cyrilzakka/clinical-trials huggingface dataset:
Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty

This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces.

This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces. Secondary goals include an assessment of osteolysis on radiographs, potential long term analysis of implant survivability, and cancer rates in the two patient populations.

Increased metal ion production has been documented in metal-on-metal arthroplasty articulations. There are several concerns over metal ion production. First, even though there is a decreased histiocytic response to metallic debris, a dose dependent cytotoxic response with Interleukin 6, Prostaglandin E2, and Tumor Necrosis Factor alpha persists and may cause osteolysis in the long term. Second, increased levels of cobalt, chromium and nickel has been shown to correlate with increased cancer rates in several animal models, and the carcinogenic risk in humans has not been fully elucidated as yet. Third, hypersensitivity reactions to metal ion develop in up to 25% of these patients, and 60% of patients with poorly functioning hip.

Ceramic on metal avoids many of these problems due to the improved wear characteristics. If the level of metal ion production is significantly reduced and the implant survivability is proven in long term studies, this articulation may become the preferred method.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 40 - 80, who has undergone a top hip arthroplasty with either metal on metal or ceramic on metal articulation for a diagnosis of non-inflammatory degenerative joint disease. We will also include subjects who have had bilateral hip arthroplasties or a second arthroplasty performed since the initial surgery.
* Patient must be able to provide consent to participate

Exclusion Criteria:

* Diagnosis other than non-inflammatory degenerative joint disease, chronic renal insufficiency, or any systemic inflammatory condition
* Evidence of active infections
* Patients whose occupations include welding or metal working
* A second arthroplasty performed since the initial will not be exclude, but their data will be analyzed as a subpopulation
* unwillingness to comply with rehabilitation program or inability to return for follow-up visits
* Any systemic steroid therapy within 3 months of surgery
* Subjects who are pregnant
Study Evaluating the Safety and Tolerability of a New Intravenous Formulation of MOA-728 in Healthy Subjects

The primary objective is to determine the safety and tolerability of the new IV formulation versus the current formulation of MOA-728 focusing on the theoretical potential for infusion-related and formulation-related complications.


Eligibility Criteria:
* A signed and dated informed consent form.
* Men or nonlactating and nonpregnant women, aged 18 to 80 years, inclusive.
* Women of nonchildbearing potential (WONCBP) must be surgically sterile (hysterectomy, oophorectomy, and/or tubal ligation) or postmenopausal for ³1 year.
* Women of childbearing potential (WOCBP) must be using an acceptable nonhormonal method of contraception (intrauterine device \[IUD\], diaphragm, or condom with spermicidal jelly or foam, abstinence) for a period of at least 1 month before and after dose administration.
* All women must have a negative pregnancy test result within 48 hours before the start of the first test article administration.
* Body mass index in the range of 18 to 32 kg/m² and body weight ≥50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
* Subjects aged 65 to 80 years should be healthy, but may be enrolled with a chronic illness, if such illness is well controlled and does not interfere with the primary objective of the study. Certain concomitant medications will be allowed for the treatment of these conditions and are listed in the Concomitant Treatment section.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking from 48 hours before and throughout the inpatient stay.
* Have a high probability for compliance with and completion the study.
High Intensity Interval Training With Strength/Power Exercises on VO2Max

Traditionally, strength training and power is the main objective of providing only muscle conditioning, without possible gains on the VO2Max, however, not for aerobic performance.

A total of 10 visits will be performed. The subjects will be divided into two exercise groups: 1) control group (CG) who performed only aerobic activity of running or walking at moderate intensity (65% VO2max); and 2) strength and power exercise group (GFP), which held the protocol circuit. On the first visit the subjects answer an initial questionnaire of risk stratification for coronary artery disease, and performed a maximal aerobic exercise test.

The subjects performed the interval protocol with strength and power exercises at high intensity in circuit. 20 seconds stimuli will be provided with 10 seconds passive recovery, totaling 4 minutes. In the last session the subjects will be performed the same initial procedures adopted in the first visit to determine the values of VO2max after training. The control group will be performed just one training session total run time conducted in eight sessions by GFP group (approx. 30 min).

Eligibility Criteria:
Inclusion Criteria:

* Strength training practitioner for at least 6 months
* 18 / 45 years
* No injuries

Exclusion Criteria:

* Use of ergogenic resource
* Hypertension and cardiovascular disease
* Drugs
The Potassium Supplementation Study

This study will test whether potassium supplementation can reduce the deleterious effect of a high sodium diet on blood vessel function, blood pressure reactivity and autonomic nervous system function in apparently healthy adults.

Excess sodium intake is linked to poor blood pressure (BP) regulation and endothelial dysfunction, both of which are implicated in the pathogenesis of atherosclerosis and high BP. Evidence suggests potassium may offset the damaging effects of sodium; however, studies in healthy adults are lacking. This is important as these pre-clinical risk factors have been observed in this population, suggesting early intervention may be critical for cardiovascular disease prevention. High potassium diets have been effective at attenuating a sodium-induced decline in endothelial function. However, potassium intake was increased using whole foods; thus, the vascular benefits cannot be attributed solely to potassium. Furthermore, whether potassium can reduce sodium-induced oxidative stress is unknown. The central hypothesis of this study is that endothelial function will be greater and BP reactivity and oxidative stress will be lower with a high potassium intake compared to a low potassium intake, in the context of a high sodium diet. The investigators will assess macrovascular function using flow-mediated dilation, BP reactivity using the cold pressor test and isometric handgrip grip test, and oxidative stress using electron paramagnetic resonance.

Eligibility Criteria:
Inclusion Criteria:

* men and women
* 18-45 years of age
* all races/ethnicities
* BMI \< 30 kg/m2
* BP \< 130/80 mmHg

Exclusion Criteria:

* presence of hypertension
* known heart disease
* diabetes
* kidney disease
* cancer
* inflammatory conditions
* blood clotting disorders
* pregnancy
* adrenal gland disorder
* history of stomach or intestinal bleeding
* history of kidney stones
* serum potassium outside of the normal range
Effects of J Stroke Myofascial Release in Patients With Planter Fasciitis

The purpose of the study is to compare the effects of j stroke myofascial release on planter fascia versus ischemic release on gastrocnemius in patients with planter fasciitis.

Planter fasciitis is commonly occur in athletes and females who wear flat shoes. It is caused by the loss of planter fascia flexibility that leads to mechanical overloading of fascial structures. There are some risk factors that are important to consider include age, leg length difference, inadequate footwear, inappropriate walking and running patterns and increased planter fascia thickness. Planter fascia thickness more than 4mm can be considered as an indicative of planter fasciitis.

Myofascial soft tissue mobilization is a low load, long duration stretch to the myofascial complex technique that is given in both acute and chronic conditions which in caused by tightness and soft tissue restriction in the patients with planter fasciitis to restore length, decrease pain and to improve function.

Cupping therapy on gastrocnemius is a medical technique that applies negative pressure over pain areas and pressure points that alleviates pain and improve blood circulation. it could be low-cost and convenient alternative technique to treat planter fasciitis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60years
* Both Genders
* Chronic pain
* Heel pain with current and previous diagnosis of planter faucitis
* Unilateral planter fascia involvement
* Mild to moderate heel pain with NPRS pain score value between 2-6

Exclusion Criteria:

* Recent surgery to ankle joint
* Impaired sensations
* Open wound
* Peripheral vascular disease
* Recent fractures (\<6 months)
Caffeine for Hypoxic-Ischemic Encephalopathy

Hypoxic-ischemic encephalopathy (HIE) due to perinatal asphyxia is common and often fatal. Therapeutic hypothermia reduces mortality and morbidity in infants with HIE. Even with the widespread use of therapeutic hypothermia, \~60% of infants with HIE die or have neurodevelopmental impairment. As a result, there is an urgent, unmet public health need to develop adjuvant therapies to improve survival and neurodevelopmental outcomes in this population.

Caffeine may offer neuroprotection for infants with HIE by blocking adenosine receptors in the brain and reducing neuronal cell death. In animal models of HIE, caffeine reduces white matter brain injury. Drugs in the same class as caffeine (i.e., methylxanthines) have been shown to be protective against acute kidney injury in the setting of HIE. However, their safety and efficacy have not been studied in the setting of therapeutic hypothermia and their effect on neurological outcomes is not known. Since these drugs reduce injury to the kidney in infants with HIE, they may also reduce injury to the brain.

This phase I study will evaluate the pharmacokinetics, safety, and preliminary effectiveness of caffeine as an adjuvant therapy to improve neurodevelopmental outcomes in infants with HIE.


Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent from parent or guardian
* ≥ 36 weeks gestational age at birth
* Receiving therapeutic hypothermia for a diagnosis of HIE
* Intravenous (IV) access
* Postnatal age \< 24 hours

Exclusion Criteria:

* Receiving \> 1 anti-epileptic drug for seizures
* Sustained (\>4 hours) heart rate \> 180 beats per minute
* Known major congenital anomaly
* Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Clinical Trial Enzyme Application Targeting Venous Leg Ulcers

This is an adaptive open-label, first-in-human (Phase IIa) study designed to assess the safety (and efficacy) of Aurase Wound Gel, an enzymatic debridement product, intended for topical application to sloughy venous leg ulcers (VLU)

The study has been designed as a dose escalation study, and will serially explore increasing concentrations of the Aurase enzyme in a relevant patient population. Five cohorts (of 10 patients each, except cohort 1 with 5 patients), will receive standard of care supplemented with increasing concentrations of Aurase and will be assessed for clinical tolerability at the wound site, systemic safety and efficacy (extent of wound debridement) over a period of 4 weeks. Patients will receive a total of 12 doses of Aurase Wound Gel. At the end of the study, patients will revert to standard of care only.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 years and older at screening
* Patients with at least one defined Venous Leg Ulcer (VLU) suitable for treatment that is no smaller than 2cm2 but no larger than 50cm2
* Presence of devitalised tissue within the reference ulcer suitable for debridement therapy
* Confirmed, clinically diagnosed VLU (30 days or more) which has been present for less than 2 years
* Willing and able to attend and comply with study visits and study related activities

Exclusion Criteria:

* Diabetic Foot Ulcer
* A clinical history of a bleeding disorder including haemophilia, purpura, or thrombocytopenia
* Current or history of use of anti-thrombotic therapy less than 7 days prior to screening.
* Stage 4 or 5 chronic kidney disease, defined as estimated glomerular filtration rate (eGFR) less than or equal to 30 mL/min
* Reference ulcer has active infection or florid oedema at screening
* Oral or intravenous antibiotics for any indication within 72 hours of screening
* Reference ulcer has exposed tendons, ligaments, muscle, or bone
* Active osteomyelitis, cellulitis or gangrene in either leg
* Patients with amputation above a trans metatarsal amputation (TMA) in the target leg
* Planned vascular surgery, angioplasty, or thrombolysis procedures within the study period, or 4 weeks before screening
Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients

This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of Cyclophosphamide in pediatric hematopoietic stem cell transplantation patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had cyclophosphamide treatment for immunosuppressant after allogeneic hematopoietic stem cell transplantation
* Patients age \<19 years
* Written Study Informed consent and/or assent from the patient, parent, or guardian

Exclusion Criteria:

* Known hypersensitivity to mycophenolate mofetil or similar class of drug substance
* Patients in a medically critical condition such as severe infection or unstable vital signs
* Any condition that would, in the Investigator's judgment, interfere with full participation in the study
* Subjects who are pregnant or breast-feeding
* Subjects with psychiatric conditions that may interfere with the study
* Subjects who have a possibility of the disease getting worse as a treatment for clinical trials
Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke

The aim of the study is to investigate treatment with Leukostim (Filgrastim; granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke.

Stroke is one of the main reasons of mortality and morbidity all over the world. In economically developed countries stroke takes 2 or 3 place in the structure of morbidity and mortality. In animal models, it was shown that autological stem cells transplantation significantly increased perfusion of ischemic area and improved lost motor and sensor functions. Granulocyte-colony stimulating factor (G-CSF) was used in some clinical trials without following autological transplantation. However, there are no enough evidence-based proved results of G-GSF safety and effectiveness in acute ischemic stroke. In order to determine safety and efficiency of G-CSF administration together with conventional treatment and conventional intensive care protocol during acute ischemic stroke we organized this clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 to 70 years old
* CT/MRI confirmed ischemic stroke in carotid area during 48 hours after the onset of clinical signs
* Level of conscious lower than 15 and higher than 8 points by the Glasgow Coma Scale
* Acute extremity paresis lower than 4 points by Medical Research Consul scale

Exclusion Criteria:

* Premorbid dependency (modified Rankin Scale \> 0)
* Intracerebral hemorrhage
* Transitory ischemic attack
* Patients with previous stroke
* Any disorders, that can affect interpretation of results (e.g. psychiatric or movement disorders)
* Hematological diseases
* Coagulopathy
* Malignancy
* Pregnancy and lactation
* Organ dysfunction that would preclude tests required for this study
* Known allergic reaction to G-CSF or a component of G-CSF
* Patients that have received a cytokine within the last 1 month or are currently receiving a cytokine treatment
Home-Based Palliative Care Impact on Providers

This research challenges our current approach to fee-for-service palliative care and is significant because it will advance the fields of palliative and person-centered care, clinical practice, public policy, and health care financing. However, the most important effect will be on seriously ill patients and their families through increased access to palliative care outside of hospitals, enhanced palliative continuity across health settings, and improved affordability via reformed payment structures. Nation-wide replication of reimbursable HBCP models is anticipated.

This study will undertake an effort to address the two-pronged gap in providing palliative care in the U.S. (episodic care and misaligned financing structures). This will be done by implementing an evidence-based Home-Based Palliative Care (HBPC) model-originally developed in managed care-into primary fee-for-service as a covered health benefit; the very first translation of this model by a private health insurer in the U.S. The purpose of the present study is to investigate the provider and organizational-level impact of implementing reimbursable HBPC in primary care with the goal of characterizing a set of implementation strategies and eliciting key mechanisms on how to widely replicate person-centered, reimbursable HBPC in primary care settings across the country. To this end, seven research questions will be answered that address the study purpose pertaining to feasibility, barriers, facilitators, person-centeredness, and job satisfaction. This study is guided by the Diffusion of Innovations theory. The investigators will conduct primary collection and analysis of qualitative focus group data at each study site. Key outcomes for the qualitative component include feasibility, barriers, and facilitators of translating HBPC, as well as characteristics associated with rate of HBPC diffusion and implementation strategies. This project challenges our current approach to fee-for-service palliative care and seeks to shift current research. Nation-wide replication of reimbursable HBCP models is anticipated.

Eligibility Criteria:
Inclusion Criteria:

• Current member of the Home-Based Palliative Care (HBPC) team or organization's leadership team

Exclusion Criteria:

* No interaction with palliative care patients or palliative care arm of organization
* Unable to speak and read English
Impact of Meal Order on Postprandial Cardiometabolic Risk Markers

The order in which the different components of a meal are eaten may have impact on the postprandial metabolic responses to carbohydrates, fat and proteins. This study will compare blood lipids and glycemia regulation following lunches of identical composition but varying the order of intake of the different meal components.

The order in which the different components of a meal are eaten may have impact on the postprandial metabolic responses to carbohydrates, fat and proteins. Some of these responses are associated with the risk for developing cardiometabolic complications.

The study will be carried out in a cohort of healthy subjects with a wide BMI range and normal fasting glycemia. Postprandial metabolic responses to a reference meal starting with bread and butter (BB) will be compared with those registered after 3 other meals of identical composition, in which the starter will be permutated. Each meal is tested on an independent experimental session, with a 1 week washout interval.

The intervention will be carried out at the Food for Health Science Centre - Lund University. Additionally, the plan contemplates an initial information visit including screening of fasting blood glucose. In total, each volunteer completing the study will pay five visits to the clinical unit.

Based on the results from the above-described phase, a second step of the study will compare various quality attributes of the most effective starter on the impact on cardiometabolic risk markers, as a way to optimize putative protective actions and to gain further mechanistic insight.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 20 and 30 kg/m2
* Fasting blood glucose ≤ 6.1 mmol/L
* No known medical condition

Exclusion Criteria:

* Smoking habits
* Treatment for high blood pressure
* Treatment for hypercholesterolemia
Oral Taxane in Combination With Pemetrexed (Alimta) in Patients With Recurrent Non-Small Cell Lung Cancer

A phase I-II dose ranging study of BMS-275183 (oral taxane) in combination with pemetrexed (Alimta) in patients with recurrent Non-Small Cell Lung Cancer (NSCLC). The safety and efficacy of this combination will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic pretreated NSCLC
* Measurable disease
* Adequate hematologic, hepatic and renal functions.
* ECOG Performance Status 0-2

Exclusion Criteria:

* Inability to swallow capsules
* Recent significant cardiovascular disease
* Women who are pregnant or breastfeeding
Brain Metastases in Norway - A Prospective Cohort Study

The overall aim and primary outcome of this study will be a descriptive analysis of the current treatment practice of BM in Norway. Specifically, it may give answers to the following research questions:

* What is the true incidence of BM in Norway?
* How are patients with BM treated at present?
* Do treatments differ between hospitals?
* How do treatments impact quality of life of the patients?
* Which factors (treatment, tumor and host variables) can explain disease control, survival, symptom relief, and general functions?
* How can BM staging be improved?


Eligibility Criteria:
Inclusion Criteria:

* Verified cancer diagnosis of solid tumors (based on radiological, histological/cytological or operative evidence).
* Brain metastases verified by computer tomography (CT), contrast-enhanced magnetic resonance imaging (MRI), or surgical biopsies
* Age ≥ 18 years
* Able to comply with study procedures
* Able to provide written informed consent after information in Norwegian

Exclusion Criteria:

* Primary brain tumors
* Primary hematological malignancies (lymphomas, leukemias)
* Previous diagnosis and/or treatment of BM
* Unable to produce written informed consent after information in Norwegian