cyrilzakka/clinical-trials huggingface dataset:
GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease

The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).


Eligibility Criteria:
Inclusion Criteria:

* Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
* Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen.
* Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
* Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockroft Gault equation.
* Willing to avoid pregnancy or fathering children.
* Able to give written informed consent and comply with all study visits and procedures.
* Able to swallow and retain oral medication.

Exclusion Criteria:

* Has received more than 1 allo-HSCT.
* Has received more than 2 days of systemic corticosteroids for aGVHD.
* Presence of GVHD overlap syndrome.
* Presence of an active uncontrolled infection.
* Known human immunodeficiency virus infection.
* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation.
* Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
* Any corticosteroid therapy for indications other than GVHD at doses \> 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization.
* Severe organ dysfunction unrelated to underlying GVHD, including:

  * Cholestatic disorders or unresolved veno-occlusive disease of the liver.
  * Clinically significant or uncontrolled cardiac disease.
  * Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.
* Currently breast feeding.
* Received JAK inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.
* Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment.
* Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
Primary Cardiac Lymphoma: Italian Multicenter Experience

The rationale of this study is to provide an overview on PCL (Primary Cardiac Lymphoma) in Italy, trying to shed light on unknown aspects of the disease and on unanswered questions about its management that could be helpful in clinical practice.

Primary cardiac lymphoma (PCL), an extranodal lymphoma involving only the heart (with possible involvement of the pericardium) is a rare entity, accounting for 2% of primary cardiac tumors and 0.5% of extranodal lymphomas. It is more frequent in males; clinical presentation is predominated by cardiac symptoms. The most common histology is Diffuse Large B Cell Lymphoma (DLBCL). Being DLBCL the most frequent histology, patients are usually treated with R-CHOP (rituximab - cyclophosphamide, doxorubicin, vincristine and prednisone) or R-CHOP-like chemoimmunotherapy regimens, with an historically poor outcome, although in the last years survival rates significantly increased. Due to the rarity of this condition, isolated case reports and a few reviews have been published so far, that in most cases included a population collected in a wide period of time, heterogeneously managed both in terms of treatments received and follow-up, and who often did not strictly respect the criteria of PCL. Indeed, while some aspects of PCL are well-known, especially the ones concerning its clinical presentation, a few topics deserve more in-depth analysis. The rationale of this study is to provide an overview on PCL in Italy, trying to shed light on unknown aspects of the disease and on unanswered questions about its management that could be helpful in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PCL (any histotype) defined as an extranodal lymphoma involving only the heart with possible involvement of the pericardium.
* Age ≥18 years.
* Diagnosis histologically confirmed. Cytofluorimetry analysis of pericardial fluid showing phenotypic features consistent with a primary cardiac lymphoma is permitted if a biopsy sample is not feasible/available for diagnosis; monoclonality is not accepted as a surrogate for diagnosis.
* Date of diagnosis: from 1st January 2000 to 31st December 2020.
* Only patients treated in first-line with chemoimmunotherapy regimens including an anti-CD20 monoclonal antibody are eligible for the study.
* Signed written informed consent (in case of unreachable subject please see chapter 11.2)

Exclusion Criteria:

* Secondary cardiac involvement from lymphoma; primary mediastinal lymphoma with pericardial infiltration or other lymphomas with involvement of the pericardium/the heart by contiguity and primary effusion lymphoma are not included in this study.
* Patients treated with chemotherapy regimens that did not include an anti-CD20 monoclonal antibody as first-line therapy.
* Refuse to sign a written informed consent
Unloader One Study on Knee Osteoarthritis Hässleholm Sweden

The purpose of this study is to assess the effect of the Unloader one brace on the clinical symptoms of patients with knee osteoarthritis (OA) by comparing a functioning brace with a dummy.

The purpose of this study is to assess the effect of the Unloader one brace on the clinical symptoms of patients with knee OA by comparing a functioning brace with a dummy. The dummy will be manufactured by Össur and has the same look as the real brace, but lacks the fundamental tightening effect of the straps of the real brace (an insert of elastic bands assures this), thereby nullifying its unloading capabilities. In a recent trial by Dr. Ingvarsson, the brace seemed to lessen the pain from knee OA, but no randomised, controlled studies have been conducted. This is mandatory if the effect of the brace and its use as an accepted treatment for knee OA is to be advocated for general use.

Eligibility Criteria:
Inclusion Criteria:

Patients fulfilling all criteria listed below will be considered to eligible for participation in the study:

* Patient, men and women, age 30 to 70 with knee OA not scheduled for surgery who understand the given information and are willing to participate in this study.
* Signed informed patient consent
* BMI \< 35
* Knee pain for more than 3 month
* Patients with Knee OA Ahlbäck grade 1 and 2 and/or Kellgren-Lawrence 1 and 2
* Patient with arthroscopic OA but do not have regular grade 1 OA

Exclusion Criteria:

Patient presenting with any of the following will not be included in the study:

* prior major surgery to the same knee
* patients with a history of stroke or neurological or psychiatric decease that potentially could affect the perception of pain
* obesity (BMI \> 35)
* active or suspected infection
* patients taking opioids or steroids
* patients suffering from rheumatoid arthritis or have a immunological depression
* patients with other severe medical problems that could affect the perioperative course
* the patient had an intraarticular steroid injection in the actual knee during the last 3 months
* Patient participating in a clinical trial
Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment

* There will be a significant difference in cognitive function between cognitive intervention group (group therapy) and a wait list control group.
* There will be a significant difference in cognitive function between a home-based cognitive intervention group and a wait list control group.

The change of Modified ADAS-cog score from the baseline to post-intervention will be compared between the cognitive intervention group and wait list control group.

Eligibility Criteria:
Inclusion Criteria:

* 50 to 85 years of age
* memory complaint corroborated by a participant and an informant
* delayed recall score on the Seoul Verbal Learning Test (SVLT) below 1.0 standard deviations from the mean of the age and education-normative values among the Korean population
* Global CDR score is 0.5, Memory CDR score is 0.5 or 1.
* above 1.5 standard deviations from the mean of normative data of the respective age- and education-matched population on the Korean Mini-Mental State Examination
* normal functional activities
* not diagnosed with dementia
* Modified Hachinski Ischemic Score (HIS): 0-4
* brain magnetic resonance imaging or CT showing no clinical evidence of other diseases (i.e., normal pressure hydrocephalus, brain tumor, cerebrovascular disease) capable of producing cognitive impairment.
* Subjects are also required to have a reliable caregiver who meet the patient at least once a week and is sufficiently familiar with the patient to provide the investigator with accurate information.
* He/She can read and write
* written informed consent

Exclusion Criteria:

* any patient who were involved in other clinical trials or treated with experimental drug within 4 weeks
* any patients with any severe or unstable medical disease that may prevent the patient from completing all study requirements (i.e., unstable or severe asthma or cardiovascular disease, active gastric ulcer, severe hepatic or renal disease)
* any patients with clinically significant laboratory abnormalities such as an abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or positive venereal disease research laboratory test
* any patients with any primary neurodegenerative disorder or psychiatric disorder other than AD (i.e., Parkinson's disease, schizophrenia, or major depressive disorder)
* any patients with any history of drug or alcohol addiction during the past 10 years
* any hearing or visual impairment that can disturb the efficient evaluation of the patient
Improving Informed Decision Making for Cancer Clinical Trial Participation

The goal of this study is to develop and pilot test a multi-communication approach to improve informed decision-making about cancer Clinical Trials (CTs) participation by increasing awareness of CTs and Mays Cancer Center (MCC) services (treatment care capacities, reputation and resources), positive attitudes towards CTs, self-efficacy and intentions to consider CTs as an appropriate treatment option for cancer (intention to participate) among patients attending the MCC (clinic-based setting) and the general public in selected Bexar County areas (community-based settings).

The proposed two-year study involves a randomized controlled educational trial featuring a 2-group parallel cohort design with random assignment of 400 cancer patients from the MCC to the intervention or usual care control group. Intervention participants will receive 3 components: 1) a bilingual culturally relevant educational video, 2) a low-literacy booklet and 3) support from a patient navigator to empower new cancer patients to make informed decisions about cancer CT participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider CTs as an appropriate treatment option for cancer. The usual care control group will receive a general CT fact sheet.

The community setting will involve a community awareness campaign including 400 community members, with 3 components: 1) an educational session delivered via PowerPoint presentation or flip chart, 2) a low-literacy booklet, and 3) support from a community health educator to raise awareness, positive attitudes and intentions to consider CTs as an appropriate treatment option for cancer and promote the MCC services among community members in Bexar County.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed cancer patients (within 1 year) attending any of the clinics at the MCC
* Patients who have not participated in a Clinical Trial before
* English or Spanish-speaking
* Able to provide informed consent

Exclusion Criteria:

* Younger than 18 years
* Patients who have already had a consultation with their doctor to discuss treatment options
* Patients who have participated in a Clinical Trial before
* Unable to provide informed consent
Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Prosthesis Rotaio (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse

This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc prosthetic devices with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.


Eligibility Criteria:
Inclusion Criteria:

* Indication for monosegmental anterior cervical discectomy with implantation of a disc prosthesis

Exclusion Criteria:

* Radiologic signs of extensive bone degeneration in the affected segment
* Necessity of implantation of a device smaller in height than 5 mm (as predicted with teh use of the Vertaplan (TM) software
* Transversal spine cord lesion
* Cervical myelopathy
* Preceding surgery on the cervical spine
* Traumatic lesions of the cervical spine
* Radiographic instability in the affected segment: flexion / extension: shift sagittal plane\> 3.5 mm or 20% and rotation in the sagittal plane \> 20 °, OR in static X-ray examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width and relative sagittal plane angulation \> 11º
* signs of instability (Olisthesis) in another segment of the cervical spine
* Active systemic infection
* diseases of the rheumatic type and all autoimmune diseases
* bone metabolic diseases (for example, Paget's disease)
* skeletal metastases
* infections in the cervical spine
* Neurological seizure disorders or other serious neurological disease with risk of falls
* Severe heart failure (NYHA III-IV)
* Bleeding disorders or clopidogrel / coumarins - treatment
* Systemic use of corticosteroids for more than a month in the last 12 months
* Pregnancy
* Legally incompetent patient
* Lactation
* Deformity, anomalies, not fully developed skeleton
* Local tumor disease
* Pre-existing neurologic abnormalities or other shortcomings, such as a Parkinson's disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy
* Drug / drug or alcohol dependence
Facilitating the Behavioral Treatment of Cannabis Use Disorder

Cannabis use disorders remain a significant public health problem. The pharmacological facilitation of behavioral treatment represents a promising strategy for addressing disordered cannabis use. Cannabis use disorders are recognized to be associated with various vulnerabilities that complicate the course of treatment and that may be amenable to glutamate modulators. The purpose of this single blind open-label trial is to test the feasibility of administering glutamate modulators in conjunction with motivational enhancement therapy (MET) and mindfulness based relapse prevention (MBRP) for cannabis use disorders.

Individuals diagnosed with cannabis dependence will receive one or two infusions of glutamate modulators during week 2 and week 3 or 4. The participants will also receive 2-week course of MET and 4-week course of MBRP. Participants will meet with staff twice weekly, except for week 2 and potentially week 3 or 4 during which participants will present to the clinic three times. Clinic visits include MET sessions, MBRP sessions, psychiatric monitoring, assessments, and study procedures (e.g., medication administration).

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for cannabis dependence, with at least 5 days of use per week over the past 30 days and displaying at least one positive utox during screening
* Physically healthy
* No adverse reactions to study medications
* 21-60 years of age
* Capacity to consent and comply with study procedures
* Seeking treatment

Exclusion Criteria:

* Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance-induced psychosis, and current substance-induced mood disorder.
* Physiological dependence on another substance requiring medical management, such as alcohol, opioids, or benzodiazepines, excluding caffeine, and nicotine.
* Pregnant, interested in becoming pregnant, or lactating
* Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
* Current suicide risk or a history of suicide attempt within the past 2 years
* On psychotropic or other medication whose effect could be disrupted by participation in the study
* Recent history of significant violence (past 2 years).
* Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
* Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (\>140/90), anemia, pulmonary disease, active hepatitis or other liver disease (transaminase levels \< 2-3 X the upper limit of normal will be considered acceptable), or untreated diabetes
* Previous history of misuse of study medications
* BMI \> 35, or a history of undocumented obstructive sleep apnea
* First degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis NOS)
Exercise in Pregnant Women With Gestational Diabetes

Gestational diabetes (GDM) impacts 1 in 10 pregnancies; hyperglycemia and hypertriglyceridemia are common features of the condition. Women are recommended to do at least 150 minutes of moderate-intensity aerobic activity a week during pregnancy and the postpartum period. Exercise both during and out of pregnancy has been shown to be an effective non-pharmacologic tool to reduce glucose and lipid profiles. The goals and purpose of this pilot study is to 1) determine the influence of exercise and the timing of exercise surrounding a meal on glucose and lipid metabolism in pregnant women with GDM and 2) determine the feasibility of low-resistance and aerobic activity and measuring exercise metrics during pregnancy. The overarching objective of this study is to determine the effects of low-resistance and aerobic exercise on glucose and lipids following a meal in pregnant women with GDM.

Gestational diabetes (GDM) impacts 1 in 10 pregnancies; hyperglycemia and hypertriglyceridemia are common features of the condition. Women are recommended to do at least 150 minutes of moderate-intensity aerobic activity a week during pregnancy and the postpartum period. Exercise both during and out of pregnancy has been shown to be an effective non-pharmacologic tool to reduce glucose and lipid profiles. The goals and purpose of this pilot study is to 1) determine the influence of exercise and the timing of exercise surrounding a meal on glucose and lipid metabolism in pregnant women with GDM and 2) determine the feasibility of low-resistance and aerobic activity and measuring exercise metrics during pregnancy. The overarching objective of this study is to determine the effects of low-resistance and aerobic exercise on glucose and lipids following a meal in pregnant women with GDM. Women will perform either low-resistance or aerobic exercise. Blood will be taken before and 2 hours after a fixed meal. For safety, women will have supervised exercise and oxygen consumption will be measured throughout the activity.

Eligibility Criteria:
Inclusion Criteria:

* diet and lifestyle controlled gestational diabetes
* Gestational age 28 weeks-32 weeks gestation
* Age 18-50 years
* Singleton pregnancy

Exclusion Criteria:

* Chronic hypertension
* Pregestational diabetes
* History of peripartum cardiomyopathy
* Any condition contraindicating for exercise
* Taking any cardiovascular modifying medications (beta-blockers, calcium channel blockers, corticosteroids)
* Asthma or other underlying lung disease that is equivalent or worse than persistent mild classification (defined as at least \>2 day/week asthmatic symptoms, 1-2x/month nighttime awakenings, \>2days/week short-acting beta-agonist use for symptom control, and minor limitations with normal activity; ≥2 exacerbations in 6 months requiring oral systemic corticosteroids, ≥4 wheezing episodes/1 year lasting \>1 day)
* Congenital anomalies
* Multifetal gestation
* Current alcohol use
* Current tobacco use
Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use

The purpose of this study is to conduct a randomized controlled trial to determine the effects of a cellphone app and a driving mode intervention on driving behavior in drivers aged 18-24 years.

For this study, 1200 teens aged 18-24 years will be randomized into one of three study groups for 6 months. Researchers aim to evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on cellphone use while driving and evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on high-risk driving events.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-24 years of age at time of recruitment
* Must have ownership and exclusive access to a passenger vehicle
* Must have car insurance with at least state-minimum coverage
* Must live in Greater Columbus (Ohio) area
* Must drive at least 2 days a week on average
* Must have functioning iPhone or Android smartphone with an active phone service account (Ex: Verizon, AT\&T, etc.)
* Must self-report handheld calling or texting while driving (≥ 1 time/week)
* Must not be enrolled in another driving-related research study during the study period.
* Must be willing to be randomized and comply with study requirements
* Must have no plans to change cellphones or vehicles in next 6 months or agree to transfer FleetSafer app/DriveCam if they change cellphones or vehicles
* Must speak and read English

Exclusion Criteria:

* Drivers under 18 years of age
* Drivers holding learner's permits
* Drivers who share a vehicle with a family member or others
* Infrequent drivers (Drive 2 days a week or less)
* Participants from the pilot R21 project
* Current users of a cellphone-blocking app or driving mode who do not agree to uninstall/de-activate the app for the duration of participation in the study
* Current users of a car insurance monitoring device (physical device or app)