cyrilzakka/clinical-trials huggingface dataset:
Growth Hormone, IGF-1 and Medical Treatment in Acromegaly: Are There Effects on Gut Hormone Physiology and Postprandial Substrate Metabolism?

Acromegaly is a rare hormonal disorder leading to increased morbidity and mortality. In the vast majority of cases, a pituitary somatotroph cell adenoma causes excess growth hormone (GH) secretion, leading to hepatic insulin-like-growth factor 1 (IGF-1) hypersecretion. Both the disease as well as its treatment with long-acting somatostatin analogs (LA-SMSA) and/or pegvisomant affect glucose and lipid metabolism, possibly contributing to increased cardiovascular risk.

In this pilot study, the investigators want to explore insulin sensitivity, postprandial gut hormone response, lipid handling and adipocytokine profile in the following 4 groups:

* controlled acromegalic patients on LA-SMSA (group 1)
* controlled acromegalic patients on combination treatment of LA-SMSA and pegvisomant (group 2)
* acromegalic patients without need for medical therapy after surgery (group 3)
* healthy control subjects (group 4)

Furthermore, a longitudinal exploration will be performed in uncontrolled acromegalic patients (i.e. patients with serum IGF-1 levels above age-specific thresholds and/or symptoms due to active acromegaly (excessive sweating , arthralgia)) on LA-SMSA monotherapy (group 5). In this group, insulin sensitivity, postprandial gut hormone response, lipid handling and adipocytokine profile will be explored before introducing pegvisomant and three months after normalisation of IGF-1 levels.

The investigators hypothesize that lipid and glucose handling will be less efficient in the controlled acromegalic patients on LA-SMSA than in controlled patients on combination therapy or after surgery, and that there will be no difference in substrate metabolism between healthy controls and controlled acromegalic patients on combination treatment or after surgery. Further, they hypothesize that introducing pegvisomant in uncontrolled acromegalic patients will improve their postprandial lipid and glucose handling.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acromegaly over 1 year ago, no changes in treatment schedule since at least 6 months (groups 1-3 and 5) OR healthy volunteer without diagnosis of acromegaly (group 4)
* Patient is willing to participate and has signed the informed consent
* Age \> 18 years and \< 80 years
* Body Mass Index 18-40 kg/m²

Exclusion Criteria:

* Biochemistry: liver function tests \> 3x ULN; HbA1C \> 58 mmol/mol
* All untreated endocrine disorders including uncontrolled diabetes mellitus type 2 (i.e. HbA1C \> 58 mmol/mol)
* Bariatric surgery; malabsorptive syndromes; hepatic or renal failure
* Current medication use: insulin, metformin, sulfonylurea, fibrates, incretin mimetics, dopamine agonists (for all but insulin, participation is allowed after a 2- week wash-out period)
* Abuse of alcohol or drugs
* Weight changes \> 10% of body weight during preceding 12 months
Effect of Kinesio Taping Application in Addition to Pilates Exercises on Core Muscle Thickness, Cognition and Mental Fatigue in Individuals With Non-specific Low Back Pain

Low back pain is a common problem. In low back pain, the core region and posture are frequently affected. However, no definitive decision has been reached regarding cognition and mental fatigue. In the treatment of low back pain, exercise and kinesio taping approaches are frequently used. The aim of this study is to evaluate the effects of kinesio taping applied in addition to pilates exercises on pain, core muscle thickness, strength and endurance, posture, cognition and mental fatigue in individuals with non-specific low back pain and to compare it with placebo taping and the control group. The primary outcome measure of this study is core muscle thickness, while other measurements will be considered as secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* • Having back pain of at least 3 out of 10 points on the Visual Analog Scale,

  * Being between the ages of 30-55,
  * Having back pain for at least 1 month,
  * Having been tested with a test piece beforehand and not having an allergy to kinesio taping.

Exclusion Criteria:

* • Having had surgery for back pain,

  * Not complying with treatment,
  * Having a neurological deficit,
  * Having a body mass index over 30,
  * Having a positive straight leg raising test,
  * Having a positive slump test,
  * Having a positive bowstring test,
  * Being pregnant,
  * Having received any treatment for back pain in the last month,
  * Doing regular exercise in the last month.
Effect of Health Education on Female Teachers' Knowledge and Practices Regarding Early Breast Cancer Detection and Screening in the Jazan Area: A Quasi-Experimental Study

The purpose of this study is to assess the effectiveness of health education in improving the knowledge and practices of female teachers regarding screening tools and the early detection of breast cancer.

A two-group quasi-experimental design was conducted among 150 female teachers, who were selected from 75 schools of the Jazan General Administration of Education. Schools were chosen by a simple cluster randomization method. Schools were non-randomly assigned to either the intervention or control group. Eligible participants were recruited by a simple randomization method, proportional to the total number of teachers at each school. Those in the intervention group (n=75 teachers) were compared to the control group (n=75 teachers) at baseline, as well as at 6 weeks and 3 months post-intervention.

Study aim:

Assess effectiveness of health education on improving knowledge and practices regarding Breast cancer(BC) early detection and screening tools among female teachers after six weeks, three months in health education group in compare with control group.

Specific objectives:

Estimate level of awareness among female teachers regarding knowledge and practices of BC early detection and screening tools in Jazan area schools.

Measure the impact of health education on female teachers knowledge and practices regarding BC early detection and screening tools in health education group in compare with control group. So Research questions are:

What is the current awareness level of female teachers in Jazan area schools regarding knowledge and practices of BC early detection and screening tools? Does health education improve knowledge and practices regarding BC early detection and screening tools among female teachers in Jazan area schools in health education group more than control group?

Eligibility Criteria:
Inclusion Criteria:

* 20 years. No personal history of BC. No first degree relative of BC. Not being pregnant or breast feeding. Ability to understand questionnaire

Exclusion Criteria:

Refused to give informed consent. Sever medical problem prevent participation.
A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients

Patients are often anxious immediately before surgery. The investigators hypothesis is that a warming blanket is as effective as the sedative midazolam in allaying anxiety before surgery.

The investigators are randomising patients aged 18-70 having elective surgery to 1) a cotton blanket and reassurance as required; 2) midazolam, a cotton blanket and reassurance as required; and 3) forced-air warming, a cotton blanket and reassurance as required. The primary endpoint is a visual analog scale of anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 70 years
* male and female
* presenting for elective surgery
* requiring general anaesthesia
* ASA 1-3

Exclusion Criteria:

* Cardiothoracic and intracranial surgery
* Day case surgery
* Pre-existing anxiety disorder
* Patients on psychotropic drugs preoperatively Febrile patients T \> 37.5 degrees Celsius Allergy to midazolam Obstructive Sleep Apnoea diagnosed on sleep study
Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

The investigators main hypothesis is that the stone free rate will be much higher (95%) in patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to determine which treatment is safe and prevent less stone recurrence.

Extracorporeal shock wave lithotripsy is preferred for small stones less than 10 mm in size. Percutaneous nephrolithotomy is the standard therapy used for large kidney stones greater than 20 millimeters or stones in the lower kidney. For moderate sized kidney stone (10-20 mm),currently the options for treatment include both methods. However, no studies have proven that one procedure is better than the other. So, we will compare both the procedures for breaking the kidney stone. Our main outcome measures will be the stone-free status after the procedure. Other outcome measures are assessment of morbidity associated with use of the procedures i.e. any minor or major complications within 3 months of initial treatment. Patient will be assessed for infection at post-operative office visits to include a basic urinalysis only if they have systemic indicators of infection (fever, dysuria, frequency, etc.). Pain will be monitored with the scale of 0-10 points. Also we will review of stone density on Computerized Tomography (CT) scans and the effect this has on success of both procedures. We hope with PCNL stone-free rates will be minimum with minimal morbidity and ultimately improve patient care.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sex with age greater than 18 years to 90 years
* Stone burden between 10 and 20 mm diagnosed by CT scan
* Patient must be agreeable to randomization between shock wave lithotripsy and percutaneous stone removal

Exclusion Criteria:

* Patients with bleeding diathesis or taking anti-platelet or anti-coagulant medication
* Patients who are pregnant based on routine pre-operative pregnancy testing
* Patients with skin to stone size greater than 12 cm (measured routinely on CT scan)
* Patients with either Horseshoe kidney, transplant kidney or a solitary kidney
* Patients with ureteral calculi
* Patients with stone size of \< 10 mm and \> 20 mm
* Ureteropelvic junction obstruction
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma

A non-profit study designed with the aim of analysing the phenotype and molecular characteristics (central review) and evaluating prospectively the role of PET-scans in the management of primary mediastinal lymphoma treated with conventional approaches.


Eligibility Criteria:
Inclusion Criteria:

* Primary mediastinal diffuse large B-cell lymphoma, CD20 positive. Patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum.
* No prior treatment of lymphoma. Patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms.
* Any stage of disease.
* Age at least 18 years.
* Fit to receive chemotherapy with curative intent.
* Able and willing to give informed consent, and to undergo staging including PET scanning
* Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.

Exclusion Criteria:

* Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
* Impairment of bone marrow function (WBC \<3.0x109/L, ANC \<1.5x109/L, PLT \<100x109/L), unless due to involvement by lymphoma.
* Major impairment of renal function (serum creatinine \>2x upper normal) or liver function (ASAT/ALAT \>2,5 upper normal, total bilirubin \>2,5x upper normal), unless due to lymphoma involvement.
* Known HIV infection. Patients will not be tested routinely.
* Pregnant or lactating women.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Treatment of Acute Pericarditis With Anakinra

The goal of this study is to determine the safety and efficacy of anakinra for the treatment of acute pericarditis when initiated within 6 hours of diagnosis and continued for 3 or 7 days.

1. to determine the efficacy of anakinra with respect to chest pain resolution
2. to determine the safety of anakinra with respect to adverse drug events

Acute pericarditis is a clinical syndrome characterized by a profound inflammation of the membrane tissue that surrounds, supports and protects the heart. Acute pericarditis can be caused by a variety of infectious and non-infectious agents, but it most commonly either follows a viral infection of the upper respiratory tract or has no apparent cause.

Acute pericarditis occurs rather abruptly in previously healthy individuals, generally a child or young adult. Most cases of acute pericarditis resolve within a few days with non-steroidal anti-inflammatory drugs. However, patients experience severe chest pain and are at high risk for life-threatening complications involving the pericardium, such as pericardial tamponade. Acute pericarditis is diagnosed in 1 in 20 (5%) ED visits for chest pain.

Anakinra (Kineret) has been shown to treat and cure refractory and recurrent pericarditis. This study is aimed at determining whether anakinra is also effective as first line treatment in acute pericarditis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥12 years in presence of a parent able to provide consent or age \>18 years
* First or recurrent episode of acute pericarditis, defined as the presence of at least 2 of the following:
* Chest pain (suggestive of pericarditis and not explained by another condition)
* Pericardial friction rub on physical exam
* ST-segment elevation and/or PR depression on ECG
* New or worsening pericardial effusion
* Pain of moderate-to-severe intensity (pain score ≥6 on a scale of 0-10 where 0 is no pain at all and 10 is the worst pain ever experienced) at time on enrollment
* Ability to provide written informed consent if 18 years or older or to provide assent in presence of parental consent if 12-17 years of age

Exclusion Criteria:

* Pericarditis due to known bacterial or fungal infection
* Pericarditis due to known malignancy
* Pericarditis after cardiac surgery
* Tamponade or need for pericardiocentesis for diagnostic/therapeutic purposes
* Pregnancy or breastfeeding
* Hypersensitivity to anakinra, latex or products derived from Escherichia coli
* Chronic pain syndrome or chronic use of analgesic drugs
A Clinical Trial to Evaluate the Preference Regarding Convenience of Medication and Efficacy/Safety of SUGAMET®XR Tablet 5/1000mg

Multi-center, open-label, single arm study to Evaluate the preference regarding convenience of medication, efficacy and safety of Sugamet XR tab. 5/1000mg in patients with Type 2 diabetes and renal diseases


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥60 years
* Subjects with type 2 diabetes mellitus
* Subjects treated with DPP-4 inhibitor and 1,000mg/day dose of metformin 1T/qd for at least 8 weeks prior to screening
* Subjects with HbA1c≤7.5% at screening
* Subjects with 45mL/min/1.73m2≤eGFR≤90mL/min/1.73m2 at screening
* Subjects with fasting glucose≤200 at screening
* Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening

Exclusion Criteria:

* Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
* ESRD or Patients who have kidney dialysis
* Subjects with ALT and AST 3 times or higher than upper normal range
Long-term Follow-up of Subjects Treated With OTL-300 for Transfusion Dependent Beta-thalassemia Study (TIGET-BTHAL)

OTL-300 is a gene therapy drug product consisting of autologous hematopoietic stem/progenitor cluster of differentiation (CD) 34+ cells genetically modified with a lentiviral vector (GLOBE) encoding the human beta globin gene. The TIGET-BTHAL is a phase I/II study evaluating safety and efficacy of OTL-300 in subjects with transfusion dependent beta-thalassemia for two years post gene-therapy. Subjects with rare disease who have undergone gene therapy are followed for efficacy and possible delayed adverse events. Thus, this study is designed to follow patients who have received gene therapy on TIGET-BTHAL for an additional six years (for a total of eight years).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed study TIGET-BTHAL i.e. who have received treatment and been followed for two years post treatment with OTL-300.
* For adults; capable of giving signed informed consent. For children; informed assent and/or consent in writing signed by the subject and/or parent(s) / legal representative (according to local regulations and age of the subject).

Exclusion Criteria:

* None
Improving Antihypertensive and Lipid-Lowering Therapy

The purpose of this study is to evaluate the impact of electronic health record clinical decision support and automated telephone outreach on antihypertensive and lipid-lowering therapy in ambulatory care.

The quality of care delivered in physicians' offices is suboptimal. Underuse of proven, potentially life-saving medications, such as anti-hypertensive agents and statins for lipid-lowering, is unfortunately no exception. Data from more than 70 million people collected for the 2005 HEDIS Report Card show that fewer than half of those patients at high risk for myocardial infarction have adequately controlled lipids and fewer than 70% of patients with hypertension have blood pressure controlled; annually this suboptimal treatment accounts for more than 10,000 avoidable deaths, $333 million in avoidable hospital costs, 27.2 million sick days and $4.5 billion in lost productivity.

The "care-gaps" in the management of blood pressure and lipids arise from numerous barriers to optimal practice at the level of the system, the provider, and the patient. Process evaluations of quality improvement efforts have cited several barriers as the most important: inadequate time, resources, and support; limitations in computer technology, including insufficient information management; little use of formal change processes; too many competing priorities; a lack of agreement about the desired changes; and inadequate physician engagement.

Both computerized clinical decision support (CDS) in the context of a robust electronic health record (EHR) and automated telephone outreach to patients with interactive voice recognition (IVR) to patients are promising interventions to overcome the barriers that physicians and patients encounter in treating hypertension and hyperlipidemia. While recent studies have begun to demonstrate the effectiveness of CDS in the ambulatory setting, there is an urgent need to implement and evaluate these systems in the practices of physicians practicing solo or in small groups in the community, outside the extensive HIT infrastructure of academic medical centers and integrated delivery systems.

IVR is a patient-outreach intervention that involves automated telephone calls to patients to patients in a conversation about specific health-related issues. Randomized control trials (RCTs) have shown that IVR monitoring with clinician follow-up can improve self-care, perceived health status, and physiologic outcomes among individuals with diabetes and hypertension.

The specific aim of this project is to evaluate, the effectiveness of CDS alone compared to IVR to improve the use of antihypertensive and lipid-lowering medications in community-based primary care practices.

Eligibility Criteria:
Inclusion Criteria:

* MDs, NPs, PAs, or DOs practicing in primary care or medical subspecialties and using eClinical Works EHR
* Patients of eligible physicians who have hypertension or hyperlipidemia
Preterm Infants May Better Tolerate Warmer Feeds

Feeding intolerance is frequent among preterm infants in neonatal intensive care units (NICUs). Although there are many studies about enteral nutrition strategies and content in preterm infants, no evidence-based standards exist for the optimal milk temperature for preterm infants. Therefore, in this study the investigators aimed to examine the effects of feeding temperature and the possible morbidities.

Feeding intolerance is one of the most frequent problems among preterm infants. These infants are fed with expressed breast milk or preterm formulas of which the temperature is not routinely measured. In this study, the investigators aimed to examine the effects of feeds with warm versus room temperature milk in preterm infants. Infants with a birth weight of ≤1500 g or gestational age of ≤ 34 weeks were included in the study and assigned to two different feeding temperature groups (22-24°C and 32-34°C). Some infants in both groups were exclusive breast milk fed and some received artificial milk. Feeding tolerance of patients in both groups and the consequences were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Infants born to birth weight of ≤1500 g
* Infants born to gestational age of ≤ 34 weeks

Exclusion Criteria:

* Genetic syndrome
* Gastrointestinal system anomalies
* Patients born small for their gestational age
A Mental Health Services Engagement Program for Racial and Ethnic Minority Young Adults

Researchers aim to test a brief culturally-responsive young adult orientation program for community mental health services. They will conduct a 24-month randomized trial with 80 young adults from racial and ethnic minority groups in a community-based mental health clinic.

The study objective is to assess the feasibility and acceptability of three new culturally-responsive components added to the brief young adult engagement intervention called Just Do You. The new components incorporate techniques from the DSM-5 Cultural Formulation Interview (CFI) and creative arts therapy to increase culturally-responsive content in Just Do You, which demonstrated evidence of keeping young adults connected to their treatment in a prior trial. Components are designed to elicit relevant cultural characteristics, experiences, and perspectives of diverse young adults enrolled in psychiatric rehabilitation as part of the Just Do You orientation program. The investigators will examine whether the new culturally-responsive components improve engagement in mental health services and increase service utilization.

A total of 80 young adults enrolled in an outpatient psychiatric rehabilitation program in New York will be recruited over 24 months to take part in a randomized full factorial pilot trial. Participants will be given a baseline assessment and randomly assigned to one of eight combinations of intervention components. Just Do You will be delivered first to all participants, with the assigned combination of new components to follow. The intervention will be delivered at the psychiatric rehabilitation program and will last up to five weeks for each participant, depending on the experimental condition. Outcome measures will be assessed at baseline, post-intervention, and 3-month follow up.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-34
* From groups other than non-Hispanic White
* Enrolled in services at the partnering clinic site

Exclusion Criteria:

* Cognitive impairments (i.e., young adult cannot understand consent process)
* Unable to comprehend and speak English