cyrilzakka/clinical-trials huggingface dataset:
Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Unstable Warfarin

Patients on warfarin but with unstable international normalized ratio (INR) will be recruited to a randomized trial comparing dosing based on an algorithm (Fearon algorithm, named after the mathematician Michael Fearon), which uses historical data to estimate patients' sensitivity to warfarin and to dose changes as well as the lag time until a dose adjustment takes effect, or to the investigators standard management Main outcome is improvement in time in therapeutic range.

Patients with very variable INRs resulting in a low proportion of time in therapeutic range (TTR) have a higher risk of both bleeding complications and thromboembolic events. A good TTR is generally considered to be over 60% and "excellent TTR" is above 72% of time in range. The investigators will recruit patients with a TTR below 50%.

The Fearon algorithm provides a more thorough understanding of the individual responses to changes in warfarin dose and with a personalized nomogram for dose adjustments and timing of laboratory tests the investigators have an opportunity to improve the TTR and on a larger scale to reduce clinically important adverse events. Before embarking on a large randomized trial with this revised Fearon algorithm-derived nomogram this pilot study with a randomized, open-label design will be performed to demonstrate proof of principle.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mechanical heart valve prosthesis managed for the warfarin therapy by the Thrombosis Service at HHS-General Hospital.
* Treated with warfarin for at least 1 year.
* Therapeutic INR range 2.0-3.0 or 2.5-3.5.
* TTR in the lowest quartile

Exclusion Criteria:

* Known poor compliance due to for example alcohol abuse or cognitive impairment
* Refusal to provide written informed consent
Natural History of Pedal Puncture Wounds in Diabetics

There are no evidence (research) based guidelines for treatment of early, closed puncture wounds of the feet in diabetics. Surgeons usually see only the limb- and life-threatening consequences of puncture wounds of the feet in diabetics, and are therefore tempted to advocate more aggressive, preemptive, invasive primary treatment for all such wounds, assuming, from this blinkered perspective that all such wounds progress to serious infection. This study is designed to determine the natural history of puncture wounds of the feet in diabetics, specifically, whether all become infected or whether some do heal without any surgical intervention. It requires administration of a questionnaire to 188 known diabetics attending 11 selected outpatient health care centers in the parish of St. James, Jamaica.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic
* 15 years and older
* Resident in the parish of St. James, Jamaica

Exclusion Criteria:

* Impairment of conscious level or mental status such that autonomy is compromised
Evaluation of a Parenting and Stress Management Programmme

The study will use a randomised controlled trial design to evaluate the effects of a combined intervention of Triple P-Positive Parenting Program Discussion Groups and Stress Control in comparison to a waitlist condition. The combined intervention will be evaluated with parents in Glasgow, United Kingdom, with a 3-8 year old child.


Eligibility Criteria:
Inclusion Criteria:

* Has a child aged between 3 and 8 years old
* Able to attend the group sessions held at Langside Halls, Shawlands in Glasgow, United Kingdom
* Able to read a newspaper without assistance

Exclusion Criteria:

* Child has a diagnosis of a developmental or intellectual disability or other significant health impairment
Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study

This purpose of this pilot and feasibility study is to determine whether attending an acute kidney injury (AKI) clinic after discharge from the hospital impacts prescription medicine use, blood pressure and recovery of kidney function as compared to usual care.

Participants with moderate to severe acute kidney injury (AKI) who are discharged from participating centers (the University of Alabama at Birmingham Hospital, Vanderbilt University Medical Center, University of Kentucky) will be randomized to coming to a dedicated AKI clinic at one of the three recruitment centers for up to four visits over 3 months or usual care. At the visits to the AKI follow-up clinics, medicine reconciliation will be done, blood pressure will be measured, information on hospitalizations and other adverse events will be taken and blood and urine samples will be collected to check kidney function and store samples to measure biomarkers of AKI. Participants randomized to usual care will be contacted by telephone to review medications currently being taken and to collect information on hospitalizations and other adverse events. The primary outcome measures will be include both process of care and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years and older
* Patients who have developed moderate to severe AKI in the hospital, defined as:

  1. At least a doubling of peak creatinine from baseline or receipt of dialysis while in the hospital
  2. AKI of any degree in individuals with an estimated glomerular filtration (eGFR) rate \< 60 ml/min/1.73m2 at baseline
  3. AKI of any degree whose discharge creatinine does not return to within 50% of baseline.
* Able to provide signed informed consent

Exclusion Criteria:

* Patients with a history of kidney transplant
* Patients who, in the opinion of the investigator, are not suitable to participate in the study
* Unable to obtain written informed consent
* prisoners or pregnant patients
Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)

The purpose of this study is to identify and evaluate the event rate of the composite endpoint of all-cause mortality (ACM) or hospitalization for heart failure (HF) for participants with Type 2 Diabetes mellitus (T2DM) and established cardiovascular (CV) disease among new users of sodium-glucose co-transporter 2 inhibitor (SGLT2i) as compared with new users of non-SGLT2i anti-hyperglycemic agent (AHA).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (T2DM), defined as: greater than or equal to (\>=) 1 anti-hyperglycemic agent (AHA) medication in the study period, and; \>=1 diagnosis of T2DM in any available diagnosis field on or prior to index
* Established cardiovascular disease, defined as \>=1 diagnosis in any diagnosis field for any of the following conditions: cerebrovascular disease; coronary artery disease (including heart failure \[HF\]); peripheral artery disease
* \>=1-year pre-index continuous eligibility; enrollment gaps of less than or equal to (\<=) 30 days will be considered continuous enrollment

Exclusion Criteria:

* Type 1 Diabetes mellitus (T1DM) diagnosis on or prior to the index date
* Secondary diabetes mellitus (DM) on or prior to the index date
* Missing sex data
Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia

The purpose of this study is to determine the efficacy and safety of intravitreal injections of bevacizumab in High Myopia´s choroidal neovascularization versus the standard treatment of Photodynamic therapy.

Bad response in choroidal neovascularization in High myopia to Photodynamic therapy, which is the current approved treatment for that pathology, and the high incidence of this pathology in these patients, together with the great functional impact in their vision has fostered the search for new therapeutic strategies.

Intravitreal bevacizumab has already been tested in small series of patients with choroidal neovascularization associated to high myopia, whether as first treatment option or after the failure of photodynamic therapy with good results. In the published series an improvement of visual acuity is described after 1-2 injections, with a reduction in the macular edema and a good safety profile.

The lack of published trials that describe the efficacy of frequency of treatment in this pathology is the main reason for this trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years old
* High Myopia with one of the following:

  * 6 or more sphere diopters in the study eye
  * Axial length of the eye greater than 26 millimeters
* Active subfoveal/juxtafoveal choroidal neovascularization confirmed by Fluorescein angiography and Ocular coherence tomography.
* Visual acuity loss of less than 6 months of evolution related to the neovascular lesion, as stated by investigator´s opinion.
* Patients previously treated with Photodynamic therapy are allowed to participate as long as the last treatment has been performed more than 3 months upon entering the study.
* Signed informed consent.
* Signed data protection consent.
* Women of childbearing potential must provide a negative pregnancy test at inclusion and must commit to the use of a contraceptive treatment during the whole study.

Exclusion Criteria:

* Previous vitrectomy surgery in the study eye.
* Tractional maculopathy and/or epiretinal membrane evaluated by Ocular coherence tomography.
* Opacities that may not allow correct fundus assessment.
* Lack of integrity of the posterior lens capsule in pseudoaphakic patients.
* Patients that may not want/be able to complete the study, based in the investigator opinion.
Renal Function During Pediatric Anesthesia

It is known that volatile anesthesia, such as sevoflurane, retain water and that this appears more pronounced in children. However, the mechanisms for this effect is unknown and it is not clear if the commonly used anesthetic propofol does the same. In this study the investigators want to compare the fluid and electrolyte conserving effects of sevoflurane and propofol in a pediatric setting and also investigate humoral changes induced by these anesthetics.

Prior studies by the investigators research group have shown water and sodium retention in experimental animals undergoing sevoflurane anesthesia. Preliminary data suggest that this is not as obvious with propofol anesthesia. The investigators aim to study if this difference is present in children.

Subjects are collected from ordinary routine operations of hypospadia. By routine, all boys undergoing this surgery get a sacral blockade and a urine catheter. The children are randomized to either sevoflurane or propofol anesthesia. Before or immediately after induction of anesthesia baseline blood samples are collected for analysis of sodium, potassium, creatinine, osmolality, angiotensin II, arginine-vasopressin and aldosterone. Perioperative fluids are started, a balanced glucose infusion with 132mmol sodium content, covering basal fluid need + 20%. This infusion is continued until the end of the protocol at the ward. At the induction of anesthesia the investigators start measuring urine output every 20th minute. The same blood samples as above are collected again during mid-operation. At the end of anesthesia the investigators collect all the urine and send a sample for urine analysis of sodium, potassium, osmolality and creatinine.

In the postoperative ward the investigators again start collecting urine every 20 minutes for 120 minutes. All urine after 120 minutes are collected, and a sample sent for analysis. After 60 minutes at the postoperative ward, blood samples are again collected for analysis.

In the childrens ward the protocol for the postoperative ward is repeated, with urine collection and sample, as well as blood samples. After 120 minutes the protocol ends.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for hypospadia surgery.

Exclusion Criteria:

* American Association of Anesthesiology class above 2
* Weight above 50 kg or below 10 kg
* Hypersensitivity towards the anesthetic agents (difficult peanut or soy allergy)
* Inability for parent to understand study information
To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors

To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).

This study is open single-arm prospective clinical study To relapse/refractory blood B cell tumor patients as the subjects, according to the expression of tumor cells, gives the corresponding double targets CART cell injection treatment, follow-up observation of the adverse reactions and the treatment effect of the drug to the data (at least 2 years), assessment of double targets CAR - T Long-term efficacy and safety of cell injection

Eligibility Criteria:
Inclusion Criteria:

1. Refractory and relapsed B-cell tumor determined by clinical diagnosis, B cell tumors include the following three categories: B cell acute lymphocyte leucocyte; Inert B cell lymphoma (CLL、 FL、 MZL); Aggressive B-cell lymphoma (DLBCL、 BL、 MCL);
2. CD19 positive and CD20 positive or CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old;

4.Estimated survival time\>3 months; 5.ECOG Scores: 0\~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF\>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.The subject or guardian understands and signs the informed consent.

Exclusion Criteria:

1. With other diseases that are not effectively controlled, including, but not limited to, persistent or poorly controlled infections symptomatic congestive heart failure unstable angina arrhythmia poorly controlled pulmonary disease or psychiatric disease;
2. Presence of other malignant tumors;
3. There are severe infections that cannot be effectively controlled;
4. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to exclude; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA positive in peripheral blood;
5. Known positive serology for human immunodeficiency virus (HIV) or syphilis;
6. A history of severe allergies to biological products (including antibiotics);
7. Patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (GvHD);
8. Female patients who are under pregnancy and/or lactation;
9. Active autoimmune disease requiring systemic immunosuppressive therapy;
10. Conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.
The Improved Ballet Shoe: a Study on the Effect of an Orthosis on Pain During Dancing on Pointe Shoes

An orthosis in the ballet shoe to see if pain reduction during dancing on pointes will decrease.

One group of pre-preprofessional ballet dancers will receive an orthosis and will train during four weeks with it. The other group without a orthosis will be the control group.


Eligibility Criteria:
Inclusion Criteria:

* girls on preprofessional ballet schools with a minimum of 30 minutes professional training a week;
* 12 to 18 years old
* pain during dancing on pointes

Exclusion Criteria:

* experience with wearing a orthosis in their ballet shoe
Achilles Tendon and Balance in Prediabetes

The aim was to evaluate the Achilles tendon size and static and dynamic balance, as well as the role of Achilles tendon on balance in prediabetes. A total of 96 patients were divided into three groups: 1)the control group, consisting of patients without diabetes; 2)the prediabetes group; 3)the diabetes mellitus group. Ultrasonographic measurements of Achilles tendon sizes were performed. Dynamic balance was assessed using the Berg Balance Scale, static balance was assessed.The Self-Leeds Assessment of Neuropathic Symptoms and Signs was utilized to identify neuropathic pain.

Background/Aims: There is a lack of studies that examine balance problems and Achilles tendon thickness in prediabetes, despite their common occurrence in diabetes. The aim was to evaluate the Achilles tendon size and static and dynamic balance, as well as the role of Achilles tendon on balance in prediabetic patients.

Methods: A total of 96 patients were divided into three groups: 1)the control group, consisting of patients without diabetes; 2)the prediabetes group; 3)the diabetes mellitus group. Ultrasonographic measurements of Achilles tendon sizes (thickness, width and area) were performed. Dynamic balance was assessed using the Berg Balance Scale, static balance (the Fall Index, Stability Indexes) was assessed using a Tetrax device. The Self-Leeds Assessment of Neuropathic Symptoms and Signs was utilized to identify neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* being between 40 and 65 years old

Exclusion Criteria:

* extremity amputation
* vitamin B12 deficiency
* Type 1 Diabetes Mellitus
* prior exposure to neurotoxic agents
* peripheral neuropathy for reasons such as chronic kidney failure, liver failure, - hypothyroidism, hereditary and inflammatory peripheral neuropathies, neuromuscular diseases, malignancies
* anti-neuropathic drug usage
* radiculopathy
* nerve trauma or surgery
* vasculitis and autoimmune disorders
* peripheral vascular disease
* pregnancy
* vestibular and cerebellar problems
* history of lower extremity surgery
* presence of medication affecting balance
* history of alcoholism
* presence of visual impairment.
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth in acute Intracerebral Hemorrhage (ICH).


Eligibility Criteria:
Inclusion Criteria:

* Spontaneous ICH diagnosed by CT (Computerized Tomography) scanning within 3 hours of onset
* Signed informed consent form, or an exception from standard informed consent requirements

Exclusion Criteria:

* Time of onset of symptoms of ICH unknown or more than 3 hours prior to CT
* Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, AVM (Arteriovenous Malformation) or severe trauma
* Surgical haematoma evacuation planned or performed within 24 hours of onset
A Clinical Trial for the Interventional Robotic System

The goal of this multi-center clinical trial is to evaluate the efficacy and safety of the interventional robotic system for cerebral angiography, researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, etc.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 85 years;
2. Plan to undergo cerebral angiography;
3. Voluntarily participated in this trial and signed the informed consent form.

Exclusion Criteria:

1. Preoperative mRS score \>2;
2. Allergy or intolerance to iodine contrast media;
3. Allergy to interventional devices;
4. Severe cardiac, hepatic and renal insufficiency;
5. Active systemic infection;
6. Severe stenosis, occlusion or skin infection at the puncture site;
7. Subjects who are to undergo surgery at the same time as cerebral angiography;
8. Subjects with severe coagulation disorders, bleeding tendencies, or contraindications to anticoagulant drugs (e.g., heparin);
9. Subjects who are enrolled in clinical studies with other devices or drugs 3 months prior to screening;
10. Female subjects of childbearing age who are pregnant or breastfeeding;
11. Other subjects who, in the judgment of the investigator, are not suitable for participation in this trial.
Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study

The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.

This is a longitudinal, observational, prospective, multicentre, cohort study, conducted in France among a representative sample of public and/or private hospital-based oncologists.

Data will be collected by the investigator during three visits using data available in the patient medical record and obtained from patient questioning and clinical examination performed during the consultations:

* Baseline visit: prescription of Nivestim®.
* Follow-up visit: during the first cycle of chemotherapy after the first course of Nivestim®.
* Final visit: after the last cycle of chemotherapy or 16-18 weeks after inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour.
* Patients for whom the oncologist has decided the initiation of G-CSF biosimilar treatment (Nivestim®) in primary or secondary prophylaxis.
* Patients informed about the computer processing of their medical data and their right of access and correction.

Exclusion Criteria:

* Patients with contraindication of use of Nivestim®.
* Patients with haematological malignancy including Myelodysplasia and Chronic myeloid leukemia treated or untreated.
* Patients participating or having participated in the previous month in a clinical trial.
* Patients refusing to participate in this study.