cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve

Study an ultrasound guided approach to radiofrequency ablation of the occipital nerve that makes it possible to see the needle during treatment procedure. It is hoped this will reduce the amount of pain after the standard of care procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-80 with a diagnosis of occipital neuralgia or migraine overlying the occipital region.
* A diagnosis of occipital neuralgia will be based on the International Classification of Headache Disorders (ICHD), whose criteria include: paroxysmal stabbing pain in the distribution of the GON, tenderness over the affected nerve, and relief of pain for at least 3 hours after bupivacaine local anesthetic block of the affected nerve.
* Patients may also be included if they have a diagnosis of migraine based on the ICHD criteria with predominance of pain over the occipital region that responded to occipital nerve block.
* Patients must have failed oral medications including NSAIDs, opioids, and anticonvulsants for the management of their pain.
* Failed treatment will be \<50% pain reduction with oral medication.
* Patients must report headache frequency of at least 10 days per month.

Exclusion Criteria:

* Patients will be excluded from the trial if they have an unstable medical or psychological condition,
* are pregnant,
* have an implanted cardiac pacemaker or defibrillator that could not be disabled,
* have had a craniotomy or scar tissue overlying the site from a previous surgery,
* have a history of cervical spine fusion,
* have evidence of elevated ICP or intracranial tumor,
* or have previous RFA treatment of the greater or lesser occipital nerve.
A Pilot Study of Changing Medication Adherence In Hypertensive African-American Patients

We will conduct an empirical test of the two intervention approaches under study. Specifically, we seek to determine the potential differential impact of positive affect induction and self affirmation.

We are interested in achieving an empirical test of the two intervention approaches under study. Specifically, we seek to determine the potential differential impact of positive affect induction and self affirmation following the qualitative phase.

1. Positive affect induction: We will tests two types of positive affect induction. 1) sending patients a small gift, and 2) reminding patients of positive thoughts about themselves.

   Gift: Prior to a telephone call, patients in the positive affect condition will receive a small gift.

   Positive thoughts about themselves: Patients will be asked to describe a time when someone was helpful to them, and they felt good about it , and were nice to them in return.
2. Self affirmation: consists of a series of items reminding people of their core values.
3. Control: Control patients will have neither self affirmation nor gifts.

Follow-up: At two weeks after enrollment all patients will be called to ascertain impact of the pilot intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be self-identified as African-Americans.
2. All patients must be aged 18 years and older.
3. All patients must be diagnosed as having hypertension: For this project, hypertension will be defined according to the widely accepted criteria of the 6th Joint National Committee (JNC VI) Guidelines on Prevention, Detection, Evaluation and Treatment of Hypertension, which is a systolic blood pressure \> 140 mm hg or a diastolic blood pressure \> 90 mm hg or if participants are taking any prescribed antihypertensive medication.
4. Patients must be able to provide informed consent in English.

Exclusion Criteria:

1. Patients who are unable to walk several blocks for any reason.
2. Patients who refused to participate
3. Patients who are unable to provide informed consent.
Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus

A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of keratoconus

Exclusion Criteria:

* Minimal corneal thickness \< 350 microns
* Non-keratoconic ectatic disease
* Contraindications or hypersensitivities to any required study medications
* Pregnancy or breastfeeding
* Certain concomitant ocular conditions
Improving Hand Recovery With Neuromodulation in Tetraplegia

This study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury, tetraplegia). Participants will be assigned to receive either active or inactive non-invasive brain stimulation.

This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of two groups by chance. One group will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their more impaired arm and hand, focusing on exercises that are meaningful to him/her.

Eligibility Criteria:
Inclusion Criteria:

1. traumatic, incomplete cervical SCI sustained at neurological level C4-C7 and classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS);
2. sustained injury at least 1 year prior to enrollment (i.e., chronic); and
3. Men and women between the ages of 18-65.

Exclusion Criteria:

1. history of head injury, seizures, severe alcohol or drug abuse, or psychiatric illness;
2. cognitive deficits severe enough to preclude informed consent;
3. positive pregnancy test or being of childbearing age and not using appropriate contraception;
4. presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain;
5. decubitus ulcers that might interfere with intervention;
6. cardiac or neural pacemakers;
7. fixed UE contractures;
8. untreated depression;
9. concurrent participation in occupational therapy;
10. within 3 months of recruitment, an addition or change in the dosage of drugs known to exert detrimental effects on motor recovery.
CyPass Clinical Experience Study

This study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent in patients with glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OAG
* IOP ≥ 21 mmHg and ≤ 31 mmHg (with or without ocular hypotensive medication)

Exclusion Criteria:

* Acute angle closure, narrow angle, uveitic or neovascular glaucoma
* Normal tension glaucoma
Examination of the Effects of Liraglutide on the Mode of Action of Insulin Detemir

This trial is conducted in the United States. The aim of this clinical trial is to investigate whether chronic liraglutide administration affects the mode of action (pharmacokinetics) of insulin detemir


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* BMI less than 45.0 kg/m2
* Insulin naive
* Currently treated with Oral Anti-Diabetic drugs (OADs) and metformin with a HbA1c between 7.0 and 9.5% or currently treated with metformin only with a HbA1c between 7.0 and 10.0%

Exclusion Criteria:

* Any clinically significant disease other than type 2 diabetes
* Currently using daily insulin
* Thiazolidinione use or other injectable diabetes medications within the last 3 months
Fentanyl Matrix in Lung Cancer Pain

The purpose of this study is to evaluate the usefulness of fentanyl matrix by assessing patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and a breakthrough pain treatment to lung cancer patients who complain of pain. Fentanyl matrix is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours).

This study is open-label, single-arm, multicenter, prospective study to evaluate the usefulness of fentanyl matrix (fentanyl transdermal patch-type system) by assessing patient satisfaction when administrating fentanyl matrix (a background pain treatment, and a breakthrough pain treatment) for patients with lung cancer for 21 days. Fentanyl transdermal patch-type system is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours). Studies about transdermal fentanyl have found that it had analgesic effects on malignant pain, and most patients receiving the medication preferred fentanyl because they experienced less constipation. Safety assessments will include adverse event monitoring, vital signs, laboratory work. starting with 12.5g/h or 25g/h of fentanyl matrix transdermally at the investigator's discretion and flexible dose depending the patient's pain relief for 3 weeks

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed lung cancer, who complain of cancer pain
* Patients who are taking Ultracet, Tramadol, or Codeine (or Codeine combination drug) for cancer pain-relief purposes, but still complain of a pain level of 4 or above on the Numeric Rating Scale (NRS) during the past 24 hours: Ultracet 3 tablets/day, Tramadol 150 mg/day, Codeine 200 mg /day, or Codeine combination less than 3 capsules/day
* Patients who are able to communicate with the investigator about his/her pain
* Patients who use proper contraceptives during the study period if they are women of childbearing potential
* Patients whose life expectancy is 3 months or longer
* Patients who have signed an informed consent form

Exclusion Criteria:

* Patients participating in other clinical trials
* Patients with a history of hypersensitivity to opioid analgesics
* Patients with a history of drug abuse
* Patients who are unable to use a transdermal product due to skin disease
* Patient with a history of CO2 retention (e.g. chronic obstructive pulmonary disease)
* Patients who are receiving radiotherapy or chemotherapy when registering for the study or who plan to receive it during the study
* Patient who are pregnant or are of childbearing potential and not using contraceptives
A Study of Eloralintide (LY3841136) in Chinese Participants With Obesity or Overweight

The purpose of this study is to evaluate how well Eloralintide (LY3841136) is tolerated and what side effects may occur in overweight and obese Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much Eloralintide gets into the bloodstream and how long it takes the body to eliminate it.

The study will last approximately 10 weeks excluding a screening period.


Eligibility Criteria:
Inclusion Criteria:

* Chinese participants. To qualify as Chinese, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
* Have had a stable body weight for 3 months prior to screening. Participants with body weight change of less than 5% will be allowed
* Have not modified diet or adopted any nutritional lifestyle modification for 3 months before randomization
* Have clinical laboratory test results within a normal range for the population or investigative site at screening and lead-in, or results with acceptable deviations that are judged to be not clinically significant by the investigator
* Have a body mass index (BMI) within the range 27 to 40 kilogram per square meter (kg/m²)

Exclusion Criteria:

* Are pregnant, or intend to become pregnant or to breastfeed during the study
* Have known allergies to related compounds of eloralintide
* Have any of the following abnormal blood pressure (BP) and/or pulse rate at screening, constituting a risk when taking the investigational product with minor deviations judged to be acceptable by the investigator:

  * Supine BP \> 160/90 millimeter mercury (mmHg)
  * Supine pulse rate \< 50 or \> 100 beats per minute (bpm)
  * Orthostatic hypotension
* Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs
* Regularly use known drugs of abuse and/or show positive findings on drug screening that are not consistent with the medical history or concomitant medication history
* Have donated blood of more than 450 mL within the previous 3 months of study screening, or intend to donate blood during the course of the study
* Have a history of chronic medical conditions involving the heart, liver, or kidneys
* Have a medical history or current evidence of clinically significant cardiac condition
A Telemedicine Mindfulness-based Intervention for People With Multiple Sclerosis and Their Caregivers

The aim of the project is to investigate the impact of a multiple sclerosis specific telemedicine mindfulness-based Intervention on the quality of life of people with multiple sclerosis and their caregivers.

The mindfulness protocol will be modified according to multiple sclerosis clinical peculiarities and implemented with a multimedia web-based software.

The project will be divided in two parts. During the first phase of the project, a standard mindfulness-based stress reduction protocol will be modified according to clinical peculiarities and specific needs of people with multiple sclerosis. In the meanwhile, a multimedia software with these teaching will be developed, so that the training could be available online, from home. The protocol and the software will be tested for ergonomics in a pilot, qualitative, study.

In the second phase, a randomized clinical trial will be performed. One-hundred and twenty multiple sclerosis patients-caregivers couples will be randomly allocated in the experimental or to the control group. Subjects in the experimental group will attend the telemedicine mindfulness intervention, while controls will join a psycho-educational telemedicine program. At baseline, post-treatment and at a 6-month follow-up, participants will be assessed for quality of life, anxiety, depression, quality of sleep and mindfulness level. A subgroup of subjects will be assessed with actigraphs, for an objective evaluation of their sleep and physical activity. Experimental subjects will be assessed for participation and engagement to the treatment. Data will be analyzed with a complex longitudinal design, considering both within and between groups comparisons.

The dissemination process will involve scientific publication on neurological and psychological journals, a book, scientific meeting presentations and communication to general media. If there will be a positive effect of the mindfulness software, it will be diffused to multiple sclerosis clinics and associations.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing-remitting or secondary progressive multiple sclerosis.
* Ability to communicate and to understand tasks.
* No change of disease-modifying treatment in the 3 months before the enrolment.
* No clinical relapses or use of steroid treatment during the 4 weeks before the enrolment.
* Availability of a personal computer, smartphone or tablet (compatible with the software).
* Provided informed consent for study participation.

Exclusion Criteria:

* Being a person who lives with the multiple sclerosis patient and provides him/her with most care and assistance
* Ability to communicate and to understand tasks
* Availability of a personal computer, smartphone or tablet (compatible with the software).
* Provided informed consent for study participation
A Range of Contact Lenses and Care System Combinations

The objective of this study is to compare the short-term clinical response to all combinations of two lens types: fanfilcon A and comfilcon A with two care systems: Hy-Care and Lite. The primary variables of interest are short-term biomicroscopy signs. Other variables of interest include subjective response and visual performance.

Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution.

Eligibility Criteria:
Inclusion Criteria:

1. They are of legal age (18) and capacity to volunteer.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They agree not to participate in other clinical research for the duration of this study.
5. They can be satisfactorily fitted with the study lens for a period of approximately 2 hours.
6. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with their habitual spectacles.
7. They currently wear daily disposable soft contact lenses or have done so in the previous six months.
8. They are willing to comply with the wear schedule (approximately 2 hours on two different days)
9. They own a wearable pair of spectacles and agree to bring these to study visits.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They currently wear reusable soft contact lenses in both eyes.
4. They are using any topical medication such as eye drops or ointment.
5. They have had cataract surgery.
6. They have had corneal refractive surgery.
7. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
8. They are pregnant or breast-feeding.
9. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
10. They have Type 2 or greater corneal staining prior to lens application at Visit 1 or 2
11. They have corneal staining covering greater than 20% in any corneal region at Visit 1a or 2a
12. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
13. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Individualised Mapping in Persistent AF Ablation

A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.)


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Signed informed consent.
3. Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation.
4. In atrial fibrillation at the time of the index procedure.

Exclusion Criteria:

1. Paroxysmal atrial fibrillation.
2. Previous ablation procedure for atrial fibrillation.
3. Left ventricular ejection fraction \< 45%
4. Obesity with BMI \> 35 kg/m2
5. Congenital heart disease.
6. Previous cardiac surgery with atriotomy.
7. Previous left atrial appendage closure/ligation.
8. Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia.
9. Pregnancy
10. Current enrolment in a study evaluating another device or drug.
Healthy Kids-Houston: A Community Childhood Obesity Intervention Program

The collaborative study is to determine the effectiveness of an after-school community-based program to prevent obesity among minority children.

Childhood obesity is a major health issue in the United States, particularly among minority children. An integrated after-school program that offers structured and fun physical activities with nutrition and behavior lessons in community centers operated by the Houston Parks and Recreation Department might prevent obesity among minority children who live in the neighborhood.

Eligibility Criteria:
Inclusion Criteria:

* Live in close proximity of the community centers

Exclusion Criteria:

* Medical or physical conditions that prevent the child from participating in the physical activities
Effects of Yoga on Phase Angle and Quality of Life in Patients With Breast Cancer

In this study,we aimed to examine the effects of Hatha yoga on PA and QoL in patients with breast cancer.

Patients will be randomized to receive the yoga group and the control group.Hatha yoga will be practiced twice a week for 10 weeks for intervention group.The PA of the patients will be assessed using a body analysis instrument and QoL was evaluated with an EORTC-Q questionnaire both before treatment and at week 10.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 70, witha diagnosis of breast cancer

Exclusion Criteria:

* Patients with recurrent or progressive disease, or with serious heart or pulmonary disease, with uncontrolled hypertension, infection, cognitive function disorder, psychiatric disease or musculoskeletal system conditions that would prevent exercise, and those who had taken part in a regular exercise program
Regulatory Hycamtin(Oral) PMS

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information

Topotecan will be administered as described the prescribing information or by physician's decision.

Eligibility Criteria:
All subjects must satisfy the following criteria.

* Subject who is under the indication to the prescribing information of oral Hycamtin.
* Subject who is treated with oral Hycamtin according to the judgement of her or his investigator.

All subjects must not satisfy the following criteria.

• Subject who is under the contraindication to the prescribing information of oral Hycamtin.

As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe oral Hycamtin according to prescribing information which approved in Korea.