of Dysport® at 2,6,12 and 24 weeks post injection.

Secondary outcome measure

1. Patient's subjective assessment of improvement in sialorrhoea using the Drooling Frequency and Severity Scale (Thomas-Stonell scale) at 2,6,12 and 24 weeks post-injection.
2. Duration to maximum reduction in salivation (as measured by the maximum reduction in weight of dental rolls)

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years old.
2. Patients with neurological disorder including stroke, motor neurone disease, traumatic brain injury and Parkinsonism, diagnosis confirmed clinically by their treating physicians.
3. Patients with a Thomas-Stonell Drooling Frequency and Severity Scale combined drooling ranking of ≥5.
4. Patients who are able to give signed informed consent and are willing and able to comply with scheduled visits, treatment plan and other study procedure.

Exclusion Criteria:

1. Patients who are pregnant.
2. Patients with bleeding disorders or who are on anticoagulants.
Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke

The purpose of this study is to determine whether the clinical pathway for acute ischemic stroke(with combination of traditional Chinese medicine and western medicine) is able to improve the outcome of acute ischemic stroke and evaluate its effect on hospital day and cost, etc. Meanwhile, the study will discuss the safety and efficiency of this kind of Clinical Pathway

Eligibility Ages Eligible for Study: 18 Years to 85 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Those clinically diagnosed with acute ischemic stroke ； 18-85 years old； Over 6 hours and within 14 days from onset 4\<=NIHSS \<=22; Informed consent signed by patient or his/her family ；

Exclusion Criteria:

Hemorrhagic stroke; Cerebral hernia; Serious heart, liver, lung, kidney functional failure，malignancy; Not cooperative with physician; Psychological disorder; Already taken part in other clinical drug trial within the past 3 months

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke diagnosed with both criteria of traditional Chinese medicine and western medicine；
* 18-85 years old；
* Over 6 hours and within 14 days from onset
* 4\<=NIHSS \<=22;
* Informed consent signed by patient or his/her family ；

Exclusion Criteria:

* Hemorrhagic stroke;
* Cerebral hernia;
* Serious heart, liver, lung, kidney functional failure,malignancy;
* Not cooperative with physician;
* Psychological disorder;
* Already taken part in other clinical drug trial within the past 3 months