cyrilzakka/clinical-trials huggingface dataset:
LFP Sensing From Directional Leads in the Acute Clinical Setting

This study plans to learn more about the optimal way to program the Medtronic Deep Brain Stimulation system in patients with Parkinson's Disease.

The investigators will conduct a prospective study in patients with Parkinson's disease (PD) implanted with standard of care, subthalamic nucleus (STN) deep brain stimulation (DBS) electrodes, to test whether monopolar sensing of the maximal power in the beta frequency range (in STN) predicts the optimal therapeutic stimulation setting for alleviation of PD motor symptoms. Participants in this study will have been implanted with a Medtronic DBS system consisting of a PerceptTM PC neurostimulator (battery) and SenSight™ DBS leads (implanted electrodes) with BrainSenseTM technology. The DBS surgery is a standard of care procedure, and no alteration of the surgical plan will occur for research purposes . The ranked response between the clinical profile (therapeutic benefit and adverse effects) and beta power will be compared for all electrical contacts on the implanted electrode. Additional analysis of monopolar sensing compared to differential bipolar sensing, location/distance and volume of neural activation (VNA) of optimal contacts identified by beta power or therapeutic window will be estimated with respect to the STN.

Aim 1- Determine whether monopolar sensing of beta power, in the outpatient clinic setting, will predict the optimal therapeutic contact for electrical stimulation of the STN.

Aim 2 - Long Term Follow Up (\>12 months) of the same consented study participants to determine the stability of the beta power to determine the optimal contact for therapeutic stimulation.

Eligibility Criteria:
Inclusion Criteria: Parkinson's Disease, scheduled to undergo bilateral subthalamic nucleus (STN) Deep Brain Stimulation (DBS) surgery at the University of Colorado Hospital, chosen to have a Medtronic Deep Brain Stimulation system implanted (Percept™ battery \& SenSight™ electrode). Parkinson's Disease causes upper extremity bradykinesia (slowness of movement) with a MDS-UPDRS1score of 2 or higher when you are off your PD medications.

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Exclusion Criteria: Dementia or other psychological disorders that precludes consent to participate. Inability to follow testing procedures as determined by the study doctor. Inability to be OFF medication for study visits. Existing implanted Deep Brain Stimulation system or implanted cardiac device. Unilateral Medtronic DBS system, or programming not occurring at the University of Colorado Hospital.

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Effectiveness of NESA in the Treatment of Cancer Survivors

Cancer is a disease, or a set of diseases, that increased in our society. However, improvements in their detection and treatment increase the number of patients who survive. Every year 2.6 million people are diagnosed in the European Union and 1.4 million become cancer survivors. However, these people suffer the late adverse effects of treatment that can seriously affect their quality of life.

the most common late effects are pain, fatigue, and sleeping difficulties. These are estimated between 58-90%. The autonomic nervous system (ANS) appears to play an important role in the manifestation and perpetuation of these symptoms.

This study aims to evaluate NESA (or NESA non-invasive neuromodulation) to treat the most common long-term side effects in cancer survivors, due to the most used treatments.

It will be compared between two groups of cancer survivors. The intervention group, with electrical stimulation, and the sham group, without electrical stimulation emission. The subjects will be assigned randomly. Neither the patient, the therapist, nor the analysts/researchers will know the assignment.

Finally, this project aims to add a passive tool to the therapeutic arsenal of health professionals in the oncology field for the treatment of late side effects.

Eligibility Criteria:
Inclusion Criteria:

* Be a cancer survivor (5 years after discharge)
* Have 1 of the 3 symptoms of the most common cluster: sleep problems, chronic fatigue, chronic neuro-muscular pain.

Exclusion Criteria:

* Not have an active oncological process
* Present any of the contraindications of the NESA-XSignal device: pacemaker, internal bleeding, skin in poor condition (ulcerations or wounds), acute febrile processes, acute thrombophlebitis, pregnancy, phobia of electricity.
The Effect of Altered Gravity Condition on Postural Control

The scientific goal of this experiment is to evaluate changes in balance control in response to microgravity during reactive balance tasks. For that purpose, kinematic and neuromuscular parameters under microgravity are compared to normal gravity conditions. To induce postural responses among the test subjects, an electromagnetic maneuverable postural platform will be used in order to randomly elicit perturbations. Postural reactions will be quantified by means of mechanical and electromyographic data. In Addition, peripheral nerve stimulation will be used to assess the spinal excitability by means of H-reflex recordings. H-reflex measurements were chosen as they allow reliable information about inhibitory and facilitatory mechanisms taking place at the spinal level.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 21 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Person with medical history of neurological disorders
* Person with medical history of musculoskeletal disorders of the lower limbs, especially of the ankle and knee joint.
* Pregnant women
Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain

Our aim is to assess usability and compliance of a wireless pedometer for monitoring step count after a lumbar epidural steroid injection for the treatment of radicular pain in low back pain patients. Our main hypothesis is to demonstrate pedometer measured step count can be used to measure efficacy of pain interventions.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Patients receiving lumbar epidural steroid injections as pain management to be scheduled at least one week away (-2 days/1 month).
* Patients who are able to understand how the Fitbit instrument works and are willing to consent to the study.
* Patient who used web-based communication frequently, e.g. Email.
* Patients who can speak, understand, and write in English.
* Prior MRI or an appointment to obtain an MRI prior to the procedure.

Exclusion Criteria:

* Workers' compensation cases.
* Patient does not have a computer at home.
* Non-ambulatory patients.
* Patients who have received a lumbar epidural steroid injection in the past 6 months.
* Nursing or pregnant women.
Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections

The study objective is to investigate the efficacy and safety of periocular injections of methotrexate in management of patients with active moderate to severe thyroid associated orbitopathy in comparison to periocular injections of triamcinolone acetonide.

Recruited subjects will be randomized such that one orbit receives 3 periocular injections of methotrexate and the contralateral orbit receives 3 periocular injections of triamcinolone acetonide at day 0, week 3 and week 6. All study subjects will be followed up for 6 months where outcome measures are assessed at 2 weeks, 1month, 3 months and 6 months after last injection

Eligibility Criteria:
Inclusion Criteria:

1. Bilateral moderate to severe thyroid associated orbitopathy.
2. Clinical Activity score (CAS) ≥ 3.
3. Duration of thyroid associated orbitopathy \< 2 years

Exclusion Criteria:

1. Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye.
2. Glaucoma patients or those known to be steroid responders
3. Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess
4. Pregnancy
5. Previous orbital or lid surgeries
6. History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months
Chronic Fatigue in Sarcoidosis

Background: Chronic fatigue (CF) is a prominent symptom in many sarcoidosis patients, affecting quality of life (QoL) and interfering with treatment. This study investigates neuropsychobiological mechanisms and markers of CF in sarcoidosis.

Patients with a histological diagnosis of sarcoidosis are included. The Multidimensional Fatigue Inventory (MFI) is used to define patients with and without CF. All patients are then characterized using several fatigue, depression, QoL and executive functioning questionnaires. Cognitive functioning and underlying neural correlates are assessed using an n-back task measuring working memory and (sustained) attention during functional magnetic resonance imaging (fMRI). Sarcoidosis disease activity is determined using lung function, laboratory parameters, and exercise capacity.

Eligibility Criteria:
Inclusion Criteria:

* histologically diagnosed sarcoidosis
* age ≥18 years
* provision of written informed consent
* sufficient German language skills to fully understand all questionnaires

Exclusion Criteria:

* patients unable to understand study-related information
* insufficient language skills in German language
* MRI-related contraindications:
* any kind of implants or extraneous material inside the body
* past thoracic or ophthalmologic surgery
* medical history of epilepsy, tinnitus or seizure
* extensive tattoos
* current pregnancy
* claustrophobia
Application of Diffusion Weighted MRI Versus CT in Evaluation of the Effect of Treating Lung Cancer

The purpose of this study is to investigate the diagnostic accuracy of ADC value of diffusion weighted MRI in comparison of conventional treatment assessment criteria in evaluation of chemotherapy. Moreover, the investigators aim to clarify the correlation of ADC value with histologic type and grade of lung cancer and survival of patients.

In recent years, lung cancer is an aggressive and heterogeneous disease, Advances in surgical and chemotherapeutic approaches have been made, but the long-term survival rate remains low. Although effective mass screening of high-risk groups could potentially be of benefit, randomized trials of screening with the use of chest radiography with or without cytological analysis of sputum specimens have shown no reduction in lung-cancer mortality. Currently, Response Evaluation Criteria in Solid Tumors (RECIST) by CT is the most commonly used to evaluate chemotherapy of lung cancer patient, but patients have to be exposed to radiation. For this reason, the investigators aim to assess the diagnostic accuracy of apparent diffusion coefficient (ADC) value, a specific parameter of radiation-free diffusion weighted MRI, in comparison of RECIST, and its correlation with histologic type and grade of lung cancer as well. Furthermore, the investigators investigate its correlation with Progression Free Survival (PFS) and Overall Survival (OS) in patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-75
2. Patients have confirmed lung cancer by histopathological methods (fiber, bronchoscopy, lung biopsy, open chest biopsy, pleural effusion exfoliated cells, sputum exfoliated cells)
3. After clinical assessment, patients who need chemotherapy (tumor stage III or IV of lung cancer or others who are reluctant to receive pneumonectomy);
4. Patients have no previous history of chemotherapy
5. Patients with at least one clearly measurable lung lesion (lesion size larger than 10mm, by spiral CT, according to RECIST)
6. Health status scoring between 0-2 by Eastern Cooperative Oncology Group(ECOG) method
7. Patients voluntarily to join this study and signed informed consents.

Exclusion Criteria:

1. Any body metal implants (pacemaker implantation, nerve stimulator, vascular stent, aneurysm clip, eye foreign body, the inner metal prosthesis) or artificial heart valves
2. Patients with claustrophobia to MRI or CT examination
3. Patients who are reluctant to comply with follow-up and subsequent examination
4. The other condition that do not meet the inclusion criteria.
Enhancing the Amount of Physical Activity Carried Out by Overweight Children at Leisure Time

The purpose of this study is to examine if internet supervised by pedometer will contribute to enhance the amount of physical activity at leisure time by obese children.

The investigators hypothesize that using pedometer will increase the amount of physical activity done by obese children in the afternoon and will improve the likelihood of success in the intervention program.

Childhood overweight \& obesity is the most common chronic disease in the western society. The prevalence of childhood obesity in Israel is among the highest in Europe. Recent data suggest that the recommended treatment for childhood obesity should be intense, multi-disciplinary intervention, including dietary, behavioral and physical activity components. Such a program exists at the Meir Medical Center in Israel for a few years with promising results.

The program includes: physical activity(PA)exercise (twice a week/1h), dietary guidance, medical supervision and behavioral intervention. The participants are asked to enhance PA at their leisure time, and to report to their coaches. Yet, the amount of time they actually exercise is not controled by us.

This study will include 3 groups of overweight\& obese children:

1. Intervention with pedometers and supervision.
2. Intervention with pedometer without supervision.
3. Control. Obese and overweight children not taking part in a treatment program.

Eligibility Criteria:
Inclusion Criteria:

* overweight/obese children
* age 5-18
* boys and girls

Exclusion Criteria:

* children with genetic obesity or obesity cased by a disease
Effectiveness of Two Different Entry Portal Pathways Into Primary Care for Musculoskeletal Injury

This study aims to compare the self-report functional outcome measures, medical readiness and healthcare utilization (overall cost of imaging, prescription medications for pain, and follow-up visits) of soldiers with musculoskeletal injuries first seen by a physical therapist versus primary care provider.


Eligibility Criteria:
Inclusion Criteria:

* Adults over age 18
* Musculoskeletal injury or complaint \< 3 months since onset
* Active duty service member, reachable by phone/e-mail within 3 months of initial encounter

Exclusion Criteria:

* Subject currently has a permanent profile for any reason OR subject has a temporary profile for a body part in the same half of the body as the current complaint OR solider is pending physical examination board (PEB) or undergoing/pending medical examination board (MEB)
* Individuals undergoing PEB/MEB are made aware that the end-state of the process includes a certain percentage of government monetary compensation based on their physical or mental disability, i.e, higher disability equates to greater pay. Because of this, individuals may be motivated to demonstrate worse outcomes as it may result in a higher disability "rating". For this reason, these individuals will be excluded from the study.
* Subject has been treated previously for the same condition within the past 3 months
* Subject has history of surgery for the same body part within the past 24 months
Evaluation of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding

The purpose of this study is to compare bonding time, bond survival, amount of adhesive remaining on the tooth surface after bracket debonding, and time required for adhesive remnant cleanup between a new "flash-free" and a conventional adhesive resin for orthodontic bracket bonding.

Patients presenting for comprehensive orthodontic treatment with fixed appliances at the University of Minnesota, who are willing to participate, will be included in the initial study. Selection criteria will include full permanent dentition through the first molars, teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide, and no previous orthodontic treatment with fixed appliances. The patients will have their maxillary incisors, canines, and premolars bonded with ceramic orthodontic brackets pre-coated with a "flash-free" adhesive resin (Clarity Advanced Brackets APC flash-free, 3M Unitek, Monrovia, CA, USA) on one side and a conventional adhesive resin (Clarity Advanced Brackets APC II, 3M Unitek) on the other side. The side allocation and order of bonding will be randomized for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Full permanent dentition including incisors, canines, premolars, and first molars
* Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide
* No previous orthodontic treatment with fixed appliances

Exclusion Criteria:

* Mental/emotional/developmental disability
* Cleft lip and/or palate, craniofacial anomaly, or syndrome
* Obvious oral hygiene issues such as excessive plaque accumulation, gingivitis, and/or pre-existing white spot lesions
* Prosthodontic or restored substrate extending on the labial surface of maxillary teeth
* Known allergies to any acrylates contained in the study materials
A Multi-center, Prospective, Single-blind, Controlled Trial Comparing Diagnostic Value of Different EUS-FNA Techniques

The aim of this study is to compare endoscopic ultrasound guided-fine needle aspiration (EUS-FNA) with a standard 22-gauge needle using "standard suction", "slow-pull" and "wet suction" for thoracic/abdominal solid/solid-cystic lesions. Investigators intend to compare the effectiveness and safety of the three methods in order to discover the optimized technique for obtaining diagnostic material and making accurate diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* In-patients and out-patients between the age of 18years and 80 years with thoracic/abdominal solid/solid-cystic lesions for EUS-FNA.

Exclusion Criteria:

* Uncorrectable coagulopathy (INR \> 1.5)
* Uncorrectable thrombocytopenia (platelet \< 50,000)
* Cystic lesions
* Inaccessible lesions to EUS
* Contraindications for conscious sedation
* Uncooperative patients
* Refusal to consent form
Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial

To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet


Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged 19 to 59 years have a complaint of CHHF.
* Patients must include at least one or more of the following symptoms:
* Those who have the symptoms of CHH in normal temperature which most individuals feel no cold;
* Those who have the symptoms of extremely cold hands in cold temperature exposure;
* Those who are on the return to a warmer environment, the symptoms of cold hands is not completely rewarmed;
* Those who have 4 cm or greater of VAS CHH score;
* A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃;
* Those who can comply with all study-related procedures, medications, and evaluations;
* Given a written informed consent form.

Exclusion Criteria:

* Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;
* Those who have one or more finger gangrene or ulceration;
* Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;
* Those who are diagnosed by autoimmune disease or have a positive ANA test result;
* Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests;
* Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;
* Those who are diagnosed with diabetes;
* Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc;
* Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL);
* Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious mental illness;
* Those who are Diagnosed with moderate anemia and hematologic disorders (adult non-pregnant women hemoglobin (Hgb) level less than 7g/dL, hematocrit (Hct) level less than 26%, white blood cell (WBC) level greater than 11,000/mm3); Those whose systolic blood pressure (SBP) 180mmHg or diastolic blood pressure (DBP) is greater than 100 mmHg based on average value of at least 2 measurements;
* Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on;
* Those who are addicted to alcohol or drugs;
* Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy;
* Those who are diagnosed with malignant tumor
* Those who are currently participated in other clinical trials;
* Those who are able to understand and speak Korean;
* Those who are judged to be inappropriate for the clinical study by the researchers.
Rebalance: Compassion Focused Therapy in a Transdiagnostic Health Group

This study evaluates the use of group Compassion Focussed Therapy in a population with various and/or multiple long term health conditions. A multiple baseline, single case experimental design will be used with a view to evaluate changes in psychological adjustment and compassion. Daily data and weekly questionnaire batteries will be collected across a baseline period and ten weeks of group intervention. Participants will be those already referred to the group by a clinician as part of their routine care.


Eligibility Criteria:
Inclusion Criteria:

* Experiencing difficulties adjusting to one or more chronic physical health condition(s)
* Willing and motivated to attend a nine-week group facilitated in English
* Exhibit sufficient interpersonal skills and impulse control to allow them to engage with group members without disrupting group dynamics
* Able to provide informed consent

Exclusion Criteria:

* Moderate or severe impairment of cognitive function
* Primary problem related to drug or alcohol misuse
* Actively suicidal or experiencing an acute deterioration in their mental health including experiencing an acute psychotic episode