cyrilzakka/clinical-trials huggingface dataset:
Safety Study of 90Y-hMN14 to Treat Colorectal Cancer

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of colorectal cancer.


Eligibility Criteria:
Disease Characteristics:

* Patients with a documented histologic or cytologic diagnosis of a colonic or rectal malignancy.
* Patients with recurrent, advanced and/or metastatic disease, who have either failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
* Patients with at least one identified (confirmed) and measurable tumor site\* with no tumor site \> 5 cm in the greatest dimension.

Prior/Concurrent Therapy:

* Surgery: Patients are excluded if they have had major surgery either during or within four weeks prior to study entry.
* Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. Patients must have completed chemotherapeutic agents four weeks prior to study entry.
* Biologic Therapy: Patients who have received a chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN-14 IgG (i.e., HAHA).
* Radiotherapy: No prior radiotherapy within four weeks of study entry. No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 3,000 cGy for the liver, and 2,000 cGy for the lungs and kidneys). Patients who have had standard pelvic field radiation as adjuvant therapy for rectal carcinoma will be eligible only after the MTD is established.
* Other: Any experimental therapy (i.e., drugs, biologicals, procedures) for the primary malignancy, either during or within four weeks prior to study entry.

Patient Characteristics/Inclusion Criteria:

* Age Range: Male or Female at least 18 years of age
* Performance Status: Patients with a Karnofsky performance status \> 70% (or equivalent, ECOG 0-1) and expected survival of at least 3 months.
* Hematopoietic: Hemoglobin \> 10 g/dL; WBC \> 3000 per mm3; Granulocyte count \> 1,500 per mm3; Platelet count \> 100,000 per mm3
* Hepatic: Total bilirubin \< 1.5 times the institutional upper limit of normal (IULN)AST or ALT \< 2 x IULN
* Renal: Creatinine \< IULN
* Cardiovascular: Patients with LVEF \>/= 50% by required MUGA/2D-ECHO study.
* Pulmonary: Patients with DFCO and FEV1 \>/= 60% by required Pulmonary Function Tests.
* Other: Patients who have had a prior imaging study with a murine monoclonal antibody may be included. Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.
Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)

The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable.

Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population.

Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic recurrent or refractory indolent NHL or B-CLL
* Adequate organ and bone marrow function
* Karnofsky greater than 50%

Exclusion Criteria:

* Candidates for autologous stem cell transplantation
* Secondary high grade lymphoma
* Concurrent severe medical condition
Clinical Study to Evaluate the Efficacy and Safety of YVOIRE® Contour Compared With Restylane SubQ™ Injected Into the Anteromedial Malar Region

This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with Restylane SubQ™ injected into the anteromedial malar region.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female, 20-65 years of age
* Have anteromedial malar region volume loss as grade 2, 3, or 4 on the Mid Face Aesthetic Scale (MFAS) symmetrically on both sides
* Desire filler treatment to correct volume loss in the anteromedial malar region
* Accept the obligation not to receive any other mid facial procedures or treatments during the study
* Signed informed consent
* Those who fall under one of the following 3 cases

  1. Males or females who are surgically sterile
  2. Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
  3. Fertile premenopausal females or males without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the last treatment of the investigational device to avoid pregnancy

Exclusion Criteria:

* Have a history of hypertrophic scars or keloids
* Other criteria as identified in the protocol
Move to Improve Physical Activity in Parkinson's Disease

Apathy is a multi-dimensional behavior characterized by impairments to motivation, planning and initiation; collectively called, goal-directed behavior. It is highly prevalent in patients suffering from neurological disorders such as Alzheimer's disease and Parkinson's disease (PD) as well as psychiatric disorders such as depression and schizophrenia. In PD, specifically, apathy is one of the more troublesome symptoms. Apathetic PD patients have greater disability, lower adherence to treatment plans and caregivers report greater stress and burden.

Interventions grounded in behavioral economic theories, namely, financial and social incentives often promote positive behavioral change such as weight loss and smoking cessation. However, the effectiveness of these interventions varies across and within conditions and incentive type. It also tends to dissipate when incentives are no longer provided. To date, these approaches have not been used to promote behavior change in PD or other neurological conditions where apathetic behaviors are a pressing problem. The overall goal of this study is to test if behavioral economic approaches will reduce apathy, and subsequently, improve goal-directed behavior in Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will have a diagnosis of Parkinson's disease, and may have either normal cognition or mild cognitive impairment (MCI). Most eligible participants will have to have smartphones with wifi, application, Bluetooth, and text messaging capabilities. The study team does have five smart phone that can be provided to participants who do not have smartphones so as to not exclude these individuals.
* Eligible participants will have to be mobile as the primary outcome measure for the study is step goals measured on the Fitbit. Participants will be eligible if they can ambulate successfully with a cane.
* Participants will also need a study partner to be eligible to participant. This partner can be anyone of the eligible participant's choosing, who also consents to participation in the study.

Exclusion Criteria:

* Individuals will be excluded if they screen positive for dementia at the screening visit or do not have the decisional capacity to give consent. Dementia will be defined as a Montreal Cognitive Assessment (MoCA) score of \<22. Decisional capacity will be tested based on their understanding of study risks and benefits.
* Individuals will also be excluded if they require a wheelchair or walker, or are unable to ambulate safely.
* Individuals will be excluded if they are currently participating in another physical activity study, have been told by a physician not to exercise, or are currently pregnant.
Q Value Customized Versus Wavefront Optimized Ablation in Femtosecond Laser-Assisted LASIK

Corneal asphericity is expressed numerically as the "Q-value". A minus value means that corneal curvature flattens towards the periphery and the cornea is prolate in shape, but when the curvature steepens towards the periphery, the cornea is oblate in shape and has a positive Q-value.

The current study evaluates the effect of LASIK eye surgery on corneal asphericity by comparing 2 software treatment platforms; the Q value customized ablation versus the conventional Wave-front optimized ablation in a fellow eye study pattern.

The standard excimer laser correction of myopia is associated with decreased visual quality in the form of a decrease in contrast sensitivity and night vision. This degradation of the visual quality is attributed to changes in the corneal asphericity that increase the high order aberrations (HOAs), such as spherical aberrations because it leads to shifting of the corneal asphericity towards the oblate shape.

The wavefront-optimized (WFO) profile avoids the creation of new HOAs, but it is not able to treat those which are already present pre-operatively.

The Q-adjusted treatments correct the sphero-cylindrical refractive errors and try to maintain the corneal asphericity at the same time, but like the WFO ablation profiles, it is limited to correcting the spherical aberrations and not the non-rotational symmetric HOAs.

Some studies compared Lasers of two different platforms on contralateral eyes of the same patient in order to minimize inter-patient differences such as corneal wound healing and corneal biomechanics. By exclusion of these inter-patient differences, a more accurate judgment on the outcomes can be achieved.

Eligibility Criteria:
Inclusion Criteria: Candidates for Laser vision correction (LVC) with

1. Myopic Spherical Equivalent up to -12 diopters.
2. Myopic astigmatism up to -6 diopters.
3. Corneal thinnest location ≥ 500 um 4- Residual stromal bed ≥ 300 um.

Exclusion Criteria:

1. Patients not candidates for LVC.
2. Hyperopic patients or mixed astigmatism.
3. Systemic disease that contraindicates LVC.
4. Intra- or post-operative complications. 5- Previous corneal surgery
InFLUenza and the HEART An Investigation Into the Acute and Lasting Cardiac Effects of Influenza Infection

"Influenza and the Heart: An investigation into the acute and lasting cardiac effects of influenza infection" the investigators aim to assess the mechanisms for cardiovascular disease in patients suffering an acute influenza infection. The project will be carried out by creating a prospective clinical cohort study of consecutive patients hospitalized at Herlev \& Gentofte University Hospital with a laboratory confirmed influenza.


Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized at Herlev \& Gentofte University Hospital with a laboratory-confirmed diagnosis of influenza
* \> 18 years of age

Exclusion Criteria:

* Persons not able to cooperate
* Persons unable to understand and sign "informed consent"
* Pregnancy
* Persons simultaneously positive with COVID-19
Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality

single-center, randomized, cross over, double-blind, placebo controlled intervention study

The single-center, randomized, cross over, double-blind, placebo controlled intervention study will include 30 subjects who will test the efficacy of three formulations with different dosages of melatonin on sleep quality parameters.

Eligibility Criteria:
Inclusion criteria:

* subject Informed consent form (ICF) is signed
* aged 24-65 years at the time of the signature of ICF
* suboptimal sleep quality according to Pittsburgh Sleep Quality Index (PSQI-SI): PSQI higher than 5
* no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI up to 9
* a body mass index (BMI) up to 32 kg/m2
* stable medications for non excluded concurrent medical conditions for six weeks prior to the screening visit
* ability to ingest oral food supplement (study product)
* willing to follow all study procedures, including attending all site visits and use of actigraphy

Exclusion criteria:

* diagnosed or subject to therapy due to sleep disorders
* acute infectious disease
* any kind of chronic pharmacological therapy with antihypertensives or antidepressants
* any kind of other pharmacological therapy that could interact with active ingredients used in the study
* pregnancy or planned pregnancy, lactation, menopause (with clinically relevant symptoms/therapy)
* use of beta-blockers
* chronic use of use of prostaglandin synthesis inhibitors (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid and ibuprofen
* supplementation with melatonin or other food supplements intendent for sleep quality during last 2 weeks
* unwillingness to maintain caffeine abstinence after 4:00 PM during the study
* not having a mobile upper extremity for attaching an actigraph
* known alcohol and/or drug abuse
* unwillingness to comply with the maximum limit of 2 alcoholic drinks per day, and only up to 1 alcoholic drink after 6:00 PM during the study
* known lactose/gluten intolerances/food allergies
* known gastrointestinal disease
* less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)
* have stomach or bowel resection
* night work (including as part of shift work)
* mental incapacity that precludes adequate understanding or cooperation
* participation in another investigational study
Web Platform to Integrate Behavioral Health

Under this Small Business Innovation Research (SBIR) Phase II project, Research Topic 155, the Contractor will create an integrated multi-module system of web software tools to aid in behavioral health screening, prevention, triage, and tracking in medical, school, and mental health settings.

Health care systems experience problems with lack of tools, lack of knowledge, process variation, and system fragmentation in addressing behavioral health. As an ongoing science-based process for improving care and lowering costs, robust increases in translational capability are needed to re-tool health delivery systems for behavioral health integration. A logic linking translational capability to behavioral health integration as an ongoing shared information process, founded on the core belief that enabling human action with new information technology tools can grow knowledge, is the most powerful way to solve problems and improve health care.

Given these connected and interacting issues and obstacles, the Contractor has developed a solution strategy, building on four tiers of prior innovation and validation:

* The Behavioral Health Screen (BHS);
* BH-Works: the web software delivery of the BHS and new production features from Phase I;
* BH-Works Portal: new production software features from Phase I; and
* BH-Works Services: expertise and professional services to help primary care providers and healthcare systems integrate behavioral health into their organizations and workflows.

Eligibility Criteria:
Inclusion Criteria:

* Potential Mental Health issue

Exclusion Criteria:

* Not Willing to be Screened for mental health issues
Comparison of BIS and PIS in Children

Comparison of bispectral index and patient sedation index during general anesthesia in children

the values of BIS and PSI of every 1 minute during general anesthesia in children

Eligibility Criteria:
Inclusion Criteria:

* general anesthesia

Exclusion Criteria:

* developmental delay
* IICP
Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

This test took the target lesion restenosis rate 6 months after the operation as the main endpoint to verify the effectiveness of the intracranial balloon expansion catheter of Biolimus coating. After completing the follow-up 6 months after the operation, a clinical summary report was issued for the registration application of the product, and on this basis, 12 months of postoperative follow-up was carried out to evaluate the mid-term curative effect.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old;
* Symptomatic intracranial artery stenosis, and the degree of visual stenosis of target blood vessels under intracranial angiography is 70\~99%(WASID method);

Exclusion Criteria:

* Target blood vessels are seriously calcified and distorted, and it is difficult to put the interventional instruments in place or recover;
* Ischemic cerebral infarction occurred 3 weeks before surgery;
* Cerebral hemorrhage 3 months before operation;
Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn

This is a prospective observational study to determine the role of colonization and identify the timing of development of drug resistance in multidrug resistant Gram-negative bacilli (MDR-GNB) causing infection among critically ill burn patients.

This is a prospective observational study. Patients will be followed during a single admission for development of colonization or infection with MDR-GNB. Patient clinical characteristics, including infections, surgeries, and antibiotic exposure, will be collected in real-time.

Weekly surveillance wound and peri-rectal swabs and, if intubated, biweekly deep endotracheal or tracheostomy aspirates will be collected, de-identified, and stored from all patients and examined for the presence of MDR-GNB. All GNB isolates from blood, urine, respiratory, and wound cultures will be collected, coded, and stored.

Eligibility Criteria:
Inclusion Criteria:

1. Severe burn injury, including partial or full thickness burn 20% or more total body surface area; or
2. inhalation injury; or
3. 18 years of age or older;

Exclusion Criteria:

1. Intensive care unit stay of less than 5 days;
2. ICU admission more than 48 hours after burn trauma.
D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care

D-CARE: The Dementia Care Study

This pragmatic randomized clinical trial of 2150 persons with dementia and their caregivers, at four diverse clinical trial sites in the United States, compares the effectiveness and cost-effectiveness of 18 months of health systems-based dementia care provided by a Dementia Care Specialist (nurse practitioner or physician assistant) who works within the heath system versus community-based dementia care provided by a Care Consultant (social worker, nurse, or therapist) who works at a Community-Based Organization (CBO).

The trial will also compare the effectiveness and cost-effectiveness of both models versus usual care.

D-CARE: The Dementia Care Study

Objective: To determine the comparative effectiveness and cost-effectiveness of two evidence-based models of comprehensive dementia care, as well as the effectiveness and cost-effectiveness of both models versus usual care.

Design: A pragmatic randomized 3-arm superiority trial. The unit of randomization is the patient/caregiver dyad.

Duration: 6.5 years. This includes 34 months for recruitment of study participants, 18 months of interventions/usual care, and simultaneously 18 months of follow-up for research purposes.

Eligibility Criteria:
Inclusion Criteria:

* The person with dementia has a diagnosis of dementia established by a physician or other primary care provider
* The person with dementia has a primary care provider who is willing to partner with the study
* The person with dementia has a caregiver who speaks English or Spanish, and has a phone
* Persons living with dementia in assisted living facilities will be eligible if they do not meet any exclusion criteria (however, no more than 25% of participants can be living in assisted living facilities at the time of enrollment. This will be monitored when the first 25% of the sample has been enrolled.)

Exclusion Criteria:

* The person with dementia resides in a nursing home at the time of recruitment
* The person with dementia is enrolled in hospice at the time of screen
* The person with dementia plans to move out of the area within the coming year
* The caregiver of the person with dementia is unwilling or anticipates being incapable of providing self-reported outcome measures for 18 months
* Baseline measures refused or not completed
* The caregiver is paid, and is not a relative or close friend of the person with dementia
* At telephone or in-person screener, the caregiver has cognitive impairment
* The person with dementia or caregiver is participating in another dementia intervention study
* Patients and caregivers who are members of a sites' Local Patient \& Stakeholder Committee
* There is already a member of the same household participating in the study.
The Effect of Postural Changes on Intraocular Pressure in Silicone Oil-filled Eyes

The study was conducted to investigate how postural changes including sitting, supine, and LDP(lateral decubitus position) affect the IOP(intraocular pressure) of SO(silicone oil-filled eyes. In addition, this study compared the IOP changes between the SO-filled eyes and the fellow eyes in each body position.


Eligibility Criteria:
Inclusion Criteria:

* patients who had a 23-gauge pars plana vitrectomy
* must be done with SO(silicone oil,5,000 centistrokes) endotamponade using the Accurus system (Alcon Laboratories, Inc, Hünenberg,Switzerland)

Exclusion Criteria:

* previous history or presence of glaucoma or uveitis
* IOP of ≥24 mmHg
* use of any antiglaucoma agents
* narrow angles
* corneal abnormality or diseases that could affect IOP
* refractive error exceeding a spherical equivalent of 6 diopters.