cyrilzakka/clinical-trials huggingface dataset:
Study in Postmenopausal Women to Investigate the Drug-drug Interaction (DDI) Between Itraconazole(ITZ) and Orally Administered Vilaprisan; Absolute Bioavailability Using Intravenous Microtracer Dose of [14C]Vilaprisan

This is a study in postmenopausal women to investigate the Drug-drug interaction (DDI) between itraconazole(ITZ) and orally administered vilaprisan; absolute bioavailability using intravenous microtracer dose of \[14C\]vilaprisan.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI): 18 ≤ BMI ≤ 32 kg/m²
* Postmenopausal state revealed by:

Medical history, if applicable (natural menopause at least 12 months prior to first study drug administration; or surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration), in addition: in women \< 65 years old, follicle stimulating hormone (FSH) \> 40 IU/L

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
* Known or suspected liver diseases
* Clinically relevant findings(e.g. blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination)
The Role of Modified Ultrafiltration Following Open Heart Surgery

This study aims to investigate the effect of combining conventional ultrafiltration and modified ultrafiltration compared to conventional ultrafiltration alone in patients who underwent open heart surgery.

The target of this study is adult patients diagnosed with coronary heart disease and valve disease who underwent open heart surgery in CICU PJT RSCM and Jakarta Heart Hospital. The research was conducted after obtaining approval from the FKUI-RSCM ethical committee, and the research subjects agreed to participate by signing an informed consent form. The anesthesia team prepared research subjects undergoing surgery with the placement of arterial cannulas, central venous catheters, sheath introducers, pulmonary artery catheters, and anesthesia management. The placement of these instruments aimed at measuring dependent variables studied included Systemic Vascular Resistance (SVR), Pulmonary Vascular Resistance (PVR), Cardiac Index (CI), and IL-6 levels. The CPB machine was used during the heart chamber opening procedure or coronary artery graft placement, and CUF was initiated. After CPB use was concluded, research subjects were allocated to either the control group or the treatment group through randomization. MUF was performed post-CPB in the treatment group, with the pump speed not exceeding 10% of full flow for 10 minutes. IL-6 levels were measured twice, namely before induction of anesthesia and 24 hours after CPB. SVR, PVR, and CI measurements were carried out before CPB, post-CPB, 10 minutes post-CPB, and 24 hours post-CPB.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years or older undergoing elective open heart surgery
* Willing to become a research participant and sign an informed consent statement

Exclusion Criteria:

* Patients undergoing redo surgery and emergency surgery
* Patients that have immune disease, chronic lung disease, undergoing hemodialysis
* Patients who are pregnant

Drop-out Criteria

* Patients who experience repeated back-on bypass
* Patients who experience reopen surgery 24 hours after surgery
* Patients who die within 24 hours after surgery
Impact of Forest Baths on Emotional Well-being in People With Sub-clinical Symptomatology of Anxiety and Depression

The investigators intend to evaluate patients aged 18 to 99 years with symptoms of anxiety and/or mild depression. A randomized controlled clinical trial will be carried out to evaluate the impact of the guided practice of forest bathing.

The practice of Shinrin-Yoku, also known as Forest Bathing, is an outdoor therapeutic modality with growing evidence suggesting positive effects on the psychological well-being and general health of individuals. However, its benefits have been studied mainly in Asian countries, needing further research to assess whether its benefits are also generalizable to other European-Mediterranean regions. To explore this question, the investigators intend to evaluate patients aged 18 to 99 years with symptoms of anxiety and/or mild depression. A randomized controlled clinical trial will be carried out to evaluate the impact of the guided practice of forest bathing. The participants will be randomly distributed in two arms, with a crossover design: arm A intervention + control; arm B control + intervention. Participation in this study consists of the execution of two sessions of guided forest bathing practice, and the completion of online evaluation forms before and after each session of guided forest bathing practice, for 24 hours afterwards, as well as before and after the program as a whole. The study includes clinical assessments, emotional well-being, social support and other complementary indicators. For hypothesis testing, a linear model of univariate analysis of variance intrasubject design will be applied to the dependent variables, with three phase conditions (pre, post and follow-up) and two treatment conditions (intervention vs. control).

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 65 years.
* Voluntary signature of informed consent.
* Symptomatology of anxiety and/or mild depression with mild interference in daily functioning.
* Motivation, attitude and ability to work in a group.
* Receptive attitude to learning new skills and sharing experiences.

Exclusion Criteria:

* Serious psychiatric disorder: Major depressive disorder with or without psychotic symptoms, uncompensated major depressive episode, dysthymic disorder, presence of suicidal ideation or suicide attempts, personality disorder.
* Lack of knowledge of Catalan and Spanish.
* Disconformity with acceptable standards of conduct.
¿Can mySugr App Improve Knowledge and Self-management of People With Type 1 Diabetes Mellitus?

This project is based on the contribution that an app can offer for improving knowledge and self-management of people with type 1 diabetes.

The main objective of this study is to assess mySugr app as a tool for empowering people with type 1 diabetes.

The study population are type 1 diabetes people, aged more than 18 years old and with more than one year from diagnosis. They will be randomised to standard care or use of mySugr app and will be followed-up during 48 weeks.

Control group will attend 5 face-to-face visits (baseline, 3, 6, 9 and 12 months) with the possibility of telephone contact and hospital assistance if necessary. Intervention group will attend 3 face-to-face visits (baseline, 6 and 12 months) and 2 telematic visits (at 3 and 9 months) and will also have the possibility of telephone contact and hospital assistance if necessary.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* People with type 1 diabetes (\> 1 year diagnosis)
* Treatment with insulin in basal-bolus regimen
* Glucometer that connects automatically with the app
* HbA1c 7-9%
* Understanding of carbohydrate counting and concepts of ratio and factor of sensitivity
* Have a smartphone or tablet

Exclusion Criteria:

* Use at the time of randomization of another app for diabetes management
* Use of continuous monitoring or flash glucose systems
* Pregnancy
* Any other disease or condition that may interfere with the completion of the protocol or completion of the study
Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis

Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic disorder that slows or stops the passage of food from the stomach to the small intestine. The purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric emptying time in diabetic subjects with gastroparesis.

This is a 4-way crossover study to assess the effect of TC-6499 on gastric emptying time in diabetic subjects with gastroparesis. The length of study participation for a subject is up to 50 days. During screening, eligible subjects will complete an oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT). During the treatment period, subjects will complete 4 overnight drug assessment visits (treatment arms) where they will receive a randomized single dose of study drug and the GEBT. Each overnight visit will be separated by approximately 7 days. At least 18 subjects will be randomized and complete all 4 dosing arms (actual = 23 randomized subjects and 21 completing all 4 arms of the crossover).

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of gastroparesis or symptoms consistent with gastroparesis for at least 6 months (and Gastroparesis Cardinal Symptoms Index total score \>22)
* Gastroparesis confirmed using the GEBT
* Type 1 or Type 2 diabetes with a Hemoglobin A1c ≤ 10%
* Fasting blood glucose (finger stick) ≤ 275 mg/dL prior to each GEBT
* Body Mass Index (BMI) ≤ 40
* Willingness to remain in clinical research facility for the protocol-required days of treatment and study procedures
* Willingness to use a double barrier method of birth control (except post-menopausal females)
* Able to understand study procedures and provide written informed consent

Exclusion Criteria:

* History of abdominal surgery including gastric banding procedure
* Chronic parenteral feeding or feeding through a gastrostomy or jejunostomy tube
* Persistent daily vomiting
* A history of eating disorder
* Recent history of poor control of diabetes
* Acute severe gastroenteritis
* Have implanted or use any type of gastric electric stimulator
* Use of opiates, anticholinergic medications, GLP-1 mimetics or amylin analogs
* Use of medications potentially influencing upper gastrointestinal motility or appetite
* Allergies or intolerance to egg, wheat, milk, or algae
* Pregnant or lactating females
* Presence of a clinically significant medical condition at any time during the study
* Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs
* Participated in an investigational drug study within 30 days of screening
Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study

The objective of this multisite study is to evaluate the performance of the Nucleus Freedom cochlear implant system in a large population of sequentially implanted pediatric subjects.

The proposed study will include 50 pediatric subjects ages 1 year to 17 years, 11 months of age, implanted at up to 5 sites in the United States and Canada. The estimated duration of this multisite study is 18 to 24 months. The duration of individual subject participation is not to exceed 12 months.

The study will be conducted as a within-subject repeated measures experiment (in which each subject serves as his or her own control) in order to accommodate the heterogeneity that is well known to characterize hearing-impaired populations

Eligibility Criteria:
Inclusion Criteria:

* 1 year to 17 years, 11 months of age.
* Bilateral severe to profound sensorineural hearing loss for those 1 to 2 years of age. Severe hearing loss for those 2 years of age and older.
* Limited benefit from bilateral hearing aids. Limited benefit is defined as a lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and intensive aural rehabilitation over a 3 to 6 month period.

  * For younger children, unable to take speech perception tests due to age-related cognitive and linguistic limitations, limited benefit will be quantified using the Infant Toddler Meaningful Auditory Integration Scale (IT-MAIS)1 or Meaningful Auditory Integration Scale (MAIS)1.
  * For older children, capable of speech perception tasks, limited benefit is defined as £ 30% on the recorded open-set Multisyllabic Lexical Neighborhood Test (MLNT)2 or Lexical Neighborhood Test (LNT) 2, depending on the child's cognitive and linguistic skills.
* English spoken as a primary language.
* Willingness to participate in and to comply with all requirements of the protocol.

Exclusion Criteria:

* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array, as confirmed by medical examination and tests including MRI.
* Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and tests including MRI.
* Medical or psychological conditions that would contraindicate undergoing surgery (e.g., active middle ear infections, tympanic membrane perforation).
* Additional handicaps that would prevent or restrict participation in the evaluations.
* Unrealistic expectations on the part of the subject or subject's parents/guardians, regarding the possible benefits, risks and limitations that are inherent to the surgical procedure and prosthetic device.
* Unwillingness or inability of the candidate or candidate's parents/guardians to comply with all study requirements.
Point-of Care Ultrasound for Patients With HIV

Rationale: Point-of-care ultrasound (POCUS) is increasingly used by various specialists in the Netherlands, but its role in managing patients with HIV is unclear. In settings endemic for tuberculosis, Fast Assessment with Sonography for HIV/Tuberculosis (FASH) has proven its value to detect extrapulmonary tuberculosis in patients with HIV. However, there is no data to support POCUS for patients with HIV in resource affluent settings.

Objective: The investigators aim to determine the feasibility and diagnostic value of POCUS in detecting opportunistic disease in HIV patients with advanced disease stages in the Netherlands.

Study design: The investigators will perform a prospective observational pilot study.

Study population: The investigators will include new adult patients with HIV presenting with a cluster of differentiation 4 (CD4) T-cell count below 350 cells/mm3, and all adult HIV patients requiring admission to hospital. Intervention (if applicable): The investigators will perform a focused ultrasound examination including FASH, and ultrasound of the lung, liver and kidneys. In case of positive findings additional examinations will be undertaken to determine the underlying pathology and/or treatment started as indicated. In case of negative findings, patients will be followed for 12 months to observe for (possibly missed) opportunistic infections.

Main study parameters/endpoints: Our primary outcomes include acceptability of POCUS by patients, interobserver variation in interpretation of POCUS images, and number of diagnosed AIDS and non-AIDS related problems. Secondary outcomes include sensitivity and specificity, negative predictive value and positive predictive value of our POCUS protocol. In addition, incidence rates of opportunistic infections will be compared to a historical matched control group.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The ultrasound examination is painless and without risk to the participants. It will take approximately 30 minutes and will be combined with routine visits to the hospital. Benefits include potential earlier detection of opportunistic disease, while adverse effects may arise from false positive findings requiring further examinations which may cause stress or anxiety. The rate of false positive findings in POCUS has not been formally investigated, but appears low. The effect of POCUS in advanced HIV/AIDS can only be studied in HIV patients.


Eligibility Criteria:
Inclusion Criteria:

* new patients with HIV presenting with a CD4 T-cell count below 350 cells/mm3
* patients with HIV who are admitted to hospital

Exclusion Criteria:

- absence of informed consent
Validation and Assessment of Novel Morphology-Voltage-P-wave Score for Diagnosing Left Ventricular Diastolic Dysfunction in Patients With Hypertension

This study aimed to assess and validate the diagnostic utility of a novel Morphology-Voltage-P-wave Score (MVP Score) in identifying left ventricular diastolic dysfunction among patients with hypertension.

Researchers will collect information of patient with hypertension and underwent transthoracal echocardiography assessment. The data consist of demographic data, clinical presentation, laboratory, and echocardiography result were collected by two investigators. Then, the data was analyzed by using IBM SPSS Statistics v26.


Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension

Exclusion Criteria:

* Secondary or resistant hypertension
* LVEF\<55%
* Congenital heart disease
* Infiltrative cardiomyopathy
* Coronary artery disease
* Chronic kidney disease
* Valvular heart disease
* Bundle branch block
* Arrhythmia
Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.

The purpose of this observational, prospective, non-interventional, multicenter, open-label, single arm study in Hidradenitis suppurativa (HS) is to assess the treatment pattern of secukinumab in a flexible dosing regimen and decision influencing factors for flexible dosing in a real-world population over 2 years.

The study will collect data from patients during routine secukinumab treatment and will be representative of the real-world patient population eligible for secukinumab treatment in Germany.

In order to attain widespread representation of health care practices related to the use of secukinumab in the approved indication of moderate to severe HS, a broad spectrum of dermatology practices and clinics who are treating patients with HS across Germany will be included.

Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment:

1. Patients who provide written informed consent to participate in the study
2. Male and female patients with ≥18 years of age
3. Diagnosis of clinically unequivocal moderate to severe HS
4. Patients for whom a therapy with secukinumab is medically indicated
5. Documented decision for treatment with marketed secukinumab regardless of this noninterventional study
6. Treatment with secukinumab according to the latest version of SmPC
7. Initial treatment with marketed secukinumab planned for up to 1 week before the baseline visit

Exclusion Criteria:

Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients:

1. Patients who have any contraindications, such as a history of or active inflammatory bowel disease (Crohn´s disease, ulcerative colitis), and are not eligible for treatment with secukinumab according to the SmPC
2. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation
3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with secukinumab
4. Previous exposure to IL-17 inhibitors
5. For biologic-naïve patients, previous exposure to another biologic drug, such as anti-TNF-α inhibitors
Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives

This study will evaluate and describe the occurrence of Acute traumatic stress and persistence of Post Traumatic Stress Disorder (PTSD) after resuscitated sudden cardiac death (SCD) in patient and relatives present during the event. The population will be composed of 40 patients: 20 with resuscitated SCD and 20 relatives. Two interviews will be performed by a psychologist within one week after resuscitated SCD and at month 3. Questionnaire Stanford Acute Stress Reaction Questionnaire (SASRQ), Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (LEC-5) and Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) will be filled during these interviews.

In spite of therapeutic advances, sudden cardiac death (SCD) remains a frequent (60000/year in France) and often fatal disease (5% survival). Because it is by definition unexpected, the psychological impact on resuscitated patients and on relatives may be important. However little studies have evaluated it. Patients who later develop PTSD, generally have acute stress disorder. In patients with resuscitated sudden cardiac death, acute psychological distress is frequent and PTSD was identified in 40% of patients. Concerning relatives, Haywood (2018) call them the "forgotten patients" to emphasize the absence of recognition of his psychological trauma. PTSD was more frequent in people who were witness of the SCD vs those who were not there. Hofland et al (2018) showed that people present during resuscitation maneuvers had more acute stress than others.

This study will evaluate acute stress disorder with SASRQ scale in patients with resuscitated SCD and their relative just after the event. At 3 months, presence of PTSD will be evaluated with PCL-5 and LEC-5 in patients and their relatives.

Eligibility Criteria:
Inclusion Criteria:

* Patients with resuscitated sudden cardiac death and/or their relative
* Patients who are fluent in French
* Patients who have given their 'no objection to participation to the research'
* Patients of both gender over 18 years
* Women with childbearing potential and effective contraception

Exclusion Criteria:

* People who are not able to give their 'no objection to participate to the research'
* People with major cognitive disorders post sudden cardiac death
* People with known psychiatric disorder
* Women who are known to be pregnant or lactating
* Person deprived of liberty by judicial or administrative decision
* People under legal protection (under the protection of a conservator)
Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City

Financial incentives for motivating health change have been increasingly employed in various healthcare sectors. They can be a potentially effective approach to promote smoking behavioral change and increase the use of evidence-based counseling and pharmacotherapy. Smoking cessation randomized clinical trials (RCT) incorporating financial incentives have been conducted in different populations; however, there has not been a randomized clinical trial coupled with a financial incentive with Asian American cigarette smokers. The purpose of this pilot study is to examine the feasibility of implementing an incentivized smoking cessation program among Asian American smokers in New York City.


Eligibility Criteria:
Inclusion Criteria:

* Asian American
* current smoker who smokes at least 10 cigarettes daily (verified by a CO level of 8 ppm or above)
* New York City resident
* able to complete three month follow-up assessments in person, can provide a telephone number
* declining the use of Chantix for smoking cessation.

Exclusion Criteria:

* \<18 years old
* pregnant
* cannot provide a telephone number, non-smokers or smokers that smoke fewer than 10 cigarettes daily, users of e-cigarettes or other tobacco products who are not interested in quitting smoking, marijuana users
* not a New York City resident
* unable to complete three month follow-up assessment in person
* unable to provide written consent
* agree to use Chantix for smoking cessation.
Effect of Prophylactic Administration of Oxytocin in Uniject™ on Postpartum Hemorrhage at Home Births in Ghana

This study is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO) at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative to home births attended by the same type of provider who does not provide a uterotonic drug.


Eligibility Criteria:
Inclusion Criteria:

* home delivery
* presence of Community Health Officer at time of delivery

Exclusion Criteria:

* None