cyrilzakka/clinical-trials huggingface dataset:
Effect of Bronchial Thermoplasty on Moderate Bronchial Asthma in China

This study aims to investigate the efficacy and safety of Bronchial Thermoplasty on moderate bronchial asthma in China, by observing the improvement of quality of life, the decrease of acute attack and emergence, as well as the incidence of related complications.

This is a multi-center, open-label and single arm study. At least 50 patients with moderate asthma receive Bronchial Thermoplasty for three times. Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ), Frequency of mild asthma acute attack, PEF, FEV1, Emergency and Hospitalization are compared between before and after BT treatment.

The unified peak flow test meter will be provided to all subjects enrolled in this study. They will get a follow-up diary book before leaving hospital. In order to ensure the efficiency, all enrolled asthma patients are trained and tested by doctors and nurses from in-patient or out-patient department when they follow up, including how to use the PEF meter, how to read and record the data. As for the dosage of medication, all the medication uses are followed the doctor's advice, once the rescue medications were used, the times and dosages are mandatory to be recorded in the diary book by the patients themselves.

Eligibility Criteria:
Inclusion Criteria:

1. age between 18y and 65y.
2. no improvement after ICS and LABA treatment in patients with moderate asthma
3. have not received BT before
4. stable more than 6 weeks before enrolled in this study
5. no implantable electrical device (e.g. cardiac pacemaker)
6. no permanent anticoagulant is being used

Exclusion Criteria:

1. Smoking and have obvious emphysema
2. Chest CT showed lower lobe bronchial stenosis or distal complete atelectasis
3. FEV1 \< 65% predicted value after using bronchodilator
4. airway infection(within 6 weeks)
5. any circumstances as the following within the past 1 year: lower respiratory tract infection (LRTI) for 4 times or above; hospitalization due to respiratory diseases for more than 3 times; increase the dosage of oral corticosteroids due to asthma exacerbation for more than 4 times
6. received endotracheal intubation or ICU admission due to asthma attack within the past 2 years
7. concomitant allergic bronchopulmonary aspergillosis
8. Implantable electronic devices (such as cardiac pacemaker)/NYHA class IV and/or acute myocardial infarction within the past 3 months
9. coagulation disorders,cannot stop taking anticoagulant、antiplatelet drugs or nonsteroidal anti-inflammatory drugs
10. increasing the risk of adverse reactions during bronchoscopy or anesthesia as the followings: pregnancy, insulin-dependent diabetes, epilepsy, or the other severe complications, such as uncontrolled coronary heart disease, acute or chronic renal failure or uncontrolled hypertension
11. others:vocal cord dysfunction、chronic nasosinusitis、airway obstruction or uncontrolled obstructive sleep apnea syndrome
SPECT-based Prediction and Evaluation of CRT Efficacy in CHF

This study evaluates the state of the cardiac sympathetic activity and the severity of ventricular dyssynchrony in chronic heart failure patients and assesses the capabilities of radionuclide indication methods in determining the prognosis and evaluating the results of cardiac resynchronization therapy in chronic heart failure patients.

In heart failure, abnormal activation of cardiac sympathetic system has been shown to be of pathophysiological significance. However, the left ventricular (LV) dyssynchrony has a detrimental effect on LV systolic and diastolic functions in heart failure patients. The effects of LV dyssynchrony on cardiac sympathetic activity are not yet fully understood. Dilated cardiomyopathy is a common cause of severe chronic heart failure. Cardiac resynchronization therapy (CRT) is a disease modifying device-driven treatment that can reduce morbidity and mortality in patients with heart failure. However, this type of treatment does not lead to the expected results in 25% to 30% of patients despite the successful implantation of a CRT device. In addition, CRT is associated with high cost and potential morbidity. Therefore, the search for new highly informative criteria for selecting patients for this type of treatment remains a relevant task of modern medicine. It is expected that the results obtained will complement and expand current state of knowledge regarding the relationships between cardiac remodeling processes and the state of cardiac sympathetic activity. In addition, obtained data will allow to predict LV remodeling dynamics after the correction of contractile dysfunction of the heart.

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure NYHA III and IV class
* LVEF ≤ 35 %
* QRS ≥ 150 ms on ECG
* The presence of LBBB on ECG
* Sinus rhythm
* Optimal pharmacological treatment of heart failure

Exclusion Criteria:

* Contraindications to SPECT due to hypersensitivity to radiopharmacuticals such as 2-methoxy-isobutyl-isonitrile-(99mTc) and (123)I-Meta-iodobenzylguanidine or any of the excipients
* Pregnancy
* Breastfeeding
* Refusal to participate
Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3

A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to moderate asthma

The study will include female and male patients, between 18 and 65 years old, with stable, mild to moderate asthma who are on short acting β2-agonist (SABA) alone, on low dose inhaled corticosteroid (ICS) (200-400 µg budesonide or corresponding) or on a combination of low dose ICS and long acting β2-agonists (LABA). Approximately 60 patients will be randomised in order to have 49 completed.

The primary objective is to demonstrate therapeutic equivalence between Bricanyl Turbuhaler M3 and Bricanyl Turbuhaler M2 using bronchoprotective effect. Outcome measure: PC20 (Methacholine provocative concentration causing a 20% drop in FEV1). The safety objective is to compare safety of Bricanyl Turbuhaler M2 and Bricanyl Turbuhaler M3. Outcome measure Adverse Events/Serious.

Study period Q1 2015 - Q1 2016.

Eligibility Criteria:
Inclusion Criteria: - Female and male aged 18 and 65 years.

* At least 6 months of documented clinical diagnosis of asthma as defined by GINA 2012 or American Thoracic Society (Expert Panel Report 3 2007) prior to visit 1
* Stable asthmatics on SABA alone, on low dose ICS (200-400 µg budesonide corresponding) or on fixed combination of low ICS/LABA
* At the enrolment visit 1a, the visit baseline FEV1 must be ≥80 % of that predicted normal (NHANES III). For LABA patients the visit baseline FEV1 must be ≥80 % of that predicted normal (NHANES III) at both visit 1a and visit 1b. If not, the patient will be withdrawn from the study
* At the enrolment visits 1a or 1b (LABA patients only) and at the end of run-in period, visit 2, eligible patients should demonstrate an airway responsiveness to methacholine PC20 \<8 mg/mL. If not, the patient will be withdrawn from the study
* Capable of using Turbuhaler inhalation device as judged by investigator. Exclusion Criteria: Diagnosed with COPD or history of cystic fibrosis, bronchiectasis or other respiratory diseases
* Pregnancy, breast-feeding, lactation, or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures
* Conditions which could alter airway reactivity to methacholine (e.g. pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within past six weeks
* Exacerbation due to asthma or change in asthma medication during the last 3 months prior to enrolment
* Night time awakenings due to asthma symptoms on 2 consecutive nights during the last 4 weeks prior to enrolment
* Smokers 6 months prior to the study start or with a history of smoking of more than 10 pack years (e.g. 20 cigarettes/day for at least 10 years, or 10 cigarettes/day for at least 20 years, or equal).
Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with osteoarthritis (OA) undergoing elective TKA under regional anesthesia (neuroaxial with or without peripheral nerve block).
* Subjects able to demonstrate sufficient psychomotor dexterity and cognitive capacity to use Patient Controlled Analgesia/Patient Controlled Epidural Analgesia if used as part of the standard of care.
* The subject's preoperative health is graded as American Society of Anesthesiology Class 1 to Class 3

Exclusion Criteria:

* Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or subjects with planned second knee total knee arthroplasty at time of present procedure.
* Subjects with inflammatory arthritides (i.e., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis); Lyme disease.
* Subjects with fibromyalgia and or other chronic pain syndromes
Cardiometabolic Outcomes With Light Exposure During Sleep

This study tested the hypothesis that acute exposure to light during nighttime sleep adversely affects cardiometabolic function.

This study tested the hypothesis that acute exposure to light during sleep adversely affects next morning glucose homeostasis and whether this effect occurs via reduced sleep quality, melatonin suppression, or sympathetic nervous system (SNS) activation during sleep. Twenty young adults participated in this parallel-group study design. The room light condition (n=10) included one night of sleep in dim light (\< 3 lux) followed by one night of sleep with overhead room lighting (100 lux). The dim light condition (n=10) included two consecutive nights of sleep in dim light.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* ages 18-40 years
* habitual sleep duration of 6.5-8.5 hours
* habitual sleep onset of 9:00 pm-1:00 am

Exclusion Criteria:

* any sleep disorder as assessed by history and screening questionnaires for obstructive sleep apnea (Berlin) and excessive daytime sleepiness (ESS \>12), and by PSG to exclude sleep apnea (apnea hypopnea index ≥ 15), periodic leg movements (movement arousal index ≥ 15), or REM sleep behavior disorder;
* history of a cognitive or neurological disorder;
* history of a major psychiatric disorder, including but not limited to mood/anxiety, eating, and alcohol/substance abuse disorders;
* depressed mood (Beck Depression Inventory II score ≥ 20);
* diabetes or other endocrine disorders;
* any gastrointestinal disease requiring dietary adjustment;
* blindness or significant vision loss;
* any unstable or serious medical conditions;
* current or recent (within the past month) of psychoactive, hypnotic, stimulant or analgesic medications;
* shift work or other types of self-imposed irregular sleep schedules;
* obesity (body mass index \> 30 kg/m2);
* history of habitual smoking (6 or more cigarettes per week) or drinking (7 or more alcoholic beverages per week) or caffeine consumption greater than 300 mg per day;
* current use of light therapy;
* use of any other legal or illicit substance that may affect sleep and/or appetite;
* allergy to heparin.
* Due to the metabolic stress associated with pregnancy and breastfeeding, patients who were pregnant or breastfeeding were also excluded.
Hip Fracture and Patent Foramen Ovale

Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of a hip prosthesis may be complicated by intracardiac embolization of various origin.

A patent foramen ovale exists in approximately one fifth of the population; it facilitates the passage of embolus from the right heart to the left one and then especially to the coronary vessels and to the brain.

The hypothesis supported in this research is that the prevalence of postoperative complications, especially neurological ones, is increased after surgery for hip fracture when patients have a patent foramen ovale.


Eligibility Criteria:
Inclusion Criteria:

* hip fracture requiring a surgical procedure

Exclusion Criteria:

* simultaneous other traumatic lesion
BIOFLOW-III UK Satellite Registry Orsiro Stent System

Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.

For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.

Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease
* Subject signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow up assessments
* Subject is ≥ 18 years of age

Exclusion Criteria:

* Subject did not sign informed consent for data release
* Pregnancy
* Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
* Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint not reached yet
New Microprocessor-Controlled Prosthetic Knee Evaluation

The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK. Subjects will also run functional tests and questionnaires to compare performances and feedback with each prosthetic knee.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and give informed consent
* Man or woman, more than 18 y.o
* Lower limb amputee KD or AKA, unilateral or bilateral
* K3/K4 activity level
* Already fitted with FR-reimbursed MPK
* Being comfortable in their socket (SCS\>=5)

Exclusion Criteria:

* Protected person
* Pregnant or breast feeding lady
* Person having pathologies affecting their sensitivity
* Using walking aids
* Weighting more than 136kg
* Insufficient hip joint or pelvic voluntary muscle control
* Insufficient cognitive ability to charge the knee and care for the device
BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects

This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.

BS-FU01 is a follow-up study for patients treated with FluBHPVE6E7 in previous phase 1 and 2 interventional studies. The aim of the follow-up study is to assess the safety and immunogenicity of FluBHPVE6E7, changes in the HPV infection status, cervical cytology, and biodistribution after treatment with FluBHPVE6E7 in previous studies.

Eligibility Criteria:
Inclusion Criteria:

* Patient who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7
* Negative pregnancy test at baseline
* Written informed consent

Exclusion Criteria:

* Pregnancy, breastfeeding
Comparison of T-loop vs Opus Loop in Canine Retraction Efficacy and Anchorage Loss Control

The primary aim of this split-mouth randomized control trial is to compare the rate of canine retraction between the T loop and the Opus loop. The secondary objectives are to compare the angulation of the canine, changes in the first molar position in terms of anchorage loss, and molar rotation for the two loops used T-loop and Opus loop will be placed randomly on the right and left quadrants of patients for canine retraction and outcomes will be measured before and after completion of canine retraction

T-loop and Opus loop will be placed in the right and left quadrants of the patient for canine retraction after initial leveling and alignment. canine retraction rate will be measured by using a calibrated caliper every month. canine angulation will be evaluated by periapical x-ray which will be taken before and after completion of canine retraction and anchorage loss and molar rotation will be assessed by model analysis

Eligibility Criteria:
Inclusion Criteria:

Age between 14 -40 years Extractions of maxillary 1st premolars Class 1, 1/4th, 1/2, and 3/4th unit Class II molar relation Presence of all teeth up to the second molar Good oral hygiene

Exclusion Criteria:

Full cusp Class II Developmental, medical, or genetic problems Patient using bisphosphonates Spacing in dentition Grossly carious upper molars that cannot be restored Patient with active periodontal disease Severe crowding
Influence of Tobacco Smoking on the Development of Obstructive Sleep Apnea (OSA)

The aim of this study was to retrospectively evaluate the influence of Tobacco Smoking on the development of Obstructive Sleep Apnea (OSA).

The aim of this study was to retrospectively evaluate the influence of Tobacco Smoking on the development of Obstructive Sleep Apnea (OSA).

Statistical analysis will be performed on this retrospective population to determine in tobacco smoking could influence the development of OSA.

Eligibility Criteria:
Inclusion Criteria:

* All patients for a preoperative anesthetic consultation between 01/01/14 and 31/12/17 who undergo a polysomnography

Exclusion Criteria:

* None
Mindful Kala: Virtual Bharatanatyam Wellness Program for Students

In the current study, the researchers propose to develop and pilot test a Bharatanatyam (i.e. Indian classical dance) program called Mindful Kala with the hopes of decreasing stress and increasing psychosocial well-being, mindfulness, cultural competence, and connectedness amongst a group of college students. The investigators hope that this program can help students cultivate well-being during the challenging and stressful time of COVID-19.

Objectives:

1. Evaluate the effects of the Mindful Kala program on outcomes of health-related measures such as mindfulness, stress, connectedness, and wellbeing amongst students. The investigators hypothesize that participants will experience fewer symptoms of stress, increased mindfulness, increased well-being, and increased connectedness.
2. Evaluate the effects of the Mindful Kala program on changes in measures of cultural competence. The investigators hypothesize that the level of cultural competence will increase among the students.
3. Develop and examine the feasibility and acceptability of a 4-week Mindful Kala program for college students.

Eligibility Criteria:
Inclusion Criteria:

* Yale student
* 18 years of age or older
* Must complete all survey measures
* Is available for all of the designated Session One \& Session Two dates and times
* Attends all of the designated Session One \& Session Two dates and times

Exclusion Criteria:

* Not a Yale student
* Not 18 years of age or older
* Does not complete all survey measures
* Is not available for all of the designated Session One \& Session Two dates and times
* Does not attend all of the designated Session One \& Session Two dates and times
Comparative Study Between Patellar Denervation and Non-patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing

The purpose of this study is to compare the post-operative anterior knee pain (AKP) between patellar denervation and non-patellar denervation in total knee arthroplasty with patellar resurfacing


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

Exclusion Criteria:

* Valgus deformity
* History of inflammatory arthroplathy
* Previous fracture or open surgery on the same knee
* History of patellar instability
The Efficacy of Plastic Stent Anchoring to Reduce Migration of Metal Stent

The aim of this study is to demonstrate that the group with an additional plastic stent to anchor the fully covered self expandable metal stent (FCSEMS) in patients with malignant biliary stricture has less stent migration than the group with FCSEMS only. The primary outcome is stent migration for 6 months. The secondary outcomes are stent related adverse events, stent patency, and overall survival.

Endoscopic retrograde biliary drainage using a plastic stent for the treatment of malignant biliary stricture has advantages in that it is easy to perform and low cost, but it has a short period of patency. To overcome this drawback, self-expandable metal stents (SEMS) have been developed and are now widely used. But, over time, the SEMS also develop restenosis, due to tumor ingrowth and the tissue hyperplasia caused by the stimulation of the surrounding tissues by the metal thin wire. To overcome these disadvantages, a fully covered self-expandable metal stents (FCSEMS) covered with a polymer coating have been developed and used. However, the FCSEMS showed more stent migration than the uncovered SEMS, which was not superior to the uncovered SEMS in terms of loss of stent function. In order to overcome the limitations of the FCSEMS, small-scale studies have shown that stent migration can be reduced by anchoring the FCSEMS using a plastic stent. To date, there has been no randomized controlled study to determine whether the FCSEMS can be anchored with a plastic stent in patients with malignant biliary stricture to reduce the stent migration. Therefore, the purpose of this study is to evaluate the efficacy of plastic stent anchoring to reduce migration of FCSEMS.

Eligibility Criteria:
Inclusion Criteria:

* Malignant biliary stricture requiring biliary drainage through endoscopic procedure

Exclusion Criteria:

* Previous history of metal stent placement for malignant biliary stricture
* Hilar cholangiocarcinoma
* Malignant biliary stricture of intrahepatic duct
* A recurrence after surgery due to malignant biliary stricture
* Life expectancy less than 3 months
* Pregnancy
* If endoscopy is not possible based on the judgement of the researcher