cyrilzakka/clinical-trials huggingface dataset:
Web-based Oncofertility Support Tool for Reproductive-age Women With Breast Cancer

The aim of this study was to develop electronic systems (e-systems) for oncofertility support, and to examine the comprehensibility, feasibility, usability, and effects on social support and preparation for decision-making.

Background: When reproductive-aged women with breast cancer lack support in making decisions about fertility, this results in conflicts in decision-making with negative effects on their mental health.

Objective: The aim of this study was to develop electronic systems (e-systems) for oncofertility support, and to examine the comprehensibility, feasibility, usability, and effects on social support and preparation for decision-making.

Methods: The study steps were guided, tested, and utilized to (a) identify the requirements of a patient, (b) guide the development of support interventions, and (c) evaluate the quality of web-based oncofertility support. Both qualitative and quantitative data were collected to explore supportive requirements related to oncofertility care, and an initial website concerning oncofertility was developed based on the resulting requirements and system review regarding social support. Alpha testing and beta testing were used to ensure the quality of the web-based oncofertility support tool. The effectiveness was evaluated using the Preparation for Decision-Making Scale and Social Support Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Health provider who ever cared the patients with breast cancer.
* Patients with breast cancer aged between 20 and 45.

Exclusion Criteria:

* Patients of severe psychiatric disorders.
* Patients under 20 years old.
Early Follicular Supplementation of Ganirelix in IVF 2004

Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results

GnRH antagonist offers many advantages when used in IVF-ET treatment, however, it is suspected to yield lower pregnancy rate when compared with the long GnRH agonist protocol.

Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results.

Consecutive patients are prospectively enrolled and randomly assigned to the study and control groups. Patients with low ovarian reserve or with uterine distortion are excluded from the study. Both groups are treated with recombinant FSH and the flexible GnRH antagonist protocol. Women in the study group are also treated with additional GnRH antagonist 0.25 mg/day on day 1, 2 and 3 of the menstrual cycle.

Eligibility Criteria:
Inclusion Criteria:

* infertility
* IVF candidate
* failure of previous IVF attempt

Exclusion Criteria:

* low ovarian reserve
* untreated distortion of uterine cavity
* medical contraindication for IVF treatment
China Adrenal Disease Registry

Epidemiologic studies have revealed a tremendous increase in the prevalence of adrenal associated disease and related mortality worldwide. In order to meet all the therapeutic challenges in adrenal disease in China, CASE was founded in 2020. The objective of CASE is to launch an adrenal disease management model based on the Internet health information platform which allows the application and evaluation of adrenal disease treatment strategies at multiple centers. The proprietary electronic medical database will help the dynamic big-data analysis in epidemiology of adrenal disease, diagnosis, and treatment.

In order to meet all the challenges in the diagnosis and treatment of adrenal diseases in China, CASE was founded in 2020. With advanced medical equipment and Internet of Things (IoT) technology, CASE is committed to creating an online and offline integrated solution for adrenal disease, and for the entire spectrum of adrenal disease, to achieve a more convenient and precise model of care for patients, aiming to establish a platform with diagnosis and treatment of adrenal disease and their long-term follow-up. It allows the application and evaluation of treatment strategies at these centers.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 16 years old and ≤ 75 years
2. Patients diagnosed with adrenal associated diseases, including cushing syndrome, primary aldosteronism, primary hypoadrenalism, congenital adrenal hyperplasia and adrenal adenomas, incidentalomas, and carcinomas, pheochromocytoma, etc.
3. Provide written informed consent
4. Satisfactory compliance

Exclusion Criteria:

1. Patients with significantly reduced life expectancy (less than 2 years)
2. With Drug abuse
3. With AIDS or syphilis or infectious diseases such as viral tuberculosis in active phase at enrollment
The Feldenkrais Method for People With Intellectual Disability

Loss of functioning and age-related health problems tend to appear earlier in individuals with intellectual disability (ID) than in their non-disabled peers and due to this people with ID who are in employment tend to need to retire earlier, producing social, economic and health problems. The Feldenkrais method (FM) is a movement-based form of learning that enhances body balance and physical functioning. We hypothesized that the FM could be helpful to improve balance and functioning of employed people with ID.

The aim of this study will be to determine the effects of a Feldenkraisn Method (FM) program in improving functionality and body balance in supported employed individuals with ID. To evaluate this effect, a total of subjects will participate in a longitudinal and clinical trial.

Sample size has been calculated to detect minimal significant effects on the variable of physical performance (SPPB): accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 26 individuals are required in order to detect a difference equal to or greater than 1.5 unit in the SPPB (SD= 1.94). It has been increased the sample size in an additional 20% (losts during follow-up) and 5% (mortality). The resultant sample size is determinate in 32 individuals, who are equally randomized in both experimental and control groups.

Statistical analysis was performed using IBM SPSS Statistics for Windows (Version 22.0). Data were presented as mean ± standard deviation. Descriptive statistics were calculated for all outcome measures. Mean differences within the groups in the functional tests and stabilometric outcomes were estimated using paired sample t-tests, while mean differences between the groups in these variables were estimated using repeated measures analysis of variance. Differences were considered significant at p \< 0.05. To determine the magnitude of the interactions between time and group, the effect size or µ2 was calculated as described by Cohen (1998) and interpreted as small (\> 0.01 and \< 0.06), moderate (≥ 0.06 and \< 0.14) or large (≥ 0.14).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 40 and 60 years old, with mild-moderate ID and able to follow FM classes in a group

Exclusion Criteria:

* Aged 40 or older than 60 years old, ID not classified as mild-moderate and absence of capacity for following FM classes in a group
Risk Stratifications for Patients With Palpitations

the aim of the study is to early diagnose and early proper mangment of those patients who have palpitations specially of cardiac origin

Palpitation : are one of the most common presentations to general practice, and while they are usually benign, they may also have life-threatening significance. Palpitations have been estimated to account for 16% of general practice presentations and are the second most common presentation to cardiologists after chest pain.

Eligibility Criteria:
Inclusion Criteria:

The present study will be conducted on patients with Palpitations "without intently selected certain gender" and had 18 years old or more

Exclusion Criteria:

patients refusing study will be excluded.
Early Detection of Barrett's Esophagus in Participants With Reflux Symptoms in Primary Care

In the Netherlands, the incidence of esophageal adenocarcinoma (EAC) is increasing. In addition, EAC has a dismal prognosis. Therefore, screening for Barrett's Esophagus (BE) has stimulated interest. Although BE is a known precursor of EAC, a minority of patients with EAC are known with a previous diagnosis of BE. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.

The ongoing increasing incidence of esophageal adenocarcinoma (EAC) in the Netherlands during the last few decades and the still dismal prognosis has stimulated interest in screening for Barrett's esophagus (BE). Although BE is a known precursor of EAC, a minority of patients with EAC (\<10%) are known with a previous diagnosis of BE, and hence, most cases of BE are undiagnosed. Screening programs to detect BE followed by endoscopic surveillance and treatment of dysplasia or early neoplasia seem able to reduce the incidence of EAC and improve survival. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. uTNE offers the possibility of a more acceptable and accurate endoscopic assessment of the esophagus with almost neglectable risks and lower costs compared to conventional endoscopy. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 50 to 75 years;
* Recorded diagnosis of reflux symptoms \>90 days OR
* Recorded prescriptions for acid suppressant therapy for this indication for at least 1 year in the past 5 years
* Written informed consent.

Exclusion Criteria:

* Upper endoscopy in the previous 5 years;
* A current or previous diagnosis and/or treatment of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC)) within the last five years;
* Already known with a diagnosis of Barrett's esophagus or gastro-esophageal cancer;
* Any argument provided by a patient's own general practitioner not to include the patient;
* Comorbidities precluding transnasal endoscopy (e.g. inability to discontinue oral anticoagulants, history of recurrent epistaxis, allergy to lidocaine derivatives).
Atrial Fibrillation Detection Using Garmin Wearable Technology

The purpose of this study is to evaluate the feasibility of detecting atrial fibrillation (AF) in patients with AF using a wearable wrist device/smart watch.

Even though AF is common and associated with increased risk of stroke, quite often it goes undetected until late in the course of the condition. If AF can be detected with simpler tools like a smart watch, it would enable providers to identify patients with AF much earlier in the course of the condition (even before being seen by a physician) and hopefully be able to prevent stroke. This study is being done to identify a technology that can likely identify AF using a smart watch.

Eligibility Criteria:
Inclusion Criteria:

* All patients with AF scheduled to undergo electrical cardioversion at the University of Kansas Health System

Exclusion Criteria:

* Patients with no detectable PPG
* Hemodynamically unstable patients
* Patients who cannot give informed consent
* Patients with tattoos on the wrists
Electrogastrography in Small for Gestational Age Preterm Infants

The purpose of this study is to determine whether small for gestational preterm infants, have delayed or decrease gastric motility compared to appropriate for gestational age preterm infants.


Eligibility Criteria:
Inclusion Criteria:

1. preterm infants 32-37 weeks' gestation
2. No sepsis or ventilation
3. Feeding orally or with NG tube.
4. Age \<48 h to be included

Exclusion Criteria:

1. GE reflux
2. Medication that affect gastric motility
Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

entGlycemic control has been found to improve clinical outcomes following Coronary Bypass Surgery. This study tests the hypothesis that obtaining tighter glycemic control(80-120mg/dl) as opposed to more moderate control (120-180mg/dl) will further improve outcomes.

150 diabetic patients will be randomized to achieve aggressive glycemic control (80-120mg/dl) vs moderate control (120-180mg/dl) using intravenous insulin infusions beginning at anesthetic induction and continuing for 18 hours following surgery.

Eligibility Criteria:
Inclusion Criteria:

* All diabetic patients undergoing Coronary Bypass Surgery

Exclusion Criteria:

* Patients with hepatic and renal failure
Emergency Department Patient Satisfaction Survey in the Imam Reza Hospital , Tabriz ,Iran, 2008

The investigators want to survey Emergency Department Patient Satisfaction in the Imam Reza hospital ,Tabriz ,Iran by questionnaire form . Finally the investigators want to improve the quality services in the department based on the research result.


Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to emergency department

Exclusion Criteria:

* patients didn't sign consent form
Telemedicine for Patients With Chronic Respiratory Insufficiency

In unstable patients needing oxygen and/or home mechanical ventilation, a nurse-centred TM programme (supported by continuous availability of a call centre and a pulsed oxygen system) is cost/effective saving health care resources.

Background: Integrated care and strict follow up have been recommended for frail patients with chronic respiratory failure (CRF) discharged at home.

Objectives: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged at home with oxygen and/or home mechanical ventilation (HMV) with a high risk of hospital readmission.

Design: Prospective randomised controlled trial. Setting: Respiratory Rehabilitation Unit S. Maugeri Foundation between May 2004 and March 2007.

Participants: 240 CRF patients will be randomised into an intervention group (TM) and a control Group, which received current usual care (educational plan, 3 months outpatient visits).

Interventions: one year TM with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing.

Main outcome measures: survival, admissions to emergency room (ER), hospitalisations, urgent general practitioner (GP) calls, home relapses; probability to remain free from the above events will be also compared among groups. TM and health Care System costs as customer satisfaction will be also collected.

Eligibility Criteria:
Inclusion Criteria:

* CRF patients discharged from Respiratory Unit with home MV

Exclusion Criteria:

* Severe co morbid conditions, i.e. lung cancer or other advanced malignancies, and extremely severe neurological disorders (with impaired cognitive status, ability to understand medical instructions, dementia or severe psychiatric illness)
* Logistical limitations due to extremely poor social conditions, such as illiteracy or no telephone access at home
* Being admitted to a nursing home
* Lack of caregiver when ventilated invasively (i.e. tracheal cannula with sounds uncertain) to allow a contact between care team and family
* Refusal to give informed consent
The Effect of Theory Menu-Based Intervention on Vitamin D Adherence in People With Osteoporosis-Pilot Study

This pilot study evaluates the effect of theory menu-based mini-videos on vitamin D adherence in older adult with osteoporosis. Half of participants will watch the videos while the other half will receive usual care (treating physician advice).

Osteoporosis is a common disease around the world. The morbidity and mortality attributed to osteoporosis is due to fracture. The evidence shows that vitamin D is effective in preventing osteoporotic fracture, however, adherence to vitamin D is low among people with osteoporosis (20%-60%). The Health Action Process Approach (HAPA) has been found useful to describe, explain, and predict changes in health behaviours in a variety of setting. Based on HAPA, mini-videos will be developed aiming to increase vitamin D adherence in people with osteoporosis. Mini-videos will address self-efficacy, outcome expectancy, risk perception and action and coping plan. This pilot study aims to evaluate the recruitment and participants' feedback about the mini-videos.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 50 years
* Have been diagnosed with primary osteoporosis
* Have low vitamin D level (less than 75nmol/L) recently (within the previous month)
* Fluent in English

Exclusion Criteria:

* Cognitive diseases
* Mal-absorption syndromes that may interfere with vitamin D absorption.
Circulating Tumour DNA (ctDNA) as a Prognostic and Predictive Marker in Colorectal Cancer - a Pilot Study

In clinical practice, there are currently no biomarkers that can guide colorectal cancer treatment in the primary and curative setting. Improved biomarker-based adjuvant treatments would be of greatest value in order to reduce the risk of relapse. There are reasons to believe that measurements of circulating tumor DNA (ctDNA) in plasma could be used to monitor minimal residual disease after surgery. To address this question, a pilot study was conducted with the purpose to demonstrate the feasibility to perform prospective profiling of ctDNA in a cohort of patients with colorectal cancer stage I-III using the already created Nordic infrastructure for clinical research built up for the ALASCCA trial. If the pilot study proves successful, a large randomised controlled Nordic multicenter study is planned where patients with positive ctDNA 4-6 weeks after radical surgery will be randomised to chemotherapy and/or a biologic agent.


Eligibility Criteria:
Inclusion Criteria:

* Colon or rectal cancer tumor stage I-III planned for radical surgery
* Clean Colonoscopy or Computed Tomography (CT) colon within 3 months preoperatively or postoperatively but before randomization
* Patient able to understand and sign written informed consent

Exclusion Criteria:

* Distant metastases
* Other cancers (excluding colorectal cancer or other skin cancer than melanoma) within 3 years from screening
* Significant medical illness that would interfere with study participation
* Pregnancy or breastfeeding females
* Current participation in another clinical trial that will be in conflict with the present study
* Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study
Conceptualisation of a Network Approach to Complete the Classification of Eating Disorders With the Aim of Better Personalising Their Management

Eating disorders (EDBs) are mental disorders with a great impact on the lives of individuals as well as a great cost imposed on society. The treatments currently available rely on different forms of psychotherapies with an unsatisfactory response rate as well as a considerable relapse rate . One of the reasons underlying the low success of available therapeutic modalities would be the heterogeneity of the clinical presentation of EDs, making their classification and the personalization of their treatment more difficult.The investigators hypothesize that a secondarily dimensional classification approach (respecting the categorical classification currently in use) of EDs based on the different dimensions disturbed in these disorders as well as in their comorbidities, would better represent their nosographic reality, which could provide patients with more personalized and potentially more effective care.

Detailed Description:

The investigators will recruit a total of 840 patients with an eating disorder in the university hospital of Montpellier.

- Participation consists of a one-day visit with a multidisciplinary assessment. No action is specific to research except the biological collection for the constitution of a genetic bank. This is the usual management of patients with eating disorders addressed to our department.

Eligibility Criteria:
Inclusion Criteria:

* Patient with an eating disorder according to DSM-V criteria
* Patient aged from 15 to 65 years
* Patient who performs the day-hospital evaluation
* Patient affiliated to a French social security system
* Patient able to understand the nature, the aim and the methodology of the study
* For minor one of the legal guardians gave his consent

Exclusion Criteria:

* Patient in an unstable somatic state (eg severe metabolic disorder making impossible or unreliable neuropsychological assessments)
* Patient's refusal to participate
* Patient protected by law (guardianship or curatorship)\*
* Pregnant or nursing women. A dosage of βHCG will be performed to ensure the absence of pregnancy
Comparative Abuse Liability Among African American and White Smokers

The study is a randomized crossover trial. Current smokers will complete a session with each product: usual brand cigarette, e-cigarette, and heat-not-burn. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring.

The study is a randomized crossover trial. Current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn). Throughout each visit, blood will be collected for nicotine analysis via an IV catheter placed in the patient's arm. Blood samples will be aliquoted into two separate vials. One will be analyzed for the current study and one will be placed in a biospecimen repository if participant provides consent for biorepository. Puff topography will be collected passively throughout the session to measure puffing patterns. Participants will complete self-report measures of nicotine withdrawal and craving. Finally, breath samples will be collected to measure changes in exhaled carbon monoxide, a potent lung toxicant, pre- and post-product use. At the final visit, participants will complete a behavioral economics concurrent choice task (see below for description) to behaviorally measure their decisions regarding use of e-cigarettes or heat not burn products in place of cigarettes. Finally, participants will be contacted by phone 6 months following the conclusion of visit 3 (or study discontinuation) to complete a phone survey. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring. We have no hypotheses related to the follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Non-Hispanic African American or white/Caucasian,
* ≥21 years old, smoke 5-30 cigarettes per day,
* daily cigarette smoker
* smoked at current rate for at least 6 months
* interested in trying e-cigarettes and heat not burn products
* not interested in or unable/unwilling to quit cigarette smoking
* willing to complete three in-person study visits
* willing to have IV catheter placed

Exclusion Criteria:

* Interested in quitting cigarettes in the next 30 days
* use of smoking cessation pharmacotherapy in the past 30 days
* use of non-cigarette tobacco products in the past 30 days
* use of e-cigarettes \>5x in lifetime
* use of e-cigarettes ≥4 of the past 30 days
* use of heat not burn products \>5x in lifetime
* use of heat not burn products ≥4 of the past 30 days
* weight \< 110 lbs
* uncontrolled hypertension (systolic BP ≥ 180 or diastolic BP ≥ 105)
* pregnant, plans to become pregnant, or breastfeeding
* live \>10 miles from study site (Fairway CRU)
* current enrollment is a research study or program that aims to alter tobacco use