cyrilzakka/clinical-trials huggingface dataset:
Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study was to investigate the prevalence of chronic bronchitis in patients suffering from moderate to very severe chronic obstructive pulmonary disease (COPD), and to assess the difference in exacerbation rates in patients suffering from moderate to very severe COPD with chronic bronchitis vs. a population of patients without chronic bronchitis.

This was an observational study so participants only took medication that was prescribed by their regular healthcare provider. No additional study medication was administered. This study enrolled patients who were previously diagnosed with moderate to very severe chronic obstructive pulmonary disease (COPD). This study looked at the prevalence of chronic bronchitis in patients suffering from moderate, severe or very severe COPD, and it also compared worsening of COPD in patients with or without chronic bronchitis. This study enrolled 976 patients. This multi-centre trial was conducted in Belgium and Luxembourg. The overall time to participate in this study was at a single, regularly scheduled visit at the pulmonologists office. There were no follow-up assessments for this study.

Eligibility Criteria:
Inclusion Criteria:

* 1. Written informed consent. 2. Age ≥ 40 years. 3. Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio (post-bronchodilator) \<70%. 4. FEV1 (post-bronchodilator) \< 80% of predicted.

Exclusion Criteria:

* 1. Moderate and severe exacerbations during the last 4 weeks. 2. Pregnancy. 3. Already participated in the study (allowed to participate only once).
Changing Vertical Self-motion Perception

The objective of this study is to explore the "vertical self-motion perception" on in healthy young individuals using an elevator as accelerator. Secondary aim is to explore the effects of repeated vertical acceleration on vertical vestibular sensibility.

The detection of displacement is important information to maintaining balance, postural control, and gait during daily living activities. This detection of displacement or self-motion perception is accomplished by the human vestibular system, particularly the otolith organs, the sacculus and utriculus. Both primarily respond to whole-body acceleration or tilt in gravity. The saccule and utricle detect linear motion as well as the static orientation of the head relative to gravity, which is itself a linear acceleration. The saccule is more sensitive to vertical acceleration (sensing elevator acceleration) and the utricle is more sensitive to horizontal acceleration (sensing a car accelerate). The signals from the vestibular system are transmitted o the central nervous system for further processing.

Testing the otolith function is difficult since it always a combination of the tested inertial acceleration (t) and gravity (g). Therefore the Vector of acceleration is skew. An isolated vertical direction testing of the saccule is to our knowledge not done. Testing the function of the saccule in an elevator would eliminate the any horizontal accelerations other than gravity. Using the decelerations phase of an elevator ride during both up and down ride could give important inside of the self-motion perception (sensation of acceleration of a subject). The reaction force F which accts on the otolith would be maximal when the elevator ride downwards would stop. The force acting on the otolith when the elevator got upwards is breaking is smaller than g.

A better understanding the adaption of the self-motion perception could be beneficial for patients with hypersensitive vestibular functioning, e.g. patients with vestibular migraine. We hypothesized that (a) healthy subjects change the self-motion perception after hyper-stimulation with repeated vertical acceleration.

The objective of this study is to explore the "vertical self-motion perception" on in healthy young individuals using an elevator as accelerator. Secondary aim is to explore the effects of repeated vertical acceleration on vertical vestibular sensibility.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young adults
* Signed informed consent after being informed

Exclusion Criteria:

* Acute pain
* Chronic neck pain
* Undergone Neck surgery
* Any vestibular disorder
* Fear of elevators / claustrophobia
* Dizziness handicap inventory score \>30
PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial

24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.


Eligibility Criteria:
Main Inclusion Criteria:

* Male or female of at least 18 years of age
* Confirmed diagnosis of portopulmonary hypertension

Main Exclusion Criteria:

* Severe hepatic impairment
* Severe obstructive or restrictive lung disease
* Pulmonary veno-occlusive disease
* Systolic blood pressure (SBP) \< 90 mmHg at Screening
* ALT/AST \>= 3 x ULN
* Bilirubin \>= 3 mg/dL at Screening
* Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results
Sutures vs. Staples Skin Closure After C-section in Obese Patients

This is a randomized prospective clinical trial designed to determine the wound complication rates for stainless steel staples versus subcuticular suture for skin closure in the obese parturient (BMI≥ 30kg/m2) undergoing cesarean delivery.


Eligibility Criteria:
Inclusion criteria:

* 18 years or older
* BMI ≥ 30kg/m2 on admission to labor and delivery
* Patient is for scheduled cesarean delivery or in non-emergent labor but has an indication for cesarean delivery
* Singleton pregnancies
* Gestational age ≥ 24weeks
* Cesarean delivery performed under regional anesthesia

Exclusion criteria:

* Refusal to participate
* BMI \< 30kg/m2
* \< 24 weeks gestation
* Intrauterine fetal demise
* Chronic pain syndrome requiring chronic narcotic use
* Emergent clinical situations which preclude obtaining informed consent
Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro

The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy.

The purpose of this study is to compare serum bilirubin levels with non-invasive bilirubin measurements in neonates during the first 12 to 192 hours of life using the "Picterus Jaundice Pro" smartphone application with a proprietary calibration card placed over the neonate's sternum. We will also validate the accuracy of Picterus Jaundice Pro bilirubin measurements before and after phototherapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* the patient is free of skin rash, bruising, or other medical conditions that can interfere with transcutaneous measurement
* (preterm) \< = 35 weeks gestational age
* (term) \> 35 weeks gestational age
* the patient has not been excluded by PI discretion.

Exclusion Criteria:

* Neonates will be excluded from participation if all four inclusion criteria listed above are not met.
Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries

In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs (local anesthetic) - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA (topical anesthetic available on the market) and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).

Dental treatment presents numerous innovations, but the pain associated with the administration of local anesthesia (LA) continuous to be a traumatic procedure for many patients. Although we use topical anesthetics (TA) to reduce pain, the commercially available formulations are only effective in preventing the pain of the needle puncture.

This project aims to evaluate the clinical efficacy of xanthan-based hydrogels (2%) containing LAs encapsulated in nanostructured lipid carriers (CLN), reducing pain during puncture and injection of LA in the palatine mucosa. In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after the removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. The computerized Morpheus® anesthetic injector will be used in order to control the variables of volume and injection speed. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS). Hydrogels containing CLN are expected to have good mechanical properties and allow the permeation of LAs efficiently through the oral mucosal epithelium. In addition, they can improve the efficacy of topical anesthesia in order to perform a painless LA in the palatal mucosa.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* No lesions in the study area
* Have already been submitted to local anesthesia without intercurrence

Exclusion Criteria:

* Used any drugs that change the pain sensibility 1 week before
* Smokers
* Alcoholic
A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers

This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate asthma. The primary objective of this study is to assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 to 65 years of age with diagnosis of mild-to-moderate asthma for Parts A and B. For part C healthy, male or female subjects 18 to 50 years

Exclusion Criteria:

* Oral/parenteral corticosteroids or anti-interleukin-6 therapy within 6 months prior to screening, or any prohibited therapies prior to screening.
* History or presence of clinically significant hypertension or other significant cardiovascular abnormality.
* Any clinically significant abnormality on electrocardiogram at screening.
* Parasitic infestation within 6 months before screening, or travel or intention to travel to a country with a high prevalence of such infections within 1 year before screening or within 85 days after the last dose of CSL311.
* Occurrence of asthma exacerbation and/or upper/lower respiratory tract infection, or any acute infection or disease within the last 6 weeks before screening.
Study on the Accuracy of Intraocular Lens Calculation Formula

In this study, we will retrospectively collect patients who have performed phacoemulsification combined with intraocular lens implantation in our hospital, collect various preoperative biometric data and postoperative refractive data of patients, conduct statistical analysis, and compare the accuracy of various IOL calculation formulas.


Eligibility Criteria:
Inclusion Criteria:

* (1) Conform to the diagnosis of cataract; (2) No complications occurred during and after operation; (3) Before and after operation, the measurement of ocular biological characteristics and refractive state can be successfully completed; (4) Patients who can be followed up regularly after operation.

Exclusion Criteria:

* (1) Serious intraoperative or postoperative complications; (2) Complicated with other eye diseases unsuitable for intraocular lens implantation; (3) Patients with systemic diseases cannot tolerate surgery; (4) Patients with incomplete follow-up data.
A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors

The goal of this clinical trial is to learn the safety, tolerability, pharmacokinetic characteristics and efficacy of FC084CSA in combination with Tislelizumab in patients with advanced malignant solid tumors.

The study includes two phases. Phase Ib adopts a "3+3" dose escalation design to assess safety and tolerability of increasing dose levels of FC084CSA in combination of fixed dose of Tislelizumab. Phase IIa is the dose expansion phase to further observe the preliminary effectiveness of the recommended Phase 2 Dose of FC084CSA in combination of Tislelizumab.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 75 years old male and female.
2. Phase Ib: Patients with histologically or cytologically diagnosed solid tumors who have failed standard therapy; Phase IIa: Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV NSCLC which surgery or radiotherapy cannot be performed.
3. No known sensitizing mutations or other actionable oncogenes with approved therapies if available.
4. Prior PD-1/PD-L1 inhibitor combined with platinum-containing therapy failed;
5. According to RECIST 1.1, there is at least one measurable lesion.
6. ECOG performance status 0-1.
7. Major organs are functioning well.

Exclusion Criteria:

1. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
2. Received anti-tumor therapy within 4 weeks before enrollment.
3. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
4. Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started.
5. Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
6. Central nervous system metastases with clinical symptoms.
7. With any situations that the researcher considers inappropriate to participate in this research.
Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.

The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies.

The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.

Objectives:

The primary objective is to evaluate the safety of the AdhVN1203/04.H5 vaccine when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.

The secondary objective is to evaluated the immunogenicity of the AdhVN1203/04.H5 vaccine at three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females in good general health, 19-49 years of age
* Subjects must provide written consent
* Willing to participate through study completion
* Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogenicity analysis
* Female of child-bearing age must have a negative urine pregnancy test and be stable on a reliable means of contraception.
* Meet screening criteria for hematology, chemistry and urinalysis

Exclusion Criteria:

* Pregnant (or possibly pregnant) and lactating women
* Any flu/cold symptoms and/or fever greater than 101 degrees in 3 days prior to study enrollment
* Any intranasal steroid medication administered in the 10 days prior to study enrollment
* History of chronic rhinitis or presence of pre-existing nasal septal defects, nasal polyps or other gross abnormalities
* Any previous nasal cautery or significant surgery for nasal septal defects
* Any regular past or current use of intranasal illicit drugs or history of intravenous illicit drug use
* Asthma that is greater than mild in severity
* Diagnosed active Hepatitis B or C
* HIV positive at screening
* Known or suspected malignancy, leukemia, or lymphoma
* Immunosuppressed, altered or compromised immune status as a consequence of disease or treatment with systemic corticosteroids
* Receipt of an influenza vaccine within the past 6 months
* Receipt of any vaccine in the past 30 days
* Receipt of any investigational drug in the past 30 days
* Known Diabetes mellitus
* History of anaphylaxis or angioedema
* Hypertension that is not well controlled
* Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator would serve to interfere or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participants's ability to give informed consent
Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine

The aim of the present study is to determine the extend to which OMT is effective on a sample of subjects affected by migraine evaluated using the headache impact test (HIT-6) questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 60 years old
* chronic migraine

Exclusion Criteria:

* secondary forms of headache,
* chronic illness,
* psychiatric illness,
* post-menopausal women
Carotid Atherosclerotic Plaque Study

First, to establish a comparison of the pathophysiology of carotid atherosclerosis and the genetic and environmental variables that cause those plaques to become symptomatic. Second, to differentiate between vulnerable plaque and other types of plaque using ultrasound elastography, MRI data, trans-cranial doppler along with RF (radio frequency) analysis of back-scattered ultrasonic echoes.

This is a multi-investigator study based on the pathophysiology of carotid atherosclerosis and the variables that cause certain plaques to become symptomatic.Patients enrolled in this study will be those patients undergoing a carotid endarterectomy. This will include both symptomatic and asymptomatic patients, and there are a variety of atherosclerotic risk factors representing this patient population.Patients may or may not have had strokes or transient ischemic attacks (TIAs).Pre-operatively patients will be reviewed for their medical history and atherosclerotic risk factors. Plaque removed during routine carotid endarterectomy will be examined for study purposes.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients aged 18-80 presenting for carotid endarterectomy

Exclusion Criteria:

* Patients not felt suitable for carotid endarterectomy and those with impaired decision-making capacity
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face

To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults 18 to 65 years of age (inclusive)
* 3 (moderate) or 4 (severe) on MFVDA-SRS
* sign the written informed consent form

Exclusion Criteria:

* have streptococcal disease or bleeding disorder
* have an active or infective skin disease, scars, or tumor on mid-face
* have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
* have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment
* have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months
* have a medical history of hypertrophic cicatrix or keloid
* have radiation therapy experience on mid-face
* have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine, hyaluronic acid products, or Streptococcal protein
Left Atrial Appendage Occlusion and Biomarker Evaluation

"Left Atrial Appendage Occlusion and Biomarker Evaluation" (LABEL) is a single-center, prospective and observational study evaluating changes of the expression of biomarkers in eligible patients before and after percutaneous implantation of a left atrial appendage (LAA) occlusion device at mid-term follow-up.

This study will evaluate the changes of different types of biomarkers before and after successful percutaneous implantation of an LAA occlusion device.

Biomarker evaluation will focus on blood derived biomarkers including neurohormones, proteins, cytokines, microRNAs and metabolomics.

Eligibility Criteria:
Inclusion Criteria:

* non valvular atrial fibrillation, that makes anticoagulation to prevent embolic stroke from the LAA
* contraindication for the therapy with oral anticoagulants:
* refusal to take oral anticoagulation
* HasBled-score more than 3
* prior bleedings under oral anticoagulation

Exclusion Criteria:

* under 18 years
* severely reduced left atrial function
* mechanical heart valve
* pulmonary embolism
* deep vein thrombosis
* myocardial infarction within the last 3 months
* electrical cardioversion within 30 days after potential occluder implantation
* atrial septum defect or interventional/surgical occlusion of ASD
* status after heart transplant
* symptomatic carotid artery stenosis
* transient ischemic attack (TIA) or stroke within last 30 days
* intracerebral bleeding within the last 2 months
* acute infection
* existing or planned pregnancy
Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection

A phase II randomised, placebo-controlled trial to identify the optimal regimen of vitamin D supplementation for rhinovirus protection, determined by host responses to a clinically induced rhinovirus challenge. The primary outcome is rhinovirus titre after inoculation with rhinovirus; secondary outcomes are self-reported respiratory symptom scores, concentrations of cytokines and chemokines sampled from the nasal mucosa, and the transcriptional responses of nasal epithelial cells.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years
2. Gives written informed consent
3. Serum 25-hydroxyvitamin D concentration \<75 nmol/L
4. Agrees not to take supplement containing vitamin D during participation
5. Agrees not to commence smoking or vaping during participation

Exclusion criteria:

1. Current smoker or vaper
2. Taken vitamin D supplement or other supplement containing vitamin D, in previous 3 months
3. Sunny holiday abroadI, defined as any location 51 degrees North/South of the equator, for ≥1 week, in the previous 3 months
4. Dependent(s) \<6 months old
5. Positive serology for anti-RV16 antibodies
6. Living with someone with severe airways disease
7. Any of the following medical conditions:

   1. Diabetes mellitus
   2. Asthma
   3. Chronic Obstructive Pulmonary Disease
   4. Respiratory allergies
   5. Sarcoidosis
   6. Hyperparathyroidism
   7. Nephrolithiasis
   8. Active tuberculosis
   9. Liver failure
   10. Renal failure
   11. Lymphoma or other malignancy not in remission for ≥ 3 years