cyrilzakka/clinical-trials huggingface dataset:
Clinical Experience of Thalidomide in Thalassemic Patients

Objectives

Primary objective:

• To determine the efficacy and safety of the combination therapy of Hydroxyurea and thalidomide in beta-thalassemia patients.

Secondary objective:

• To determine the change in liver and spleen size of beta-thalassemia patients on the combination therapy

A single-arm non-randomized trial to evaluate the efficacy and safety of combination therapy of hydroxyurea and thalidomide in beta-thalassemia patients. It was a twelve months study. Participants were monitored for six months on Hydroxyurea alone and then the combination therapy of hydroxyurea and thalidomide for another six months. Findings of physical examination, vital signs, laboratory, and ultrasound findings were recorded at baseline, during and end of the study.

Sample Size and Population This study included 135 Beta-thalassemia patients.

The purpose of the study was to evaluate the efficacy and safety of the combination therapy of hydroxyurea and thalidomide in beta-thalassemia patients. The participants were evaluated on the basis of eligibility criteria, consent was obtained and baseline investigations were performed on the screening visit. Participants were continued on Hydroxyurea (10-20mg/kg/day) for the first six months and then for the next six months thalidomide (2-5 mg/kg/day) was added to the intervention. Aspirin was also added (2-4mg/kg/day).

Efficacy:

Maintenance or rise in Hemoglobin (Hb) levels and changes in transfusion frequency before and after the use of combination therapy was used to evaluate the efficacy of the combination therapy. Good responders were the patients who were on transfusion and went off-transfusion after the combination therapy or individuals who were already off transfusion and after combination therapy demonstrated an increase in Hb of at least 1gm/dl. Responders were those who remained on transfusion on combination therapy but displayed a 50% reduction in blood requirements. Whereas, non-responders, were individuals who were off-transfusion before combination therapy and had improvement in Hb of \<1gm/dl, or those who remained on transfusion during combination therapy and did not experience transfusion reduction of at least 50%.

Safety:

Safety of the drug was evaluated on the basis of the following parameters and intervention was discontinued or put on hold if:

* Creatinine \>1.1mg/dl, Urea \>43mg/dl),
* Liver function (SGPT \>35mg/L)
* Absolute Neutrophil counts\<2\*109/L
* Platelets \< 100\*109/L

Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinical and genetic diagnosis of β-thalassemia major and intermedia
2. Patients who showed partial response or a decline in response to hydroxyurea
3. Patients who are not the candidates for the bone marrow transplant procedure.

Exclusion Criteria:

1. Married Patients
2. Patients with comorbidities such as liver, cerebrovascular, cardiovascular, or kidney diseases
3. Patients allergic to the drug ingredients
4. Patients with mental disorders
5. Patients who are enrolled in other clinical trials
6. Patients with a history of venous or arterial thrombosis
Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

In a case series intranasal submucosal bevacizumab has been shown to reduce epistaxis in patients suffering from Hereditary Haemorrhagic Telangiectasia together with KTP Laser therapy. The aim of this study is to evaluate the effectiveness of submucosal intranasal bevacizumab compared to placebo in a randomized double blind trial setting.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed and staged HHT (Shovlin et al 2000)
* Age 18-80
* Minimum of 2 episodes of epistaxis/ week
* Ability and willingness to complete diary and comply with study requirements.

Exclusion Criteria:

* Uncontrolled hypertension (systolic blood pressure \> 150mmHg, diastolic blood pressure \> 90mmHg)
* History of a thromboembolic event, including myocardial infarction or cerebral vascular accident
* Malignancy of the upper respiratory tract within the last year
* Recent (\<3 months) or planned surgery
* Proteinuria
* Nasal intervention (Laser or Cautery) in pretreatment phase
* Allergy to local anesthetic
Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK, PD and immunogenicity, and to evaluate preliminary antitumor activity of XmAb5574 in patients with relapsed or refractory CLL/SLL.


Eligibility Criteria:
Inclusion Criteria:

* relapsed or refractory CLL/SLL
* at least 18 years of age
* able to receive outpatient treatment and follow-up at the treating institution
* completed all CLL therapies \> 4 weeks prior to first study dose

Exclusion Criteria:

* previously treated with an anti-CD19 antibody therapy
* undergone prior allogeneic stem cell transplantation within 6 months or having active graft versus host disease
* active Richter's syndrome
* designated Class III or IV by the New York Heart Association (NYHA) criteria
* history of myocardial infarction or stroke within the last 6 months
* active viral, bacterial, or systemic fungal infection requiring treatment
* HIV or Hepatitis C positive
* Hepatitis B infection
Hypotension After Anesthetic Induction with Remimazolam in Elderly

Even though remimazolam is known to be safely administered without hemodynamic instability, hypotension is the one of the common side effects of remimazolam. Because elderly patients are susceptible to hypotension due to old age, multimodality, and multiple medications, hypotension can be harmful in elderly patients. Remimazolam can be administered either bolus or continuous for anesthetic induction. In our study the investigators aimed to compare the incidence of hypotension after anesthetic induction using remimazolam by bolus injection and continuous infusion in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients with age over 60 years old
* scheduled for elective surgery under general anesthesia
* American Society of Anesthesiology Physical Status I-III

Exclusion Criteria:

* Arrhythmia
* Liver dysfunction
* Kidney dysfunction
* Uncontrolled hypertension
* Uncontrolled diabetes mellitus
* Allergic to benzodiazepines
* Heart failure
* Drug intoxication
* Alcoholics
* Cognitive dysfunction
* Unable to understand and consent voluntarily
Rapid Evaluation of Seasonal Influenza Vaccine

This is an invitation to consider taking part in a research study occurring just before the upcoming influenza vaccination program across Canada. The purpose of the study is to closely assess influenza vaccine safety and immune responses, as part of a nationwide, annual surveillance project sponsored by the Public Health Agency of Canada. Such scrutiny is important given the changing nature of flu vaccines from year to year.

Trivalent inactivated vaccines (TIVs) are the principal tools for minimizing seasonal influenza morbidity and mortality in populations at increased risk of adverse outcomes. To keep pace with the evolution of circulating viruses the composition of TIVs is annually updated. Depending upon circumstances, the seasonal formulation may contain 1-3 new variant strains representing Canada's supply of H1N1, H3N2 and B 2009 vaccine. Standardized manufacturing processes favour consistent vaccine safety and immunogenicity profiles from year to year but unanticipated differences can and do occur. As a consequence of the unusual occurrence of "oculorespiratory syndrome" in recipients of a Canadian-made TIV for 2000-2001, the Canadian regulatory agency has required pre-approval clinical testing of seasonal vaccines in adults. This small scale testing (120 subjects) cannot exclude the occurrence of infrequent, troublesome adverse effects. Expanded testing is desirable and would best be done soon after vaccines are approved for distribution so that results could inform the public vaccination programs that follow. Having an established capacity for rapid evaluation of a new influenza vaccine will be invaluable in the event of a pandemic, when vaccines will be less thoroughly tested before being made available to protect the public.

The objectives of this study are two-fold:

1. To assess the safety and immunogenicity of a seasonal TIV influenza vaccine quickly enough to inform subsequent public delivery programs.
2. To use the opportunity to refine preparedness for rapid evaluation of a pandemic influenza vaccine.

Eligibility Criteria:
Inclusion Criteria:

Eligibility Inclusion:

* Good general health
* Written informed consent
* Adults 20-64 years of age

Exclusion Criteria:

* compromised immune system
* allergies to eggs or thimerosol
* life-threatening reaction to previous Flu vaccine
* chronic illness, bleeding disorder

any Flu vaccine within 6 mths planning any other vaccine during study
Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation?

No one knows how long bupivacaine finger blocks last. Many use bupivacaine with and without epinephrine, but no one knows how the epinephrine affects the duration of the block. We also don't know how long the pain part of the block lasts, which is what counts.

The goal of the study is to determine the duration of action of bupivacaine digital nerve blocks (with and without epinephrine) on finger temperature and the sensory modalities of pain, touch, and pressure. 2 ml of bupivacaine 0.5% with and without epinephrine will be injected at the base of each ring finger on the palm surface. At the end of 1 hr, 6 hrs, 12 hrs, 14 hrs and each additional hour, patients will use an insulin lancet to measure pain, the Semmes Weinstein monofilament test to measure light touch and pressure and a body surface thermometer to measure finger temperature. The time for the finger to return to normal sensation and temperature will be measured.

Lidocaine finger blocks have been shown to provide analgesia for nearly 5 hours without epinephrine and approximately 10 hours with epinephrine - essentially doubling its duration.1,2 The analgesic effect of epinephrine on the duration of bupivacaine finger blocks remains unknown.

Bupivacaine finger injection provides a much longer duration of action than lidocaine. Previous studies have shown the duration of action to be as long as 24.9 hours.1 In the senior author's experience, however, patients who get bupivacaine blocks start asking for pain medication as early as 7 hours after the block. Is it possible that the pain blocking effect of bupivacaine has a different duration than the touch and pressure effects? The answer to this question also remains unknown.

The third unknown question about bupivacaine digital blocks is their effect on fingertip temperature. It has been shown that lidocaine wrist blocks increase temperature in finger tips, and this has been postulated to be potentially helpful in frostbite to provide pain relief and hyperemia.3 Previous studies have shown bupivacaine to exhibit vasodilatory properties at clinical concentrations of injection.4-7 Does bupivacaine provide increased warmth to the finger tip? How long does it last?

The goals of this study are three fold: 1.) To determine what effect epinephrine has on the duration of bupivacaine finger block anesthesia. 2.) To assess the duration of action of bupivacaine with and without epinephrine on the digital sensory modalities of pain, touch and pressure, and 3.) To assess the finger tip temperature changes that result from bupivacaine digital blocks with and without epinephrine.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteer

Exclusion Criteria:

* Under the age of majority
* Unable to give consent
* Pregnancy
* Diabetes
* Allergy to local anesthetic
* Prior finger surgery
* Preexisting digital vascular ischemia
A Phase IIIb Study to Evaluate the Safety and Efficacy of Gemigliptin in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment(GUARD Study)

Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term peirod (52 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus
* Patients with moderate or severe renal insufficiency
* All patients give written informed consent

Exclusion Criteria:

* Has type 1 diabetes mellitus or a history of ketoacidosis
* Is on dialysis or is likely to need dialysis during the study
* Has active liver disease
C-reactive Protein Levels Among Individuals With COVID-19

The primary objective of this multi-center study is to clarify the value of a CRP measurement for triage of patients initially presenting with light symptoms of the COVID-19 infection.

Current recommendations of management of COVID-19 include large-scale tests for virus. Such tests reveal whether an individual is infected with the virus, however, the demonstration of virus per se has no prognostic value for the ensuing course of the COVID-19 disease. Publications of possible treatments strategies increase exponentially, while evidence of triage of the affected individuals is mainly based on the level of pulmonary affection as measured by the Oxygen saturation.

To inform decision making for which patients are to be hospitalized due to risk of developing more severe affection, this study addresses the question, whether triage may be performed with the aid of a simple CRP measurement.


Eligibility Criteria:
Inclusion Criteria:

1. A test for COVID-19 taken at the check point
2. Signed, informed consent for blood test to be drawn for the Biobank

Exclusion Criteria:

1. Former admission to hospital for COVID-19
2. Direct admission from check point.
Study of Catheter Based Renal Denervation Therapy in Hypertension

The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation:

1. reduces daytime ambulatory blood pressure,
2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.


Eligibility Criteria:
Inclusion Criteria:

* They have a mandatory \> 3 antihypertensive medication therapy, including a thiazide or a loop diuretic (according to the patient's renal function, unless documented side-effects) and at least one attempt to treat with spironolactone, given at usual recommended dose since at least 8 weeks, before inclusion,
* A mandatory check list of secondary cause of hypertension has been excluded
* They succeed the pill count test.
* They have a mandatory ambulatory blood pressure monitoring before inclusion with at least 70% of valid readings during daytime (08:00 am 08:00 pm, using a sampling frequency of 20 minutes, only devices validated according to http://www.dableducational.org are permitted), where daytime ambulatory blood pressure of systolic and/or diastolic blood pressure exceeds 135 mmHg and/or 85 mmHg, respectively. Daytime ambulatory blood pressure of systolic and/or diastolic blood pressure below 135 mmHg and/or 85 mmHg, respectively, is acceptable for inclusion in the study if the patient takes four or more antihypertensive medication (3).

Exclusion Criteria:

* Patients with an eGFR \<30ml/min/m² are excluded,
* patients with known renal atherosclerotic lesions,
* previous procedures in the renal arteries,
* known unsuitable anatomy for the procedure,
* previous nephrectomy,
* contrast agent allergy,
* hyperthyroidia.
Exploring the Association of Imaging and Tumor Microenvironment in Liver Cancer Using Radiogenomic Approach（Radiogenomics-Liver）

This is the prospective, observational cohort study (Radiogenomics-Liver), which aims to explore the relationship between the imaging information of liver cancer patients, tumor microenvironment and the prognosis of liver cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients treated for liver cancer in Wuhan Union Hospital from August 2024 to August 2027;
2. Aged \> 18 years old;
3. At least one CT scan or MRI scan before treatment;
4. Tissue biopsy pathological examination confirmed the diagnosis of the above tumors.

Exclusion criteria：

1. Poor image quality;
2. Incomplete clinical data or loss of follow-up;
3. Presence of another primary malignancy other than liver cancer;
4. Unclear pathological diagnosis.
Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns

Low systemic flow as measured by Doppler-echocardiography has been associated with poor neurological outcome. Yet, it has not been systematically evaluated whether the treatment of this hemodynamic condition is beneficial or not. This study aims to evaluate if treating low systemic flow in preterm infants with dobutamine has any effect on the cerebral circulation and in newborn prognosis.

While rates of survival for very preterm infants are increasing, a significant number of these patients suffer from neurodevelopmental disabilities. The pathophysiology of brain injury in the preterm infant is unclear, although haemodynamic disturbances during the period of transitional circulation after birth leading to ischemia-reperfusion events seem to play an important role. Up to one third of infants born under 30 weeks of gestation develop low systemic flow as measured by Doppler-echocardiography (low superior vena cava flow, SVCF); this finding has been associated with poor neurological outcome. Yet, it has not been systematically evaluated whether the treatment of this hemodynamic condition is beneficial or not. This study aims to evaluate if treating low systemic flow in preterm infants with dobutamina, DB, (inotrope-sympathicomimetic drug) has any effect on the cerebral circulation; specific interest of our research would be to target DB dose for individual patient´s response. Secondly, by means of two non-invasive technologies (cerebral and cardiac ultrasonography-Doppler and near infrared spectroscopy, NIRS), the investigators search to characterise eventual differences in brain perfusion patterns during the adaptation to the transitional circulation that might be associated with the development of brain injury in the most vulnerable population.

Eligibility Criteria:
Inclusion criteria

* Newborn infants born at ≤ 28 weeks of gestational age.
* Newborn infants born at \> 28 weeks of gestational age and ≤ 30 weeks of gestational age with moderate-severe respiratory distress syndrome, defined as the necessity of respiratory support with a mean pressure ≥ 4 cm H2O or FiO2 ≥ 0.3
* Admission at the NICU in the first 6 hours of life
* Inotrope treatment absent
* Inform consent signed

Exclusion criteria

* Early systemic hypotension, defined as a mean arterial pressure (MAP) lower than the gestational age, during at least 60 minutes and maintained after volume infusion
* Major congenital malformation
* Informed consent declined
Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis

The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.

Neonates and young infants will be stratified by estimated gestational age and by world region

Eligibility Criteria:
Inclusion Criteria:

* Infant greater than 48 hours of life after birth up to day of life 120 at the time of culture acquisition
* Diagnosis of proven invasive candidiasis within 4 days prior to study start
* Subject's parent or legal guardian agrees not to allow subject to participate in another study with another investigational drug while on treatment.

Exclusion Criteria:

* Infant with any history of a hypersensitivity or severe vasomotor reaction to any echinocandin or systemic amphotericin B product
* Infant who has received more than 48 hours of systemic antifungal therapy prior to the first dose of study drug
* Infant who has a breakthrough systemic fungal infection while receiving amphotericin B product or an echinocandin as prophylaxis
* Infant who has failed prior systemic antifungal therapy for this episode of invasive candidiasis
* Infant who is co-infected with a non-Candida fungal organism
* Infant whose positive yeast cultures are solely from an indwelling bladder catheter (unless obtained at the time the indwelling catheter was placed) or sputum.
* Infant previously enrolled in this study
Pain Inflammation and Cannabis in HIV

This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. The investigators will observe how varying ratios of THC (tetrahydrocannabinol) and CBD (cannabidiol) in medical cannabis impact neuropathic pain, inflammation and adverse events.

This study will examine how medical cannabis use affects neuropathic pain in PLWH with neuropathic pain. The investigators will enroll adults with HIV who have a) neuropathic pain, b) are actively certified for medical cannabis, and c) intend to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary). The investigators will observe how pain and inflammation change in participants after they are randomized to receive high THC:low CBD product, an equal THC:CBD product, a low THC:high CBD product, or placebo by our collaborator in a separate study. Over 14 weeks, data sources will include questionnaires, blood samples, urine samples; medical, pharmacy, and Prescription Monitoring Program (PMP) records. The primary independent variable will be type of medical cannabis product dispensed at dispensary, and the primary outcome will be self-reported pain.

Eligibility Criteria:
Inclusion criteria:

-\>=18 years old

* Diagnosis of HIV
* Fluency in English
* Active certification for medical cannabis
* ICD-10 diagnosis code for neuropathic pain, OR Neuropathic pain in problem list of electronic medical record, OR Neuropathic pain per medical cannabis certification form, OR Neuropathic Pain Questionnaire-Short Form\>0

Exclusion Criteria:

* Inability to provide informed consent
* Inability to complete 14 weeks of study visits
* Medical cannabis use within 14 days of enrollment, and no medical cannabis dispensed within 30 days of enrollment
* Unique pain symptoms (e.g., multiple sclerosis, rheumatoid arthritis)
* Terminal illness
* Current or prior psychotic disorder
* Unregulated cannabis use in the past 14 days; opioid or cocaine use in the past 30 days
* Dispensed opioids within 30 days
* Non-steroidal anti-inflammatory use within 7 days prior to enrollment
* Steroid use within the past 14 days with duration of therapy \>=21 days
* COVID vaccination or booster within 14 days of screening
* Active or acute cardiac disease based on clinician chart review.
Study of the Compliance With Phosphorus Restricted Diet and Phosphate Binder Therapy in Hemodialysis Patients

Hyperphosphatemia is a common and severe complication in chronic kidney disease patients treated with hemodialysis. A phosphate restricted diet and oral phosphate binders are the cornerstones in the prevention and treatment of this complication. However, noncompliance is an prevalent problem resulting in poorly controled hyperphosphatemia in a substantial proportion of hemodialysis patients. The present study aims at identifying risk factors for non compliance and also test the hypothesis that compliance can be improved by education patients on the consequences of hyperphosphatemia and the importance of diet and phosphate binder therapy.


Eligibility Criteria:
Inclusion Criteria:

* prevalent (\>3months) hemodialysis patients
* aged \> 18 years
* informed consent

Exclusion Criteria:

* decreased consciousness
* unstable
* medical contraindication for phosphorus restricted diet or phsophate binder therapy