cyrilzakka/clinical-trials huggingface dataset:
COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial

This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).

Patients with spleen growth of greater than 25% based on an increase in spleen volume from Baseline were eligible for early unblinding, and for patients on placebo, cross over to ruxolitinib prior to the primary study endpoint being reached. If this spleen growth occurred before Week 24, it must have been accompanied by specific worsening of symptoms, based on worsening early satiety accompanied by weight loss or worsening pain requiring daily narcotic use. After Week 24, asymptomatic spleen growth alone was sufficient for early unblinding and potential cross over. Patients found to have been randomized to ruxolitinib after early unblinding prior to Week 24 were discontinued.

When half of the patients remaining in the study completed the Week 36 visit and all patients enrolled completed Week 24 or discontinued, the database was frozen and the primary analysis was conducted. Once this was complete, all patients were unblinded and patients who had been randomized to placebo were given the opportunity to cross over to ruxolitinib treatment, provided hematology laboratory parameters were adequate; Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF) according to the 2008 World Health Organization criteria
* Subjects with myelofibrosis requiring therapy must be classified as high risk OR intermediate risk level 2 according to the prognostic factors defined by the International Working Group
* Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
* Subjects who have not previously received treatment with a Janus kinase (JAK) inhibitor

Exclusion Criteria:

* Subjects with a life expectancy of less than 6 months
* Subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts
* Subjects with inadequate liver or renal function
* Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy
* Subjects with an active malignancy over the previous 5 years except specific skin cancers.
* Subjects with severe cardiac conditions
* Subjects who have had splenic irradiation within 12 months
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex

Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not interventional, multicentric)

This clinical study is one of the Post-Market Clinical Follow-Up (PMCF) measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Complex system.

The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in deformity disorders.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent in the documentation of clinical and radiological results of patients who are minimum 18 years old
* Informed consent in the documentation of clinical and radiological results of patients AND legal representative (parent) for patients who are younger than 18
* Patient's indication according to IFU
* Patient is not pregnant

Exclusion Criteria:

* Patient's clear unability or unwillingness to participate in follow-up examinations
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)

Anticancer drugs can lead to various adverse events. This study analyses reports of adverse events for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse events following treatment with antineoplastic agents, endocrine therapy, immunostimulants or immunosuppressants drugs.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports at the time of the extraction
* Adverse events reported were including in the MedDRA terms. The research could include the report with SOC, HGLT, HLT, or PT MedDRA terms
* Patients treated with Antineoplastic and immunomodulating agents included in the ATC L.

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
Standardized 1µg Adrenocorticotropic Hormone Stimulation Test, and Salivary Cortisol Concentration During the Test

Study objectives: First, to determine whether intravenous injection of 1 mcg adrenocorticotropic hormone (ACTH) through short cannula, in healthy participants, provides reliable results of cortisol response, and whether this method would replace the conventional technique of injecting ACTH by a needle directly into a peripheral vein. Secondly, to determine salivary free cortisol concentration during the test in healthy controls.

Rationale of study: Intravenous injection of synthetic ACTH1-24 concentration through venous short cannula appears to be feasible and simple method. On the other hand, injection of ACTH1-24 by a needle directly into peripheral vein, is not infrequently complicated by technical problems in subjects with challenging veins. The investigators suppose that, both methods would have the same yield in predicting cortisol response.

Salivary free cortisol test has an evolving importance in assessing the adrenal function. This test would be reliable for use in low dose ACTH stimulation (1 mcg) test. The investigators will examine the concentration of salivary free cortisol during ACTH stimulation test, in order to determine level range in normal controls.

The study will include 20 healthy participants of both sexes, aged 18-70 years, that have no clinical suspicion of hypoadrenalism, or any active medical condition or treatment that might alter blood cortisol levels. Pregnant women and patients whose medical or mental condition precludes obtaining informed consent will be excluded.

In the morning of the first visit, 1 mcg of ACTH1-24 will be injected directly into a peripheral vein. Blood and salivary samples will be drawn before injection, and 30 minutes after. Salivary cortisol will be drawn also 60 minutes after injection. At least two days later, in the morning of the second visit, 1 mcg of ACTH1-24 will be injected through short cannula in a peripheral vein, followed by injection of 5 ml of normal saline. Blood and salivary samples will be drawn before injection, and 30 minutes after. Salivary cortisol will be drawn also 60 minutes after injection. Blood cortisol results and salivary free cortisol results will be compared between tests.

Eligibility Criteria:
Inclusion Criteria:

* healthy participants of both sexes
* aged 18-70 year

Exclusion Criteria:

* any clinical suspicion of hypoadrenalism, or any active medical condition or treatment that might alter blood cortisol levels
* pregnant women and patients whose medical or mental condition precludes obtaining informed consent
Patient Education in Rheumatoid Arthritis and Osteoarthritis

This project will evaluate the effectiveness and general usefulness of two arthritis patient education programs. The first, the Arthritis Self-Management Program, is a 6-week, community-based program taught in small groups by peer leaders. The second, the Self-Managed Arthritis Relief Therapy (SMART) Program, is a computer-driven program delivered through the mail. Participants in this project are people with rheumatoid arthritis or osteoarthritis who are taking part in the larger long-term studies being conducted by ARAMIS (the Arthritis, Rheumatism and Aging Medical Information System).

In a changing health care environment, the role of patients in managing their arthritis is increasingly important. Patient education is the primary means for teaching patients how to fulfill this role successfully. The goal of self-management health education is not merely to provide information but also to change patient attitudes and behavior so that patient outcomes are improved. These programs represent a new treatment for arthritis.

This project will evaluate the relative effect on health status and cost-effectiveness of two arthritis patient education programs that use different delivery systems. The Arthritis Self-Management Program (ASMP) uses a small group, multi-class format. It is taught by trained lay leaders and has been evaluated for effectiveness and widely disseminated. The Self-Managed Arthritis Relief Therapy (SMART) Program is a computer-driven, individualized, mail-delivered intervention. Results of a pilot study suggest that it is effective in improving health status and reducing health care use.

The project will also evaluate how generalizable the SMART program is and its effectiveness for patients with different diagnoses (OA and RA). It will also determine the attributes of patients who choose and do not choose to participate in patient education programs as well as the attributes of those who complete and do not complete the ASMP and SMART programs.

Through use of the ARAMIS data collection system, the project allows us to describe the differences between people who volunteer to receive patient education and those who refuse patient education. This project is directed at improving patient outcomes in both RA and OA through wide availability of a low-cost, mail-delivered arthritis self-management program that is the next generation in arthritis health education.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of OA or RA
* Participation in the ARAMIS longitudinal study

Exclusion Criteria:

* Age under 18
Estrogen Alternatives Study

Healthy postmenopausal women not currently taking hormone replacement or hormone modulating therapy take a 3-month course of estradiol/raloxifene/placebo to evaluate the effects of each on vascular function, as indicated by PET coronary flow reserve studies and brachial artery ultrasound, before and after use of the therapies. This is a randomized, placebo-controlled, blinded study.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (no menses for greater than or equal to 12 months, or s/p \[status post\] hysterectomy with bilateral ovariectomy) not currently taking hormone replacement therapy (within previous 3 months)
* Normal mammogram within previous 12 months

Exclusion Criteria:

* Current or recent (within previous 3 months) hormone replacement therapy
* Current or recent (within previous 3 months) use of hormone alternatives such as raloxifene, tamoxifen, or soy estrogen preparations.
* LDL Cholesterol \> 160 mg/dl.
* History of hypertension, diabetes mellitus, peripheral vascular disease, cerebrovascular disease, current smoking, history of DVT (deep vein thrombosis) or PE (pulmonary embolism), active gallbladder disease, family history of premature (men under 55 yrs, women under 65 yrs) coronary artery disease
* History of breast, uterine, or ovarian cancer Contraindication to adenosine administration (i.e., significant bronchospastic pulmonary disease, higher degree heart block)
* Inability to give informed consent
* Inability to temporarily (for 24 hours) discontinue potential vasoactive drugs, such as anti-inflammatory agents and aspirin, at least 24 hours prior to the examinations.
* History of coronary heart disease
Validation of a Portable Medical Device for Diagnostic in Vitro

This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).

This device was created as an alternative to blood sample, that have to be done in a medical laboratory.

The main goal is to evaluate the accuracy of the International Normalized Ratio (INR) measurement of this new portable device for diagnostic in vitro, among healthy patients and patients under anti-vitamin K treatment.


Eligibility Criteria:
Inclusion Criteria of healthy volunteers:

* Man or woman between 18 and 70 years
* Body Mass Index \>18 and \<29
* Absence of any acute pathology in the month preceding the study
* To be affiliated or beneficiary of social security

Exclusion Criteria of healthy volunteers:

* Pregnant, partutient or breastfeeding woman
* Patient with Raynaud's syndrome
* Person deprived of liberty by legal or administrative decision, person to a legal protection order
* Deferral periods for other clinical studies
* Annual threshold compensation attain for biomedical search participations

Inclusion Criteria of patients:

* Man or woman between 18 and 80 years
* Patient treated by oral anti vitamin K anticoagulants (coumadine, warfarine, fluidione)
* Absence of any acute pathology in the month preceding the study
* To be affiliated or beneficiary of social security

Exclusion Criteria of healthy patients:

* Pregnant, partutient or breastfeeding woman
* Patient with Raynaud's syndrome
* Person deprived of liberty by legal or administrative decision, person to a legal protection order
* Deferral periods for other clinical studies
* Annual threshold compensation attain for biomedical search participations
Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors

Zactima will be used in this study to determine the highest dose that can be given safely as well as the side effects of Zactima when in combination with two FDA approved drugs; gemcitabine and capecitabine. This combination will be given to patients with advanced solid tumors. Once the highest dose of the combination has been determined, additional patients with biliary cancers (cholangiocarcinomas and gallbladder cancer) and locally advanced or metastatic pancreatic cancer will be treated at the highest determined dose for further studies.

This phase I study will access a novel regimen using a multi-targeted anti-angiogenic agent which targets the tyrosine kinase of vascular endothelial growth factor (VEGF) receptor 2 and epidermal growth factor receptor (EGFR) in combination with cytotoxic agents: gemcitabine and capecitabine. The rationale is based on observations that there is an additive / synergistic effect when cytotoxic agents are combined with angiogenesis inhibitors. There is also evidence that EGFR mediated signaling pathways are potent stimulators of VEGF production. Also the concept of dual targeting of tumor and endothelial cells may provide more encouraging results.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (measure of your ability to perform everyday tasks)
* Life expectancy of at least three months

Blood samples and other testing may apply for further testing of eligibility.

Exclusion Criteria:

* Uncontrolled illness (for example, current infections or heart conditions)
* Abnormal laboratory tests (such as blood or urine testing)
* Pregnant or breastfeeding women

Further exclusion criteria may apply.
Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713

This study evaluated the feasibility of an 8-week physical therapy program for persons with chronic low back pain provided entirely using telehealth with real-time, interactive video sessions with a physical therapist.

At the time of the onset of the COVID pandemic, the research team was conducting a clinical trial (the OPTIMIZE trial) investigating different nonpharmacologic treatments for persons with chronic low back pain (NCT03859713). One intervention arm in this trial is in-person physical therapy. COVID-related restrictions on in-person care prompted suspension of the OPTIMIZE trial. In order to accommodate persons in the midst of receiving treatment at the time of suspension, the study team adapted the in-person protocol for physical therapy for telehealth delivery using two-way, real-time video sessions. Because of the lack of research examining the feasibility of telehealth physical therapy provided in this manner, the study team decided to conduct a pilot study to examine the feasibility of the telehealth protocol.

This study was a prospective, longitudinal cohort of persons with chronic LBP seeking care in one of three healthcare systems; University of Utah Health and Intermountain Healthcare in Salt Lake City, Utah, and Johns Hopkins Medicine in Baltimore, Maryland. All participants were offered up to 8 weekly sessions of telehealth physical therapy. Outcomes included measures of acceptability, appropriateness, feasibility and fidelity as well as effectiveness measures including the Oswestry Disability Index and the PROMIS-29 health domains. Assessments occurred at baseline and after 10- and 26-weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 64 years at the time of enrollment.
* Meets NIH Task Force definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem for you? and 2) How often has LBP been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the NIH definition of chronic LBP.
* Healthcare visit for LBP in the past 90 days.
* At least moderate levels of pain and disability requiring ODI score \>24 and pain intensity rating \> 4.

Exclusion Criteria:

* Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
* Evidence of a specific spinal pathology as the cause of LBP including spine fracture, spinal stenosis, radiculopathy, etc.
* Knowingly pregnant
* Unable to participate in telehealth due to lack of technology or internet access
* Has received physical therapy for LBP in prior 90 days
* Currently receiving substance use disorder treatment
* Any lumbar spine surgery in the past year.
Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder

This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder


Eligibility Criteria:
Inclusion Criteria:

1. Completion of the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)

Exclusion Criteria:

1. Patients who, during the core study, developed any psychiatric condition that requires treatment with medication or that may interfere with study participation and /or study assessments.
2. Patients who during the core study developed cardiovascular disorders.
3. Pregnant women.
4. Patients who developed seizures during the core study.
5. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
6. Diagnosis or family history of Tourette's syndrome.
7. Patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke

Other protocol-defined inclusion/exclusion criteria may apply
An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.

The objectives of the study are:To compare the renal function of a quadruple immunosuppressive regimen (including basiliximab in combination with an optimized cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and corticosteroids) versus a standard triple therapy regimen (including cyclosporine standard dose, mycophenolate mofetil and corticosteroids)


Eligibility Criteria:
Inclusion Criteria

* First cadaveric liver transplant
* ABO identical or compatible graft

Exclusion Criteria

* Multiple organ transplant
* renal impairment defined as glomerular filtration rate (GFR) \< 30 ml/min
* Fulminant liver failure

Other protocol-defined exclusion criteria may apply.
Correlation Between Interdialytic Weight Gain and Cardiovascular Diseases in Children With End-Stage Kidney Disease Undergoing Hemodialysis

This study aimed to discuss the correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing chronic hemodialysis. The cardiovascular parameters used include left ventricular hypertrophy, systolic and diastolic function, carotid intima-media thickness, myocardial circumferential strain, and strain rate.


Eligibility Criteria:
Inclusion Criteria:

* End-stage kidney disease (chronic kidney disease stage 5)
* Undergo hemodialysis at least twice a week

Exclusion Criteria:

* History of congenital heart disease
* Critically ill patients with unstable hemodynamic status
Home Exercise Adherence in Physical Therapy

The purpose of this study is to determine the effectiveness of an individualized video recording in improving adherence in home exercise programs for orthopaedic physical therapy patients.

Specific aims:

1. Evaluate whether individualized video recordings improve adherence with home exercise programs (HEP) as compared with conventional printed instructions measured by a self-report exercise log. (1-tail analysis)

This investigation will focus on the specific issues surrounding adherence to the use of individualized video recordings via smartphone versus conventional printed instructions in patients with orthopaedic injuries. The data reported will be used to explore the feasibility and potential benefits of smartphone usage for home exercise adherence.

Eligibility Criteria:
Inclusion Criteria:

* Participants who can read and understand the English language,
* adults between 18-65 years of age,
* have a referral to an outpatient physical therapy clinic for an orthopaedic condition, and
* who own a smartphone with video recording capabilities and available data storage space (at least 500 MB or 0.5 GB).

Exclusion Criteria:

* Individuals referred for non-orthopaedic conditions,
* individuals currently on an established, prescribed home exercise program,
* individuals requiring more than 4 home exercises at one time as part of their rehabilitation program, and
* individuals who do not own a smartphone device with the required storage and recording specifications.