cyrilzakka/clinical-trials huggingface dataset:
Get Fit for Function

The purpose of this study will be to implement and evaluate a prehab program for pre-frail and frail adults who need to undergo thoracic surgery. The study team hypothesizes using an implementation framework will increase the reach, effectiveness, adoption, and implementation of the prehab program.

Approximately 70% of thoracic surgery patients are pre-frail or frail, characterized by reduced strength, endurance, and physiologic function. Frailty is associated with poor perioperative outcomes, including increased complications, length of stay, post-discharge institutionalization, healthcare costs, and mortality. As a result, surgical and geriatric clinical societies now recommend including a frailty assessment in older adult pre-operative surgical evaluations. To mitigate the risks associated with frailty, prehabilitation (prehab) has been included as a component of the American College of Surgeons "Strong for Surgery" quality initiative. Evidence-based practices to optimize preoperative health have been shown to improve physical conditioning and return to autonomy, as well as, reduce length of stay, postoperative complications, and healthcare costs. Older patients who need surgery view prehab favorably, particularly if it is home-based, recommended by a medical professional, and free. The primary objective will be to conduct a feasibility evaluation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The secondary objectives will be to measure functional status and clinical outcomes longitudinally in patients undergoing prehab.

Participants will receive the prehab program from 2-12 weeks prior to undergoing elective inpatient thoracic surgery. Participants will complete surveys at 2-3 weeks, 2 months, 3-4 months, and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18, of any racial or ethnic origin
* Will be undergoing elective thoracic surgery lung resection using thoracic approach (thoracotomy, Video-assisted thoracoscopic surgery (VATS), Robotic-Assisted Thoracic Surgery (RATS)
* Able to complete baseline evaluations at time of enrollment

Exclusion Criteria:

* Unable to give informed consent
* Unable to read/speak English
* Age \<17
COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication

The aim of this multi-centre survey is to assess treatment adherence and quality of life in a Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled essential hypertension being on antihypertensive treatment for at least 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 21 years of age
* Patients newly diagnosis with essential hypertension or with hypertension that is uncontrolled after being under the same antihypertensive treatment for at least 6 months (based on the criteria established by the Joint National Committee VII)
* Patients capable of providing an informed consent

Exclusion Criteria:

* Patients with secondary hypertension
* Pregnant women or nursing mothers
* Patients with acute illnesses or psychiatric diagnosis
Acute Pain Study Following Bunionectomy

The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.

The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol.

After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.

Eligibility Criteria:
Inclusion Criteria:

Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy

Exclusion Criteria:

* Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures
* Drug allergies to hydrocodone, acetaminophen
* Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction
Effects of Single Plasma Exchange and Double Filtration Plasmapheresis (DFPP) on Peripheral Lymphocyte Phenotypes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

CIDP, a rare disorder affecting young adults, causes gradual weakness of the limbs, areflexia and impaired sensory function. New CIDP phenotypes without antibodies but with modified cell profiles have been described. Treatments include corticotherapy, IVIg and plasmapheresis but the latter's action mechanisms remain unclear. Plasmapheresis supposedly removes toxic agents like antibodies from plasma but it is uncertain whether it has an immune-modulating effect. Also, the refining mechanisms of the two main plasmapheresis techniques - single plasma exchange and double filtration plasmapheresis (DFPP) - are different and unclear. This study aims to compare the evolution of peripheral lymphocyte profiles in patients with CIDP according to their treatment (single centrifugation plasmapheresis or DFPP) to better grasp the action mechanisms of both techniques.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) without pathogenic antibodies and stable under therapeutic plasmapheresis with one session every 2-3 weeks for at least two months.
* Patients who have given free written informed consent.
* Patients who have signed the consent form.
* Patients affiliated to or beneficiaries of a health insurance scheme.
* Adult patients (≥18 ans).
* Healthy subjects of the same age and sex

Exclusion Criteria:

* Patients Under the age of 18.
* Patients under immunosuppressive treatment for less than 3 months.
* Patients participating in Category 1 research involving human subjects.
* Patients in an exclusion period determined by another study.
* Patients under legal protection, guardianship or curatorship.
* Patients unable to express consent.
* Patients for whom it is impossible to give informed information.
* Pregnant, parturient or breastfeeding patients.
* Healthy subject with chronic pathology or drug treatment
Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study

Viscous dietary fibers including oat β-glucan are one of the most effective classes of functional food ingredients for reducing postprandial blood glucose. The mechanism of action is thought to be via an increase in viscosity of the stomach contents that delays gastric emptying and reduces mixing of food with digestive enzymes, which, in turn, retards glucose absorption. Previous studies suggest that taking viscous fibers separate from a meal may not be effective in reducing postprandial glycemia. The purpose of this study is to re-assess the effect of consuming a preload of a commercially available oat-bran (4.5, 13.6 or 27.3 g) containing 22% of high molecular weight oat β-glucan (O22) mixed in water before a test-meal of white bread on glycemic responses in 10 healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Pregnancy
* Diabetes
* Recent medical or surgical hospitalization
* Use of drugs influencing glucose metabolism
* Use of drugs influencing gastrointestinal function
* Allergy to oats or wheat
A Web-based Bystander Education Program

This is a study to determine whether a theoretically-driven web-based 3-hour intervention designed for male college students called RealConsent is effective in increasing prosocial intervening behaviors and in preventing sexual violence perpetration. Sexual violence programs for this population have been implemented for decades in the United States, but a program that is web-based and incorporates the bystander education model has never been implemented or tested. In this study, male college students will be recruited online, enrolled and randomly assigned to RealConsent or to a comparison condition. Prior to the intervention, investigators will ask questions about their intervening and sexually coercive behaviors and other theoretical and empirical factors related to the study outcomes. Investigators will survey the young men again at post-intervention, and at 6-months follow-up to determine whether young men in the RealConsent program intervened more often and engaged in less sexual violence compared to young men in the comparison condition. The main hypotheses are: (1) college men in the RealConsent program will report more instances of prosocial intervening; and (2) college men in the RealConsent program will report less sexual violence against women.


Eligibility Criteria:
Inclusion Criteria:

* Student matriculated at Georgia State University
* Male
* 18 to 24
* Undergraduate
* Self-identify as heterosexual or bisexual

Exclusion Criteria:

* Graduate student
* Self-identify as homosexual
Deconstructing Fast-Food Consumption Among Female University Students University Women

This study aims to explore the relationship between fast food consumption and identity formation among adolescent female university students, examining how their dietary choices reflect and shape their self-perceptions.

This study aims to investigate the relationship between fast food consumption and identity formation among adolescent female university students, with a specific focus on how their dietary choices reflect and shape their self-perceptions. Key research questions include understanding the factors that drive fast food consumption, exploring how these choices influence self-identity, and examining the role of social and cultural dynamics in shaping dietary behavior. The study also seeks to highlight the role of nurses in communicating nutritional knowledge and supporting adolescents in developing healthier eating habits. By examining the psychosocial drivers behind fast food consumption, this research aims to inform public health initiatives and health education strategies that are attuned to the needs and identities of university students.

The findings from this study are expected to contribute valuable insights into the relationship between food choices and identity among adolescent women, providing a foundation for health interventions that consider both the social and personal aspects of dietary behavior. Understanding that food choices are intertwined with self-concept, social belonging, and cultural trends can help public health professionals and nurses develop targeted strategies that resonate with the lived experiences of young women. By addressing these factors, universities can implement health policies and education programs that not only encourage healthier dietary habits but also respect and support the identity development of adolescent female students. Ultimately, this research underscores the importance of a holistic approach to health education, where nurses and other healthcare professionals play a proactive role in guiding adolescents toward healthier lifestyle choices in a way that is meaningful, sustainable, and aligned with their values.

Eligibility Criteria:
Inclusion Criteria:

1. Female students.
2. Aged between 18 and 24 years,
3. Currently enrolled as a student at Mansoura University
4. Students from all grades (1 to 5) within the selected faculties.
5. accept to provide written informed consent to participate in the study

Exclusion Criteria:

1. Male students.
2. outside the age range of 18 to 24 years.
3. medical conditions that significantly affect dietary choices or
4. eating behaviors disorder
5. eating disorders,
6. metabolic disorders
7. specific dietary regimens prescribed by healthcare professionals.
8. previously participated in this study or similar research
Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)

The purpose of this study is to investigate how blood flow to the brain affects cognition in women who are postmenopausal, and how the use of hormone therapy early in menopause might change brain function. The testing in this study will add to the knowledge about brain aging in women. Researchers will determine if blood flow to the brain, brain structure, and cognition differences among women who took hormones in the past as part of Kronos Early Estrogen Prevention Study (KEEPS; NCT00154180), are currently taking hormones, or never took menopausal hormones.

This is a continuation of the Kronos Early Estrogen Prevention Study (KEEPS) (KEEPS; NCT00154180), a multicenter double blinded, placebo-controlled, randomized trial funded by the Kronos Longevity Research Institute, Phoenix, AZ to test the hypothesis that hormone therapy started early in menopause (within the "window of opportunity") would slow progression of atherosclerosis as measured by changes in carotid artery intima-medial thickening and coronary arterial calcification.

This study will involve a single follow-up evaluation of brain imaging and cognitive function of women who were randomized to menopausal hormone therapy (mHT) or placebo, approximately 13 years post-randomization and nine years after the end of mHT administration phase in KEEPS (NCT00154180). No interventions are given as part of this study; any current hormonal treatments are by choice and prescribed by the participant's personal physician.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the original KEEPS trial.
* Able to understand study procedures.
* Willing to sign an authorization of consent in order to participate in this study.

Exclusion Criteria:

• Women who have contraindications to MRI or PET for safety reasons, such as an MRI-incompatible implant or claustrophobia.
Anorectal Manometry of Patients With Constipation Predominant IBS

The aim of The study is to compare between the anorectal manometric profile of patients with functional constipation and patients with constipation predominant irritabe bowel syndrome

Chronic constipation (CC) is a common medical problem throughout the world \[1-3\] The global prevalence of CC in the community varies from 11% to 18% \[4\].

In patients presenting to tertiary care facilities, specific pathophysiological abnormalities like defecatory disorder and slow colonic transit contribute to CC.

CC has a significant burden on the utilization of healthcare resources, including the cost of inpatient and outpatient care, laboratory tests, and diagnostic procedures \[5, 6\].

CC is characterized by difficulty in passing stools or a low frequency of bowel movements, often accompanied by straining during defecation or a feeling of incomplete evacuation \[7, 8\].

For western population, CC is defined by Bristol stool form (BSF) I-II, while in Indian patients, addition of type III Bristol stool form increases diagnostic sensitivity \[2\]. In the ROME IV criteria, it has been suggested that all patients with CC without evidence of structural or metabolic abnormalities to explain symptoms should be considered under the umbrella of functional constipation (FC) \[8\].

FC is defined as the presence of two or more of the followings during the previous 3 months:

1. Defecatory straining (\> 25% of bowel movements)
2. Hard or lumpy stools (\> 25% of bowel movements)
3. Feeling of incomplete evacuation (\> 25% of bowel movements)
4. Defecatory obstruction (\> 25% of bowel movements)
5. Manual maneuvers to facilitate defecation (\> 25% of bowel movements)
6. Fewer than three spontaneous complete bowel movements per week. Symptoms must be present for at least 6 months before the diagnosis, and diarrhea must not be present except after using a laxative \[8\].

Patients with FC should not meet irritable bowel syndrome (IBS) criteria, although bloating may be present. In contrast, patients with irritable bowel syndrome with constipation (IBS-C) have abdominal pain as the predominant symptom along with Bristol stool form types 1 or 2 more than 25% of the times. \[8\].

Among patients presenting with CC, Indian studies have reported FC to be commoner than IBS-C \[9, 10-12\].

High-resolution (HR-) anorectal manometry has significant diagnostic value in the assessment of anorectal disorders \[13\] This study aimed to compare the clinical and anorectal manometry profile of patients with FC and constipation-predominant irritable bowel syndrome

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18- 60 years old .
2. Patients fulfill ROME IV criteria of chronic constipation.

Exclusion Criteria:

* Patient with secondary causes of constipation :-

  1. Thyroid disease
  2. Acute or chronic kidney disease
  3. Acute or Chronic Liver Disease.
  4. Malignancy 5 -Medication 6 -Uncontrolled diabetes mellitus 7 -Inflammatory bowel diseases
Develop and Implement Asthma Controlling Strategies

To develop and implement asthma-controlling educational strategies for inner city and high risk populations.

BACKGROUND:

Asthma is a serious chronic disease affecting about 12 million Americans; about 3 million are children. The study was part of an initiative, "Developing and Implementing at the State and Local Level Educational Strategies and Interventions for Controlling Asthma in Inner City and High Risk Populations", released in February 1993 by the National Asthma Education Program of the Office of Prevention, Education and Control.

DESIGN NARRATIVE:

A computer-assisted multimedia instructional and feedback system, "Asthma Patient/Provider Partnership System" (APPPS), was developed for African American and Hispanic school-age children that was suited for adoption and implementation in clinical and other settings based on the National Asthma Education Program's Expert Panel Guidelines on the Diagnosis and Management of Asthma. A formative evaluation of the educational intervention was conducted. Also, an efficacy study of the intervention in three clinical settings was conducted and the findings of this study were incorporated into the APPPS. Finally, a recommended dissemination strategy was prepared for diffusion of the system to other settings.

Eligibility Criteria:
No eligibility criteria
Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma

The purpose of this study is to assess the outcome of a muscle sparing, minimally invasive open surgical technique for unstable ribcage injuries after trauma. The investigators will compare the results from the study participants to a historical cohort who were operated with a different surgical technique with large incisions and simultaneous thoracotomy.

This is a prospective follow-up study where the investigators aim to study patients who have undergone surgery with a muscle sparing, minimally invasive technique for unstable ribcage after trauma. The investigators plan on seeing the participants as out patients 6 months and 1 year after surgery. The results will be compared to results from a historical cohort with patients who participated in earlier studies with a different surgical method with large incisions and simultaneous thoracotomy. The investigators plan on including 50 patients since a preliminary analysis has suggested this should be enough to notice statistically significant differences between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chest wall trauma who underwent surgical stabilisation for unstable chest wall using a minimally invasive, muscle sparing technique without thoracotomy or thoracoscopy no more than 6 months prior to inclusion.

Exclusion Criteria:

* Severe head injury (Abbreviated Injury score (AIS) \>3)
* Spinal injury
* Neurological or musculoskeletal disease affecting chest wall mobility
Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia

The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.


Eligibility Criteria:
Inclusion Criteria:

* Requirement for treatment of acute episode of schizophrenia (according to DSM-IV diagnostic criteria)
* PANSS total score of ³ 75
* CGI \> 4

Exclusion Criteria:

* Any DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th Edition) Axis I disorder not defined in the inclusion criteria
* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
* Substance or alcohol dependence at enrollment
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy combined with HIPEC is superior to only radical gastrectomy in terms of overall survival.

To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive postoperative chemotherapy (6 circles together with neoadjuvant chemotherapy) and are followed up for 5 years or until death.

The trial is designed as a prospective, randomized, open and parallel group study.

Eligibility Criteria:
Inclusion Criteria:

* Histological proved diagnosis of locally advanced gastric cancer.
* No evidence of distant metastases or peritoneal metastases.
* Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
* Eligible for radical gastrectomy with D2 lymphadenectomy.
* Have not received cytotoxic chemotherapy or radiotherapy.
* Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

* Existence of distant metastasis or peritoneal metastasis during surgery (M1).
* Any previous chemotherapy or radiotherapy
* Active systemic infections
* Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
* Female patients who are pregnant or breast feeding