cyrilzakka/clinical-trials huggingface dataset:
Exercise Pressor Reflex and Lifelong Training

Cardiovascular diseases represent the first mortality cause in the world. Ageing is considered as the most prominent risk factor for this kind of diseases. Also, hypertension represents one of the modifiable risk factors. Blood pressure response to exercise is governed by three systems: central command, baroreflex, and a feedback mechanism originating in the skeletal muscle. An abnormal cardiovascular response to exercise facilitates the occurrence of cardiovascular events. The goal of the study is to characterize the cardiovascular response in lifelong trained individuals and explore the potential benefits of endurance and strength training on cardiovascular regulation to exercise onset.

Population ageing represents a problem both for health outcomes and for social dynamics in the social welfare states. Currently, the over 60 represents the fastest growing segment of the population. Despite a downward trend in the incidence of cardiovascular diseases, they remain the main culprits for what concern mortality rates in the world. Increasing age is considered the major risk factor for cardiovascular mortality.

One of the main components of the cardiovascular response to exercise is dictated by the exercise pressor reflex originating in the exercising muscle and responding to metabolic and mechanical stimuli. Research indicates that at least 20% of the regulation of blood pressure could be ascribed to these cardiovascular reflexes. A dysfunctional reflex-mediated response increases the chances of cardiovascular events that may end up in severe consequences.

Chronic exercise training is recognized to be an important tool to control blood pressure. The mechanisms through which exercise exerts its effect are multiple. Among these, an improvement of the neural control of the reflex originating in the muscle seems a likely contributor. However, at present, the effect of chronic exercise training on the EPR response in the elderly has not been elucidated. The aim of the study is to characterize the central and peripheral cardiovascular response in the lifelong endurance and strength trained elders population.

Eligibility Criteria:
Inclusion Criteria

General:

* Young: 18 - 30, males, non smokers
* Old Sedentary: 65 -75, males, non smokers
* Old Endurance Trained: 65 -75, males, non smokers
* Old Strength Trained: 65 - 75, males, non smokers

Exercise history (different for each group):

* Young: ≤ 5 h/week
* Old Sedentary: ≤ 2h/week
* Old Endurance Trained: ≥ 5 h/week, ≥ 30 years of practice, ≥ 4 sessions/week
* Old Strength Trained: ≥ 5 h/week, ≥ 30 years of practice, ≥ 4 sessions/week

Exclusion Criteria:

* History of cardiovascular events/diseases
* Respiratory, musculoskeletal, renal, and insulin-resistant diseases
* Hypercholesterolemia
* Use of beta-blockers
* BMI ≥ 30
Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury

Care partners of persons with traumatic brain injury (TBI) are often faced with considerable physical and emotional stress resulting from their caregiver role. The researchers hypothesize that the care partners who receive the intervention will show improvements in caregiver strain and mental health.


Eligibility Criteria:
Inclusion Criteria:

* Be caring for an adult (age 18 or above) with a medically documented TBI that is ≥1-year post-injury and meets the TBI Model Systems (TBIMS) criteria for complicated mild, moderate or severe TBI and who sustained their TBI at age 16 or older
* Provide emotional, physical, and/or financial support/assistance to the individual with the TBI, indicating a response ≥1 to the following question: "On a scale of 0-10, where 0 is "no assistance" and 10 is "assistance with all activities", how much assistance does the person you care for require from you to complete activities of daily living due to problems resulting from his/her TBI? Activities could consist of personal hygiene, dressing and undressing, housework, taking medications, managing money, running errands, shopping for groceries or clothing, transportation, meal preparation and cleanup, remembering things, etc."
* Have access to necessary resources for participating in a technology-based intervention (smartphone/tablet and internet access) and be willing to use their personal equipment/internet for this study, including downloading the study app and the Fitbit® app on their mobile device
* Is able and willing to complete all study assessments for the duration of their study participation (approximately 375 days)

Exclusion Criteria:

* Is a professional, paid caregiver (e.g., home health aide)
* Anything that would preclude safe or meaningful participation in the study
Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis

Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).

Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX). In addition, data on the safety profiles of both products, including immunogenicity and local tolerability at the injection sites, will be collected and compared.

An additional study objective is to identify any potential risk of the transition from Enbrel to GP2015 in terms of general safety and immunogenicity in RA patients

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR 20110 criteria \>/= 6 months at the time of baseline visit
* Patient must have active disease defined as DAS28-CRP\>/=3.2
* Patients must have CRP level above ULN \>5mg/l) or erythrocyte sedimentation rate (ESR) \>/=28mm/h
* Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after proper dose escalation according to local standards

Exclusion Criteria:

* Previous exposure to etanercept in the past
* Patients with functional status class IV according to the ACR 1991 revised criteria
* History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by imaging and/or by the QuantiFERON-TB Gold test at screening
Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance

The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with impaired glucose tolerance and mild to moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate hypertension
* naive to antihypertensive medication or on two or less antihypertensive medications
* impaired glucose tolerance
* mild obesity

Exclusion Criteria:

* Diagnosis of Type 1 or Type 2 diabetes
* History of severe heart failure
* AST, ALT levels more than twice the normal range
Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes

This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to NPH insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Fasting c-peptide below lower limit of normal fasting range
* Duration of type 1 diabetes for at least 12 months
* Current treatment: Basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections
* HbA1c maximum 9.0% (using Biorad Variant method)
* Able and willing to perform self-monitoring of blood glucose
* Basal insulin requirement at least 30% of the total daily insulin dose
* BMI (body Mass Index) maximum 35 kg/m\^2

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring acute treatment
* Total daily insulin dose above 1.4 IU/kg/day
* Known unawareness of hypoglycaemia
* Impaired hepatic function
* Impaired renal function
* Cardiac problems
* Uncontrolled, treated/untreated hypertension
* Known or suspected allergy to trial product or related products
Etiology, Clinical Picture, Complications and Outcomes of Necrotizing Pancreatitis in Children.

The aim of this research is to study the etiology, the clinical picture, the management, the complications and the outcomes of necrotic pancreatitis in children.

Currently, there is a significant number of errors in the early diagnosis of AP in children associated with the complexity of differential diagnosis, which leads to the untimely verification of the correct diagnosis and, consequently, to incorrect treatment tactics, which could be accompanied by an increase in the severe forms of the disease and an increase in mortality.

Acute pancreatitis (AP) is an acute inflammatory disease of the exocrine pancreas. Clinical manifestations vary from mild abdominal discomfort to metabolic disorders, sepsis, fluid sequestration, multiple organ failure and death. According to the international data, the annual incidence of AP in children is 3-13 cases per 100,000 people, but in recent years, there has been an increase in the incidence of this pathology. Necrotic pancreatitis in children accounts for up to 25-30% of the cases of all forms of AP. Despite the successes achieved in the diagnosis and treatment of AP, the mortality rate for this pathology is up to 5%, according to various authors. In addition, given the varying degrees of the prevalence of the destructive process in the pancreas and the parapancreatic tissue, the choice of surgical treatment still remains a subject of discussion. The treatment of moderately severe (MSAP) and severe (SAP) necrotic pancreatitis is a complex task due to the variety of causes of the disease, the incompletely understood pathogenesis and the uncertainty in predicting the results.

Paralytic ileus with the development of intestinal failure is the main pathogenetic factor in the development of a septic condition in AP, but there is tendency of insufficient attention being paid to this fact in pediatric practice, which determines the lack of a unified approach to the treatment of intestinal failure syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Consent of the patient or legal representative
* Age from 0-18 years
* Moderate severe (MSAP) or severe acute pancreatitis (SAP) according to Atlanta criteria revisited in 2012
* Acute Pancreatitis was established in the presence of at least two of three criteria according to the classification developed by the INSPPIRE group (International Study Group of Pediatric Pancreatitis: In Search for a Cure): abdominal pain corresponding to the diagnostic hypothesis; an increase in amylase and / or lipase in the blood serum by ≥3 times; imaging findings characteristic of AP: abdominal ultrasound and/or contrast-enhanced CT.

Exclusion Criteria:

* mild acute pancreatitis
* chronic pancreatitis
* no consent from patient or legal representative
Oral and Perioral Herpes Simplex Virus Infection Type I in a Five-month-old Infant: A Case Report

A five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles.

The investigators present the case of a five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles. The investigators discuss the pathophysiology of primary herpes simplex virus infection and the effect of maternal antibodies on the infant's immune system. In addition, the investigators explain the diagnosis, management, and prognosis of herpes simplex virus infection in young infants.

Eligibility Criteria:
Inclusion Criteria:

* Five-months-old infants or younger

Exclusion Criteria:

* Six-months-old infants or older
Headstrong Intervention for Pediatric Headache

Purpose of this study is to determine if a CD-ROM computer program (called "Headstrong") is effective in helping children cope with chronic headaches.

Children, 7-12 years, with recurrent headaches are randomly assigned to an educational CD-ROM program or the Headstrong CD-ROM program. We anticipate that those assigned to the active (Headstrong) program group will have significantly greater reductions in headache frequency, duration, and severity and improvements in mood and quality of life.

Eligibility Criteria:
Inclusion criteria:

* 7-12 years of age
* having recurrent, intermittent, nonmalignant headaches occurring on an average of at least once per week by parental or child report and separated by symptom-free periods
* having a diagnosis by a nurse practitioner, pediatrician, or pediatric neurologist of migraine, muscle-contraction, or chronic daily headaches

Exclusion criteria:

* their medical history and/or neurological exam suggests that headaches are secondary to another physical or developmental condition
* their parents report they have been diagnosed with a mental health condition or they are receiving concurrent psychotherapy
* their baseline headache diaries indicate an average headache frequency of less than one per week
Iron Therapy in Erythropoietic Protoporphyria

Giving oral iron to patients with erythropoietic protoporphyria (EPP) who is iron deficient is thought to be beneficial. This is, however, not well documented. The purpose of this study is to investigate the effect and safety of oral iron in patients with EPP who is taking iron tablets due to iron deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with EPP
* Taking standard dose of iron tablets due to iron deficiency

Exclusion Criteria:

* Pregnant
* Lactating
Nerve Changes in Patients Who Are Undergoing Chemotherapy or Biological Therapy for Cancer

RATIONALE: Learning about the effects of chemotherapy and biological therapy on nerve function may help doctors plan treatment and help patients live more comfortably.

PURPOSE: This clinical trial is studying peripheral neuropathy in patients who are receiving chemotherapy or biological therapy for cancer.

OBJECTIVES:

* Determine the change in peripheral nerve function in cancer patients during and after treatment with chemotherapy or biologic therapy.
* Determine the clinical measurement of hearing-related air and bone conduction and vibratory sensation in these patients.
* Correlate the changes in orthostatic blood pressure using both the Vasotrac automated blood pressure device and the standard clinical automated blood pressure equipment.
* Determine the patient's perception of hearing quality before and after treatment with chemotherapy or biologic therapy.

OUTLINE: This is a multicenter study.

Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of cancer
* Scheduled to be treated with 1 of the following agents:

  * Cisplatin/paclitaxel combination
  * Biologic therapy with high-dose interferon alfa

PATIENT CHARACTERISTICS:

* Normal vision OR vision corrected with glasses or contact lenses
* No diseases or disorders reducing peripheral nerve function, including any of the following:

  * Diabetes mellitus
  * HIV/AIDS
  * Uremia
  * Spinal injuries
  * Alcoholism
  * CNS problems
* No hearing impairment

PRIOR CONCURRENT THERAPY:

* No prior biologic therapy or neurotoxic chemotherapy
Effect of Shock Wave Therapy on Myofascial Pain Syndrome in Adolescent Athletes

The purpose of the study is to determine the effect of extracorporeal shockwave therapy on pain, neck range of motion, and functional activity in adolescent athletes.

Myofascial pain syndrome is a syndrome characterized by pain and accompanying muscle spasms, referred pain patterns, stiffness, and restricted range of motion caused by trigger points on constricted fibers of muscles and/or fasciae. Myofascial pain syndrome is the most common reason for back pain, shoulder pain, tension-type headaches, and regional pains such as facial pain.

Myofascial trigger points (MTrPs) are understood as the morphological correlate of the myofascial pain syndrome (MPS), an acute or chronic muscular pain condition affecting a single muscle or a group of muscles. Active MTrPs are spontaneously painful, while latent MTrPs are only painful upon pressure. MTrP stimulation can also cause referred pain and the characteristic local twitch response.

The main goal of MPS treatment is to break down the vicious circle of "spasm - pain - spasm" and release trigger points. Various physical therapy modalities such as trigger point injection, stretching-spray technique or ultrasound (US), heat packs and transcutaneous electrical nerve stimulation (TENS), and extracorporeal shock wave therapy (ESWT), are used for the treatment of MPS. These modalities inactivate the trigger point with their thermal and mechanical effects.

Due to the lack of research area of extracorporeal shock wave therapy on myofascial pain syndrome on upper trapezius in adolescents' athletes, so the purpose of the study is to know impact of the extracorporeal shock wave therapy on myofascial pain syndrome on upper trapezius in adolescents' athletes.

Eligibility Criteria:
Inclusion Criteria:

* Age ranges from 14 to 18 years.
* All adolescents have regional pain complaint.
* Tenderness in cervical trigger points in the midpoint of the upper border of the trapezius muscle, from grade 2 to grade 4 according to the tenderness grading scheme (Hubbard, 1993) (Appendix II).
* Palpation of a trigger point elicits a stereotypic zone of referred pain specific to that muscle.
* Identification of a palpable taut band, as well as a palpable, and exquisitely tender spot along the length of that taut band.
* All adolescents are allowed to practice their regular sports activities.

Exclusion Criteria:

* Dermatological disorders.
* Having myofascial trigger points injection.
* Chronic pain in both sides of the body.
* History of findings of cervical injury whether orthopedic or soft tissue injury.
* Analgesic drugs or NSAIDs during the treatment period.
A Novel Mat Exercise Program Improves Functional Fitness, Activity Levels, and Quality of Life in Older Adults

In this study, investigators recruited older adults aged 60 to 80 years and utilized a parallel experimental design. A total of 32 participants were randomly assigned to either the experimental or control group. The intervention consisted of a 70-min-long exercise game-based mat training session conducted twice weekly for 10 consecutive weeks. Each session included a 10-min warm-up, approximately 45 min of primary training, and a 15-min cool-down and stretching routine. Participants completed the International Physical Activity Questionnaire (IPAQ) and the World Health Organization Quality of Life questionnaire (WHOQOL, Taiwanese Version) before and after the intervention. Additionally, the functional fitness assessment were conducted.

The mat-based exercise facility (Stampede, Taipei, Taiwan) assists participants in exercise training by incorporating interactive light and sound effects to guide users through various exercises while progressively increasing intensity. The training program is divided into two phases: the first phase focuses on fundamental movements, whereas the second phase introduces more advanced exercises. With progress, additional exercise equipment is incorporated, along with increased sets, duration, movement variations, and training intensity. Training sessions can be conducted in a simple, progressive manner or a game-competitive format. Throughout the training, participants wore a heart rate monitor (ALATHEC Obeat1, Taichung, Taiwan) that recorded their exercise intensity and heart rate fluctuations. However, the exercise intensity and frequency were adjusted based on participants' adaptation. This study encompassed five different lighting modes, namely all light on, circle on, four corners, two lines, and diamond. Each mode was paired with different training protocols and movement patterns, supplemented by training equipment, such as medicine balls, resistance bands, and balance pads.

Eligibility Criteria:
Inclusion Criteria:

(i) Elderly individuals (aged 60-80) who have not experienced any muscle or skeletal injuries in the past month and are able to participate in training normally.

(ii) Completion of the Physical Activity Readiness Questionnaire and meeting the conditions for initiating moderate-intensity exercise intervention.

(iii) Ability to comply with the exercise frequency required by this study and travel to and from the training site independently.

Exclusion Criteria:

(i) individuals with severe musculoskeletal disorders, (ii) individuals deemed unsuitable for exercise training based on a Physical Activity Readiness Questionnaire evaluation or psychiatric disorders, and (iii) individuals under medications that may influence study outcomes.
Clinic Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics

The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response.

Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteers or patients with age more than 18 yeas;
2. The patients have been diagnosed with cancer or suspected with cancer;
3. It must fulfill the ethical requirements and subjects have signed an informed consent.

Exclusion Criteria:

1. Pregnancy or nursing mothers;
2. Having drugs or alcohol dependence;
3. Hypersensitive to the active or inactive ingredients of the study drug;
4. Having attended other drug clinical trials within three months;
5. Cardiac functional insufficiency;
6. Hepatic and renal function insufficiency;
7. Hypertensive patients with serious complications;
8. Endangering the safety of life.