cyrilzakka/clinical-trials huggingface dataset:
Analgesia in Lingual Frenulotomy in the Newborn

Ankyloglossia (tongue-tie) is a congenital anomaly characterized by a short lingual frenulum that limits the physiological tongue movement and occurs with an estimated prevalence between 4 and 10% of the newborns. This condition can be associated with difficulty in breastfeeding which can be painful for the mother, dysfunctional swallowing and future speech difficulties. The prevalence of nipple pain among women breastfeeding newborns with ankyloglossia is estimated to be between 36 and 80%. Since an early intervention can prevent the difficulties that may occur during the child's growth and can also improve the mothers and patients' quality of life, it is important to evaluate the lingual frenulum in the first days of life. The treatment of ankyloglossia consists in the frenulotomy which allows the release of the lingual frenulum and is a relatively simple procedure with few side effects and minimal post-operative. Different methods performed with or without local anaesthesia by means of scissors, blade, laser (etc.) are described in literature for the procedure the newborn.

The hypothesis of the study is that the addition of a water and sugar solution to the standard analgesia with lidocaine may lead to a greater benefit in terms of pain control and determine the activation of different brain areas.

The primary aim of the study is to evaluate whether the administration of a water and sugar solution to newborns undergoing frenulotomy receiving topical lidocaine as standard analgesic protocol, may lead to an additional benefit in terms of pain reduction evaluated according to the Neonatal Infant Pain Scale (NIPS).

The secondary aim of the study is to evaluate through a Hitachi multichannel near-infrared spectroscopy (NIRS) the effects of the addition of a water and sugar solution to the standard analgesic protocol with topical lidocaine on the cortical activation.


Eligibility Criteria:
Inclusion Criteria

1. Term newborns (37 - 41 weeks of gestational age) within the first 10 days of life;
2. Birth weight ≥ 2500 grams;
3. Presence of ankyloglossia;
4. Indication to the frenulotomy according to the Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF): anatomical-functional evaluation with a score lower than 8.

Exclusion Criteria:

1. Syndromic diagnosis (genetic/hereditary);
2. Pathology of main organ (heart disease, brain disease etc.);
3. Drugs intake that may interfere with the collected data (sedatives).
Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients

This is a non-interventional, prospective, observational study of the outcomes for post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT\*\*\*/CCWET\*).

Patients will be assessed for monocular and binocular distance, intermediate, and near vision.

This is a non-interventional, prospective, single center, bilateral, observational study of the outcomes for 40 post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT\*\*\*/CCWET\*) performed by 4 surgeons using similar surgical techniques. 40 subjects will be enrolled.

Patients will be assessed for monocular and binocular distance, intermediate, and near vision.

The hypothesis is that post-refractive patients that have high spherical aberration (SAs) will have excellent outcomes and satisfaction with a Vivity IOL

Eligibility Criteria:
Inclusion Criteria:

1. Adults, 40 years of age having already undergone cataract removal by phacoemulsification with a clear corneal incision in both eyes with implantation of the Vivity IOL (DAT\*\*\*/CCWET\*)
2. Prior uncomplicated, distance-targeted, bilateral myopic LASIK or PRK (photorefractive keratectomy) surgery and corneal spherical aberration greater than ≥0.30 μ and ≤ 1.20 μ in at least one eye (6.00 mm) as measured at their cataract pre-op visit
3. Able to comprehend and willing to sign informed consent and complete all required testing procedures
4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
5. Clear intraocular media
6. Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)
7. Residual refractive astigmatism ≤0.50 diopters
8. Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent

Exclusion Criteria:

1. Any corneal abnormality, other than regular corneal astigmatism or myopic LASIK/PRK surgery, (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
2. Any complication during cataract surgery (capsular tear, vitrectomy, etc)
3. History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
4. Amblyopia or strabismus in either eye
5. History of or current anterior or posterior segment inflammation of any etiology
6. Any form of neovascularization on or within the eye
7. Glaucoma (uncontrolled or controlled with medication)
8. Optic nerve atrophy
9. Subjects with diagnosed degenerative eye disorders
10. Postoperative CDVA worse than 0.10 logMAR in either eye.
11. Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)
Intelligent Follow-up of Neonatal Jaundice Based on Early Indicators and Internet Communications

In this prospective multi-center randomized clinical trial, a new follow-up strategy for neonatal jaundice after discharge will be evaluated. It is based on current risk factors of neonatal hyperbilirubinemia, added with the rate of bilirubin production (exhaled carbon monoxide measurement) as a new indicator,and incorporated with Internet Plus technology. Traditional methods following the Chinese guideline for neonatal hyperbilirubinemia were applied in the control group. The morbidity of BIND, the number of outpatient follow-up after discharge and the convenience will be compared between the two groups. The accuracy, effectiveness, safety and convenience of the study strategy will be testified.

The eligible newborns will be randomized into two groups: the study group (innovative strategy) and the controlled group (traditional strategy).

The innovative strategy included the ETCOc measurement in the risk evaluating process and the Internet Plus approach in the follow-up process.

Eligibility Criteria:
Inclusion Criteria:

1. gestational age between 35(+0)\~41(+6)
2. birth weight ≥ 2500 g
3. ethics approval obtained
4. parental consent obtained

Exclusion Criteria:

1. severe perinatal asphyxia
2. infectious diseases
3. persistent need for respiratory support
4. major congenital malformation
5. inborn errors of metabolism
6. pathological neonatal hyperbilirubinemia due to the defects of red blood cell membrane and erythrocyte enzyme
Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage

The investigators will test the central hypothesis that DFO treatment after SAH may improve cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective neuroprotectant against delayed ischemic injury after SAH.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of spontaneous SAH
* impaired cerebral autoregulation on day 2-4 post SAH

Exclusion Criteria:

* traumatic SAH
* other central neurological disorders such as tumors, known prior stroke, hemorrhage or vascular malformations
* pregnancy
* severe renal disease or anuria
Feasibility Study for a Web Based Health Coaching Program

This study is designed to compare an intensive lifestyle and activity coaching program (\&quot;Sessions\&quot;) to usual care for diabetic patients who are sedentary. The question to be answered is whether the Sessions program improves clinical or patient centric outcomes.

Recruitment is through invitiation only.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients age 18 or greater

Exclusion Criteria:

* Patients aged 17 or less,
* Patients with cognition impaired such that they could not comprehend enrollment materials.
Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BEA 2180 BR in Healthy Male Volunteers

Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral doses of BEA 2180 BR


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
2. Age ≥21 and ≤55 years
3. BMI ≥18.5 and \<30 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

1. Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
2. Evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
8. Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to enrolment in the study or during the study
10. Participation in another trial with an investigational drug within 30 days prior to randomisation
11. Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
12. Inability to refrain from smoking on trial days as judged by the investigator
13. Alcohol abuse (regularly more than 40 g alcohol per day)
14. Drug abuse
15. Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
16. Excessive physical activities within 1 week prior to randomisation or during the trial
17. Any laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of the study centre

    The following exclusion criteria are specific for this study due to the known class side effect profile of anticholinergic drugs:
19. History of hypersensitivity to tiotropium and/or related drugs of these classes
20. History of narrow-angle glaucoma
21. History of prostatic hyperplasia
22. History of bladder-neck obstruction
Total Contact Insole for Chronic Nonspecific Low Back Pain (LBP)

Non-specific low back pain is a common condition. Insoles are one of the many treatment form for chronic nonspecific LBP. The investigators hypothesized the contact total insole group will present pain reduction and functional improvement.

The aim of this study is to assess the effectiveness of contact total insole for people with nonspecific chronic low back pain and the impact of this insole on function, quality of life, load distribution in the plantar region, gait variables and satisfaction with insole use.

A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Eighty-four patients with nonspecific chronic low back pain will be randomly into a study group and control group. One week following the baseline evaluation, the study group will receive a contact total insole made of ethyl vinyl acetate and the control group will receive a flat insole made of the same material, color and density. The groups will be evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters will be employed: low back pain numerical pain scale; functional capacity (Oswestry and roland morris questionnaire, six minute walk test and timed to up and go test); quality of life (Short Form-36) and foot pressure analysis using the AMCube FootWalk Pro program.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain for more than 3 months, with numeric pain scale between 3 - 8 cm;
* Over 18 years;
* No distinction of sex;
* Understand Portuguese well enough to be able to fill in the questionnaires;
* Agree to participate of the study and sign the informed consent form.

Exclusion Criteria:

* Inflammatory/rheumatological diseases, tumor, infection or vertebral fracture;
* Litigation;
* Fibromyalgia;
* Other symptomatic musculoskeletal diseases in lower limbs;
* Symptomatic diseases of the central and peripheral nervous system;
* Diabetes Mellitus;
* Rigid deformities on foot;
* Use of insoles in the last three months;
* Medical or physiotherapeutic treatment for low back pain or any problem in lower limbs in the last three months;
* People who had changed physical activity or undergone physical therapy in the previous 3 months;
* Pregnancy;
* Difference of lower limbs greater than 2 cm
* Less than 6 months after lumbar spine, lower limb or abdomen surgery
* Previous spinal surgery;
* Previous spinal infiltration for pain relief in the last 3 months;
* Serious scoliosis;
* Allergy to the material of the insole.
* Planned travel in the next 12 weeks;
* Geographic inaccessibility.
Brain and Cognitive Function of Patients With RPD

To evaluate the influence of restoring lost posterior occlusal contacts with removable partial denture (RPD) on the brain activity and cognitive function in controlled type 2 diabetic patients


Eligibility Criteria:
Inclusion Criteria:

* Loss of posterior occlusal contact unilaterally or bilaterally in both maxilla and mandible.
* No previous partial dentures experience.
* Nonsmokers.
* Skeletally Angle's class I.
* Controlled type 2 diabetes.

Exclusion Criteria:

* History of brain diseases (e.g. cerebral infarction, and Alzheimer's).
* Neuromuscular disorders.
* Temporomandibular joint disorder.
* Psychiatric illness.
* Participants with parafunctional oral habits.
Vaccine+HBIG Versus Vaccine+Placebo for Newborns of HBsAg+ Mothers

Prevention of perinatal transmission is essential to decrease the global burden of chronic HBV. Recombinant HBV vaccine and hepatitis B immunoglobulin (HBIG) given after delivery to the newborns of HBsAg positive mothers is the standard of care for prevention of HBV in babies. Some studies have however, shown that vaccine alone may be equally effective. Hence, immunoprophylaxis with hepatitis B vaccine with or without HBIG is effective in prevention of transmission of overt HBV infection to the babies. The primary outcome measure of most of the trials on immunoprophylaxis was the occurrence of hepatitis B, defined as a blood specimen positive for hepatitis B surface antigen (HBsAg). However, whether this immunoprophylaxis also prevents HBsAg negative HBV infection (occult HBV infection) in babies is not known. In the present study the investigators evaluated the efficacy of the two regimens; vaccination alone and compared it with vaccination plus HBIG administration at birth in preventing transmission of both overt and occult HBV infection to the newborn babies.


Eligibility Criteria:
Inclusion Criteria:

* Newborn babies of mothers who were found to be HBsAg positive

Exclusion Criteria:

* Babies of mothers who had any symptoms of liver disease during the pregnancy such as jaundice, pruritus, ascites, or gastrointestinal bleed;
* Babies of mothers taking anti-viral treatment during pregnancy;
* Babies of mother with pregnancy related complications; and
* Babies of mothers who refused to participate in the study.
Lumbar Stabilization, Strengthening and Stretching in Chronic Low Back Pain

The purpose of this study was to compare the efficacy of three exercise programs in patients with chronic low back pain: Segmental stabilization, superficial strengthening and stretching. Groups were contrasted regarding pain, functional disability and TrA muscle activation capacity. The three groups of exercise improved pain and functional disabilities, and the Segmental stabilization group was better in the ability to recruit TrA muscle.

Objective: To contrast the efficacy of three exercise programs, segmental stabilization and strengthening of abdominal and trunk muscle and lumbar stretching on pain, functional impairment, and activation of the transversus abdominis muscle (TrA), in individuals with chronic low back pain.

Design: Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus) (n=15, mean age 42,02 ± 8,15), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) (n=15, mean age 41,71±6,41) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles) (n=15 mean age 41,53 ± 4,41). Groups were contrasted regarding pain (visual analogical scale and McGill pain questionnaire), functional disability (Oswestry disability questionnaire) and TrA muscle activation capacity (Pressure Biofeedback Unit = PBU). The program lasted 6 weeks, and sessions happened twice a week, with duration of 30 minutes each. Analysis of variance was used for inter and intragroup comparisons. Significance level was established at 5%.

Patients attended two weekly sessions during six weeks and were evaluated for pain (visual analogue scale and McGill Pain Questionnaire), functional disability (Oswestry disability index), and ability to contract the TrA (Pressure biofeedback unit) before and after the treatment. The treatment program consisted of 30 minutes sessions. The Anova one-way and Tukey´s Post Hoc were used to compare groups. The significance level adopted was 5%.

Eligibility Criteria:
Inclusion Criteria:

* low back pain for more than 3 months
* patients willing to participate and could participate in an exercise program safely and without cognitive impairments that would limit their participation.

Exclusion Criteria:

* past history of back surgery
* rheumatologic disorders
* spine infections
* spine exercise training in the 3 months before study onset.
The Effect of Energy Drink Consumption on Alcohol-Substance Use and It's Relationship With Impulsivity In University Students

The objective of this study is to investigate the prevalence of energy drink, alcohol and substance use among university students; to explore whether there is a relationship between energy drink consumption and alcohol-substance use in university students or not and to evaluate effect of impulsiveness and sensation seeking on this relationship.


Eligibility Criteria:
Inclusion Criteria:

* To be university student
* To be ≥ 18 years old

Exclusion Criteria:

* Not willing to participate the study
Glasgow Natural History Study Of Covered Coronary Interventions

Covered stents (CS) are a potentially lifesaving treatment for grade III coronary perforation but delivery can be challenging, and the long-term durability and safety including risk of acute stent thrombosis are unknown. The GNOCCI study aims to evaluate long term outcomes after coronary perforation including patients treated with covered stents.

Covered stents (CS) are a potentially lifesaving treatment for grade III coronary perforation but delivery can be challenging, and the long-term durability and safety including risk of acute stent thrombosis are unknown. Using an electronic data base, details of all coronary perforations are identified and anonymised patient and procedural details are recorded.Procedural major adverse cardiac events (pMACE) are defined as a composite of death, myocardial infarction, stroke, target vessel revascularization or cardiac surgery within 24 hours of the index procedure. Two independent cardiologists adjudicate outcomes and differences in opinion are resolved by consensus with a third cardiologist.

The overall GNOCCI study aims are:

1. Evaluate procedural and long term outcomes after coronary perforation
2. Long term safety and clinical events in patients treated with covered stents.

Eligibility Criteria:
Inclusion Criteria:

* Any coronary artery perforation during percutaneous coronary intervention

Exclusion Criteria:

* Nil
Yoga vs. Education for Veterans With Chronic Low Back Pain

Chronic low back pain (cLBP) is the most common pain condition in the military, causing substantial physical and psychological suffering, reduction in force readiness, and high economic cost. Yoga has been studied in 10 RCTs in civilian populations with cLBP suggesting it may be effective in reducing pain intensity, improving back-related function, and lowering pain medication use. Multiple differences exist between civilian and military populations with cLBP, making it necessary to adapt and test yoga for cLBP in military populations. This study's primary aim is to evaluate the effectiveness of yoga for reducing pain in military personnel and Veterans with cLBP through a structured, reproducible 12-week series of hatha yoga classes, supplemented with home practice, compared to an education group. Additionally, the enormous mental health burden often shouldered by returning military personnel presents another important distinguishing factor. Thus, the study's secondary aim is to assess yoga's capacity to reduce post-traumatic stress symptoms (PTSS). The third aim is to evaluate the cost-effectiveness of yoga for cLBP at 3 months and 6 months from the perspective of the provider, the Veteran, and the Veterans Health Administration. The fourth and final aim is to evaluate the effect of back pain and yoga on marital and family functioning. The proposed RCT will (1) establish a structured reproducible yoga protocol uniquely suited to Veterans populations with cLBP; (2) develop web-based delivery systems to assist Veterans in yoga home practice; (3) increase our knowledge of the feasibility and impact of yoga for Veterans' cLBP and psychological comorbidities. These results will help determine whether yoga is an effective modality for addressing cLBP in a Veteran population.


Eligibility Criteria:
Inclusion Criteria:

* Veteran of any branch of military service
* Current low-back pain present for at least half the days over the past 6 months mean pain intensity for the previous week ≥4 on 0-10 rating scale

Exclusion Criteria:

* Significant yoga practice in the previous 6 months
* Have read The Back Pain Helpbook in the previous 6 months
* New LBP treatments started within the previous month or anticipated to begin in the next 3 months
* Known pregnancy
* Known inflammatory or systemic causes of LBP
* Severe and/or progressive medical, neurological, or psychiatric comorbidities
* Inability to understand/speak English
* Plans to move out of the area in the next 6 months
* Lack of informed consent
* Unwillingness to be randomized