cyrilzakka/clinical-trials huggingface dataset:
Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera

The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The primary purpose is to determine the impact of clinical and laboratory characteristics of myelofibrosis on the prognosis of patients treated with ruxolitinib, understood as long-term survival.

The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Laboratory tests and histological, cytogenetic, molecular, and radiological investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular. data on systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. The minimum planned duration of individual patient observation is 3 months and the planned duration of the study is 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients diagnosed with Primary Myelofibrosis or secondary to Essential Thrombocythemia/Polycythemia vera who are being treated or have been treated with ruxolitinib therapy in accordance with normal clinical practice.
* Availability of data on clinical history prior to initiation of Ruxolitinib therapy
* Obtaining informed consent for data collection and processing

Exclusion Criteria:

* None
Objective Vision Evaluation of Two Cosmetic Contact Lenses

This is a single visit, single site, brand-masked, non-dispensing, 2×2 bilateral crossover study. Each subject will be bilaterally fitted with one of the two test articles in each of the study periods.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Subjects between 18 and 39 (inclusive) years of age at the time of screening
  4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report.
  5. The subject must be willing to be photographed and/or video-taped.
  6. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -5.00 D (inclusive) in each eye
  7. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye
  8. Have spherical best corrected visual acuity of 20/25 or better in each eye.

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or lactating
  2. Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion).
  3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion).
  4. Any previous or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
  5. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment
  6. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician).
  7. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigators discretion).
  8. Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Long-Chain Fatty Acid Oxidation Disorders Online Disease Monitoring Program

The objectives of this study are to characterize the disease impact, the disease management and resource utilization, and provide benefits to the LC-FAOD community, by use of a convenient online platform for participants (or caregivers) to self-report information.

The online LC-FAOD DMP is a non-interventional, prospective, observational disease-monitoring program conducted through a mobile/web-based application developed by the Sponsor. Participant data will be captured via the mobile/web-based application and entered into the database designed and maintained by the Sponsor and/or its designee. Additional objectives of the study are to benefit the LC-FAOD community by developing a comprehensive database for use by the LC-FAOD community to characterize patient experience, inform disease management, and enable further research, utilize the digital platform to notify patients, caregivers, and relevant patient advocacy groups of research studies and clinical trials and share aggregated and de-identified outputs to facilitate the exchange of information with patients and/or caregivers.

Participants can be on any treatment in order to participate. Medical management of the disease should continue as directed by the patient's physician(s). Specifically, no treatments, investigational agents, or experimental interventions will be provided as part of this online LC-FAOD DMP.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of LC-FAOD including: carnitine palmitoyltransferase (CPT I or CPT II) deficiency, very long chain acyl-CoA dehydrogenase (VLCAD) deficiency, long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD) deficiency, trifunctional protein (TFP) deficiency, or carnitine-acylcarnitine translocase (CACT) deficiency.
* Willing and able to provide consent or, if a minor, provide assent and informed consent by their legally authorized representative.
* Access to the internet and an internet-enabled device.
* Reside in the geographical regions where the platform is supported and approved by applicable IRB/IEC and /or health authority.
* Not receiving triheptanoin through an Ultragenyx-sponsored interventional clinical trial or Ultragenyx Investigator Sponsored Trial (IST). NOTE: Individuals are eligible to participate in this online DMP if they previously participated in UX007 clinical trials, are currently participating in the in clinic UX007-CL401 (NCT04632953), are receiving triheptanoin through Expanded Access or Compassionate Use programs, or are receiving commercially available triheptanoin via prescription.
Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer

RATIONALE: Pirfenidone may prevent or lessen fibrosis caused by radiation therapy.

PURPOSE: Pilot trial to study the effectiveness of pirfenidone in preventing or lessening fibrosis in patients who have undergone radiation therapy for cancer.

OBJECTIVES:

* Determine the safety and therapeutic efficacy of pirfenidone in cancer patients with radiation-induced fibrosis.

OUTLINE: Patients receive oral pirfenidone 3 times daily. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Principal functional abilities are assessed at baseline, every 3 months, and at termination of therapy.

PROJECTED ACCRUAL: A total of 10-25 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Regional post-radiation fibrosis of a specific body area (e.g., neck, back, or extremities)

  * At least moderate impairment in at least 1 of the following principal functional abilities:

    * Range of motion
    * Strength
    * Edema
    * Swallowing
* Prior radiation for cancer received more than 6 months ago
* No evidence of recurrent or metastatic cancer
* No history of collagen vascular disease
* No positive antinuclear antibody

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Hepatitis B and C negative

Renal:

* Not specified

Other:

* HIV negative
* No evidence of second primary cancer
* No life-threatening situation requiring rehabilitation intervention
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent anticancer immunotherapy

Chemotherapy:

* No concurrent anticancer chemotherapy

Endocrine therapy:

* No concurrent anticancer hormonal therapy

Radiotherapy:

* See Disease Characteristics
* No concurrent anticancer radiotherapy

Surgery:

* Not specified

Other:

* No other concurrent anticancer investigational agents
* Stable doses of medicine (e.g., non-steroidal anti-inflammatory drugs) currently being taken are allowed
Screening for Youth Alcohol and Drug Use: A Study of Primary Care Providers

This study evaluates the implementation and effectiveness of two modalities of Screening, Brief Intervention and Referral to Treatment (SBIRT) to reduce adolescent alcohol and other drug (AOD) use in a large pediatrics clinic.

Health systems have not implemented Screening, Brief Intervention and Referral to Treatment (SBIRT) for adolescents despite research demonstrating its effectiveness. Based on prior research that identified barriers to AOD screening for adolescents in pediatric Primary Care (PC) and a pilot study that found SBIRT was feasible, well-received and promoted referrals to and initiation of specialty treatment, the current research application proposes to randomize 45 Primary Care Physicians (PCPs) in the pediatrics clinic of a medical center within a large, managed care health system, Kaiser Permanente Northern California, to three arms - 1) Usual Care; 2) SBIRT delivered by PCPs; and 3) SBIRT delivered by Behavioral Medicine Specialists (BMS). The study objective is to compare the implementation, effectiveness and cost-effectiveness of SBIRT for adolescents in PC in the three study arms. Patients will complete evidence-based screening and AOD assessment measures which have been embedded in the health plan's electronic medical record (EMR). A mixed model will be used to compare implementation outcomes (rates of screening and identification, brief intervention, referral to Chemical Dependency treatment and treatment initiation), and effectiveness (patient outcomes of AOD use and abstinence) at 12 months. The model accounts for the intra-class correlations across patients within providers. Cost-effectiveness relative to implementation and patient outcomes will be examined. Barriers and facilitators of implementation, and feasibility via qualitative interviews with clinicians and administrators will be examined as well. The study is significant in that it examines issues that must be addressed to spur widespread adaptation of SBIRT. The proposed interventions are highly feasible in the current environment of health reform due to increased resources and training to Federally Qualified Health Centers and private health plans. It is innovative in using the EMR to change clinical practice and systematically integrate AOD in PC, and as a platform for collecting research data.

Eligibility Criteria:
There are two study populations as described below thus the large age limit range.

Inclusion Criteria:

* All adolescent primary care providers at the pediatric primary care clinic will be included.
* All adolescent patient electronic records, ages 12-18, at the pediatric primary care will be examined.

Exclusion Criteria:

* Any adolescent primary care providers not practicing at the pediatric primary care clinic research site will be excluded.
* Adolescents electronic records who are not part of the research site pediatric clinic will be excluded.
Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder

The purpose of this study is to evaluate the feasibility and short-term efficacy of MBCT as an add-on (i.e. patients must be stable with their regular mood stabilizing medication) for the maintenance therapy of bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* Males or females (\>18 years old)
* Bipolar disorder (as per the Structured Clinical Interview for DSM Disorders (SCID)(22)), euthymic state: Complete remission for at least four weeks ((Montgomery and Asberg Rating Scale (MADRS) ≤ 6 and item-1 (depressed mood) = 0 and no suicidal ideations (MADRS(item-10) \< 4)
* Must have had at least 3 depressive phases in the last 5 years
* Cooperative and willing to complete all the aspects of the study and especially the 45 minutes of exercise per day
* Must have completed a Secondary V (11th grade) education

Exclusion Criteria:

* Other active psychiatric disorders (as per the SCID)
* Rapid cycling
* Bipolar disorder secondary to a medical condition or substance-induced mood disorder
* Suicidal ideations (MADRS(item 10)\>3)
* Active i.e. unstable and/or untreated medical condition
* Substance abuse (defined as per DSM-IV) in the last four weeks
* CBT (No more than four sessions (ever))
* Previous participation in a psychoeducation group within the last 6 months
* Current other psychotherapy (more than once a month)
* Practice of meditation (more than once a month) during the last two years
* Practice of yoga (more than once a week) during the last year
* Previous participation in a MBSR group
* Electroconvulsive Therapy (ECT) within the last three months
Essential Oil Aromatherapy Intervention

Lab sampling for clinical trial participants can be a stressful and painful experience. Most trial participants will have blood drawn for lab samples at multiple study visits. The participants must fast for up to ten hours before the blood sampling, in many cases, and patients often report a painful experience if more than one venipuncture occurs. In addition, the number of collection tubes can increase the anxiety level of the patient and the phlebotomist.

This project proposes to evaluate if essential oil aromatherapy results in less pain and /or anxiety when compared to usual care.

The process of drawing blood for can be painful and stressful for any patient. Those patients who participate in a clinical trial agree to frequent lab sampling to monitor for effect and safety of the investigational product. The frequency is variable, from several times a day for a participant in the hospital to annually for some trials. Participants have reported anxiety regarding the number of tubes to be drawn, even resulting in near syncope, and pain with the venipuncture process.

The clinical trial nurses at HealthEast have utilized a variety of therapeutic techniques to ease the pain and anxiety experienced by the trial subjects, such as redirection, deep breathing, hand massage and guided imagery. These techniques have not been evaluated for effectiveness in easing pain and anxiety nor have they been compared with no intervention to determine if any intervention was more efficacious in alleviating pain and/or anxiety.

The primary objective of this study is determine if aromatherapy with an essential oil has a higher reported effect in anxiety and pain relief with venipunctures than standard of care (no therapy) among participants in HealthEast Clinical Trials Office studies.

Secondary objectives include comparing the number of venipunctures and blood collection tubes in the treatment arms.

This is a randomized, open label, prospective single site study designed to determine the effect of essential oil aromatherapy compared to usual care on pain and anxiety associated with venipunctures for clinical trial participants in the HealthEast Heart Care Clinic.

Eligibility Criteria:
Inclusion Criteria:

1. Must be at least 18 years of age
2. Must be currently participating in a clinical trial at HealthEast

Exclusion Criteria:

1. Known allergy to any of the oils used for aromatherapy
2. Less than age 18
3. Declined to participate
Intrathecal Morphine for Unilateral Total Knee Arthroplasty

This study evaluates postoperative numerical pain score and systemic opioid requirement within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of intrathecal morphine; 0,50, 100 ug with multimodal analgesia.

Intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity surgery. However there are some limitations such as nausea, vomiting, pruritus, dizziness. Nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral analgesic drugs, adductor canal block and local analgesia infiltration.

This study evaluates whether intrathecal opioid should be added in the role of multimodal analgesia in total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Aged more than 18 years old undergoing unilateral total knee arthroplasty
* American Society of Anesthesiologists physical status classification 1-3

Exclusion Criteria:

* Participants deny to enroll the study
* Allergy to local anesthetics, opioid and NSAIDs
* Hepatic disease
* Contraindication for neuraxial block or adductor canal block
* Uncontrolled cardiovascular disease
* Creatinine clearance less than 50 ml/min
Exploring the Characteristics of Epileptogenic Foci in Drug-Resistant Epilepsy Based on Multimodal Imaging Technology

Using multimodal imaging technology, this study aims to explore the characteristics of epileptogenic foci in patients with drug-resistant epilepsy and identify key network nodes (such as central nodes) to provide more assistance for the diagnosis of drug-resistant epilepsy.

This study is a prospective observational cohort study. It prospectively recruited 50 patients with drug-resistant epilepsy from the Epilepsy Center of the Department of Neurology at Xijing Hospital, all aged 18 years or older. It collected general information and clinical baseline data such as magnetic resonance imaging; gathered multimodal imaging data once; analyzed the characteristics of epileptogenic foci in patients with drug-resistant epilepsy; and performed statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 years old;
2. Meet the 2010 International League Against Epilepsy (ILAE) diagnostic criteria for drug-resistant epilepsy;
3. Duration of epilepsy ≥2 years, with an average seizure frequency of ≥2 times per month in the 3 months prior to enrollment;
4. Adequate intake of two or more anti-epileptic drugs, with no intervention in the treatment plan during the trial period;
5. Capable of cooperating to complete treatment and related examination items; The patient and family fully understand and voluntarily sign the informed consent form.

Exclusion Criteria:

1. In a state of continuous epileptic seizures;
2. Complicated with severe infections, cerebrovascular diseases, malignant tumors, and other diseases, accompanied by severe dysfunction of the heart, liver, kidney, or other organs, or with mental disorders, or with uncorrectable hyperglycemia, or 3.patients on long-term use of corticosteroid medications;

4.Pregnant or lactating women; 5.Contraindications for PET, MR, EEG examinations; 6.Patients with examinations (with ferromagnetic metal implants in the body; high fever); 7.Participating in other clinical trials at the same time; 8.The patient or family withdraws the informed consent form.
Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients

Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration.

The investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 1 diabetes mellitus included in the phase II therapeutic trial with a humanized non-mitogenic CD3 monoclonal antibody (ChAgly CD3) at time of clinical diagnosis and who agree and are likely to comply with the investigator's instructions

Exclusion Criteria:

* Any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient
* Use of illicit drugs or over consumption of alcohol (\> 3 beers/day)
* Being legally incapacitated, having significant emotional problems at the time of the study
Effects of Red Light LED Therapy on Body Contouring

The purpose of this study is to determine whether red light therapy using LED 650nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.

Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.

Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after a single 28 minute treatment. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.

The Vevazz therapy program uses the Vevazz LED device for fat removal using LED red light therapy. This multi-site study reviews results from 66 randomly selected patients after a single treatment using the Vevazz LED device.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years or older.
* May be male or female.
* Generally good health.

Exclusion Criteria:

* Minors.
* Open wounds or sores.
* Pacemaker.
* Photosensitivity.
* Epilepsy.
* Any form of cancer.
* Severe kidney or liver problems.
* Thyroid problems.
* Pregnant or nursing.