cyrilzakka/clinical-trials huggingface dataset:
Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery

This clinical trial test whether taking part in a diet support intervention will help with patients nutrition and quality of life after surgery for esophagus or stomach cancer. The information learned by doing this research study may help patients get more information and/or support on eating after esophagus and stomach cancer surgery.

PRIMARY OBJECTIVES:

I. Assess the feasibility, retention, and satisfaction of the Telehealth Intervention for Self-Management of Eating after Gastric Surgery (TIMES) intervention as measured by the percentage of patients who a) agree to participate; b) complete a majority of the intervention (at least 2 sessions); and c) report satisfaction with the intervention (through structured exit interviews).

II. Assess the preliminary efficacy of TIMES for patient reported outcomes for quality of life (QOL), dietary symptoms, and self-management.

III. Assess the preliminary efficacy of TIMES for objective measures of patient nutrition.

OUTLINE: Patients are randomized in to 1 of 2 arms.

ARM I: Patients receive 4 telehealth sessions over 1 hour each over 4 months. Patients also receive an intervention guidebook.

ARM II: Patients receive standard nutritional support.

After completion of study, patients are followed up for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* The ability to understand English or Spanish.
* Undergone curative intent surgery for gastric or gastroesophageal (GE) junction cancer.
* Began oral intake within the past month.
* Aged 21 years and older.
* Able to participate in telehealth sessions.
* This study will be conducted in patients aged 21 years or older who have undergone curative intent surgery for gastric or GE junction cancer.
* Age criterion for this trial is based on the National Institute of Health (NIH')s age criteria, which defines an adult as individuals aged 21 years and over. There are no restrictions related to performance status or life expectancy.
* All subjects must have the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease

The study aimed to prove EEN is effective for inducing early clinical remission, mucosal healing, promoting fistula closure and reducing the size of abscess to adult CD patients. They plan to include about 50 patients and observe the effect of EEN.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Patients with CD was diagnosed clinically according to previously established international criteria \[9\]
* The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation but not fibrosis.

Exclusion Criteria:

* Patients do not macth the inclusion criteria and those who refuse to taking part in the study
College Student Daily Life and Alcohol Use Study

Heavy alcohol use among college students is associated with a range of negative consequences. However, college students rarely seek resources or treatment to change their alcohol use. Brief alcohol interventions (BAIs) have been developed as an alternative method to address heavy alcohol use among college students and show promise in reducing hazardous alcohol use in college students. Despite the established efficacy of BAIs, effects are often small and short-lived, and additional research is needed to investigate how BAIs can become more efficacious and endure for longer periods of time, particularly for computer-delivered interventions to improve accessibility and scalability of these interventions to a wider range of college students. Boosters or adjunctive components to BAIs have been suggested as a method to enhance the magnitude and duration of intervention effects. However, there remains a need to identify and test booster approaches that are both appealing and engaging to college students and effective in reducing heavy/hazardous alcohol use above and beyond the magnitude and duration seen by BAIs alone. The purpose of the study is to develop and test a novel, text-messaging booster as an adjunct to a current, evidence-based brief intervention, eCHECKUP TO GO, aimed at reducing college student heavy/hazardous alcohol use. Participants will complete baseline measures and will then be randomized to 1 of 3 conditions, stratified by sex at birth: 1) assessment only, 2) BAI only, and 3) Enhanced Intervention (BAI + four weeks of text messaging boosters). It is hypothesized that those randomized to the enhanced intervention condition will show a greater reduction in heavy/hazardous alcohol use at 3-month follow-up compared to the BAI and assessment only groups.


Eligibility Criteria:
Inclusion Criteria:

* 1) Ages 18-30; 2) report at least 2 heavy drinking episodes in the past month; 3) be enrolled in an undergraduate degree program; 4) own a smartphone with capability to run smartphone application

Exclusion Criteria:

* 1) current or past-year treatment (counseling or medication) for alcohol or drug use, 2) history of delirium tremens and/or seizures as a result of alcohol withdrawal, and 3) a lifetime diagnosis of either bipolar disorder or schizophrenia
High Flow Therapy in ICUs Across Ibero America

The study aims to describe the use of Nasal High Flow (NHF) in the intensive care units of participating centers in Iberoamerica. It will describe the indications for the use, the clinical outcome of patients , and the therapeutic failure of NHF therapy in patients staying in an intensive care unit in the participant centers in Iberoamerica.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Admitted to medical or surgical ICU
* Requirement of high nasal flow therapy

Exclusion Criteria:

* Post-extubation failure
* Patient unable to protect airway
* Diagnosed shock
* Glasgow equal or under 8
ESWL vs URS in Management of Upper Third Ureteric Calculi

comparative study of two treatment modalities (ureteroscopy and extracorporeal shock wave lithotripsy) in management of upper third ureteral calculi

Large impacted upper ureteral calculus is defined as a stone located above the lower border of the fourth lumbar vertebra, remaining fixed at the same site for at least six weeks. Moreover, it is associated with hydronephrosis and/or prevents contrast medium from passing below the calculus on intravenous urography (IVU).Moreover, there is inability to pass a guidewire or catheter beyond the stone at initial attempts. The treatment for patients with large impacted proximal ureteral stone remains controversial; the surgical options for the treatment of proximal ureteral stones include extracorporeal shockwave lithotripsy (ESWL), Ureteroscopy, PCNL and rarely Laparoscopic or Open surgery. Every technique has its own limitations. The aim of this study is to compare and to evaluate the outcome and complications of two main treatments procedures for impacted proximal ureteral calculi, Extracorporeal Shock Wave Lithotripsy (ESWL) and Ureteroscopy.

Extracorporeal Shock Wave Lithotripsy (ESWL) and Ureteroscopy are two common modalities in the management of Proximal Ureteral Calculi.European Association of Urology (EAU) and American Urological Association (AUA) guidelines have recommended URS or ESWL as first-line treatment Options.ESWL is an effective and non-invasive treatment method in urolithiasis, particularly in stones located in the upper third of the ureters.However, URS is a more invasive technique when compared to ESWL, URS became the most efficient treatment method in proximal ureteral calculi after the development of small-caliber, semi-rigid and flexible endoscopes and the holmium:YAG laser. Today, the greatest dilemma faced by Urologists is to choose between ESWL and URS. A number of factors influence the final results of ESWLand if no fragmentation occurs after several unsuccessful sessions, the stone is considered ESWL-resistant; the case is deemed an ESWL-failure and the patient therefore undergoes URS.URS has been described as a salvage or second line treatment option in cases of ESWL-resistant calculi

Eligibility Criteria:
Inclusion Criteria:

- The study will include patients in the age group of 18-70 years with body mass index of less than or equal to 30 kg/m2 with Upper Ureteral Calculi more than or equal to 1 cm with density about 900 - 1100 HU

Exclusion Criteria:

* Patients with distal obstruction
* Impacted stones : An impacted stone is defined as a stone where a guidewire will not pass without ancillary measures and/or a stone that does not move when forceful irrigation is applied ureteroscopically
* Marked hydronephrosis : gross dilation/ballooning of the renal pelvis and calyces with loss of borders between the renal pelvis and calyces and renal atrophy seen as cortical thinning
* Radiolucent stones
* Pregnancy
* Stones in Children
* Spinal deformity
* Morbid obesity
* Patients on Aspirin
A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis

The primary objective of the investigation is to determine whether the addition of exercise (resistance training or modified physiotherapy) improves functional capacity in Multiple Sclerosis (MS) participants undergoing Disease Modifying Therapy (DMT) treatment. We hypothesize that the Progressive Resistance Training (PRT) will improve functional capacity without increasing the risk of relapses in participants undergoing standard DMT treatment. The secondary objectives are to determine whether exercise (resistance training or physiotherapy) improves fatigue, mood and Quality of Life (QoL) in MS participants undergoing DMT treatment. Also as a secondary objective, the study aims at determining whether exercise (resistance training or modified physiotherapy) has an impact on Expanded Disability Status Scale (EDSS), time to first relapse, number of relapse free participants, and immunological factors. We hypothesize that the exercise (resistance training) will improve fatigue, mood and QoL and that an impact on immunological factors will be seen in participants even though they are undergoing standard DMT treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Age \> 18 years and age \< 65 years at screening
* Relapsing Remitting Multiple Sclerosis (RRMS) diagnosis according to McDonald Criteria
* Subjects who have been on Avonex treatment for 3-6 months prior to screening
* A signed informed consent form (ICF) is obtained before any study activity
* EDSS \> 1.5 and \< 5 at Screening with at least a score of 1 in pyramidal function
* Are able to walk at least 100 meters
* Are able to transport themselves to and from the training facility

Key Exclusion Criteria:

* Suffer from dementia, alcoholism or if they use pacemaker
* Have any serious medical co-morbidities like cardiovascular, respiratory, orthopedic or metabolic diseases
* Have had a MS relapse within an eight week period prior to the study start
* Are pregnant
* Have trained systematic resistance training for one day or more each week in the prior 3 months before study start.
* Only able to participate in less than 70% of the planned training sessions.
* Suffers from major depression

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus

This study aimed to evaluate the levels of interleukin 18 and tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF) of children with type 1 diabetes mellitus and gingivitis.

Eighty eight children (44 with type 1 diabetes mellitus and 44 healty; age range 7-14 years) will be recruited for the study. The children will be classified into four subgroups based on their periodontal status; 1) Children with gingivitis and diabetes mellitus (MG, n=22); 2) Children with type 1 diabetes mellitus with healthy periodontium (MH, n=22); 3)Healthy children with gingivitis (HG, n=22); 4) Healthy children with healthy periodontium (HH, n=22). Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded. Interleukin-18 and TNF-α will be analyzed in GCF and saliva samples by ELISA.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed as type 1 diabetes mellitus
* Age between 7 and 14 years

Exclusion Criteria:

* Having another systemic problem except type 1 diabetes mellitus
* Children carrying orthodontic appliances
Transitions of Care Clinic (TOCC)

The transition period from hospital to home is a time of heightened risk for patients to experience adverse events, medication errors, and readmission to the hospital. Patients at the highest risk include older adults and patients with low health literacy, socioeconomic disadvantages, and/or multiple comorbidities. This project proposes to expand the Transitions of Care Clinic (TOCC) which was recently introduced in our institution, to bridge the gap in care between hospital discharge to home and connect discharged patients to the outpatient provider focusing on patients with heart failure (HF).

The existing TOCC seeks to improve transitions of care by providing patients with the education, tools, and resources to help manage their chronic disease. With this project, we propose to expand TOCC by offering extensive education to patients via iPad videos and providing them with HF kits prior to their discharge. We will also connect patients to outpatient providers, assist with scheduling appointments and follow up with patients after the appointment takes place to re-evaluate their needs to discuss short- and long-term care plans.

By targeting patients being treated for acute exacerbation of heart failure with preserved ejection fraction (HFpEF), this program aims to facilitate the transition of care, reduce hospital readmissions and improve patients' quality of life and satisfaction. The kits will provide essential tools for self-management such as monitoring daily weights, monitoring fluid intake, and vital signs. Patients provided with a kit will receive an initial phone call from TOCC within 24 to 72 hours of discharge and an additional phone call will be made prior to 30-days post discharge. The funding provided by this grant will facilitate care coordination, enhance the TOCC program, and improve community health, ultimately demonstrating the need for further external funding.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18 to 90 years old discharged from Ocean University Medical Center (OUMC)
* Inpatient admission for heart failure with preserved ejection fraction (HFpEF) exacerbation
* Patient discharged home

Exclusion Criteria:

* Refuse to participate in TOCC phone calls
* Discharged to a facility
* Discharged with homecare services
* Discharged on hospice services
* Hemodialysis
* Leave against medical advice (AMA)
* Pregnant
* Diagnosed with dementia
* Without medical capacity or unable to provide own consent
Vitamin D Regulates the Expression of Glucocorticoid Receptors in Blood of Severe Asthmatic Patients

Vitamin D (VitD) deficiency is a significant public health concern in many areas around the globe which has been associated with many immune-mediated diseases, including asthma. Severe asthma has been linked with a decreased glucocorticoid receptors (GR) ratio (GR-α/ GR-β ratio), indicating steroid hyporesponsiveness. Using combined in silico and in vivo approaches, aimed to explore the immunomodulatory effect of VitD on asthmatic patients diagnosed with hypovitaminosis D.

Vitamin D (VitD) deficiency is a significant public health concern in many areas around the globe which has been associated with many immune-mediated diseases, including asthma. Severe asthma has been linked with a decreased glucocorticoid receptors (GR) ratio (GR-α/ GR-β ratio), indicating steroid hyporesponsiveness. Using combined in silico and in vivo approaches, the investigators aimed to explore the immunomodulatory effect of VitD on asthmatic patients diagnosed with hypovitaminosis D. Methods: In silico tools were used to identify the regulatory effect of VitD supplementation on GR genes. The investigators measured the expression levels of GR-α and the inactive isoform, GR-β, in the blood of adult asthmatics diagnosed with hypovitaminosis D before and after VitD supplementation. Moreover, the blood levels of inflammatory cytokines associated with asthma severity were determined.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma
* age group between 18 and 65 years
* low level of 25-hydroxyvitamin D3 (25 D3) level less than 20ng/mL

Exclusion Criteria:

* smoker patients
* less than 18 years old
* patient on Vitamin D supplementation already
NIV Application in the Treatment of Asthmatic Children

Asthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness and chronic airway inflammation and pharmacological treatment for this condition is done with bronchodilators and anti-inflammatory.

Pharmacologic therapy has clinical efficacy in the control, but the patient often does not adhere adequately.

There is need for further research into non-pharmacological therapies for clinical asthma control and in turn the use of CPAP and bilevel pressure in the airways has shown beneficial effects on autonomic modulation and bronchial responsiveness leading to the hypothesis that these therapies also have effects on the BIE.The aim of this study is to evaluate the effect of these non-pharmacological therapies in several variables and especially the BIE.

Eligibility Criteria:
Inclusion Criteria:

* Age between 5:11 years;
* Both sexes;
* Do not be included in any regular physical activity program;
* Having a diagnosis of asthma, according to the Global Initiative for Asthma (GINA);
* Not having received Theophylline or aminophylline and oral corticosteroids in the last 30 days;
* not have presented respiratory infection in the last two months;
* Signature of IC

Exclusion Criteria:

* Have done inhaled bronchodilator in less than 12 hours before the assessment;
* Inability to understand or perform any of the tests, due to physical and mental limitations;
* Intolerance proposed activities;
* Have heart disease inflammatory, congenital or ischemic origin;
* Being in the presence of any infectious process with fever.
The Detection of Small Early Liver Cancer With Natural History Follow up

The SELINA study will recruit 200 patients with cirrhosis and small HCC and 50 patients with HCC but without cirrhosis (most of whom are expected to have FLD). Blood, urine and liver tissue samples (where available) will be collected for laboratory analysis. In a subgroup of patients (N=80, around 64 patients with HCC with liver cirrhosis and around 16 patients with HCC without liver cirrhosis), additional magnetic resonance liver imaging will be performed. The findings of the SELINA study aim to identify biomarkers that can be used to detect liver cancer at the earliest possible time, something we expect will increase the survival rate of HCC.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation in the study.
2. Male or Female aged 18 years or above.
3. Diagnosed with small HCC (Barcelona Clinic Liver Cancer Staging Criteria (BCLC) stage 0/A; 1-3 nodules \<3cm, preserved liver function, performance status 0) with liver cirrhosis from any aetiology
4. Diagnosed with small HCC (as above) and without cirrhosis
5. Diagnosis of small HCC shown or confirmed within 3 months of study Visit 1
6. Patients with a diagnosis of HCC that was fully ablated or resected more than 6 months ago and now presenting with a new diagnosis of HCC in a different site in the liver may be included in the study
7. Histological confirmation is required to establish the diagnosis of HCC in patients without cirrhosis (imaging alone is not considered sufficient to establish the diagnosis of HCC).

Exclusion Criteria:

1. Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. where the investigator feels that the participant will not be able to comply with the study procedures)
2. HCC with liver cirrhosis at BCLC stage B/C
3. Patients who have had a previous liver transplant (note, it is permitted to enrol patients on the liver transplant waiting list if they fulfil all inclusion/exclusion criteria)
4. Participants of the Pearl study
5. Patients who have had a previous diagnosis of HCC followed by therapy, and now have a recurrence at the same site in the liver
6. Patients who have received HCC specific therapy 3 months prior to study visit 1 (including resection, ablation \[microwave/radiofrequency\]), transarterial chemoembolization \[TACE\], select internal radiation therapy \[SIRT\] or stereotactic body radiation therapy \[SBRT\] 3, chemotherapy, immune modulators and other experimental therapies).

Exclusion Criteria for Imaging Subgroup

1. Any contra-indication to Magnetic Resonance Imaging (MRI) (e.g. claustrophobia, metal implants/fragments, implants, pregnancy, other conditions the scanner operator deems unsafe for MR scanning).
Helping Mothers Select Better Childbirth Hospitals

The investigators aim to conduct a randomized controlled trial of women who are pregnant or considering pregnancy to understand whether women provided with specific data on hospital-level cesarean delivery rates are more likely to select higher quality hospitals, defined as hospitals with cesarean delivery rates below the Federal HealthyPeople 2020 target of 23.9%.

The choice of a childbirth provider is one of the most consequential decisions a pregnant woman makes. The hospital she delivers at is a better predictor of many treatment decisions than her own risks or preferences. For example, choosing the wrong hospital can increase the risk of cesarean delivery up to 10-fold. Cumulatively, avoidable cesarean deliveries are estimated to cause 20,000 major surgical complications, $5 billion in spending, and unmeasured pain each year in the United States.

The proposed project aims to prevent these harms by empowering women to choose hospitals with risk-appropriate cesarean delivery rates. Preliminary research indicates that the majority of women may not understand how hospital-level quality data applies to them personally. In a test sample of 1,000 demographically diverse pregnant mothers, over half do not know if hospital-level cesarean delivery rates are important, and the overwhelming majority do not know if obstetrical infection rates, maternal or neonatal birth trauma rates, or hospital quality metrics are important when selecting their hospital. The investigators will conduct a randomized controlled trial of women using Ovia Health mobile applications to track their fertility or pregnancy to understand whether women provided with location-specific cesarean delivery rate data along with education about the importance of hospital-level cesarean delivery rates are more likely to select higher quality hospitals than women provided with education alone.

The study is labeled double blind, but the investigators recognize uncertainty on this framework. Though subjects will be exposed to different information they do not know they were in a trial. At the point that outcomes are collected, researchers will not know which group the subject was randomized because outcomes are self-reported.

Eligibility Criteria:
Inclusion Criteria:

* Ovia Fertility users that are trying to conceive and are not infertile or Ovia Pregnancy users within the United States in their first trimester who have NOT chosen a delivery hospital or provider.

Exclusion Criteria:

* People who do not use Ovia Health mobile applications, Ovia Pregnancy users beyond the first trimester of their pregnancy, Ovia Fertility users that are not infertile (as defined by women under 35 that have been trying for more than 12 months, and women over 35 that have been trying for over 6 months) and Ovia Pregnancy/Fertility users who have selected their delivering hospital or provider.