cyrilzakka/clinical-trials huggingface dataset:
Early Family-Centered Prevention of Drug Use Risk (Aka Early Steps)

The investigators are testing the efficacy of a family-based preventive intervention, which began when the children were age 2, with children at risk for developing significant conduct problems. Families who were originally recruited from Women, Infants and Children (WIC) were randomly assigned to a family-centered intervention developed by Dishion and colleagues (Dishion \& Kavanagh, 2003; Dishion \& Stormshak, 2006) referred to as an 'ecological approach to family intervention and treatment' (EcoFIT). The current study expands the Early Steps intervention into the elementary school years beyond what is currently available for a WIC service delivery venue, in which children are no longer eligible for services at age 6.

The investigators are testing the hypothesis that periodic, tailored, and adaptive interventions delivered to caregivers at school entry will (a) reduce the probability of elevated risk associated with early-onset problem behavior, including the eventual use of drugs and other health-risking behaviors; (b) reduce the likelihood of mental health problems such as childhood depression, anxiety, conduct problems and co-morbidity; and (c) promote children's development of self-regulation, which underlies school readiness, early school literacy academic achievement, and positive peer relations.

Aims of the current project are:

1. Refine the intervention model to address the child's adaptation to school and development of self-regulatory skills and underlying multiple dimensions of school success.
2. Examine and test the consistency of developmental models of problem behavior, emotional adjustment, and normative self-regulation in childhood.
3. Evaluate the long-term impact of intervention on risk pathways to later drug abuse and health-risking behaviors by examining early risk markers, including children's problem behavior, poor emotional adjustment, and lack of school readiness.

Eligibility Criteria:
Original Inclusion Criteria:

* Parents with children between ages two and three
* Currently enrolled with Women, Infants, and Children (WIC)
* To qualify for the original study, families needed to meet criteria for child, family, and sociodemographic risk. Specifically, families either had to meet "child risk" factors or they had to have at least two of the three factors present to qualify for the study. To meet criterion for child risk, scores must be at least one SD above the normative average on the Eyberg Intensity of Problems factors, the Bates difficulty (i.e. negative emotionality) factor, or the conflict factor of the Adult-Child Relationship Scale. Family risk was determined by a score of one SD above the normative average on maternal depressive symptoms or parenting daily hassles, having substance use/abuse problems, or teen parent status. Sociodemographic risk was established using educational attainment because all WIC participants met criteria for low income. Families in which educational attainment is less than three years of college for both parents satisfied the requirement of sociodemographic risk.
Relation of Helicobacter Pylori in Prediabetic Patients

The primary objective of this study is to : find the relation between H.pylori infection and pre-diabetic patients with lipid profile

. Specifically, the study aims to:

1. affect of H.pylori infection in pre-diabetic patients
2. realation between Pre-diabetic patient and lipid profile
3. Risk factor of H.pylori infection in pre-diabetic patients D)HbA1C test measures your average blood sugar level over the past 2 or 3 months.

e)Fasting Blood Sugar Test. f) the IgG antibody of h.pylori.

Pre-diabetic state is aphase of impaired glucose tolerance 2 hours Postprandial Glucose (PG) in 75 g oral glucose tolerance test 140 mg/dL-199 mg/dL and/or impaired fasting glucose 100 mg/dL-125 mg/dL and/or HbA1c 5.7-6.4% \[5\]. Pre-diabetes is pathophysiologically similar to Type II Diabetes with basic defect being insulin resistance and early beta cell failure. The amplitude of large pulses and the rapid oscillations of insulin secretion are lost in pre-diabetes. In pre-diabetes, the glycaemic excursions are usually lower than normaland there is a delay and prolongation in the second phase of insulin secretion \[6\]. Recent studies have shown that colonisation with H.pylori is associated with increased development of diabetes mellitus \[7-11\]. A step towards identifying treatable causes of diabetes mellitus will aid the medical health system in developing new strategies in preventing the progression of pre-diabetes to overt diabetes mellitus .Dyslipidemia is a complex disease and a major risk factor foradverse cardiovascular events \[12\]. High levels of Low Density Lipoproteins (LDL) and low levels of High Density Lipoprotein (HDL) are associated with increased incidence of stoke and myocardial infarction \[13\]. dyslipidemia also plays a major role in macrovascular complications of Diabetes \[14\]. There is increasing evidence for the role of H.pylori infection in the initiation, development or persistence of atherosclerosis and coronary heart disease \[15,16\]. Therefore, exploring the role of treatable causes of dyslipidemia like H.pylorimay help in preventing the progression of dyslipidemia and its adverse effects.The present study aimed to assess the possible role of H.pylori infection on diabetic profile and lipid profile in pre-diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis ofPre-diabetic patients, age 30-60 years of either gender with fasting glucose 100 mg/dL-125 mg/dL and/or HbA1c 5.7-6.4%

Exclusion Criteria:

* insulin dependent diabetes
* hyperlipidemia
8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension

The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy).
* Patients with an office BP ≥ 140/90 mmHg and \< 180/110mmHg at the randomization visit and the preceding visit
* Patients must have an absolute difference of ≤ 10 mmHg in both their msSBP and their msDBP between the randomization visit and the preceding visit

Exclusion Criteria:

* Malignant hypertension or severe hypertension (grade 3 of WHO classification; msSBP ≥180 mmHg or msDBP ≥110 mmHg)
* History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease (PKD).
* Type 1 or Type 2 diabetes mellitus with a fasting glycosylated hemoglobin (HbA1c) \> 8%
* Evidence of renal impairment as determined by one of the following: serum creatinine \>1.5 x ULN or eGFR \< 30 ml/min/1.73m2 at Visit 1, a history of dialysis, or a history of nephrotic syndrome

Other protocol-defined inclusion/exclusion criteria may apply.

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A Better Choice for Patients Undergoing Endovascular Coil Embolization

The investigators designed a double-blind, randomized placebo-controlled study to determine the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.


Eligibility Criteria:
Inclusion Criteria:18-65 years old ASA I or ASA II patients undergoing ECE treatment for intracranial aneurysms were included.

Exclusion Criteria:Patients were excluded based on the following parameters: older than 65 yrs, a history of mental illness, recent use of sedatives or analgesics and with sensation.
Clinical-pathological Evaluation of Pit-NETs

Pituitary adenomas, namely pituitary neuroendocrine tumors (PitNETs), are recognized as rare neoplasia by national and international institutions.

Albeit most PitNETs are slow-growing with an indolent behavior, about one-third do not achieve biochemical control, recur, re-grow, and resist conventional treatments.

The predictors of aggressive behavior have not been identified for PitNETs. In 2013 Trouillas and coworkers developed a five tiered clinicopathological score by mixing histopathological data and clinico-radiological evidence of invasion. This system proved of prognostic value. Nonetheless, unlike for NET of gut and lung, no formal grading and/or staging tools were developed. In addition, PitNETs have not been thoroughly investigated by radiomics to predict clinical behavior, nor have druggable pathways been elucidated in PitNET cells to unveil new potential therapeutic approaches.

The first aim of this project is to define grading and staging tools for PitNETs based on: i) lineage-specific transcription factors ; ii) cell type specification by hormone production (prolactin, TSH, LH, FSH, ACTH, GH or none); iii) integration of standard radiological measures with recognized tools for clinical and pathological staging.

The second aim of this project is to investigate radiomics features as predictors of PitNETs behavior, prognosis, and treatment outcome.

The third aim of this project is to investigate whether the expression of molecular biomarkers \[Vascular Endothelial Growth Factor (VEGF), Epithelial Growth Factor Receptor (EGFR), somatostatin receptors 1-5 (SSTRs), Fibroblast Growth Factor (FGF), mTOR (mammalian target of rapamycin), Programmed cells Death 1 (PD1) and its ligands (PD-L1), and Cytotoxic T Lymphocyte Associated protein 4 (CTLA4)\] may impact on patients prognosis. Identifying new molecular pathways may help fine-tune and schedule the emerging targeted therapies for aggressive PitNETs, including mTOR inhibitors, VEGF, EGFR, and immune check-point inhibitors.

This study will investigate a large multicenter retrospective series of 740 PitNET patients and a prospective cohort of 200 patients to reach these objectives.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients older than 18 years;
* availability of tumor samples for the required pathology analyses;
* clinico-radiological follow-up of at least 5-10 years

Exclusion Criteria:

- Not applicable for this study
Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation

The aim is to investigate impact of exogenous estrogens on cotisol Levels during synacthen stimulation in female hypogonal patients on estrogen substitution. Both patients with and withour adrenal insufficiency will be studied

The aim is to investigate impact of exogenous estrogens on cotisol levels during synacthen stimulation in female hypogonal patients on estrogen substitution. Both patients with and without adrenal insufficiency will be studied . All patients (inclusion criteria age 18-50 years, BMI \<35) will be followed for 6 months and have 3 synacthentests performed: One on transdermal estrogen (minimum 3 months), one on oral estrogens (min 3 months) and one without estrogen substitution for at least 3 months. Primary endpoint is change in serum cortisol 30 minutes after synacthen stimulation

Eligibility Criteria:
Inclusion Criteria:

* Hypogonadism
* Treatment with estrogen substitution

Exclusion Criteria:

* Other formulations of glucocorticoid than oral hydrocortisone
* Pregnancy
* BMI \> 35
A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety

The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults

The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

Eligibility Criteria:
Inclusion Criteria:

* Obese adults with a body mass index \> or = 30 kg/m2; \> or = to 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia

Exclusion Criteria:

* Pregnancy
* Diabetes
* Adults with serious or unstable current or past medical conditions
Levosimendan Versus Dobutamine for Renal Function in Heart Failure

Although inotropes have a favorable effect on central hemodynamics in patients with heart failure, their effect on renal hemodynamics is incompletely defined. The purpose of this study is to evaluate the efficacy of a 75 min intravenous infusion of levosimendan compared to a 75 min infusion of dobutamine on renal hemodynamics and function in patients with chronic heart failure and signs of cardiorenal syndrome. The investigators hypothesis is that patients treated with levosimendan will show greater increases in renal blood flow and glomerular filtration rate (GFR) than those treated with dobutamine.


Eligibility Criteria:
Inclusion Criteria:

* Written, signed and dated informed consent
* Male and Female subjects ≥18 years of age
* Chronic congestive heart failure scheduled for right sided cardiac catheterization
* Left ventricular ejection fraction ≤ 40% determined by echocardiography
* Elevation of N Terminal-proBNP ≥ 500 ng/L
* Cardiorenal syndrome (30ml/min ≤ estimated GFR ≤ 80 ml/min (MDRD)

Exclusion Criteria:

* Acute heart failure, untreated
* Systolic blood pressure \< 80 mmHg
* Tachycardia above 100 bpm
* Angina Canadian Cardiovascular Society (CCS) class III or higher
* Aortic stenosis
* Hypertrophic cardiomyopathy
* Restrictive cardiomyopathy
* The presence of kidney disease diagnosed before heart failure
* Administration of radiographic contrast \< 1 week
* Radiographic contrast allergy
* In the Investigator's opinion, the patient has a clinically significant disease that could be adversely affected by study participation
Efficacy of Buffered Lidocaine in Patients With Facial Swelling

The purpose of this study is to determine the clinical efficacy of a buffered 4% lidocaine solution for incision and drainage. Ninety patients will be examined clinically to determine a diagnosis of cellulitis or fluctuance. The diagnosis will be confirmed by incision and drainage. Patients will receive either 3.6 ml 4% lidocaine with 1:100,000 epinephrine or 3.6 ml 4% lidocaine with 1:100,000 epinephrine buffered with 8.4% sodium bicarbonate. Patients will rate pain prior to and throughout the procedure.

Incision and drainage of swellings is painful and anesthetic failure is common. One reason may be related to the lowered pH of inflamed tissue reducing the amount of the base form of anesthetic. A buffered anesthetic solution may result in more effective anesthesia than a non-buffered solution.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* in good health (ASA classification I or II)
* able to give informed consent
* necrotic tooth with associated facial swelling

Exclusion Criteria:

* allergies to local anesthetics or sulfites
* history of significant medical problems (ASA classification III or greater)
* pregnancy
* inability to give informed consent
The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases

The aim of the study is to assess the role of statins and different dosage regimens in the prevention of contrast-induced acute kidney injury in patients with cardiovascular diseases requiring intravenous contrast media administration before computer tomography


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Indications for computer tomography with intravenous contrast media administration
* Cardiovascular diseases (arterial hypertension, arrhythmia etc)

Exclusion Criteria:

* Pregnancy
* Statin therapy before inclusion in the study
* Acute coronary syndromes
* Contraindications for statins administration
* Patients with chronic kidney disease stages 4-5
* Contraindications for computer tomography with contrast media administration
* Nephrotoxic drugs use (NSAIDS, vancomycin etc)
Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases)

Osteosyntheses employed in treating fractures at the upper end of the femur play a critical role in facilitating a swift recovery by minimizing immobilization periods and enabling early rehabilitation of the affected joints, thereby promoting a speedy return to normal walking function.

Osteosynthesis alters the mechanical dynamics of the bone segment, which undergoes continual changes during the consolidation and mobilization phases of recovery. Throughout these stages, a range of mechanical complications may arise, posing challenges despite the successful prevention of infections. Non-infectious complications associated with the presence of osteosynthesis materials, especially in weight-bearing areas like the lower limb, remain a concern.

In light of these considerations, surgeons must exercise meticulous care in selecting synthetic materials to mitigate the risk of osteosynthesis failures. In cases where internal fixation fails, the standard recourse often involves converting to total hip arthroplasty (THA).

However, it is essential to note that THA subsequent to complications arising from proximal femur osteosynthesis presents a higher incidence of both intraoperative and postoperative complications compared to the implantation of primary total hip prostheses. Thus, while osteosynthesis remains a valuable intervention for femur fractures, careful attention to material selection and postoperative management is crucial in optimizing patient outcomes and minimizing complications.

The aim was to identify the causes of mechanical failures of osteosynthesis in order to prevent them. Methods: We present the experience of the Department of Surgical Orthopedic Surgery, concerning 35 cases summarized after failure of surgical treatment of a fracture of the proximal end of the femur for a period spreading between January 2015 and December 2021. . The literature already found evidence of the greater complexity of this type of procedure compared to a first-line total hip prosthesis. Accordingly, all this, Prevention is better than cure these stiffnesses through good preoperative planning. Other factors related to the terrain or to untimely loading of the implant are more difficult to control. Whatever the cause, the surgeon remains by the rigor in these indications, the choice of the synthetic material the essential element in the prevention of osteosynthesis failures.

Eligibility Criteria:
Inclusion Criteria:

* • Diagnosis of a fracture of the proximal end of the femur.

  * Subsequent surgical intervention(s) due to failure of initial surgical treatment

Exclusion Criteria:

* • Those initially treated with total hip arthroplasty.

  * Patients lost to follow-up, not consistently monitored, or untreated after diagnosis of the complication.
  * Cases with incomplete medical records
Systolic Hypertension in the Elderly Program (SHEP)

The primary objective was to assess whether long-term administration of antihypertensive therapy to elderly subjects with isolated systolic hypertension reduced the combined incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the effect of long-term antihypertensive therapy on mortality from any cause in elderly people with isolated systolic hypertension; possible adverse effects of chronic use of antihypertensive drug treatment in this population; the effect of therapy on indices of quality-of-life; the natural history of isolated systolic hypertension in the placebo population.

BACKGROUND:

More than 3 million persons in the United States over the age of 60 have isolated systolic hypertension. They face an excess risk (2-3 fold) of stroke, other cardiovascular disease and death. Population-based data show that the prevalence rises from approximately 8 percent in the age group 60-69 years to approximately 20 percent over the age of 80. Based on available data, an annual stroke rate of 2.0 percent has been estimated in this population. The full-scale clinical trial followed a pilot study conducted from 1980 to 1983. Recruitment in the trial began in March 1985 and was finished in January 1988. Follow-up ended in February 1991. Data analysis continued through October 1996.

DESIGN NARRATIVE:

A randomized, double-blind trial in which 2,365 subjects were assigned to active treatment and 2,371 to placebo. For the active treatment group, a stepped-care regimen was used which included chlorthalidone 12.5 or 25 mg/day, and as needed, addition of atenolol 25 or 50 mg/day or reserpine, 0.05 or 0.10 mg/day. Treatment goal was to reduce systolic blood pressure by at least 20 mm Hg from baseline and to below 160 mm Hg with minimal amounts of study medication. The primary endpoint was the incidence of fatal and non-fatal stroke. Secondary endpoints were cardiovascular and coronary morbidity and mortality, all-cause mortality, and quality-of-life measures.

Eligibility Criteria:
Men and women, aged 60 or over, with isolated systolic hypertension.
NDT Effectiveness Study

The purpose of this study is to determine whether there is a functional change in children with Cerebral Palsy (CP) and other neuromuscular disorders participating in Neurodevelopmental Treatment (NDT) intervention using the contemporary practice model (CPM).


Eligibility Criteria:
Inclusion Criteria:

* The children will be aged 2 to 15 years with a diagnosis of CP, hypotonia, global developmental delay and/ or neuromuscular disorders not otherwise specified.
* Children must also be willing to receive physical guidance for movement and clearly attempt to respond to simple instructions on request.
* Children and their families are available and willing to attend the practicum portion of the course for both blocks.

Exclusion Criteria:

* Parent/Guardian unable to complete the 4 required interview sessions.
* Unable to commit to attending 75% of practicum sessions.