cyrilzakka/clinical-trials huggingface dataset:
Rehabilitation of Children With Multiple Disabilities

The objective of the study is to compare the usual care and treatment of children and youth (0-19 years) with multiple developmental delays and disabilities and their families in Simcoe York with a co-ordinated, navigated approach to care using the Children's Treatment Network (CTN) services.

The Children's Treatment Network (CTN)links existing children's services rather than creating a new Centre. The purpose of the evaluation is to compare the effectiveness and efficiency of this service with the usual care that people receive. 500 Children will be randomized to receive either usual care (250) or the co-ordinated, navigated care from CTN (250). The primary question to be addressed is whether the more integrated CTN model of service improves family-centered services, parent mental health, parenting, family function and the quality of the child's life and the families resource needs as well as reduce expenditures for the families' use of all other health and social services compared to the outcomes of usual care alone. What children and families with what characteristics and circumstances most benefit from which approach to the treatment of childhood disability in Simcoe-York? At what cost?

Agencies providing services to children will be evaluated as to how effective their integration of teams are functioning, their partnership with each other and capacity building in the community.

Eligibility Criteria:
Inclusion Criteria:

* Children and youth up to 19 years of age
* living in Simcoe-York.
* English speaking
* multi-need family
* children on agency service wait lists
* children under the care of Children's Aid Societies
* Families with more than 1 disabled child

Exclusion Criteria:

-youth over 19 years.
Two Different Surgical Techniques on Postoperative Circumcision Pain

To compare the effect of two different surgical techniques, the dorsal slit and double incision technique, on postoperative pain.

Two different circumcision techniques result in different kinds of pain.This research aims determine which is more beneficial to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Children

Exclusion Criteria:

* Patients with any bleeding
Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty

The purpose of this prospective study is to examine the effect of two local anesthetics used in adductor canal blocks, with relation to pain, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay. The two agents are bupivacaine and ropivacaine. The purpose of this trial is to examine the effect of these drugs being used in adductor canal blocks for pain relief, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay.

Total knee arthroplasty (TKA) is associated with intense early postoperative pain. Effective pain management following total knee arthroplasty is imperative to facilitate early ambulation, mobilization and rehabilitation. The postoperative pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. To manage postoperative pain effectively, multimodal analgesia including acetaminophen, Toradol, Solu-Medrol, opioids and local anesthetics are used. Periarticular infiltration performed intra-operatively combined with ultrasound guided adductor-canal peripheral nerve blocks are effective in reducing pain following a TKA without causing quadriceps motor block which can impede mobilization. There are no published trials that the investigators could find to date, comparing adductor canal block with a single dose Exparel and adductor canal block with standard ropivacaine.

A liposome is a manufactured spherical lipid vesicle that can be used to slowly release a drug thereby extending its duration of action. Exparel is such a compound that slowly releases bupivacaine. Local anesthetics block the conduction of all excitable tissue in a dose related fashion. The first tissues that are affected are nerves, which make these drugs of choice in neural block. Their local adverse effects include neurovascular manifestations are prolonged numbness, tingling, feeling of "pins and needles" or strange sensations. These effects are reversed with time. There are no additional potential risks or adverse effects due to the procedures or drugs being administered. The procedure is well established and the local anesthetics have a history of long term use in humans.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and up undergoing a total knee replacement with single surgeon. American Society of Anesthesiologists Physical Status Classification Scale (ASA) 1-3.

Exclusion Criteria:

* Allergy to local anesthestic, pre-existing peripheral neuropathy, revision surgery
Comparison of the Accuracy and Reliability of AMH, FSH and AFC in Predicting Ovarian Response

Serum bio-markers have different prediction values for ovarian response during ovarian stimulation in-vitro fertilization


Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 45 years at the time of FSH starting
* BMI \< 25 kg/m2,
* First IVF attempt
* Receiving GnRH-antagonist protocol
* Had oocyte retrieval

Exclusion Criteria:

* Had ovarian stimulation or ovulation induction within 2 months prior to the study
* PCOS
* Had ovarian tumor or endometrioma
* Hyperprolactinemia
* Thyroid hormone disorders
* Pituitary failure
* Had other medical situations such as liver failure, renal failure, heart disease, diabetes, depression
* Had IVM
Evaluation of a Telehealth Lifestyle Management Program to Improve Healthy Behaviors Post Head Injury

Interventions to help individuals with traumatic brain injury manage their healthy lifestyle behaviors have been limited. Thus, the goal of this project is to evaluate the efficacy of a telehealth lifestyle program on reductions in weight and improvements in health behaviors/lifestyle choices.


Eligibility Criteria:
Inclusion Criteria:

1. age 19 years or older
2. English speaking
3. sustained a moderate or severe TBI (as defined by a period of confusion after the injury of more than 24 hours)
4. overweight or obese as defined by a BMI score of ≥ 25 kg/m2
5. 1-year or greater post-injury
6. not currently enrolled in a weight loss program or receiving weight loss medication
7. regular access to a computer/laptop with internet capability which allows internet and telephone access simultaneously
8. if person with TBI who meets criteria 1-7 but does not cook, shop, and/or prepare meals independently, he or she must have a non-paid, study partner willing to participate in the study.

Exclusion Criteria:1

1. pregnant or planning to become pregnant in the next 7 months
2. concurrent medical condition for which changes in exercise or diet would be contraindicated
3. severe hearing or visual impairment
4. significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded)
5. unable to communicate
6. significant cognitive impairment and without a study partner, and/or
7. person with TBI who does not cook, shop, and/or prepare meals independently who does not have a non-paid, study partner willing to participate in the study
8. currently enrolled in an organized weight loss program
9. has lost \> 10% of body weight over the past 6 months
10. history of an eating disorder
Unexpected ABR Results in Patients Suspected With Auditory Neuropathy Spectrum Disorder

This study aimed to assess the clinical evaluations and potential underlying pathologies in patients diagnosed with Auditory Neuropathy Spectrum Disorder (ANSD) who exhibited unusual results in audiological tests. The research involved the retrospective analysis of audiological tests of 11 patients conducted by expert audiologists at Istanbul Medipol Mega Hospital between 2010 and 2020. These patients displayed abnormalities in their Auditory Brainstem Response (ABR) tests. The study sought to investigate patients with ANSD who presented atypical audiological findings, shedding light on the associated clinical aspects and potential causes of such anomalies.


Eligibility Criteria:
Inclusion Criteria:

* Presence of wave V with cochlear microphonics

Exclusion Criteria:

* Type B tympanogram
Intra-arterial Albumin in Acute Ischemic Stroke After Endovascular Treatment for

Stroke is an acute focal injury of the central nervous system caused by cerebral vessels. One in every four people is affected by stroke at different times in life. Globally, stroke is the second leading cause of death and third leading cause of disability in adults. we hypothesized that in patients with acute large vessel occlusive ischemic stroke treated with mechanical thrombectomy, the infusion of 20% human serum albumin solution into the revascularization area can exert a stronger neuroprotective effect.

In the previous period, we have conducted a clinical trial on the safety and feasibility of arterial infusion of 20% human serum albumin solution. The results of the study found that after arterial infusion of 20% human serum albumin solution at a dose of 0.6g/kg to the subject's vascularization area, the subjects did not develop significant complications related to albumin solution. There were no serious adverse events associated with arterial infusion of albumin solution in all subjects. After the evaluation of the Data Safety Monitoring Board, the clinical study was considered to be the next step, which is to initially explore the effectiveness of 0.6g/kg arterial infusion of 20% human serum albumin solution for neuroprotection of subjects.

Eligibility Criteria:
Inclusion Criteria:

1.Male or female, age≥18 and ≤ 80; 2. anterior circulation large vessel occlusion confirmed by CTA, MRA and DSA; 3. baseline National Institute of Health Stroke Scale (NIHSS) score ≥6； 4. Alberta Stroke Program Early CT Score (ASPECTS) 6-10; 5. Stroke symptoms present to femoral artery or brachial artery puncture within 24 hours； 6. occluded vessel reaches eTICI level ≥2b after thrombectomy confirmed by DSA；7. Informed consent obtained;

Exclusion Criteria:

(1) history of congestive heart failure or jugular dilatation, third heart sound, resting tachycardia due to heart failure (\>100 beats/min), hepatomegaly and lower limb edema without obvious cause on admission physical examination; (2) hospitalization for acute myocardial infarction within 3 months; (3) symptoms of acute myocardial infarction or admission electrocardiogram; (4) second or third degree heart block or arrhythmia with hemodynamic instability; (5) acute or chronic renal failure (blood creatinine \> 2.0 mg/dL); (6) severe anemia (hematocrit\<32%); (7) symptoms or CT evidence of subarachnoid hemorrhage; (8) pregnancy; (9) allergy to albumin; (10) admission blood pressure higher than 185/110 mmHg; (11) any chronic lung disease, including chronic obstructive pulmonary disease, bronchiectasis, and other lung diseases that interfere with daily activities; (12) presence of other diseases that may endanger life.
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females

This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants. The study will also assess the safety and tolerability of the SC and IV formulations. In Part 1 of the study, four cohorts will be treated with a single dose of Herceptin as follows: Cohort 1 (6 milligrams per kilogram \[mg/kg\] IV in healthy male participants); Cohort 2 (6 mg/kg IV in HER2-positive female participants); Cohort 3 (6 mg/kg SC in healthy male participants); Cohort 4 (10 mg/kg SC in healthy male participants). An additional cohort of healthy volunteers (Cohort 5) will be opened if both SC dose levels from Cohorts 3 and 4 result in Herceptin exposures different from the target concentration produced by a single IV dose, or if the variability in pharmacokinetic (PK) parameter values cannot be used to define the target SC dose level. In Part 2 of the study, HER2-positive female participants will receive a single dose of SC Herceptin at the dose level defined in Part 1. Participants from Part 1 are eligible to enter Part 2 provided they receive the second (Part 2) study dose of Herceptin a minimum of 22 days after their first (Part 1) dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Participants (Part 1 only)

  * Males 18 to 45 to years of age
  * Baseline left ventricular ejection fraction (LVEF) greater than (\>) 60 percent (%)
* HER2-Positive Females (Parts 1 and 2)

  * Females greater than or equal to (≥) 18 years of age
  * Eastern Cooperative Oncology Group (ECOG) performance status of 0
  * Previous non-metastatic operable primary invasive HER2-positive breast cancer
  * Baseline LVEF \>55%

Exclusion Criteria:

* Healthy Participants (Part 1 only)

  * Clinically significant abnormalities in laboratory test results or electrocardiogram
  * History of significant allergies, gastrointestinal, renal, hepatic, cardiovascular, or pulmonary disease
  * History of hypersensitivity or allergic reaction, spontaneous or following drug administration
  * History of cardiac conditions
* HER2-Positive Females (Parts 1 and 2)

  * Metastatic disease
  * Concurrent other malignancy requiring therapy of any modality which may interfere with PK investigations or result in unexpected toxicity
  * Use of Herceptin in previous 5 months
  * Serious cardiac illness
Treatment With Low-Dose Cytarabine in Elderly Patients (Age 70 Years or Older) With Acute Myeloid Leukemia: A Single Institution Experience.

The treatment of very elderly patients (≥70 years) with acute myeloid leukemia remains controversial. Although the outcome in younger adults has improved because of cytarabine- and anthracycline-based chemotherapy with advanced supportive care and introduction of hematopoietic stem cell transplantation, the benefit associated with standard intensive chemotherapy in older patients remain debatable. Life expectancy in elderly patients is a function of age, disability and comorbidity, performance score, along with leukemia characteristics such as genetic alterations or white blood cell count at diagnosis 'Older' patients are generally considered those aged 60 years or older.

Intensive chemotherapy delivered to the very elderly with AML (patients _70 years of age), may not be beneficial to most and could be harmful to some. However, these patients are often referred to as 'unfit' or ineligible for intensive remission induction therapy. In daily practice, the final decision to treat intensively or not is made by the treating hematologist on a case by case basis according to patient's age, cytogenetics, performance score, concomitant diseases and type of AML (de novo or secondary).

In older patients considered 'unfit' for intensive treatment, LD-AraC has been demonstrated to be more beneficial than best supportive care and hydroxyurea. The recent availability of new drugs that may have an improved side effect profile and in some cases bioavailability may offer future improvement for this patient population. The efficacy of hypomethylating agents has been studied in older AML patients with conflicting results. Recent publications refined prognostic information, which not only optimize existing treatments but also could lead to the development of additional targeted therapeutic approaches.

In this study, the investigators focus on patients with AML (_20% blasts) aged 70 or older seen in our institution over a 14-year period. The objectives of the analysis are to describe the demographic, clinical and biological characteristics of this population and to evaluate how these characteristics and the treatment chosen affect


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of AML according to World Health Organization (WHO) classification
* Are at least 70 years of age

Exclusion Criteria:

- Patients with M3 AML of FAB classification (APL, Acute Promyelocytic Leukemia)
Non-interventional Surveillance of Effectiveness of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Moderate and Severe Asthma

This is a 3-month non-interventional, observational study on patients with moderate and severe asthma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate and severe asthma on Symbicort SMART treatment

Exclusion Criteria:

* Under 18 years old
High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT)

This study is being performed to find out if a new kind of breast imaging (called dedicated breast CT or BCT) can help doctors to see the small structures in breast tissue more clearly. The investigators also want to find out if using the BCT will provide a more accurate diagnosis of breast cancer.

The breast imaging device that will be used in this study (breast computed tomography or BCT) is not FDA-approved for this use so this is a research study. The machine has been redesigned to see if doctors can see smaller structures and use a lower radiation dose.

The breast CT device will take multiple pictures of the subject's breast and create a 3-D image of the breast. It does not compress or squash the breast like a mammogram.

Eligibility Criteria:
Inclusion criteria: All subjects that are eligible to participate in the study will be women who satisfy all of the inclusion criteria stated below:

* who are 40 years of age or older (typical screening age range)
* who are undergoing or scheduled for screening or diagnostic imaging, or need a biopsy to investigate an abnormality in the breast.

Exclusion criteria: Subjects that present with any of the criteria listed below will be excluded:

* Males,
* women less than 40 years old,
* women unable to self-consent,
* prisoners,
* pregnant, suspected to be pregnant, or lactating women (self-reported)
* women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker;
* women who are unable to tolerate study constraints, frail, or unable to cooperate;
* women who weigh more than 440 lbs (200 Kg), which is the weight limit for the patient support table of the BCT system;
* women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) treatment for enlarged thymus gland as an infant, irradiation for benign breast conditions, including breast inflammation after giving birth, and treatment for Hodgkin's disease;
* women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram;
* women who have received large number of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) tuberculosis, and severe scoliosis.
The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function

The aim of the study is to examine whether the compound herbal formula (RHD-1) is effective on HBV Carrier With Abnormal Liver Function.

% change HBV DNA title and liver function.

Eligibility Criteria:
Inclusion Criteria:

* 40 \< GPT \<200 HBV carrier Age: 18-65 yrs old

Exclusion:

Creatinine \>2.0 mg/dL Total bilirubin \> 2.0mg/dL Not suitable patients diagnosis by physician in charge.
Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?

The purpose of this study is to determine whether there is a relationship between serial B-natriuretic peptide (BNP) and implantable device measured intrathoracic impedance in symptomatic and asymptomatic heart failure patients over a 1-year period. Furthermore, this study will establish whether implantable device measured intrathoracic impedance trends with the distance walked on a six-minute hall walk (6MHW), an exercise-based acute measure that has also been associated with heart failure clinical status.

This is a prospective non-randomized longitudinal study. One hundred subjects will participate in 6 monthly and 3 bi-monthly serial assessments of plasma-based BNP, implantable device measured intrathoracic impedance, and clinical evaluation of heart failure status. Each patient will be enrolled in the study for a period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Baseline BNP \> 80 pg/ml
* Meets current guidelines for ICD implantation with or without CRT
* Receiving a Medtronic InSync Sentry, Concerto, Virtuoso, or subsequently approved Medtronic ICD with the OptiVol feature.
* Walk \< 450 meters during 6 minute hall walk test

Exclusion Criteria:

* Less than 18 years of age
* Life expectancy \< 6 months
* History of non-compliance with clinic visits or study-related tasks which may decrease chance of completing of the study
* Physical disability which limits exercise
Effect of Fu's Subcutaneous Needling on Postoperative Acute Pain in Patients With Lumbar Spine Surgery.

The goal of this clinical trial is to evaluate Fu's Subcutaneous Needling (FSN) in postoperative pain in patients with Lumbar Spine Surgery (LSS). The main questions it aims to answer are:

* Is FSN effective for postoperative pain?
* Dose FSN decrease the tissue hardness after LSS?
* Dose FSN have the effect of anti-inflammatory after LSS?

Participants will receive routine analgesic and FSN after LSS. Researchers will compare Sham group to see if FSN being effective for postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Pain and neurological symptoms are caused by degeneration of the spine (L1-S1) and require surgery.
* One hour after lumbar spine surgery (evaluated after returning to the ward from the recovery room) Visual analogue scale (VAS) score ≥ 5 points
* After being explained, join the trial voluntarily and sign the subject's consent form.

Exclusion Criteria:

* Pain caused by acute trauma.
* major diseases such as heart and lung failure, cancer, chronic kidney disease.
* psychiatric disorder.
* History of substance abuse.
* A history of spinal surgery.
* Refused sign the consent form.