cyrilzakka/clinical-trials huggingface dataset:
Whole-body Electromyostimulation in Inpatient Rehabilitation

Based on various studies, scientific evidence has proven the effectiveness of whole-body electromyostimulation (WB-EMS) on parameters such as increased physiological performance and body composition.

As a pilot project, the aim of the study is to determine the effect of additional WB-EMS as part of the inpatient four-week rehabilitation of sarcopenic subjects.

The loss of muscle mass in the age-associated process (sarcopenia) is a common indication in the field of orthopedic and cardiac rehabilitation, which may also be reinforced by previous immobilization and disuse of the muscles (atrophy of muscle). Sarcopenia is defined as 2 standard deviations of average of the same sex in middle adult life. The present project focuses on the sarcopenia definition of the Foundation for the National Institutes of Health (FNIH). Their limits are \< 0.789 (men) and \< 0.512 (women) and are calculated by adding the absolute muscle mass of the extremities divided by the body mass index (BMI).

Due to reduced muscle mass and thus limited strength / performance, the implementation of conventional training tools with regard to generate corresponding intensities is no longer possible, or in persons with additional cardiac or orthopedic restrictions heavily limited.

In view of the existing indications, the alternative training technology whole-body electromyostimulation (WB-EMS) is an adequate training tool for the rehabilitation process. The time-saving (max 20 minutes per training session) and effective training method is characterized by low orthopedic and cardiac stress. Thus, WB-EMS combines both relevant aspects of a joint-friendly training with effects on muscle mass and functionality. Through the simultaneous activation of up to 10 muscle regions with corresponding, subjectively decidedly adjustable intensity per muscle group, up to 2,800 cm2 can be addressed. Synchronized to a motion video, the participants perform light physical exercises in parallel to the current pulses.

The aim of the study is, to evaluate the effect of additional WB-EMS during a 4-week period of inpatient rehabilitation, comparing 3 groups:

1. WB-EMS, stimulating 8 muscle groups (legs,arms, core, gluteal region)
2. partial-WB-EMS, just stimulating the lower extremities (legs, gluteal region)
3. control, just performing the functional, mainly eccentric motion pattern without stimulation

Eligibility Criteria:
Inclusion Criteria:

1. skeletal muscle index (SMI) \< 0,789 (men); \< 0,512 (women)
2. A general state of good health
3. Medically approved unrestricted sports participation as shown by diagnostic performance test
4. Willingness to provide signed informed consent

Exclusion Criteria:

1. Post-coronary artery bypass graft (ACVB) surgery in the last 3 months
2. Condition after pacemaker and defibrillator implantation
3. renal insufficiency from stage 3a
4. epilepsy
5. feverish diseases or infectious diseases
6. Taking medicines the affect muscle metabolism
7. severe neurological disorders
8. Skin injuries in the area of electrodes
Glu298Asp Polymorphism and Blood Pressure

The Glu298Asp polymorphism has been linked to increased risk of cardiovascular events, proposed to be due to reduced nitric oxide production by eNOS reported in some but not all studies. We hypothesise that beetroot-enriched bread interacts with the Glu298Asp polymorphism of the eNOS gene to lower blood pressure and increase plasma nitrate/nitrite, particularly in carriers of the T allele, which have been associated with lower eNOS activity and increased risk of hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male
* A signed consent form
* Age 18-64 years
* Body mass index - 18.5-30 kg/m2
* Non-smoking, healthy individuals
* Normal blood pressure at screening (\< 150/90)

Exclusion Criteria:

* Subjects with anaemia
* Sufferers of chronic illnesses
* Individuals with food allergies
* People with diabetes
* People with coeliac disease
* Women
* Vegetarians
Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial

The present study is a randomized, controlled trial that investigates the effects of parathyroidectomy or medical observation in mild asymptomatic pHPT on morbidity and quality of life (QoL).

The patients are included and randomized by block randomization to medical observation or parathyroidectomy by an experienced parathyroid surgeon.

The patients will be followed up for 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Untreated, asymptomatic pHPT
* 2.60\>S-Ca\<2.85 mmol/liter
* Age between 50 and 80 yr
* No medications interfering with Ca-metabolism
* Informed consent

Exclusion Criteria:

* Hyperparathyroid bone disease
* Previous operation in the neck
* Impaired kidney function
* Kidney stones
* Complicating medical conditions
* Psychiatric disorders
* Multiple endocrine neoplasia,
* Familial hypocalcuric hypercalcemia
* Familial HPT
Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Leucovorin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.

OBJECTIVES: I. Evaluate the quantitative and qualitative toxicities of oxaliplatin combined with fluorouracil and leucovorin calcium in patients with advanced adenocarcinoma of the colon or rectum.

OUTLINE: Patients receive leucovorin calcium IV over 10-20 minutes followed within 10 minutes by fluorouracil IV bolus on days 1, 8, 15, 29, 36, and 43. Patients receive oxaliplatin IV over 2 hours prior to leucovorin calcium and fluorouracil on days 1, 15, 29, and 43. Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses upon approval by the sponsor. Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven advanced adenocarcinoma of the colon or rectum No prior systemic chemotherapy OR Adjuvant chemotherapy only, completed 6 months prior to study and with subsequent development of recurrent disease At least 1 bidimensionally measurable lesion No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL (no greater than 5.0 mg/dL if due to intrahepatic biliary obstruction not amenable to biliary decompression, if approved by the protocol investigator) SGOT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No neurologic disease No active or uncontrolled infection No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No medical or psychiatric disorders that would prevent compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for malignant disease Surgery: Recovered from any prior surgery Other: At least 30 days since other prior investigational agent No other concurrent investigational agents No concurrent anticancer agents
Safety of Romiplostim (Nplate®) Following UCBT

This is a single institution, phase I dose escalation study of weekly romiplostim post umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8, and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20% or less.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who has undergone a single or double umbilical cord blood transplant (UCBT) except those with primary myelofibrosis.

  * Those with acute leukemia must be in remission at the time of transplant
* Must have achieved neutrophil engraftment (defined as an ANC \>500 for three consecutive days) and be off daily G-CSF prior to starting romiplostim. Intermittent G-CSF is allowed.
* Failure to achieve platelet engraftment (defined as platelet count ≥20x10\^9/L on 3 consecutive measurements without transfusion for 7 days) by day +28 post UCBT
* Between day +28 and day +42 status post myeloablative or nonmyeloablative UCBT (single or double cord blood transplant)
* Age ≥ 18 years
* Adequate organ function within 7 days of enrollment defined as:

  * Creatinine: ≤ 2.0 mg/dL
  * Hepatic: SGOT and SGPT \< 5 x upper limit of institutional normal (ULN)
* Women of child bearing potential agree to use effective contraception during therapy and for 4 months after completion of therapy
* Voluntary written consent

Exclusion Criteria:

* Known pregnancy - Pregnancy Category C: there are no adequate and well-controlled studies of romiplostim in pregnancy
* Recurrence of AML or myelodysplastic syndrome on bone marrow evaluation done within 21 days of enrollment
* Presence of clinically significant bone marrow fibrosis on the bone marrow examination immediately prior to UCBT
* Patients requiring more than one platelet transfusion per day
* History of an allergy to romiplostim
Smart Autonomous Neuro-Rehabilitation System

Cognitive rehabilitation is defined as a systematic functionally oriented intervention of therapeutic cognitive activities based on the assessment and understanding of patient's brain behavior deficits. This project focuses on restoring cognitive functions in order to understand the underlying deficits in the patient's brain by developing integrated cognitive rehabilitation scenarios in virtual reality that combine memory, attention and problem solving training with context specific motor movements.


Eligibility Criteria:
Inclusion Criteria:

* Score on Mini-Mental State Examination between 18 - 24
* Score on Montreal Cognitive Assessment less than 26
* More than 2 points in upper limb motor scale MRC
* Sufficient cognitive ability to understand and follow the experimental instructions

Exclusion Criteria:

* Score on Mini-Mental State Examination below 18 or above 24
* Score on Montreal Cognitive Assessment of 26 or above
* Below 2 point in upper limb motor scale MRC
* Hemianopia
* Cognitive capacity that prohibits the execution of the experiment
* Severe impairment like spasticity, aphasia or apraxia, major pain or other neuromuscular impairments or dependent on use of orthopedic devices that would interfere with the correct execution of understanding of the experiment
* History of serious mental-health problems in acute or subacute phase
* Patients that do not give their consent to participate in the study
Molecular Biomarkers Associated With Degenerative Joint Disease in the Knee

This investigation describes a novel complex of structural degradation proteins that is associated with pain in individuals with meniscal pathology undergoing arthroscopic partial meniscectomy. The presence of the complex in the synovial fluid of the knee is sensitive and specific for the painful state compared with similar aged controls. The absence of the complex in asymptomatic controls makes it a useful biomarker for the disease state.

Background: Molecular biomarkers associated with knee pain may be useful as diagnostic tools, prognostic indicators, and surrogate endpoints for therapeutic trials. This study describes a novel complex of structural degradation proteins which are present in the knees of patients with meniscal pathology.

Methods: This prospective cohort study included 30 patients with knee pain, mechanical symptoms, and MRI positive for meniscus tear who elected for arthroscopic partial meniscectomy after failing conservative management. Synovial fluid was aspirated at the time of surgery and assayed for a complex of structural degradation proteins by means of heterogeneous ELISA. The results were compared to knee aspirates from 10 asymptomatic volunteers with no pain. The complex was identified by a proteomic analysis of including multiplexed-bead immunoassay, purification by anion exchange and size exclusion chromatography, and mass spectrometry of individual chromatographic fractions.

Eligibility Criteria:
Inclusion Criteria:

* the presence of mechanical symptoms including locking, catching, or giving way;
* positive physical exam findings including joint line tenderness, McMurray's exam, or Steinman's exam; and
* MRI of the knee positive for meniscus tear in a location correlating with physical examination.

Exclusion Criteria:

* the presence of high grade gonarthrosis including Kellgren-Lawrence grade IV;
* a history of prior knee surgery or trauma; ligamentous incompetence on examination or MRI; and
* diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases.
Targeted Polymeric Nanoparticles Loaded With Cetuximab and Decorated With Somatostatin Analogue to Colon Cancer

Due to the great toxicity of chemotherapeutic drugs to both the healthy and cancerous area, the efficient targeting could be of great benefit for a patient with advanced or metastatic tumors. Colorectal cells carry somatostatin receptors which make them a promising target for antitumor therapy since this would reduce side effects and increase drug delivery efficacy to the target site.

The investigator's aim is to deliver polymeric nanoparticles loaded with anti-cancer drug Cetuximab and decorated with somatostatin analogue in the form of oral polymeric nanoparticles, which can release at only above pH 6.8 using ethylcellulose polymer. The polymeric nanoparticles were prepared using the solvent evaporation method, further will be characterized for its drug content, size, encapsulation efficiency and drug-loading using UV spectroscopy. Moreover, the ethylcellulose nanoparticles loaded Cetuximab will release the Cetuximab at pH above 6.8, while can hold the Cetuximab at pH 1.5 which protecting the stomach from the toxicity Cetuximab. Then, the nanoparticles will target the colorectal cancer cells using octreotide, the somatostatin receptor agonist which will lead it to SSTRs overexpressed in colorectal cancer cells. The strategy of deposition of ligand will depend on using the advantage of the positive charge surface of nanoparticles which can absorb the negative charges of the targeting ligands. Final outcomes: this project will present a novel formulation for the treatment of colorectal cancer which can be delivered safely to the patients in a high dose to the affected tumor cells with reduced side effects on the other healthy cells.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of colon cancer
* Follow up and collect data for a local and systemic activity of cetuximab
* The systemic oral capsule of cetuximab be also given to enhance the activity as an anti-cancer activities

Exclusion Criteria:

* Peptic ulcer
* Stomach disease
* Colon cancer
Multi-parametric Magnetic Resonance Imaging for Prostate Cancer Patients

This is a pilot study of implement multi-parametric MR imaging for organ delineation and tumor response assessment of prostate cancer patients being treated with radiation therapy.

The study aims to generate intraprostatic lesions maps based on imaging, perform the treatment planning to compute the highest feasible simultaneous boosting dose to intraprostatic lesion and characterize longitudinal changes in imaging characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma

Exclusion Criteria:

* Patients with metal fragments or implanted devices such as pacemakers and aneurysm clips are not eligible for the study considering
Effect of PDE5 Inhibition on Adipose Metabolism in Humans

This is a randomized, double-blinded, placebo-controlled study of the effects of PDE5 inhibition with tadalafil on adipose tissue in obese individuals. Adipose metabolism will be measured using magnetic resonance imaging (MRI) scans and by aspirating a small amount of adipose to measure gene expression.

The purpose of this study is to test whether tadalafil causes subcutaneous adipose tissue to have a "beige" phenotype. Participants will be randomized to either placebo or tadalafil for 12 weeks. Investigators will study adipose metabolism using MRI scans and aspiration of subcutaneous adipose from the abdomen. In addition to MRI scans at room temperature, the investigators will use a cooling protocol to test the combined effects of tadalafil and on adipose metabolism. Investigators will also measure the effects of the drug on body composition. In addition to the study visits, participants will wear an activity tracker (Fitbit) and log their dietary intake several times using an online tool. There will be a small amount of radiation exposure. Participants will be compensated for participation in this study.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Obesity (BMI ≥ 30 kg/m2)

Exclusion Criteria:

* Age \<19 or \> 50
* BMI \< 30 kg/m2
* Systolic blood pressure (SBP) \< 100, \> 150 mmHg
* Current anti-hypertensive medication use, including diuretics
* Current use of organic nitrates
* Current use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil)
* History of reaction to PDE-5 inhibitors
* Known HIV infection
* Use of medications that strongly alter CYP3A4 activity
* History of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure
* Known non-arteritic ischemic optic retinopathy (NAIOR)
* History of hearing loss
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2 by the modified diet in renal disease (MDRD) equation
* Hepatic transaminase (AST and ALT) levels greater than three times the upper limit of normal
* Known pregnancy or breastfeeding or those unwilling to avoid pregnancy during the course of the study
* History of priapism
* Use in excess of four alcoholic drinks daily
* History of diabetes mellitus or use of anti-diabetic medications
* Known anemia (men, Hct \< 38% and women, Hct \<36%)
* Menopause
* Weight \> 300 pounds
* Individuals with circadian rhythm disorders, shift workers, or those who travel across time zones frequently
Exercise, Cognitive Function and Neuroplasticity in Healthy Adults

The overall goal of the proposed study is to compare the effects of 4 weeks of moderate or high intensity aerobic exercise on neuroplasticity, cognitive performance and gait and postural control in sedentary healthy adults.

The primary aim of the study is to compare the effects of a moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate) with a high intensity aerobic exercise intervention (delivered at 65%-90% age-predicted maximal heart rate) on measures that probe cortical synaptic plasticity using transcranial magnetic stimulation (TMS) in sedentary healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females aged 18-70 years old
* Primary language is English
* Sedentary (defined as not engaging in purposeful physical activity more than 2 times over the last two months)
* Exercise clearance

Exclusion Criteria:

* Presence of cognitive, neurologic or orthopedic conditions that could affect performance of the testing and training procedures
* History of migraines.
* History of fainting spells of unknown or undetermined etiology that might constitute seizures
* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or family history of treatment resistant epilepsy
* Any current history of a psychiatric illness
* Any unstable medical condition
* No medication is an absolute exclusion from TMS. Medications will be reviewed by the Principal Investigator and a decision about inclusion will be made based on the following:

  * The subject's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS active drugs.
  * The published TMS guidelines review medications to be considered with TMS (Rossi, Hallett, Rossini, Pascual-Leone, \& Safety of TMS Consensus Group, 2009).
* Any metal in the brain, skull or elsewhere unless approved by the responsible MD
* Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator)
* Intracranial lesion
* Substance abuse or dependence within the past six months Subjects who, in the Investigator's opinion, might not be suitable for the study
Reinnervation and Neuromuscular Transmission in ALS

The aim of this study is to describe the changes in the neuromuscular connection in patients with amyotrophic lateral sclerosis (ALS). The study consist of three substudies that have the following main hypothesis:

1. that ALS patients do not demonstrate equal capacity for muscle reinnervation and that reinnervation preserves muscle function and thereby slows down progression.
2. that blood concentrations of c-terminal agrin fragment (bCAF) reflect neuromuscular transmission deficiency and that blood concentration of neural cell adhesion molecule reflects degree of muscle denervation in patients.
3. that ALS patients with decrement when examined with repetitive nerve stimulation have more physical fatigue, slower progression, higher degree of reinnervation and higher bCAF compared to ALS patients without decrement.

There will be 3 inclusion groups.

1. patients referred for neurophysiological examination on suspicion of motor neuron disease.
2. healthy controls
3. disease control: patients with another motor neuron disease with slow progression.

All participants will be invited for at least 1 visit (baseline). If participants in group 1 eventually receive the diagnosis of ALS they will be invited for 2 additional visits 4 og 8 months after baseline visit, respectively.

Examinations will consist of:

* nerve conduction study
* repetitive nerve stimulation (except for healthy controls) to examine impairment of the neuromuscular connection.
* motor unit number estimation with MScanFit to estimate number and size of motor units.
* ultrasound examination of muscles to measure size and condition of muscles.
* questionnaires on fatigue and functional status.
* blood sample for measurement of specialized analysis (c-terminal agrin fragment and neural cell adhesion molecule) and routine analysis (liver and kidney function as well as neurofilament light chain)
* muscle strength assessment manually and by dynamometer to follow progression of muscle weakness
* bioelectrical impedance measurement to follow the overall body composition.


Eligibility Criteria:
Inclusion Criteria:

* Referred to clinical neurophysiological examination on suspicion of motor neuron disease or diagnosed with ALS according to Gold Coast criteria within the last 3 months.
* Age ≥18 years old
* Able and willing to provide informed consent

Exclusion Criteria:

* Former central or peripheral nervous system disease
* Diabetes
* Electrophysiological signs of polyneuropathy at baseline visit
* Pacemaker
* Pregnancy

For disease controls the exclusion criteria are the same, but the inclusion criteria:

* Diagnosed with disease with slow, progressive loss of motor neurons
* Age ≥18 years old
* Able and willing to provide informed consent