cyrilzakka/clinical-trials huggingface dataset:
Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy

The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in non-small cell lung cancer (NSCLC) patients using the real-world data. The main questions it aims to answer are:

* What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment?
* How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data.

The objective of this observational study is to assess the effectiveness and long-term clinical outcomes of various neoadjuvant immunotherapies in patients with non-small cell lung cancer (NSCLC), using the real-world data. The primary inquiries it seeks to address include:

* What is the optimal strategy for utilizing immune checkpoint inhibitors as neoadjuvant therapy?
* How can we identify specific patient subgroups that derive the greatest benefit from neoadjuvant immunotherapy? Participants will undergo neoadjuvant immunotherapy, and the study will meticulously analyze real-world data to provide insights into these pivotal questions, contributing to the refinement of treatment strategies and patient care in NSCLC management.

Eligibility Criteria:
Inclusion Criteria:

1. Histological diagnosis of non-small cell lung cancer (Stage I-IV, International Association for the Study of Lung Cancer staging eighth edition)
2. Patients who have previously undergone immune checkpoint inhibitors as the neoadjuvant treatment;
3. No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
4. Eastern Cooperative Oncology Group (ECOG) score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
5. At least one measurable lesion (RECIST v1.1).

Exclusion Criteria:

1. Patients included in unblinded clinical trials or anti-tumor drug intervention.
2. Radiotherapy or systemic therapy were used for NSCLC patients before the surgery.
A Study of JNJ-87890387 for Advanced Solid Tumors

The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed, metastatic, or unresectable solid tumor of one of the following types: a) Renal cell cancer (RCC)-clear cell or papillary carcinoma; b) Endometrioid ovarian cancer c) Endometrioid uterine carcinoma; d) Colorectal adenocarcinoma (CRC); e) Lung adenocarcinoma
* Have measurable or evaluable disease: Part 1- Either measurable or evaluable disease; Part 2- At least 1 measurable lesion per RECIST v1.1. Participants with ovarian cancer without a measurable lesion must have disease evaluable per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or have cancer antigen (CA) 125 greater than (\>) 2\*upper limit of normal (ULN) during screening
* All participants in Part 1 and Part 2 must consent to provide an archived tumor tissue sample at screening
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening
* Be willing and able to adhere to the lifestyle restrictions specified in this protocol.

Exclusion Criteria:

* Active Central Nervous System (CNS) involvement with the exception of locally treated brain metastases that are clinically stable and asymptomatic for \> 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to \[\<=\]10 milligrams \[mg\] prednisone or equivalent) for at least 2 weeks prior to start of study treatment
* Toxicity from prior anticancer therapy that has not resolved to Grade \<=1 (except alopecia, vitiligo, Grade \<=2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement)
* History of Grade greater than or equal to (\>=) 2 immune-related AE(s) with prior immunotherapy that led to discontinuation of previous immunotherapy with the exception of Grade 2 and Grade 3 immune-related AEs that responded to treatment and that did not recur following rechallenge. Endocrinopathies that are stable on hormone replacement therapy or that have resolved are allowed.
* History of solid organ or hematologic stem cell transplantation
* Any episode of partial or complete bowel obstruction requiring hospitalization within 30 days prior to first dose of study treatment
Decentering and Relapse/Recurrence in MBCT for Depression in Adults

Objective: "Decentering" is defined as the ability to observe one's thoughts and feelings as temporary, objective events in the mind, and is increasingly regarded as a candidate mechanism in mindfulness-based interventions. The current study sought to examine the role of decentering, and other related variables, in the efficacy of Mindfulness-based cognitive therapy (MBCT) as compared to two active comparison conditions.

Method: Formerly depressed individuals (N = 227), randomly assigned to MBCT (n = 74), relaxation group therapy (RGT; n = 77) or treatment-as-usual (TAU; n = 76), completed self-report measures of decentering and symptoms of depression at pre-, mid-, and post-treatment, and relapse was assessed at 3, 6, 9, and 12 months, post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* a Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM IV-TR; American Psychiatric Association (APA), diagnosis of major depressive disorder (MDD) without psychotic features, in Full Remission;
* three or more prior major depressive episodes;
* age between 18 and 65 years;
* cognitive reactivity (CR) or mood-activated dysfunctional beliefs score greater than or equal to eight (see assessment procedure below);
* a score of less than 10 on the Hamilton Rating Scale for Depression (HRSD);
* minimum of a 10 week period free of psychotropic medication other than stable dosage of antidepressant medication for a minimum of four weeks;
* fluency in English; An increased cognitive reactivity score of eight points or more and,
* ability to give informed consent and complete questionnaires unassisted.

Exclusion Criteria:

* a diagnosis of bipolar disorder (past or present), schizophreniform disorders, substance abuse or dependence (current or within the past six months), borderline or antisocial personality disorder, or neurocognitive disorders;
* current psychotherapy or counselling more frequently than twice per month;
* current practice of meditation more than once per week or yoga more than twice per week;
* electroconvulsive therapy within the past six months; or
* self-reported ingestion of alcohol or other psychoactive substances within the past 48 hrs.
Development and Pilot Testing of the Sense2Quit App

This is a pilot randomized controlled trial to examine the feasibility, acceptability and preliminary efficacy of the Sense2Quit App in a sample of 60 PLWH who smoke.

The estimated 40-70% of persons living with HIV (PLWH) who smoke cigarettes experience substantial tobacco-related morbidity and mortality. For PLWH, apart from achieving and maintaining a suppressed viral load, tobacco cessation is the most important health behavior they can undertake to maximize both quality of life and life expectancy. However, the currently available evidence for improving tobacco cessation among PLWH is inadequate. Few tobacco cessation interventions have been tested among PLWH, and of those which have, there is 'very low' quality evidence that they were effective in the short-term and 'moderate' quality evidence indicating similar outcomes to controls in the long-term. Thus, it is critical to develop evidence-based tobacco cessation interventions to address the complex and unique needs of PLWH. In response to this need, the investigators propose to develop a mobile intervention for PLWH who smoke building on Sense2Quit, a multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential trigger. This real-time feedback is critical especially in the first few weeks of a quit attempt.

The proposed Sense2Quit intervention for PLWH who smoke cigarettes is a novel and evidence-driven intervention using mobile technology to improve tobacco cessation. This will be the first study to develop and pilot test an innovative tobacco cessation intervention for PLWH. The final product of this study will be the basis for an R01 application to conduct a large-scale efficacy study for this population.

The investigators are confident that the proposed intervention will be a high impact intervention for improving tobacco cessation among PLWH and have long-term implications for overall improvement in the public's health.

Eligibility Criteria:
Inclusion Criteria:

* PLWH confirmed through medical records or pill bottles for antiretroviral therapy (ART)medications.
* ≥ 18 years of age;
* Own an Android smartphone;
* Understand and read English;
* Not pregnant or breastfeeding (due to contraindications for Nicotine Replacement Therapy \[NRT\]);
* Permanent contact information;
* Smokes ≥5 cigarettes per day for the past 30 days;
* Interested in quitting smoking within 30 days;
* Blows ≥5 ppm eCO into a breath analyzer at baseline.

Exclusion Criteria:

* Use of tobacco products other than cigarettes (i.e. cigars, piped tobacco, chew, snuff)
* Planning to move within 3 months of enrollment;
* Positive history of a medical condition that precludes nicotine patch use;
* Current use of NRT or other smoking cessation medications (e.g., Chantix or Zyban);
* Current enrollment in another smoking cessation program.
* Alcohol dependence measured through the AUDIT-C
* A household member is also participating in the Sense2Quit study (due to study contamination).
Banding Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

Whether beta-blockers or banding is the best therapy for primary prophylaxis of variceal bleeding is subject to debate. A randomized comparison between the two treatments was performed in candidates for liver transplantation. Patients with Child B and C cirrhosis with high risk varices and no previous variceal bleeding are randomized to propranolol or variceal bleeding. Primary end point is variceal bleeding


Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis
* child pugh\>=B7
* studied for transplantation
* age between 18 an 65 ys
* no previous bleeding from varices
* signed informed consent

Exclusion Criteria:

* esophageal varices less than F2 blue
* gastric varices
* previous variceal surgical or radiological or endoscopical treatment
* hepatocarcinoma
* portal vein thrombosis
* severe heart, respiratory or renal failure
* contraindications to betablockers
* treatment with nitrates, calcium antagonist or anti-arhythmic drugs that can not be suspended
* Pregnancy
* neoplasias
* non cooperation
A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication

The purpose of this study is to track changes in overactive bladder (OAB) medical regimen and/or OAB medication dosage requirements.

Subjects will complete a study specific survey questionnaire at Screening and the Month 1 through Month 6 visits. Subjects will be followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject has overactive bladder as determined by their prescribing physician
* Subject is currently receiving pharmacotherapy for overactive bladder
* Subject is willing to comply with required protocol/study requirements

Exclusion Criteria:

* Subject has a history of a clinically significant illness or medical condition prior to screening that would preclude participation in the study
* Male subjects with Lower Urinary Tract Symptoms (LUTS) or Bladder Outlet Obstruction (BOO)
RAVE: Radial Artery Vascular Complication and Resource Utilization

The primary objective of this study is to determine if there is a reduction in time to hemostasis in subjects treated with SoftSeal®-STF hemostatic pad when used in conjunction with a vascular compression device after radial transcatheter procedure.

The SoftSeal-STF hemostatic pad and compression devices (TR BAND® and RadAR EasyCLik) function to stop bleeding without obstructing radial artery flow, and have been shown to reduce the occurrence of radial artery occlusion.

The SoftSeal-STF hemostatic pad is an FDA-approved, chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot. Its mechanism of action is believed to be due to bioadhesion between the chitosan polymer chains, which are positively charged, and the negatively charged blood and tissue components, thereby stopping bleeding.

In this study the RadAR EasyCLik and TR BAND® Compression devices will be used with the SoftSeal®-STF hemostatic pad to promote hemostasis at the puncture site. Both vascular compression devices are FDA approved.

The VascBand™ Hemostat is an FDA-approved compression device designed to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an angiogram/PCI
* Planned transradial approach

Exclusion Criteria:

* Evidence of impaired dual perfusion to the hand when tested using Allen's test
* Inaccessible radial arteries due to anatomic variations
* Infection or other skin disorder at the puncture site
* Undergoing an emergent or unplanned angiogram using the transradial approach
* Evidence of severe cognitive impairment or inability to understand the study procedures and answer follow-up questions
* Known sensitivity or allergic reaction to materials in the study devices
* Unwilling to participate in the study and follow all study-related procedures
* Participating physician deems the subject to not be a good candidate
* Inability to achieve radial access
Intervening on Women's Health for Rural Young Breast Cancer Survivors

The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young breast cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young breast cancer survivors' engagement in goal-concordant oncofertility care.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer (Stages 0-IV) diagnosis
* Primary language English or Spanish
* Receiving oncology care at participating clinical sites
* Living in Imperial County, California

Exclusion Criteria:

- Women who are pregnant at recruitment
A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes

The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.


Eligibility Criteria:
Inclusion Criteria:

• Eastern Cooperative Oncology Group Performance Status of 0 to 2

For Parts A \& B:

* Relapsed or refractory (R/R) acute myeloid leukemia (AML) as defined by the 2016 WHO Classification
* R/R myelodysplastic syndromes (MDS) as defined by the 2016 WHO Classification with intermediate, high or very high risk by Revised International Prognostic Scoring System (IPSS-R)

For Part C:

• Treatment-naïve (TN) (ie, previously untreated) MDS as defined by the 2016 WHO Classification with intermediate, high or very high risk by IPSS-R

For Part D:

• TN AML as defined by the 2016 WHO Classification, including secondary AML and therapy-related AML in participants who are ineligible (IE) for intensive chemotherapy (IC) and allogeneic hematopoietic stem cell transplant (HSCT)

Exclusion Criteria:

* Acute promyelocytic leukemia
* Immediately life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection, uncontrolled bleeding, and/or uncontrolled disseminated intravascular coagulation
* Participants who have received prior treatment with a CD47 or SIRPα targeting agent
* Participant is on chronic systemic immunosuppressive therapy or corticosteroids
* Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting study treatment, whichever is shorter (relapsed or refractory participants only).
* Any condition including, active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study
* Pregnant or nursing participants.

Other protocol-defined inclusion/exclusion criteria apply
Effects of Feet and Ankle Mobilization on Balance of Older Adults

This study aims to assess whether mobilization of the ankle and foot produces significant improvements in the balance of the elderly.

To this end, a randomized study was designed with a control group that performs proprioception exercises and an experimental group that also performs a mobilization of the ankle and foot joints.

Aging leads to a decrease in physical activity and a reduction of postural control, which implies a loss of balance control, both static and dynamic, thus compromising the autonomy of the elderly and increasing the risk of suffering a fall. It has been observed that the balance degenerates in an accelerated way from 60 years of age. Basically appears a natural physiological degeneration of the organism, which affects strength, range of mobility, reduces vestibular function, there is loss vision and lower cardiopulmonary capacity.

In the older adult who suffers falls, in relation to the one who does not suffer, a series of differences or determinants have been observed. In this group, a series of characteristics such as the lower flexibility of the ankle joint and the muscle-tendon complex are present, hallux valgus appears, lower foot tenderness or a decrease in the strength in the first plantar flexor finger. They appear to have poorer balance and have less force in the flexors of the soles accompanied by less mobility of the foot inversion-eversion.

One of the causes that seems to contribute in the decrease of the balance in the older adult are the alterations in the ankle and foot, besides supposing a worse capacity of adaptation to the possible environmental changes. Before a deficit of this type, the subject tends to compensate for his position with compensatory strategies in other joints of the lower limb. It has also been shown that as we grow older, there is an increase in the demand for articulation of the other joints, such as the hip and knee, secondary to a decrease in joint range of ankle and foot or weakness of the dorsal flexors of the foot.

It follows that there is a relationship between alterations in the ankle and foot and the balance in the elderly, all related to the forces that suffer the ankle in the gait and to the low normal activity. Any alteration in this joint could predetermine an alteration of its function in maintaining stability in the elderly.

Eligibility Criteria:
Inclusion Criteria:

* Old adults over 60 years

Exclusion Criteria:

* Subjects with balance disorders whether vestibular or central.
* Subjects with lower limb prosthesis.
Feasibility and Safety of Bile Duct Clearance by Transcystic Sphincter of Oddi Balloon Dilatation

To investigate feasibility and safety of intraoperative bile duct clearance by sphincter of Oddi balloon dilatation via cystic duct at cholecystectomy.

Primary endpoint: rate of successful bile duct stone clearance (feasibility). Secondary endpoints (safety): rate of peri-interventional complications (injury to the common bile duct, bleeding, injury to surrounding organs: stomach, duodenum, liver) and short-term postoperative complications (bile leak, cholangitis, lipasaemia, pancreatitis, pneumonia). Duration of procedure. Length of hospital stay.

Standard approach to address common bile duct stones is endoscopic retrograde cholangiography (ERC) with sphincterotomy. Those interventions are performed either before or after gallbladder removal (cholecystectomy), thus, requiring at least two interventions. Moreover, ERC with sphincterotomy is associated with a considerable rate of short and long-term morbidity. The main complications are pancreatitis (2-7%), post sphincterotomy bleeding (1-2%), impaired function of the sphincter with reflux of duodenal content to the bile ducts and a consecutive risk for cholangitis, stone recurrence and even a potential higher risk for cholangiocarcinoma.

The aim of this study is to evaluate an alternative surgical approach of bile duct clearance at the time of cholecystectomy. Literature of this approach is scarce; however, it has shown a trend to lower postoperative complications if compared to ERC. The technique of sphincter of Oddi balloon dilatation and bile duct clearance from stones via cystic duct at cholecystectomy has been described in a few case series. These small case series have shown a good success rate of bile stone clearance and low complication rates when applying the balloon dilation technique for smaller stones.

The investigators have used this technique in selected cases with good success as well. However, the technique needs to be assessed regarding feasibility and safety in a consecutive group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Patients ≥ 18 years of age
* Patients with gallbladder stones and known or expected concomitant bile duct stones
* Bile duct stones ≤ 6mm in size measured by intraoperative cholangiography

Exclusion Criteria:

* Women who are pregnant
* Declined consent
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Patients with moderate or severe acute cholangitis
* Patients with moderate or severe pancreatitis
Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease

Common barriers to receiving appropriate guideline-driven care for patients with severe aortic stenosis include referral biases by primary care providers (lack of provider education), patient comorbidities (degree of fragility), as well as psychosocial issues and cultural barriers. Additionally, race, ethnicity, socioeconomic status (SES) and education level are shown to be persistent barriers to accessing healthcare services and healthcare systems, creating a significant practice gap between various patient populations. The most recent transcatheter valve therapies (TVT) registry data show that \>94% of TAVR recipients are Caucasian, followed by less than 4% of African-Americans and Hispanics, respectively. There is a critical need to understand the barriers to treatment and care among severe aortic valve disease patients of disparate groups. This study is a multi-center, retrospective and prospective cohort study of patients diagnosed with severe aortic stenosis. Additionally, we will be surveying referring primary care providers, cardiologists and cardiovascular surgeons to assess their current referral practices for patients with severe aortic stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Disparity/Diversity background (either race/ethnicity, low SES (adults with incomes at or below the federal poverty level (family income to poverty ratio, ≤1), language (non-English speaker) or education (≤9 years of education))
* Patient scheduled for transcatheter aortic valve replacement using the Edwards Sapien valve, OR recently implanted with Edwards Sapien valve (up to 1 year post-TAVR)
* Echocardiographic diagnosis of severe, symptomatic AS and intermediate to high surgical risk per Society of Thoracic Surgeons (STS) mortality risk-score

Exclusion Criteria:

* Age \< 18
* Patients who do not allow their records to be used for research