cyrilzakka/clinical-trials huggingface dataset:
Weight Loss Effects of M-health App in Obesity Multidisciplinary Outpatient Clinic

This is a randomized, open, controlled, single-center trial to identify the weight loss effects of adding mobile health application in obesity multidisciplinary outpatient clinic.

This is a randomized, open, controlled, single-center trial to identify the weight loss effects of adding mobile health application in obesity multidisciplinary outpatient clinic.

The team of obesity multidisciplinary outpatient clinic includes endocrinologists, dietitians, and exercisers. The endocrinologist assesses the patients' conditions, manages the patients, and decides on appropriate medications. Dietitians participate in dietary propaganda and education, and develop personalized diet prescriptions. Exercisers conduct behavior and exercise propaganda, and issue personalized exercise prescriptions. Patients in the experimental group combine m-Health APP with routine obesity clinic management. The m-Health APP could help patients set weight loss targets, record body weights online, learn the calories they consumed in real time, and exercise based on the prescriptions suggested by the exercisers.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 65 years old;
* 24kg/m\^2 ≤ BMI \< 37.5kg/m\^2;
* Proficient in using mobile applications;
* Agree to sign the informed consent

Exclusion Criteria:

* secondary obesity (such as hypothyroidism, Cushing's syndrome, hypothalamic obesity or long-term use of obesity-causing drugs, etc.);
* Patients with chronic diseases that require special diet and affect exercise;
* Patients suffering from severe liver, kidney or heart dysfunction;
* Patients with a history of malignant tumor;
* Pregnant or lactating women;
* Low level of education or illiteracy;
* Inability, unwillingness, or refusal to comply with study requirements (including lifestyle adjustments, follow-up, and subject duties)
Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units

Patients with compensated chronic liver disease who have an episode of acute deterioration of liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate. Hepa Wash(R) is a newly developed liver and renal support system that is based on the use of recycled albumin dialysate. The new system has shown a high detoxification capacity in in-vitro and preclinical studies. The aim of the study is to evaluate the safety and efficacy of the Hepa Wash system in patients with acute-on-chronic liver failure in the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with documented clinical or histological evidence of cirrhosis AND
2. Acute decompensation in previously stable cirrhotic liver disease AND
3. Bilirubin ≥ 2 mg/dl AND
4. SOFA ≥ 9 calculated after 12 hours of optimal medical therapy AND
5. Patient is in the intensive care unit AND
6. Informed consent of the patient or the legal representative AND
7. Patients are 18y or older AND
8. Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-5)

Exclusion Criteria:

1. Untreatable extrahepatic cholestasis
2. Patient has a survival prognosis of less than 6 weeks because of a chronic disease (e.g. metastasizing cancer) and before the acute event which lead to the ICU admission.
3. PaO2/FIO2 ≤ 100 mmHg (respiratory SOFA-score of 4)
4. Patients who receive a vasopressor support of Dopamine \>15 µg/kg/min or epinephrine \>0.1 µg/kg/min or norepinephrine \>0.1 µg/kg/min (cardiovascular SOFA-score of 4)
5. Patients with creatinine ≥5 mg/dl or urine output \<200 ml/day (renal SOFA-score of 4)
6. Patients on kidney dialysis
7. Patient with MELD-score of 40
8. Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment
9. Patient testament excludes the use of life-prolonging measures
10. Post-operative patients whose liver failure is related to liver surgery
11. Uncontrolled seizures
12. Active or uncontrolled bleeding
13. Weight ≥ 120 kg
14. Pregnancy
15. Patient diagnosed with Creutzfeldt-Jakob disease
16. Participation in another clinical study
Comparing Outcomes of Non-surgical Versus Surgical Treatment of Shoulder Fractures With Different Shoulder Replacements

The optimal treatment of complex shoulder fracture is controversial. In general, non-surgical treatment is recommended for older patients, but results are often unsatisfying. Therefore different surgical approaches have been tried to improve outcomes for this group of patients. Reverse shoulder arthroplasty has shown promising results for these types of fractures and changes in the design of the implant might improve outcomes further. The aim of this study is to compare the outcomes of complex shoulder fractures after non-surgical versus surgical treatment and compare two different types of implants.

The optimal treatment of proximal humeral fracture (PHF) Neer type III and IV AO B1.1,1.2 and C1.1,3.1 is controversial. National guidelines for Denmark have been published in 2015 and updated 2019. They recommend conservative treatment to all kinds of PHF for patients aged above 60 years. Exceptions are fracture-dislocations, headsplits or surgical conditions, where intervention is mandatory like open fractures and impaired nerve- and circulation.

Recently reverse shoulder arthroplasty (RSA) has gained expanding popularity in treating PHF . Compared with osteosynthesis (ORIF) or hemiarthroplasty (HA) outcomes were superior , . The importance of tuberosity healing for good functional outcomes has lead to development of different implants and fixation techniques. The original RSA design by Grammont with 155 degree inclination of the humeral stem was made for cuff-arthropathy. This design moves the center of rotation in a medial direction, and increase the tension on the tuberosities.

In contrast "anatomical" designed humeral implants with 135 degree enables more anatomical refixation of the tuberosities with less tension and might reduce the risk of resorption or displacement of the fragments. To implant a 155 degree RSA the surgeon has to remove parts of the rotator cuff, to enable the sliding rotation. On the other hand with a 135 degree inclination humeral component, a cuff sparing technique is possible.

The aim of this study is to compare outcomes of two different designed RSA stems versus conservative treatment of PHF Neer type III or IV / AO B\&C.

Eligibility Criteria:
Inclusion Criteria:

Displaced Proximal Humeral Fractures (PHF) Neer type III or IV / AO B\&C. Radiological confirmed

Exclusion Criteria:

other types of PHF, Head splits, gleno-humeral dislocations, pathological fractures. Refuse to participate in the study. Non-compliant, drug/alcohol abuse or institutionalized, (Low-cooperative),
Integrated Genetic and Functional Analysis of the Influence of Menstrual Hygiene Products on Female Health

Women's reproductive health has attracted increasing attention in recent years, including in the field of microbiology. Vaginal infections, such as vulvovaginal candidiasis, bacterial vaginosis and aerobic vaginitis, are common and a huge burden on our society. The vaginal microbiome is important in the prevention of these infections, in fertility and for healthy pregnancies. The composition, and therefore the 'health' of the vaginal microbiome, is influenced by many internal and external factors, including intimate health. However, it is not yet known how intimate health, and specifically the use of menstrual hygiene products, affects the microbiome and women's intimate comfort and health. In this study, the researchers aim to understand the influence of 5 menstrual hygiene products (tampon, menstrual cup, menstrual pad and 2 types of menstrual underwear) on women's intimate health (n = 100). First, this will be evaluated at the microbiome level, focusing on the female intimate microbiome, consisting of the skin in the groin, vulvar and vaginal microbiome. These sites are all closely linked and are affected in vaginal infections or by contact with menstrual hygiene products. Second, in addition to the direct impact on the microbiome, the impact on the participant's immune system will be evaluated, as some well-known menstrual hygiene products can cause irritation and inflammation. As a third goal, participants will assess the comfort and usability of each menstrual hygiene product and provide data on their lifestyle and other factors that may influence our results. The main goal is to investigate and define the impact of menstrual hygiene products on women's intimate health so that women can make an informed choice. In a first phase participants (n = 1500) will fill in a survey containing questions on general health, lifestyle and menstrual health. Based on these responses a selection of 100 participants will be made by the researchers to participate in the intervention trial.


Eligibility Criteria:
Inclusion Criteria:

* female
* contraception: combination pill with stop week or no hormonal contraception
* premenopausal
* Dutch-speaking living in Belgium
* regular menstrual cycle (if no hormonal contraception)

Exclusion Criteria:

* Pregnancy
Implementation of a Pediatric-to-adult Asthma Transition Program

Despite the clear and often stated need, a formal transition program does not exist for asthma patients as they move from pediatric to adult care in Western Canada. This population is not having their health care needs met. The investigators proposed study would evaluate a well structured transition program designed to facilitate continuity of care for this at risk patient population.

Primary hypothesis: A pediatric-to-adult asthma transition program will improve the asthma-specific quality of life of young asthma patients in the Calgary area over a 1 year period.

Secondary hypothesis: A pediatric-to-adult asthma transition program will improve asthma control, decrease asthma exacerbations, and reduce health care utilization in young asthma patients in the Calgary area over a 1 year period.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of asthma (as confirmed by a pediatric respirologist or pediatrician with asthma expertise, and including evidence of variable airflow obstruction, bronchial hyperresponsiveness, airway inflammation, and/or response to therapy)

Exclusion Criteria:

* patients who are known to be non-adherent within the Calgary Regional Pediatric Asthma Clinic (defined as \>50% missed appointments over a 2 year period)
* patients unable to complete pulmonary function testing
* patients with a history of significant respiratory comorbid conditions (including history of cystic fibrosis, alpha-1 antitrypsin deficiency, and lung transplant - rhinosinusitis patients will not be excluded)
* patients unable to provide consent.
Radiofrequency Splanchnic Denervation Versus Retrocrural Neurolytic Celiac Block for Pancreatic Cancer Pain

The investigators will evaluate the analgesic efficacy of radiofrequency splanchnic nerve denervation versus neurolytic retrocrural celiac denervation for patients with abdominal pain due to cancer pancreas


Eligibility Criteria:
Inclusion Criteria:

* patients with abdominal pain due to cancer pancreas

Exclusion Criteria:

* coagulopathy
* infection at site of the procedure
Mobile-Web Emotion Self-management Tool

The investigators developed a responsive mobile-web app, "Jauntly," which was designed to take advantage of the known connections between positive emotions, stress reduction and stress resilience. The app's goal was to lead users through research-proven positive emotion-enhancing exercises and relevant educational materials. Intervention activities covered five well-being-generating content areas: 1) promoting the experience and recognition of gratitude; 2) encouraging positive social relationships and feelings of social support; 3) improving stress resilience via mindfulness and other relaxation-focused activities; 4) focusing and capitalizing on individual strengths (as opposed to limitations and weaknesses); and 5) general positive mood inducing activities. Program content was adapted from a variety of stress-relevant research areas including health psychology/psychosomatic medicine, social/personality psychology, positive psychology, and clinical psychology.

The overarching goal of the Jauntly mobile app was to experience exercises that encourage one to take care of oneself emotionally, improve positive emotions, and decrease stress and other negative emotions. The user interacted with the app through evidence-based activities (e.g. writing gratefulness notes, helping others, practicing mindfulness). The activities were selected based on the goals the user selected upon initiation of program and throughout engagement with the app. In order to promote sustained use of the program and mastery of the positive emotion based skills, the design of the program included activities that range in difficulty so that the user could progress and improve (i.e., simple "1 and done" types of goals versus multi-week goals).

Research in positive psychology interventions suggests that increases in well-being are highest when the activity: 1) fits the person's interests and values and 2) is performed neither too frequently nor too seldom. Because of our desire to have a product with long-lasting usability and sustained engagement, it was critical that there were a diverse number of activities from which individuals could choose based on interest, current mood, and past success. The Jauntly user experience is structured around free use of the app partnered with regular emails, in-app messaging, videos, and articles. Emails remind users to utilize program content (including users in the control group who were reminded to visit the stress-management website). Use of the app and viewing of videos and other content is not restricted and users are able to self-tailor use according to their interest.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Employed at least part-time
* Self-report stress at work
* English speaking
* Access to a computer with high-speed internet connection, audio-video capability and an active email account

Exclusion Criteria:

* High level of self-reported grief
* High level of self-reported depression (PHQ-2)
Trace Elements and Heavy Metals at PPROM

Objectives: To evaluate maternal serum trace elements and heavy metals namely, aluminum (Al), chromium (Cr), manganese (Mn), cobalt (Co), nickel (Ni), copper (Cu), zinc (Zn), arsenic (As), molybdenum (Mo), cadmium (Cd), tin (Sn), antimony (Sb), mercury (Hg), and lead (Pb) in pregnant women complicated by preterm prelabour rupture of the membranes (pP-ROM) and to compare the results with healthy pregnancies.

Methods: Maternal serum levels of Al, Cr, Mn, Co, Ni, Cu, Zn, As, Mo, Cd, Sn, Sb, Hg, and Pb were measured in the study group, which included 55 pregnant women complicated with pP-ROM and 60 healthy pregnancies (control group) with respect to maternal age and gestational weeks. The maternal serum levels of trace elements and heavy metals in both groups were measured using an inductively coupled plasma-mass spectrometry (ICP-MS) and compared.

This current observational study was conducted at Cengiz Gokcek Women's and Children's Hospital Gaziantep, Turkey at the Department of Obstetrics and Gynecology between dates of August 2018 and March 2019. The experiment was conducted according to the Declaration of Helsinki. All subjects included in the study gave oral and written informed consents. The study population consisted of 55 women with a singleton pregnancy who were diagnosed with pP-ROM between 24+0 and 36+6 weeks of gestation. The control cases were recruited from the healthy pregnant women with a gestational age-matched cohort who admitted for routine obstetric care to our outpatient clinic. Sixty healthy pregnant women who delivered at term were included in the study as the control group. All patients will gave their oral and written informed consent before their inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

* preterm prelabor rupture of the membranes
* healthy pregnancy

Exclusion Criteria:

* • pregnant women who had the diagnosis of chorioamnionitis at the time of first admission

  * women with chronic medical diseases
  * gestational diabetes mellitus
  * women with a history of drug use throughout pregnancy
  * drug users
  * pregnant women who have received any treatment for pP-ROM at the time of admission
  * patients who had fetal congenital abnormalities or genetic syndromes
  * genetic syndromes
  * multiple gestation
  * active labor
  * fetal hypoxia
  * fetal growth restriction
A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy

This trial is a follow-up companion study to Protocol ICA-17043-10, a Phase III, multi-center, efficacy and safety study of ICA-17043. This is an open-label extension study collecting safety data on the use of ICA-17043 in subjects with sickle cell disease (SCD) (e.g., HbSS, HbSC, HbSb0-thalassemia, HbSb+-thalassemia subjects). All subjects who have successfully completed ICA-17043-10 will, if deemed appropriate by their study Investigator and appropriate consent by subject is given, enroll in the ICA-17043-12 study (Study 12). Only patients who participated in ICA-17043-10 are eligible for this open label study


Eligibility Criteria:
Inclusion Criteria:

* Successfully completed Study ICA-17043-10
* Discontinued Study 10 or 12 following the DMC recommendations because he/she was not on HU, and has since been on a stable dose of HU for at least 3 months prior to Day 1
* Male, or female not capable of becoming pregnant or using appropriate birth control
* Has willingly given written informed consent to participate in this study

Exclusion Criteria:

* The subject, if female, has a positive urine pregnancy test on Day 1 (before entering study)
* The subject is presently unsuitable for participation in this long-term study
Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study

The study is a Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis. It is a First-in-Man Trial.

This clinical trial will serve as a first-in-human (FIH) experience for the BA9™ DCB in a population of patients with coronary artery disease who have an indication for interventional treatment of in-stent restenosis (ISR) in a bare-metal stent (BMS) or drug-eluting stent (DES).

The study uses a prospective, multi-center, single blind, randomized controlled trial design to enroll 195 patients. The study will seek to prove that the BA9-DCB is non-inferior to the approved CE marked Sequent Please® Paclitaxel Coated Balloon with respect to % Diameter Stenosis and has similar safety characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with in-stent restenosis (ISR) and clinical symptoms of ischemia and/or (i) evidence of ischemia on non-invasive testing or (ii) hemodynamically relevant lesion defined by FFR ≤ 0.80 or iFR ≤ 0.89 or \> 90% stenosis.
* Patient presenting with a lesion that can be fully covered with one DCB length. - Patients can have up to two index lesions with ISR, which can both be treated and evaluated.
* Patient has provided written informed consent
* Age ≥ 18 years.
* Patient is willing and able to comply with the study procedures and follow-up.

Exclusion Criteria:

* Patient presents with a ST-elevation myocardial infarction (STEMI) or had an acute MI within 48 hours prior to presentation (according to the universal definition of myocardial infarction).
* Patient with acute cardiac decompensation or acute cardiogenic shock
* Documented left ventricular ejection fraction (LVEF) ≤ 30%
* Patient with impaired renal function (glomerular filtration rate \< 80 mL/min/1.73 m2).
* More than 2 epicardial vessels requiring revascularization
* Significant left main stenosis (by visual estimation) or an ISR located in the left main (LM).
* Patient has an ISR lesion that cannot be covered with one DCB length.
* Patient has an ISR in the target segment in a stent of a smaller diameter than 2.5mm.
* Severe calcification that might prevent a sufficient expansion of the DCB, if not pre-treated with rotablation or a shockwave application device.
* Known hypersensitivity or contraindication to biolimus, paclitaxcel, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.
* Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
* Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.
* Anticipated difficulties to complete the angiographic follow-up study.
* Patient with a life expectancy of less than 12 months.
* Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.
Mobile Health Technology to Promote Physical Activity in Persons With Parkinson Disease

Persons with Parkinson Disease (PD) face significant declines in function resulting in greater disability. Function can improve through participation in exercise, yet many people with PD are physically inactive. Given that people with PD live long lifespans following diagnosis; it is essential to include routine exercise into their lives over the long-term. Physical therapy is effective in improving function in persons with PD. However, participation in on-going physical therapy indefinitely is not a realistic option due to limited healthcare resources. Interventions using mobile health technologies allow physical therapists to stay connected to patients over time potentially improving their ability to meet the changing needs of patients with PD. Innovative approaches using mobile health technology may improve outcome; however, the effectiveness of different approaches to improve function and reduce disability in PD is unknown.

The purpose of this study is to compare the effectiveness of two interventions to improve function and health-related quality of life in 65 people with PD. In one study group, participants receive a home exercise program, in written format, to continue on an independent basis. In the other study group, participants are instructed to continue with an exercise program, in their home, delivered using videos of the exercises on a computer tablet device. This use of mobile-Health technology allows the physical therapist to remotely monitor participants' progress and modify the exercise program to meet the changing needs of each patient. The long-term objective of this research is to determine the most efficient and effective way to improve function that can be widely disseminated to persons with PD.


Eligibility Criteria:
Inclusion Criteria:

* Inactive over the last 3 months
* Clinical diagnosis of idiopathic Parkinson's disease
* Mild to moderate disease severity
* Sufficient cognitive ability to follow study instructions
* Stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 12 month study period unless medically necessary
* Able to walk without physical assistance or an assistive device for at least 6 continuous minutes
* Be interested in participating and provide informed consent

Exclusion Criteria:

* A diagnosis of atypical Parkinsonism
* Balance impairment (More than 2 falls in the previous month)
* Significant freezing
* Serious co-morbidities or medical conditions that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))