cyrilzakka/clinical-trials huggingface dataset:
Effects of Attention Training on Children

Using a double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with Attention Deficit Hyperactivity Disorder who are receiving conventional rehabilitation programs due to developmental delay.

A total of 30 children with Attention Deficit Hyperactivity Disorder conducting conventional rehabilitation programs well be enrolled.

The children are randomized into two groups, including study group with conventional rehabilitation programs and interactive attention training: 2 times per week, 15 min per session, with a total of 24 sessions in 3 months; and control group with conventional rehabilitation programs without interactive attention training.

Therapeutic effects, including working memory, attention, functional performance, physical function, health-related quality of life will be evaluated at baseline, and 3 months and 6 months after the intervention.

The evaluator and children will be blinded to the group's allocation during the whole course of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater

Exclusion Criteria:

* age less than 4 or greater than 8 of children diagnosed with Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient less than 70
Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).

The study included Screening Period (Day -28 to Day -1), double-masked treatment period (Day 1 to Week 72), and post-treatment follow-up period (Week 72 to Week 76). Treatment visits were scheduled in 4-week intervals. After 6 initial monthly injections of brolucizumab or aflibercept (loading phase), subjects entered a one-year individualized flexible treatment (IFT) phase. During the IFT phase, an assessment of disease stability was performed at each monthly visit and subjects received either an active or a sham injection. Treatment with active was interrupted when disease stability was reached.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study.
* Patients with visual impairment due to ME secondary to CRVO diagnosed \< 6 months prior to screening.
* BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and baseline visits.

Exclusion criteria

* Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g. structural damage of the fovea, vitreous hemorrhage, retinal vascular occlusion other than CRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema).
* Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline
* Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 mmHg on medication, or according to investigator's judgment, at screening or baseline
* Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA \< 20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract)
* Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline
* Previous use of intraocular or periocular steroids in study eye at any time prior to baseline
* Macular laser photocoagulation (focal/grid) in the study eye at any time prior to baseline and peripheral laser photocoagulation in the study eye within 3 months prior to the baseline
* Intraocular surgery in the study eye during the 3-month period prior to baseline
* Vitreoretinal surgery in the study eye at any time prior to baseline
* Aphakia with the absence of posterior capsule in the study eye
A Clinical Trial to Compare Lasotronix Alone or in Combination With CPP-ACP to Treat DH

Dentin hypersensitivity (DH) is defined as sharp pain of a shorter duration arise from exposed dentin in response to several chemicals and thermal or tactile stimuli that cannot be ascribed to other dental defects". DH has a prevalence rate ranging from 1.3% to 92.1%, commonly affecting old ages. The use of laser has opened new dimensions in the treatment of DH. To the author's knowledge, not much research work has been conducted using LASOTRONIX as a treatment modality with CPP-ACP. Therefore, this research aims to determine the effectiveness of Casein phospho peptide paste (CPP-ACP) used alone or combined with a diode laser (LASOTRONIX).

DH has a prevalence rate ranging from 1.3% to 92.1%, commonly affecting old ages, and the frequency of DH in patients suffering from periodontal disease is 3-57%. Pakistan has reported prevalence from different cities, with 36.4% from Karachi and 22% from Lahore.

The use of laser has opened new dimensions in the treatment of DH. Theories that support laser therapy explain that irradiation blocks the pain in dentinal tubules by melting and recrystallization of dentin or by tertiary dentine production or evaporation of dentinal fluid. Considering the oral soft tissues which contain high amounts of water, Lasotronix SMARTm laser diodes have been carefully designed to show their high transmission. The 635nm wavelength is optimal for activating tolonium chloride dye for photo-activated chemo therapy, eliminating all bacteria and biofilms without any side effects. 200 mW power provides safe cold bio stimulation and photo disinfection within a reasonably short therapy time. Application of Sodium fluoride (NaF) has also been indicated for hypersensitivity pains. Its application in the form of gel occludes the tubule by calcium fluoride precipitation. Agents like potassium nitrate also have promising effects, which increase the concentration of potassium ions in nerve endings and alter the nerve action potential in conducting the sensory stimuli.

Recently DH treatment has been conducted with different types of laser with different wavelengths, either alone or in combination with desensitizing agents and varnishes and has revealed effective results. To the author's knowledge, not much research work has been conducted using LASOTRONIX as a treatment modality with CPP-ACP. Therefore, this research aims to determine the effectiveness of Casein phospho peptide paste (CPP-ACP) used alone or combined with a diode laser (LASOTRONIX).

Eligibility Criteria:
Inclusion criteria:

* Patients of either gender, with ages between 25-65 years
* should have at least more than one hypersensitive and vital tooth without any carious lesion or defective restoration

Exclusion criteria:

* History of desensitizing therapy on the affected tooth/teeth in last six months (use of desensitizing toothpaste)
* use of antibiotics /analgesic/anti-inflammatory drugs
* history of smoking
* pregnancy
* those who are not willing to participate or give follow-ups
A Multiple Ascending Dose Study of KBP-7072 in Healthy Subjects

This is a randomized, single-blind, placebo-controlled, sequential parallel-group and multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of KBP 7072 in healthy subjects. The safety will be assessed at each dose level before progressing to the next higher dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subject
* Are between the ages of 18 and 55 years (inclusive);
* Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg.

Exclusion Criteria:

* Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
* Known or suspected malignancy;
* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody;
* Positive pregnancy test result.
Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block

In our clinic, routine suprainguinal fascia iliaca block (SIFIB) has been administered for postoperative analgesia in patients undergoing knee arthroplasty. Recently, we have introduced the IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block to this regimen, and the aim of this retrospective study is to determine whether the addition of the IPACK block enhances the quality of analgesia.

Knee arthroplasty, also known as knee joint replacement surgery, is a common procedure performed to alleviate pain and improve joint function in patients with knee osteoarthritis or other knee-related conditions. Postoperative pain management is crucial for patient comfort and overall recovery.

In this study, we aimed to compare the two techniques mentioned earlier, namely the SIFIB (Suprainguinal Fascia Iliaca Block) and the SIFIB+IPACK, by examining the data of patients who underwent knee arthroplasty under spinal anesthesia at our clinic between January 1, 2023, and September 1, 2023.


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the following criteria and whose postoperative follow-up forms were completed in full were included in the study
* Patients underwent total knee arthroplasty (TKA)
* ASA class I to III.
* operated under spinal anesthesia
* patient controlled analjgesia device was used for analgesia

Exclusion Criteria:

Patients whose data were inaccessible or had incomplete follow-up forms were excluded from the study to ensure the accuracy and reliability of our analysis.

* PCA device problems in follow up in 24 hours
* anesthesia plans were converted to general anesthesia
* spinal anesthesia failure
* peripheral blocks used other than protocol
Novel Compositions for Treating or Preventing Dermal Disorders

This trial examines the impact of a topical formulation of rapamycin on dermal thickness and senescence.

Aging of the skin is the most prominent feature of the aging process, being caused by multiple factors such as intrinsic aging process and UV light exposure.

Dermal atrophy, also called skin atrophy or atrophy, is a disorder manifesting thinning or depression of skin due to reduction of underlying tissue. Dermal atrophy is a major clinical problem in the elderly population. Loss of dermal integrity leads to increased fragility of the skin and precludes the use of intravenous lines in many cases. Skin tears are a significant concern in elderly individuals directly related to dermal atrophy. Impairment in wound healing is an important clinical sequelae of reduced dermal integrity leading to an increase in the number of the infections and complications following injury. Seborrheic keratosis, which comprise focal areas of epidermal thickening, can occur, possibly representing a response to damage. It has been estimated that 100% of individuals over 50 years of age harbor at least one of these lesion. There is not treatment for dermal atrophy and seborrheic keritoses require excision if they become large enough to cause discomfort or distress.

Therefore, there is a need to develop novel compositions and methods for treating or preventing certain age-related dermal conditions.

Rapamycin is an FDA approved drug that has been in clinical use for over 15 years. Systemic application of rapamycin has been a central part of immuno suppressive therapy for transplant patients in combination with other immuno suppressants. The safety record for systemic use of rapamycin is excellent and few side effects are associated with extended use.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Individuals with any chronic disease will be excluded from the study including those with the following conditions:

  * Diabetes
  * Any type of Malignancy
  * Severe coronary artery disease
  * HIV infection
  * Hepatitis C or B
  * Any sign of skin disorder or disease aside from normal aging, dermal atrophy, or seborrheic keratoses.
  * Premenopausal women will be excluded
  * Patients taking the following medications will be excluded:
  * Cyclosporin
  * Calcium channel blockers: diltiazem, verapamil
  * Antifungal agents e.g. clotrimazole, fluconazole, itraconazole
  * Antibiotics: clarithromycin, erythromycin, rifampicin
  * Anticonvulsants: carbamazepine, phenobarbitone, phenytoin
  * Antinausea drugs e.g. metoclopramide
  * Other drugs e.g. danazol, protease inhibitors (e.g. for HIV and hepatitis C including ritonavir, indinavir, boceprevir, and telaprevir)
  * Grapefruit juice
  * St John's wort (Hypericum perforatum, hypericin)
Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

This is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Embolization will be performed with LC Bead LUMI particles using a balloon occlusion microcatheter or standard microcatheter.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 45 years and ≤ 85 years old
* Prostate volume ≥ 40 mL and ≤ 300 mL
* Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS)
* Refractory or intolerant to medical management
* Ineligibility for or refusal of surgical management
* No evidence of prostate cancer

Exclusion Criteria:

* History of pelvic cancer
* Neurogenic bladder disorder
* Bladder diverticula greater than 5 cm or bladder stones
* Acute urinary retention with Foley catheter dependence
* Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months
* Prior surgical prostate intervention
* Active participation in another clinical trial
Effect of Nicardipine on Renal Function in Deliberate Hypotension

The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance, serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.

To induce deliberate hypotension, pharmacological agents such as inhalation anesthetics, calcium channel blockers, beta-adrenergic blockers have been used alone or in combination. Nicardipine, classed as a calcium channel blocker, has a peripheral vasodilator effect via relaxation of smooth muscle fiber and sympathetic nerve inhibition. Nicardipine expands the renal artery and increases glomerular filtration rate. Previous studies reported the renal protective effect of nicardipine in cardiac surgery with cardiopulmonary bypass and robot-assisted laparoscopic surgery.

The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance , serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing anterior or posterior spine interbody fusion

Exclusion Criteria:

* Patients with American Society of Anesthesiologists physical status III or IV
* Liver dysfunction with aspartate transaminase/alanine transaminase greater than 60/60 IU/L
* Cerebrovascular disease
* Anemia of less than hematocrit 24%
* Diabetes mellitus
* Severe malnutrition
* those diuretics or antihypertensive drugs
A Study of LY3502970 in Participants With Type 2 Diabetes

The main purpose of this study is to learn more about the safety of LY3502970 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits (including three overnight stays) in the study center.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes mellitus (T2DM) for at least 6 months
* Have a glycated hemoglobin (HbA1c) value at screening of greater than or equal to (≥)7.0 percent (%) and less than or equal to (≤)10.5% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
* Have a body weight of ≥45 kilograms (kg) and have a body mass index of 18.5 to 45 kilograms per square meter (kg/m²), inclusive
* Have had a stable body weight for the 3 months prior to screening (less than \[\<\]5% body weight change)
* Males and females (not considered woman of childbearing potential)

Exclusion Criteria:

* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
* Have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure
* Show evidence of hepatitis B, and/or positive hepatitis B surface antigen
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Any glucose-lowering medications other than metformin within 3 months prior to screening
Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil

The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.


Eligibility Criteria:
Inclusion Criteria:

* non-smoker
* Body mass index (BMI) of 19-28 kg/m2
* no relevant food allergies

Exclusion Criteria:

* any subject for whom gemfibrozil is contraindicated
* any subject with a history of hypoglycemia or who tend to get easily hypoglycemic
* clinically significant history of or current abnormality or disease of any organ system
Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

The purpose of this study is to determine the incidence of pegfilgrastim-induced back and leg pain and to determine whether the antihistamine loratadine can prevent pegfilgrastim-induced back and leg pain.

Pegfilgrastim is a myeloid growth factor that stimulates neutrophil precursors and can be used to decrease infection risk associated with neutropenia. However pegfilgrastim may induce back and leg pain in 20-50% of patients. No intervention has been consistently successful in treating or preventing this pain.

The exact mechanism of pegfilgrastim-induced pain is unknown but may be related to histamine-mediated inflammation. Several case reports and anecdotal reports have suggested efficacy of antihistamines for this indication.

This study will have two parts. In the first part (Observational Phase), patients receiving pegfilgrastim will be surveyed to document the incidence of significant pegfilgrastim-induced back and leg pain. In the second part (Treatment Phase), patients who previously experienced such pain will be randomized to receive a 7-day course of either the antihistamine loratadine or placebo to determine whether pegfilgrastim-induced back and leg pain can be prevented with this intervention.

Eligibility Criteria:
Inclusion Criteria:

* histologic or cytologic evidence of malignancy
* scheduled to receive pegfilgrastim with two consecutive cycles of similar chemotherapy with at least a 14 day interval between cycles
* adequate renal function: estimated creatinine clearance \> 30 ml/min
* adequate hepatic function: AST, ALT, total bilirubin \<= 2.5 x ULN
* age \>= 18 years
* performance status 0-3
* able to read and understand English
* signed Informed Consent

Exclusion Criteria:

* history of hypersensitivity or intolerance to antihistamines
* concurrent use of antihistamines other than study medications during or for 2 days prior to the study period except for a single dose of antihistamine as required for administration of chemotherapy or blood transfusion
* concomitant use of amiodarone
* previous use of pegfilgrastim or filgrastim
Pegylated Liposomal Doxorubicin Containing Chemotherapy in the Treatment of Older Non-Hodgkin's Lymphoma Patients

Currently there is no one standard of care for older patients with Non-Hodgkin's Lymphoma (NHL). The study will examine the tolerability and feasibility to the combination of Cyclophosphamide, Pegylated Liposomal Doxorubicin, Vincristine, Prednisone (CDOP) plus Rituximab.

Elderly NHL patients tend to tolerate the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) less well when compared to the younger population. Cardiotoxicity, as well as neutropenia, are the most common side effects in the elderly population with age being a risk factor for doxorubicin induced cardiac toxicity. Treatment related toxicity in the older population can preclude adequate therapy and potentially contribute to poor outcomes. Pegylated liposomal doxorubicin has shown similar efficacy with a significant lower incidence of cardiotoxicity ad significantly fewer cardiac events compared with conventional doxorubicin. Exploration of alternative regimens to maximize tolerability and thus enhance overall efficacy in this population is warranted. Both safety and efficacy will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and older;
* Diagnosis of Non-Hodgkin's lymphoma where therapy with CHOP plus rituximab is considered;
* Previously untreated;
* ECOG 0-2
* Adequate renal and hepatic functions;
* Cardiac ejection fraction at least 50% by MUGA. No significant cardiac abnormalities by EKG;
* Signed informed consent

Exclusion Criteria:

* CNS involvement by lymphoma;
* Hypersensitivity to study drugs;
* Active infection;
* Prior treatment with monoclonal antibodies for cancer;
* History of cardiac disease with New York Heart Association Class II or greater or clinical evidence of congestive heart failure