cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

Previously, the investigators have developed a minimal invasive lens surgery in the purpose of reduce post-operative complications of congenital cataract. This prospective, randomized controlled study aims at comparing the prognosis of the minimal invasive lens surgery and the traditional cataract surgery for treating congenital cataracts.

Patients with congenital cataract that requires surgical intervention are enrolled.

Then the participants are assigned to two groups: Group I: the participants receive a minimal invasive lens surgery, while in Group II, the participants receive a traditional cataract surgery. A secondary intraocular lens implantation is performed when the patient is two years old for both Group I and Group II. Investigators then compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups, to evaluate and compare the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.

Eligibility Criteria:
Inclusion Criteria:

* Age between 1 month and 24 months
* Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag
* Informed consent signed by a parent or legal guardian

Exclusion Criteria:

* confirmed or suspected hereditary cataract, including and not restricted to family history of congenital cataract
* Intraocular pressure \>21 mmHg
* Preterm birth (\<28 weeks)
* Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy)
* History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family
* History of ocular trauma
* Microcornea
* Persistent hyperplastic primary vitreous
* Rubella
* Lowe syndrome
Sleep as a Mechanism of Change in Alcohol Use

This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.

Heavy alcohol use is prevalent in the United States and results in significant physical and psychological burden. One in 10 adults in the United States reports binge drinking on a weekly basis, and few are willing to seek mental health treatment. Thus, additional strategies are needed to engage and treat individuals at risk for alcohol-related harm. Half of those who screen positive for hazardous drinking report clinically significant symptoms of insomnia. Insomnia tends to be less stigmatized than other mental health disorders, and it is one condition for which the field has highly efficacious treatment. Thus, one potential strategy to engage individuals in mental health treatment and reduce the burden of alcohol use in the United States is to target insomnia. This project aims (1) to examine change in insomnia as a mediator of insomnia treatment effects on alcohol use outcomes and sex as a moderator of those effects and (2) to identify mechanisms linking change in insomnia to alcohol use outcomes. Adults who drink alcohol and have insomnia will be randomly assigned to Cognitive Behavioral Therapy for Insomnia (CBT-I, n=112) or waitlist control (WLC, n=112). Outcomes will be assessed weekly during treatment, at the end of the active intervention period (post-treatment), and at 1-, 3-, and 6-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* report heavy drinking in a typical week in the past month
* meet DSM-5 criteria for Alcohol Use Disorder
* meet DSM-5 and research diagnostic criteria for Insomnia Disorder

Exclusion Criteria:

* ≥50 years
* unable to provide informed consent
* report contraindications for CBT-I (mania or seizure disorder)
* moderate to severe sleep apnea that is untreated
* have symptoms requiring immediate clinical attention (e.g., psychosis, suicide plan)
* are already receiving behavioral treatment for insomnia or alcohol use
An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.


Eligibility Criteria:
Inclusion criteria:

1. diagnosis of essential hypertension
2. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
3. provision of written informed consent

Exclusion criteria:

1. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)
Oxytocin's Effect on Social Pain Empathy

The aim of the present experiment is to examine oxytocin's behavioral and neural effects on social pain empathy

In the current study, the investigators plan to examine whether oxytocin modulates behavior and neural activity during observing another person being excluded in an online ball-tossing game (a modified cyberball paradigm).

Eligibility Criteria:
Inclusion Criteria:

* healthy participants without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness
* smoking or drinking 24 hours before experiment
Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%

The primary objective of this study is to investigate potential differences in treatment adherence by teenagers among four interventions during treatment for acne.

Same as above.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent subjects with a diagnosis of moderate to severe Acne vulgaris

Exclusion Criteria:

* Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring more than topical treatment (e.g. oral isotretinoin)
MULTICENTER ULNAR NERVE ULTRASONOGRAPHIC and NEUROPHYSIOLOGICAL STUDY: NORMATIVE DATA COLLECTION

The study population will include a total of 500 subjects, selected from outpatients accessing the Neurophysiology Service for a neurophysiological study of the upper limbs. Only those whose neurophysiological examination results negative for Peripheral Nervous System pathology (i.e., negative electroneurography and electromyography according to AANEM guidelines) will be recruited. The subjects will be enrolled in 22 centers distributed throughout Italy, with our center planning to recruit 50 subjects.

The diagnostic procedures include electroneurography and electromyography, which are standard clinical practice. Ultrasound (ultrasonographic study) is not an experimental technique but is considered an additional procedure specifically included in the study protocol.

The primary objective of the study is to establish normative values for the CSA of the ulnar nerve and assess the reliability of the measurement through inter-operator comparison (between a physician and a neurophysiology technician). Therefore, during an evaluation lasting approximately 30-60 minutes, the enrolled subjects will undergo an electroneurographic/electromyographic and ultrasound study of the ulnar nerve. The latter will be performed by two independent operators (a physician and a neurophysiology technician).


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old EMG/ENG completely negative for pathologies of the peripheral nervous system (ENG and EMG negative according to the regulatory data of each single Center) Signature of the informed consent

Exclusion Criteria:

* Diabetes, Hepatitis, Renal Failure History of NPL or previous CT Previous pathologies of the peripheral nervous system Previous trauma to the limb in question Positive familiarity for neuromuscular disorders
Evaluation of Accuracy of Rapid Tests for Group A Beta Hemolytic Streptococci in Out-patients With Sore Throat

The purpose of this study is to evaluate accuracy of rapid tests for group A beta hemolytic streptococci in patients who presented with sore throat at out patient department in Siriraj Hospital.

The patients who presented with sore throat at out patient department less than 5 days and age over 6 years old would be enrolled by the primary physicians and the consent forms will be completed by researcher.

The throat swab would be performed by using Sofia, QuickVue rapid tests compare to the gold standard which is a throat swab culture to evaluate the accuracy of the rapid tests.

The sample size for validation of sensitivity and specificity of rapid tests is 358 patients.

The primary outcome is will be evaluated sensitivity and specificity of both rapid tests.

Eligibility Criteria:
Inclusion Criteria:

* Patients who came with sore throat less than 5 days.

Exclusion Criteria:

* No
Ultrasound in Airway Assessment of Morbidly Obese Patients

the study aims to evaluate the role of airway ultrasound as a new evolving modality in assessment and management of airway in surgical patients


Eligibility Criteria:
Inclusion Criteria:

* all surgical list patients planned for general anesthesia from october 2015 to may 2016

Exclusion Criteria:

* Patient refusal
Comparison of Visual Fields: Humphrey Field Analyzer (HFA) SITA Strategy, SCOPE (GATE Strategy) and Humphrey MATRIX Perimeter

The purpose of this study is to compare three perimetric techniques regarding progression of the visual field.


Eligibility Criteria:
Inclusion Criteria:

* max. ± 8 dpt sph, max. ± 3 dpt cyl
* distant visual acuity \> 10/20
* isocoria, pupil diameter \> 3 mm
* at least one risk of progression: optic disc (splinter) hemorrhage / cup to disc ratio (CDR) \> 0.7 / inter-eye asymmetry of CDR \>0.2 / notching of the optic disc /retinal nerve fibre layer (RNFL) defects / intraocular pressure( IOP) \>22 mmHg / central corneal thickness \< 520 µm / advanced visual field defect stage Aulhorn III / elder than 70 years

Exclusion Criteria:

* pregnancy, nursing
* diabetic retinopathy
* asthma
* HIV+ or AIDS
* history of epilepsy or significant psychiatric disease
* medications known to effect visual field sensitivity
* infections (e.g. keratitis, conjunctivitis, uveitis)
* severe dry eyes
* miotic drug
* amblyopia
* squint
* nystagmus
* albinism
* any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields,disc imaging or accurate IOP readings
* keratoconus
* intraocular surgery (except for uncomplicated cataract surgery) performed \< 3 month prior to screening
* history or signs of any visual pathway affection other than glaucoma
* allergies with regard to topic glaucoma medication
* history or presence of macular disease and / or macular edema
* ocular trauma
* medications known to affect visual field sensitivity
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis

Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis
* Spigelman score of duodenal adenoma equal to II or III

Exclusion Criteria:

* Incapability of signing informed consent
* Active gastric or duodenal ulcer, gastrointestinal bleeding
* Cardiovascular disease or risk:

  * Congestive cardiac failure: NYHA class II to IV
  * Proven ischemic heart disease and/or cerebrovascular disease
  * Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (≥2 first degree family members \<55 years)
* Renal dysfunction: creatinine clearance below 50mL/min
* Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10
* Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid
* Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study
* Use of lithium
* Symptomatic gallstones
* Inflammatory bowel disease
* (Possible) pregnancy or breast feeding
Effect of HeartMath Intervention on Stress, Emotional Vitality and Sense of Coherence

This study aims to investigate the effect of Heart math intervention program on stress, emotional vitality and sense of coherence among intensive care units Nurses

This study aims to investigate the effect of Heart math intervention program on stress, emotional vitality and sense of coherence among intensive care units Nurses.

The intervention was implemented in form of 2 sessions per week according to the following 7 sessions, each session about 45- 60 minutes.

Session (1)

Aims:

Introduce Heart Math definition of stress. Assess client's current stress level.

Handouts for patients:

Handout 1 : Stress What is stress? How stress affect health? How stressed are you? What can I do about it? Session (2) Aim: Introduce concept of heart coherence

Handouts for patients:

Handout 1: Heart Coherence How dose Heart Math work? How can I create and practice physiological coherence? The Quick Coherence Technique. Handout 2: Depletion to renewal plan. Session (3)

Aims:

Teach Heart-Focused Breathing and Quick Coherence Introduce personal practice plan to use for

Handouts for patients:

Handout 1: Heart-focused breathing. Handout 2: Quick coherence technique. Handout 3: Personal practice log. Session (4)

Aims:

Assess client's current anxiety level. Review this week's homework on Personal Practice Log. Review and practice Quick Coherence Technique. Teach Heart Lock-In Technique.

Handouts for patients:

Handout 1: Anxiety Checklist. Handout 2: Quick Coherence Technique. Handout 3: Heart Lock-In Technique. Handout 3: Personal Practice Log. Session (5)

Aims:

Review this week's homework on Personal Practice Log. Review Heart-Focused Breathing and Quick Coherence Techniques. Review and practice. Heart Lock-In Technique. Teach Freeze Frame Technique.

Handouts for patients:

Handout 1: Heart Lock-In Technique. Handout 2: Freeze Frame Technique. Session (6)

Aims:

Review this week's homework on Personal Practice Log. Review Heart Lock-In and Freeze Frame Techniques. Teach Attitude Breathing Technique.

Handouts for patients:

Handout 1: Personal Practice Log. Handout 2: Freeze Frame Technique. Handout 3: Attitude Breathing Technique. Session (7)

Aims:

Review this week's homework on Attitude Breathing Technique. Teach Coherence Communication Technique.

Handouts for patients:

Handout 1: Attitude Breathing Technique. Handout 2: Coherent Communication Technique.

Eligibility Criteria:
Inclusion Criteria:

* Nurses who work in selected intensive care units and agree to participate

Exclusion Criteria:

* Nurses who refuse to participate in this study
Supplemental Oxygen Study

The purpose of this study is to compare umbilical cord gases in subjects receiving oxygen at 10L/min via simple facemask to subjects receiving room air in those presenting for scheduled cesarean sections.

Objective:

To compare umbilical cord gases in subjects receiving oxygen at 10L/min via simple facemask to subjects receiving room air in those presenting for scheduled cesarean sections. The investigators hypothesize that umbilical artery pH levels will not be significantly lowered in the oxygenated group.

Primary outcome: umbilical artery pH levels in the oxygenated versus room air group

Secondary outcomes: Apgars, respiratory distress syndrome, necrotizing enterocolitis, interventricular hemorrhage, intubation, number of NICU days and neonatal mortality.

Methods:

Only term elective c-sections will be approached for study consent. Once enrolled subjects will be randomized either receive 10L/min via simple facemask or to room air. Once regional anesthesia is completed, then the facemask with oxygen will be placed. The time from oxygen administration to uterine incision will be at least 10 min. At the time of delivery umbilical cord gases will be collected by and will be processed within one hour of delivery.

Inclusion criteria:

* 18 years or older
* Scheduled cesarean section
* Singleton
* Term gestation; at 37 0/7 weeks gestation or greater

Exclusion criteria:

* Maternal lung disease including asthma
* Evidence of hypoxemia prior to enrollment
* Intrauterine growth restriction
* Chronic hypertension
* Preeclampsia
* Fetal anomalies
* Breech position
* Multiple Gestation

Statistical analysis:

Subjects will be randomized via block randomization. The estimated umbilical arterial pH in the scheduled cesarean section room air group is 7.31. To identify a 0.05 or greater difference between the control and treatment group, a power of 0.8, alpha of 0.05 the investigators would need 64 subjects total. To account for drop out the investigators intend to enroll a total of 70 subjects.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Scheduled cesarean section
* Singleton
* Term gestation

Exclusion Criteria:

* Maternal lung disease including asthma
* Evidence of hypoxemia prior to enrollment
* Intrauterine growth restriction
* Chronic hypertension
* Preeclampsia
* Fetal anomalies
* Breech position
* Multiple gestation
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Eligibility Criteria:
Inclusion Criteria:

* Age 18 : 70 years old.
* NYHA Class III-IV Heart Failure.
* Heart failure with a reduced ejection fraction (HFrEF) LVEF ≤ 40% calculated using 2D echocardiography and Biplane Simpson's .
* Optimal tolerated Medical Therapy for Heart Failure.

Exclusion Criteria:

* Active Malignancy.
* Acute heart failure including pulmonary edema or cardiogenic shock.
* Severe, life-threatening non-cardiac disease.
* Pregnancy.
* Localized infection.
* Coagulopathy or anticoagulated patients.
* Refused this procedure.
Couples Fertility and Pregnancy Awareness

Recent evidence has shown that young people that want to have children have low fertility knowledge. This study evaluates the efficacy of a video intervention on fertility knowledge, on changes in lifestyle and on the decision to start to get pregnant.

This study will compare the efficacy of a video intervention versus control (no video) in couples that intend to have children in the next three years. The couples will be randomized to the two groups. The video contains information concerning age-related fertility decline, fertility risk factors, the success of infertility treatments, and emotional consequences of childlessness.

Eligibility Criteria:
Inclusion Criteria:

* Female member of the couples has between 24 to 40 years
* Childless couples trying to conceive or couples who desired to have children in the next 3 years
* Relationship length minimum of one year

Exclusion Criteria:

* Couples that already had achieved a successful pregnancy
* Couples with children
Quality of Life After Interventional Thyroid Treatment

In this study, patients are prospectively followed after radioiodine treatment to assess the relationship between thyroid status and their quality of life after thyroid ablative treatment.

A third treatment arm after surgery has been stopped, as deemed currently not feasible to achieve its target.

Patients are frequently dissatisfied with LT4 replacement treatment. The reasons for persisting patient complaints are poorly understood. Conversion efficiency and impaired T3/T4 ratios in athyreotic patients may play a major role. We hypothesised that the extent of ablation either by surgery or radioiodine treatment may result in biochemical disequilibria between FT3, FT4 and TSH and those may be, in turn, associated with persisting symptomatology.

The study follows patients after radioiodine therapy as well as a control group over half a year, assessing thyroid status, set points, conversion rates, thyroid volume, LT4 administration and dosing, demographic characteristics and quality of life measures. The treatment mode is not part of the study, and determined by criteria and procedures of best standard care. For that reason, a randomised or blinded design is not possible.

Changes and interrelationships between thyroid parameters and QoL measures are analysed within-subjects and between treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of a thyroid disease requiring radioiodine treatment
* Clinical diagnosis of a thyroid disease requiring follow-up but no ablative treatment (controls)
* Clinical diagnosis of a thyroid disease requiring surgery stopped recruiting

Exclusion Criteria:

* paediatric patients
* interfering comorbidity
* non-thyroidal illness
* pregnancy
* psychiatric disease
* severe psychological disorder
* lack of consent
Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents

Large studies of children show that over half of the children in the United States of America do not have enough vitamin D stored in their bodies. In children who are overweight or obese, the percentage of children who do not have enough vitamin D is even higher.

Vitamin D is essential for the body to maintain normal calcium levels and strong bones. Recent research shows that through the actions of inflammatory markers, levels in the blood that measure inflammation in the body, vitamin D plays many other important roles in the body like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat.

The purpose of this study is to determine the effect of vitamin D supplementation on inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin D stores and inflammatory cytokines.

In an observed, randomized controlled trial over 6 months we will provide observed vitamin D supplementation or placebo to healthy obese and overweight adolescents and measure changes in inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that administration of vitamin D to these patients will improve their inflammatory profile and cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).

Supplementation with vitamin D at 150,000 IU every 3 months failed to increase serum 25-hydroxy vitamin D (25OHD) or alter inflammatory markers and lipids in overweight and obese youth. Further studies are needed to establish the dose of vitamin D required to increase 25OHD and determine potential effects on metabolic risk factors in obese teens.

During the course of the study, blood pressure removed from the prespecified outcome measures.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 11 years to 17.99 years old
2. BMI: 85 percentile for age and gender

Exclusion Criteria:

1. Patients who currently receive:

   * vitamin D supplementation \>= 400 IU/day
   * daily glucocorticoids or anti-epileptics
2. Patients who currently have or history of:

   * 25-OH vitamin D level \< 10 ng/ml or \> 60 ng/ml
   * rickets
   * diabetes mellitus
   * liver or kidney disease
   * malabsorptive disorders
   * genetic syndromes associated with obesity (i.e. Prader-Willi)
   * lactose deficiency or insufficiency
   * galactosemia