cyrilzakka/clinical-trials huggingface dataset:
A Study of AL2846 Capsule Combined With Standard Chemotherapy Regimen in Subjects With Advanced Colorectal Cancer

This is a study to explore the safety, tolerance and efficacy of AL2846 capsules combined with mFOLFOLX6 or FOLFIRI standard chemotherapy regimen in subjects with advanced metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

-1. Histologically confirmed advanced metastatic colorectal cancer. 2. Has received only first-line standard chemotherapy regimen for metastatic disease, and which was failed.

3. At least one measurable lesion. 4. Has received systemic chemotherapy, palliative radiotherapy or other anti-tumor therapy before first dose at least 4 weeks.

5.18 and 75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

6. Adequate laboratory indicators. 7. No pregnant or breastfeeding women, and a negative pregnancy test. 8. Understood and signed an informed consent form.

Exclusion Criteria:

* 1. Diagnosed and/or treated additional malignancy within 5 years with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix.

  2. Has received radiotherapy, chemotherapy and surgery before and less than 4 weeks from the first administration and less than 5 half-lives of oral targeted drugs after the completion of treatment.

  3. Has multiple factors that affect oral medications. 4. Has gastroduodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.

  5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.

  6. Has arterial or deep vein thrombosis events in 6 months. 7. Hypersensitivity to AL2846 or its excipient. 8. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.

  9. Has symptomatic brain metastases, spinal cord compression, and cancerous meningitis within 8 weeks,or brain or pia mater disease confirmed by CT or MRI examination before the first dose.

  10.Has adverse events caused by previous therapy that did not recover to ≤ grade 1, with the exception of alopecia or ≥ grade 2 neurotoxicity caused by Oxaliplatin.

  11. Subjects plan to receive FOLFIRI chemotherapy regimen with uridine diphosphate glucuronyltransferase homozygous variant or double hybrid variant.

  12. Has drug abuse history that unable to abstain from or mental disorders. 13. Has any serious and/or uncontrolled disease. 14. Has received allogeneic organ transplants, hematopoietic stem cell transplants or bone marrow transplants.

  15. Has participated in other clinical trials within 4 weeks before the first dose.

  16. According to the investigators' judgment.
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease

The purpose of this study is to assess whether the investigators can treat insomnia in people with Crohn's disease, and if insomnia treatment can make other things better, like pain or inflammation.

People with Crohn's disease often suffer from sleep problems. Long term, sleep problems may lead to more flares of Crohn's disease or other complications. In general, patients with Crohn's disease also report that sleep problems can worsen symptoms of Crohn's disease the next day. In people with other medical problems, research has also shown that having sleep problems can make other things worse, such as pain and inflammation. In this study, the investigators want to understand if they can treat sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. If this study is successful, it will help the investigators understand more about how to treat insomnia in people with Crohn's disease and how sleep impacts pain and inflammation. Long term, this information will be helpful in understanding how best to take care of people with Crohn's disease.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate CD based on PRO-3 \& 50% with objective evidence of active disease
* Insomnia Severity Index score ≥ 8 and SOL or WASO ≥ 30 minutes
* Stability of sleep \& CD meds for ≥ 3 months
* Access to internet or cell phone service sufficient for telehealth

Exclusion Criteria:

* PHQ-9 depression score ≥ 15
* GAD-7 anxiety score ≥ 15
* Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)
* Current alcohol or substance abuse
* Current opioid use for pain control
* Current systemic corticosteroid use
* Current pregnancy or nursing
* Ileostomy or colostomy
* Diagnosis of seizure disorder
* Diagnosis of sleep apnea or positive WatchPAT screen
* Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen
* Night shift, rotating shift work, or frequent travel outside of time zone
The Impact of Medicare Bundled Payments

Bundled payments (BP) are a key part of Medicare's shift away from the traditional fee-for-service (FFS) payment model. The investigators propose to study a nationwide randomized-controlled trial (RCT) of bundled payments for knee and hip replacements that was designed and implemented by CMS and launched in April 2016. Randomization was conducted at the Metropolitan Statistical Area (MSA) level with 67 MSAs and about 800 hospitals assigned to the treatment group. The investigators will examine the impact of bundled payments on Medicare spending, utilization, and quality. Study findings should be directly relevant for the design of payments for knee and hip replacements, two common and expensive medical procedures. Average impacts, as well as variation in impact across types of providers and markets may also shed light on economic mechanisms, which should be relevant for bundled payment initiatives under consideration for other medical services.


Eligibility Criteria:
Inclusion Criteria:

* Acute care hospital paid under the inpatient prospective payment system (IPPS)
* Hospital admission for major joint replacement or reattachment of lower extremity with and without major complications or comorbidities (MS-DRG 469 and 470)

Exclusion Criteria:

* MSA exclusion criteria:
* MSAs with low volume of LEJR
* MSAs with high take-up of BPCI
* MSAs with large share of LEJR in Maryland hospitals
* Hospital exclusion criteria:
* Hospitals participating in certain models of BPCI.
* Patient exclusion criteria (the episode is cancelled if any of the following occurs during the episode):
* Patient not covered by both Medicare Parts A and B
* Patient eligibility for Medicare is due to end stage renal disease (ESRD)
* Patient is in a managed care plan
* Patient is in a United Mine Workers of America Plan
* Medicare is not the primary payer for the patient
* Patient dies during the episode
* Patient is re-admitted to an ACH for one of the two CJR DRGs during the episode
* Patient initiates an LEJR episode under BPCI during the episode
* Payments and services that occur in the episode that are excluded are:
* hemophilia clotting factors
* new technology add-on payments
* transitional pass-through payment for medical devices
* payments from certain incentive programs
* otherwise included payments that exceed two standard deviations of the regional mean
* services unrelated to the index admission as defined by CMS (including certain inpatient hospital stays, Part B services, and per beneficiary per month (PBPM) payments).
Biologic Therapy in Pediatric JIA Uveitis

Juvenile Idiopathic Arthritis (JIA) remains the most common systemic disorder associated with pediatric uveitis. Studies estimate that 28-67% of patients with JIA-associated uveitis develop ocular complications, with 12% developing poor visual outcome. The only means of improving long term effects of uveitis, is early and aggressive anti-inflammatory treatment, including biologics.

Juvenile Idiopathic Arthritis (JIA) remains, globally, the most common systemic disorder associated with pediatric uveitis consisting 75% of anterior uveitis cases (AU)1. In a cohort study from Cairo University Pediatric Hospital, JIA accounted for 39% of all cases of pediatric uveitis (unpublished data). Studies estimate that 28-67% of patients with JIA-U develop ocular complications, with 12% developing poor visual outcome2,3,4. Thus, early and aggressive anti-inflammatory treatment is the only means of improving long term effects of uveitis5-7.

In 2019, the American College of Rheumatology/Arthritis Foundation recommended, that in severe, active, chronic AU or in the presence of sight-threatening complications, methotrexate (MTX) and a monoclonal antibody Tumor Necrosis Factor inhibitor (TNFi) should be immediately administered8. Biologic drugs act against specific cytokines or their receptors, in order to reduce tissue damage9. Currently, infliximab, and adalimumab are the main TNF inhibitors available for children10 and are used in the treatment of refractory or chronic childhood uveitis 11,12 . Our study aims to analyze the value and outcome of using biologics at Abou el Reesh, Cairo University Hospital, being a main tertiary referral center in Egypt for children with JIA-U.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed JIA according to rheumatological criteria with ocular affection
* Any type of arthritis (oligoarticular, polyarticular, systemic onset, ocular JIA)
* ANA positive or negative
* Uncontrolled uveitis or frequent relapses

Exclusion Criteria:

* Patients without definitive diagnosis as JIA
* JIA patients on biologics without ocular affection (for systemic control) or with uveitis controlled without the use of biologics
* Patients without adequate duration for follow-up (less than 3 months) or lost follow up data
* Patients without available data prior to the start biologics (to compare control of the uveitis)
Clinical Trial on Efficacy of rTMS to Improve ECT in Treatment-Resistant Depression

It's a prospective, multicentric, randomized, controlled study concerning 56 patients with treatment-resistant depression (TRD). The main objective of this study was to evaluate the efficacy of priming repeated Transcranial Magnetic Stimulation (rTMS) sessions before Electroconvulsive therapy (ECT) for treatment of TRD patients. The primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating Scale For Depression (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the safety and most particularly the cognitive effects of this association.

Included patients are adults, aged between 18 and 70 years, with major depression (Hamilton Rating scale for Depression, HAMD ≥ 15). Patients don't have any experience concerning repeated Transcranial Magnetic Stimulation (rTMS).

Patients with treatment-resistant depression (TRD) were assigned to two treatment groups in addition to their current pharmacotherapy regimen : one group received 5 active-rTMS before Electroconvulsive therapy (ECT) and the other one received sham-rTMS before ECT. The depressive symptoms and the cognitive functions are evaluated before rTMS, after 5 rTMS and after 5 ECT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Major Depressive Disorder (HAMD≥15)
* Level of resistance ≥ 3 (Thase and Rush)
* Participants who gave their informed, written consent

Exclusion Criteria:

* Contraindication of Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia
* History of epilepsy; severe neurological or systemic disorder that could significantly affect cognition
* Pregnancy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002)

This study evaluated adverse events (AEs), study discontinuation due to AEs, and pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension.

This study evaluated AEs, discontinuation due to AEs, and effects on hemodynamic parameters, including systolic blood pressure (SBP) and aortic augmentation index (AIx), following multiple oral doses of MK-8266. Five serial panels, each consisting of eight participants (40 participants in Panels A, B, C, D, and E), were randomized to receive either MK-8266 or matching placebo twice daily (BID) or three times daily (TID) for 10 consecutive days. Although the original plan was to evaluate MK-8266 treatment in Panels D and E using both BID and TID regimens, the study actually evaluated identical TID regimens in these panels.

Eligibility Criteria:
Inclusion Criteria:

* Participant is male with essential hypertension (high blood pressure)
* Participant is in good general health (with the exception of hypertension)
* Participant has a Body Mass Index (BMI) \<= 33 kg/m\^2 at the Screening visit
* Participant has a platelet count \>= 150,000 cu/mL at the Screening visit
* Participant has a positive AIx at the Screening visit

Exclusion Criteria:

* Participant has a history of stroke, chronic seizure, or major neurological disease
* Participant has a functional disability that can interfere with rising from a seated position to the standing position
* Participant has any history of a bleeding or clotting disorder
* Participant has a history of cancer
* Participant is unable to refrain from or anticipates the use of any prescription or non-prescription medication
* Participant consumes excessive amounts of alcohol or caffeinated beverages daily
Pilot Study: Stress Reduction in Caregivers of Children With ASD Using ACT

Parents/Caregivers of children with autism need psychological flexibility and self-efficacy for the ACT program to be effective.

This study will compare intervention differences between groups. Repeated measures will be given three times (pre-intervention, post-intervention, and follow-up) to an ACT intervention group and a support group (control). The purpose of the present study is to compare the effects of a brief ACT-based workshop for parents of children with autism with a concurrent parent support control group using a variety of self-report measures addressing psychological flexibility, depression, thought suppression, cognitive fusion, positive aspects of caregiving, stress, self-compassion, and valued living.


Eligibility Criteria:
Inclusion Criteria:

* Individuals will be eligible for entry if (1) they are the biological or adoptive parent (and primary caregiver) of a child with a diagnosis of an autism spectrum disorder, (2) the child is 2-17 years of age inclusive, (3) speak English, and (4) they plan to live in the area for at least six months and (5) present proof of vaccination and (6) agree to masking and social distancing during the in-person workshop.

Exclusion Criteria:

* Individuals will be excluded from the study if (1) they are involved in a concurrent clinical trial of psychosocial interventions for parents/caregivers or (2) they (or their child/spouse) indicate during telephone screening or on the demographics questionnaire active major medical issues such as cancer, organ transplant, or severe mental health disorders that prevent active participation.
A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop

The objective of this study is to evaluate the safety and effectiveness of lubricating and rewetting drop (Test) compared to OPTI-FREE® Replenish® Rewetting Drops (Control) when used by habitual contact lens wearers to bilaterally lubricate and rewet soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and gas permeable (silicone acrylate and fluoro silicone acrylate) contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent
* Subjects must be habitual wearers of included contact lenses.
* Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must agree to wear their lenses on a daily wear basis for approximately 1 month.

Exclusion Criteria:

• Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
Lidocaine Administration Using STAR Particles

This study is being done to answer the question: Do STAR particles (tiny pieces of ceramic with small spikes) help numbing gel (a gel that helps you feel less pain) work more quickly to provide local anesthesia or numbing in a specific area? Research participants will provide feedback on how quickly the STAR particles with the numbing gel can provide anesthesia. Participants will report their sensation at either 10 or 20 minutes after application of the numbing gel.

This study aims to find out if the combination of STAR particles with numbing gel can deliver anesthesia faster than applying the gel by itself. STAR particles are very small particles with microneedles on the surface that can increase and create small punctures in the skin. The small punctures should allow for the numbing gel to work more quickly and allow the area to become numb more quickly.

After pretreatment with STAR particles (applied to the right or left arm) and aloe gel (used as a control condition in the contralateral arm) a numbing gel will be applied. A Pin-Prick test will be performed to evaluate local anesthesia from the numbing gel; half the participants will be evaluated 10 minutes after application of the numbing gel and the other half will be assessed 20 minutes after the numbing gel is applied. The study team will also assess pain after needle insertion and measure how much water is being lost from the skin using a device called a Vapometer before and after the STAR particle and aloe gel applications. Participants will have follow-up calls 24 hours and 1 week after the visit to ask about any changes to the skin where the STAR particles were applied.

Eligibility Criteria:
Inclusion Criteria:

* Children, adolescents, and young adults, 10 to 21 years of age
* In good general health as determined by a medical history
* Willing to provide informed assent with parental consent and follow study requirements

Exclusion Criteria:

* Is chronically using pain medication
* Has a plan to move to another location in the next 12 months or foresees any other reason that participation in the study would be disrupted during the next 12 months
* Has skin disorders or skin allergies
* Has any previous allergy or adverse reaction to STAR particle ingredients (Titanium Dioxide)
* Has abnormal (e.g., tattooed) skin at proposed the site(s) of STAR particle application
* Has known neurological conditions that might affect sensory function or perception of pain
* Has any condition (social or medical), which in the opinion of the investigator would make study participation unsafe, would interfere with adherence to the clinical study requirements, or would complicate data interpretation
Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser

The goal of this pilot study is to investigate the safety and efficacy of micropulse (MP) macular laser in combination with intravitreal aflibercept for the treatment of centre-involved diabetic macular edema.

Diabetic macular edema (DME) is one of the major causes of visual decline among diabetic patients. Early Treatment of Diabetic Retinopathy Study has established focal/grid macular laser as the standard of treatment for clinically significant macular edema. More recently, intravitreal injections of anti-VEGF agents, either as monotherapy or in combination with focal/grid laser, have proven to be superior for the treatment of DME compared to laser alone.

Micropulse (MP) macular laser involves applying the laser in a fraction of the time within very small pockets of energy. Unline traditional focal/grid macular laser, the micropulse method of delivery does not leave any visible burns on the retina.

A recent release by the Diabetic Retinopathy Clinical Research Network has shown that deferring focal/grid laser and treating diabetic macular edema with only anti-VEGF may lead to better visual outcomes. Since MP laser does not have the undesired side effect of leaving laser scars on the macula, the study is to show that prompt MP laser in addition to anti-vegf injections may lead to better visual outcomes and/or decreased treatment burden without the undesired side effect of macular scarring.

Eligibility Criteria:
Inclusion Criteria:

* Type I or Type II Diabetes Mellitus
* Presence of centre-involved Diabetic Macular Edema (DME) with the Central Macular Thickness (CMT) of ≥ 310µm on the spectral-domain Optical Coherence Tomography (OCT)
* Best corrected Visual Acuity (BCVA) between, and including, 20/30 and 20/400 in the study eye.
* Patient's willingness and ability to attend the study visits

Exclusion Criteria:

* Any other potential causes of macular edema such as active uveitis, epiretinal membrane, post-operative CME, and vitromacular traction
* Any history of major intraocular surgery (such as cataract surgery or vitrectomy) in the study eye within prior six months, or anticipated need for intraocular surgery within the next six months from the enrollment
* Any major ocular pathology limiting potential vision such as large macular scars, vitreous hemorrhage, corneal opacities, visually significant cataracts, advanced glaucoma, or other types of optic neuropathy
* Any history of Panretinal Photocoagulation (PRP) in the study eye or anticipated need for PRP within the next 6 months from enrollment
* Any history of DME treatment (focal laser, anti-VEGF, or intraocular/periocular steroids) in the study eye in the past 4 months prior to the enrollment
* Significant renal disease requiring dialysis
* Significant heart disease, stroke or transient ischemic attack requiring hospitalization in the past 4 months prior to the study
* Presence of active ocular or periocular infection
* Presence of active intraocular inflammation
* Known hypersensitivity to aflibercept or to any ingredient in the formulation or to any component of the container