cyrilzakka/clinical-trials huggingface dataset:
The Multi-stakeholder Assessment of Economic and Managerial Determinants and Impacts of Telemedicine

The study aims to conduct a comprehensive evaluation involving multiple stakeholders to assess the factors influencing and the consequences of telehomecare in comparison to traditional care models. The integration of technology into the healthcare sector necessitates significant changes in care of patients, organizational structures, production processes, organizational responsibilities, and the management of service delivery processes.

The delivery of telemedicine services through integrated devices represents a method of service production that demands active involvement from patients or, in the case of pediatric patients, their caregivers. This collaborative process of patient engagement in healthcare services is referred to as "co-production." In this research, telehomecare will be examined as an illustrative instance of co-producing healthcare services.

Co-production implies that the inputs into a production process are contributed not only by the organization producing a good or service but also by the users. In the case study, co-production occurs through the interaction between patients/caregivers and professionals during telehealth visits for device-mediated monitoring activities. Throughout the televisit, patients/caregivers play a crucial role in collecting and sharing the necessary parameters with professionals using the device, thereby serving as essential actors in the care process.

The investigators explored the impact of a transitional care program, utilizing an user-friendly mobile medical device, to support an early discharges in a pediatric setting. Clinical outcome and economic advantages are considered. This study will contribute to implement knowledge on the role of telemedicine on HaH healthcare in pediatrics.

This is a single-center, two-arm, randomized, open-label, parallel-group study that was conducted at Buzzi Children's Hospital, a hospital in a metropolis located in Milan (Italy). The different arms consisted of an experimental group with an early discharge adopting telehomecare and a standard care group with in-person physical care until the end of hospitalization.

Eligibility Criteria:
Inclusion criteria:

* Age: 0-18 years.
* Gender: Both males and females
* Patients: Hospitalized at the end of treatment.
* Stable Vital Signs (heart rate, respiratory rate, oxygen saturation)
* Stable/Improving/Resolved biochemical Tests.
* Absence of Fever
* Consent/Assent: Willingness to participate with appropriate consent or assent based on age.
* Proximity to Domicile: Residence within a maximum distance of 45 minutes.
* Adequate Home Facilities.
* Language Proficiency: Adequate knowledge of the Italian language.
* Possession of Compatible Device

Exclusion criteria:

* Refusal to Participate
* Vital Signs Instability
* Presence of Fever
* Deteriorating biochemical Test Results
* Residence More Than 45 Minutes Away
* Inadequate Home Facilities
* Language Barrier
* Lack of a Compatible Device
* Not owning a device with an operating system suitable for supporting the Tytocare app.
Evaluating Incentive Designs to Increase Physical Activity Goal Adherence in a Wellness Program

This is a 4-week, five-arm, randomized, controlled trial to compare a standard wellness incentive program for physical activity to four other designs.

Increased physical activity is associated with numerous health benefits including lower risk of cardiovascular disease. However, many individuals do not achieve physical activity goals. Vitality is a wellness program in South Africa that uses a program called "Active Rewards" to incentives achievement of weekly physical activity goals. In this study, the investigators will compare the standard active rewards program to doubling the magnitude or adding lottery designs with and without broadcasting the # of winners.

Eligibility Criteria:
Inclusion Criteria:

* Vitality member that has activated "active rewards" program

Exclusion Criteria:

-
Evaluation of New Semen Collection & Transportation Kit

Examine the effect of overnight transport conditions on sperm parameters on semen samples collected and mailed to Cleveland Clinic Andrology center.


Eligibility Criteria:
Inclusion Criteria:

* Normal healthy men with normozoospermic semen parameters
* Infertile men referred by the infertility specialist (urologist)

Exclusion Criteria:

* Controls with abnormal semen parameters
* Infertile men from other referrals (Gynecologists)
* Severe oligozoospermic (\<1 x 106 sperm/mL) infertile men
Analysis of Related Factors Affecting the Secondary Implantation of Intraocular Lens in Congenital Cataract

The ocular biometric parameters of the children with congenital cataract including preoperative pupil diameter, corneal diameter, axial length, anterior and posterior capsule size, iris adhesion. And then analysis whether the preoperative parameters were correlated with the implantation site of secondary implantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed as congenital cataract without lens after surgery
* Secondare IOLs implantation surgery was performed in Eye hospital of Wenzhou Medical University

Exclusion Criteria:

* Suffers from uveitis, glaucoma and other ocular diseases
Imatinib Mesylate in Treating Patients With Recurrent Ewing's Family of Tumors or Desmoplastic Small Round-Cell Tumor

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.

OBJECTIVES:

* Determine the effectiveness of imatinib mesylate in patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.
* Determine the toxic effects of this drug in these patients.
* Determine the duration of disease-free and overall survival of patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of Ewing's family of tumors OR desmoplastic small round-cell tumor
* Must have immunohistochemical evidence of expression of greater than 2+/4+ for either Kit (CD117) or platelet-derived growth factor receptor -a or -b
* No symptomatic brain metastases

  * Asymptomatic brain metastases are allowed provided patient is not on concurrent anticonvulsants or corticosteroids

PATIENT CHARACTERISTICS:

Age

* Over 16

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 9 g/dL

Hepatic

* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT less than 2.5 times ULN
* No chronic active hepatitis
* No cirrhosis
* No other acute or known chronic liver disease

Renal

* Creatinine less than 1.5 times ULN

Cardiovascular

* No concurrent poorly controlled or severe cardiovascular disease

Pulmonary

* No concurrent poorly controlled or severe pulmonary disease

Other

* HIV negative
* No concurrent poorly controlled or severe central nervous system disease
* No other concurrent poorly controlled or severe nonmalignant disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* At least 3 weeks since prior chemotherapy

Endocrine therapy

* See Disease Characteristics

Radiotherapy

* At least 3 weeks since prior radiotherapy

Surgery

* More than 2 weeks since prior major surgery

Other

* More than 28 days since prior investigational agents
Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia

The purpose of this study is to determine the efficacy of C-reactive protein and procalcitonin based guidelines versus standard of care to reduce duration of antibiotic exposure in patients hospitalized with community acquired pneumonia.

BIO-CAP is a prospective randomized intervention study which aims to evaluate the efficacy of C-reactive protein (CRP) based guidelines and procalcitonin (PCT) based guidelines to reduce duration of antibiotic exposure in adult patients hospitalized with community-acquired pneumonia (CAP) compared to standard-of-care.

Hypothesis: the duration of antibiotic exposure can be reduced when a biomarker algorithm - in addition to standard of care - is used to stop antibiotic treatment.

1) CRP based guidelines can reduce duration of antibiotic exposure equally to procalcitonin based guidelines and 2) Either of these two biomarker algorithms ( CRP or PCT) are superior compared to standard of care.

Sample size. Preconditions: significance level (α) 5 % and power (β) 80 %. Test: unpaired T-test. Mean treatment time 11 days (SD 5) in this population. Relevant detection limit defined at 2 days. The bonferroni correction has been used to correct for the fact that 2 primary analysis will be performed, why α = 0.005/2 = 0.025. Estimated 100 patient in each arm, thus n = 300.

Site monitoring and auditing. The study is monitored by the unit for Good Clinical Practice, Bispebjerg Hospital, Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older admitted to hospital with community acquired pneumonia defined as a new infiltrate on x-ray and at least one of the following; cough, expectoration, dyspnea, fever and pathological lung-auscultation.
* Not admitted to hospital within the last 14 days
* The patients has been prescribed antibiotic treatment for pneumonia
* The patient can comprehend the written and verbal information and has provided written consent.

Exclusion Criteria:

* Patient are unable to give written consent or patient does not understand the Danish language.
* Active pulmonary tuberculosis
* Severe immunosuppression determined by the treating physician (i.e. treatment with highdose corticosteroid for more than 2 weeks, chemotherapy and neutropenia with neutrophils \< 0.5x109/l, ongoing treatment with biological drugs, chronic HIV-infection with CD4 cell count \< 350 mio./l, immunosuppression after organ transplantation).
* Pregnancy and breastfeeding
* Patients admitted to hospital and treated against their will.
* Terminal ill patients where active treatment is stopped within the first 48 hours of admission.
* Patients who are, from the date of inclusion, prescribed antibiotic treatment for more than 3 days on a different indication than pneumonia.
Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients

The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* COPD
* Current or exsmokers, 10 pack years

Exclusion Criteria:

* Asthma
* Any clinically relevant abnormal findings at screening examinations
* Recent COPD exacerbation
Written Exposure Therapy for Veterans With SUD and PTSD

The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD/PTSD.

This study is a randomized clinical trial within a Substance Use Disorder (SUD) specialty clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing condition on both PTSD and addiction outcomes for Veterans in SUD treatment. Veterans with a current diagnosis of SUD and comorbid PTSD will be randomized to either WET plus TAU or TAU augmented by a neutral topic writing condition. During the first writing session, participants will be asked to write about either a personal traumatic experience (WET) or a neutral topic (control). In sessions 2 through 5, participants will again meet with the study therapist for 45 minutes (maintaining the same writing condition as assigned in session one). Measures of trauma symptoms, distress, and mood will be collected at each writing session, with additional assessments at baseline, at post-treatment (following 5 writing sessions), 8-weeks, and 12-weeks post-baseline assessment. The primary aim of this study is to examine whether WET augmentation of TAU improves trauma symptoms for Veterans with SUD and PTSD who are receiving outpatient SUD treatment compared to TAU with a neutral writing control. The secondary aim will examine whether WET improves SUD outcomes for Veterans with comorbid PTSD compared to TAU with a neutral writing control. If results prove promising, they will support WET as an effective brief, cost efficient, easy to disseminate, adjunct to current SUD treatment for Veterans with comorbid PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Veterans ages 18 years old or older;
* Meets DSM-5 criteria for at least one substance use disorder (SUD);
* Meets DSM-5 criteria for PTSD;
* Approved for SUD treatment at VA Connecticut Healthcare System.

Exclusion Criteria:

* Veterans who meet current criteria for schizophrenia, schizophrenia-type disorders, or unmedicated mania or bipolar disorder as determined by QuickSCID-5;
* current suicidal or homicidal risks necessitating a higher level of care;
* Veterans who have received an Evidence-Based Psychotherapy for PTSD protocol within the past 6 months;
* Problems that would prevent a participant from completing the writing intervention or study assessments (e.g., illiteracy). To assess for literacy, participants will read parts of the consent out loud.
Localized Body Cooling Technology on Sleep and Metabolism in African, American With Overweight and Obesity

The goal of this study is to see the effect that a cooling pillow pad called Moona has on sleep quality.

Obesity and diabetes pose a signiﬁcant burden on healthcare systems worldwide. Evidence from large cross-sectional and longitudinal epidemiologic studies, and well-designed experimental sleep manipulations, demonstrated that insufficient sleep is a risk factor for obesity-induced insulin resistance and type 2 diabetes. Limited available evidence suggests that optimizing sleep duration and quality in individuals who experience deficient sleep could have beneficial effects on weight maintenance, facilitate weight loss and improve glucose metabolism. It is well known that body temperature impacts sleep. A rapid decline in core body temperature increases the likelihood of sleep initiation and may facilitate an entry into the deeper stages of sleep.

Pharmacological treatment is often prescribed for sleep disturbances, primarily insomnia. But sleep extension with benzodiazepines/sedative-hypnotic agents does not appear to have beneficial effects on metabolism, in fact, these drugs may even have an adverse effect on glucose metabolism. Many people use melatonin as a sleep aid, however, the available data do not support a major role of melatonin in body weight regulation and the evidence supporting melatonin administration in improving glucose metabolism has been mixed.

Limited studies suggest that localized cooling could represent a non-pharmacological strategy to favor sleep onset or improve sleep duration and/or quality.

Eligibility Criteria:
Inclusion Criteria:

* African American men and women
* Aged 21-50 years
* BMI ≥ 27 to 45 kg/m2
* Self-report of short or poor sleepers (\>5 \< 7hrs /night and/or a score \> 5 on the PSQI),
* Sleeping between 22:00 and 08:00.
* Ability to provide informed consent before any trial-related activities
* Controlled hypertension or dyslipidemia.

Exclusion Criteria:

* Previous diagnosis or reveled during the screening PSG (Polysomnography) of obstructive sleep apnea (AHI≥30) or other sleep disorders based on DSM-V (Diagnostic and Statistical Manual of Mental Disorders, fifth edition) criteria.
* Shift work
* Diagnosis of diabetes based on history or screening tests
* History of cognitive or other neurological disorders
* History of major psychiatric disorder based on DSM-V criteria
* Presence of unstable or serious medical conditions
* Use within the past month of melatonin, psychoactive, hypnotic, stimulant or pain medications (except occasionally)
* Caffeine consumption of greater than 500 mg per day
* Medically managed weight loss program within the past 6 months
* History of bariatric weight loss surgery.
* Women who are pregnant, plan on becoming pregnant, are breastfeeding,
* Men or women who have a child at home that does not sleep through the night.
* Active drug/alcohol dependence or abuse
Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT

To evaluate the safety and tolerability of HMPL-653 in patients with advanced solid tumors who have failure of standard of care or can not tolerate standard of care or those with TGCT, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II clinical study dose (RP2D) of HMPL-653 in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Able to understand and willing to sign the ICF.
2. Aged 18 to 75 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy at least 12 weeks.
5. Adequate bone marrow, liver and kidney function.

Exclusion Criteria:

1. Toxicity associated with previous antitumor therapy not recovered to ≤CTCAE grade 1；
2. Previous treatment with anti-CSF1R therapy and have progressive disease;
3. Receiving approved systematic antitumor therapy or in the treatment period of other interventional clinical study within 4 weeks prior to the first dose.
4. Patients with central nervous system (CNS) malignant tumor or malignant solid tumor with known CNS metastasis;
5. Pregnant or lactating women.
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia

The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.


Eligibility Criteria:
Inclusion Criteria:

* Peri- or postmenopausal women
* DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes
* Some awakenings co-occur with a hot flash
* Score on the Insomnia Severity Index (ISI) measure ≥15
* Hot flashes present, including at night

Exclusion Criteria:

* Diagnosis of other primary sleep disorders
* Shift workers
* Current or expected use of hypnotic medications
* Current major depressive episode
* Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
* Current alcohol/substance use disorder
* Obesity
* Renal or hepatic disease
* Pregnancy or breastfeeding
* Recent malignancy
* Recent surgery
* Neurological disorder or cardiovascular disease raising safety concerns
* Medical instability considered to interfere with study procedures
* Concomitant medications with drug interaction or co-administration concerns
* Contraindications or allergic responses to suvorexant
* Recent or planned travel across time zones
* Excessive coffee or cigarette use
Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen

This is an open-label, multicenter, randomized (1:1 randomization ratio) study of either exemestane or exemestane plus celecoxib in postmenopausal women with ABC having progressed on tamoxifen.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female patient with histologically or cytologically confirmed breast cancer having progressed on Tamoxifen.
* Advanced disease: patients with advanced breast carcinoma with disease progression who had progressed/relapsed following \> 8 weeks of treatment with Tamoxifen for advanced disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months depending on receptor status; or progressed within 12 months from completion of adjuvant treatment with Tamoxifen.
* at least one measurable lesion

Exclusion Criteria:

* More than one previous chemotherapy and/or more than one hormonotherapy for advanced disease.
* Previous hormonotherapy for advanced disease other than Tamoxifen.
* Myocardial infarction within previous 6 mo
Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents

This study will evaluate the effects of a pharmacist-led, deprescribing-focused medication review on the use of inappropriate medications by nursing home residents

Nursing home residents are often prescribed inappropriate medication, drugs whose negative effects outweigh potential benefits or which are not useful anymore. Inappropriate medication have been linked with worse health outcomes, hospitalisations and death. Deprescribing, the structured process of withdrawing or tapering inappropriate medications, has been studied as a potential solution to this problem.

In this study, nursing home residents living in institution which are already engaged in a deprescribing process will be randomly allocated to receive a medication review or usual care. The medication review will be performed by the nursing home pharmacist an its results will be discussed with the responsible physicians and nurses to create a deprescribing plan specifically tailored to the needs of the resident.

Eligibility Criteria:
Inclusion Criteria:

* Take 5 or more prescribed drugs daily;
* Reside in the Nursing Home since at least 4 months.

Exclusion Criteria:

* Physician judges that discussing deprescribing with them risks destabilising them.
Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.

Open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of male and female healthy subjects, aged at least 18 years.

The study will be performed at 3 study centers in Germany and Austria. Three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch IC51/07F/008 of IC51

Eligibility Criteria:
Inclusion Criteria:

* Male and female healthy adults aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test.

Exclusion Criteria:

* History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including alcohol dependence, prior vaccination against JE