cyrilzakka/clinical-trials huggingface dataset:
Chronic Pain and Brain Activity in Spinal Cord Injury

This study compares five different procedures to see how they affect pain and brain activity. The procedures include neurofeedback, self-hypnosis training, meditation, and two different levels of transcranial direct current stimulation (tDCS). Subjects will be compensated for their time.

During the first study visit, subjects will receive a physical exam and an electroencephalogram (EEG), which measures brain activity. Research staff will put a cap on your head that has sensors which measure your brain activity. There is no risk of electrical shock. In addition to the sensors in the cap, two clips will be put on your ears. EEG activity will be collected for 20 minutes: you will have your eyes open for ten minutes, and then have your eyes closed for ten minutes.

Additional study visits will follow where we will perform five different procedures (neurofeedback, self-hypnosis, two levels of transcranial direct current stimulation, and meditation). All subjects will receive all five procedures and each procedure will be conducted for 20 minutes.

Self-Hypnosis Training: You will be given verbal suggestions from an audio recording (via headphones) for relaxation and changes in the way you think about pain.

Meditation: You will be asked to focus on a single word ("one") for the entire session.

Neurofeedback Training: During this procedure, three sensors will be placed on your scalp, and one on each earlobe. A small amount of electrode paste will be used when placing the sensor on your scalp. There is no risk of electrical shock. You will be able to see images on a computer screen that correspond to your brain waves. You will learn how to change your brainwaves by changing the images on the computer.

Electric Stimulation (two different levels): This procedure consists of direct stimulation of the brain by a weak electrical current. The two procedure sessions will differ in the characteristics of the stimulation. Two electrodes will be placed on your scalp and secured by a rubber strap. The tDCS procedure is considered experimental and is not currently approved by the FDA but has been studied previously, at the same level of current, in spinal cord injury.

Before and after each procedure we will complete a 10 minutes EEG assessment similar to what is described above. The final procedure session will end with a 20 minute assessment to determine how responsive you are to hypnosis. Each procedure visits may last up to three hours. There will be a total of 6 study visits over approximately 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Spinal Cord Injury
* 18 years of age or older
* Daily pain
* At least 12 months since injury
* Read speak and understand English

Exclusion Criteria:

* History of seizure disorder or non-normative brain activity
* Presence of traumatic brain injury or significant skull defects
* Exhibit moderate to severe cognitive impairment
Elhafez Technique Combined With Dynamic Scapulohumeral Mobilization in Shoulder Adhesive Capsulitis

Elhafez Technique Combined with Dynamic Scapulohumeral Mobilization in Adhesive Capsulitis

Elhafez Technique is an emerging rehabilitation approach that integrates axillary ultrasound, axillary laser therapy, and post-isometric facilitation (PIF) to target capsular stiffness, inflammation, and neuromuscular dysfunction. These techniques aim to enhance tissue healing, improve joint mobility, and reduce pain. When combined with Dynamic Scapulohumeral Mobilization (DSM), which focuses on restoring scapular control and shoulder joint biomechanics, this comprehensive approach may offer superior outcomes compared to conventional treatments.

This study aims to evaluate the biomechanical and functional effects of combining Elhafez Technique with DSM in patients with shoulder adhesive capsulitis. By assessing pain levels, ROM, and functional recovery, this research seeks to determine whether this combined intervention provides faster and more effective relief for patients suffering from this condition.

Eligibility Criteria:
Inclusion Criteria

1. Adults aged 30-60 years diagnosed with Stage 2 (Frozen) or Stage 3 (Thawing) Shoulder Adhesive Capsulitis based on American Shoulder and Elbow Surgeons (ASES) guidelines.
2. Pain score ≥4/10 on the Visual Analog Scale (VAS) for at least 3 months.
3. Restricted external rotation of ≥25% compared to the unaffected shoulder.
4. No prior shoulder injections, surgery, or physiotherapy within the last 3 months.

Exclusion Criteria

1. History of shoulder fractures, rotator cuff tears, or labral injuries.
2. Systemic inflammatory conditions (e.g., Rheumatoid Arthritis, Uncontrolled Diabetes).
3. Neurological disorders affecting the shoulder (e.g., Stroke, Parkinson's Disease).
4. Current participation in another physiotherapy intervent
Morphological Changes of the Brain by MRI in Chronic Kidney Disease

The purpose of this study is to describe brain´s morphological changes induced by chronic kidney disease (CKD) in advanced stages (stages 4 and 5 defined by KDOQI guidelines) and also by haemodialysis using MRI.

Based on the hypothesis that hypotension may cause damage in some organs including brain the investigators study if intradialytic hypotension (IDH) causes any type of changes in gray and white matter of the brain.

There will be two groups: one in haemodialysis treatment and the other with chronic kidney disease patients in advanced stages (stages 4 and 5 defined by KDOQI guidelines).

Both groups will be evaluated with a MRI without contrast. A second MRI to identify brain´s morphological changes will be performed in patients of the first group a year later and in patients of the second group that will have been begun haemodialysis six months after.

In a first transverse evaluation, eighteen haemodialysis sessions from the first group will be studied with a retrospective analysis. The first three sessions of each month for six months before the MRI will be considered.

In each session the investigators will collect haemodynamic variables (systolic arterial blood pressure pre and post dialysis), intradialytic hypotension based on different definitions (Nadir90, Nadir100, Fall20, Fall30) and proper haemodialysis variables (KtV, convective transport).

In the first group and patients with CKD that will start haemodialysis, the investigators analyse the variables considered in the transverse evaluation until complete one year follow up.

Statistical analysis will be done with SPSS version 20.

Eligibility Criteria:
Inclusion Criteria:

* Prevalent patients of haemodialysis (6 months minimum)
* Patients with CKD (stages 4 and 5)
* Informed consent signed

Exclusion Criteria:

* Refusion to participate in the study
* Presence of contraindications for MRI
* Presence of clinic neurologic disorders
Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED)

Phase 1/2, multicenter, multiple dose clinical study designed to evaluate lonigutamab in subjects with TED.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, ≥18 and ≤75 years of age.
* Proptosis defined in the study eye as ≥3 mm above normal.
* Clinical Activity Score (CAS) ≥4 (using a 7-item scale) for the most severely affected eye
* Onset of active TED symptoms prior to baseline
* Must agree to use highly effective contraception as specified in the protocol

Key Exclusion Criteria:

* Pathology related to inflammatory bowel disease or irritable bowel syndrome.
* Clinically significant pathology related to hearing or history of hearing impairment
* Optic neuropathy
* Corneal decompensation unresponsive to medical management.
* Previous orbital irradiation (for any cause) or any previous surgical treatment for TED.
* Subjects with diabetes or hemoglobin A1c \&gt;6.0% at screening
* Any steroid use (intravenous \[IV\] or oral) with a cumulative dose equivalent to \&gt;3 g of methylprednisolone for the treatment of TED within the last year.
* Previous steroid use (IV or oral) specifically for the treatment of TED not to exceed 1 g total dose in the 8 weeks prior to Screening.
* Previous use of teprotumumab or any other IGF-1 receptor (IGF-1R) inhibitor.
* Any previous treatment with a biologic drug for the treatment of TED (eg, rituximab and tocilizumab)
* Any other immunosuppressive agent within 1 month of screening.
* Cohort 4 only: Prior history of craniofacial surgery or medical conditions that could alter orbital or facial features.
Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts

This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.

This is a randomized, double-blind, placebo-controlled Phase 1b/2 study in women diagnosed with persistent cervical hrHPV infection. This study is designed to assess safety, tolerability, and efficacy following the use of ABI-2280 Vaginal Insert delivered intravaginally. Sentinel cohorts will be utilized to assess tolerable regimens, which may trigger cohort expansions if some evidence of efficacy is observed.

Dose range and dosing regimens in this study will be evaluated through the enrollment of up to 11 sentinel cohorts, each enrolling up to 8 participants.

Eligibility Criteria:
Inclusion Criteria

* Female sex, 25 to 55 years of age
* Positive hrHPV result on at least 2 consecutive tests prior to randomization, one hrHPV+ result at least 12 months prior to screening
* Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.

Exclusion Criteria

* History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia
* Any clinically significant immune suppressing condition
* History or current diagnosis of cervical cancer, suspected or confirmed
* Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study.
Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity

Innlandet Hospital in Gjøvik is a center for patients suffering from morbid obesity in Hedmark og Oppland, Norway. Patients with either BMI \> 40 kg/m2 or with BMI \> 35 kg/m2 and complications who opt for "gastric bypass" surgery, go through a standard program including a thorough clinical examination and information on the operation, followed by a learning and coping program that consists of standard dietary advise for weight loss and includes weekly visits during 8 weeks.

This research project concerns a subgroup in the patient population described above: morbidly obese patients with irritable bowel syndrome (IBS). In this group it will be investigated how an 8 week preoperative milk-free diet affects digestive functions and weight loss. It is known that milk may cause stomach complaints and may make it more difficult to loose weight.


Eligibility Criteria:
Inclusion Criteria:

* morbid obesity

Exclusion Criteria:

* no consent
* contraindications to surgery
Imaging with [89Zr]Panitumumab-PET/MRI in Patients with Newly Diagnosed Colorectal Cancer

This clinical study will investigate the utility of PET imaging with \[89Zr\]Panitumumab for imaging of EGFR expression in newly diagnosed colon cancer patients to assess lymph node involvement. If promising, this data will be used to design larger trials.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 19 years of age.
* Diagnosis of colon cancer
* Scheduled to undergo surgical resection

Exclusion Criteria:

* Inability to provide informed consent
* Pregnancy
* Inability to lie still for the imaging study
* Weight over 350 lbs., due to the scanner bore size
* Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
* Inability to receive Omnipaque (iohexol) iodinated contrast
* Inability to receive glucagon
* Inability to receive Eovist (gadoxetate disodium) gadolinium based contrast agent
* Allergy to contrast imaging agents
* Finding or suspicion of distant metastases on CT
Evaluation of the Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers

A Phase 1, single-center, open-label, single arm, baseline-controlled (for safety) study in normal volunteers. Study will determine biodistribution and excretion of the radioactive drug substance and evaluate the safety and tolerability of 99mTC-Etarfolatide in normal volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years of age or older.
* Subject must not have any major health problems as deemed by principal investigator.
* Subject must provide informed consent prior to enrollment.

Exclusion Criteria:

* Subject is pregnant or breast-feeding.
* Subject is simultaneously participating in another investigative drug or device study.
* Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this study.
* Subject has a known history of chronic abuse of drugs or alcohol or tests positive in pre-study urine drug abuse screen.
* Subject is currently taking folic acid supplements and cannot stop taking the supplements for a period of 8 days (7 days prior to the study and one day after last imaging procedure).
* Subject's physical condition unsuitable for radionuclide imaging.
* Subject has been administered another radiopharmaceutical that would interfere with the assessment of the biodistribution of 99mTc-etarfolatide.
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment), Child-Pugh A (CP-A) cirrhosis (mild hepatic impairment) and participants with normal hepatic function as healthy control.


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>50 Kilogram (kg) and body mass index (BMI) within the range 19 to 40 Kilogram per square meters (kg/m2) (inclusive)
* Capable of giving signed informed consent.
* Child-Pugh B cirrhosis (moderate hepatic impairment; Part 1) or Child-Pugh A cirrhosis (mild hepatic impairment; Part 2) or a healthy control participant based on a medical evaluation including medical history, physical examination (PE), laboratory tests.

Exclusion Criteria:

* Diagnosed or suspected hepatocellular carcinoma.
* History of malignancy within the past 5 years except for cancers that are cured by surgical resection (e.g., skin cancer).
* History of vasculitis or presence of symptoms and signs of potential vasculitis or history/presence of other diseases that may be associated with vasculitis condition.
* Unstable cardiac function or high blood pressure that is not controlled (based on the investigator's discretion).
* Any other medical condition which, in the judgment of the investigator and Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant.
* Participants who have taken or are currently taking any therapies not allowed by the protocol.
* A positive test for human immunodeficiency virus (HIV) antibody.
* History of sensitivity to GSK3228836 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study

This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation.

The purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted in a home setting.

After the run-in phase, there is a 21-night trial in which each night is randomly assigned 2:1 to have either the predictive low-glucose suspend (PLGS) system active (intervention night) or inactive (control night).

Three predictive algorithm versions were studied sequentially during the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older,
2. Type 1 diabetes for at least 1 year
3. Current user of the MiniMed Paradigm Real-Time Revel system and Sof-sensor glucose sensor
4. Hemoglobin A1c level of \< 8.0%,
5. Home computer with access to the Internet,
6. At least one CGMglucose value \< 70 mg/dL during the most recent 15 nights of CGM glucose data.
7. Not pregnant or planning to become pregnant

Exclusion Criteria:

The exclusion criteria for this study is the following:

1. The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
2. The presence of any of the following diseases:

   * Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
   * Cystic fibrosis
   * Angina (recurrent heart pain)
   * Past heart attack or coronary artery (heart vessel) disease
   * Past stroke or impairment of blood flow to the brain
   * Other major illness that in the judgment of the investigator might interfere with the completion of the protocol Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
3. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
4. Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
5. Severe hypoglycemic event, as described as a seizure, loss of consciousness, severe neurological impairment, or neurological impairment suggestive of hypoglycemia and requiring an emergency department visit or hospitalization within 18 months of enrollment.
Omega-3 Fatty Acids, the Omega-3 Index, and Atherosclerosis

An increase in intake of omega-3 fatty acids should increase the Omega-3 Index. Current evidence indicates that this may lead to a reduction in risk for sudden cardiac death and atherosclerotic diseases like myocardial infarction. The aim of the study is to investigate, how supplementing a convenience drink with omega-3 fatty acids influences the Omega-3 Index, as compared to an unsupplemented matching convenience drink. Palatability and safety of the drink are also to be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must meet the current guideline criteria for atherosclerosis, like coronary, peripheral or carotid artery disease, like previous myocardial infarction or acute coronary syndrome, coronary revascularization (operation or transluminally), or positive angiography or ultrasound.
2. Age: 30 - 75 years
3. Low Omega-3 Index (\<5%)
4. Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
5. Stable intake of food containing EPA+DHA before and during study
6. Subjects must be able and willing to give written informed consent, and to comply with study procedures.

Exclusion Criteria:

1. Subjects for whom the intake of omega-3 fatty acids is mandatory according to recent treatment guidelines or who take omega-3 fatty acids supplements on a regular basis.
2. Patients consuming \>2 portions of fatty fish / week
3. Patients with serious bleeding disorder. Use of platelet inhibitors or anticoagulation with a target INR of 2.0 - 3.0 is not an exclusion criterion.
4. Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.
5. Subjects with significant medical co-morbidity, seriously limiting life expectancy or insulin-treated diabetes mellitis or a BMI\>30
6. Allergy/intolerance or history of hypersensitivity to components of study intervention, like lactose.
7. Pregnant subjects - due to any possible teratogenic effects of study nutrition on the fetus - and breastfeeding subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded.
8. Subjects who, in the investigator's judgement, will not likely be able to comply with the study protocol or with known drug- or alcohol abuse/dependence in the past 2 years.
9. Use of any investigational agents within 30 days prior to t0