cyrilzakka/clinical-trials huggingface dataset:
A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1.18 to 75 years old, both male and female;

2.ECOG score: 0-1;

3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;

4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;

5.Measurable lesions available;

6.Major organ function is basically normal;

7.Estimated survival time is at least 6 months;

8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.

Exclusion Criteria:

1. Histologically or cytologically confirmed mixed SCLC and NSCLC;
2. Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);
3. Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;
4. Previous thoracic radiotherapy;
5. Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;
6. Systemic immunostimulant therapy before the first dose;
7. Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
8. Subjects with autoimmune diseases;
9. Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
10. Known or suspected interstitial pneumonia;
11. Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
12. Severe cardiovascular and cerebrovascular diseases;
13. Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
14. Arteriovenous thrombotic events within 3 months before the first dose;
15. Positive HIV test;
16. Active hepatitis B or C;
17. Evidence of active tuberculosis infection within 1 year before the first dose;
18. Serious infection within 4 weeks before the first dose;
19. History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;
20. Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose;
21. Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
22. History of severe allergic reactions to other monoclonal antibodies/fusion proteins;
23. Allergic to any component of the randomized treatment regimen;
24. Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;
25. Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse;
26. Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.
The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus

Globus pharyngeus or sensation may be defined as a feeling of something a lump in the throat without dysphagia. Kinesio tex tape is a medical tap developed by Dr. Kase for therapeutic purposes and has been widely used in physical therapy applications in recent years. Although it is not a treatment with full consensus, the patient's complaints can be corrected with a small number of different therapy techniques or regulations on life.

We conducted a therapy program with kinesio taping on patients who diagnosed with globus pharyngeus for 8 session with sham kinesio taping controlled group. This study aimed to assess of efficacy of the kinesio taping with therapy on patients patients who diagnosed with globus pharyngeus.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with globus pharyngeus
* 18 -65 years
* give a consent form

Exclusion Criteria:

* patients with dysphagia or odynophagia
* laryngeal organic pathologies
* pharyngeal organic pathologies
* epiglottic retroversion
* malignancy
* pregnancy
* mental disorders
* neurological disorders
* major psychiatric disorders
* give not a consent form
Effects of an Exercise Rehabilitation Programme With a Nasal Inspiratory Restriction Device in COPD Patients

This study evaluates the effects of a nasal restriction device for inspiratory muscle training (FeelBreathe) after 8 weeks of exercise intervention on exercise capacity, quality of life, dyspnea and inspitarotory muscle strength in patients with stable COPD. Participants were divided in three groups: 1) exercise intervention using the Feelbreathe® device (FB group), 2) exercise intervention with oronasal breathing without FB (ONB group) and 3) no participation in the exercise intervention as control group (CG).

The Feelbreathe® device, tested in the investigator's study can be used in static and dynamic situations and is a nasal ventilatory flow restriction device made by a strip of hypoallergenic material (3M Spain, S.A. Medical Specialties / O.E.M.) that is placed and adhered under the nostrils impairing the free pass of air through the nose by producing resistance to flow. Depend on the size or/and porosity of the device, the inspiratory process is more or less difficult. It can be used while performing dynamic exercise or doing daily living activities. The Feelbreathe® device (FB) has been authorized by the Spanish Agency for Medicines and Health Products for application on COPD patients (Expedient 521/15/EC. AEMPS-Madrid-Spain-Patent Nº: P200902402).

Eligibility Criteria:
Inclusion Criteria:

* men with diagnosis of COPD according to guidelines criteria
* with moderate or severe airflow obstruction (GOLD 2 or 3)
* dyspnea grade 2 or greater by mMRC scale
* stable clinical condition for at least 2 months.

Exclusion Criteria:

* poor compliance
* treatment with oxygen therapy or non-invasive mechanical ventilation
* CO2 retention
* medical conditions that can produce or increase dyspnea on exercise in addition to COPD (cardiovascular, metabolic or other respiratory diseases)
* osteoarticular or neuromuscular diseases that may limit the correct performance of the 6MWT
Post-operative Analgesia Efficacy Using Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Ultrasound-guided Quadratus Lumborum Type II Block.

Post-operative analgesia efficacy using ultrasound-guided transmuscular quadratus lumborum block versus ultrasound-guided quadratus lumborum type II block

The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics between the quadratus lumborum muscle and latissimus dorsi muscle, which is called quadratus lumborum type II block. 〝 Transmuscular quadratus lumborum block demonstrates that injectate spreads over the posterior abdominal wall to the psoas major muscle and includes the upper branches of the lumbar plexus.〞described by Adhikary in 2016. However there are no published reports comparing the 2 techniques. In our study, compared of ultrasound-guided QL2-blocks with transmuscular quadratus lumborum block to investigate analgesic consumption, pain level, opioid related side effects and mobilization.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists classification (ASA) 1\~3
* adequate communication skills
* Body mass index \< 32

Exclusion Criteria:

chronic pain neurological illness/ neuropathy contraindication against local anesthetics
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Female
* ECOG performance status 0-1
* Age 65 years or older
* cT1 or cT2 (≤3.0 cm)
* Invasive ductal carcinoma histology
* Estrogen receptor positive (ER+)
* Grade 1 or Grade 2
* Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
* Suitable for breast conserving surgery and radiation therapy
* Patient must be able to provide study-specific informed consent

Exclusion Criteria:

* Multi-centric cancer not amenable to single lumpectomy
* Prior ipsilateral whole breast radiation
* Known BRCA 1 or BRCA 2 mutation
* Status post neoadjuvant hormonal or chemotherapy
* Invasive lobular histology
* Pure ductal carcinoma in situ (DCIS)
* Grade 3
* Diffuse suspicious microcalcifications
Comparison of Standard and Endoscope Assisted Endotracheal Intubation

Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation

Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures are typically performed using general anesthesia. During anesthesia, the anesthesiologist inserts a breathing tube (endotracheal tube) into the patient's wind pipe (trachea) and a machine helps the patient breathe (mechanical ventilation) while they are unconscious. The breathing tube is inserted with a patient laying on his/her back using a rigid metallic device (laryngoscope) to guide tube placement. The unconscious patient is then moved from the portable bed onto the X-ray table by nursing staff. The patient also has to be turned to lie on their stomach on the X-ray table for the procedure. This standard approach carries a small risk of patient injury during breathing tube placement as well as while moving and turning the unconscious patient onto the X-ray table.

At our endoscopy unit, endoscopists have, on several occasions, used a slim gastroscope to place the breathing tube under direct visualization in patients who are already positioned on their stomach for ERCP. This approach is rapid and has been uniformly successful and safe.

We hypothesize that this endoscopist-facilitated intubation approach may expedite the procedure and minimize ergonomic strain for staff during patient repositioning while minimizing patient injury during breathing tube placement and repositioning. This study seeks to formally compares the two approaches for placement of a breathing tube.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ERCP at Stanford University Medical Center

Exclusion Criteria:

* Unable to consent
* Contra-indication to general anesthesia
Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation

Mycocardial systolic function (contractility) is an essential element of cardio-circulatory physiology during major visceral surgery, in particular during liver transplantation during which several factors are likely to be at the origin of a ventricular dysfunction: acute hemorrhage, major volume changes, acute pulmonary arterial hypertension and ischemia-reperfusion syndrome.

Ventricular dysfunction is an underestimated intraoperative liver transplantation phenomenon while it constitutes a risk factor for peroperative and postoperative morbidity and mortality established that graft function can be compromised through the phenomena of low cardiac output and hepatic congestion.

Also, better analyzing myocardial systolic function during liver transplantation could guide practitioners in the treatments to be undertaken, evaluate their effects and diagnose various complications.

In addition, the usual cardiac output measurement systems (transpulmonary thermodilution techniques and pulse wave contour analysis) are poorly suited to liver transplantation. Frequent variations in blood volume, vasomotor tone and temperature require regular recalibrations and prevent a continuous and reliable estimate of cardiac output.

Thus, the choice of hemodynamic monitoring during liver transplantation performed in our center is transesophageal ultrasound, a semi-invasive method with a favorable benefit-risk ratio in this category of the population. However, analysis of right ventricular systolic function by classical indices is difficult in transesophageal ultrasound for reasons of alignment of the ultrasound shot on the right ventricular. The analysis of left ventricular systolic function is complex due to the sudden variations in volume and the difficulty in carrying out planimetry measurements in real time.

Myocardial strain imaging has been developed in recent years and is widely validated for the assessment of left ventricular contractile function. It was subsequently applied to the exploration of the right ventricular. Its measurement can be performed from recordings on dedicated software.

Thus, the strain could make it possible to better assess myocardial systolic dysfunction in liver per-transplantation from the transesophageal echographic loops recorded in current practice at the different operating times. Strain measurements will be carried out a posteriori from the images which are acquired in a standard way during the operation.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years old and more
* Patients undergoing a liver transplantation

Exclusion Criteria:

* Contraindication to transesophageal ultrasound
* Refusal to participate
* Age \<18 years old
The EvAluation of TaBlo In-CLinic and In-HOme

The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
* Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.

Exclusion Criteria:

* Life expectancy less than 12 months from first study procedure.
* Subject has had a recent major cardiovascular adverse event within the last 3 months.
* Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%.
* Subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
* Subject has uncontrolled blood pressure.
* Subject is intolerant to heparin.
* Subject is seroreactive for Hepatitis B Surface Antigen.
* Subject has an active, life-threatening, rheumatologic disease.
* Subject has a history of adverse reactions to dialyzer membrane material.
* Subject is expected to receive an organ transplant during the course of the study.
* Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation

The purpose of this project is to reduce health disparities in obesity risk among 8-10 year old African American girls using a culturally sensitive and developmentally appropriate internet-based program with no face-to-face interaction. This study will conduct an outcome evaluation to test short and longer term effects on obesity risk.

This research will conduct an outcome evaluation on a promising web based obesity prevention program for 8-10 year old African American girls. A pilot study with 80 girls established its feasibility: recruitment goals were met; attrition rates were \< 10%; logon rates to the online program were 74.5%; and statistically significant increases in fruit and vegetable consumption and time spent being physically active were observed. The outcome evaluation will recruit 400 child-parent pairs to examine short and longer term effects of the program on obesity risk. It will also conduct mediation analyses to examine pathways of effect. At the end of the study, the web based program will be hosted on the CNRC web site. Although the use of the internet as a method for changing health behavior is not new, the use of an internet program alone, with no face to face interaction, is novel. This is one of the first programs to attempt this, particularly in an at-risk population.

Eligibility Criteria:
Inclusion Criteria:

* 8-10 years old
* healthy
* African American
* parent willing to participate in data collection
* internet access
* personal email address

Exclusion Criteria:

* mental, physical, or medical conditions that limit fruit-vegetable consumption, physical activity, or ability to fully participate in the program and/or complete baseline and post assessment data collection
* taking medications that influence dietary behaviors, appetite, and/or physical activity
Clinical Trial of Menu Labeling

The current study sought to examine the effect of menu labeling on food ordering and food consumption, including the effect of displaying calories along with other nutrients, such as sodium, fat, and sugar, as well as in different formats, such as traffic lights.

The investigators hypothesize significant differences in the calorie amount of menu selections and food consumption across experimental conditions. The investigators anticipate that calorie amounts will be significantly higher in the no calorie information) compared to each of the other 3 conditions, and significantly lower in the Traffic Light conditions compared to calories only condition.

2) Individuals in Condition 1 (no calorie information) will be significantly more likely to underestimate the calorie content of their meals compared to individuals in the intervention conditions.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* able to speak and read English

Exclusion Criteria:

- no food allergies to gluten or other grain products
Intervention in a Small-scale Study of Game Based Cognitive Change Skills

This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy

Preliminary efficacy will be tested in an emotion-regulation framework. Children included in this study will be allocated to play Level 4 of the REThink game on cognitive change or to no intervention Control condition. Children and adolescents in the intervention group will be distributed afterwards in two groups: with or without ecological momentary intervention (EMI) using the PsyPills app for following-up with the cognitive change ER personalized strategy reminder during a real exam situation. Outcomes considered will be stress reactivity (both subjective and physiological) using EMA before, during and after the test (Colombo et al., 2020), and cognitive change, namely irrational and rational beliefs, and reflective functioning improvements.

Eligibility Criteria:
Inclusion Criteria:

* children and adolescents between 10 and 16 years old
* provided written parental consent
* able to access mobile/internet applications on their device

Exclusion Criteria:

* Intellectual disability or physical limitations precluded the use of the computer program
* Had a major mental health disorder
Directly Observed Therapy in High Risk Populations in Newark, NJ

30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michael's Medical Center and be given Directly observed therapy.

30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michael's Medical Center. Consent will be obtained, their regimens will be switched to QD based on previous therapies and resistance patterns if available. Patients will be placed on direct observed therapy.Each patient will be placed on Fortovase/Ritonavir (1600mg/100mg)QD plus two or three NRTIs based on a phenotypic baseline testing to a protease inhibitor. Patients will visit the office at baseline, weeks 1, 4, 8, 12, 16, 24, 32, 40, and 48. Patients will also be visited daily by the social worker (or designee) to observe patients taking their antiretroviral therapy for 6 months. After six months of direct observed therapy patients will be given a diary card to record administration of medications and the social worker ( or designee) will visit the home twice weekly. If the patient experiences a change in therapy secondary to virologic failure, the patient will return to baseline visit for the new once a day regimen. Virologic failure will be defined as \< .5 log drop between each visit or \> 400 copies/mL at week 24 on two separate occasions at least 14 days apart

Eligibility Criteria:
Inclusion Criteria:

1. Men and Women \> 18 years of age with a confirmed HIV-1 diagnosis 2. CD4 count \<350 and or history of opportunistic infection 3. HIV PCR \>55000 and \>55,000 on one occasion in last 12 months 4. Patients with poor compliance (Poor compliance will de defined as taking less than 80 percent of prescribed medication 5. Patients with mental illness, HIV dementia, substance abuse or social factor prohibiting compliance 6. Willingness to sign informed consent or legal guardian

-

Exclusion Criteria:

1. ALT/AST \> 5X ULN
2. CReatinine \>2.0 -
5HTP Regulation Of Asthma In Children

The purpose of this study is to learn more about if taking a supplement called 5-hydroxytryptophan (5HTP) can improve breathing and anxiety symptoms related to asthma. To help learn more subjects will either be assigned to a group that is taking the supplement (5HTP) or a group that is taking a placebo. This will be decided randomly. Later in the study subjects will crossover to the other group.There are 5 study visits over the course of about 12 weeks.

The objective of this study is to test the hypothesis that over-the-counter amino acid supplement 5HTP (isolated from the plant Griffonia Simplifolia) reduces human allergic lung responses and consequently improves lung function. The primary outcome is the change in FEV1. We anticipate the 5HTP at the proposed doses will improve lung function as in preclinical studies that used clinically relevant 5HTP. Secondary outcomes will be blood eosinophil counts and reduced symptoms for anxiety/depression, as seen in changes in the anxiety-depression scores from questionnaires (CES-DC \& SCARED). The results from these studies have the transformative potential to influence approaches to improve lung function and asthma-associated anxiety/depression.

* Aim 1: Test that 5HTP improves lung function in children with allergic asthma
* Aim 2: Test that 5HTP reduces eosinophil numbers in the blood and nasal fluid of patients with asthma from Aim 1
* Aim 3: Test that 5HTP decreases lung inflammation, increases cortisol and prolactin without altering systemic plasma concentrations of 5HTP, serotonin, 5-hydroxyindoleacetic acid (5-HIAA), and dopamine

Eligibility Criteria:
Inclusion Criteria:

* Age 8-18 Years of Age
* Mild to Moderate Asthma based on ATS guidelines
* Positive Allergy Test (positive skin or serum IgE)
* Weight ≥ 70 lbs (32 kg)
* CES-DC cut-off ≥ 15 (total score range is 0 to 60) or SCARED cut-off

  * 25 (total score range is 0 to 142)
* Ability to comply with study visits and study procedures
* Informed Consent by participant and if applicable the parent or legal guardian

Exclusion Criteria:

* Currently taking a SSRI
* Taking a leukotriene inhibitor (montelukast, Zileuton)
* Severe Asthma Based on ATS Guidelines
* Taking a biologic medication (omalizumab, mepolizumab, benralizumab, dupilumab)
* Medical History of Adverse Reaction to 5HTP
* Physical findings that would compromise the safety of the study or the quality of the study data