cyrilzakka/clinical-trials huggingface dataset:
Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE

EUROSCUP MOBILE is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSCUP MOBILE performances and safety

Post market observational study. This study is retropective and prospective, non comparative.

Eligibility Criteria:
Inclusion Criteria:

* Patient who received EUROSCUP MOBILE.
* Patient informed of its participation to the study
* Patient aged between 18 and 80 years old (\<80).

Exclusion Criteria:

* Patient presenting a contraindication to EUROSCUP MOBILE implantation.
* Patient who refused to participate to the study
* Vulnerable subjects
Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

This patient study will determine the safety and toxicity of a permanently implantable brachytherapy source - CivaSheet® - which is designed to deliver a therapeutic dose of low dose rate (LDR) radiation with polymer encased Palladium-103. CivaSheet will be implanted in sarcoma patients with disease presenting in the retroperitoneum, abdomen, pelvis and trunk.

CivaSheet® is an FDA-cleared product from CivaTech Oncology®. It is a series of small radioactive palladium-103 (Pd-103) sources on bio-absorbable, flexible, bio-compatible membrane. The CivaSheet can be custom cut in the operating room. The CivaSheet is 5 cm wide by 15 cm long and has a rim to allow an easy surface to suture. This flexible device can contour the surgical cavity delivering highly conformal and targeted radiation dose. CivaSheet can deliver a very high radiation dose to the surgical margin to potential prevent local cancer recurrence.

Sarcoma patients have up to 80% local recurrence rates, depending on histology and location of disease presentation. CivaSheet will be implanted at the surgical margin follow tumor removal. Monitoring the rate of acute toxicity is the primary endpoint. Secondary endpoints include disease progression and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

1. Subject Signed Inform Consent
2. Subject plans to remain in the long-term care of his/her enrolling center/investigators.
3. Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate.
4. Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk
5. Subject is able to undergo surgery

Exclusion Criteria:

1. Is unable or unwilling to comply with protocol requirements.
2. Is enrolled in another study/registry not approved by CivaTech Oncology.
3. Pregnancy, breast feeding
The IM ABLE Study: A Study of Warriors & Veterans Following Neuromusculoskeletal Injury of the Lower Limb

The purpose of the IM ABLE(Injuries Managed with Advanced Bracing for Lower Extremities) study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.

There were approximately 20,000 extremity trauma cases associated with the wars in Iraq and Afghanistan. Many of these individuals have experienced multiple limb-sparing surgeries and orthotic utilization. Many continue functioning with use of their orthosis while others may seek delayed amputation. It is unclear if limb salvage or amputation is more advantageous functionally or preferred following lower extremity(LE) trauma. The IDEO (Intrepid Dynamic Exoskeletal Orthosis) was developed to assist in maintaining high functional performance in patients who have experienced high energy lower extremity trauma (HELET) and limb salvage surgeries primarily effecting the LE below the level of the knee joint. The IDEO represents one "advanced" orthotic option for a traumatized and surgically spared limb however there are other "advanced" orthotic options. Problematically, few studies have reported outcomes associated with these devices. In the few studies available, sample sizes are small which greatly reduces generalizability of study findings. The purpose of the IM ABLE study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.

Eligibility Criteria:
Inclusion Criteria:

1. Lower extremity injury of any etiology requiring use of an AFO
2. Male or Female, of any ethnicity
3. 18-65 yrs of age
4. 100-275 lbs
5. ≥ 1 yr. of orthotic experience

Exclusion Criteria:

1. Body weight \<100 or \>275 lbs
2. Does not speak English or Spanish
3. Known cognitive impairment (i.e. Diagnoses such as Traumatic Brain Injury, Dementia)
Identification of Gene Polymorphism in Patients With Sick Sinus Syndrome in Chinese Population in Taiwan

Background: Sinus node dysfunction is a major cause of bradycardia necessitating pacemaker implantation. Evidences of genetic study supported that some genes involved in the pacemaker current or renin-angiotensin system were related to sinus node dysfunction. However, the influence of gene polymorphisms on sinus node dysfunction was not well studied.

Methods: A group of 100 patients with documented sinus node dysfunction and 100 age- and sex- matched healthy control patients will be enrolled into this study. Gene polymorphism study includes the angiotensin-I converting enzyme gene, angiotensin II type 1 receptor gene, HCN1-4, SCN5A, KCNE and other possible gene polymorphisms which are related to sinus node function based on previous reports. Genetic polymorphisms are identified with polymerase chain reaction-based restriction analysis. Comparison of multiple haplotype analysis and single-locus analysis will be analyzed between the cases and controls.

Estimated Results: Some genetic polymorphisms of these genes which are related to sinus node function or rennin-angiotensin system will show association with sinus node dysfunction. In multilocus haplotype analysis, some genetic haplotype profiles may demonstrate significant difference between cases and controls. In single locus analysis, some genetic polymorphisms may be associated with sinus node dysfunction.

Estimated Conclusion and Clinical Implication: This study will demonstrate the genetic polymorphisms in RAS genes or some other genes associated with sinus node dysfunction. These results will support the roles of these genetic polymorphisms in determining the risk of sinus node dysfunction among the Chinese population in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

1. Heart rate was less than 40/min or long pause more than 3 seconds in series EKG or 24-hour EKG.
2. Sinus nodal recovery time exceeds 1600 ms in cardiac electrophysiology study.

Exclusion Criteria:

1. Severe systemic disease.
2. Acute coronary syndrome.
3. Bradycardia with reversible cause.
Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition

Every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be ( four (4) visits.

Every participant will receive active study drug and one (1) comparator in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit.

The Screening Visit will be followed by the Baseline (Visit 1) 1-14 days later. At the Baseline Visit participants will be given written tests to measure thinking process. You will also be asked to take a computer driving simulation test.

Visits 2 and 3 approximately one (1) week apart will be the dosing days after eating a high fat meal within 30 minutes. The testing from the Baseline Visit will be repeated at four (4) hours and 1.5 hours after dosing with comparator drug.

The End of Study safety visit will take place two (2) weeks later. Participants will be given discharge instructions.

Eligibility Criteria:
Inclusion Criteria:

* equal to or greater than 20 years old
* weight at least 120 pounds
* medically healthy
* able to eat a high fat meal

Exclusion Criteria:

* medications known to affect sleep-wake cycle
* current use of cimetidine
* current use of certain anti-depressants
* current us of certain antibiotics
* positive urine drug test for mind altering medications
An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer

The first part of the study is the Dose Escalation Phase designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B virus (HBV)-infected subjects).

The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses for each of the 3 cohorts. A third cohort has been added in this study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and nivolumab with ipilimumab in combination with cabozantinib.

Study Classification: Pharmacokinetics/Pharmacodynamics

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
* Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less

Exclusion Criteria:

* History of autoimmune disease
* Any prior or current clinically significant ascites
* Any history of hepatic encephalopathy
An Algorithm for Prognosis of Upper Limb Paresis in Patients With Subacute Stroke

Aim study 1:Assess the accuracy of PREP2 when applied in a subacute rehabilitation setting.

Aim study 2: Prediction of real life UL use. Method: A prospective cohort study. Main outcome measure study 1: Action Research Arm Test (ARAT), measuring UL motor function.

Main outcome study 2: use ratio between affected and unaffected UL measured by accellerometer.

Secondary outcome measure: Fugl-Meyer Motor Assessment for UL (FM).

Background Accurate prediction of recovery of UL function after stroke can lead to targeted rehabilitation. The Predict Recovery Potential (PREP2) algorithm combines individual prediction of UL function with recommendations for treatment. The PREP2 algorithm is based on clinical assessment of UL paresis combined with transcranial magnetic stimulation (TMS) to examine corticospinal tract integrity. For this PhD project the PREP2 is modified to be applicable in a rehabilitation setting and the initial assessment of PREP2, the SAFE score, is carried out at day 14.

Study 1 Aim: Assess the accuracy of PREP2 when applied in a subacute rehabilitation setting.

Hypothesis: PREP2 applied at day 14 post stroke accurately predicts UL function 3 months after stroke for a minimum of 75 % of the patients.

Method: A prospective cohort study. Setting and population: The study will take place at Hammel Neurorehabilitation Centre and University Research Clinic. Ninety patients will be included.

Inclusion criteria: First or recurrent ischemic or hemorrhagic stroke (diagnosis verified by CT or MR scan); New upper limp impairment; Less than 15 days post stroke; ≥ 18 years; Able to follow simple commands and cooperate with examinations Main outcome measure: Action Research Arm Test (ARAT), measuring UL motor function.

Secondary outcome measure: Fugl-Meyer Motor and sensory Assessment for UL. Functional Independence Measure (FIM).

Examined at baseline: Pain wil be assessed with a verbal rating scale. Inferior subluxation in the glenohumoral joint. Neglect will be assessed with star cancellation test and line bisection test

Study 2 Prediction of real life UL use Hypothesis: PREP2 can be used to predict real life UL use 3 months post stroke. Patients: The entire cohort from study 1 will be included. Real life use will be assessed with accelerometers at 3 months follow up.

Main outcome: is the use ratio between affected and unaffected UL.

Eligibility Criteria:
Inclusion Criteria:

* First or recurrent ischemic or hemorrhagic stroke (diagnosis verified by CT or MR scan)
* New upper limp impairment; Less than 15 days post stroke
* ≥ 18 years
* Able to follow simple commands and cooperate with examinations

Exclusion Criteria:

* Subarachnoid hemorrhages
* UL motor residuals from former stroke
* Severe illness with life expectancy \< 6 months
* Place of residence more than 1½ hours drive away and not reachable for follow up assessments
* Patients with contraindications for TMS are excluded from the TMS part of the study.
Autophagy Maintains Vascular Function Through a Novel Glycolysis-linked Pathway Regulating eNOS

Aging is inevitable and is the primary risk factor for developing cardiovascular disease. The molecular mechanisms that drive vascular dysfunction in the context of aging are incompletely understood. The overall hypothesis is that the age-related decline in endothelial cell (EC) autophagy leads to arterial dysfunction. This study will determine whether physiological shear-stress affects autophagosome formation and nitrous oxide (NO) generation in ECs.

It is hypothesized that genetic autophagy suppression prevents shear-stress induced purinergic signaling to endothelial nitrous oxide synthase (eNOS) and this pathway will be evaluated in primary arterial ECs obtained from older adult (\> 60 years) and adult (18-30 years) subjects before and following rhythmic handgrip exercise that elevates brachial artery shear-rate similarly in both groups. ECs will be used to quantify markers of EC autophagy, eNOS activation, and NO generation. The study will also determine whether exercise-training attenuates the aging-associated decline in EC autophagy, and whether intact autophagy is required for training-induced vascular improvements. To evaluate this potential, it will be determined whether one-limb rhythmic handgrip exercise training by older adult (\> 60 y) human subjects is sufficient to elevate basal and shear-induced EC autophagy initiation, eNOS activation, and NO generation vs. the contralateral sedentary limb. Results from this work have tremendous potential to reveal a new therapeutic target and approach for restoring / maintaining vascular function in the aging population.

Eligibility Criteria:
Inclusion criteria:

* Candidates must be between 18 and 90 y of age
* Candidates must be free of overt disease as assessed by a) medical history; b) standard blood chemistries (chem. 7 panel), c) ECG at rest; d) limb vascular examination (ankle-brachial BP index \> 0.9); e) resting BP \< 140/90 mmHg; and f) skinfold % body fat assessment.
* Subjects will have a body mass index (BMI) between 19 and 30 and have plasma glucose concentrations \< 7.0 mmol/L under fasting conditions and \< 11.1 mmol/L at 120 minutes of an oral glucose tolerance test (OGTT)

Exclusion criteria

* Candidates \<18 or \>90 y of age
* Candidates demonstrating abnormal ECG, ankle-brachial BP index \<0.9, resting BP \> 140/90
* Candidates demonstrating a BMI \<19 or \> 30
* Candidates demonstrating plasma glucose concentrations \> 7.0 mmol/L under fasting conditions and \> 11.1 mmol/L at 120 minutes of an oral glucose tolerance test (OGTT)
* Candidates demonstrating dyslipidemia (plasma total cholesterol \> 240 mg/dl with LDL-cholesterol \> 160 mg/dl)
* Candidates reporting a history of myocardial infarction, unstable cardiac ischemia, recent cardiac catheterization, carotid artery disease, transient ischemic attack
* Women taking hormone replacement therapy (HRT) currently or in the preceding year will be excluded from the proposed studies due to the direct vascular effects of HRT.
Transporters for Organic Cations and Glycemic Control in Patients With Neuropathic Pain.

This study aimed to investigate the influence of the glycemic control of type 2 diabetes (DM2) and of cetirizine (OCTs inhibitor) on gabapentin kinetics disposition and pharmacodynamics (PK-PD) in patients with neuropathic pain. Thus, non-diabetic patients (Control Group, n=10), patients with controlled diabetes (n=9) and patients with uncontrolled diabetes (n=10), all with neuropathic pain of intensity ≥ 4 in pain visual analog scale (0-10) were investigated.

Gabapentin (GBP), anticonvulsant used to neuropathic pain treatment, is mainly eliminated unchanged in urine. Renal active tubular secretion has been suggested to contribute on GBP excretion by renal excretion. Studies performed on rats with experimental diabetes suggest that hyperglycemia reduces the activity of organic cation transporters (Oct). Thus, the aim of the study was to investigate the role of OCTs on kinetic disposition and pharmacodynamics of GBP in patients with neuropathic pain and to verify the regulation of these transporters' activity by glycemic control in diabetes. A cross-over clinical study was performed in patients with neuropathic pain (n=10, Control) to evaluate the influence of CTZ on GBP kinetic disposition. To evaluate the effect of glycemic control, patients with controlled DM2 (DC, n=9) and uncontrolled DM2 (DNC, n=10) were investigated. All participants investigated had neuropathic pain of intensity ≥ 4 evaluated by analogue visual scale (EVA) and were treated with oral single-dose of 300 mg of GBP (Phase 1) or cetirizine (20 mg/day) for 5 days and single-dose of GBP on the last day (Phase 2). Only participants of Control group participated of Phase 2. Serial blood and urine samples were collected up to 36 hours after GBP administration. The intensity of pain was evaluated at the same time of blood sampling, using the visual analog scale. GBP concentration in plasma and urine was validated by JPLC-UV. All participants were genotyped for polymorphisms SLC22A2 808G\>T and SLC22A4 1507C\>T. The pharmacokinetic parameters were estimated by non-compartmental analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, both gender
* Patients with neuropathic pain with score ≥ 4 in visual analog scale
* Patients with controlled type 2 diabetes (glycated hemoglobin ≤ 8.0%) and diabetic neuropathy with score ≥ 4 in visual analog scale
* Patients with uncontrolled type 2 diabetes (glycated hemoglobin ≥ 8.0%) and diabetic neuropathy with score ≥ 4 in visual analog scale
* Patients that suspend the use of analgesics for 10 times half-life before starting the protocol

Exclusion Criteria:

* Patients with acute or chronicle severe renal failure (creatinine clearance ≤ 30 mL/min)
* Patients with gastrointestinal diseases
* Patients with history of alcohol and drug abuse
* Patients with acute myocardial insufficiency
* Patients with another kind of chronicle pain as severe as neuropathic pain
* Patients in chronicle use of drugs that interact with gabapentin (antacids and cimetidine)
Berlin Beat of Running Study

This prospective observational study will investigate the frequency of new onset atrial fibrillation (AF) and of further cardiac arrhythmias as well as of (clinically silent) cerebral lesions in endurance runners before, during and after the BMW-Berlin Marathon 2011.

Up to 120 experienced marathon runners will participate in the "Berlin Beat of Running Study" and will wear a transportable electrocardiogram (ECG) recorder at least 24 hours before, during and 24 hours after the BMW-Berlin Marathon. All participants will undergo brain MRI examinations to detect cerebral lesions within days before and after the marathon race, respectively. Moreover, serial blood samples will be taken a few days before, immediately after as well as a few days after the BMW-Berlin Marathon.

Eligibility Criteria:
Inclusion Criteria:

* Age 35-65 years
* at least 2 marathon runs within the last 5 years
* weekly running of at least 40 km

Exclusion Criteria:

* Known cardiac arrhythmia or prior stroke
* contraindication for MRI.
Prevention of the Older Adult's Loss of Autonomy at Home Through a Targeted Physical Exercise Program

Physical exercise program (PEP) have demonstrated their benefit to the health of older people. They are effective in functional performance and in the incidence and severity of falls.

We hypothesize that intervention with targeted Physical exercise programs PEP on appropriate muscle strengthening devices allows, through its action on the muscle, to slow down the loss of autonomy in the elderly living in the home. Our main objective is to evaluate the impact of a PEP, targeted on adapted muscle strengthening devices, on the loss of autonomy for the acts of daily life in the person aged over 70 living at home.

The elderly will be identified during their call in the home centers of the town halls to get a housekeeper. After information, inclusion and randomization into two groups in the consultation site, the intervention group volunteers will follow the PEP for 24 weeks; the control group volunteers will receive a counseling booklet. Both groups will be followed at week 24 and 52.

Eligibility Criteria:
Inclusion Criteria:

* People over 70 years old
* Living at home
* With at least one instrumental activity of altered daily life (a disturbed criterion on the IADL scale) and making a request to set up a housekeeper.
* Major, able to give their consent
* Having signed the informed consent
* Affiliation to a social security scheme,

Exclusion Criteria:

* Surgical procedure within 6 months on the hip or knee,
* myocardial infarction or cerebrovascular accident diagnosed within 6 months,
* Respiratory insufficiency requiring long-term oxygen therapy
* Heart failure requiring hospitalization in the previous month or considered severe by the cardiologist
* Known or disabling muscle or joint pathology
* Subject benefiting from rehabilitation through physiotherapy sessions in progress or not wishing to stop physical exercise workshops
* Subject already in loss of autonomy for the ADL
* Life expectancy of less than 6 months any cause combined