cyrilzakka/clinical-trials huggingface dataset:
Analysis of Sex Hormones and Lipoproteins in Young Males

To analyze the relationship of sex hormones to lipoproteins in young males.

BACKGROUND:

The investigators conducted a secondary analysis of the Sex Hormones and Lipoproteins in Adolescent Males Study (HD/HL18281), a 3-year (1984-1987) study of lipids, blood pressure, weight, fat patterning, and sex steroid hormones (SSH) in adolescent males. A total of 664 black and white males, ages 10-15, were enrolled into a study designed as a series of repeated data collections over two years within age cohorts. Cross-sectional analyses were used to explain differences during adolescence in sex steroid hormones and sex steroid hormone-lipid relationships between black and white boys and between boys with and without a family history of coronary heart disease.. When the data were originally collected for this study, theoretical models of flexible longitudinal analytic techniques had been developed, but were not available for computer use. These techniques, now supported by software, allow a more powerful and complete analysis of these data.

DESIGN NARRATIVE:

The primary aim of these analyses was to explain the contribution of changes in sex steroid hormones and fat patterning to changes in plasma concentrations of high (HDL-C) and low (LDL-C) density lipoprotein cholesterol, triglycerides (TG), and apolipoproteins (apo) Al, All, and B occurring during puberty in males. Sex steroid hormones assayed included estradiol (E2) and free testosterone (T). The following hypotheses were tested: (1) increasing free T predicts/leads to decreases in HDL-C and increases in LDL-C, apo B, and the LDL-C/HDL-C ratio in adolescent males; (2) increasing E2 predicts decreases in apo B, LDL-C and the LDL-C/HDL- C ratio, but the resultant effects will vary with adiposity and fat patterning; (3) rapid weight gain predicts increased central adiposity, defined as the ratio of truncal skinfolds to total skinfolds, and with greater decreases in HDL-C and increases in triglycerides, apo B, LDL-C and the LDL- C/HDL-C ratio. Rapid weight gain predicts increased E2, but the atherogenic effects of increased central adiposity on lipids are greater than the anti- atherogenic effects of E2. These analyses provided a better understanding of metabolic factors underlying obesity-hormone-lipoprotein relationships.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.

The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven colorectal carcinoma
2. Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
3. T3 or deeper lesion without involvement of other organs
4. Without multiple lesion other than carcinoma in situ
5. Cancer classified as N0-2 and M0, according to the TNM classification system
6. Tumor size \< 8 cm
7. No bowel obstruction
8. Age 20 \< and \> 75 years
9. Sufficient organ function
10. No history of gastrointestinal surgery
11. No history of chemotherapy or radiotherapy
12. Provided written informed consent

Exclusion Criteria:

1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2. Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
3. Pregnant or lactating women
4. Severe mental disease
5. Continuous systemic steroid therapy
A Novel Formulation of Pasteurized Maple Cough Syrup Compared With Placebo on Nocturnal Cough and Sleep Quality in Infants With Upper Respiratory Infection

Cough is a frequent symptom in children and infants and is one of the most common reasons parents visit a healthcare provider for their child. The US Food and Drug Administration has issued a warning that over-the-counter cough and cold medicines including antihistamines, decongestants, anti-tussives, and expectorants should not be administered to children younger than 2 years of age due not only to lack of proven efficacy, but also because of important safety concerns. A product that has been used in alternative medicine for cough is maple syrup. Although no studies have formally evaluated the use of maple syrup for nocturnal cough associated with URI, the demulcent effect of maple syrup may provide some relief from cough in children. A novel formulation of pasteurized maple cough syrup, when compared to placebo, should provide superior relief on nocturnal cough and the sleep difficulty associated with URI in children under 12 months and sleep difficulty of their parent/caregiver.


Eligibility Criteria:
Inclusion Criteria

1. Otherwise healthy male or female infant who is between 0 and 12 months of age.
2. Presents to clinic with a URI characterized by the presence of rhinorrhea and cough for 7 or fewer days' duration.
3. Patient is an appropriate candidate, in the judgment of the investigator, to participate in the study.
4. Parents/caregivers provide an answer of at least "somewhat" (3 points on a 7-point Likert scale) for a minimum of 2 of the 3 questions related to nocturnal cough frequency, effect on child's sleep, and effect on parental/caregiver sleep based on the previous night's symptoms (see Section 11.0).
5. Parent/legal authorized representative provides written informed consent for child to participate in study.
6. Parent/caregiver who is willing and able to comply with study requirements.

Exclusion Criteria

1. Signs or symptoms of a more treatable disease (eg, asthma, pneumonia, laryngotrachebronchitis, sinusitis, allergic rhinitis).
2. Diagnosis of influenza, bronchiolitis or respiratory syncytial virus (RSV).
3. History of reactive airways disease, asthma, or chronic lung disease.
4. Use of any medication to treat cough within 6 hours of bedtime on the evening prior to or on the day of enrollment. (Use of analgesic medications such as acetaminophen or ibuprofen is not exclusionary.)
5. Presence of any significant disease including immunodeficiency, hepatic, renal, cardiovascular, or hematologic disease or any other health condition that, in the opinion of the investigator, would preclude participation in the study.
Effect of Retrograde Autologous Blood Priming on Pulmonary Mechanics in Pediatric Cardiac Surgery

The present study hypothesized that beyond its hemodynamic affects,retrograde autologus blood priming of cardiopulmonary bypass (RAP) has a positive impact on hemodynamics and pulmonary mechanics subjected to cardiac surgery.

This prospective randomized study analyzed the clinical records of 124 children subjected to cardiac surgery for congenital heart diseases with left to right shunt. They comprised 64 patients with RAP and 60 patients conventional cardiopulmonary bypass priming. The preoperative, intraoperative and postoperative data of the studied patients were reported.

Eligibility Criteria:
Inclusion Criteria:

* children complained of congenital heart disease with left to right shunt pressure or volume load

Exclusion Criteria:

* cyanotic heart disease
Comparative Study of Clinical Endpoint in DMD: Handheld Myometry (HHM) Versus CINRG Quantitative Measurement System (CQMS)

The aim of the proposed research is to compare two commonly used pediatric strength testing measures: handheld myometry (HHM) and CINRG Quantitative Measurement System (CQMS), with the goal of identifying a sensitive and valid tool for measuring muscle strength in children with DMD. The data obtained from this study will be used to make recommendations for strength measurement endpoints in prospective muscular dystrophy trials and provide more reliable and accurate recommendations in the clinic for strength assessment. This study will be performed at six participating sites in the Cooperative International Neuromuscular Research Group (CINRG).

We propose to compare the reliability of CQMS vs. HHM in the DMD population. The importance of this study is to be able to compare the results of clinical trials done by different networks using distinct strength endpoints. If results indicate a distinct difference in reliability of one tool over the other, a standardized tool could be established for research groups throughout the world to interpret strength in the context of clinical trials. If the results indicate minor differences then it would be possible to interpret and compare/contrast strength measurements used in different studies.

Understanding the relationship between the HHM vs CQMS will help us examine other surrogate measures capable of predicting functionality that are based on strength measurements.

Eligibility Criteria:
Participants should meet the following criteria:

1. Confirmed clinical and molecular diagnosis of DMD
2. 6- 18 years of age
3. Ability to follow 2 step instructions
4. Ability to transfer to and from the wheelchair-mat with moderate assistance defined as no greater than 75% assistance.
5. Signed informed consent of parental or legal guardian(s) is required for participants. Assent from children 7-18 years old may also required.

Exclusion Criteria:

Participants must confirm:

1. No Surgical procedures were performed ≤ 8 weeks before study procedures.
2. No musculoskeletal injuries were experienced ≤ 8 weeks before study procedures.
3. Investigator assessment that patient or parent/legal guardian are not willing or able to comply with study procedures.
Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

Chronic Subdural Hematomas (cSHD) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. Surgery is typically performed once neurological symptoms develop. Recent studies suggest that arteries nourished by the middle meningeal artery (MMA) may be responsible for hematoma progression and that MMA embolization is clinically useful. There is less evidence, that embolization of MMA also may be a treatment option for individuals without surgical treatment. The investigators propose a multicentre study to investigate both potentials: (1) Assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial (randomization arms; Arms 1 and 2), (2) Assessment of embolization-alone efficacy when surgery is contraindicated or refused (embolization-only arm, Arms 3 and 4).

Evidence to support the benefit of MMA embolization remains limited and the risk-benefit balance remains unclear. Case series have shown that recurrence rates with embolization are much lower, and that embolization is generally very safe. Risks associated with neurointerventional procedures will be directly discussed with patients or their caretakers as part of the conventional consenting procedure. Risks include access site hematoma, radiation exposure, vascular injury, brain ischemia, death (theoretic and extremely unlikely) and typical risks associated with general or local anaesthesia. The potential efficacy of MMA embolization as a treatment therefore requires higher level evidence in the form of randomized control trials.

The benefit of the embolization is a substantial reduction in recurrence of cSDH, which has been reported to be as high 1 in 3-4 patients. Recurrence of cSDH can lead to additional surgery and complications.

First objective: Evaluate the recurrence rates of cSDH after combined surgical and MMA embolization treatments (Arm 2) versus surgery alone (Arms 1).

Second objective: The second objective is to evaluate the stability and regression of cSDH after for all the Arms of the study at follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-100
* Consent possible
* cSDH located at the convexities
* Patients with symptomatic cSDH
* Patients with asymptomatic large chronic/subacute hematoma after 6 weeks of failed conservative treatment

Exclusion Criteria:

* Consent not possible
* Pregnancy
* Prisoner
* Angiography contraindication
* Patient for whom follow-up is problematic (e.g. distant residency, homeless ...)
* Previous surgery for cSDH
Vitamin D3, Folic Acid and Fexofenadine in Healthy Volunteers

The study is conducted to assess the effect of a vitamin D3 supplementation on the activities of two intestinal transporters and on the pharmacokinetics of the transporter substrates folic acid and fexofenadine.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

1. male or female
2. age 18 to 65 years at study entry
3. signed informed consent form
4. Body Mass Index \> 18 - \< 30 kg/m2
5. Participants must not have any other diseases (as assessed by the screening examination)
6. Participants must not take any concomitant medications except oral contraceptives in females
7. Normal blood count

Exclusion criteria:

1. Subjects with confirmed or suspected hypersensitivity towards the study medications
2. Contemporaneous participation in any other study
3. Females only: pregnancy
4. Females only: breast-feeding
5. Clinically significant abnormal laboratory findings
6. Known or suspected present or past malignancies of any kind
7. Known or suspected active infections, serious infections in the preceding 3 months
8. Positive hepatitis B, hepatitis C and / or HIV 1/2 serology
9. Subjects known or suspected not to comply with the study regulations
10. Subjects employed at the participating departments of the University Hospital Zürich.
11. Known or suspected present or past diseases which may interfere with the study
12. smokers
13. alcohol or drug abuse
Efavirenz in Treating Patients With Metastatic Prostate Cancer

RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with metastatic prostate cancer.

OBJECTIVES:

Primary

* To assess the effect of efavirenz on the PSA non-progression rate at 3 months in patients with castration-refractory metastatic prostate cancer.

Secondary

* To assess the effect of efavirenz on the PSA non-progression rate at 6 months.
* To assess the effect of efavirenz on overall survival.
* To assess the effect of efavirenz on PSA progression-free survival..
* To assess the tolerability and safety profile of efavirenz.

OUTLINE: This is a multicenter study.

Patients receive oral efavirenz once daily in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed prostate cancer

  * Metastatic disease
  * Castration-refractory disease
* No clinical symptoms related to disease progression

PATIENT CHARACTERISTICS:

* WHO performance status 0-2

PRIOR CONCURRENT THERAPY:

* Not specified
Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH

The purpose of this study is to evaluate the effectiveness of a modified natural cycle in patients with previous poor response to infertility drugs and high basal FSH, prior to proceeding to oocyte donation or abandoning fertility treatment.

Poor responders are a diverse group of IVF patients who fail to respond to IVF drugs. In these patients pregnancy rates remain disappointingly low and usually oocyte donation is their only viable option. The need for lengthy ovarian stimulation regimes can be avoided by performing IVF during a natural menstrual cycle. However, the main problem with a natural cycle is that successful IVF outcome can be compromised by a premature LH surge. This problem can be solved by the administration of GnRH antagonists that suppress endogenous gonadotropin levels, comprising a modified natural cycle (MNC). Previous studies have shown that MNC offers no realistic chances of pregnancy prior to oocyte donation. In this study we will re-assess this view by showing that MNC offers some, albeit small, chances of positive IVF outcome in patients with known previous poor response prior to oocyte donation.

Eligibility Criteria:
Inclusion Criteria:

* Regular menstrual cycle (21-35 days)
* Basal FSH\>12 IU/ml
* One or more failed IVF attempts (\<3 oocyte retrieved)

Exclusion Criteria:

* PCOS
* Normal responders
A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral total hip arthroplasty

Exclusion Criteria:

* Subjects with risks of hemorrhage
* Subjects with thromboembolic risks
* Subjects who weigh less than 40 kg
* Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
Bridging the Gap to Adult Diabetes Care

Adolescents with type 1 diabetes face particular challenges related to having a chronic illness that requires daily intensive self-management and medical follow-up during a period when their social, developmental, educational, and family situations are in flux. When transitioning from pediatric to adult care, over a third of youth have a care gap of \>6 months. During this vulnerable period youth are at risk for acute life-threatening complications such as diabetic ketoacidosis, and for poor glycemic control, which confers an increased risk of chronic diabetes complications. Gaps in care may be a result of deficiencies in transition processes causing some young people to be poorly prepared for adult care and dissatisfied with the transition process. Ineffective transition can lead to decreased frequency of diabetes visits and an increased risk of adverse events in young adulthood. Further, risk factors such as psychiatric comorbidity and behavioural problems in adolescents with type 1 diabetes are associated with poor outcomes in early adulthood. Quality improvement initiatives can be designed to optimize care processes such as referral systems to adult diabetes providers.

Our overall objective is to optimize care and outcomes for youth with diabetes as they transition to adult care.

Specific Aim 1: To improve glycemic control in youth around the time of transition from pediatric to adult diabetes care Specific Aim 2: To evaluate the fidelity and quality of a quality improvement intervention designed to improve transition care processes and to identify contextual factors associated with variation in outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All youth with a clinical diagnosis of type 1 diabetes followed at participating centres at the time of their final pediatric clinic visit between Jan 1, 2018 and Dec 31, 2020.
* Participants will be transitioning to Adult Care (ages \~16-19 yrs).
* Capacity to read and understand English (we estimate that \>95% of participants will fulfill this requirement).
* Capacity to consent for themselves.

Exclusion Criteria:

* Individuals with non-type 1 diabetes.
* Individuals with type 1 diabetes who move out of Ontario within 12 months after their final pediatric visit.
* Individuals with type 1 diabetes who do not have the capacity to consent for themselves.
Selective Ultrasound Screening for DDH 1991-2006

Early treatment is considered essential for developmental dysplasia of the hip (DDH), but the choice of screening strategy is debated. The investigators evaluated the effect of a selective ultrasound (US) screening programme.

All infants born in a defined region during 1991-2006 with increased risk of DDH, i.e. clinical hip instability, breech presentation, congenital foot deformities or a family history of DDH, were subjected to US screening at age one to three days. Severe sonographic dysplasia and/or dislocatable/dislocated hips were treated with abduction splints. Mild dysplasia and/or pathological instability, i.e. not dislocatable/dislocated hips were followed clinically and sonographically until spontaneous resolution, or until treatment became necessary. The minimum observation period was 5,5 years.

Of 81564 newborns, 11539 (14,1%) were identified as at risk, of which 11190 (58% girls) were included for further analyses. Of the 81564 infants, 2433 (3•0%) received early treatment; 1882 (2,3%) from birth and 551 (0,7%) after six weeks or more of clinical and sonographic surveillance. Another 2700 (3,3%) normalised spontaneously after watchful waiting from birth. Twenty-six infants (0,32 per 1000, 92% girls, two from the risk group) presented with late subluxated/dislocated hips (after one month of age). Another 126 (1,5 per 1000, 83% girls, one from the risk group) were treated after isolated late residual dysplasia. Thirty-one children (0,38 per 1000) had surgical treatment before age five years. Avascular necrosis was diagnosed in seven of all children treated (0.27%), four after early and three after late treatment.

Interpretation The first 16 years of a standardised selective US screening programme for DDH resulted in acceptable rates of early treatment and US follow-ups, and low rates of late subluxated/dislocated hips compared to similar studies.

Eligibility Criteria:
Inclusion Criteria:

* born at Haukeland University hospital January 1991-December 2006

Exclusion Criteria:

* Children with DDH due to neuromuscular syndromes were excluded.
Zometa Study in Pediatric Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for one fourth of all childhood cancers \& 74 % of childhood leukemia. Based upon drug registry data, children prescribed more than three courses of systemic glucocorticoids yearly faced a 20% increase in age-adjusted fracture rates. Rapid recovery occurred once glucocorticoids were discontinued, and fracture rates returned to expected for age by 1 year after treatment (Journal Of Clinical Endocrinology \& Metabolism 2009). The investigators will study the role of bisphosphonates in the prevention of secondary osteoporosis in children \& adolescents treated for ALL in the Children's Cancer Hospital -Egypt.


Eligibility Criteria:
Inclusion Criteria:

* Age above 5 \& below 18 years at the time of diagnosis.
* Newly diagnosed ALL patients.
* Not previously treated, previous steroid intake not more than 72 hours.
* Treated according to St Judy study XV protocol.

Exclusion Criteria:

* Previous steroid intake more than 72 hours.
* Less than 5 years