cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands

The purpose of this study was to assess the safety, tolerability, and efficacy of IONIS-GHR-LRx in up to 60 participants with acromegaly.

This short-term study assessed changes in serum insulin-like growth factor 1 (IGF-1) over a 16-week treatment period in a participant population diagnosed with acromegaly being treated with long-acting somatostatin receptor ligands (SRL).

Eligibility Criteria:
Inclusion Criteria:

1. Males or females with documented diagnosis of acromegaly, aged 18-75 years old (inclusive) at the time of informed consent
2. Participants must be on stable maximum or maximally tolerated dose of SRL (Lanreotide Autogel or Octreotide LAR, per treating physician judgment) every 28 days for a minimum of 3 months prior to screening and will be required to continue their stable dose of SRL throughout the study. Prior use of other medications for treating acromegaly is allowed but not within 6 weeks of screening.
3. At Screening, serum insulin-like growth factor 1 (IGF-1) (performed at central lab) between 1.3 to 5 x upper limit of normal (ULN), inclusive, adjusted for age and sex
4. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, abstinent, or using 1 highly effective method of birth control

Exclusion Criteria:

1. Participants who received surgery for pituitary adenoma within the last 6 months before the trial, or planning to receive surgery during the trial
2. Participants who received radiotherapy for pituitary adenoma within the last 3 years before the trial, and/or planning to receive radiotherapy during the trial
3. Participants with pituitary tumor that, per Investigator judgement, is worsening as assessed by pituitary/sellar magnetic resonance imaging (MRI) protocol at Screen or within 6 months of screening
4. Evidence of decompensated cardiac function per medical judgement and/or New York Heart Association (NYHA) class 3 or 4
5. Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment
6. Participants may not have chronic systemic use of glucocorticoids, weight loss medications or participate in weight loss programs within 2 months before randomization and during study participation.
7. Participants on anti-diabetes medication or estrogen containing medications must be on a stable dose and regimen for \>= 3 months prior to screening and throughout the trial
8. Participants taking glucagon-like peptide 1 (GLP-1) agonists or insulin can be allowed with prior consultation with the Sponsor Medical Monitor
Myoinositol Supplementation, Insulin Resistance and Fetal Sonographic Parameters in Gestational Diabetes Diet Treated

The aim of this study is to verify the beneficial effects on insulin resistance and fetal sonographic parameters of a diet supplementation of myoinositol taken during the third trimester by pregnant women affected by gestational diabetes. Participants should be randomly allocated to take either myoinositol or placebo twice/day for 8 weeks. The effect of myoinositol will be checked in blood samples (insulinemia and Homeostasis Model Assessment - Insulin Resistance "HOMA-IR") and in fetal sonographic parameters after 4 and 8 weeks from the beginning of the nutritional supplementation.

Background and Aim:

Gestational diabetes mellitus (GDM) is a carbohydrate intolerance diagnosed during pregnancy that is not clearly an overt diabetes. It is characterized by an increase of the physiological insulin resistance of the pregnancy status. Myo-Inositol is an insulin sensitizing agent that ameliorate the insulin resistance. The investigators have already demonstrated that myoinositol, administered in first half of pregnancy, may reduce insulin resistance and GDM incidence in pregnant women at risk for family history, obesity and overweight . But the experiences in women affected by GDM are few and controversial. So the aim of this study is to test the effectiveness of myoinositol to ameliorate the insulin resistance in GDM patients, diet treated. Moreover the investigators would like to verify the impact of this nutritional supplementation on the fetal sonographic parameters.

Design:

The study is a randomized, prospective, placebo-controlled trial, including the first 80 consecutive gestational diabetes patients diagnosed, according to the Italian Guidelines, from November 2018 to December 2019, in the Department of Obstetric and Gynecology of Messina University (ITALY). After an informed consent participants will be randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) alone, or (n. 40) diet, folic acid (400 mcg per day) and myo-inositol (2 g. twice a day + 50 mg alfa-lactalbumin) supplementation. Multiple pregnancy or known or suspected fetal congenital abnormality had been previously excluded. The insulin sensitivity index (HOMA-IR) and fetal sonographic profile will be monitor for each patient at GDM diagnosis and after 4 and 8 weeks of treatment. The pregnant women who will delivery before the time treatment (8 weeks) or who need insulin will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy affected by gestational diabetes

Exclusion Criteria:

* Multiple pregnancy and known or suspected fetal malformations
Familial Hyperlipidemia Family Registry

The aim of the study is to identify children and families that are at risk for cardiovascular disease because of a condition known as familial hyperlipidemia. This condition may increase the risk of cardiac events such as hardening of the arteries anywhere in the body which can result in heart attacks, strokes, and death over ten fold.

Children have already been assessed in the Healthy Hearts screening program and identified as having elevated cholesterol. A buccal smear will identify whether the familial hyperlipidemia condition exist in your child.

If the child's test shows that they have the specific gene for familial hyperlipidemia and shows a genetic tendency towards premature heart disease, we would encourage genetic testing for as many blood family members as possible.

The study plan is to determine whether the Healthy Hearts screening program is a more effective way of identifying students at risk since it is estimated that less than 10% of those individuals with the problem have been identified. If it is effective, then it will be incorporated as part of the standard screening process in the Healthy Hearts program.

Aim 1: Is a school screening program a more effective method to identifying those at risk for familial hyperlipidemia? Aim 2: What percent of children with elevated cholesterol ≥ 200 mg/dl have familial hyperlipidemia?


Eligibility Criteria:
Inclusion Criteria:

\* Primary family member of child from school screening program with documented FH variant

Exclusion Criteria:

* none
Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06687234

This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation study in healthy subjects, females of non childbearing potential and males between the ages of 18 and 55 years, inclusive. There may be up to 11 Cohorts in the study. Approximately 7 cohorts are anticipated in the Single Dose (SD) portion of the study and up to 4 cohorts are anticipated in the Multiple Dose (MD) portion of the study.

Following the last subject Day 28 visit from the first two single dose cohorts (Cohorts 1 and 2), all available data inclusive of Day 28 will be evaluated for PK, immunogenicity, safety and tolerability. FDA review and agreement to move forward will take place before the remaining single dose cohorts and the multiple dose phase (Cohorts 3 to 11) can be initiated.

A total of up to approximately 82 subjects are anticipated to be enrolled in the study. The duration of dosing in the multiple dose cohorts would be 4 weeks and the regimen may include weekly (total of 5 doses), every 2 weeks (total of 3 doses) or monthly dosing (total of two doses).


Eligibility Criteria:
INCLUSION CRITERIA

* Healthy females of non childbearing potential and healthy males
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
* Ability to personally sign and date the informed consent document and able to comply with schedule of activities
* For Single Dose Cohort 7 only, Japanese subjects must have four biological Japanese grandparents born in Japan.

EXCLUSION CRITERIA

* Evidence or history of clinically significant health concerns
* Treatment with an investigational drug within 30 days
* Exposure to any live vaccines within 28 days prior to investigational product administration.
* History of drug and/ or alcohol abuse and tobacco use equivalent of 5 cigarettes per day.
* Known history of infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
* Pregnant female subjects
* History of sensitivity to heparin
* Unwilling or unable to comply with the Lifestyle Guidelines as stated in the protocol
The Study Observes Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer

This study aims to observe the sequential strategy with afatinib as first-line treatment and to find the optimal treatment strategy for long-term chemotherapy-free regimens in Chinese patients with EGFR-mutated advanced NSCLC. Furthermore, this study can also assess the effectiveness and safety of afatinib as first-line treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with locally advanced or metastatic NSCLC with EGFR sensitive mutation positive
* Patients who will initiate afatinib as first-line treatment for EGFR mutation-positive NSCLC
* Male and female patients with age ≥18 years
* Written informed consent per local regulatory requirement

Exclusion Criteria:

* Patients who have received previous systemic therapy (previous adjuvant or neoadjuvant therapies are permitted)
* Patients with symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication) at the start of afatinib treatment
* Patients with concurrent participation in an interventional oncology clinical trial during the first-line treatment phase or within the last 30 days prior to the first-line treatment phase. If patients join another interventional study during the period of second-line treatment or later-line treatment, this patient should not be excluded from this study
An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease (CKD) in Type 2 Diabetes Patients

This non-interventional, multi-centric, cross-sectional study is aimed to determine the prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000 patients will be enrolled from 30 investigative sites all over the country. Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.

This is an observational, multicenter, cross-sectional study to be conducted at 30 sites in India. Endocrinologist/ Diabetologist from multiple private clinics will evaluate the Type 2 Diabetes patients. The study will be conducted over 9-10 months and will be started after obtaining written approval of Independent Ethics Committee (IEC) and written Informed consent of the patient. . Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.

Eligibility Criteria:
Inclusion Criteria:

1. Known cases of T2DM.
2. Male and female patients aged 18 years and above.
3. Must provide written Informed consent.

Exclusion Criteria:

1. Patients with known type-1 diabetes.
2. Patients with any form of acute kidney injury based on investigator's discretion.
3. Patients on maintenance dialysis or known renal transplant patients.
4. Patients who have participated in any interventional study within past 3 months prior to entry in this study.
5. Pregnant women.
6. Patients with symptomatic Urinary Tract Infection (UTI) or with history of hematuria.
Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.

An intraperitoneal implanted catheter is always necessary to perform Peritoneal Dialysis. Catheter insertion has been associated with infectious complication such as Exit Site Infection (ESI), Tunnel Infection and Peritonitis. The last one may lead to loss of the technique because the need of catheter removal. Most of international guidelines recommends the use of prophylactic antibiotics. Different protocols has been used, mostly intravenous single injection before the procedure. For the last 25 years our unit gives a single intraperitoneal dose of Cefazolin immediately after the catheter insertion. The aim of this study is compare the effect of a pre- operative IV dose os Cefazolin with a post- procedure intraperitoneal single dose administration of the same drug.


Eligibility Criteria:
Inclusion Criteria:

Subjects suffering from Chronic Kidney Disease, candidates to a intra- peritoneal catheter insertion

Exclusion Criteria:

Pregnancy; Active antibiotic treatment before the procedure; Known allergy to Cefazolin
Adjuvant FEC Versus EP in Breast Cancer (MIG5)

In this multicenter, randomized phase III trial, node positive early breast cancer patients are randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles of EP (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). The primary study endpoint is overall survival (OS). Secondary endpoints include toxicity and event free survival (EFS).

At the time the Gruppo Oncologico Nord-Ovest- Mammella Intergruppo trial 5 (GONO-MIG5) was designed in 1996, paclitaxel was known to have efficacy in patients with advanced breast cancer, but its role was still to be established in the adjuvant setting. Therefore the GONO-MIG5 trial was designed to compare a standard anthracycline-containing chemotherapy regimen, i.e. 5fluorouracil, epirubicin, ciclophosphamide (FEC), given for 6 cycles to a new regimen containing both epirubicin and paclitaxel (EP), given concurrently, for 4 cycles. This latter regimen was chosen on the basis of the results obtained in metastatic breast cancer patients, where the combination of doxorubicin and paclitaxel was associated with more than 90% of objective response . Only four cycles of the new regimen were planned since the expected toxicity, particularly the cardiotoxicity, was high, and a short treatment duration was hoped to be the best strategy to obtain a favourable balance between the toxicity and the expected high efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically confirmed breast cancer who had undergone radical mastectomy or breast-conserving surgery in addition to full ipsilateral axillary lymph node dissection
* Lymph node-positive disease with less than 10 involved axillary lymph nodes
* Surgery performed not more than 5 weeks before randomization
* ECOG performance status 0
* Absolute neutrophil count ≥ 2,000/mm³
* WBC ≥ 3,000/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 1.5 times ULN
* Postoperative regional radiotherapy limited to the remaining breast admitted for patients who received breast-conserving surgery
* Written informed consent

Exclusion Criteria:

* Prior or concurrent ipsilateral or contralateral invasive breast carcinoma within the last 10 years
* Metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes
* Prior chemotherapy or prior cytotoxic regimens or prior hormonal therapy
* Pregnant or nursing
* Other serious medical illness requiring medication, uncontrolled infections
* Other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
* Recent myocardial infarction, congestive heart failure, or serious arrhythmia
The Relation Between Serum Zinc and Lupus Nephritis

The goal of this observational study is to investigate the relation between serum zinc and lupus nephritis by search Prevalence of hypozincemia in lupus nephritis and Association between serum zinc and urea, serum creatinine, hemoglobin, estimated glomerular filtration rate (eGFR).

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting various organs including the skin, joints, kidneys, brain and heart...

Lupus nephritis (LN) is one of the most common severe organ manifestations of SLE . LN is clinically evident in 50-60% of patients with SLE , and it is histologically evident in most SLE patients, even those without clinical manifestations of kidney disease.

LN is associated with significant morbidity and mortality in SLE patients, as up to 20% of patients progress to end-stage renal disease (ESRD). The clinical manifestations of LN are variable, ranging from asymptomatic proteinuria to a myriad of manifestations associated with nephritic and nephrotic syndromes and ESRD.

Zinc is a vital micronutrient involved in numerous physiological processes including immune function, antioxidant defense, and cellular repair. It is a cofactor for over 300 enzymes and plays critical roles in DNA synthesis, protein production, and cell division. Zinc deficiency can impair immune function, increase oxidative stress, and hinder tissue repair, which are all relevant factors in autoimmune diseases like SLE, making its study in the context of LN particularly relevant.

However, further research is needed to fully understand the mechanisms and to develop evidence-based guidelines for zinc supplementation in lupus nephritis patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lupus nephritis

Exclusion Criteria:

* other patients with other renal diseases .
* patients with other autoimmune diseases.
* patients on dialysis.
* patients with Diabetes mellitus.
* patients with liver diseases.
Comprehensive Pain Programme to Determine Mechanism of Transition of Acute to Chronic Postsurgical Pain

To determine whether central sensitization is a mechanism of CPSP (chronic postsurgical pain) in women who will develop CPSP compared to women with no CPSP after hysterectomy. This mechanism is illustrated by a higher pain score in experimental pain models such as tonic heat stimulation, increased evoked mechanical temporal summation and increased wound hyperalgesia.

Chronic pain affects 9% of Singapore population resulting in major socioeconomic burden. Chronic postsurgical pain (CPSP) that persists for over 3 months could be related to nerve injury making this a strategic model to study the transition of acute to chronic pain. CPSP occurs in up to 50% after surgery and up to 32% after hysterectomy. Over 600000 hysterectomies were performed in the US in 2003 making CPSP a significant problem.

Investigators will perform this prospective cohort study to determine whether increased central sensitization and negative psychological experience are involved in the transition of acute to chronic pain after hysterectomy. Investigators will recruit 444 women undergoing hysterectomy and employ validated physical pain testing including tonic heat stimulation, mechanical temporal summation and wound hyperalgesia which had been shown to be related to central sensitization. Pain catastrophizing (negative thoughts of pain) and state trait anxiety scoring will be assessed for the impact of negative cognitive-affective experience on CPSP. A phone survey will be performed at 4 months to determine the primary outcome of CPSP. Arterial spin labeling will be used to delineate cerebral blood flow using arterial spin labeling, functional connectivity and structural connectivity to evaluate insula-anterior cingulate cortex differences in 30 women with CPSP compared to 30 women without CPSP.

In addition to evaluating whether central sensitization, negative psychological experience and activation of brain regions are different in women with CPSP after hysterectomy, the results of this study will elucidate potential mechanisms of CPSP development that will guide in future studies on potential novel therapeutic targets.

Eligibility Criteria:
Inclusion Criteria:

* Anthropometric profile within the following range: age 21-70 yr, American Society of Anesthesiology status I and II women
* Benign condition such as fibroids or adenomyosis
* Abdominal or laparoscopic hysterectomy

Exclusion Criteria:

* Vaginal hysterectomy
* being pelvic pain
* Failure to adequately determine tonic heat stimulation and mechanical temporal summation
* History of drug dependence or recreational drug use
* Allergy to any study drugs
Effect of Novel High-intensity Interval Training on Health and Fitness Outcomes in English Adolescents

Low-volume high-intensity interval exercise training may improve aspects of health and fitness in young people, but interventions must be practical and engaging. The investigators examined the effect of a novel school-based low-volume high-intensity interval training programme on health, fitness and physical activity outcomes in adolescent school pupils. 101 English adolescents aged 13-14 years took part in the study. Participants were healthy male and female volunteers, recruited from four schools in Northeast England. Using a non-randomised design, two schools took part in the intervention, and two were assigned to the control. Those in the intervention group completed a 10-week school-based high-intensity interval exercise training programme. The intervention took place three times per week, and comprised of 4-7 repetitions of 45 s maximal effort exercise (boxing, dance, soccer and basketball drills), each interspersed with 90-s rest. Participants were encouraged to work maximally during the 45-s repetitions. Control participants were instructed not to change their lifestyle, dietary or physical activity habits during the intervention period, and maintain their normal school physical education routine. Study outcomes were blood lipid and glucose levels, body composition, cardiorespiratory fitness, carotid intima-media thickness, physical activity levels, serum C-reactive protein levels and blood pressure.


Eligibility Criteria:
Inclusion Criteria:

1. Must attend one of the four schools that the study will take place in
2. Must be in the Year 9 English school year (aged 13-15 years)
3. Must provide parental consent and participant assent
4. Must be free from exclusion criteria

Exclusion Criteria:

1. Symptoms of or known presence of heart disease or major atherosclerotic cardiovascular disease
2. Condition or injury or co-morbidity affecting the ability to undertake exercise
3. Diabetes mellitus
4. Early family history of sudden cardiac death
5. Condition or disorder which is communicable via blood
6. Pregnancy or likelihood of pregnancy
Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

Lichtenstein technique, inserting a mesh over the inguinal cord in the neurological plane, is considered the standard of inguinal hernia repair, but it has 4% recurrence and 12% chronic postoperative pain. Rives technique inserts the mesh in the preperitoneal space behind the neurological plane and the muscular plane, thus better fulfilling the principle of hydrostatics.

These techniques have not been compared randomly for assessment of chronic pain, postoperative complications and recurrences

Eligibility Criteria:
Inclusion Criteria:

Men or women aged between 18 and 93 years (inclusive) at the time of the first screening visit.

They must provide signed written informed consent and agree to comply the study protocol

Exclusion Criteria:

Refusal to give informed consent. Refusal to participate giant inguinal hernias