cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

Primary Objective:

Evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH).

Secondary Objectives:

* Evaluate the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules.
* Determine the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.

The total study duration per patient will be approximately up to 28 weeks.

Eligibility Criteria:
Inclusion criteria :

* Male or female aged 5 to 18 years old.
* Weight ≥15 kg.
* Chronic kidney disease (CKD) Stage 3 or 4 not on dialysis, defined as glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73m\^2 (established by Schwartz equation) at Week -2 visit.
* Intact parathyroid hormone (iPTH) value \>100 pg/mL for CKD Stage 3 or \>160 pg/mL for CKD Stage 4, at Week -2 visit.
* Signed informed consent/assent form.

Exclusion criteria:

* The patient has a serum 25-hydroxyvitamin D level \<30 ng/mL at screening.
* The patient has a corrected calcium ≥10 mg/dL at the Week -2 visit.
* The patient has a serum phosphorus \>4.5 mg/dL for children 13 to 18 years of age; \>5.8 mg/dL for children 5 to 12 years of age at the Week -2 visit.
* The patient is anticipated to require maintenance hemodialysis within 3 months.
* The patient used cinacalcet or vitamin D sterol therapies such as calcitriol, doxercalciferol, or paricalcitol within 14 days prior to the baseline visit.
* The patient has a history of, or active, symptomatic heart disease within 12 months prior to the baseline (Week 0) visit.
* The patient currently has a chronic gastrointestinal disease (ie, malabsorption, severe chronic diarrhea, chronic ulcerative colitis, or ileostomy).
* The patient currently has primary hyperparathyroidism or has had a total parathyroidectomy.
* The patient has an active malignancy.
* The patient is unable to swallow a capsule in size similar to the Hectorol® and Rocaltrol® capsules.
* The patient has a history of sensitivity or allergy to doxercalciferol, calcitriol or other vitamin D analogs.
* The patient currently uses aluminum or magnesium-based binders.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description of Patients With Type 1 Diabetes Treated With Teplizumab

Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment.

Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient informed consent or assent (for patients \< 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity.
* Patient received ≥ 1 day of teplizumab treatment.

Exclusion Criteria:

* Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol.
GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease

The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia with no circulating blasts and \< 5% blasts in the bone marrow.
* Subjects with non-Hodgkin lymphoma, including but not limited to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell, or mantle cell lymphoma must have chemosensitive disease at time of transplant. Subjects with Hodgkin lymphoma with chemosensitive disease at the time of transplant.
* Must be candidates for reduced-intensity conditioning regimens.
* Must be candidates for peripheral blood stem cell transplants.
* Karnofsky Performance Status score ≥ 70% or Eastern Cooperative Oncology Group Performance Status score of 0 to 2.
* Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockcroft-Gault equation.
* Be willing to avoid pregnancy or fathering children.

Exclusion Criteria:

* Has previously received an allogenic hematopoietic stem cell transplant.
* Presence of an active uncontrolled infection.
* Known HIV infection.
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation.
* Prior malignancies.
* Severe organ dysfunction.
* Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment.
* Currently breastfeeding.
* Known allergies, hypersensitivity, or intolerance to any of the study medications.
* Receipt of live (including attenuated) vaccines during the study, or anticipation of need for such a vaccine during the study.
* History of primary idiopathic myelofibrosis or any severe marrow fibrosis that would prolong neutrophil engraftment to \> 28 days after transplant.
* Post-transplant maintenance therapy for the hematologic malignancy or plans to initiate maintenance therapy during study treatment.
Efficacy of Lung Ultrasound in Monitoring Fluid Resuscitation in Chest Trauma Patients

Efficacy of Lung ultrasound in monitoring fluid resuscitation in chest trauma patients with lung contusions

Trauma is a public health problem, associated to high morbidity and mortality, In Egypt the mortality from road traffic crashes is about 12000 victims per year.

* Chest trauma represents from 10% to 15% of the total number of traumas worldwide.

According to ATLS protocol , early diagnosis and management of Chest trauma are essential. \*Pulmonary contusion is found in 30-75% of cases of chest injury.

* point of care Ultrasound (POCUS) is Now a corner stone in Emergency management it can predict lung contusions within the first 72 hours after trauma.
* Recently, LUS Play a major role in assessment of the volume status in Trauma patients.
* B-lines score (BLS) has been validated as a lung ultrasound quantification of pulmonary congestion.The sum of all B-lines yields a score, B-lines score (BLS), which assess the degree of lung contusion. So that LUS may provide a valuable safety threshold to conduct fluid therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* chest trauma patients either with or without other injuries.
* Any patient with either blunt or penetrating chest trauma.

Exclusion Criteria:

* - Patients in cardiac arrest.
* Patient refusal to participate
* Pregnant females.
Effectiveness of a 12 Week Theory Driven Intervention Promoting Adherence to the MIND Diet

This study aims to test the feasibility and acceptability of a 12 week online dietary promoting MIND diet behaviour. This study also tests the effectiveness of the MIND diet on cognitive function, mood, quality of life and participants capability, opportunity and motivation towards adoption of the MIND diet.

This study is a randomized controlled prospective follow up study, condition (control Vs intervention) x time(baseline Vs follow up) ANOVA with repeated measures design. Outcome measures for COM-B, cognitive function, mood and quality of life were recorded for both the intervention and control groups. With power set at .80, and alpha = .05, G\*Power indicated that a sample size of 36 would be required. Forty-one participants took part in the study. Participants were healthy male, and female aged between 40-55 years old living in Northern Ireland.

There are 2 intervention arms and one control group. The intervention was designed using the Behaviour Change Wheel, with prior qualitative research informing the intervention.

All statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) with significance set at P \< 0.05 throughout

Eligibility Criteria:
Inclusion Criteria:

. Healthy male and female aged 40-55 living in NI

Exclusion Criteria:

* Anyone on a specific dietary pattern (veganism, vegetarian, Atkins)
* Anyone on a specific diet recommended by their Doctor (eating disorder)
* Specific illnesses such as high cholesterol, diabetes, heart disease, dementia.
ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)

The purpose of the study is to document the natural history of hemophilia A disease and long-term outcomes in terms of effectiveness, safety and quality of life in participants receiving Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) in routine clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Participant has hemophilia A {FVIII lesser than or equal to (\<=)5%}
* Participant is prescribed Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) by the treating physician
* Participant or participant's legally authorized representative provides informed consent

Exclusion Criteria:

* Participant has known hypersensitivity to the active substance or any of the excipients
* Participant has known allergic reaction to mouse or hamster proteins
* Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving another FVIII concentrate or device during the course of this study
Quadratus Lumborum Block : Local Anesthesia Versus Placebo

Opioid analgesics have many side effects. Quadratus lumborum (QL) block is one kind of regional nerve block that can reduce the side effects of opioid analgesics. The investigators hypothesize that QL block with local analgesics (ropivacaine) can significantly reduce pain intensity in comparison with placebo.

Opioid analgesics have been used to control the pain. However, many postoperative complication, such as nausea, vomiting, constipation, ileus, etc are related to opioid usage. Recently, local or regional pain nerve block, such as transversus abdominis plane block, wound infiltration, have been reported in several studies. Quadratus lumborum (QL) block was first introduced in the abstract of 2007 European Society of Regional Anesthesia. The effect is longer and more than that of transversus abdominis plane block because it works close to the spinal cord nerves. The QL block can be an effective pain control method for patients who underwent ileostomy closure. The aim of this study is to compare pain intensity after ileostomy closure between QL block (ropivacaine) group and placebo group (normal saline).

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-75 years, either sex
* Patients scheduled to undergo elective ileostomy repair surgery under general anesthesia.
* Patients underwent curative surgery and ileostomy due to colorectal cancer.
* Willingness and ability to sign an informed consent document

Exclusion Criteria:

* Allergies to anesthetic or analgesic medications
* Contraindication to the use of locoregional anesthesia
* Chronic opioid use
* Coagulopathy, Impaired kidney function, uncontrolled diabetes, psychiatric disorders, severe cardiovascular impairment or chronic obstructive lung disease
* Necessity of major resection other than colorectal, palliative surgery
* BMI above 35kg/m2
* American Society of Anesthesiologists (ASA) physical status above 3
the Safety and Efficacy of Antiplatelet Therapy in Patients of CAA

Ischemic cardiovascular and cerebrovascular diseases are the main causes of death among people. Antiplatelet threrapy is very important for patients to prevent ischemic cardiovascular and cerebrovascular diseases.Ischemic cardiovascular patients of cerebral amyloid angiopathy (CAA) patients is as high as 20%, aspirin and clopidogrel is applied to prevent or treat the patient with CAA is controversial, there is no valid evidence of CAA crowd is safe to use of antiplatelet drugs, but progress in clinical treatment is usually based on patient condition for antiplatelet agents to prevent the occurrence of adverse events, such as blood clots.Therefore, this study is intended to be a single-center, prospective study of patients with ischemic cardiovascular and cerebrovascular diseases taking aspirin and clopidogrel, to determine whether the patients are combined with CAA , and to conduct a follow-up study for 12 months after team inclusion:1) The prevalence rate and gene spectrum of ischemic cardiovascular and cerebrovascular diseases among CAA patients enrolled in our hospital were analyzed;2) To explore the correlation between aspirin and clopidogrel drug genes and blood drug concentrations and diseases in patients with ischemic cardiovascular and cerebrovascular diseases complicated with CAA;3) To evaluate the efficacy and safety of aspirin and clopidogrel in patients with ischemic cardiovascular and cerebrovascular diseases who combined with CAA.

This project intends to observation of bleeding the application of antiplatelet in patients with CAA, so as to provide effective clinical evidence for the further application of clopidogrel and aspirin in patients with CAA in the future, and to provide reference basis for the accurate formulation of clinical treatment plans and the balance of health risks brought by adverse bleeding reactions.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of CAA
* Must be able to swallow tablets

Exclusion Criteria:

* Clopidogrel gene was non-CYP2C19 \*1 patients.
* Patients with surgical thrombolysis .
* Patients with arteritis, aneurysms, arterial trauma and other risk factors were excluded.
* Patients with tumours, infections, fever, inflammatory diseases, post-embolization bleeding, peripheral vascular thrombosis or embolization, and other blood diseases such as hemophilia were excluded.
* Currently receiving treatment in another experimental device or drug study, or completing treatment in another experimental device or drug study ≤30 days.
* Patients are allergic to any of the ingredients known to be given aspirin or clopidogrel.
* Patients has an unstable medical condition, or is otherwise considered unstable by the investigator, based on medical history, physical examination, and routine laboratory tests.
* Patients who need to change or discontinue aspirin or clopidogrel, fail to take medication, or fail to come to the hospital on time due to their condition, and some information is missing.
Development of the Oncology Opportunity Cost Assessment Tool

This study develops and tests an instrument to measure opportunity costs called the Oncology Opportunity Cost Assessment Tool (OOCAT) in cancer patients. Patients experience significant costs, both direct financial as well as indirect costs, associated with seeking cancer treatment. While the direct financial impact of care on patients is receiving increased attention, other important consequences, such as opportunity cost, remain largely unmeasured. Opportunity cost is an economics term that refers to the loss of potential benefits from other options when one option is chosen - if resources are used for one purpose, they are no longer available for the next best option. The information and knowledge gained from this study may help researchers develop the OOCAT, which may allow them to understand the opportunity cost of treatment for each patient. The OOCAT may then be used to determine not just the best medications for patients, but also the best comprehensive treatment plan that will allow them to get the right treatment in the right place at the right time.


Eligibility Criteria:
Inclusion Criteria:

* Treated for cancer at one of the 3 participating sites (Jefferson Center City, Jefferson Methodist Hospital, Jefferson Abington)
* English speaking
* Able to attend and participate in a focus group

Exclusion Criteria:

* Treated at a Jefferson site other than the ones mentioned
* Non-English Speaking
Evaluation of Benztropine for Cocaine Craving - 2

The purpose of this study is to compare the efficacy of benztropine (or DA reuptake inhibitor) with atropine and placebo in affecting stimulated craving to cocaine cues.


Eligibility Criteria:
Please contact site for information.
Understanding the Increased Risk of Atrial Fibrillation in Athletes: a Case-control Study

Exercise is beneficial to heart health, however, there appears to be a 'U' shaped relationship where too much exercise may increase the risk of an irregular heart rhythm, called atrial fibrillation. Endurance athletes may have up to a 2.5-fold higher risk of developing atrial fibrillation than non-athletic controls.

The mechanisms behind this increased risk of atrial fibrillation are not the well understood. It is thought to be a mixture of enlarged heart chambers, low resting heart rate, genetic predisposition and possibly scarring in the heart. In this study, the investigators will investigate the electrical activity changes in the heart, using a high-quality electrocardiogram (ECG) and relate this to changes in the heart size measured by ultrasound and MRI. Cardiopulmonary exercise testing will determine fitness (V̇O2 max) and assess the heart's electrical activity during exercise.

This will be a case-control study where athletes with and without atrial fibrillation will be recruited. The investigators hope the results of this study can improve our understanding of atrial fibrillation in athletes by associating atrial fibrillation with structural and electrical differences which may aid the prediction of future atrial fibrillation development and help guide more athlete-specific treatment pathways.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age at the time of enrolment, male and female.
* History of atrial fibrillation confirmed on ECG - either paroxysmal or persistent.
* Competitive athlete. Defined as:

  1. Competed in endurance sports with a total cumulative moderate to high intensity of \> 1500 hours.
  2. Have participated in at least one competitive event in the last 10 years.

Exclusion Criteria:

* Permanent atrial fibrillation.
* History of pre-existing cardiovascular disease :

  1. Atherosclerotic disease: previous myocardial infarction, symptomatic coronary artery disease or Peripheral peripheral arterial disease
  2. Left ventricular systolic dysfunction (EF \< 45%)
  3. Heart muscle disease: cardiomyopathies, Infiltrative diseases of the heart
  4. Complex Congenital heart disease
  5. Moderate or severe valvular disease
  6. Uncontrolled hypertension (\>180/100mmHg)
Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease

This trial is a randomized, parallel-group, double-blind, controlled clinical trial to evaluate the effect of hyaluronic acid (HA) on dry eye disease.

This trial is a randomized, parallel-group, double-blind, controlled clinical trial to compare intervention treatment (Per-Young Eye Drops: preservative-free 0.15% HA) against control treatment (AIM Artificial Tears: salt solution without 0.15% HA). All participants will be received Per-Young Eye Drops (4 to 8 times per day) or AIM Artificial Tears (4 to 8 times per day) with 12 weeks. Two drugs are identical in appearance and order of administration will be double-blind randomized.

Primary endpoint:

To compare the central tear meniscus height (TMHc) of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA at 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged greater than or equal to 20 years (\>= 20 years).
* The symptom criterium of ocular surface disease index (OSDI) score \> 13.
* One of the two following examination criteria:

  1. Central tear meniscus height (TMHc) \< 0.20 mm,
  2. Noninvasive tear-break time (NITBUT) \< 6 s, for at least one eye.
* Informed consent form (ICF) signed by the participant or a legal guardian.

Exclusion Criteria:

* Male or female subjects aged less than 20 years (\<20 years).
* The symptom criterium of ocular surface disease index (OSDI) score \< 13.
* Central tear meniscus height (TMHc) \> 0.20 mm and Noninvasive tear-break time (NITBUT) \> 6 s for each eye.
* Acute inflammatory eye diseases.
* Receive ocular or eyelid surgeries before 6 months (except cataract surgery).
* Allergy to HA
* Pregnancy
* Conditions judged by the investigator as unsuitable for this trial.
Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women

The infertility patients who are performed saline infusion sonohysterography (SIS) for studying the pathology inside the uterine cavity has pain. From pilot study the pain score is 6.80. It will have more benefits if we can manage this procedure with less or no pain. Many studies have tried to decrease pain such as types of catheter, intrauterine lidocaine infusion. Some have real effects but no study with oral Mefenamic acid or Hyoscine before the procedure.The drugs are safe and easy to administration and chief.


Eligibility Criteria:
Inclusion Criteria:

* infertility female
* no history of HSG or Hysteroscopy

Exclusion Criteria:

* vaginal or pelvic infection
* abnormal Pap smear
* contraindications for Mefenamic acid including upper and lower GI ulcers, bleeding disorder, Asthma or allergies, renal disease, using Warfarin,Aspirin, Lithium, history of Mefenamic acid or Hyoscine allergies