cyrilzakka/clinical-trials huggingface dataset:
The Families and Middle School Success Project

The purpose of the proposed research is to conduct an efficacy trial of the Family Check-Up (FCU) Online to prevent emotional and behavioral disorders among middle-school students at-risk for disability during the transition back to school after the COVID-19 pandemic. Mental health and behavior problems are at epidemic proportions as a result of the COVID-19 pandemic, with the highest rates in adolescents and children with disabilities. We propose to evaluate the efficacy of the FCU Online, a school-based, ecological approach to family intervention and risk reduction, across a group of students at-risk or identified with disability during the middle school years. The FCU Online for middle school youth has been evaluated in a randomized trial in prior research during the development of the program but has never been tested as a large-scale, school-based intervention or delivered by providers working in schools. It has recently been adapted for COVID-19 and includes new modules on coping with stress and home-to-school engagement to support the return to school after COVID-19 for students at-risk. Students in schools will be identified for services using indicators that are natural to the school environment (attendance, office discipline referrals, and grades), and will be followed for 2 years. We predict that engagement in the FCU Online will be associated with student reductions in emotional and behavior problems, improvements in academic skills, and improvements in attendance. Parenting skills such as home-to-school communication, positive parenting, and behavioral routines will be tested as mediators of intervention efficacy.


Eligibility Criteria:
Inclusion Criteria:

* A caregiver must have a child between the ages of 11 and 14
* The child must be a middle school student enrolled at a participating middle school including: Alder Creek Middle School in Milwaukee, Oregon, or Wilbur Rowe Middle School in Milwaukee, Oregon
* The caregiver must be the parent or legal guardian of the participating youth
* The caregiver must have a smartphone with text messaging capability and access to email
* The student must have one or more of the following risk factors: 1) two or more office discipline referrals; 2) grades below a 2.5 GPA; 3) poor attendance, i.e., missing more than 10% of school days; 4) IEP for emotional disturbance or related disabilities; or 5) concerns about the child on the behavioral and mental health screener (as indicated by a score of 3 on any one item, or a score of 2 or higher on at least two items).

Exclusion Criteria:

* The caregiver is unable to read in either English or Spanish
* The child is unable to complete the survey without parent's help
* The family is already participating in another study of the University of Oregon's Prevention Science Institute
Osteogenesis and Dental Eruption Through Electrical Stimuli

The closure of the alveolar cleft as part of cleft lip and palate deformities is a procedure that, to this date, still demands great efforts from plastic surgeons. The feasibility of periosteoplasty for reconstruction of the alveolar arcade as well as the use of electrical stimulation in order to increase osteoneogenesis have been proven in the past. The present study attempts to combine both procedures that have only been reported separately worldwide. The objective of this study is to increase the osteogenic capacity and hence, dental eruption.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral cleft lip and palate deformities and alveolar defects

Exclusion Criteria:

* Patients without alveolar cleft
* Patients with syndromes that did not require periosteoplastic procedures as well as patients with systemic illnesses that may affect the result of the study (for instance diabetes)
Biological Variation of Cardiac Biomarkers in Aortic Valve Stenosis

Calcified aortic valve stenosis (CAVS) is a progressive disease and nowadays, the cornerstone in diagnostics and follow-up is echocardiography. Cardiac biomarkers (such as cardiac troponins T and I and NT-pro-BNP) hold promise to fulfil a role in early recognition of complications concerning the aortic valve and decompensation. For this purpose, it is important to assess the normal biological variation (BV) of cardiac biomarkers in CAVS. The assessment of biological variation will contribute to a better understanding of fluctuation of cardiac biomarkers in subjects with stable CAVS. These data will improve monitoring of CAVS using cardiac biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable moderate aortic valve stenosis
* No evidence of acute cardiovascular disease

Exclusion Criteria:

* Acute myocardial infarction in the last six months
* Pulmonary embolism in the last six months
* Hospitalisation for heart failure in the last six months
* Chronic kidney disease
Insulin-free Cow Milk Formula in Prevention of Type 1 Diabetes Associated Autoimmunity - FINDIA Pilot Study

The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion Criteria:

* Pre-term, maternal diabetes with insulin treatment
The Effect of Mother-Infant Contact Barrier on Maternal Sadness and Adaptation

This study was conducted to investigate the effect of mother-infant contact deprivation on maternal sadness and maternal adaptation. The research is a randomized controlled experimental study. The intervention group consisted of mothers who had vaginal births or cesarean deliveries with epidural/spinal anesthesia (n: 198), while the control group included mothers who had cesarean deliveries under general anesthesia (n: 99). In the intervention group, mother-infant skin-to-skin contact was ensured within the first 10 minutes after birth. No intervention was made with the mothers in the control group. Both groups were assessed within the first 48 hours postpartum using the Mother-Infant Contact Barrier Scale, and on the 14th day postpartum, the Postpartum Self-Evaluation Scale and the Postpartum Maternal Sadness Evaluation Scale were administered to compare the results.

This study was conducted to investigate the effect of mother-infant contact deprivation on maternal sadness and maternal adaptation. The research is a randomized controlled experimental study. The intervention group consisted of mothers who had vaginal births or cesarean deliveries with epidural/spinal anesthesia (n: 198), while the control group included mothers who had cesarean deliveries under general anesthesia (n: 99). In the intervention group, mother-infant skin-to-skin contact was ensured within the first 10 minutes after birth. No intervention was made with the mothers in the control group. Both groups were assessed within the first 48 hours postpartum using the Mother-Infant Contact Barrier Scale, and on the 14th day postpartum, the Postpartum Self-Evaluation Scale and the Postpartum Maternal Sadness Evaluation Scale were administered to compare the results.

Eligibility Criteria:
Inclusion Criteria:

Had given birth at Mardin Training and Research Hospital

* No physical and/or mental health issues
* No infectious diseases transmitted through contact
* Agreed to participate in the study
* Able to speak Turkish and/or does not have communication issues
* Single live birth with the baby
* Mothers who gave birth vaginally or via spinal anesthesia and had skin-to-skin contact with their baby within the first 5 minutes postpartum

Exclusion Criteria:

Foreign nationals, immigrants, or those with communication issues

* Individuals with any physical and/or mental health problems
* Those with infectious diseases transmitted through contact
* Individuals who did not agree to participate in the study
* Mothers whose baby was stillborn (ex) after birth
* Mothers whose babies were receiving treatment in the intensive care unit
* Those who do not wish to provide a phone number
* Women who gave birth vaginally or via spinal anesthesia and do not wish to establish contact with their baby
* Mothers who gave birth to twins or more babies
Music Intervention for Preterm Birth

This study will test a music intervention (MI) versus a sham control (SC) arm which only includes a verbal intervention, to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women, reduce preterm birth, and improve infant outcomes.

Preterm birth occurs at unacceptably high rates in the United States, with Black women disproportionately affected. A long-recognized risk factor for preterm birth in this population is the relentless exposure to intersectional stress related to racial and sexual discrimination, poverty, and neighborhood disadvantage that Black women often experience from an early age. In this interdisciplinary study, the investigators bring together experts in preterm birth, music therapy, and metabolomics to address this health disparity by testing the efficacy of a live, culturally based music intervention to reduce the production of metabolites and metabolic pathways associated with chronic stress and thereby improve birth outcomes.

Eligibility Criteria:
Inclusion Criteria

* Aged 18 to 40 years
* Generally healthy pregnant women in the first trimester of pregnancy

Exclusion Criteria:

* Non-pregnant women
* Women with a chronic medical condition that could impact pregnancy health or duration
* Women regularly taking any medications other than prenatal vitamins
Memantine for the Treatment of Cognitive Dysfunction and Negative Symptoms in Patients With Chronic Schizophrenia

The purpose of this study is to evaluate the efficacy and safety of 24 weeks memantine add-on treatment to risperidone for the treatment of negative symptomatology and cognitive impairment in patients with chronic schizophrenia.

This study examines the efficacy and safety of 24 weeks memantine add-on treatment to risperidone for the treatment of negative symptomatology and cognitive impairment in patients with chronic schizophrenia. The trail was double-blind, prospective, randomized, placebo-controlled, parallel-group and consisting of a 'placebo-run-in' period, treatment, and follow-up periods. Study personnel and participants were blinded to group assignment. In the 'run-in' period, patients received Lorazepam for the treatment of anxiety and tension states for two weeks before starting antipsychotic therapy. After the 'run-in' period treatment, patients began receiving antipsychotic therapy with Risperidon with continuous concomitant administration of a 24 weeks Memantine, 20 mg/d, or placebo. Adherence was assessed at each clinic visit by pill count. In cases of anxiety and tension states, an experienced psychiatrist decided whether patients should receive Lorazepam, 5 mg/d, as rescue medication in addition to the study medication (Memantine or placebo), to which the patients remained blinded. In cases of pseudo parkinsonism patients were allowed to receive Biperiden, up to 8 mg/d, and for the treatment of patients suffering from sleep disorders Zopiclon (15 mg/d) was allowed. The consumption of alcohol and drugs were not allowed during the trial. In both study parts, psychiatric assessments were performed at baseline as well as after 2; 4; 6; 12 and 24 weeks after treatment (that is, during the follow-up period). The neuropsychological examination was performed at baseline, and after 6 and 24 weeks. Psychiatric changes, adverse events, laboratory values, dose adjustments of the antipsychotic therapy, and possible pharmacologic adverse effects were systematically monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia (DSM-IV)
* Age 18 to 40
* Stable negative syndrome (PANSS negative score \> 20)
* At least one previous schizophrenic episode
* Informed consent
* Subjects must be considered by the investigator to be compliant with investigations and appointments
* Subjects must have an educational level and a degree of understanding such that they can meaningfully communicate with the investigator

Exclusion Criteria:

* Axis I disorder other than schizophrenia within 12 months, e.g. schizoaffective disorder
* Severe positive symptomatology (PANNS positive score \> PANNS negative score)
* Dependency on alcohol or addictive drugs within 6 months of the baseline evaluation
* Contraindication of risperidone
* Significant neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests
Epidemiology of Gallbladder Sludge and Stones in Pregnancy

The specific objective of this project is to study the impact exercise has on gallstone formation during pregnancy when women are at increased risk due to biochemical and physiological alterations.

The female gender and multiparity are the two most important positive correlates of cholesterol gallstone disease. Pregnancy represents the period of time when the 'lithogenic' pressure on a woman is the highest. Biliary sludge is a precursor stage of gallstones. The investigators studied the etiological factors associated with the development of sludge and stones during pregnancy, and their early results suggest that it is inversely related to physical activity. They also found that being overweight, a known risk factor for gallstone disease, is associated with high blood leptin levels. In addition, the risk associated with high leptin levels is partially mitigated by physical activity.

In order to disentangle the effects of physical activity, leptin and gestational diabetes on gallbladder disease risk, and to understand the mechanisms behind the observed associations, the investigators propose to conduct a randomized controlled trial. This interventional study is a logical extension of their previous observational investigation. Their specific aims are:

* To evaluate whether an endurance exercise program is associated with lower risk of gallbladder disease in overweight pregnant women;
* To evaluate whether an endurance exercise intervention program changes leptin levels in pregnancy among overweight women;
* To examine the associations between gallbladder disease incidence and potential causal variables in this prospective trial. These variables include leptin levels, HDL, insulin levels, BMI (as it varies within women classified as overweight), as well as changes in these variables.

Gallstone disease affects 15-20% of adult Americans. Cholecystectomy is one of the most commonly performed operations. The morbidity, and the burden of cost, incurred by gallstones are staggering. Yet there is a dearth of understanding in the epidemiology and the cause of this disease. The results of this investigation should generate new, important and useful insights into the pathogenesis, and provide a rational strategy for the prevention, of this common and costly disease.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Over 18 years of age
* Eligible for care at Madigan Army Medical Center

Exclusion Criteria:

* Prior gallbladder surgery
* Non-English speaking
* Medical reason not to exercise during pregnancy
* Moving from area within 3 months
Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome

The objective of this study is to evaluate the efficacy of noninvasive ventilation with helmet in reducing endotracheal intubation rates in comparison with Noninvasive Ventilation (NIV) facemask among patients with Acute Respiratory Distress Syndrome (ARDS)


Eligibility Criteria:
Inclusion Criteria:

* Patients with (Acute Respiratory Distress Syndrome) ARDS as per Berlin definition
* Age: 18 and more

Exclusion Criteria:

* Patients with altered sensorium \[Glasgow Coma Scale (GCS) less than 13\]
* Pregnancy
* Hemodynamic instability
* Morbidly obese
* Patients with tracheostomy
* Severe acidosis \[PH less than 7.15\]
* Patients with glaucoma
* Patients with history of vertigo
Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors.

The objective of this trial is to determine whether the use of letrozole during the luteal phase in oocyte donors diminishes the ovarian volume, as well as to evaluate its effect on the duration of the luteal phase, taking into account hormonal and biochemical markers.

Two groups will be established with random allocation of patients and 1:1 proportionality, as follows:

* Control group: No specific treatment.
* Study group: Oral administration of letrozole 5 mg (each capsule is 2.5 mg) once a day for 5 days starting on the night of the follicular puncture.

Letrozole is a widely used drug in the context of hormone-dependent malignant tumors due to its antiestrogenic effect. Its mechanism of action allows its application to the field of Assisted Reproductive Medicine, mainly as an inductor of ovulation, by means of a blockage in the negative feedback signalization of the hypothalamus-pituitary-gonadal axis. In the last years, it has also been tested with the goals of preventing ovarian hyperstimulation syndrome (OHSS) or analyzing its effects on several endocrinological and biochemical markers such as LH, progesterone or VEGF. However, the results are inconsistent on every account. Data regarding the effect on ovarian size and the duration of the luteal phase following the administration of letrozole after the oocyte pick-up can be useful to evaluate the benefit of this drug in patients with a tendency towards hyperresponse, in which both the discomfort after the stimulation and the risk of ovarian torsion are increased.

The objective of this trial is to determine whether the use of letrozole during the luteal phase in oocyte donors diminishes the ovarian volume, as well as to evaluate its effect on the duration of the luteal phase, taking into account hormonal and biochemical markers

Eligibility Criteria:
Inclusion Criteria:

* Hyper-responsiveness to stimulation, defined as the presence of ≥18 follicles of size ≥11 mm (22-24) on the day of the last ultrasound visit prior to ovarian puncture.

Exclusion Criteria:

* Participation in another clinical study, prior to inclusion in the present study, that could affect the objectives of this study.
* Known allergy to letrozole.
* Known lactose intolerance.
Preoperative Pain Control in Gastric Bypass Surgery Patients

Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly obese patients undergoing laparoscopic gastric bypass surgery.

Pregabalin is a popular adjunct for relieving neuropathic pain in diabetics. There have been multiple studies evaluating its use in pre and post-operative pain control in various surgeries. Post-operative pain control is a challenging problem in bariatric patients due to the high doses of narcotic required, related to the high body mass, and the danger of concomitant respiratory depression. In the obese patient, the goal of postoperative pain management is provision of comfort, early mobilization and improved respiratory function, without causing inadequate pain control, respiratory compromise or increased nausea.

Methods: A Randomized Controlled Trial, whereby patients undergoing Laparoscopic Roux-en-Y gastric bypass will be administered a single pre-operative dose of Pregabalin or a placebo. We plan to follow their immediate post-operative course in the hospital, with regard to the following primary endpoints:

* Post-operative analgesic requirements
* Post-operative pain scale (rated 0-10)
* Episodes of vomiting
* Post-operative antiemetic requirement
* Length of stay

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery.

Exclusion Criteria:

-
Epidemiology of Speed Skating-related Injuries

Speed skating is a sport in which there´s a lack of epidemiological studies. In line with the well-established model of sports injury prevention research proffered by van Mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden. Through an online survey filled by semiprofessional athletes, it is posible to obtain all this important information. This way, it will be possible to fulfill a gap in the literature and take action in the near future in order to reduce the prevalence of injuries in this sport.

A retrospective study will be performed in speed skaters. 100 speed skaters will be recruited. Data of all injury along a whole season will be collected. Patients' information, including age, number of years playing, skill level and injured body part, will be analysed

Eligibility Criteria:
Inclusion Criteria:

* Being a speed skater and having competed in the 2018 spanish national championship

Exclusion Criteria:

* Being unable to understand the questionaire, do not accept on participating in the study.
A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer

The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old.
* Advanced cancer potentially sensitive to single agent docetaxel; ie.. locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment.
* ECOG performance status of 0-2 and Karnofsky Score of 100-70.

Exclusion Criteria:

* Patients who have more effective therapy available than single agent docetaxel for the malignancy.
* Pregnancy or lactation.
* Intolerance to any antineoplastic agents belonging to the taxoid family.
* Hypersensitivity to drugs formulated with polysorbate 80.
* Active infection.
* Prior anticancer therapy within 30 days prior to the first day of study treatment.
* Participation in another experimental drug study within 30 days prior to the first day of study treatment.