cyrilzakka/clinical-trials huggingface dataset:
Study of Proteins in Tumor Samples From Patients With Non-Small Cell Lung Cancer

This research studies protein in tumor samples from patients with non-small cell lung cancer. Finding specific proteins in tumor tissue samples from patients with cancer may help doctors tell what type of lung cancer a patient has and plan better treatment.

PRIMARY OBJECTIVES:

I. To validate a novel 4-protein signature's ability to subtype non-small cell lung cancer (NSCLC) in a treatment-naive, multi-institutional cohort, Cancer and Leukemia Group B (CALGB) 9761.

SECONDARY OBJECTIVES:

I. To estimate the NSCLC misclassification rate in a multi-institutional clinical-trial setting for stage 1 NSCLC (adenocarcinoma versus squamous cell).

OUTLINE:

Previously collected tissue samples are analyzed via hematoxylin and eosin (H\&E) staining and immunohistochemistry (IHC).

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been registered on CALGB-9761

  * Stage I disease
  * Treatment-naive patients
* A representative paraffin block of the primary tumor must be available from patients on CALGB-9761 and submitted to the CALGB Pathology Coordinating Office
* A separate consent form is not required for this study, as permission for research to be performed on the tissue blocks is included in the consent form for CALGB 9761
* Institutional review board (IRB) review and approval at the institution where the laboratory work will be performed is required
Effect of Neuromuscular Stimulation and Mindfulness Breathing in Patients With Stroke

It is an interventional study in which 60 stroke patients were estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation and mindfulness breathing, while the control group will receive neuromuscular stimulation only.

It is an interventional study in which 60 stroke patients will be estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation and mindfulness breathing, while the control group will receive neuromuscular stimulation only. The experimental group participants will receive neuromuscular electrical stimulation that will last 12 consecutive weeks, three sessions per week protocol with Mindful breathing is a mindfulness exercise that involves using breathing as an object of attention.

Eligibility Criteria:
Inclusion Criteria:

* The subject selection will be according to the following criteria:
* All Patients of this study will be diagnosed as stroke and the diagnosis will be confirmed by computed tomography or MRI (El-Tamawy et al., 2021).
* Age of patients will be ranged from 50 to 65years (males and females).
* All patients will be hemodynamically stable.
* Patients with good cognition that enables them to understand the requirements of the study.

Exclusion Criteria:

* • The potential participants will be excluded if they meet one of the following criteria:

  * Patients who cannot follow instructions as sensory aphasia, blindness, dementia, and deafness.
  * Patients with any orthopedic, neurological, or chest disorders that affect trunk muscles control or cause respiratory disorders as COPD.
  * Patients with cognitive and psychiatric disorders.
  * Patients with unstable cardiovascular conditions.
  * Patients with contraindications to neuro electrical stimulation as:
  * Cardiac pace maker.
  * Acute abdominal surgery.
Mechanisms of Insulin Facilitation of Memory

The study described in the present application will test the hypothesis that insulin mediated facilitation of memory in Alzheimer's disease (AD) is achieved through enhanced glutamatergic neurotransmission due to improvements in cerebral glucose metabolism. The effect of a single dose of intranasal insulin on memory and cerebral glutamate concentrations in adults with mild AD or amnestic mild cognitive impairment (aMCI), the presumed prodromal phase of AD will be studied. Successful completion of this study may set the stage for a larger-scale treatment trial of intranasal insulin for adults with memory disorders. However, the use of insulin in this manner at this point in time is purely experimental.

The specific aims of this project will be accomplished through a cross sectional repeated measures design in which 15 participants with mild AD or amnestic MCI will undergo assessments of brain structure and function 15 minutes after a single dose of insulin (20 IU) or placebo. Insulin and placebo conditions will be counterbalanced across participants.

Intranasal insulin or placebo administration: Saline and insulin (NovoLog) will be ordered though the UT Student Health Services Pharmacy (Sharon Roberson, Chief Pharmacist) and stored at 4°C, according to standard pharmacy protocols. Three ml doses of saline or insulin will be packaged in nasal spray bottles (e.g., Spectrum Pharmacy Products bottles 969-17404P and actuators 551-24362P) designed to deliver 100μL dose with each spray. A total volume of 200μL will be delivered during each administration (one 100μL dose in each nostril).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of probable AD
* Age over 21
* Clinical Dementia Rating of 0.5 or 1.0
* Mini Mental State Exam Score\>15

Exclusion Criteria:

* preexisting diabetes
* significant neurological disease that might affect cognition, other than AD, including stroke, Parkinson's disease, multiple sclerosis
* severe head injury with loss of consciousness \> 30 minutes or with permanent neurological sequelae
* significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
* current use of anti-psychotic or anti-convulsant medications
* current or previous use of hypoglycemic agents or insulin
* MRI contraindications
* claustrophobia
* pregnancy
Effects of Benson Relaxation Exercise on Anxiety Level and Sleep Quality in Adolescents

Purpose: The purpose of this study is to examine the effects of Benson relaxation exercise applied to children and adolescents receiving inpatient treatment in a psychiatric clinic on anxiety levels and sleep quality.

Design: The study is a randomized controlled trial with a pretest-posttest control group.

Method: The study will be conducted in a private psychiatric hospital in Turkey between October 2024 and June 2025. When hospital records were examined, it was determined that 100 patients received inpatient treatment in the last year. Therefore, the universe of the study consisted of 100 patients. The effect of some instructions in the Benson relaxation exercise on delusions and hallucinations is unknown. Therefore, psychosis and schizophrenia patients with delusions and hallucinations will be excluded from the scope of the study. Patients who meet the inclusion criteria will be randomly assigned to the intervention and control groups. The study will be terminated when a total of 60 patients are reached, 30 in the intervention and 30 in the control group. Benson relaxation exercise will be applied to the patients in the intervention group. No application will be made to the patients in the control group. Research data will be collected with the "State-Trait Anxiety Scale" and "Pittsburgh Sleep Quality Index".

Hypotheses:

H1: The anxiety level of patients who applied Benson relaxation exercise is lower than the patients who did not.

H2: The sleep quality of patients who applied Benson relaxation exercise is better than the patients who did not.


Eligibility Criteria:
Inclusion Criteria:

* Being treated in the child and adolescent clinic at the hospital where the study was conducted
* Being between the ages of 14-18
* Not diagnosed with psychotic disorder or schizophrenia
* Scoring between 20 and 59 on the STAI I-II scale
* Scoring 5 and above on the PSQI scale
* Being willing to participate in the study
* Parents giving verbal consent for participation in the study and signing the written voluntary consent form

Exclusion Criteria:

* Not receiving treatment in the child-adolescent clinic at the hospital where the study was conducted
* Not being between the ages of 14-18
* Being diagnosed with psychotic disorder and schizophrenia
* Not receiving a score between 20-59 on the STAI I-II scale
* Receiving a score below 5 on the PSQI scale
* Not being willing to participate in the study
* The parent not giving verbal consent for participation in the study and not signing the written voluntary consent form
CGM Use in Poorly Controlled Youth With Type 1 Diabetes

The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 1 diabetes for \>3 months

Exclusion Criteria:

* CGM use in the last 6 months
Evaluation of the Impact of Corneal Width on Surgically Induced Astigmatism (SIA) and Functional Results After Bimanual 1.4 mm Microincision Cataract Surgery (B-MICS), Coaxial 1.8 mm MICS (C-MICS) and 2.4 mm Small Incision Cataract Surgery (C-SICS).

The aim of the study is to compare functional results and complications of 3 methods of cataract phacoemulsification: bimanual 1.4 mm cataract surgery (B-MICS), coaxial 1.8 mm cataract surgery (C-MICS) and coaxial 2.4 mm small incision cataract surgery.

Reduction of the width of the corneal incision was one the main changes taking place in cataract surgery in recent years. The common use of foldable intraocular lenses (IOLs) and technological development of phaco machines allowed to reduce clear corneal incision below 3 mm. Term of Microincision Cataract Surgery (MICS) understood as cataract phacoemulsification performed with the incision width below 2 mm was defined by professor Alio in 2003. However, despite various modifications introduced in recent years, phacoemulsification still causes damage of the tissues that results in surgically induced astigmatism.

Two MICS techniques have been developed: bimanual microincision cataract surgery (B-MICS) and coaxial microincision cataract surgery (C-MICS).

In the bimanual technique cataract phacoemulsification can be performed through the main incision 1.4 mm wide due to the usage of sleeveless phaco tip (without irrigation) and irrigation chopper. The advantage of separation the irrigation from aspiration is improvement of liquid dynamics in the anterior chamber. Moreover, due to the usage of the irrigation chopper, in B-MICS it is possible to lower the mean ultrasound energy.

In coaxial technique MICS phacoemulsification is performed through the incision 1.8 mm wide with usage of phaco tip with a silicon irrigation sleeve.

The aim of the study is to compare functional results and complications of 3 methods of cataract phacoemulsification: bimanual 1.4 mm cataract surgery (B-MICS), coaxial 1.8 mm cataract surgery (C-MICS) and coaxial 2.4 mm small incision cataract surgery. Moreover, this study aimed to evaluate the impact of corneal width on best corrected visual acuity (uncorrected and corrected), surgically induced astigmatism, endothelial cell loss, intraocular pressure, anterior segment of the eye and central retinal thickness.

Eligibility Criteria:
Inclusion Criteria:

* lens opacities which were an indication for cataract surgery and absence of exclusion criteria,
* cataract sclerosis grade from II to IV in Lens Opacities Classification System LOCS III scale (The Lens Opacities Classification System III).

Exclusion Criteria:

* history of ocular surgery, ocular trauma,
* congenital ocular malformations, amblyopia,
* corneal disorders (including corneal opacities and scars),
* best corrected visual acuity (BCVA) ≥ 0.9,
* preoperative endothelial cell density \<1500 cells/mm2,
* history of uveitis, diabetic retinopathy,
* retinal and macular disorders,
* eventful phacoemulsification
* presence of other diseases that could affect the postoperative visual outcomes.
Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.

OBJECTIVES:

* Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2.
* Assess toxicity, overall response rate, and response duration in these patients when treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses.

Patients are followed every 2 months for 6 months, then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed melanoma that is metastatic and unresectable
* Measurable, progressive disease (by physical exam and/or noninvasive imaging)

  * No prior irradiation of indicator lesions
* No CNS metastases (confirmed by CT or MRI)

PATIENT CHARACTERISTICS:

Age:

* 18 to 70

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Greater than 3 months

Hematopoietic:

* WBC at least 2,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* No serious hepatic disease

Renal:

* Creatinine no greater than 1.65 mg/dL
* No serious renal disease

Cardiovascular:

* No serious cardiac disease

Pulmonary:

* No serious pulmonary disease

Other:

* No organ allograft
* No autoimmune disease
* No uncontrolled infection
* No active peptic ulcer
* No hyper or hypothyroidism
* No requirement for corticosteroids
* No second malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior immunotherapy with interleukin-2
* No prior interferon alfa in combination with cisplatin or dacarbazine

Chemotherapy:

* No prior chemotherapy with cisplatin in combination with dacarbazine
* More than 3 months since prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior radiotherapy allowed

Surgery:

* Not specified
Avoid Transvenous Leads in Appropriate Subjects

The purpose of the study is to compare standard, single chamber transvenous ICD to sub-cutaneous ICD in occurrence of perioperative and long term device related complications and failed appropriate clinical shocks and arrhythmic death.


Eligibility Criteria:
Inclusion Criteria: patient must satisfy any ONE of the following two criteria:

1. Patient is ≥ 18 - 60 years old AND has a standard indication for ICD; OR
2. Patient is ≥ 18 years old AND has any one of the following present:

   * An inherited arrhythmia syndrome (i.e. Long QT, Brugada, ARVC, hypertrophic or dilated cardiomyopathy, early repolarization syndrome, idiopathic ventricular fibrillation, etc.)
   * Prior pacemaker or ICD removal for infection
   * Need for hemodialysis
   * Prior heart valve surgery (repair or replacement)
   * Chronic obstructive pulmonary disease (with FEV1 \< 1.5 L)

Exclusion Criteria:

* Mechanical tricuspid valve
* Fontan repair
* Presence of an intra-cardiac shunt
* Known lack of upper extremity venous access
* Need for cardiac pacing for bradycardia indication
* PR interval of \> 240 msec
* Patients with permanent pacemaker
* Clinical indication for biventricular pacing
* Patients unwilling to provide informed consent or comply with follow-up
* Pregnant at time of enrollment and implant
* Patients who currently have a ventricular assist device (i.e. LVAD)
Reminiscence, Anxiety and Early Alzheimer's Disease

This study seeks to establish the acceptability and evaluate the limited efficacy of Simple Reminiscence (SR), a home-delivered non-pharmacological intervention designed to relieve stress, improve affect, and prevent or quell disruptive or maladaptive behaviors in community-residing individuals diagnosed with early Alzheimer's disease (EAD). Unmanaged episodes of anxiety can be antecedents of maladaptive behaviors, including agitation, anger, and sometimes even violence.

SR is a dyadic strategy; both the person with EAD and the caregiver engaged the patient's memory to interrupt a current episode of anxiety.

Through the intervention, family caregivers are trained to collaborate with and guide patients to access positive memories as a way to manage or move past the anxiety that plagues individuals with EAD - often arising when confronted by common complex tasks they previously were able to perform.

During the project's first six months (phase 1), the investigators will develop a series of 4 video-vignettes illustrating dyads (including one member with EAD) managing a variety of anxiety provoking scenarios associated with EAD (e.g., trouble reconciling a checkbook) through the use of SR.

During the second phase of the project, a research assistant will administer SR at four home visits. The SR intervention has three components:

1. A didactic component using the SR manual that the couple retains (15 minutes);
2. Viewing one of the brief video-vignettes illustrating the application of reminiscence techniques (5 minutes; a different video-vignette will be viewed at each visit; and
3. Facilitation of caregiver practice in applying the techniques, using a recent example of anxiety-linked experience of the person with EAD (10 minutes). The caregiver is encouraged to learn and practice the techniques in order to cue and coach the person with EAD in their use.

The attention control treatment, a Social Visit, is a 30-minute activity in which the person with EAD, the caregiver and the research assistant (RA) review and discuss the day's newspaper headlines. The RA will use communication techniques specifically designed to keep the conversation present focused.

Both members of the dyad will collect saliva to evaluate diurnal cortisol secretion.

Eligibility Criteria:
Inclusion Criteria:

* Live in the community
* Reside with a primary caregiver who must be willing to participate in all study activities (the primary caregiver must have a familial or marital relationship with the person with EAD of sufficient length to support reminiscence activity \[i.e., an adult child, a long-term spouse or committed partner\])
* Have received a diagnosis of Early Alzheimer's Disease from a primary care provider
* Achieve a score on the mini-mental state examination (MMSE) between 19 and 25

Exclusion Criteria:

* Unable to give consent
* MMSE score lower than 19 or greater than 25.
Correlation Between the Volume Flow of the CFA After Angioplasty of Critical Ischemic Limb and Wound Healing

in our study we are examining the volume flow of the common femoral artery before and after angigraphy of a critical ischemic limb, as a predictor for wound healing after the treatment

All patients with threatened limbs, that was decided upon to have angioplasty will be asked to sign consent form to participate in this study.

Before having the angioplasty, all participants will be examined with ultrasound duplex to determent their common femoral artery volume flow. Day after the angioplasty, they will be reexamined (this is the usual practice) to detriment the new volume flow in the CFA.

The participents examinations in the outpatient clinics will be documented and time for healing will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* All patients with threatened limbs, that was decided upon to have angioplasty .

Exclusion Criteria:

* those who are not willing to sign a consent form to participate in this study
Observation of the Efficacy of Different Vitrectomy Systems to Treat Proliferative Diabetic Retinopathy

In recent years, vitrectomy has moved toward a minimally invasive vitrectomy surgery (MIV) system, which could effectively reduce the occurrence of operation complications, while reducing the time of post-operation recovery.

With an improved design of bevel tip and a high cutting rate capacity of 10000cpm, Advanced ULTRAVIT® probes potentially provide an strong technical support for the application of MIV. The new probe facilitates great control during delicate surgical maneuvers, such as separating the hyaloid from the retinal surface, dissecting fibrovascular tissue off the surface of retina.

However, there was no sufficient clinical evidence to support the benefits of Advanced ULTRAVIT ® probes in the complicated vitreoretinal surgery, such as proliferative diabetic retinopathy. More importantly, there is an urgent need of clinical evidence to support 10000cpm launch and conversion which is major objective of 2021 VR growth strategies.

This exploratory study, aiming to demonstrate the beneficial of 27 Gauge probe, which can be flexibly applied as a multifunctional tool for membrane removal by reducing frequencies of switching device, reducing the traction to eyeball during device entering and leaving the eye. Moreover, the outcomes from this study would be an strong evidence to support further comparative study to comprehensively demonstrate the superior function compare to current heavily used 5K 25 gauge probe.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with vitreous hemorrhage and tractional retinal detachment (TRD) confirmed by fundus image and B ultrasound examination, consistent with the diagnosis of severe proliferated diabetic retinopathy (PDR).
2. Patient that could follow up postoperatively at the clinic for 6 months more.
3. All the surgeries were performed by one well-experienced retinal surgeon.

Exclusion Criteria:

1. Corneal lesions affecting operative field, such as corneal opacity or scar; History of vitreoretinal surgery;
2. External eye infections;
3. History of systemic thromboembolism;
4. Uncontrolled hypertension or hyperglycemia;
5. Coagulation abnormalities or currently using anticoagulant drugs other than aspirin;
6. Unable to meet postoperative position requirements;
7. Unable to be followed up regularly.