cyrilzakka/clinical-trials huggingface dataset:
Sustainment of Mental Health Supports

Schools are in great need of service delivery systems that can improve school climate and also attend to students' mental health. One effective approach is Positive Behavioral Interventions and Supports (PBIS), a multitiered framework for defining and organizing practices and interventions (including mental health practices).


Eligibility Criteria:
Inclusion Criteria:

* Schools: Any school in the School District of Philadelphia (SDP) already implementing Positive Behavioral Interventions and Supports (PBIS).
* Tier 2 Team Members: Any staff from participating schools involved in the PBIS leadership team at that school.
* Tier 2 Implementers: Any Masters-level staff assigned by their school's principal to deliver Tier 2 interventions.
* Tier 2 Coaches: Any Masters-level clinician employed by the SDP to support staff implementing Tier 2 interventions
* Students: Any student at participating schools in grades 4-8 who scores as eligible for PBIS based on the Social, Academic, and Emotional Behavioral Risk Screener (SAEBRS), which is standard screening criteria in the SDP for Tier 2 services and scores above \> 1 SD above the mean on the Emotional Symptoms or Conduct Problems scales of the Strengths and Difficulties Questionnaire (SDQ) plus Impact Supplement scores of 1 (A medium amount) or 2 (A great deal) completed by a parent or a teacher

Exclusion Criteria:

* Schools: Any schools not currently implementing PBIS at Tier 1.
* Tier 2 Team Members and Implementers: Any school personnel that are not involved in the leadership team or tier 2 team.
* Students: Any student with a Special Education classification of "Intellectual Disability;" or with a history of psychotic or autistic spectrum disorders according to school records will be excluded because they would be unlikely to benefit from our tier 2 interventions
Percutaneous Cannulated Screws Versus Open Reduction and Internal Fixation in the Treatment of Displaced Isolated Medial Malleolar Fractures in Adults

The aim of this prospective randomized controlled trial is to compare the functional and radiographic outcomes of closed reduction and percutaneous cannulated screws fixation and ORIF in treatment of displaced isolated medial malleolar fractures.

Medial malleolar (MM) fractures occur in about 50% of all ankle fractures, and may occur as isolated MM fractures or as part of a bi- or tri-malleolar ankle fractures.

MM fractures may occur following road traffic accident, twisting injury to ankle, assault, and falling from height.

When MM fractures occurring as a part of a bi- or tri-malleolar ankle fractures, MM fractures are typically treated with surgical fixation. Isolated non-displaced MM fractures can be treated conservatively by below knee cast application. Displaced isolated MM fractures are usually treated surgically.

Many fixation techniques for MM fractures have been proposed including; unicortical partially threaded compression screws, bicortical fully threaded screws, buttress or neutralization plates, and tension band wiring. The choice of a particular fixation technique depends on the fracture geometry and the extent of comminution. Surgical procedures can be done by open reduction internal fixation (ORIF) or closed reduction percutaneous fixation.

In comparison to an ORIF, a percutaneous approach to MM fractures have potential advantages of decreased surgical morbidity, decreased postoperative pain, and decreased risk of wound complications. However, without direct fracture site visualization, it is possible that acceptable reduction could be hindered, leading to higher rates of nonunion and malunion. Some studies have shown that even in unstable medial malleolus fractures percutaneous screw fixation is excellent technique.

There is dilemma in the existing literature which treatment method is better for MM fractures management. Up to my knowledge, there is no comparative prospective study of ORIF versus percutaneous approach in surgical treatment of isolated medial malleolar fractures.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with closed, displaced (˃2mm), isolated medial malleolar fractures of Herscovici type B or C.

Exclusion Criteria:

* comminuted fractures, open fractures, bi-, tri-, or quadri-malleolar ankle fractures, associated syndesmotic or lateral collateral ligament injuries, skeletally immature patients, any other ipsilateral lower limb fractures, or previously fractured ankle.
Retransfusion or Not of Cardiotomy Blood

This randomised controlled trial has a non-inferiority design. The aim is to test if the blood loss (volume in mL and hemoglobin) is effected by heart and lung cardiotomy retransfusion, or not? Forty CABG (Coronary Artery By pass Grafting) patients will be allocated to either receive retransfusion (n=20) of cardiotomy blood via the heart and lung mashine, or no retransfusion (n=20).


Eligibility Criteria:
Inclusion Criteria:

* Elective CABG.

Exclusion Criteria:

* Anaemia, infection, massive bleeding, CABG off pump.
The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia

This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of the allogeneic human adipose derived stem cell component extract on androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of allogeneic human adipose derived stem cell component extract per month or a placebo for 16 weeks.

This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of the allogeneic human adipose derived stem cell component extract on androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of allogeneic human adipose derived stem cell component extract per month or a placebo for 16 weeks. Hair count and thickness will be primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* androgenic alopecia basic and specific(BASP) classification: M2, C2, U1, V1, or F1 or higher

Exclusion Criteria:

* patient of scalp disease
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk

The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune response in healthy term infants.

Infant formulae are the only alternatives to breast milk for infants when, for whatever reason, human milk becomes unavailable.

New-generation infant formulae contain functional ingredients able to mimic some benefits of human milk.

The study formula is supplemented with galacto-oligosaccharides, which favor intestinal positive microflora growth, beta-palmitate, enhancing fat and calcium absorption and softer stool formation, and acidified milk which contributes to immune system maturation.

The aim of this study is to verify the safety of the study formula in healthy term infants and to deepen the efficacy of the functional ingredient blend in term of prebiotic effect, gastrointestinal tolerance and immune response improvement.

Eligibility Criteria:
Inclusion Criteria:

* Infants of both sexes born to natural or cesarean delivery
* Gestational age between 37 and 42 completed weeks
* Birth weight between 10th and 90th percentile of birth weight for gestational age, according to the North-Italian growth charts
* Single birth
* Caucasian parents
* Infants being exclusively formula-fed by the 21st day of life

Exclusion Criteria:

* Infants with genetic and/or congenital diseases
* Infants receiving antibiotic therapy
* Infants with neonatal diseases requiring hospitalisation for longer than 7 days
* Infants at risk for atopy and/or having familial history for atopy
* Mothers with metabolic or chronic diseases
* Infant selected for another clinical study
* Parents refusing to sign a written informed consent
Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease

The goal of this observational study is to determine the factors associated with a delayed diagnosis and/or an immediately complicated disease for CD patients.

A questionnaire will be completed by the patients, each questionnaire has a patient section and a physician section.

Number of patients expected : at least 600, coming from all types of practices (ANGH (expert hospitals), GETAID (expert university hospitals) and CREGG (expert private practice)).

Recruitment period : 1 year

Primary endpoint : The primary endpoint is the description of the factors linked to:

* The IBD
* The patient (see patient questionnaire in annex 1)
* The health care system
* The patient's self-care

Secondary endpoint :

* Validation of the "red flags" in a prospective cohort.
* Comparison with the EPIMAD population, especially the location and severity.

Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease diagnosed less than a year prior to inclusion
* Written consent
* Age ≥ 18 years

Exclusion Criteria:

* Diagnosis of Crohn's disease more than one year before inclusion
* Patient protected by the law
* Patient without health cover
Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery

Currently, total intravenous anesthesia (TIVA) and inhaled anesthesia are both commonly used for transsphenoidal pituitary adenoma resection. However, optimal choice for anesthesia maintenance in transsphenoidal surgery remains unclear. Previous studies focusing on this question provided fragmentary assessment and controversial results. The goal of this clinical trial is to investigate whether propofol and sevoflurane have different effect on post-anesthetic recovery after transsphenoidal resection of pituitary adenoma.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women, aged from 18 to 70
2. American Society of Anesthesiologists (ASA) class I - III
3. Patients scheduled for transsphenoidal surgery requiring general anesthesia managed with endotracheal intubation

Exclusion Criteria:

1. Patients allergic or contraindicated to sevoflurane, propofol, or other drugs used during surgery
2. Severe pulmonary disease, saturation of peripheral oxygen (SpO2) \< 90%
3. Severe nervous system disease with consciousness disorder
4. Patients scheduled for intensive care unit (ICU) after surgery
5. Pregnancy
Application-Enabled Shared Decision-Making

To develop application-enabled shared decision-making among patients with early breast cancer and evaluate the preliminary effects of the interventions.

Female breast is an amazing organ that it symbolizes not only the female gender, but also the continuity of human race. In the past treating breast cancer may signal a termination of the breast's predestined role in a woman or a mother. Nowadays, surgical treatment of early breast cancer has two options, one is breast-conserving surgery and the other one is total mastectomy. The former treatment option preserves most of the breast tissue but may spare dormant cancer cells in the preserved tissue. The latter treatment option spares no breast tissue and as a result no dormant cancer cells would remain. This treatment dilemma may bother most of the patients especially when they are still under the shade of the bad news. Many women are reluctant to discuss their diseased breasts with their folks or even their doctors because of privacy; instead they would seek information through internet. Unfortunately, most of their final decision is doctor's preferred choice despite they may have doubts or concerns on doctor's choice of treatment.

Share decision making (SDM) is a recently developed strategy that allows patients taking part in their treatment plan. Patients are invited to join the meeting where doctors explain the latest treatment options and patients express their concerns and finally a decision, both doctors' and patients' concerns well integrated, is reached. One of the drawbacks of SDM is too time consuming; doctors have to prepare a lot of pertinent information, while patients have to try their best to understand the provided information, though many patients may not fully understand their treatment options. It has been reported that a well designed patient decision aids (PDAs) could serve as a virtue connection between patients and doctors. Instead of merely taking information from the PDAs, it allows patients to know all the possible options of treatment and the side effects in an interactive way. It is supposed that patients could be well prepared to discuss with their doctors after interaction with the customized PDAs. In Taiwan, decision conflict and decision regret are commonly encountered among most cancer patients. The impetus for developing a PDAs for female breast cancer patients and evaluating its role on lowering decision conflict and decision regret among these patients comes from the high rates of decision conflict and decision regret among cancer patients in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* women, aged \>20 years
* newly diagnosed early breast cancer (stages 0-II)
* no surgery yet
* no metastases
* tumor size \<3 cm

Exclusion Criteria:

•tumor located \<2 cm from the nipple
Visual Acoustic Biofeedback for RSE Via Telepractice

This research will meet a public health need by evaluating the efficacy of speech intervention supplemented with real-time visual-acoustic biofeedback when delivered using remote technologies.

In a crossover design, participants will be randomly assigned to receive 10 weeks/20 sessions of visual-acoustic biofeedback treatment via telepractice followed by a 10-week period of no treatment, or the same two conditions in the reverse order. Production accuracy will be assessed with standard probes (20 syllables, 30 words, and 10 sentences containing /r/ in various phonetic contexts) administered prior to the beginning of treatment (baseline), after the first 10-week phase, and again at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 9;0 and 15;11 years of age at the time of enrollment.
* Must speak English as the dominant language (i.e., must have begun learning English by age 2, per parent report).
* Must speak a rhotic dialect of English.
* Must pass a pure-tone hearing screening at 20dB hearing level.
* Must pass a brief examination of oral structure and function.
* Must exhibit less than 30% accuracy, based on consensus across 2 trained listeners, on a probe list eliciting rhotics in various phonetic contexts at the word level.
* Must exhibit no more than 3 sounds other than /r/ in error on the Goldman-Fristoe Test of Articulation-3 (GFTA-3).

Exclusion Criteria:

* Must not receive a T score more than 1.3 SD below the mean on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2) Matrix Reasoning
* Must not receive a scaled score of 7 or higher on the Recalling Sentences and Formulated Sentences subtests of the Clinical Evaluation of Language Fundamentals-5 (CELF-5).
* Must not have an existing diagnosis of developmental disability or major neurobehavioral syndrome such as cerebral palsy, Down Syndrome, or Autism Spectrum Disorder
Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score

An interventional controlled trial to test the feasibility of applying risk score based prevention for critically ill patient at high risk to develop acute kidney injury (AKI)

Background and rationale AKI is common in the intensive care unit .It contributes significantly to mortality and morbidity .the estimated incidence or AKI among critically ill patients is 30-40% and morality is high.

There is a well recognized gap between the optimal care and the delivered care regarding prevention and management of AKI.

The focus over the last few years has been on early detection. A panel of urinary biomarkers have proved helpful for early detection of AKI. However the cost and low specificity make no single one of them solely reliable .using a panel of bio-markers increases their specificity.

The concept of electronic alerts has been recently introduced. Some trials have been testing its impact on the outcome of AKI. The benefit of electronic alerts is still uncertain .A meta-analysis is currently underway to synthesize stronger evidence of electronic alerts benefit.

Another evolving area, is the development of risk score to predict AKI and and hence applying timely preventive measures.

KDIGO recommends applying preventive measures to high risk patients. However no study to date has tested risk scores based interventions

Hypothesis:

We will use the recently validated score to predict AKI in ICU patients. We will then apply preventive measures. To patients at risk .To our knowledge this is the first study to apply preventive interventions based on AKI risk score assessment

Eligibility Criteria:
Inclusion Criteria:

All adult patients (≥18 year old) admitted to the intensive care unit and do not fulfill the criteria for the diagnosis of AKI by Kidney Disease Improving Global Outcome (KDIGO) definition

Exclusion Criteria:

1. Patients who have already developed AKI at the time of intensive care unit ICU admission.
2. Patients with insufficient medical records to obtain previous medical history
3. Patients who lack mental capacity
Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology

The purpose of this study is to compare urinary tract infection rates among women undergoing urogynecological procedures with a silver-alloy suprapubic catheter compared to the standard suprapubic catheter.

Urinary catheters are used routinely in the postoperative care of urogynecology patients after surgery involving the genitourinary tract. However, Urinary tract infections(UTI) associated with indwelling catheter is the second leading cause of nosocomial infections. 20% of hospital acquired bacteremia arise from UTI with an associated mortality of 10%.

There are many different types of catheters available for use. Standard indwelling catheters are made from a variety of materials including polyvinyl chlorine, plastic, plain latex, polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer. Specialized catheters have been developed with the aim of reducing infection. Strategies generally involved coating the inner, outer or both surfaces of the catheter with antimicrobial materials. These materials can be antibiotic or antiseptic with the most common antiseptic material used being silver. Silver ions are bactericidal, are used safely when applied topically to humans and used in controlling infections.

Previous studies comparing UTI rates in transurethral catheters have reported a significant reduction of UTI rate in silver-alloy catheters with a range of 5-12% compared to standard catheters with a range of 7-50%. There are no studies comparing the UTI rate in silver-alloy supra-pubic catheters to standard supra-pubic catheters. The investigators hypothesize that this study will show a statistically significant decrease in UTI rate among the individuals with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.

Eligibility Criteria:
Inclusion Criteria:

* patients requiring intra-operative placement of suprapubic catheters as part of routine post-operative care for repair of vaginal anterior compartment prolapse i.e. patients undergoing anterior colporrhaphy, Burch colposuspension, with or without mid-urethral sling

Exclusion Criteria:

* Known UTI at time of surgery
* Unable to provide informed consent
* Use of chronic intermittent self-catheterization pre-operatively
* Use of chronic prophylactic antibiotics
* Use of antibiotics for any indication other than UTI during peri-operative and 6-week post-operative period
* Presence of fistula involving urogenital tract
* Use of chronic steroids or immunosuppressant
* Immunocompromised patient
The Effects of Whole Body Vibration With Plyometric Training on Physical Performance in Basketball Players

Purpose: The purpose of this study was to determine whether whole body vibration with plyometric training has effect on physical performance parameters and balance also this study searched for if vibration support additional benefits to normal plyometric training. Methods: 24 elite basketball players divided into two group as 12 players with the mean age of 24 ± 6,96 years (Study Group) and 12 players with the mean age of 22,45 ± 5,22 years (Control Group). Plyometric training were applied to study group on whole body vibration platform for 6 weeks (2 days/week) with routine basketball training, in control group plyometric training were applied on whole body vibration platform with the similar period of time but platform had been closed. All the assessments (physical measurement, vertical and horizontal jump tests, one-repetition maximum (1-RM) half squat strength test, 20 m speed test, T agility test, sit and reach flexibility test, star excursion balance test) were applied before and after 6 weeks plyometric training for both groups.


Eligibility Criteria:
Inclusion Criteria:

* male basketball player
* professional basketball player
* age between 18-28

Exclusion Criteria:

* lower extremity injuries
* upper extremity injuries
Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis and Epicardial Adipose Tissue(EAT)

The purpose of this study is to determine whether olmesartan medoxomil is effective in the treatment of coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume reduction in patients with coronary atherosclerosis detected by coronary CT angiography(CCTA).

Epicardial adipose tissue(EAT) is directly deposited around the pericardium and coronary artery. By means of paracrine action, it can generate various kinds of cytokines, inflammatory factor and free fatty acids, that can affect the state of coronary endothelial function, inflammation and oxidative stress, which finally aggravate the progression of coronary atherosclerosis. In recent years, clinical studies have shown that EAT is a newly discovered independent risk factor of coronary atherosclerosis.Studies confirm that olmesartan medoxomil can improve endothelial function, resisting thrombosis, improve tissue reconstruction, resisting oxidative stress so as to achieve atherosclerosis resistant. Latest researches show that olmesartan medoxomil can better inhibit rat epididymal adipose cell hypertrophy and inflammatory reaction. Coronary CT angiography(CCTA) has emerged as a noninvasive imaging method for analysis coronary atherosclerosis. The purpose of this study is to determine whether olmesartan medoxomil is effective in the treatment of coronary atherosclerosis progression and EAT volume reduction in patients with coronary atherosclerosis detected by CCTA.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery stenosis between 30% and 70% determined by CCTA in essential hypertension patients
* resting diastolic blood pressure (DBP) between 90 and 110 mmHg
* type A and B for coronary artery vascular lesions

Exclusion Criteria:

* secondary hypertension
* coronary artery stenosis less than 30% or greater than 70% determined by CCTA
* contraindications to treatment with olmesartan medoxomil (allergy, glaucoma, digestive ulcer, is currently taking phosphodiesterase-5 inhibitor)
* resting systolic blood pressure (SBP) \> 200 mmHg or resting diastolic blood pressure (DBP) \> 110 mmHg
* Severe calcification, distortion or type C for coronary artery vascular lesions
* pregnancy
* unwillingness or inability to provide informed consent