cyrilzakka/clinical-trials huggingface dataset:
Intern Health Study 2024

The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

Due to their high stress workloads, medical interns suffer from depression at higher rates than the general population. Interns also tend to have lower sleep and decreased physical activity. The goal of this trial is to evaluate the efficacy of a mobile health intervention intending to help improve the mental health of medical interns. The intervention sends mobile phone notifications which aim to help interns improve their mood, maintain physical activity, and obtain adequate sleep during their internship year.

The primary aim of the study is to evaluate how notifications affect participants' weekly mood, as measured through a daily one question mood survey. The second primary aim of the study is to evaluate how notifications affect participants' long-term mental health, as measured by the Patient Health Questionnaire. The first secondary aim is to evaluate how mood notifications affect participants' weekly mood. The second secondary aim is to evaluate how activity notifications affect participants' weekly step count. The third secondary aim is to evaluate how sleep notifications affect participants' weekly sleep duration. In order to better optimize notification delivery, the final aim (exploratory) is to understand moderators of these effects. Moderators of interest are previous week's mood, previous week's step count, previous week's sleep duration, study week, sex, previous history of depression, and baseline neuroticism.

Eligibility Criteria:
Inclusion Criteria:

* Medical intern during the 2024-2025 internship year
* iPhone or Android phone user
* Logged into the Intern Health Study mobile app, completed consent, and filled out baseline survey by June 30 prior to the start of intern year

Exclusion Criteria:

* None
A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer

The standard systemic treatment for ovarian cancer is platinum-based chemotherapy. However, majority of patients relapse and eventually progress to platinum resistance. In patients with platinum-resistant or refractory ovarian cancer, effective treatment options are limited and the prognosis is very poor. Angiogenesis is essential for tumor growth and metastasis, and VEGF/VEGF receptor(VEGFR) signaling pathway is the most promising angiogenic target. This study aim to assess the efficacy and safety of the combination BD0801 and chemotherapy in patients with platinum-resistant recurrent ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* female patients, \>/=18 years of age;
* epithelial ovarian, fallopian tube or primary peritoneal cancer;
* platinum-resistant disease (disease progression within \<6 months of platinum therapy)
* Eastern Cooperative Oncology Group（ECOG）performance status of 0-1

Exclusion Criteria:

* non-epithelial tumours
* ovarian tumours with low malignant potential
* Received 1 line of systemic therapy for ovarian cancer following platinum resistance and/or \> 1 line of non-platinum systemic therapy prior to platinum resistance.
* prior radiotherapy to the pelvis or abdomen
Moxibustion Plus Cupping in Convalescent Patients With COVID-19

This trial is designed to evaluate the efficacy and safety of moxibustion plus cupping in the convalescence of COVID-19.

Moxibustion plus cupping may be effective and safe for convalescent patients with COVID-19, but evidence is limited. The randomized clinical trial may help to provide evidence-based factors for improving the patients' symptoms in the convalescence of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of the convalescence of COVID-19 (defined by the Chinese Guideline for COVID-19 in 2020 Trial Version 7).
2. 18-70 years old;
3. chest tightness/fatigue/shortness of breath/cough, with at least 2 of the above symptoms and the average VAS score (last 48 hours) ≥ 40 points;
4. Volunteers with informed consent;

Exclusion Criteria:

1. Surgery in the lung that affects lung function;
2. Rely on mechanical ventilation to maintain lung function;
3. Chronic lung diseases affecting lung function;
4. Diseases affecting heart function;
5. Severe basic diseases;
6. Resting heart rate \> 120/min, systolic blood pressure \> 180mmHg, diastolic blood pressure \> 100mmHg;
7. Unstable angina or myocardial infarction in the past 1 month;
8. Severe obesity (BMI\>30kg/m2);
9. Allergic constitution;
10. Pregnant or lactating women;
11. Disabled patients;
12. Mentally ill Patients;
13. Participating in other clinical trials;
14. Poor compliance or other complicate conditions according to the researchers.
AI-Powered DIY Screening System for Diabetic Retinopathy

A pragmatic trial will be conducted in two representative clinics in each of the three types of targeted settings. It will be run for 3 months in each clinic to complete data collection of up to 100 patients in SPGC and Optometry Clinics, 200 at GPGC and 200 in GOPC in total. All the subjects will conduct a DIY screening, physician consultation, survey with questionnaires and a phone interview three months after their baseline assessment. This study will assess automated screening in terms of success rate of the DIY system without active assistant help, accuracy, screening rate and detection rate, adherence to referral and experience of participants, as well as cost-effectiveness in real-world settings.


Eligibility Criteria:
Inclusion Criteria:

1. subjects who are 50 years of age or older, or subjects who are 18 years of age or older and have diabetes, and
2. have not undertaken an eye examination in the previous 12 months (elevated risk of undiagnosed disease).
3. Provide written informed consent.

Exclusion Criteria:

1. individuals with physical disabilities that prevent the use of a fundus camera, or
2. individuals with speech impairments who are unable to complete telephone follow-ups.
Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea

Sleep apnea is a common sleep disorder characterized by temporary stops in breathing during sleep and has been associated with the development of cardiovascular disease. This research will investigate one potential mechanism leading to the development of cardiovascular disorder, specifically, the blockage of blood vessels called "vascular occlusion", in subjects with sleep apnea. A group of healthy controls will be used for comparison. All subjects will undergo clinical evaluation followed by an overnight sleep study and a morning blood draw. Subjects with sleep apnea will be treated according to standard clinical management and followed under the research protocol for one month. At the end of one month, a repeat blood draw will be performed on the sleep apnea subjects for comparative analysis. If a control subject is found to have any abnormality during this research study, he or she will be referred for further clinical evaluation.

The importance of this project is to investigate mechanisms of vascular disease in sleep apnea and determine pathways for intervention, aiming to prevent the development of cardiovascular disease in these individuals.

This proposed research aims to evaluate both NTPDase activity in lymphocytes and levels of circulating endothelial cells (CECs) in patients with intermittent hypoxemia (IH) due to obstructive sleep apnea (OSA) and healthy controls. This is an original approach to define mechanisms which underlie the high incidence of occlusive vascular events in patients with OSA. The evaluation of such pathophysiological mechanisms will lead to a better understanding of the pathways involved and the development of therapeutic strategies targeting the reduction or avoidance of endothelial injury with the ultimate goal of reducing morbidity and mortality associated with these pathologic events in sleep apnea. The standard of care will be used in this protocol, which involves the use of CPAP (continuous positive airway pressure) for treating sleep apnea.

Eligibility Criteria:
Study Group 1: Sleep Apnea

Inclusion Criteria:

* 21 years or older
* Presence of intermittent hypoxemia (IH) and obstructive sleep apnea (OSA)
* No diagnosis of hypertension, coronary artery disease, diabetes, stroke, or evidence of underlying vascular disease

Exclusion Criteria:

* Smoking
* Pregnancy
* Known cardiovascular disease, stroke, or diabetes
* Current or previous treatment for sleep apnea
* Central or Cheyne-Stokes sleep apnea
* Use of supplemental oxygen at night
* Alcohol abuse
* Regular use of sedatives
* Regular use of aspirin or cholesterol lowering agents

Study Group 2: Normal Controls

Inclusion Criteria:

* 21 years or older
* No diagnosis of intermittent hypoxemia (IH) or obstructive sleep apnea (OSA)
* No diagnosis of hypertension, coronary artery disease, diabetes, stroke, or evidence of underlying vascular disease

Exclusion Criteria:

* Smoking
* Pregnancy
* Known cardiovascular disease, stroke, or diabetes
* Use of supplemental oxygen at night
* Alcohol abuse
* Regular use of sedatives
* Regular use of aspirin or cholesterol lowering agents
Inter Individual Variability in Initiation Pathway Activation and Regulation and Phenotypic Heterogeneity in Patients With Haemophilia A and B

Severe haemophilia A and B (SHA, SHB) are X - linked inherited bleeding disorders, characterised by factor VIII and IX levels of \<1 IU/dL respectively. The mainstay of treatment in SHA and SHB is replacement therapy with intravenous infusions of factor VIII and IX. However, there is significant variability in the bleeding phenotype within severe haemophiliacs with some presenting with minimal bleeding episodes even on less intensive treatment regimens. A significant contributor to inter-individual variability in the bleeding phenotype is the coagulation phenotype, but there are no established assays in routine clinical practice that can be used to quantify this. This study aims to study novel assays and characterise the observed phenotypic heterogeneity.


Eligibility Criteria:
Patients

Inclusion Criteria:

1. Patients with haemophilia A or B (baseline FVIII/FIX level \<30%)
2. Age ≥ 18 years
3. Written informed consent in accordance with local and institutional guidelines.

Exclusion Criteria:

1. Patients currently enrolled into a clinical trial of investigational medicinal product for haemophilia.

Healthy Volunteers

Inclusion Criteria:

1. Currently not receiving any antiplatelet or anticoagulant therapy or other drugs that can affect the coagulation system.
2. Age ≥ 18 years
3. Written informed consent in accordance with local and institutional guidelines.
Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects

Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive
* Female subjects who are heterosexually active and of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-514.
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of clinically significant active infection.
* A positive urine drug screen at Screening or Day -1.
* Current tobacco smokers or use of tobacco products within 3 months prior to Screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).

  • Clinically significant laboratory abnormalities at screening or Day -1, as determined by the Investigator (including but not limited to hypokalemia, hypocalcemia, or hypomagnesemia for Part 3 participants).
* History of regular alcohol consumption
* Participation in a clinical trial within 30 days prior to the first dose of study drug.

For Part 2 (Carbamazepine) participants:

* Participants of Asian ancestry, given association of carbamazepine and severe rash (Stevens Johnson Syndrome \[SJS\] and Toxic Epidermal Necrolysis \[TEN\]) with HLA-B 1502 in this population.
* Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.
Essential Oils in Stoma Bags on Deodorization, Life Satisfaction, Stoma Adaptation in Individuals With Colostomy

This study was planned to examine the effects of using the lavender essential oil and peppermint essential oil in stoma bags on odor removal, life satisfaction, and stoma compliance in patients with a stoma.

There are commercially available products that health insurance does not pay for to eliminate the odor caused by gas and stool output in patients with colostomy. The limited variety of these products in our country makes it difficult for patients to access the product. In addition, it was seen in the patient feedback that they thought these products had chemical content and were worried that they would damage the colostomy. For these reasons, there was a need to search for more accessible, affordable, and non-chemical products. Essential oils are volatile, aromatic, concentrated oily liquids taken from the essence of various plant parts. Research results on the antibacterial, antifungal, antiviral, antioxidative, and antimutagenic effects of plant essential oils are generally positive. Lavender essential oil and peppermint essential oil have been used in the past, for reasons such as creating a pleasant smell, providing wound healing, antibacterial and anxiolytic properties, and improving the quality of life. For this reason, it is accepted that the use of herbal essential oil and extract can be one effective solution. In the study of Kazemi et al. (2021); Lavender essential oil has also been found to be effective in wound healing. In Duluklu's (2018) study on patients with colostomy, it was determined that there was a significant improvement in the living conditions of the experimental group formed by dripping lavender oil into the colostomy bag. It was observed that there was a significant difference between the stoma compliance scale acceptance sub-dimension and the overall stoma compliance mean score. In rainbow trout, Metin et al. (2015), in his study; They found that the use of peppermint oil did not cause any toxic effects on fish. Anderson et al.) in a randomized double-blind study with individuals experiencing postoperative nausea and vomiting, given lisinopril alcohol, peppermint oil, and placebo (saline) effective products, and nausea determined at the second and fifth minutes following inhalation of peppermint oil applied to gauze before the application of peppermint oil extract. It was determined that it decreased significantly according to the feeling of nausea. In literature reviews; There are limited studies on using lavender essential oil for odor removal in individuals with colostomy. There is no use of peppermint essential oil. Using lavender oil and peppermint oil in a stoma bag is a simple, natural, and low-cost method for odor removal.

Eligibility Criteria:
Inclusion Criteria:

* Have a stoma
* To be compatible with essential oils

Exclusion Criteria:

* Patients with allergic reaction
Socioeconomic Status, Secondary Prevention Activities and Recurrence After a Myocardial Infarction

This is a nationwide cohort study on real-world patients (n≈30,000) surviving a first myocardial infarction (MI) 2006-2013 and alive to attend a routine 1-year follow-up. Associations between Socioeconomic Status (SES) and secondary preventive actions (SPAs) throughout the first year is studied and assessed as possible mechanisms underlying the increased risk of a first recurrent hard cardiocvascular (CV) outcome, recurrent atherosclerotic cardiovascular disease (rASCVD), in patients with low Socioeconomic Status during long-term follow-up (2006-2018).


Eligibility Criteria:
Inclusion Criteria:

* Swedish resident
* Alive and registered in The Swedish Websystem for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART)'s secondary prevention subregistry between 1 January 2006 and 31 December 2013 at the 1-year-revisit

Exclusion Criteria:

* Age \>76 years at baseline
* Missing data for disposable household income
* History of MI, stroke, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) prior to the index MI
* Not present in initial care registry (RiksHIA)
* Date of index MI before 2004 or missing
* revisit outside 13±2 month window post-MI
Surface Roughness of a Dental Restorative Material and Biofilm Formation

In this study we intend to find out the pattern of biofilm accumulation in vivo on various surface finishings.

Our intention is to prepare Polymethylmetacrylate squers on orthodontical brackets,then prepare the surface of the sample and measure the surface roughness with a profilimeter and get the mean value in Ra units, then place the brackets on lower premolars and molars for 12 hours, remove them and examine the biofilm formed with confocal scanning microscope.

Several studies in the past to assess the effects of surface roughness on the amount of plaque accumulation in vitro, whereas only few performed a modern in vitro assessment of the plaque accumulation. In this study we intend to find out the pattern of biofilm accumulation in vivo on various surface finishings.

Our intention is to prepare Polymethylmetacrylate squers on orthodontical brackets,then prepare the surface of the sample and measure the surface roughness with a profilimeter and get the mean value in Ra units, then place the brackets on lower premolars and molars for 12 hours, remove them and examine the biofilm formed with confocal scanning microscope.

Statistical evaluation of pilot study determined the need to perform this research on twelve(12) candidates. It is our intention to check two materials in each candidate: composite resin and polymethylmetacrylate.

Eligibility Criteria:
Inclusion Criteria:

* any patient with intact buccal surfaces of lower molars and premolars

Exclusion Criteria:

* patients that used antibiotics in the three months prior to the experiment
Significance of Platelet Indices and Ratios in Different Degrees of Burn

Study the correlation between the platelet indices and different degrees of burn Study the correlation between the platelet ratios and different degrees of burn.

Burns are a major traumatic pathology characterized by tissue destruction and cellular degradation resulted by energy transfer and mainly affect skin, which serve as significant cause of morbidity and mortality. burns are classified as first,second and third degree depending on how deep and severe they penetrate the skin surface.

Platelets play important role in primary homeostasis, thrombosis, inflammation and tissue regulation in the processes of wound healing. Platelets can contact exposed collagen and extra cellular matrix and releasing clotting factors to achieve homeostasis as well as essential growth factors and cytokines to repair the wound.In clinical, Platelet-rich plasma (PRP) is a concentrate of autologous platelets,has been used to effectively accelerate burn wound healing Platelet indices (PI), markers of platelet activation, are parameters obtained daily as a part of an automatic blood count, Platelet indices are related to platelets morphology and proliferation kinetics. Most commonly assessed platelet indices include the mean platelet volume (MPV), mean distribution width(PDW),Platelet larger cell ratio (PLCR) ,platelet crit (PCT), mean platelet mass (MPM),mean platelet component (MPC),Platelet component distribution width (PCDW) and immature platelet fraction (IPF).

The ratio of red blood cell distribution width (RWD) and platelet (PLT) (RPR) is considered an inflammation biomarker associated with the poor prognosis of number of diseases. There is two studies about PRP related to prognosis of major burn injury . results indicate that RPR-as an inflammatory index- can be used as a biomarker for prognosis of adult patients with major burn injuries.

Blood-based platelet parameters, due to their fairly easy accessibility and inexpensive methods of measurement, seem to be on the rise as potential novel biomarkers of numerous ,both acute and chronic disease. However, To date ,there are no data on the significance of platelets indices in evaluation with different degrees of burn .In this study we will evaluate the significance of platelet ratios and indices in different degrees of burn.

Eligibility Criteria:
Inclusion Criteria:

* burn degree ( 1,2,3)

Exclusion Criteria:

* patient with ITB
Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers

Background: Preterm birth has major medical, psychological and socio-economic consequences worldwide. A recent systematic review suggests positive effects of music therapy (MT) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of infant and parental outcomes are missing. Drawing upon caregivers' inherent resources, this study emphasizes caregiver involvement in MT to promote attuned, developmentally-appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalization and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.

Methods: Design: International multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. A feasibility study has been completed; ethical approval for the main trial is pending. Participants: 250 preterm infants and their parents. Intervention: MT focusing on singing specifically tailored to infant responses, will be delivered during NICU and/or during a post-discharge 6-month period. Primary outcome: Changes in mother-infant bonding until 6 months corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: Mother-infant bonding at discharge and over 12 months CA; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months.

Discussion: This study fills a gap by measuring the long-term impact of MT for preterm infants/caregivers, and of MT beyond the hospital context. Outcomes related to highly involving parents in MT will directly inform the development of clinical practice in Scandinavia and other contexts with similar social welfare practices. By incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.


Eligibility Criteria:
Inclusion Criteria (infants):

* born below 35 weeks gestational age
* determined by medical staff to have achieved sufficient medical stability to start MT
* likely to be hospitalized longer than 2 weeks from time of recruitment

Inclusion Criteria (parents):

* willing to engage in at least 2 of 3 MT sessions per week during NICU and/or in 5 of 7 MT post-discharge sessions, if randomized to receive MT
* live with reasonable commuting distance from the treating NICU
* sufficient understanding of the respective national language(s) to answer questionnaires and participate in MT

Exclusion Criteria (parents):

* documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments