cyrilzakka/clinical-trials huggingface dataset:
SOP's for CKD-MBD-Biomarkers

CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) is an extensive disease and includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular diseases in the context of renal insufficiency. Clinical pictures of peripheral artery occlusive disease (PAOD), Coronary artery disease (CAD) and arterial hypertension favours among other main risk factors (smoking, obesity, etc.) additional cardiovascular complications. For this reason it makes sense to monitor these patients regularly. For this purpose the determination of different biomarkers would be appropriate for control of the course of disease.

During various studies the biomarkers FGF23, s-klotho, sclerostin, DKK1, BMP2, YKL-40 und MGP were established as indicators for the disease activity, as diagnostic criteria for the existence of CKD-MBD or as risk markers for the incidence of adverse events (incl. death) within the scope of CKD-MBD. For the clinical routine care application of these parameters standard operating procedures (SOP) are missing for the determination method relating to optimal pre-analytic and analytic procedures. These analyses are necessary to ensure the reproducibility of study results and to transfer these parameters in the clinical daily routine for risk stratification.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are regularly (3 times a week) on dialysis in the Maria-Hilf-Clinic or healthy subjects
* Male or Female at the age of at least 18 years
* Patients who will be admitted to the clinics of the University Hospital RWTH Aachen or of the Maria-Hilf-Clinic Mönchengladbach or healthy subjects
* written informed consent form
* Subjects who are contractually capable and mentally able to understand and follow the instructions of the study personnel

Exclusion Criteria:

* age \< 18 years
* subjects who are unwilling or not able to consent
* pregnant or lactating women
* subject has been committed to an institution by legal or regulatory order
* dependency or working relationship with the investigator
* participation in a parallel interventional clinical study
* Hb-value \< 10 g/dl
The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial

The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial


Eligibility Criteria:
Inclusion Criteria:

* who have idiopathic scoliosis, showing at Cobb's angle over 20 degrees,less than 45 on X-ray

Exclusion Criteria:

* Patients who underwent spinal surgery
* Patients with spinal scoliosis due to cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities
* Patients observed with Cobb's angle less than 20 degrees, over 45 degrees
* Patients complaining of acute low back pain
* Patients with cognitive impairment, severe mental illness, and inability to communicate
Perioperative Bleeding and Aspirin Use in Spine Surgery

The investigators would like to further the current understanding of aspirin and its effects on perioperative bleeding by conducting a randomized controlled trial of spinal surgery patients receiving varying doses of aspirin or no aspirin perioperatively. The investigators hypothesize that there will be no significant difference in perioperative blood loss between the different groups.

Selected patients will be given either no aspirin, low-dose aspirin (81 mg), or high-dose aspirin (325 mg) in the perioperative period. These dosages are based on the Pharmacist's letter/Prescriber's letter which provides aspirin dosing recommendations for varying cardiovascular indications. Allocation of dosing will be based on computerized randomization in order to achieve approximately 100 patients in each group. Patient records will then be assessed for demographic characteristics, comorbidities, symptoms, functional outcome scores (Sf-12), operative time, intraoperative estimated blood loss, postoperative blood loss in drainage tubes (when applicable), cumulative blood loss, transfusion of blood products, hemoglobin level, preoperative International Normalized Ratio (INR), preoperative platelet count, hospital length of stay, and morbidity and mortality including development of NSTEMI, atrial fibrillation, surgical site infection, pulmonary embolism, and hospital 30-day readmission rates.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years old, who are not taking aspirin at the time of operation as part of a current cardiovascular treatment plan, who will undergo spinal surgery from 2016-2019 in the practice of Dr. Eubanks.

Exclusion Criteria:

* Any patient under the age of 18 and/or is already taking anticoagulant therapy for an established cardiovascular disease at the time of surgery as part of a cardiovascular therapy.
A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency

The purpose of the study is to monitor initiated Diafer® therapy administered according to hospital practice and the product labeling in routine clinical practice in haemodialysis patients with Chronic Kidney Disease.

Parenteral iron is the iron treatment of choice for haemodialysis (HD) patients with Chronic Kidney Disease (CKD), who may suffer from absolute iron deficiency due to continuous blood losses and/or functional iron deficiency due to erythropoiesis stimulating agent treatment or impaired release from iron stores.

Much evidence indicates that adequate iron supply is necessary to achieve optimal responses to ESAs and thereby potentially avoid ESA induced ADRs.

Pharmacosmos has been working with dialysis providers for many years and identified a medical need for a new safe and cost-effective low dose intravenous (IV) iron that can be administered frequently. Diafer® is a new low dose iron formulation based on iron isomaltoside 1000, with doses restricted to maximum 200 mg iron pr. injection. No test dose is needed and Diafer® may be administered as a push injection.

The primary objective of the study is to monitor initiated Diafer® therapy administered according to hospital practice and the product labeling in routine clinical practice in HD patients with CKD. The scientific rationale being to fulfil a need for systematic information/auditing on applied practice including long term experience with the use of IV iron in the HD setting. This information will provide an evidence base for optimised treatment procedures.

Eligibility Criteria:
Inclusion Criteria:

* HD patients ≥ 18 years of age in a stable phase of CKD as judged by the investigator
* Patients must have been on HD \> 3 months
* Patients must have received at least one dose of iron sucrose treatment within the last 6 months

Exclusion Criteria:

* Diafer® contraindications
* Patient not able to give informed consent
* Significant disease not related to CKD and likely to impact study results as evaluated by investigator
* Inability to estimate retrospective baseline data
* Planned change of iron dosing protocol or routines around iron administration during the study
Effect of Laser Biostimulation With Mandibular Ridge Splitting and Peek Overdenture

This study was conducted to determine the effectiveness of two-implant retained polyetheretherketone (PEEK) overdentures on reducing the transmitted forces on implants placed with ridge splitting either treated with laser biostimulation or not.

This randomised controlled trial was executed on 18 completely edentulous patients from the Outpatient Clinic of the Faculty of Dentistry at Mansoura University in Egypt.

Eligibility Criteria:
Inclusion Criteria:

- eligible patients must have mandibular knife edge ridge

Exclusion Criteria:

* contraindicated any systemic disease preventing surgical intervention such as bone metabollic disease , diabetes mellitus
Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors

Based on \[68Ga\]B7H3 Affibody-BCH, this study investigates its radioactive uptake and imaging capabilities in tumor patients, with the aim of establishing a correlation between radioactive uptake and B7-H3 receptor expression. Utilizing whole-body PET technology, the pharmacokinetic dynamics of \[68Ga\]B7H3 Affibody-BCH are examined to ascertain its pharmacological characteristics. Ultimately, this research establishes a framework for pharmacokinetic analysis using whole-body PET.


Eligibility Criteria:
Inclusion Criteria:

1. Age range 18-75 years, open to both male and female participants;
2. Participants must meet the following hematologic and hepatic/renal function criteria: Hematology: WBC ≥ 4.0 × 10\^9/L or neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L; Prothrombin time (PT) or Activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN); Hepatic and renal functions: Total bilirubin (T-Bil) ≤ 1.5 times the upper threshold limit (ULT), ALT/AST ≤ 2.5 ULN or ≤ 5 ULT for subjects with liver metastasis, Alkaline phosphatase (ALP) ≤ 2.5 ULN (or ≤ 4.5 ULN in cases of bone or liver metastasis); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT;
3. Normal cardiac function;
4. Expected survival of at least 12 weeks;
5. Good adherence to follow-up;
6. Presence of at least one measurable target lesion according to RECIST 1.1 criteria;
7. Women of childbearing age (15-49 years) must undergo a pregnancy test within seven days prior to the commencement of the study and test negative; sexually active male and female participants must agree to utilize effective contraception to prevent pregnancy during the study and for three months following the final examination;
8. Patients for whom a clinical physician recommends PET/CT scans for the diagnosis and staging of tumors;
9. Participants must fully understand and voluntarily agree to participate in the study, and must sign an informed consent form.

Exclusion Criteria:

1. Severe abnormalities in liver and renal function and blood counts;
2. Patients planning to conceive;
3. Pregnant or lactating women;
4. Individuals unable to lie flat for thirty minutes;
5. Individuals who refuse to participate in this clinical study;
6. Individuals suffering from claustrophobia or other psychiatric disorders;
7. Other situations deemed unsuitable for trial participation by the researchers.
Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion

Current practice for the provision of late second trimester abortion (dilation and evacuation, or D\&E) often involves the administration of digoxin into the fetal compartment to induce fetal demise prior to the procedure. Digoxin may be administered transabdominally or transvaginally into the fetal compartment. Both modes of administration have been shown in prospective studies to be highly effective and safe. Both modes of administration are considered standard of care. This pilot study will directly compare transabdominal and transvaginal digoxin with respect to patient preference (i.e, patient pain score describing discomfort with injection).


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Singleton viable gestation
* Identifying as primarily English-speaking
* Body mass index less than 40 kilograms/meters squared
* Already a consented patient for second-trimester abortion procedure with digoxin to be performed for termination of pregnancy at the study site
* No medical contraindication to digoxin (i.e., no cardiac dysfunction, no renal dysfunction, no hypersensitivity to digoxin)
Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique

Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation due to craniosynostosis.

The investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation and Implantation of an external ventricle drain or a subdural ICP Monitoring devise. The second ICP probe is fixed epicutaneously on the skin over the frontal fontanel. The hourly measured ICPs within 24 hours postoperatively were compared with the Bland-Altman two methods analysis.

Eligibility Criteria:
Inclusion Criteria:

Child with open fontanel Need of ICP monitoring

Exclusion Criteria:

closed fontanel No Need of ICP monitoring
Evaluate the Safety and Pharmacokinetics of Ricolinostat

This study is an open-label, phase I clinical study to evaluate the safety and pharmacokinetics of ricolinostat in healthy Chinese adult subjects.

This study is an open-label, phase I clinical study to evaluate the safety and pharmacokinetics of ricolinostat in healthy Chinese adult subjects.

12 subjects are planned to be enrolled, both male and female, and all will receive the investigational drug.

Eligibility Criteria:
Inclusion Criteria:

* Only patients who meet all of the following inclusion criteria can be enrolled in this study:

  1. Healthy adult male or female subjects aged 18 to 55 years;
  2. Body mass index of 19 - 26 kg/m2 (including the boundary value); the weight of male subjects should not be lower than 50 kg, and the weight of female subjects should not be lower than 45 kg;
  3. Subjects have no pregnancy plan and voluntarily take effective contraceptive measures during the study to 3 months after the last dose and have no sperm or egg donation plan.
  4. Subjects who fully understand the objective, nature, method and possible adverse reactions of the study, volunteer to be subjects and sign the informed consent form;
  5. Able to complete the study according to the protocol requirements.

Exclusion Criteria:

* Subjects who meet any of the following exclusion criteria are excluded:

  1. Allergic to ricolinostat (including excipients) and other similar drugs;
  2. Have had a history of drug abuse in the past five years or have used drugs three months before screening, or who have positive result for drug abuse screening at screening;
  3. Smokers (people who smoked tobacco products in the past 3 months), or habitual use of nicotine-containing products, or those who are tested positive for nicotine at screening;
  4. Drinking more than 14 units of alcohol per week within 6 months before screening (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) or have taken alcoholic products 48 hours before dosing, or tested positive for alcohol breath test;
  5. Diseases or factors judged by the investigator to be abnormal and clinically significant, including but not limited to neurological, mental, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immune, skeletal system diseases or other factors;
BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy

A randomized trial will compare 6-months of low-dose (65mg elemental iron daily) among prospective blood donors who are deferred for low haemoglobin but have passed all of the other pre-screening requirements for blood donation to a group of donors who were deferred from donating and receive the current standard of care (nutrition counseling only). An automated full blood count (FBC) will also be done to identify any safety concerns. The randomized trial will evaluate effectiveness with the primary outcome of at least one successful donation during a 12-month follow-up period. Safety will be evaluated by tracking iron supplementation related adverse events (e.g., lower gastrointestinal) and acceptability (e.g., compliance to study prescribed regimen) with monthly phone calls. Participants will be followed for a total of 12 months from screening with follow up phone calls at 4 weekly intervals. All participants will receive nutrition counselling and haemoglobin will be evaluated at screening. Individuals with very low haemoglobin (\<10g/dl in females and \<11g/dl in males) will be identified by an automated FBC at screening and referred for proper medical care.

Sample size will be 264 per group: this gives 80% power for detecting an odds ratio of 2.6. With 2 donors recruited at each donation event, this will require 264 donation events. This corresponds to 2.5 donation events per week for 2 years or 2 donation events per week for 2.5 years.


Eligibility Criteria:
Inclusion Criteria:

* individuals between 18 - 60 years who weigh at least 50kg
* pass pre-donation screening using the NBSG standardized donor screening questionnaire
* vital signs meet the NBSG requirement for blood donation
* non-contact forehead temperature not exceeding 37.5°C
* meeting acceptable requirements for skin lesions, needle marks and physical appearance.
* willingness and ability to consent
* understands one of English, Twi, Ewe, or Ga
* deferred for low haemoglobin
* intend to remain in the study during the entire length of the study

Exclusion Criteria:

* persons who have used iron supplementation within the past one month
* potential donors who are found to have haemoglobin Hb \< 10g/dl (females) and Hb\<11g/dl (males) at screening
A Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Formulations in Healthy Volunteers

This Phase 1 study aims to determine the oral bioavailability of a single dose of a new vapendavir tablet formulation and compare it to that of the previous vapendavir capsule formulation. The safety of both drug products will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening
* Capable of giving written informed consent
* Subject is able to understand and comply with the protocol requirements, instructions and restrictions
* Healthy on the basis of physical examination, medical history, medication usage, VS, ECGs, and clinical laboratory tests
* Female subjects must be of non-childbearing potential
* Male subjects must agree to use a double barrier method of birth control

Exclusion Criteria:

* Positive results for Hepatitis B, Hepatitis C, or HIV
* Frequent use of tobacco products, including cigarettes, cigars, chewing tobacco
* A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event; Current or recent respiratory infection
* Presence or history of significant allergy
* Clinically significant abnormalities noted on ECG
* Screening vital signs representing sustained elevated blood pressure
* Presence of significant gastrointestinal abnormalities
* Safety laboratory abnormalities noted at screening which are clinically significant
* Current or defined history of abuse of alcohol or illicit drugs
* A positive pregnancy test at screening
* Poor vein access or fear of venipuncture or sight of blood
CopeSmart: Using Mobile Technology to Promote Positive Mental Health in Young People

This study evaluates the effectiveness of a mental health mobile app (CopeSmart) in promoting positive mental health through emotional self-awareness in adolescents. Participants will be recruited from second-level schools in Ireland. Schools will be randomly assigned to the intervention or control condition. Participants in the intervention condition will use CopeSmart for a four week period. Those in the control condition will not use any mental health app.


Eligibility Criteria:
Inclusion Criteria:

* Must be between 14 and 19 years
* Must be enrolled in second-level education
* Must have access to an iPhone, iTouch or Android mobile device
* Must obtain signed parental consent to participate

Exclusion Criteria:

- No parental consent
Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma

The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066/ABBV-066 (risankizumab).


Eligibility Criteria:
Inclusion criteria:

1. Pre-bronchodilator clinic measured forced expiratory volume (FEV1) of =40% and =85% of predicted normal.
2. One year history of asthma diagnosed by a physician, and have FEV1 reversibility of =12% and an absolute change of at least 200 mL after administration of 400 µg salbutamol.
3. Must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
4. Must have documented history of two or more severe asthma exacerbations in the last 12 months.

Exclusion criteria:

1. Patients with a significant disease other than asthma.
2. Patients who are not able to produce sputum or sputum samples of sufficient quality.
3. Patients who had clinically relevant history of intubation for asthma exacerbation in the past year.
4. Patients diagnosed with any concurrent respiratory disease.
5. Recent history (within 6 months) of myocardial infarction or hospitalized for cardiac failure in the past year.
6. Patients who have undergone thoracotomy with pulmonary resection.
7. Patients who have undergone bronchial thermoplasty or radiotherapy procedure in the past year or have planned procedures during the study.
8. Patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone (or equivalent) in the past 6 weeks.
9. Pregnant or nursing women.
10. Women of childbearing potential that, if sexually active, is unwilling to use a highly effective method of birth control.
11. Clinically relevant acute infections or chronic infections.
12. Have received any live bacterial or live viral vaccination in the last12 weeks.
13. Have received Bacille Calmette-Guerin (BCG) vaccination in the last 12 months.
14. Have received treatment with ustekinumab (Stelara®).
15. Have received treatment with any other biologics in the last 3 months or within 6 times the half-life of the compound.
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries

This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with acute blunt trauma injuries.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 16 years and over Fresh impact injury of the upper or lower limbs, not requiring admittance to hospital \& meeting baseline pain intensity level Anticipated time between injury and treatment must be ≤ 6 hours

Exclusion Criteria:

* Pain medication prior to randomization Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated Any physical impairment that would influence efficacy assessments, such as peripheral or central neurological disease, significant back pain, painful conditions of the upper or lower extremities Other protocol-defined inclusion/exclusion criteria may apply
Effects of PEEP on Optic Nerve Sheath Diameter During Robot-Assisted Laparoscopic Prostatectomy

The investigators aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Effects of positive end-expiratory pressure ventilation on intracranial pressure have not been evaluated in patients undergoing laparoscopic surgery. We aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo robot-assisted laparoscopic prostatectomy

Exclusion Criteria:

* Patients who have cerebrovascular disease or history of cerebrovascular disease
* Patients who are younger than 20 years