cyrilzakka/clinical-trials huggingface dataset:
PEEP and V/Q Mismatch in Premature Infants

Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for gas exchange. This study measures the feasibility of enrolling and completing study maneuvers in premature infants for a prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or level) of PEEP.


Eligibility Criteria:
Inclusion Criteria:

1. Preterm birth before 32 weeks gestational age by best obstetric estimate, determined by the clinical obstetric team during antepartum admission
2. Birth weight less than 1500 grams, as measured by the clinical team at neonatal admission.
3. Presence of endotracheal intubation and invasive mechanical ventilation
4. Less than or equal to 28 days chronologic age
5. Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) equal to or greater than 0.25 as documented on the bedside infant flow sheet.

Exclusion Criteria:

1. Congenital anomalies, as determined by the clinical supervising physician
2. Current of prior air leak syndrome, as determined by the clinical supervising physician.
3. Non-English speaking parents
4. Non-viable birth, as determined by the clinical supervising physician
Efficacy of Ultrasound-guided Transverse Carpal Ligament Release for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is one of the most common peripheral nerve entrapment neuropathies, and it is characterized by pain, numbness, tingling, and weakness in the regions innervated by the median nerve (MN). CTS is believed to result from compression of the MN as it passes through the narrowed carpal tunnel with regard to gradual ischemia and fibrosis.Ultrasound-guided needle release of transverse carpal ligament(TCL) is an effective method to decompress the carpal.There are two main approaches to perform the release, short-axis or long-axis. However, there is no consensus about the optimal strategy.Thus, this study aimed to compare the efficacy of these two approaches for patients with mild-to-moderate CTS.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* typical clinical signs of CTS present for at least three months, including pain, numbness, and tingling of the hands
* positive Phalen or Tinel sign
* electrophysiological parameters supportive of mild to moderate CTS
* high-resolution ultrasonography demonstrated MN compression at the carpal.

Exclusion Criteria:

* bifid MN or bilateral CTS
* pregnancy
* disorders such as rheumatic immune diseases, chronic renal failure, diabetes mellitus, hypothyroidism and other systemic diseases
* any accompanying disorder that could mimic CTS, such as thoracic outlet syndrome, cervical radiculopathy, polyneuropathy, proximal median nerve entrapment
* history of carpal tunnel surgery or injection into the affected carpal tunnel
* CTS caused by trauma, surgery, intracarpal lesions, or MN lesions malignant tumors or severe cardiorespiratory diseases
The Effectiveness of Doin (Conduction Exercise) of the Pelvic Joint for HLD With Radiating Leg Pain

A prospective pilot study will be conducted to investigate the effectiveness and safety in herniated lumbar disc (HLD) patients receiving integrative Korean medicine treatment including Doin (conduction exercise) at a Korean medicine hospital through assessment of pain, functional disability, and quality of life.

A prospective single-center observational pilot study will be conducted to investigate the effectiveness and safety in herniated lumbar disc (HLD) patients with radiating leg pain receiving integrative Korean medicine treatment including Doin (conduction exercise) of the pelvic joint at Daejeon Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, quality of life, satisfaction, and safety.

The study is expected to be performed over a period of 6 months, during the former 3 months of the study period of which the Integrative Korean medicine treatment group will be recruited, and after a wash-out period of 2 weeks, during the latter 3 months of the study period of which the Doin with integrative Korean medicine will be recruited separately.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients with radiating leg pain distal to the gluteal fold with or without low back pain (LBP)
* Patients with onset of radiating leg pain occurrence within the last six months, and current pain intensity of numeric rating scale (NRS) ≥5
* Patients with disc protrusion or extrusion at the neural segment level with significant correlations with the radiating leg pain symptoms as identified on L-spine magnetic resonance imaging (MRI)
* Patients with plans of receiving Korean medicine treatment for herniated lumbar disc (HLD) through hospitalized care
* Patients who give voluntary written informed consent to study participation

Exclusion Criteria:

* Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
* Surgery and surgical procedure in the last three weeks in areas of clinical relevance as a result of HLD
* Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis)
* Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)
* Pregnant patients or patients planning pregnancy
* Patients with serious psychological disorders
* Participating in other clinical studies other than observational studies
* Patients unable to fill out study participation consent form
* Subjects deemed unsuitable for study participation as assessed by the researchers
Inter-observer and Intra-observer Variability of the Wrinkle Test

Skin wrinkling of the fingers following immersion in warm water depends on intact sympathetic innervation. It is abolished by lesions affecting both central and peripheral sympathetic pathways. It affords a simple and reliable clinical test of sympathetic function.

Fingertip skin wrinkling after prolonged immersion in water is a well-recognized phenomenon, whereas a denervated digit does not exhibit normal skin wrinkling while a finger with a regenerated or repaired nerve shows at least partial reappearance of wrinkling. This is the basis for the bedside immersion-wrinkling test of autonomic digital nerve function. The exact mechanism of fingertip skin wrinkling is still subject to controversy. the purpose of this study is to examine the Inter-observer and Intra-observer Variability of the Wrinkle Test.

Eligibility Criteria:
Inclusion Criteria:

* patients after suture of full cut of digital nerve

Exclusion Criteria:

* other nerve injury
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

This clinical trial will evaluate two non-surgical devices designed to improve eye lid opening for patients with severe Blepharoptosis (incomplete opening of the eyelids).

Two non-surgical devices for patients with Blepharoptosis will be evaluated. The Magnetic Levator Prosthesis (MLP), is an external device that makes use of a newer class of permanent magnets (made of alloys of neodymium (Nd), iron (Fe) and boron (B)) to restore eyelid movement. The Kinesiotape Frontalis Sling (KTFS), involves the use of tape to help facilitate levator muscle contraction to open the eyelid. Video recordings of spontaneous and volitional blinks will be used to evaluate the effects of each device on eyelid reanimation.

The clinical trial will employ a crossover design in which participants will try each device at home in counterbalanced order with a washout period between. In each period of the crossover, participants will receive training (during study visits at Massachusetts Eye and Ear) in how to apply the device and will then try the device at home for one week with daily follow up by video calls. At the end of the one-week period of home use there will be a study visit at Massachusetts Eye and Ear when the device will be returned and additional video recordings of eye blinks will be made.

At the end of the crossover period, participants will be asked to complete a questionnaire comparing the two devices and to select their preferred device.

Eligibility Criteria:
Inclusion Criteria:

* Presence of ptosis for at least one eye which occludes the visual axis in the resting position (without frontalis drive, lifting with forehead muscles)
* Moderate cognitive function or better defined as greater than or equal to 18 out of 30 on a pre-screening of the Mini-Mental State Exam (MMSE)

Exclusion Criteria:

* Absence of ptosis which occludes the visual axis
* Presence of a corneal ulcer of any size
* Age less than 5 years
* Severe Cognitive impairment defined as MMSE score less than 18, behaviors consistent with delirium (combinations of disorientation, hallucinations, delusions, and incoherent speech), or lethargy.
* Presence of corneal hypoaesthesia;
* Orbicularis weakness on the side of the ptosis
* Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
* Previous ptosis surgery less than 3 months prior to Visit 1.
* Lid position affected by lid or conjunctival scarring.
* History of herpes keratitis.
* Periocular neurotoxin (eg, Botox, Xeomin, Dysport, Myobloc) injections on the side of the ptosis within 3 months prior to Visit 1 and during the study.
* History of hyperthyroidism or thyroid eye disease (ie, exophthalmos, upper eyelid retraction, diplopia secondary to extraocular muscle involvement). Hypothyroidism that is controlled on medication is allowed
The Effect of Different Types of Exercise on Insulin Resistance and Visceral Adipose Tissue in Community Residents.

Background: Exercise has been proven to effectively reduce incidence of diabetes mellitus and metabolic syndrome. However, there is controversial data from prior studies to inform the type of exercise training recommendations.

Aim: The aim of this study will determine the differences of different type of exercise in the effects of reducing insulin resistance and visceral adipose tissue for community residents.

Methods: The four-arm randomized controlled trial will conducted in adults aged 40 to 70 years old in Tainan. A total of at least 177 patients will randomly assign to the group of aerobic exercise (AE), aerobic exercise combined with resistance exercise (RE), AE combined with medium intensity interval training, and placebo. The participants in exercise group will received 12 weeks, 3 times per week program, including twice a week intervention guided by the intervenors, and once a week exercise guided by the video at home. All the exercise keeps moderate-intensity by monitoring with 64%-75% of the maximum heart rate. Insulin resistance status will be checked by HOMA index at baseline and at exercise intervention after 12 weeks (HOMA index= insulin μU/mL）× glucose（mmol/L）/22.5).

Relevance to clinical practice: The research findings will help the clinical health works to know which type of exercise is the best choice in reducing insulin resistance and visceral adipose tissue in community residents, and can be promoted to the general public to reduce the prevalence of metabolic syndrome as well as prevent the root causes of ill health.


Eligibility Criteria:
Inclusion Criteria:

* adults aged 40 to 70 years old.
* without regular exercise in the past six years.

Exclusion Criteria:

* recent unstable condition involving stroke or those with heart disease, handicap, pregnancy, mental disorders, systolic BP \> 200 mmHg, or diastolic BP \>110 mmHg.
* those with contraindications in body composition analyzer measurement including people with pacemakers, artificial metal joints, amputated hands or feet, and those who cannot be cooperated with standing during testing.
Technology-Enabled Remote Hypertension Management To Advance Health Equity

The primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Finally, the investigators will estimate the economic impact of the intervention in terms of resource utilization.

The study design is a non-blinded pragmatic cluster-randomized controlled trial with a single intervention. Participants with uncontrolled hypertension will be identified from a randomly selected group of primary care clinics. Participants from half of the clinics will be enrolled in the intervention arm while the others will receive usual care. Participants in the intervention arm will undergo a series of software-driven medication initiation and titration steps until they reach a blood pressure target of systolic blood pressure \< 130 mmHg and diastolic blood pressure \< 80 mmHg. Participants will be subsequently monitored for up to 12 more months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years - 100 years
* uncontrolled hypertension: as defined as SBP \> 140 or DBP \> 90 on 2 successive clinic visits

Exclusion Criteria:

* hearing impaired
* visually impaired
* cognitively impaired
* hospice care
* on hemodialysis at enrollment
* New York Heart Association Class IV heart failure
A Comparison of Transcervical Foley Catheter and Prostaglandins for Induction of Labor at Term

The purpose of this study is to assess the effectiveness and safety of transcervical foley catheter as compared to prostaglandins for preinduction cervical ripening and labor induction in term nulliparous women with unfavorable cervix.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* nulliparous women
* gestational age \>= 37.0 weeks
* Bishop score \<= 5
* intact amniotic membrane
* abscence of labor
* live fetus with vertex presentation
* no previous uterine surgical procedure

Exclusion Criteria:

* major congenital anomaly
Effect of Statins on Asthma Control in Smokers With Asthma

Asthma is a chronic inflammatory condition of the lungs.

There is evidence that cigarette smoking can make asthma symptoms worse and that smokers with asthma do not respond as well to standard therapies as non-smokers.

Statins are drugs which are already used to lower cholesterol. They have also been shown to have some anti-inflammatory properties.

In this trial the investigators will give a randomised group of smokers Atorvastatin and the remaining group a placebo or blank tablet. The investigators will then monitor patients' responses in terms of peak flow data, symptom diaries, questionnaires and breathing tests.

Despite several studies, which have shown that smokers with asthma have more severe symptoms, accelerated decline in lung function and diminished response to treatment with inhaled and oral corticosteroids, more than 25% of asthmatics continue to smoke. Smoking cessation advice is often ineffective.

Statins are used as cholesterol lowering agents, however, there is now also evidence that they have additional anti-inflammatory effects which may be useful in treatment of smokers with asthma.

This is a randomised placebo controlled double-blind parallel group study.

Following screening to assess suitability for the study, patients will be randomised to treatment with either Atorvastatin 40mg or placebo (blank tablet)for 8 weeks.

After 4 weeks of treatment, all patients will be commenced on a low dose inhaled corticosteroid for the remainder of the study to assess whether treatment with statins can overcome steroid resistance in smokers with asthma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma for more than 1 year
* Symptomatic asthma
* Smoker with greater than 5 pack year history
* On short acting bronchodilator only- although may have medication weaned if stable

Exclusion Criteria:

* Ex-smokers or non-smokers
* Patients already on statin therapy
* Unstable asthma
* Previous statin sensitivity or myopathy or myositis
* On any medications known to interact with statins

Note separate entry criteria for pilot study of COPD patients
Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth

Chemomechanical caries removal systems have emerged as a possible valuable alternative to conventional rotary caries removal techniques in pediatric patients. Carie-Care™ is an economically minimally invasive approach that selectively removes caries-infected tissue leaving the caries-affected tissue to conserve tooth structure


Eligibility Criteria:
Inclusion Criteria:

* Open carious lesions with a moderately deep dentin carious lesion(scores five or six, according to the International Caries Detection and Assessment System\[ICDAS\].
* The access of the carious lesion has to be large enough to allow the penetration of the excavator
* Children with behavior rating 3 or 4 according to the Frankl scale

Exclusion Criteria:

* Clinical or radiographic evidence of pulp, furcation, or periapical pathosis
* Proximal caries evidenced by bitewing x-ray
Reliability of the Melbourne Assessment

The aim of the study is to investigate the reliability of the Melbourne Assessment.

Children with central motor disorders will be tested twice within one week with the Melbourne Assessment. The assessments will be video scored. At a later time point, different raters will rate the same video for inter-rater reliability, the same rater will score the same video for intra-rater reliability, and the same rater will score the repeated assessment videos for test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* central motor disorders
* ambulant or stationary patients of the Rehabilitation Center Affoltern am Albis
* ability to understand test instructions
* ability to sit upright for 25 minutes
* minimal activity in the assessed upper limb

Exclusion Criteria:

* severe visual and/or auditory problems
* acute lesion in the to assessed upper limb
* lack of compliance
Left Atrial Appendage Ligation Using the Atriclip Device

The purpose of the study is to collect data regarding ligation of the left atrial appendage at least 12 months after surgery for patients that had exclusion of the left atrial appendage as a primary minimally invasive procedure or in conjunction with other open cardiac or minimally invasive cardiac procedures.

The purpose of this study is to collect data regarding ligation of the left atrial appendage at least 12 months after surgery for patients that had exclusion of the left atrial appendage as a primary minimally invasive procedure or in conjunction with other open cardiac or minimally invasive cardiac procedures. The patient will undergo a transesophageal echocardiogram (TEE) to collect the following data: Left Ventricular Ejection Fraction; Left Atrial diameter size; confirmation of Left Atrial Appendage exclusion defined by the absence of left atrial to LAA (left atrial appendage) communication measured in millimeters and absence of LAA pocket measured in millimeters; presence of thrombus in left atrium.

Eligibility Criteria:
Inclusion Criteria:

* All adult patient who had a heart procedure where an Atriclip device was deployed as the primary or secondary procedure between 3/2013-12/20/2016
* Patient is willing to undergo a trans esophageal echocardiogram, or if unable a CT angiogram
* If female, must be of non-childbearing potential or have a negative pregnancy test within 7 days prior to the procedure
* Patient is willing to sign an IRB approved Informed Consent

Exclusion Criteria:

* Patient did not have an Atriclip device as part of the surgical procedure between 3/2013 and 12/2016.
* Patient is unwilling or unable to undergo trans esophageal echocardiogram with general anesthesia or a CT angiogram
Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer

This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients and explore the genetic model which can predict neoadjuvant endocrine therapeutic results.

This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients.This study will recruit 30 patients. The 30 patients will receive 25 mg exemestane QD for 26 weeks. Tucidinostat will be prescribed 30 mg BIW from week 3 to week 26. During neoadjuvant treatment biopsy, CEUS and MRI will be perfomed according to protocol to evaluate the therapeutic results. Genetic testing will also be performed before and after neoadjuvant treatment to explore the predictive value. MRI evaluated ORR is primary end point. CEUS evaluated ORR, pCR, AE and RCB are secondary end point.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be signed；
2. Eastern Cooperative Oncology Group Performance Status: 0\~1;
3. Histological confirmation of estrogen receptor (ER) positive and HER 2 negative invasive breast cancer;
4. Age ≥18 years old；
5. No distant metastatic disease；
6. The disease condition is stage II or stage III;
7. Laboratory exam criteria for enrollment: HGB≥10g/dl, WBC≥4,000/mm3, PLT≥100,000/mm3, GOT, GPT, ALP≤2 times ULN, TBIL, CCr≤1.5 times ULN.

Exclusion Criteria:

1. Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
2. Patients who received organ transplantation (include bone marrow autologous transplantation and stem cell transplantation).
3. Patients who have other malignant diseases within 5 years, except for cured skin basal cell carcinoma, flat cell carcinoma or cervical carcinoma in situ
4. Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.
5. Patients with sever hepatic, renal,cardiovascular, respiratory, digestive diseases or uncontrolled diabetes.
6. Patients who had myocardial infarction in the past 12 months.
7. Patients who participate in other clinical trail.
8. Patients who allergy to goserelin, leuprorelin, tucidinostat or aromatase inhibitor.