cyrilzakka/clinical-trials huggingface dataset:
Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings

The PRISM pilot feasibility study consists of two phases to determine: 1) to delivery practices, rates of primary and secondary outcomes, and feasibility of enrollment rates, and 2) to assess the feasibility and acceptability of the intervention and expected enrollment rates, and estimate the effect size of sildenafil citrate on maternal and neonatal outcomes in a low resource settings in preparation for the main RCT.

The primary objectives of the PRISM pilot study relate to feasibility of a large randomized controlled trial of intrapartum sildenafil citrate and will aid in design of a definitive trial among pregnant women to day 42 postpartum (pp) and their newborns to day 28 pp. The pilot will help prepare for the main trial by allowing the investigators to:

* Determine the rate and indication for fetal heart rate monitoring practices;
* Determine the rate and indications for operative delivery;
* Inform the rates of relevant primary and secondary outcomes to possibly target in a large randomized controlled trial of intrapartum sildenafil citrate;
* Assess the feasibility and acceptability of the intervention and expected enrollment rates;
* Estimate the effect size of sildenafil citrate on maternal and neonatal outcomes in a low resource setting.

Eligibility Criteria:
Inclusion Criteria:

* Admission to facility with plan for spontaneous or induced vaginal delivery
* Early stage of labor (≤ 6 cm cervical dilation per local standard) at ≥ 37 weeks gestation
* Age ≥ 18 years of age
* Presence of single live fetus confirmed via a fetal heart rate by Doptone in cephalic position
* Provision of written informed consent \[Note: if written consent is obtained at an early time, verbal re-confirmation is required at time of enrollment\]

Exclusion Criteria:

* Non-emancipated minors (as per local regulations)
* Plan for Cesarean delivery or history of cesarean section prior to enrollment\*
* Unknown gestational age
* Advanced stage of labor (\>6 cm or 10 cm cervical dilation per local standards) and pushing or too distressed to understand, confirm, or give informed consent regardless of cervical dilation
* Not capable of giving consent due to other health problems such as obstetric emergencies (for example, antepartum hemorrhage) or mental disorder;
* Any medical condition considered a contraindication, including contraindication to sildenafil therapy, per the judgement of site investigators
* Any maternal medical condition or status that precludes informed consent
* Recognized fetal anomaly
The Effect of Sleep Hygiene and Exercise Therapy in Children With Sleep Bruxism

The aims of this study were to determine the relationship between sleep bruxism, oral habits, and sleep habits and establish treatment approaches in children.

This cross-sectional study was conducted on children aged between 6-and 13 years, diagnosed with sleep bruxism (SB). Initially, 82 children with a diagnosis of SB were evaluated. Among those, 37 children volunteered were followed for 8 weeks to investigate the effects of the education, sleep hygiene and therapeutic exercise program.

Sleep hygiene education includes routines about bedtime, sleeping room environment, and timing for exercise.

Therapeutic exercises program 5x5 included breathing exercises, head-neck, and scapular posture exercises which included jaw muscle and neck muscle stretching and strengthening exercises. They were asked to repeat each exercise 5 times and 5 times a day for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 6 - 13,
* Having a diagnosis of sleep bruxism,,
* And a parent signing informed consent for participation in the study.

Exclusion Criteria:

* Children who received orthodontic treatment,
* Children with the dentofacial anomaly, a history of TMJ surgery, having a medical history of neurological or psychiatric disease
* and those who could not cooperate were excluded from the study.
Using Real Time Biofeedback to Alter Running Mechanics

The purposes of this study are 1) to assess foot strike patterns initially, at six months and at one year between two groups of runners attempting to transition to a non-rearfoot strike pattern (NRFS) with and without the use of biofeedback technology, and 2) to prospectively compare injury incidence rates at one year between NRFS and rearfoot strike (RFS) runners.


Eligibility Criteria:
Inclusion Criteria:

1. Between the age of 18 - 50 years
2. Run on average 12mi per week
3. DOD beneficiaries who intend to remain at West Point, NY for the next 12 months at time of study enrollment
4. Read and speak English well enough to provide informed consent and follow study instructions

Exclusion Criteria:

1. Known pregnancy currently or in the previous 6 months
2. Lower extremity or low back pain in the previous 3 months
3. Lower extremity or low back surgery in the previous 6 months
4. Any lower extremity or low back exercise limiting profile
5. Previous stress fracture of the foot
6. Participant who has a non-rearfoot strike running pattern
Glucosamine Periodontal Adjunctive Therapy

This study is the first evidence based work evaluated the systemic use of glucosamine as an adjunctive therapy to closed mechanical debridement in chronic periodontitis. The use of glucosamine sulphate was correlated with clinical outcomes and IL1-β level in the GCF of patients with moderate to advanced chronic periodontitis

Targeting the inflammatory response may be a rational approach to the medical treatment of chronic periodontitis. Glucosamine sulphate (GS) was proven to have anti-inflammatory actions with minimal side effect profile. Objectives; The main objectives of this study were to evaluate clinically the efficacy of GS; as a novel adjunctive host modulating agent in periodontal therapy and to investigate its effect on gingival crevicular fluid (GCF) level of IL-1β. Methods; Forty patients with moderate to severe chronic periodontitis (CP) were included in this study. They were randomly divided into two groups. Group I (G1) patients (n=20) received 500 mg GS capsules three times daily for 3 months following full mouth scaling and root planing (SRP), while group II (G2) patients (n=20) received a placebo for the same period following full mouth SRP. Clinical periodontal parameters and GCF IL-1β levels were analyzed at baseline and 3 months following therapy.

Eligibility Criteria:
Inclusion Criteria:

1. good compliance with the plaque control instructions following initial therapy
2. each subject contributed a single premolar or molar tooth with interproximal probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm
3. teeth involved were all vital with score 0-1 mobility
4. availability for the follow-up and maintenance program;

Exclusion Criteria:

1. no systemic diseases which could influence the outcome of therapy as evidenced by Burket's Oral Medicine health history questionnaire
2. absence of periodontal treatment for the previous year
3. absence of systemic medication or antibiotic treatment for the previous six months
4. absence of a smoking habit.
5. post menopausal, pregnant or breast feeding women were excluded from participating in the study. Patients with contraindications to glucosamine sulphate therapy e.g., hypersensitivity to any of the product's components or with inadequate compliance with the oral hygiene maintenance schedule were also excluded from the study.
Prescribing Exercise as Medicine in Pregnancy

This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.

This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise. Once screened and consented, participants will be randomized to either the intervention or control group in a 1:1 fashion. The intervention group will receive the PARMED-X prescription and the control group will receive routine care as usual. Physical activity will be monitored with a Polar fitness tracking device.

Maternal and neonatal outcomes will be collected from the electronic medical record. Maternal outcomes include demographics, total gestational weight gain, pre-pregnancy body mass index (BMI), BMI at the time of delivery, mode of delivery, glucose screen value, presence or absence of gestational diabetes and presence or absence of hypertensive disorders of pregnancy. Neonatal outcomes include gestational age at delivery, birth weight, Apgar scores, arterial cord blood gases.

Psychological outcomes will also be assessed using several validated scales in pregnancy including The Edinburgh Postnatal Depression Scale (EPDS) and The State Trait Anxiety Inventory (STAI).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45 years of age
* Singleton pregnancy
* Gestational age at or less than 20 0/7 weeks at the time of enrollment
* Low risk pregnancy
* Willing and able to participate in a more active lifestyle/exercise program
* Smart phone able to add the "Flow mobile app".

Exclusion Criteria:

* Twins or higher order multiple gestations
* Known congenital anomaly
* Underweight BMI ( BMI less than 18.50)
* High risk pregnancy - ie. hypertension, pre-existing diabetes
* Women with a known contraindication to exercise
* Persistent 2nd or 3rd trimester vaginal bleeding
* Hemodynamically significant heart disease
* Restrictive lung disease
* Incompetent cervix or cerclage
* Placenta previa
* Premature labor or rupture of membranes
* Preeclampsia
* Severe anemia
* Poorly controlled hypertension, seizure disorder, or hyperthyroidism
* Known intrauterine growth restriction
* Not cleared for exercise by the "Contraindications to Exercise from PARMED-X" form
* PAVS score greater than or equal to 150 minutes/week
Effect of PPCI on Diastolic Function & Levels of Galactin-3 in Patients With STEMI

* 2D Echocardiography with color Doppler assessment: It will be done within 24 h after PPCI
* Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.
* Follow up 2D Doppler echocardiography:

will be repeated at 40 days of the event.

2D Echocardiography with color Doppler assessment:

It will be done within 24 h after PPCI. Measurements will be as following:

1. Pulsed wave (PW) Doppler will be performed in the apical 4chamber view within a 3 mm sample volume at the tip of the mitral leaflets to obtain mitral inflow velocities to assess LV filling.
2. E (early diastolic)/A (late diastolic) - Using PW Doppler, the peak E and A velocities were recorded, then the ratio of E/A will be calculated.
3. IVRT (isovolumic relaxation time) - derived by placing the cursor of Continuous wave (CW) Doppler in the LV outflow tract to simultaneously display the end of aortic ejection and the onset of mitral inflow.
4. Deceleration time (DT) - from the peak of E wave to baseline.
5. E/e'- PW tissue Doppler imaging (TDI) was performed in the apical views to acquire mitral annular velocities. The sample volume will be positioned at or 1 cm within the mitral leaflet's septal and lateral insertion sites.
6. Left atrial volume and left atrial volume index (LAVI) - The maximal left atrial (LA) volume measured from the apical four-chamber view using the modified Simpson method in end-systole before mitral valve opening. The LAVI obtained for all patients by dividing the LA volume by the body surface area.

Biochemical measurements:

Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.

Follow up 2D Doppler echocardiography:

All previous echocardiographic measurements will be repeated at 40 days of the event.

Eligibility Criteria:
Inclusion Criteria:

* All patients of sample size admitted to the cardiology department of Assiut university hospital with:

  1. Acute typical chest pain
  2. Positive cardiac enzymes.
  3. ECG shows ST-segment elevation MI
  4. Documented occlusion of CA then treatment by PPCI

Exclusion Criteria:

* 1. Patients with well-known factors of left ventricular diastolic dysfunctions, including high blood pressure (over 140/90 mmHg), hypertrophic cardiomyopathy, left ventricular hypertrophy, bundle branch block, ventricular fibrillation, ventricular arrhythmia, severe valvular disease, complete heart block, and previous CABG.

  2. Patients with the end-stage renal disease usually have markedly increased galactin-3 levels 3. Prior use of thrombolytic agents 4. Refusal of PPCI due to social or religious concerns 5. ST elevation on ECG without obvious coronary artery diseases such as acute myocarditis, early repolarization, or Takotsubo cardiomyopathy 6. Atrial fibrillation at the time of echocardiography examination.
MEningioma Detection Using Non Contrast MRI TecHniquEs

Meningioma, an extra-axial brain tumor developed at the expense of meninges, accounts for 35% of central nervous system tumors, and its incidence is estimated at 3% in large autopsy series.

The current gold standard for screening and monitoring cerebral meningiomas is MRI with injection of gadoline-contrast product. However, the use of some of these products is problematic, due to gadolinium deposits observed in patients who have had several injections during their lifetime, especially in patients followed for multiple sclerosis.

Recently, the French National Agency for the Safety of Medicines and Health Products (ANSM) issued recommendations concerning the screening of meningiomas in patients at risk, particularly in people treated with cyproterone acetate. It is a synthetic progestogen steroid with anti-androgenic properties. It is used to treat hyperandrogenic syndromes in women or in the palliative treatment of prostate cancer in men. Its long-term use seems to be associated with a significant over-risk of developing meningiomas, brain tumours affecting meninges. This increased risk is multiplied by 7 in women exposed to high doses of cyproterone acetate, and by 20 over a cumulative dose of 60 grams, or about 5 years of treatment at 50 mg/day or 10 years at 25 mg/day. The ANSM recommends that a cerebral MRI be performed at the beginning of treatment for all patients, as well as a control MRI renewed at 5 years and then every 2 years if the MRI at 5 years is normal. These recommendations will lead to a large number of MRIs involving an injection of contrast agent in this population, with potential immediate or delayed serious adverse effects.

New techniques, such as Arterial Spin Labelling (ASL), or black blood sequences optimized for contrast detection, have been developed. These could detect meningeal anomalies and more particularly meningiomas without contrast injection, or with a significantly lower dose of contrast agent.

These techniques have not been specifically studied for screening or monitoring meningeal lesions, but it seems relevant and important to be able to validate protocols that reduce gadolinium doses given the high number of screening and follow-up MRIs in the general population.

Patients presenting for brain MRI for meningioma screening or follow-up will have the usual MRI sequences for their management, and the FABIR sequences without injection, added for research. These new sequences will add approximately 8 minutes of additional examination time.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient performing MRI as part of a screening or follow-up of known meningioma
* Express consent to participate in the study

Exclusion Criteria:

* Contraindication for MRI (electrical device, metallic foreign body, claustrophobia)
* Known hypersensitivity to the contrast medium (Gadolinium)
* Known renal failure: glomerular filtration rate \<30mL/min
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents

The purpose of this investigation is to test the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens), and to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.

Peer violence and depressive symptoms have mutual, reinforcing negative impacts on teens' emotional and behavioral regulation strategies.

The emergency department (ED) is the primary source of care for many high-risk teens. It provides an opportunity to initiate preventive interventions, to complement existing mental health treatment or to stand alone for those who may lack access to formal care. Personalized text-message interventions are accessible, feasible, and may be effective with these adolescents.

The purpose of this study is to expand on the PI's pilot randomized controlled trial (RCT) of iDOVE (K23 MH095866; PI: Ranney) by testing the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens). The investigators will use a 2x2 factorial design to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.

Participants will be identified in the course of usual clinical care in the ED. If eligible, parents will be consented and participants assented. Participants will complete a baseline assessment and will be randomized to one of four groups: Brief ED Intervention (BI) + Text; BI + No Text; No BI + Text; or No BI + No Text. Youth in the Text arm who show no signal of improvement at 7 days, per daily self-reported mood ratings, will be re-randomized to additional "LiveText" (once-weekly real-time micro-counseling via text) or to continue with standard, automated Text intervention curriculum.

At baseline and follow-ups at 2 months, 4 months, and 8 months, participants will complete assessments on depressive symptoms, violence, cognitive/behavioral skill-sets, and resource utilization.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* presenting to the emergency department for routine care
* reporting past-year physical violence (using a modified version of The Revised Conflict Tactics Scales (CTS-2) score ≥1), as identified on a brief screen administered in the ED
* reporting past 2-week mild-to-moderate depressive symptoms (using Patient Health Questionnaire (PHQ-9) score 5-19), as identified on a brief screen administered in the ED
* Accompanied by a parent/guardian who is present and able to consent
* Possession of a cell phone with text-messaging capability

Exclusion Criteria:

* Chief complaint of suicidality, psychosis, sexual assault, or child abuse
* In police or child protective services' custody (as per state law)
* Unable to assent
* In need of emergency psychiatric care
Perineural Dexmedetomidine and Femoral Nerve Block

The duration of sensory block after single dose of long acting local anesthetics is not sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our knowledge, the use of Dexmedetomidine as adjuvant to local anesthetic was not previously reported for femoral nerve block.


Eligibility Criteria:
Inclusion Criteria:

* all patients with ASA physical status I or II, scheduled for diagnostic knee arthroscopy

Exclusion Criteria:

* Patients who are refusing regional block, patients with diabetic peripheral neuropathy, renal or hepatic dysfunction, inflammation or infection at the puncture site, and history of allergic reaction to study medications
Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa.

The project serves to evaluate a new treatment method with outreach services as a supplement to family-based therapy in the treatment of children and adolescents with eating disorders.

The project is intended to help identify different family structures and which families will benefit most from the new outreach service of home-based treatment.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 12 -20 years.
* Successful registrations in the special consultation for eating disorders at the Clinic for Child and Adolescent Psychiatry and Psychotherapy (KJPP) of the Psychiatric University Hospital (PUK) Zurich.
* Diagnosis of anorexia nervosa or atypical anorexia nervosa (ICD-10 F50.00/ F50.01/ F50.1)
* Existing informed consent of patients\* (14 years and older) and parents or legal guardians (12-14 years).
* IQ over 75
* Resident in the canton of Zurich
* Good knowledge of German

Exclusion Criteria:

* No written consent
* Children under 12 years
* Other forms of eating disorders apart from anorexia nervosa or atypical anorexia nervosa.
Intraoperative Mechanical Ventilation and Postoperative Pulmonary Complications After On-pump Cardiac Surgery in High-risk Patients

Controversies remain concerning the best intraoperative mechanical ventilation regimen for major cardiac surgery. While the use of intra operative low tidal volumes is now standard practice, the optimal level of positive end-expiratory pressure (PEEP) and the use of recruitment maneuvers (RM) remain controversial. The aim of this study is to compare two regimens of intraoperative mechanical ventilation on postoperative outcomes in cardiac surgery patients at risk of postoperative pulmonary complications

In this randomized controlled trial, cardiac surgery patients at risk of postoperative pulmonary complications will be assigned to intraoperative ventilation with high PEEP and RM or intraoperative mechanical ventilation with low PEEP and without RM. The primary endpoint will be a composite endpoint including major postoperative complications within the first postoperative week and death within the 28 days after surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years-old,
* Evaluated before cardiopulmonary bypass for any cardiac surgical procedure (e.g. coronary artery bypass grafting, valve, aorta, or combined procedures),
* With a pulmonary risk score ≥ 2
* Who gave written informed consent
* affiliated to a social security system

Exclusion Criteria:

* BMI \> 40kg/m2 ;
* Left Ventricular Ejection Fraction \< 35% ;
* Preoperative shock ;
* Aortic surgery with planned circulatory arrest ;
* Minimally invasive cardiac surgery ;
* Emergency surgery with patient unable to give written informed consent
* Heart transplantation
* Mechanical circulatory support surgery
* Pregnant or lactating women
* Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty