cyrilzakka/clinical-trials huggingface dataset:
Short Term Outcome Following Post Operative Enhanced Recovery Implementation in Patients With Perforated Peptic Ulcer

This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcome.

The current study anticipated better outcomes in the form of early functional recovery, reduced length of hospital stays, less thirty days post operative morbidity, and better gastrointestinal quality of life after implementing post operative enhanced recovery in patients with perforated peptic ulcer.

This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcomes.

Methods: Quasi- experimental research design was utilized. The study was conducted at Assiut University Hospital.

A purposive sample of thirty patients (study group) who received postoperative enhanced recovery after open surgical repair of perforated peptic ulcer compared with thirty patients (control group) who exposed to routine care.

patient assessment sheet and gastrointestinal quality of life index were the tools used for data collection.

Eligibility Criteria:
Inclusion Criteria:

* Age ranged from 18 to 65 years,
* Diagnosed with perforated peptic ulcer,
* Ulcer size less than 10 mm.
* Underwent emergent surgical intervention

Exclusion Criteria:

* Malignant ulcer.
* Other GIT diseases (corn's disease \& ulcerative colitis)
* Pregnant women
* Psychiatric or neurological illness.
* Who refused to participate in the study
Chronic Obstructive Pulmonary Disease Patient Preferences Survey

The purpose of this study is to distribute a questionnaire created for individuals living with chronic obstructive pulmonary disease (COPD) to assess their activities, participation, and healthcare and COPD-related research priorities. The data collected will be compared across diagnosed COPD stages and disease severity to determine the extent to which adults with COPD participate in the listed activities and identify their primary research and healthcare related priorities. The questionnaire was originally developed based on past research then verified by a panel of COPD and participation experts; as well as, individuals living with COPD in the form of focus groups. The questionnaire will now be administered to 200 individuals living COPD (50 in each GOLD stage) at three sites across Montreal where clinical data for each participant will be available. This phase will help establish the reliability of the questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD
* English or French speaking
* Patient at one of the three participating sites with medical chart

Exclusion Criteria:

* No diagnosis of COPD by a healthcare professional
* Unable to communicate in English or French
* Unable to provide informed consent
* No medical chart information at one of the three participating sites
Prospective Evaluation of the Role of MRI in the Perioperative Management of Pancreas Adenocarcinomas

The precision of MRI has improved over the past few years, in particular for the hepatobiliary and pancreatic pathologies. The role of MRI in the management of operated pancreas tumors remains nevertheless unclear and few studies have compared MRI to the actual gold standard (CT). Compared to CT, MRI is not only a morphologic imaging technique but also a functional imaging technique. MRI could therefore evaluate in a non-ionizing and dynamic way several important pre- and postoperative aspects after pancreaticoduodenectomy (PD). This study on the perioperative role of MRI includes 3 parts:

First, CT is known to minimize the real size of the pancreatic tumors and to underestimate the vascular invasion correlated to resectability. The preoperative determination of the resection surgical margins could be improved thanks to the high-contrast resolution of MRI.

Moreover, PD is a complex surgery encompassing a fragile anastomosis between the pancreatic parenchyma and the digestive tract. The permeability of the pancreatic anastomosis after PD remains presently unknown and has not been correlated to the clinical state of the patient. MRI associated with secretin injection allows evaluating this permeability, which cannot be done by CT due to the absence of functional evaluation.

Finally, present radiological follow-up after PD for tumors of the pancreatic head is performed with CT. The MRI performance has not been demonstrated yet in the context of follow-up. This imaging modality nevertheless offers unique specificities that are very interesting and that could be helpful for the diagnosis of recurrence.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* indication for a PD for a resectable adenocarcinoma of the pancreatic head.

Exclusion Criteria:

* chronic pancreatitis
* absence of discernment
* patients not speaking French
* preoperative radio/chemotherapy
* patients with claustrophobia
* patients with metallic implants.
What Makes People Better at Retrieving Proper Names?

This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce names of pictured people. Participants will perform a brief mental exercise, then see 83 celebrity photographs to produce the names of. Participants will also complete other surveys and measures. Collected data will give researchers a better understanding of how different variables relate to proper name production.

This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce names of pictured people. Adult participants ages 18-35 and 60-80 will participant in videoconference calls during which they will perform a brief mental exercise, then see 83 celebrity photographs with instructions to name each pictured person. The naming task will be video recorded for later scoring. Participants will also complete other surveys and measures, including some about demographics and other personal characteristics. Participation will take approximately 60-75 minutes. Collected will be de-identified and the aggregate data will give researchers a better understanding about how individual's personality and cognitive traits and the mental exercise performed before the study relate to people's proper name production.

Eligibility Criteria:
Inclusion Criteria:

* fluent speaker of English
* ages 18-35 or 60-80
* lived in the United States for at least 5 years

Exclusion Criteria:

-
Description of Compliance With Hydroxychloroquine Treatment in Patients With Systemic Lupus Erythematosus

The project focuses on non-compliance in patients with systemic lupus erythematosus taking Plaquenil. More than half of patients with chronic illness are not or only poorly compliant with their treatment and lupus is one of them.

The investigators want to use an already validated existing questionnaire in English, the Morisky Medication Adherence Scale 8 (MMAS 8). These results will make it possible, after a multivariate study with reference to the gold standard which is hydroxychloroquinemia, to see which exact questions in the questionnaire can be used in general medicine practices in order to detect less or non-compliant patients as early as possible.


Eligibility Criteria:
Inclusion Criteria:

Age \>18 years

* Patient with systemic lupus erythematosus
* Treatment with PLAQUENIL for \> 6 months with dosage of hydroxychloroquinemia planned during the consultation.
The Effect of Parental Presence on Pain and Anxiety Levels During Peripheral Intravenous Catheterization in Infants

Children's changing emotional and physical needs, continuous, comprehensive, accessible, coordinated and family requires a centered care.Parental presence during invasive procedures is important in family-centered-care. Family-centered-care is a basic principle of pediatric nursing. It is extremely important that parents are with their children during painful procedures. Research; parents during peripheral intravenous catheterization in infancy It was planned to determine the effect of inclusion on pain and anxiety.

This randomized controlled trial included data from 120 cases in the Pediatric Health and Diseases Department of Istanbul, during March 2020-August 2020 (parental involvement group, n = 46; parental presence group, n = 42; parental absence group, n = 32). Information form, State-Trait Anxiety Inventory and FLACC scale were used to collect data.

Eligibility Criteria:
Inclusion Criteria:

* Children within the age group of 1-24 months Parents know Turkish language

Exclusion Criteria:

-
Microclinic Social Induction Pilot Intervention for Diabetes and Obesity Management in Qatar

The purpose of the study is to pilot-phase test the effectiveness of the microclinic social induction model and its effects on behavioral and metabolic outcomes in different levels of social and familial relationships in Qatar. The investigators novel microclinic model is based on the principle that both healthy and unhealthy behaviors spread through preexisting social networks. A microclinic is a small group of approximately 2-8 friends or family members who are taught to modify their own behaviors as well as the behaviors of those around them, with a particular focus on the four "M's": Meals, Movement, Monitoring, and Medication. More than social support groups or peer-to-peer interventions, the microclinic model is unique in its focus on the long-term propagation of healthy behaviors throughout a participant's entire social network. Qatar is uniquely positioned (with its central geographic location in the Gulf region and its leadership in science and education) to spearhead a regional intervention focused on managing and preventing diabetes in the Gulf region.

This pilot study, "Microclinic Social Induction Intervention for Diabetes and Obesity Management in Qatar," is a two-arm randomized controlled trial of a 7-week condensed intervention to evaluate the efficacy of the microclinic social induction model on propagating lifestyle changes and in improving glycemic and metabolic control in Doha, Qatar.

The microclinic social induction model leverages different levels of social and familial relationships to positively influence behaviors relating to diabetes and other metabolic conditions through small treatment units called 'microclinic groups,' consisting of 2-8 peers and family members of the same social network. The intervention model brings microclinic groups to a larger classroom network (\~25 people/class) where each class shares access to a culturally salient diabetes educational curriculum and group support to promote health behavior changes such as improvement in diet, exercise, medication adherence, and blood pressure management to then influence better glycemic and metabolic control.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Mentally competent
* Body Mass Index of 30 or higher
* Body Mass Index of 25 or higher and self-reported pre-diabetes or type II diabetes

Exclusion Criteria:

* They do not meet the above criteria
* They are pregnant
* They have significant medical complications that prevent them from making changes to diet or level of physical activity.
Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System

This study is the first in man study of WeFlow-Arch Module Embedded Aorta Arch Stent Graft System

The WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System first in man study is a prospective, single center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Arch Moduler Embedded Aorta Arch Stent Graft System in the treatment of patients with lesions of the aortic arch.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 85 years old；
2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, dissection and ulcers involving the aortic arch;
3. The length of the ascending aorta is greater than 4cm (from the junction of the aortic sinus tube to the proximal edge of the innominate artery)；
4. Ascending aorta diameter ≥24mm and ≤44mm；
5. The diameter of the iliac artery ≥7mm ；
6. The diameter of the innominate artery ≤24mm, and the length ≥20mm；
7. Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.

Exclusion Criteria:

1. Patients with ascending aortic aneurysm, dissection, ulcer, hematoma；
2. Experienced systemic infection during past three months;
3. History of aortic valve repair or replacement；
4. History of aortic surgery or endovascular repair surgery；
5. Carotid artery is severely narrowed, calcified, clotted, twisted；
6. Right axillary artery is severely narrowed, calcified, thrombosis, twisted；
7. Heart transplant；
8. Suffered MI or stroke during past three months；
9. Class IV heart function (NYHA classification)；
10. Pregnant or breastfeeding；
11. Allergies to contrast agents；
12. Life expectancy less than 12 months。
Caffeine Vs. Carbohydrate Mouth Rinsing in Soccer

The present study evaluated the influence of carbohydrate mouth-rinsing (CHO-MR), caffeine mouth-rinsing (CAF-MR), and control-substance mouth rinses on Loughborough soccer passing test (LSPT) performance. The study participants were involved in a randomized, double-blind, repeated-measures design that employed four sessions (familiarization, CHOMR, CAFMR, and CONT) over ten days at a testing facility. Participants took part in six test sessions 72 hours apart. In the CHO group, 6% w/v glucose solution was used. In the CAFF group, 6% w/v glucose solution was used. CONT group, only exercise was performed without any condition.

Participants were involved in a randomized, double-blind, repeated-measures design that employed four sessions (familiarization, LSPTCHO, LSPTCAFF, and LSPTCONT) over ten days at a testing facility. The initial session was an orientation, allowing participants to acclimate to the LSPT protocol and provide written informed consent. This session used water as a mouth rinse. Anthropometric data were also collected. Before the LSPT, participants completed 15-minute standardized warm-up sections, including jogging, sprinting, and integrating soccer-specific actions. The participants were asked to complete the LSPT at any time. During the tests, participants were blinded to the test scores. The following three sessions were test trials conducted between 15.00 h and 17.00 h at 32°C and 40% humidity. The participants performed the LSPT 72 h apart, LSPTCHO (6% w/v glucose solution), LSPTCAFF (1.2% w/v caffeine solution), and LSPTCONT conditions. Caffeine and CHO solutions were prepared in an equivalent saccharin base to ensure indistinguishability within the Falcon Sterile Tube and agitated for 30 seconds on a vortex mixer. Participants were instructed to avoid intense activity 24 hours before testing, observe a 2-hour fast before sessions, and abstain from caffeinated products on test days. All the test sessions were performed at 32°C and 40% humidity.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy
* Male soccer players
* Willing to maintain the intervention for all sessions

Exclusion Criteria:

* Being under 14 years old
* Having a chronic disease
* Contraindication for caffeine mouth-rinsing (CAF-MR)
* Contraindication for carbohydrate mouth-rinsing (CHO-MR)
* Contraindications for exercise
A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome


Eligibility Criteria:
Inclusion Criteria:

* Dry eye patients with Sjögren's syndrome
* Corneal and conjunctival damage

Exclusion Criteria:

* Severe ophthalmic disorder
* Punctal plugs or surgery for occlusion of the lacrimal puncta
Evaluation of Treatment Response Using Multiparametric MRI After Prostate Radiotherapy

The purpose of this study is to better understand prostate cancer changes after radiation treatment, through magnetic resonance imaging (MRI). MRI is an imaging test that allows doctors to see prostate gland without any operation procedures. It can help identifying the tumors in the prostate. For patients with newly diagnosed prostate cancer, MRI may help doctors manage treatment better and sooner.


Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy proven (completed and/or reviewed at MSK) adenocarcinoma of the prostate, who will undergo external beam radiotherapy using conventional fractionation IGRT including moderate hypofractionated radiation, low rate brachytherapy alone, brachytherapy (either high dose or low dose) combined with supplemental image guided radiation (including IGRT, EBRT, and SBRT), SBRT, or proton radiotherapy.
* Age ≥ 18 years old
* Baseline MP-MRI, which is obtained at MSKCC Main Campus on the 3-Tesla Philips MRI unit as part of the standard (clinical) staging assessment demonstrates at least one dominant or visible lesion which measures \> 0.5 cm in maximum axial diameter as assessed on T2-weighted images.
* No prior history of androgen deprivation therapy within the last month. However patients who will receive neoadjuvant and concurrent and adjuvant hormonal therapy will be eligible.
* Willing to come to MSK Main Campus for baseline and follow-up MP-MRIs.

Exclusion Criteria:

* History of radical prostatectomy
* Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
* Patients with a metallic hip implant, metallic implant or device in the pelvis or ferromagnetic fiducial beacons (Calypso) that might distort local magnetic field and compromise quality of MP-MRI
* Patients in which gadolinium contrast is contra-indicated.
* Metastatic disease
Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers

Oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number of studies and the data are convincing. The THRIVE technique is able to oxygenate patients safely and vital parameters has been shown to be stable. But it is of great importance to evaluate this new concept regarding other potential negative physiological aspects such as biological stress response detected by blood-bourne biomarkers before implementing it into clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Adults, \>18 years old.
2. Laryngeal-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery).
3. Capable of understanding the study information and sign the written consent.

Exclusion Criteria:

1. American Society of Anaesthesiologist severity score \>2
2. New York Heart Association score \>2
3. Pacemaker or ICD.
4. Body Mass Index \>35
5. Pregnancy
6. Manifest cardiac failure or coronary disease
7. Severe gastrointestinal reflux.
8. Neuromuscular disorder
Study of Probuphine in Patients With Opioid Dependence

Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patients with opioid dependence. Patients who have completed at least 24 weeks of treatment in the Open-Label, Multi-Center Study of Probuphine in Patients with Opioid Dependence (PRO-807 Study), will be re-treated with Probuphine over an additional 24 weeks.

This is a 6-month, open-label, multi-center extension study. It is estimated that approximately 200 patients will be enrolled at approximately 25 sites in the United States (US). Following completion of either the PRO-807(NCT00630201) or PRO-808 studies, eligible patients will be implanted with Probuphine implants in the opposite arm for the PRO-809 study. Safety, BPN plasma levels, and efficacy measures will be collected during the 24-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet the following eligibility criteria:

* Expected to complete 24 weeks of treatment in PRO-807 or PRO-808
* Voluntarily provide written informed consent prior to the conduct of any study-related procedures
* Deemed appropriate for entry into this re-treatment study by the Investigator
* Females of childbearing potential and fertile males must use a reliable means of contraception

Exclusion Criteria:

Patients are not eligible for enrollment if any of the following criteria are met:

* Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal and/or creatinine ≥ 1.5 X upper limit of normal, measured at the time of the Week 20 Visit for the previous trial (PRO-807 or PRO-808), or any time less than 5 weeks prior to the Implant Visit.
* Current diagnosis of chronic pain requiring opioids for treatment
* Pregnant or lactating females
* Current use of agents metabolized through cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
* Current history of coagulopathy and anti-coagulant therapy (such as warfarin)
* Current use of benzodiazepines other than physician prescribed use
* Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator, would preclude compliance with the protocol, patient safety, adequate cooperation in the study, or obtaining informed consent
* Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in study; and/or any pending legal action that could prohibit participation and/or compliance in the study
Study In Adults And Adolescents With Seasonal Allergic Rhinitis.

Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as 'hay fever', it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.


Eligibility Criteria:
Inclusion criteria:

* Informed consent.
* Must be an outpatient.
* Females must be using appropriate contraception.
* Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen.
* Must be able to comply with study procedures.
* Must be literate.

Exclusion criteria:

* A significant concomitant medical condition.
* Use of corticosteroids or allergy or medications or tobacco.
* Clinically significant abnormal ECG.
* Laboratory abnormality.
* Positive pregnancy test.
* Allergy to any component of the investigational product.