cyrilzakka/clinical-trials huggingface dataset:
Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation

The purpose of this research is to study the effects of Vitamin D supplementation on the body's response to insulin (a hormone that controls blood sugar), on inflammation, and on specific cells and processes in fat tissue.

Over the last several years, studies have shown that low vitamin D levels may increase risk of developing Type 2 Diabetes. The investigators will administer vitamin D3 (cholecalciferol) to non-diabetic, insulin resistant subjects with vitamin D deficiency (total vitamin D levels \<20 ng/ml) to increase the level of vitamin D3. The investigators will study the effects of increased Vitamin D on insulin action, adipose tissue inflammation, and on certain cells and processes in fat tissue.

Investigators will study participants with a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Adipose tissue inflammation will be measured using the following inflammatory markers: IL-6, PAI-1, TNF-alpha, and iNOS.

Eligibility Criteria:
Inclusion Criteria:

* Serum 25(OH)D\<20ng/ml
* Insulin Resistant based on HOMA-IR score of \>3
* Able and willing to provide informed consent
* BMI 20-35

Exclusion Criteria:

* HIV/AIDS
* History of any cancer
* Sarcoidosis
* Alcohol or substance abuse
* Cushing's syndrome
* Primary hyperparathyroidism
* Nephrolithiasis
* Pregnancy or breastfeeding
* Regular visits to a tanning salon
* Hypercalcemia or hypocalcemia
* Untreated or uncontrolled hypertension
* Any chronic illness requiring medication, other than arthritis, hypertension and hyperlipidemia
Risk Factors for Primary Cesarean Section in Egypt

women in their first pregnancy evaluated till delivery for associated risk factors for cesarean delivery

Evaluation of maternal , fetal, delivery place and health care provider rules to determine route of delivery in women during their first pregnancy

Eligibility Criteria:
Inclusion Criteria:

* women in their first pregnancy
* Delivery between 37 and 42 weeks
* Singleton pregnancy _ cephalic presentation

Exclusion Criteria:

* women asked for CS on demand
Promoting Playfulness

Health inequalities, social isolation, and family adversity impact a child's development. Play is the context for child development in all areas. A parent's ability to support children at play while being playful contributes to their psychological adjustment. The proposed tier 1, strengths-based educational program for parents of children aged 2 to 5 years with and without disabilities combines elements of a play-based approach and tips on effective parenting to support children's development by equipping parents with knowledge and empowering them to become change agents in their children's lives.

Parents will be recruited through a convenience sampling method to either an intervention group delivered online or a control waitlist group. Parents will be asked to complete a set of questionnaires online to assess the proposed programs effectiveness. Data analysis will explore between and within group differences in parental sense of competency, parental stress, child's behavior, and ability to support child's play. Qualitative data will be collected through online open-ended questions and sessions' transcript which will be analyzed to identify benefits. The project will produce tangible outcomes that will contribute to fostering the resilience of families with young children.

Eligibility Criteria:
Inclusion Criteria:

* Parent of a child aged 2 to 5 with no major disability (sensory, intellectual disability, neuromuscular disability).
* Can commit to participating in two online sessions;
* Has a device with a stable internet connection; and
* Communicates with high school-level English.

Exclusion Criteria:

• Parents with children who have severe behavioral or sensory issues.
rhTSH, Radioiodine Uptake and Goiter Reduction Following 131I Therapy in Patients With Benign Nontoxic Nodular Goiter

The study aims at clarifying (in a randomized, double-blinded design):

1. Whether stimulation with 0.1 mg rhTSH 24, 48 or 72 hours before induction of a 131I-tracer dosis increases the 131I uptake in patients with atoxic multinodular goitre and to study which time interval is the most optimal (Part I)
2. Whether patients suffering from atoxic multinodular goitre obtains a corresponding goitre reduction compared with a control group when stimulating with 0.1 mg rh TSH 24, 48 or 72 hours before 131I therapy and when reducing the thyroid radiation dose to 50 Gy (Part II)

The two studies will be carried out successively on the same patient population. The 131I uptake will be carried out first followed by the I therapy itself. The patients are compared with a placebo-treated control group going through the same course of treatment, but the 131I dosis will be 100 Gy (standard treatment). After the 131I therapy, all patients are followed during one year with a regular ultrasound scan of the thyroid gland and control of the metabolic status. The patient satisfaction is monitored by the use of a visual-analogue-scale.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Apart from benign non-toxic goiter no other serious illness
* Signed proof of participation

Exclusion Criteria:

* Treatment with Levothyroxine
* Former 131I-therapy
* A thyroid volume above 100 ml or a retro-clavicular component
* Unsafe contraception
* Pregnancy or breastfeeding
* Participation in another clinical trial
* Previous allergic reaction toward rhTSH
* Suspicion of malignancy in the thyroid gland either by clinical examination, laboratory findings (a raised serum calcitonin or ionized calcium)or by fine-needle aspiration biopsy
* Physically or mental condition making it impossible to participate
* Acute ischemic heart attach within the last 3 months
* Alcohol and/or drug addicts
Evaluation of the Effectiveness of Dry Needling Treatment in Patients Diagnosed with Greater Trochanteric Pain Syndrome

Greater Trochanteric Pain Syndrome (GTPS) is characterized by lateral hip pain, pain radiating to the lateral leg, tenderness and rotation around the greater trochanter, and pain with specific activities such as abduction or adduction. GTPS is primarily diagnosed clinically. Conservative treatment for GTPS includes activity modification, physiotherapy, nonsteroidal anti-inflammatory drugs, local corticosteroids, and platelet-rich plasma injections. Particularly, regional muscle sensitivity, such as in the gluteus maximus, is prominent. In recent years, dry needling therapy, which has gained popularity and increased research attention, has become an alternative treatment option, especially if the underlying cause is myofascial pain syndrome or deeper issues like piriformis syndrome.

The provided text discusses dry needling as a treatment for various neuromusculoskeletal pain conditions, emphasizing its use as a minimally invasive procedure that involves applying filiform needles to the relevant muscle tissue without the administration of pharmacological drugs. The literature suggests that dry needling therapy has the ability to induce biochemical, biomechanical, endocrinological, and neurovascular changes associated with the reduction of pain and disability in individuals. However, the optimal treatment dosage has not yet been determined, and there is inconsistency in the literature regarding the number of needles to be inserted and the duration of needle retention.

Studies evaluating the effectiveness of dry needling are often designed to compare or add it to other injection therapies. Additionally, there is a limited number of studies conducted with real-time imaging. In the planned study, the use of ultrasound-guided dry needling aims to provide a sham application opportunity, where the patient is blinded to the nature of the procedure, allowing for a meaningful investigation of efficacy. This aspect of the study is expected to contribute significantly to the literature.


Eligibility Criteria:
Inclusion Criteria:

Age between 18 and 80 years old. Ability to read and write. Clinically diagnosed with greater trochanteric pain syndrome. Pain Visual Analog Scale (VAS) score of 6 or higher.

Exclusion Criteria:

History of previous lumbar and hip surgery. Lesions, atrophy, or scars in the skin around the hip area. Received physiotherapy for the hip, lumbar, or lower extremities in the last 6 months.

Underwent an interventional procedure for the hip or lumbar region for the same reason in the last 3 months.

Used steroids in the last 1 month. Special conditions such as epilepsy, pregnancy, injection phobia, etc. Inability to comply with the restriction on the use of both steroid and non-steroidal anti-inflammatory drugs during the treatment period.

Subcutaneous fat tissue thickness in the hip area being 5 cm or more.
Longitudinal Study of Traumatic Brain Injury (TBI) in (University of Florida) UF Athletes

To identify the changes in the brain following repeated sports-related concussion in men's football, women's soccer, and women's lacrosse college athletes by reviewing the findings of MRI studies that look at the structure of the brain and the appearance of the white matter at baseline, during the acute phase of a concussive injury, and upon completion of collegiate athletic play and correlate these findings with standard clinical measures.

This proposal seeks to study Diffusion Tensor Imaging and functional MRI of the brain at 1) baseline, 2) after concussion and 3) at the end of an athlete's college career. Findings will be compared to standard clinical measures already performed in the management of concussion at the University of Florida Athletic Association and to serum biomarkers already being obtained as part of a UF/ Banyan Biomarker Study. As in the biomarker study, UF athletes on teams with higher incidences of sports related concussion; men's football, women's soccer, and women's lacrosse will be offered enrollment.

Longitudinal examinations will allow identification and quantification of concussive DTI findings as comparisons can be made to the individual athlete's baseline data. This will provide valuable correlation of imaging findings with severity of clinical symptoms at the time of injury and also with timing of return to play.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled and active UF student athlete in Mens Football, Womens Soccer, or Womens Lacrosse.
* Age 18-30

Exclusion Criteria:

* Contraindications to MRI, such as retained metal
* Pregnancy
Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension

This study will compare the clinical efficacy of inhaled iloprost as an invasive, selective vasodilator in the cardiac catheterization laboratory in patients with pulmonary hypertension to the gold standard of inhaled nitric oxide. It will also examine whether echocardiographic estimates of response to inhaled iloprost can predict responsiveness to invasive vasodilator testing in patients with pulmonary hypertension.

Iloprost was the first inhaled prostacyclin analogue to be FDA-approved for the treatment of pulmonary arterial hypertension. Iloprost aerosol has been shown to significantly improve pulmonary hemodynamics in patients with idiopathic pulmonary hypertension (PH), with an effect greater than nitric oxide and sildenafil. It has also been shown to be more effective than nitric oxide at reducing pulmonary arterial pressure (PAP) than prostacyclin infusion when used in the cardiac catheterization laboratory. Because of its administration through inhalational means, iloprost has the advantage of selective action on the pulmonary vasculature with avoidance of the systemic side effects that plague many of the other treatments for PH. The investigators intend to compare the efficacy of inhaled iloprost in reducing pulmonary artery pressure to the gold standard of nitric oxide in patients with pulmonary hypertension.

Without an established noninvasive algorithm to identify beneficial hemodynamic response to vasodilators, patients with pulmonary hypertension (PH) are routinely subjected to expensive and invasive testing. Echocardiography is routinely used to facilitate a diagnosis of PH and a few echocardiographically-derived estimates have even been shown to correlate with vasodilator responsiveness and survival. Dynamic, real time changes in echocardiographic parameters have not been previously evaluated as a predictor of vasodilator responsiveness or of clinical outcome. The investigators will examine whether echocardiographic changes in response to inhaled iloprost can predict invasively derived vasodilator responsiveness and help assess prognosis in patients with pulmonary hypertension, possibly even obviating the need for invasive testing.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients no younger than 18 years of age
* Recently diagnosed pulmonary hypertension (defined by RV systolic pressure of ≥ 40 mmHg as measured by echocardiography), going for invasive hemodynamic assessment for pulmonary hypertension
* Normal left ventricular function defined as a left ventricular ejection fraction (LVEF) greater than or equal to 50%

Exclusion Criteria:

* Heart failure (LVEF \< 50%, diastolic dysfunction \> stage 1, history or symptoms of left heart failure) - Group II pulmonary hypertension
* 2+ or higher MR or AI
* Inadequate echocardiographic windows
* Pregnancy
* Systolic blood pressure ≤ 90 mmHg
Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement

To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years with type 1 or 2 diabetes mellitus
* Subjects with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye
* Decrease in vision determined to be primarily the result of DME in the study eye
* Best-corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 73 to 24 (20/40 to 20/320) in the study eye

Exclusion Criteria:

* Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
* More than 2 previous macular laser treatments in the study eye
* Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
* Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
* Active proliferative diabetic retinopathy (PDR) in the study eye
* Uncontrolled diabetes mellitus, as defined by HbA1c \>12%
* Only 1 functional eye even if that eye is otherwise eligible for the study
Electroconvulsive Therapy in Clozapine-resistant Schizophrenia

Electroconvulsive therapy (ECT) is one of the oldest neuromodulation treatments still used in psychiatry. Only case reports and open label non-randomized studies have been published of ECT in clozapine-resistant schizophrenia patients. The purpose of this trial is to study the efficacy and cognitive effects of add-on ECT treatment (10-course) in schizophrenia patients taking clozapine.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia or schizoaffective disorder
* treatment-resistant to clozapine
* age 18 - 64 years
* capacity and willingness to give informed consent

Exclusion Criteria:

* serious somatic illness
* progressive neurological illness, recent brain damage or sequela of serious brain damage
* ECT less than 3 months prior to this trial
Evaluation of the Diagnostic Utility of INS316 in Patients With Interstitial Lung Diseases (01-701)

The objective of the present work is to explore and compare the diagnostic quality of sputum specimens obtained by BAL, induction with hypertonic saline (3%), and induction with INS316 in patients diagnosed with interstitial lung diseases.


Eligibility Criteria:
Inclusion Criteria:

* between 18 years or older
* undergone diagnostic bronchoalveolar lavage within the previous 21 days
* diagnosed with sarcoidosis or other ILD

Exclusion Criteria:

* having resting hypoxemia
* receiving corticosteroid treatment
Multicenter Assessment of the Pancreas in Type 1 Diabetes

The overall goal of this research is to develop and validate standard operating procedures (SOP) to assess the human pancreas in individuals with type 1 diabetes (T1D) and other forms of diabetes using advanced, quantitative magnetic resonance imaging (MRI) approaches.

This research applies magnetic resonance imaging (MRI) techniques to study the pancreas of individuals with type 1 diabetes (T1D) and other forms of diabetes. Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults, and in non-diabetic individuals expressing islet autoantibodies that portend the development of T1D. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas. These unexpected findings raise fundamental questions that challenge our understanding of T1D pathogenesis. These changes in pancreatic volume and size before and soon after onset of T1D, as detected by MRI, appear to be a marker of the T1D pathogenic disease process. There is an urgent need to determine whether similar observations can be obtained at different centers using different MRI platforms. Discovery of unknown changes may lead to new ways to treat disease. The MRI techniques may also be useful for following how T1D is progressing in different people, determining whether new drugs are effective, and ultimately detecting T1D in people earlier than currently possible.

Eligibility Criteria:
Inclusion Criteria:

* Subjects at least 8 years of age
* Subjects with T1D must be imaged within 100 days of their date of diagnosis
* Subjects must be able to read and provide assent/informed written consent

Exclusion Criteria:

* Subjects with pancreatitis, cystic fibrosis, pancreatic adenocarcinoma, or neuroendocrine tumors
* Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means because such devices may be displaced or malfunction
* Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced
* Subjects who are pregnant or breast-feeding. Urine pregnancy test will be performed on women of child bearing potential who are not practicing appropriate contraception measures or menstruating.
* Subjects who exhibit significant anxiety and/or claustrophobia
* Subjects incapable of giving assent/informed written consent
* For controls: subjects who have first degree relatives with T1D
Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism

The aim of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intra hepatic- and intramyocellular lipid content in patients with hypothyroidism


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* must be of legal age and competent
* Age \> 18 years
* presently diagnosed with hypothyroidism

Exclusion Criteria:

* alcohol consumption \>21 units per week
* Malignant disease
* pregnancy
* magnetic implants or material in the body
* BMI \> 30
* Heart disease (NYHA \>2)
* Uncontrolled hypertension
* Manifest diabetes mellitus
* Changes in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.
Inflammatory Gene Polymorphism and Prolonged Mechanical Ventilation After Liver Transplantation

Mechanical ventilatory lung care is essential for postoperative care in liver transplantation recipients, for such patients are under massive fluid challenge and hemodynamic alterations perioperatively. Some of the recipients experience difficulty in weaning off from the mechanical ventilator due to various causes. This study is to investigate the relationship between the inflammatory gene polymorphism, known for acute lung injury, and the duration of mechanical ventilatory care for such liver transplantation recipients.


Eligibility Criteria:
Inclusion Criteria:

1. 20-65 years old
2. scheduled for liver transplantation

Exclusion Criteria:

1. Patients under mechanical ventilation prior to surgery
2. patients with muscular skeletal disorder, probable cause for respiratory depression
3. patients not able to read, or understand the consent form
4. ethnicity, other than asian
5. patients refusal
Emotion And Symptom-focused Engagement (EASE): An Intervention for Individuals With Acute Leukemia

The purpose of this study is to test the feasibility of an individual psychological and physical symptom intervention, called Emotion And Symptom-focused Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute leukemia.

This study involves the pilot-testing of a newly developed, brief manualized individual psychotherapy and physical symptom control intervention, called Emotion And Symptom-focused Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute leukemia. The purpose of this study is to conduct a two-arm randomized pilot trial (RPT) to test the feasibility, acceptability, and preliminary efficacy of EASE against usual care (UC) for the reduction of traumatic stress and physical symptom burden in patients with acute leukemia. Usual care for individuals with acute leukemia treated at the Princess Margaret Cancer Centre includes referral for non-standardized, and primarily instrumental, psychosocial care and palliative care service as needed.

The design will be an unblinded RPT consisting of two conditions (EASE and UC), with a baseline assessment and follow-ups at 4, 8, and 12 weeks. The trial will take place at the Princess Margaret Cancer Centre, University Health Network; a comprehensive cancer center in Toronto, Canada. Participants will be newly diagnosed with acute leukemia, within one month of diagnosis and/or admission to hospital for treatment with curative intent.

Eligibility Criteria:
Inclusion Criteria:

* new or relapsed diagnosis of acute leukemia (an amendment to allow recruitment of relapsed patients was approved on 24-Sep-2015, although no relapsed patients were ultimately recruited)
* will be receiving induction chemotherapy with curative intent and within 1 month of diagnosis and/or admission to hospital at the Princess Margaret Cancer Centre
* age ≥ 18 years
* fluency in English
* no cognitive impairment indicated in the medical record, communicated by the hematology clinical team, or determined by research staff at recruitment.

Exclusion Criteria:

* inability to pass the cognitive screening test (Short Orientation-Memory Concentration Test \[SOMC\] score \<20)
* actively receiving psychological/psychiatric counseling or palliative care services from the Department of Psychosocial Oncology and Palliative Care (POPC), now called the Department of Supportive Care, at the Princess Margaret Cancer Centre at the time of recruitment to this study