cyrilzakka/clinical-trials huggingface dataset:
Efficacy of the CLP® Hip - Retrospective

The purpose of this study is to evaluate the survivorship and efficacy of the Encore CLP® Hip stem in a group of no more than 200 patients from whom data has already been collected.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 18 years of age or older.
2. Noninflammatory degenerative joint disease including

   * Osteoarthritis of the natural femoral head
   * Avascular necrosis of the natural femoral head
   * Rheumatoid arthritis
3. Correction of functional deformities
4. Femoral fracture
5. Patients must be able and willing to complete all study-related visits.

Exclusion Criteria:

1. Anyone who is under 18 years of age
2. Infection or sepsis
3. Insufficient bone quality which may affect the stability of the implant
4. Muscular, neurological or vascular deficiencies, which compromise the affected extremity
5. Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock, poor skin coverage around hip joint which would make the procedure unjustifiable
6. Osteomyelitis
7. Rapid joint destruction or bone absorption apparent on roentgenogram
8. Pathological conditions of the acetabulum which would prevent achieving proper range of motion, appropriate head stability, and/or a well-seated and supported smooth articulation of the head within the acetabulum
9. Alcoholism or other addictions
10. Materials sensitivity
11. Loss of ligamentous structures
12. High levels of physical activity (e.g., competitive sports, heavy physical labor)
13. Pregnancy
Therapeutic Effects of Plyometric Exercises in Children With Type 1 Diabetis

Despite the benefits of physical rehabilitation among adults and children with chronic illness such as Diabetes mellitus avoid engaging in different physical activities especially pediatric population. Most of the children with type 1 Diabetes mellitus receive their medical treatment and follow-up with no change of their functional performance.

We still lack the evidence of plyometric exercises in pediatric population with Diabetes mellitus . Therefore, the primary aim of this study is to explore the effects of plyometric exercises on blood glucose level, balance and muscle strength in children with 1 Diabetes mellitus

Eligibility Criteria:
Inclusion Criteria:

* Age will range from six to 10 years
* Both sexes
* Chronicity of the disease ranges from 3 to \<5 years.
* Controlled diabetes with insulin dosage described by physician.

Exclusion Criteria:

* Heriderty sensory or autonomic peripheral neuropathy.
* Unstable cardio-vascular disorders
* History of fractures or surgery in the lower extremities in the past 12 months.
* Diagnosed with other hormonal diseases.
* Children who practice regular sports.
Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II

Individual differences in drug efficacy and adverse reactions are common in the clinical application of drugs. Individual differences are caused by many factors, among which genetic factors account for more than 20%. Novel oral anticoagulant drugs (NOACs, including rivaroxaban, apixaban, edoxaban, dabigatran, etc.) and novel antiplatelet drug ticagrelor have the advantages of convenient use and no need for monitoring. But novel oral antithrombotic drugs also increase the risk of bleeding, and there is currently a lack of effective antagonists when antithrombosis is excessive or emergency surgery is required. At present, there are few studies on the causes of individual differences in novel antithrombotic drugs, and there is a lack of predictable biomarkers or drug genotypes, especially in China. Therefore, on the basis of previous studies on NOACs and ticagrelor individualized medication cohorts, this study plans to establish a validation cohort for novel antithrombotic drugs bleeding related biomarkers, conduct multi-omics testing and long-term follow-up, and explore markers related to pharmacodynamics of antithrombotic drugs, adverse bleeding reactions and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

(I) Chinese Patients taking NOACs

* In accordance with anticoagulation indications of NOACs, include prevention of thrombosis in non valvular atrial fibrillation, prevention and treatment of deep vein thrombosis / pulmonary embolism and prevention of thrombosis after knee / hip replacement;
* More than 18 years of age, male or female;
* Never received NOACs in a month and intend to take NOACs or have received NOACs for more than one week continuously;
* sign informed consent.

(II) Chinese Patients taking ticagrelor

* With diagnosis of acute coronary syndrome (ACS), included unstable angina, non ST segment elevation myocardial infarction and ST segment elevation myocardial infarction;
* More than 18 years of age, male or female;
* Never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously#
* sign informed consent.

Exclusion Criteria:

* With history of immunodeficiency disease, including positive HIV index;
* Positive Hepatitis B surface antigen (HBsAg) and HCV index;
* Combined therapy of CYP3A4 strong inhibitors and P-gp inhibitors (e.g., systemic pyrrole antifungal agents such as ketoconazole, itraconazole, voriconazole and posaconazole; human immunodeficiency virus (HIV) - protease inhibitors such as ritonavir), CYP3A4 strong inducers and P-gp inducers (e.g., rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort, etc.) in 14 days before treatment with NOACs;
* Severe liver dysfunction and abnormal renal function;
* Include contraindications of antithrombosis, such as hypersensitivity, active bleeding, moderate or severe liver disease, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days.
French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia

This is an observational study to explore how different treatment regimens affect continuation with treatment in the first 6 months following initiation of XAGRID into adult patients' essential thrombocythemia therapy.


Eligibility Criteria:
Inclusion Criteria

1. Patients aged 18 years and older.
2. High-risk ET Patients, uncontrolled by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons.
3. Patients who have been on second- or third-line XAGRID treatment for up to 1 month, or for whom a decision has been documented to commence second line XAGRID treatment.
4. Patients able to understand and able and willing to participate in the study, and provide a personally dated and signed written informed consent form.

Exclusion Criteria

1. Patients with a known or suspected intolerance or hypersensitivity to XAGRID, closely related compounds, or any of the stated ingredients.
2. Patients for whom there is an intention to treat with combinations of cytoreductive therapy.
3. Patients participating in a separate clinical trial where their treatment is defined by that study protocol.
Compression and CO2 Laser for Leg Wounds

The purpose of this study is to determine the efficacy and safety of compression bandaging with fractional ablative carbon dioxide laser (FACL) compared to compression and standard dressings alone for healing of post-operative wounds of the leg.

This is a randomized, SMART design, clinical trial. Approximately 80 participants will be randomized to initially receive compression bandages or standard wound dressings after surgery on the lower leg. After 4 weeks, the group assigned to compression bandages will be further randomized to either continue with the compression bandages only or continue with the compression bandages and also receive (FACL). The study is designed as an 6-month study. This study was a pilot study designed to determine feasibility of these procedure.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.


Eligibility Criteria:
Inclusion Criteria:Patients will be identified through the clinic where their skin is to be treated by excisional surgery on the lower leg. Those considered for enrollment must also meet the following criteria:

1. \>18 years of age
2. Wound size of at least 1 cm in width
3. Cutaneous excision of the lower leg
4. Surgeon elected repair of healing by secondary intention
5. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

1. Current smoker
2. Uncontrolled diabetes mellitus
3. Uncontrolled hypothyroidism
4. Severe renal impairment or hypoalbuminemia
5. Chronic lymphedema
6. Severe venous insufficiency (large varicose veins, atrophie blanche)
7. Arterial insufficiency (ABI \< 0.8)
8. Rubber or rubber accelerator allergy
9. Prior radiation to the surgical site
10. History or evidence of a clinically significant medical or psychiatric disorder, condition or disease that in the opinion of the treating physician would pose a risk or interfere with evaluation or completion of the study
11. Subject un willing to sign an IRB approved consent form
12. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
Adjustment of Adopted Adolescents in Their Families

The adjustment of adopted adolescents has been studied in the U.S. and England, but few other European countries have conducted research into this topic. As countries differ greatly in their cultural practices, a comparative study of the adjustment of internationally adopted teenagers in 4 European countries (France, Italy, Spain, Norway) is planned. The adjustment of teens and their families will be studied in relation to the openness of communication related to adoption within the families.

The aim of the study is to evaluate the status of internationally adopted adolescents in relation to the characteristics of their families, and to explore the similarities and differences in 4 different European countries. Parents and adolescents will complete questionnaires which incorporate and adapt many standard measures. The parent questionnaire includes components of : a) Family Adjustment and Cohesion Scale (FACES), b) Strengths and Difficulties Questionnaire for parents (SDQ-parent), c) Parent Stress Index (PSI), d) Adoption Satisfaction Questionnaire (ASQ), d) Brodzinsky Scale (openness in family communication related to adoption), and e) basic demographic information.

The adolescent questionnaire includes elements of : a) SDQ-adolescent, b) Health Behavior in School Children questionnaire (HBSC), c) Life Orientation Test-Revised (LOT-R), d) Lee Scale (Discrimination Scale for Adoptees).

It is hoped that the study will permit a better understanding of the experiences of families and their children after international adoption. This knowledge will help potential adoptive families as well as families who have already adopted. This information is not yet available in a European context. In addition, the information will be valuable to adoption professionals. Moreover, the opportunity to compare outcomes and experiences of families and adolescents in 4 European countries will allow a better understanding of the contribution of different cultural contexts to these outcomes. It is hypothesized that different cultural practices and beliefs about adoption likely impact the experience of adoption by adolescents and parents. A better understanding of this dynamic will be useful clinically as well as at the community level and beyond.

Eligibility Criteria:
Inclusion Criteria:

* Parents: have an internationally adopted adolescent between ages of 11-17 years child arrived in the family at least 6 months ago Adolescents: internationally adopted, between ages of 11-17 years arrived in the family at least 6 months ago

Exclusion Criteria:

* Parents: unwilling or unable to complete questionnaire Adolescent: unwilling or unable to complete questionnaire
Comparative Efficacy of Saccadic and Biofeedback Training in Homonymous Hemianopia

This pilot study aims to understand how eye movements change in people with vision loss from stroke after completing one of two types of training. The study will look at how eye movements and reading performance change after training. Researchers will compare the results of two groups: one group will complete five clinical training sessions using an eye-tracking machine for 30 minutes each, while the other group will do at-home reading exercises for 20 minutes a day, 5 days a week, for 6 weeks. The goal is to see if there is a difference in performance between the two types of training.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke
* Presence of hemianopia with central vision involvement
* Stroke occurred at least 6-months before enrollment

Exclusion Criteria:

* Presence of hemianopia with macular sparing
* Diagnosis of hemispatial neglect
The Effect of Mirror Therapy on Upper Extremity Motor Function in Stroke Rehabilitation

The study aimed to determine the effect of mirror therapy versus conventional physical therapy treatment in improving upper extremity impairments and motor function among chronic hemiplegic subjects.

Research Objectives:

1. To discover the effectiveness of conventional physical therapy treatment on improving upper limb motor function among chronic hemiplegic subjects.
2. To find out the effect of mirror therapy along with conventional physical therapy treatment on improving upper limb motor function among chronic hemiplegic subjects.
3. To find out the effectiveness of mirror therapy combined with conventional physical therapy treatment versus conventional physical therapy treatment alone on improving upper extremity motor function among chronic hemiplegic subjects.


Eligibility Criteria:
Inclusion Criteria:

* Duration of stroke more than six months
* Subjects of chronic stroke with left or right hemiplegia.
* Genders of male and female with age ranging between forty-five to sixty-five years.
* MMSE scores greater than 23 out of 30.
* Scored one or one plus on MAS on all muscles of the affected upper limb.
* Have normal visual perception.
* Able to follow oral commands.

Exclusion Criteria:

* Unable to follow visual and oral commands.
* Unilateral neglect.
* Cognitive impairments (MMSE scores less than 24 out of 30), or language deficits.
* Any other neurological disorders and recent surgeries.
* Previous exposure to MT.
Influence of Participation in Randomized Controlled Trials on adheRence to Medicines' Intake and regUlar viSits to the docTor

A prospective non-interventional single-center study aimed to evaluate the influence of participation in international randomized controlled trials (RCT) of cardiovascular patients on their compliance and adherence to medicines' intake and regular visits to the doctor in comparison with those patients, who had never participated in RCT within the outpatient registry PROFILE (prospective, observational study).


Eligibility Criteria:
Inclusion criterion for study group

• All patients of the outpatient register PROFILE who participated in the international randomized clinical trials from 2011 to 2018, (n≈100).

Inclusion criterion for control group

• Patients of the outpatient register PROFILE, who from 2011 to 2018 were observed in the research center for preventive medicine and never participated in international randomized clinical trials (n≈100).

Exclusion criteria for both groups

* Patients whose life status is defined as "dead"
* Patients who refused to participate in our study
Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

Study Design

* Open, escalating single-dose design.
* 7 ascending dose cohorts
* In each cohorts, subjects will receive a single dose of HM61713.
* Main objective of this study is to evaluate the pharmacokinetics of HM61713 tablet.

Primary objectives

• To assess the PK characteristics of HM61713 and metabolites in healthy male volunteers

Secondary objectives

* To assess the safety and tolerability of HM61713 tablet in healthy male subjects.
* To assess the food effect on PK characteristics of HM61713 tablet in healthy male subjects.
* To assess the ethnic differences of PK characteristics of HM61713 (Korean, Japanese, Caucasian)
* To investigate genotype of drug metabolism.transport that affect PK characteristics of HM61713
* To investigate the change of endogenous metabolic markers after administration of HM61713

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, age between 20 and 45
* Informed of the investigational nature of this study and voluntarily agree to participate in this study
* BMI of \>18.5kg/m2 and \<28kg/m2 subject

Exclusion Criteria:

* Use of any prescription medication within 2 weeks prior to Day 1
* Use of any medication within 1 weeks prior to Day 1
* Has a severe medical history of hypersensitivity to drug
* Participation in another clinical study within 8 weeks days prior to start of study drug administration
Use of a Lifeline Graft in the A-V Shunt Model

This study will assess the safety and efficacy of a completely autologous and completely biological tissue engineered blood vessel (TEBV) called Lifeline™ used as an arteriovenous fistula for dialysis access.


Eligibility Criteria:
Inclusion Criteria:

* Have signed an informed consent
* Patients ≥ 21 years old
* Patients not candidates for a Brescia-Cimino A-V fistula (own vessels)
* Have an AV shunt or fistula that will likely fail within 12 months because of:

  * Signs of clinical dysfunction: increment of venous pressure, limited site of puncture, stenosis, aneurysm dilatations that cannot be surgically repaired or by other media, or
  * Previous angioplasty, or
  * Previous thrombolysis
* Fall into category of ASA grade 2 or below (or UK equivalent)
* Are willing and able to comply with 2, 4, 6, 8, 10, 12, 16, 20, 24, 36 and 52 week follow up and able to comply with biannual follow up thereafter.

Exclusion Criteria:

* A need for urgent surgery
* Penicillin allergy
* Patients with uncontrolled hypertension
* Morbid obesity (\> 300 lbs)
* Active systemic infection
* Contraindication for anticoagulation
* Coagulopathy
* Acute renal failure
* Connective tissue diseases (i.e. Marfan's syndrome)
* Pregnant or nursing
* Life expectancy \< 1 year
* Participation in another study involving an investigational device or new drug
* Other medical, social or psychological issues that, in the opinion of the principal investigator, preclude them from receiving the treatment and the procedures/evaluations of the post-operative follow up
* Inability or unwillingness to comply with the scheduled follow-up visit
The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population

The study aims to examine the effect of auricular acupuncture on improving oral health in older population. The hypothesis of this study is that older people receiving auricular acupuncture can increase salivary secretion. By identifying the effectiveness of auricular acupuncture can increase salivary secretion; suitable care can be suggested to improve oral health in older population living in long-term institutions.

The elderly living in long-term institutions are mostly limited to physical dysfunction and highly dependence. In addition, the chronic diseases are affected by taking a variety of drugs, which may easily lead to dry mouth. Thus, providing oral health to increase secretion of saliva is high recommended to those older population. The study is used to examine the effect of auricular acupuncture on improving oral health in older population. The eligible participants are random assign to experimental group receiving auricular acupuncture and control group having ineffective auricular acupuncture. Outcome measures include demographic variables, general health status and secretion of saliva, such as: Subjective dry mouth condition and objective mouth condition. Generalized linear model will be used to examine the effect of auricular acupuncture on improving oral health. By identifying the effectiveness of auricular acupuncture can increase salivary secretion; suitable care can be suggested to improve oral health in older population living in long-term institutions.

Eligibility Criteria:
Inclusion Criteria:

1. Residents in long-term institutions aged over 65 years old
2. Living in long-term institutions at least six months and above
3. Having normal cognitive functions with Mini-Mental State Examination scores more than 25 scores.

Exclusion Criteria:

1. The resident whose acupuncture point has Trauma, eczema or ulcer.
2. Incapable of salivary secretion caused by disease,sush as radiation-induced xerostomia among patients with nasopharyngeal carcinoma, Sjogren's Syndrome,acute sialadenitis,chronic recurrent sialadenitis,viral salivary gland infection,salivary gland stones.
Standard Dose Versus High-Dose Inactivated Flu Vaccine in Pediatric Solid Organ Transplant Patients

This is a phase I trial in which the both the safety and immunogenicity of the standard dose flu vaccine will be compared with high dose flu vaccine in children that have undergone solid organ transplantation (SOT).

A prospective, randomized, double-blind phase 1 safety and immunogenicity study of the HD compared with the SD TIV in pediatric patients between the ages of three and 17 yr that have undergone SOT (Clin-Trials.gov. NCT01525004) was conducted. Subjects were randomized in a 2:1 fashion to receive 0.5 mL of either the HD (60 μg) or SD (15 μg) TIV intramuscularly. Subjects \<9 yr of age received either one or two doses of the vaccine based on ACIP recommendations \[19\]. The study was approved by Institutional Review Boards at both institutions (Vanderbilt University, Nashville, TN, and the University of Pittsburgh, Pittsburgh, PA) and conducted during the 2011-2012 influenza season. Subjects were randomly allocated to either the HD or SD group by a computer-generated allocation system. Participants, their families, and research staff who performed clinical evaluations remained blinded to the child's assigned dosage, while designated unblinded nurses administered the requisite vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric SOT patients (kidney, liver, heart, lungs, intestine, and/or multi-visceral)
* Must be at least 6 months after transplant.
* 3-17 years of age, inclusive.
* Available for duration of study.
* Parent or guardian able to be reached by phone.

Exclusion Criteria:

* History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein.
* History of Guillian-Barre syndrome.
* Receipt of rituximab within the past one year.
* Rejection treatment with intravenous steroid bolus within 30 days.
* Rejection treatment with monoclonal antibody or antilymphocyte preparation (e.g. Alemtuzumab, Muromonab-CD3, etc.) within 90 days.
* Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
* Have any condition that the investigator believes may interfere with successful completion of the study.
* History of received 2011-2012 influenza vaccine.
* Pregnant female.
* History of proven influenza disease after September 1, 2011.
* History of known infection with HIV, hepatitis B, or hepatitis C.
* History of known latex hypersensitivity.