cyrilzakka/clinical-trials huggingface dataset:
Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing

This study evaluates topical loperamide 5% gel in reducing pain during repeat finger lancing (finger stick) in healthy adults. Half of participants received 5% loperamide gel applied to their fingertip prior to their second lance and the other half received the gel only.

Lancing the finger and heel to obtain capillary blood for specimen collection and diagnostic testing is a painful and tissue damaging procedure. With each lance, there is direct splicing of capillaries along with free nerve endings resulting in an immediate localized pain response and hyperalgesia from the release of pain producing substances. Opioid agonists (morphine, fentanyl, loperamide) have demonstrated significant analgesia when locally injected or topically applied to a site of inflammation/injury in animal models.

Loperamide, a piperdine derivative with a structure similar to the synthetic opioid meperidine, has strong affinity for Mu opioid receptors. It was approved by the FDA in 1969 as an anti-diarrheal agent with Mu opioid activity mimicked the constipating effects of other opioids, but with markedly reduced CNS effects due to its affinity for p-glycoprotein, preventing crossing the blood brain barrier (BBB) under normal circumstances.

This prospective, double-blind, repeated measures, randomized investigational new drug trial used loperamide developed as a topical gel in 34 adult participants to determine its analgesic effects during repeat finger lancing. The investigators also assessed for any local skin reaction to the gel application and for any constipation or abdominal cramping which might be evidence of systemic absorption and Mu opioid agonist activity on the gut.

This study would be applicable for use in 28.9 million adults who are diabetic and require finger lancing for blood glucose monitoring and the high risk newborn population who require repeat heel lancing for specimen collection.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers willing to have 2 consecutive finger sticks completed.

Exclusion Criteria:

* Participants are excluded if they have a history of drug induced hypersensitivity reactions; took any anti-inflammatory medications in the past 12 hours; if they routinely performed finger lancing for blood specimen monitoring (e.g. diabetes); or had calloused fingers pads.
Multi-centric Study

Patients with relapsed/refractory adult acute lymphoblastic leukemia (ALL)have a very dismal prognosis. In this case, allogeneic transplantation is the only curative treatment when patient have obtained a second complete remission (CR. In France, in patients younger than 60 years old,the HyperCVAD regimen used by the MDAnderson in Houston is generally applied. In older patients (\>=60 years)or young patients \<= 60 years no eligible for intense chemotherapy, a combination of vincristine + Dexamethasone is generally chosen in order to avoid too much toxicity but the result is worse in term of CR.

More than 90% of ALL with a B phenotype (2/3 of cases in adults)express the surface antigen CD22 on leukemic blasts which thus represents an interesting target for therapy. Epratuzumab is a humanized anti-CD22 antibody produced by Immunomedics, Inc, Morris Plain (New Jersey, USA). Epratuzumab has already shown efficacy in lymphoma patients. Only one study, including 15 children, has been published so far reporting the efficacy and the toxicity of Epratuzumab in the setting of ALL in monotherapy, one can observe 8 stable disease, 3 progressions and 4 partial responses. When combining chemotherapy and Epratuzumab, 9CR were observed with acceptable toxicity. Tolerance was acceptable.

The French GRAALL group proposes to test an age-adapted combination of chemotherapy + Epratuzumab, in refractory/relapses CD22+ B ALL patients in order to improve their prognosis, in term of CR, survival and of number of patients eligible for allograft.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* B-ALL (OMs) with \>= 20 % of blasts in bone marrow
* CD22+ expression \>= 30% of the blast population
* Refractory B-ALL defined by treatment failure after 2 successive courses of induction therapy or relapse \< 6 months after first CR
* First relapse of B-ALL
* Second relapse or beyond
* Performance status 0-2
* Creatinine clearance \>= 50 ml/min (Cockroft formula)
* Serum bilirubine \<= 30 µmom/l
* Written informed consent

Exclusion Criteria:

* T-ALL
* Meningeal involvement
* CD22 expression on tumor cells or \< 30%
* HIV positive
* Active Hepatitis B or C
* Left ventricular ejection fraction \< 50% in patients \<60 years
* Contra-indication to Epratuzumab
* Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Participation at the same time in another study in which investigational drugs are used
* Absence of written informed consent
Study to Evaluate the Efficacy of the décoLITE LED Device in Treating the Signs of Skin Aging of the décolletage Area

To assess the efficacy of the décoLITE LED system in reducing the signs of skin aging of the décolletage area one week after a six-week treatment course.

This was an open-label, single-center trial. Subjects carried out 5 treatments on separate days each week for 6 weeks. The plan for the study was to recruit 25 subjects to consider any dropouts to arrive at a final study total of 20.

Treatments were of 10 minutes duration using a combination of red (630nm) and near infrared (830nm) emitted from light emitting diodes. The device emitted 30mW/cm2 of light, delivering a dose of 18J/cm2 per treatment.

Subjects were assessed at baseline, at 5 weeks, and at 7 weeks (one week after the last treatment).

Assessments included separate evaluations of lines and pigment of the décolletage using the validated scale developed by Landau et al. by the principal investigator and a third party blinded physician, standardized photography, and recording of safety incidents. Subjective responses were based on treatment efficacy and ease of use of the device.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female, 30 to 65 years of age.
* Fitzpatrick phototype I-VI skin.
* Gave written informed consent.
* Photoaging of the décolletage area.
* Agreed NOT to use anti-aging products that contain active ingredients such as retinol and glycolic acid on the treatment area during the study period.
* Agreed NOT to undergo any aesthetic treatments (such as chemical peels, microdermabrasion, laser surfacing, etc.) in the treatment area during the study period

Exclusion Criteria:

* Suffering from a systemic photosensitive disorder such as Lupus erythematosus, photosensitive eczema, or Albinism.
* Currently taking (or with a history of taking) medication that is known to induce photosensitivity.
* Having known malignancy and/or undergoing chemotherapy, radiotherapy, or high doses of corticosteroids.
* Suffering from keloid scars or birth marks in the treatment area.
* Suffering from eczema, psoriasis, or skin rashes in the treatment area.
* Had used an anti-aging product within the 4 weeks prior to commencing the study.
* Underwent plastic surgery within the last 6 months.
* Pregnant, breast-feeding, or wishing to become pregnant during the study period.
* Being enrolled in another clinical trial during the same study period.
* Having a planned hospital admission and/or surgical procedure for an illness or disease which existed before enrollment into the clinical trial, and which may interfere with the course or outcome of the study.
* Having medical or psychological condition(s) associated with a risk of poor protocol compliance (e.g., alcoholism or drug abuse).
* Undergoing or is likely to undergo other treatments of the décolletage area.
Young Goalkeeper's Fracture: Radiographic Findings

The aim of this project is to evaluate retrospectively goalkeeper's fractures in children using the children fracture classification and to evaluate the distal radius tilt angle of the growth plate on plain radiographs of the forearm.

Patients positive for goalkeeper's fracture will prospectively answer a questionnaire concerning risk factors and circumstances during the injury.

Distal forearm or radius fractures in young goalkeepers have been named "the young goalkeeper's fracture" in the literature. While catching the soccer ball the child suffers a distal forearm fracture due to axial forces to the immature bone of the child. These goalkeeper's fractures on radiographs may be subtle or difficult to discriminate from normal radiographs.

Retrospective study for the evaluation of radiographs of the forearm from 2005 - 2016 of children with history of catching a ball. Two radiologist are blinded for history, age, name and findings on final reports.

First reading without measurement of distal tilt angle, second reading with measurement of distal tilt angle and after consensus meeting.

Questionnaire: prospectively all patients with goalkeeper's fracture will answer a questionnaire concerning circumstances and risks during the accident.

Eligibility Criteria:
Inclusion Criteria:

* Children 1-16 years of age with distal radius fracture and the clinical history: "child catches a ball", between 1/2005 - 7/2016.
* Control group (1-16 years) with normal distal radius and no history to catch a ball and no fracture.

Evaluation of the normal distal tilt angle of the radius.

Exclusion Criteria:

* pathological fractures
* other history of trauma than to catch a ball
* patients older than 16 years
Comparative Effects of Spider Cage Therapy and Modified Suit Therapy in CP

Spider Cage is a part of universal exercise unit. It is a suspension system, which works with use of belts, elastic cords and Thera suits (Thera suits especially for cerebral palsy). Cords are dynamic and provides an appropriate amount of support with the help of which patient can perform movement independently. Cerebral Palsy (CP) is a condition where non progressive disorders of posture caused by abnormal development of, or damage to, motor control centers of brain resulting in abnormal movements.

It will be Randomized Controlled trial in which non probability convenience sampling technique will be used. Two groups of 8 to 12 age will be formed in which participants will be randomly divided by lottery method. Group A will be given modified Thera suits and the other group B will receive spider cage therapy on trunk stability and pelvic control. Improvement will be identified by Trunk Control Measurement Scale (TCMS), Trunk impairment scale (TIS) and Gross motor function classification system. (GMFCS) level I-II. The result after statistical analysis will show that which treatment will be more effective. Results will be analyzed on SPSS 29. Data analyzed by repeated measures ANOVA

Eligibility Criteria:
Inclusion Criteria:

* • 8 to 12 years of age

  * Both male and female
  * Hemiplegic cerebral palsy according to (GMFCS) severity level I-II
  * Ability to follow instructions and participate in therapy session

Exclusion Criteria:

* • Presence of any medical conditions that would severely limit a child's participation in the study as vision or hearing loss, cardiac anomalies.

  * severe cognitive impairments that would hinder the participant's ability to actively participate in therapy sessions.
  * Complicated systemic disorders.
  * Uncontrollable seizures.
  * Usage of Botulinum toxin A injection within 3 months of prior
Pharmacokinetics of Cyclosporin in Nephrotic Syndrome

The purpose of this study is to evaluate whether there are differences in the pharmacokinetics of cyclosporine in remission nephrotic syndrome compared to relapsed disease in children.

This is a prospective study on ten children using Cyclosporin-A (CSA) microemulsion to treat idiopathic nephrotic syndrome (INS), with normal renal function, who achieved complete remission with CSA. The objective is to compare the pharmacokinetic (PK) parameters of CSA in INS during remission and relapse of the disease. The PK profile of CSA was evaluated with the 12-hour area under the time-concentration curve (AUC0-12) using seven time-point samples. This procedure was done on each patient during remission and relapse with the same CSA dose in mg/kg/day. The AUC0-12 was calculated by trapezoidal rule. All PK parameters and the resumed 4-hour area under the time-concentration curve (AUC0-4) were correlated with AUC0-12. This study is very important because the cyclosporin is a nephrotoxic drug with narrow therapeutic window.

Eligibility Criteria:
Inclusion Criteria:

* children with steroid-resistant nephrotic syndrome and steroid-dependent nephrotic syndrome in use of cyclosporine
* renal function evaluated by creatinine clearance estimated by stature ≥ 90 ml/min/1.73m2
* cyclosporine trough level (C0) between 50 and 150 ng/ml
* complete remission with cyclosporine according to the guidelines of International Society of Kidney Diseases in Children

Exclusion Criteria:

* renal and hepatic function abnormalities
* presence of infectious disease
* clinical or histological signs of CSA nephrotoxicity and suspicious of non-compliance
Reverse Walking With And Without Whole Body Vibration in Children With Cerebral Palsy

To determine the effects of reverse walking with and without Whole-body vibration on postural balance in children with cerebral palsy.

Current study concluded that reverse walking with and without whole body vibration were effective in improving postural balance, reach and quality of life in cerebral palsy children. However (whole body vibration+ reverse walking) provides more clinical benefits than reverse walking alone in improving postural balance, side reach and quality of life. Whereas both techniques were equally effective in improving forward reach in cerebral palsy children.

Eligibility Criteria:
Inclusion Criteria:

Aged 6-12 years

* Confirm diagnosis of Cerebral Palsy
* GMFCS level I \& II
* Both genders (28)

Exclusion Criteria:

* o Visual impairment

  * Patients who can't follow command
  * Hearing impairment
  * Malignancy
  * Infection (such as Osteomyelitis)
  * Inflammatory arthritis
  * Lower extremity bones fracture
  * Cardiovascular disease
  * Traumatic cases
Comparison of Safety and Efficacy of de Novo Everolimus

Nowadays, de novo everolimus regimen in renal transplant patients is considered for reduction of cyclosporine dose and it is mentioned that this regimen not only has similar safety and efficacy, but also could prevent Cytomegalovirus (CMV )infections. So, the aim of this study was comparison of safety and efficacy of de novo everolimus plus low dose of cyclosporine with standard dose of cyclosporine plus cellcept on CMV virus infections prevention in renal transplant patients.

This randomized clinical trial was conducted in Shahid Labbafi nejad hospital. 35 renal transplanted patients enter the study and randomized to one of two groups: everolimus or control (Sandimmun or tacrolimus). However, 34 patients completed study (17 patients in each group). The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose and in control group was standard dose of Sandimmun or tacrolimus plus cellcept. All patients gave Antithymocyte Glubolin and prednisolone. In addition, they gave CMV prophylaxis until 3 months. Kidney biopsies were done for raise of creatinine or protocol biopsy at 6 month after transplantation. Demographic, renal disease and transplantation characteristics, CMV and BK virus status, rejection, and routine laboratory tests recorded during study period and compared between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Adult Transplanted patients \> 18 years

Exclusion Criteria:

* Simultanous Kidney -Pancreas Transplantation
Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases

A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse and focal diseases in stomach, we performed this single-blinded multi-center prospective study compared MCE with gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients presented with gastric symptoms and ready for the first Upper GI endoscopy
* Patients with known focal gastric diseases: gastric ulcer, gastric polyps, early gastric cancer, gastric stromal tumors and so on.
* Age of 18 years to 70 years

Exclusion Criteria:

* Patients with impaired bowel movement from ileus or organic digestive diseases
* Patients with known large and obstructing tumors of the upper GI tract
* Patients after upper GI surgery or abdominal surgery altering GI anatomy
* Patients under full anticoagulation
* Patient in poor general condition
* Patients using equipment that may be affected by radio transmission
* Patients using equipment that may be affected by magnetic field
* Pregnancy or suspected pregnancy
Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation

The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.

Purpose:

Eligibility Criteria:
Inclusion criteria:

* Pradaxa® prescribers (cardiologists and primary care physicians)
* Patients with atrial fibrillation treated with Pradaxa®

Exclusion criteria:

As defined in Summary of Product Characteristics for patients treated with Pradaxa®
The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics

The RAPID trial is a randomized controlled trial that looks at the clinical impact of a rapid respiratory test in a pediatric emergency department. Participants will be randomized to the intervention group - results available to medical providers, or the control group- results not available to medical providers.

The RAPID trial is a randomized controlled trial of rapid respiratory viral testing in children presenting to an Emergency Department setting with acute respiratory symptoms. The patient cohort will be children 1 month to 18 years of age presenting to the Children's Hospital Colorado (CHCO) Emergency Department with influenza like illness who are triaged as level 3, 4, or 5 by the Emergency Severity Index, representing the typical patient population who are evaluated in an urgent care setting. All eligible participants will undergo a nasopharyngeal swab and point of care testing, and participants will be allocated 1:1 by computer-generated randomization to either the intervention group - test result available to providers, or the control group- test result not available (routine clinical care). The investigators will compare the clinical outcomes between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Age 1 month to \< 18 years
2. For children aged 1 month to 12 months of age: Presentation to the study sites with temperature \> 37.8°C or cough, sore throat, runny nose or nasal congestion
3. For children aged \> 1 year to 18 years of age: Presentation to the study sites with influenza like illness, defined as temperature of \>37.8⁰C and at least one of the following: cough, sore throat, runny nose or nasal congestion
4. Triage Level 3,4,5 based on Emergency Severity Index (refer to Appendix B for algorithm)

Exclusion Criteria:

1. Respiratory symptom duration \> 14 days
2. Previous enrollment in study within past 14 days
3. Nurse-only visit
4. Triage levels 1 and 2 based on Emergency Severity Index
Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft

Reperfusion of renal graft in kidney transplantation can change the pharmacokinetic-pharmacodynamic (PKPD) parameters of rocuronium. The immediate increase of urine output during surgery may change the PKPD parameters of the drugs, including elimination rate. The goal of this study is to characterize the PKPD model of rocuronium during kidney transplantation and establish a basis for adequate dosage of rocuronium in kidney transplantation.

Through PKPD modeling, the changes during reperfusion of the renal graft will be evaluated. Furthermore, the factors related to the changes will be assessed. Adjusting the infusion rate according to the step of kidney transplantation will lead to stable muscle relaxation and fast recovery.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective living donor kidney transplantation
* end stage renal disease with oliguria or anuria
* normal BMI (BMI 18.5 \~ 25)
* obtained informed consent

Exclusion Criteria:

* patient with underlying neuromuscular disease
Promoting Self-Regulation Skills and Healthy Eating Habits in Early Head Start

The purpose of this study is to test the effectiveness of a new curriculum on toddlers' self-regulation skills and healthy eating habits. The curriculum is being delivered as part of Early Head Start home visits and compared to the effectiveness of usual practice Early Head Start home visits.


Eligibility Criteria:
Inclusion Criteria:

* Children must be receiving Early Head Start home visits and be at least 2 years old at the beginning of the study.

Exclusion Criteria:

-