cyrilzakka/clinical-trials huggingface dataset:
Bump the Lump - Intervention for the Treatment of Globus Pharyngeus

To develop a standardized speech-language pathology treatment protocol to systematically address Globus pharyngeus (GP) as a proof of concept

Globus pharyngeus (GP), often described as a persistent lump or tightness in the throat, accounting for 4% of new referrals to Ear, Nose, and Throat (ENT) clinics. This condition is reported in the literature in up to 46% of healthy individuals and has been shown to significantly impact patients' quality of life. The key diagnostic criteria for GP include at least 12 weeks duration of symptoms without dysphagia or gastroesophageal reflux as the causative symptom, and in the absence of major esophageal motor disorders. While the exact etiology of GP remains elusive, research suggests a multifactorial nature involving physical, psychological, and functional components. Behavioral therapy with a Speech-language pathologist is often recommended as a treatment option for patients with GP. A review of the literature examining SLP interventions for GP shows that SLP treatments lack standardization, leading to inconsistency and limited efficacy across therapeutic interventions. Therefore, there is an urgent need to further investigate behavioral interventions for GP and develop a standardized treatment protocol to address the condition systematically.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer adult patients (age 18 and over) evaluated at the Atrium Health Wake Forest Baptist Center for Voice and Swallowing Disorders who report a complaint of globus pharyngeus

Exclusion Criteria:

* Patients diagnosed with a swallowing disorder will be excluded from the study
Multi-Slice CT of the Chest( MSCT Findings After Lung Transplantation)

The purpose of the study is to compare Multi-Slice Computer Tomography findings with histological and physiological changes observed in transplanted lungs with Progressive Graft Disfunction.


Eligibility Criteria:
Inclusion Criteria:

* All patients that have had a lung transplantation

Exclusion Criteria:

* Under 18,
* Reduced kidney function,
* Known contrast allergy; and
* Language problems that make cooperation difficult.
Pulmonary Artery Harmonic Ace+7 Energy Sealing in VATS Lobectomy

Video-assisted thoracic surgery (VATS) anatomical lung resection provides an effective minimally invasive treatment strategy for stage I and II lung cancer. VATS lobectomy is associated with significantly less postoperative atrial fibrillation, blood transfusion, renal failure, and other complications when compared with lobectomy via thoracotomy.

Although VATS lobectomy has been proven to be effective and safe in experienced hands, it is not devoid of risk. Intra-operative surgical complications can be at times catastrophic. Complications include: pulmonary vascular injuries (Pulmonary artery (PA), pulmonary vein) necessitating urgent conversion to open thoracotomy and even death. Causes of conversion included PA injury, difficult anatomy, bulky/calcified lymph nodes, and technical problems including stapler misfire. PA injury alone constituted 37.5% of all conversions. Proper dissection of all tissue around PA branches is sometime difficult especially in the presence of adhesions or large, calcified lymph nodes and may increase the risk of vascular injury.

Currently, in spite of being a safe and effective technique in experienced hands, a minority of anatomical pulmonary resections are being performed by VATS. In an analysis utilizing the Nationwide Inpatient Sample (NIS) database in the United States, only 15% of anatomical lung resections were performed by VATS.

The technical difficulty and danger of VATS lobectomy is directly related to PA branch manipulation, stapling and division. PA manipulation is the main hesitation of many thoracic surgeons regarding the adoption of VATS lobectomy. We believe that if we can decrease the manipulation and dissection required by the surgeon on the PA branches, we can make these procedures safe and therefore more prevalent for anatomical pulmonary resections.

This study consists of evaluating the safety and efficacy of energy sealing lobar PA branches for lobectomy in humans. All patients planned to undergo a lobectomy by VATS at the CHUM - Hôpital Notre-Dame will be approached. In our institution, lobectomies are either done open (thoracotomy) or by minimally invasive approach, known as VATS (video assisted thoracoscopic surgery). This decision is based on the surgeon, tumor size, tumor localization and patient characteristics. Only patients already planned for a VATS lobectomy will be approached. Potential patients will be selected by going over the operation request forms. Patients booked for a VATS lobectomy will be approached either in the preoperative clinic or the day before surgery, when admitted. Aim is to recruit 20 patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients planned to undergo a VATS lobectomy at the CHUM-Hopital Notre-Dame

Exclusion Criteria:

* Age \> 18 years old
* Inability to consent to the study
The Effect of Information on Physical Fitness Measures and Training in Overweight Children

In the present study the investigators will examine the impact of varying information (positive compared to standard information) concerning a drink for improving physical fitness in overweight children.

The present study will explore the short and medium term effects of receiving information concerning a drink (water) (positive compared to standard information) on the physical fitness in overweight children.

Study subjects will be 30 overweight children aged 6 to 13, new participates in a nutritional, behavioral sport program,The control group of 30 normal weight children.

The first stage of the study the investigators will examine the short-term influence of different types of information concerning water on subjects' fitness which will be measured by treadmill performance. First, the water will be presented to the participants children as an ordinary water while in the second case it will be presented as an "energy drink".

The second stage of the study will examine the impact of varying information on the subjects' sports participation/level of physical activity over a 6 week period of training, Study subjects will be 30 over-weight children aged 6 to 13, who participate in a nutritional, behavioral sport program. During this period, information on the type of drink will be changed every week. Children will be assessed in all training sessions and their level of activity will be monitored to examine whether the information on the drink led to a different exercise behavior.

The study hypothesis is that the use of these positive information will increase participants' fitness and levels of activity compared to standard information.

Eligibility Criteria:
Inclusion Criteria:

* Pre pubertal children
* Study group: BMI precentiles over 85 (overweight and obese children)
* Control group: BMI precentiles between 5-85 (normal weight children)

Exclusion Criteria:

* Children with organic Disease
* Competitive athlete
Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis

The purpose of this study is to determine whether transendocardial injections of autologous endothelial progenitor cells CD 133 is safe and feasible in patients with refractory angina.

The PROGENITOR trial is a randomized, double-blinded, multicenter controlled trial including patients with Canadian cardiovascular society angina classification (CCS): II-IV and ischemic zones by SPECT but without any option for revascularization. Primary endpoint was to assess the safety and feasibility of transendocardial injection of selected CD133+cells. All patients were treated for 4-days with granulocyte colony-stimulating factor and underwent apheresis. CD133+ cells were selected with CliniMacs system and were injected transendocardially guided by the NOGA XP system.

Eligibility Criteria:
Inclusion Criteria:

* Functional class II- IV angina on maximal medical therapy
* Myocardial Ischemia/viability demonstrated by a reversible perfusion defect by means imaging techniques
* Patients should not be amenable to any type of revascularization procedure (percutaneous or surgical)
* Signed informed consent

Exclusion Criteria:

* Age \<18 years or \>75 years.
* Atrial fibrillation.
* LV thrombus
* Acute myocardial infarction in the last 3 months
* An LV wall thickness of \<8 mm at the target site for cell injection
* A history of malignancy in the last 5 years
A Phase II Clinical Trial of YH23537 in Patients With Chronic Periodontal Disease.

This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.

at screening visit, at least existing 18 teeth,Mild/moderate/severe periodontitis patients diagnosed with chronic periodontitis according to the CDC / AAP (Center for Disease Control / American Academy for Periodontology) periodontitis classification (2012).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 19 years of age or older
* Have at least 18 natural teeth
* have been diagnosed with chronic periodontitis
* have been diagnosed Mild/Moderate/Severe periodontitis with according to CDC / AAP periodontal classification (2012))
* Provide informed consent and willingness to cooperate with the study protocol

Exclusion Criteria:

* Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 4 weeks after the last dose of investigational product.
* Pregnant or lactating females
* Systemic diseases such as diabetes and hypertension
* Patients who take Anticoagulants or Antiplatelet Agents
* Continually use for phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month
* Patients who received periodontal treatment within the last 6 months
* Patients who have malignant tumor
* History of positive serologic evidence of current infectious liver disease including HbsAg, or anti-HCV.
* Patients with mental retardation and dementia
A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. The entire study included a screening period, a double-blind controlled treatment period, a conversion and maintenance treatment period, and a safe follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥18≤75 years old.
2. Atopic dermatitis (AD) diagnosed at least 1 year before screening.
3. Subject with eczema area and severity index (EASI) score ≥16, Investigator Global Assessment (IGA) score≥ 3, Body Surface Area (BSA) score ≥ 10% at screening and baseline.
4. Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable

Exclusion Criteria:

1. Acute onset of AD within the first 4 weeks of randomization.
2. Have participated in any clinical research on AK120 in the past
3. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
4. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
5. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
6. Received allergen specific immunotherapy within the 3 months before randomization.
7. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
Non-Eosinophilic Neutrophilic Asthma

Define and characterize the neutrophilic phenotype of severe asthma.

Neutrophilic asthma (NA) is the asthma phenotype less known, causes a severe disease and does not have a specific treatment. Research on the neutrophilia mechanisms, new neutrophil (NEU) types and bronchial microbiome, can provide an opportunity to better understand the NA pathogenesis.

OBJECTIVES: 1. To describe the clinical characteristics of NA and its sub-phenotypes (SUBSTUDY 1); 2. To determine the NEU types associated with the NA and its sub-phenotypes (SUBSTUDY 2); and 3. To identify the bronchial microbiological flora of the NA, specifically related to lung microbiome and the immune response against Chlamydia Pneumoniae (SUBSTUDY 3).

METHODS: Multicenter prospective study including 100 patients with severe asthma (GINA/GEMA criteria): 50 with non-neutrophilic asthma (\<65% NEU in induced sputum \[IS\]); and 50 with NA (\> 64% NEU in IS). SUBSTUDY 1: clinical variables (years of evolution, exacerbations, asthma control test, mini asthma quality of life questionnary), comorbidities (GERD, nasal polyposis, obesity, ASS), pulmonary function (FEV1, exhaled fraction of nitric oxide, total lung capacity, Aspergillus), prick-test and CT scan chest; SUBSTUDY 2 (in IS and plasma): apoptotic index by means NE culture and flux cytometer (Annexin-V-FITC), NEU phenotype by surface markers (CD16, CD66b, CD62L, HLADR, CD177, CD11b, CD63, CXCR2, CXCR4) with density gradient study and determination of cytokines (IL-6, IL-8, IL-17, IL-1, IL-22) by ELISA; SUBSTUDY 3 (in IS): bronchial microbiome for 16 subunit rRNA by Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt), and anti-Chlamydia Pneumoniae Immunoglobuling A by ELISA.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 80 years old
* Confirmed diagnosis of asthma (according to spanish guideline GEMA)
* Severe persistent asthma (step 5-6 GEMA)
* Eosinophils\<300/mm3 in peripheral blood

Exclusion Criteria:

* Respiratory infection during the previous month
* Significant lung pathology not attributable to asthma (bronchiectasis with Reiff score\>3)
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Primary Objective:

To evaluate the efficacy of alirocumab (75 or 150 milligrams \[mg\] depending on body weight \[BW\]), administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels at Week 12 of treatment in children and adolescents with homozygous familial hypercholesterolemia (hoFH) of 8 to 17 years of age on top of background treatments.

Secondary Objectives:

* To evaluate the efficacy of alirocumab after 24 and 48 weeks of treatment on LDL-C levels.
* To evaluate the effects of alirocumab on other lipid parameters (eg, apolipoprotein B \[Apo B\], non-high density lipoprotein cholesterol \[non-HDL-C\], total cholesterol \[Total-C\], high density lipoprotein cholesterol \[HDL-C\], lipoprotein a \[Lp (a)\], triglycerides \[TG\], apolipoprotein A-1 \[Apo A-1\] levels) after 12, 24, and 48 weeks of treatment.
* To evaluate the safety and tolerability of alirocumab up to 48 weeks of treatment.

The study duration was up to 62 weeks, which included (if needed) a run-in period of up to 4 weeks, a screening period of up to 2 weeks, a treatment period of up to 48 weeks, and a follow-up of 8 weeks.

Eligibility Criteria:
Inclusion criteria :

* Participants genetically diagnosed with hoFH.
* Participants treated with optimal dose of statin +/- other lipid modifying therapies (LMTs), or non-statin LMTs if statin-intolerant at stable dose(s) for at least 4 weeks.
* A signed informed consent indicating parental permission with or without participants assent.
* For participants on apheresis, currently undergoing stable LDL apheresis therapy prior to the screening visit (Week -2) and had initiated apheresis treatment for at least 6 months.

Exclusion criteria:

* Participants with LDL-C \<130 milligram per deciliter \[mg/dL\] (3.37 millimoles per liter \[mmol/L\]) obtained during the screening period after the participant had been on stable apheresis procedure or LMT (i.e., stable optimal dose of statin ± other stable LMTs, or stable non statin LMTs in statin-intolerant participants) treatment for at least 4 weeks.
* Participants with BW \<25 kg.
* Participants aged 8 to 9 years not at Tanner Stage 1 and participants aged of 10 to 17 years not at least at Tanner Stage 2 in their development.
* Participants with uncontrolled Type 1 or 2 diabetes mellitus.
* Participants with known uncontrolled thyroid disease.
* Participants with uncontrolled hypertension.
* Participants who will receive statin de novo during the run-in period.
* Fasting triglycerides greater than (\>) 350 mg/dL (3.95 mmol/L) at the screening visit.
* Severe renal impairment (i.e., estimated glomerular filtration rate \<30 milliliter per minute/1.73 meter square) at the screening visit.
* Alanine aminotransferase or aspartate aminotransferase \>2 \* upper limit of normal (ULN) at the screening visit.
* Creatine phosphokinase \>3 \* ULN at the screening visit.

The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial.
Technology Enabled Mental Health Intervention for Individuals in the Criminal Justice System

In the United States, over 60% of the 2.2 million people who are incarcerated struggle with mental health problems. Currently, correctional facilities are limited in their ability to provide care. As technology-enabled interventions for mood disorders have demonstrated efficacy outside of correctional facilities, the investigators propose to build and test a technology-enabled mood disorder treatment intervention for individuals who are incarcerated.

In the United States, over 2.2 million people are incarcerated. While these numbers are alarming, even more distressing is the rapid growth in the number of mentally ill individuals caught in this system. Within any given year, approximately 73% of females and 55% of males in jail will experience a mental health problem. This results in the criminal justice system serving as a de facto mental health treatment facility for hundreds of thousands of individuals, despite constrained funding and a paucity of qualified providers and interventions. More than one in five jails have no access to mental health services.

There is strong evidence that technology-enabled interventions for the treatment of mood disorders are efficacious and cost effective. Technology-enabled mental health care has many strengths, including the ability to deliver treatment reliably, increase privacy for those seeking services, and provide a scalable evidence-based intervention at a lower cost than traditional face-to-face services.

Edovo has previously developed secure tablet hardware, protected networks and a learning management system that deliver static content in the areas of academic, job skill, and life skill programming to those incarcerated. The aim of this project is to develop and demonstrate the feasibility of a dynamic intervention for the treatment of inmates with mood disorders utilizing the Edovo system. A user centered design approach will be used to modify existing evidence-based, technology-enabled mood interventions to be appropriate for the incarcerated population. Software will be modified to run the intervention on the existing Edovo system. The resulting intervention will be tested in a sample of inmates for an initial clinical signal. The development of such a technology would help correctional facilities more effectively meet their treatment requirements and rehabilitation goals.

Eligibility Criteria:
Inclusion Criteria

* Incarcerated Middlesex County Jail or Woodford County jails;
* Has access to the Edovo tablet;
* is at least 18 years of age;
* Is able to speak and read English Exclusion Criteria
* None
Hydrogen-rich Water and Appetite in Obesity

The main goal of this study is to investigate how dihydrogen supplementation impacts body composition, appetite, quality of life specific to obesity, and levels of the hormone GLP-1 in men and women with obesity. This randomized controlled trial aims to explore whether dihydrogen can improve these health indicators.

The primary aim of this randomized controlled trial is to evaluate the effects of dihydrogen supplementation on body composition indices, appetite, obesity-specific quality of life, and circulating GLP-1 levels in obese men and women

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Body fat \> 30% in women and \> 25% in men
* Not physically active
* Informed consent signed

Exclusion Criteria:

* Major chronic disease and acute injuries
* History of dietary supplement use during the past 4 weeks
* History of obesity pharmaceuticals use during the past 8 weeks
* No consent to randomization
* Participation in other studies
Cycle Ergometer Training and Heart Failure on Heart Rate Recovery and Mind Fullness

To evaluate the effects of cycle ergometer training on heart rate recovery in Newyork Heart Association (NYHA) class I and II heart patients. To evaluate the effects of cycle ergometer training on mind fullness in NYHA class I and II heart patients. Previous studies were designed to target only cardiac functions and no psychological aspect was studied so this study cover this aspect as well so from the outcomes of this study we can determine both psychological satisfaction and cardiac function as well.

A review stated that "clinical and experimental data shows that physical training is an important aspect in the management of chronic heart failure patients. Also, it stated that physical exercise training plays an important role to modulate peripheral immune responses if congestive heart failure (CHF) patients show high pro-inflammatory cytokines, soluble cellular adhesion molecules, which further resulted in an improvement in exercise capacity in CHF patients.

Heart rate recovery (HRR) improved in patients who were enrolled in the cardiac rehabilitation stage 2 program while similar outcomes were not noted among the control group. It was concluded that cardiac rehabilitation exercise program improves heart rate recovery. Also, HRR may be used in a cardiac rehabilitation program to recognize high risk factors and also useful in evaluating the outcomes.

a systematic review about the effects of exercise training in patients with CHF was published who concluded that short-term physical exercise training in selected subgroups of patients with CHF, has physiological benefits and positive effects on quality of life.

A meta-analysis by the Collaborative Group concluded that there is no evidence that supervised medical training programs for patients with CHF are dangerous and indeed there is clear evidence of an overall reduction in mortality. The authors did not perform a quantitative analysis on the outcome of cardiac performance, exercise capacity, or quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Vitally stable Patients with HF 6-8 weeks post-discharge from the hospital
* NYHA class I, II
* EF: 25-40%

Exclusion Criteria:

* Arrhythmias /Regular Pvc/Permanent pacemaker/Tpm
* Any systematic disease /infections
* Uncontrolled DM/HTN
* Unable to perform the 6-min walk test