cyrilzakka/clinical-trials huggingface dataset:
German Register of Outpatient Parenteral Antibiotic Therapy

Many infectious diseases require a therapy that is administered intravenously due to a lack of oral treatments. Affected patients often have to stay weeks or even months in hospital just for receiving their therapy although they do not feel severely unwell.

Outpatient parenteral antibiotic therapy (OPAT) allows these patients under certain requirements to get discharged from hospital and apply the antibiotic treatment on their own. For these patients quality of life improves by feeling more comfortable at home and being able to participate in everyday life or even go back to work. For the hospitals a reduced inpatient health care means a clear reduction of costs.

The aim of OPATReg is to examine under which conditions the OPAT can be established at different locations of patient care. For this purpose, patients with APAT are to be treated and data collected at 7 university institutions in Germany. All centers have the expertise to provide comprehensive care for patients with infectious diseases, to transfer them from inpatient to outpatient care and to continue to provide care there.

If successful, the project should help to identify the potential of OPAT for all of Germany. If positive effects and feasibility can be demonstrated OPAT could become an important therapy option with many advantages for certain patients.


Eligibility Criteria:
Inclusion Criteria:

* patients who get OPAT

Exclusion Criteria:

* patients who don't get OPAT
Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors

This study will explore feasibility and acceptability of using a daily mobile mindfulness app to cope with stress. In addition, feasibility of digital health data collection procedures including wrist-worn devices and ecological momentary assessments will be examined.

PRIMARY OBJECTIVES

* Determine the feasibility and acceptability of completing the 30-day mobile mindfulness program
* Evaluate the feasibility of digital health data collection procedures to detect autonomic nervous system (ANS) activation associated with stress (e.g., electrodermal activity, pulse rate variability, skin temperature) via wearable devices and self-reported ecological momentary assessments (EMA) among adult survivors of childhood cancer in the SJLIFE cohort
* Generate preliminary data to estimate the effect size and power needed for an extramurally funded randomized controlled trials (RCT) examining the impact of daily mindfulness mediation on biomarkers of ANS activation, coping, health behaviors, and cardiometabolic outcomes in a cohort of survivors of childhood cancer.

Prior to engaging in the intervention participants will complete baseline assessments of stress and coping. Participants will then engage in a daily mindfulness practice via the Headspace mobile application. The basic application program includes daily 10-minute sessions in guided mindfulness meditation that include mindful breathing, body awareness, emotion and thought recognition, and attentional control. During the first and fourth week of the intervention, participants will complete EMAs assessing mood, current activity, and intervention engagement. Participants will also wear a wrist-worn device to assess biomarkers of stress. At the completion of the intervention participants will complete follow-up assessments related to intervention and data collection procedures feasibility and acceptability as well as coping behaviors and stress.

Eligibility Criteria:
Inclusion Criteria:

* Research participant is at least 18 years old at enrollment
* Research participant is followed by St. Jude Children's Research Hospital (SJCRH)
* Research participant has a diagnosis history of leukemia or lymphoma
* Research participant takes part in the St. Jude Lifetime Cohort Study (SJLIFE)
* Research participant has elevated psychological stress scores of 6 or greater on most recent SJLIFE questionnaire
* Participant can speak and read English

Exclusion Criteria:

* Research participant currently engages in mindful stress-reduction practices \>2x per week (e.g., tai chi, meditation)
* Research participant takes psychiatric medications or medications that impact cardiac functioning, beta-blockers, alpha-blockers
* Research participant wears a pacemaker
* Research participant has a diagnosis of a congenital heart disease
* Research participant has no access to a smartphone
* Research participant has elevated pain interference scores (T≥70)
90° Rotation Technique for LMA FlexibleTM Insertion

The 90° rotation technique is known to improve the success rate of conventional LMA but its effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could increase the first attempt success rate of the insertion of LMA FlexibleTM compared to standard technique.

One hundred and sixteen adult patients undergoing breast surgery were randomized to the two insertion techniques. The ease of insertion was assessed by the success rate at the first attempt. Heart rate and mean blood pressure were recorded 1 min before and 1 min after insertion. Postoperative complications were checked.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class I - II
* Scheduled for elective breast surgery under general anaesthesia using LMA FlexibleTM

Exclusion Criteria:

* known difficult airway
* mouth opening less than 2.5 cm
* limited extension of neck
* recent sore throat
* gastroesophageal reflux disease
Effect of Nurse Navigation Program on Cervical Cancer Screening Behaviour of the Women Aged 30-65

This study was designed as a randomized controlled experimental study to examine the effect of the 'Nurse Navigation Program' on cervical cancer screening behaviors (Human Papilloma Virus (HPV) DNA screening test and/or pap smear test) and health beliefs about cervical cancer screening in women aged 30-65 years.

An important step in the fight against cervical cancer is access to early diagnosis, early screening culture and the creation of screening opportunities. Problems in access to health services, barriers and cultural reasons play an important role in participation in cervical cancer screening. Nurse The Navigation Program is important to help individuals overcome and cope with these barriers. There are international studies showing the positive effect of the nurse navigation program on cervical cancer screening behaviors. However, it is thought that this study will contribute to the literature because the number of studies on this subject is not sufficient and no research is found in national sources.

It is aimed to contribute to overcoming the problems and obstacles in front of the patients' access to cervical cancer screening with the Nurse Navigation Program application developed based on the Transtheoretical Model to the experimental group and to provide evidence for the nurse navigation program application to be a method used in the cervical cancer screening process.

The population of the study will consist of female members of Non-Governmental Organizations in the 30-65 age group. The data of the study will be collected between September 13, 2024 and February 15, 2025 after ethics committee approval and institutional permission. The design of the study is a randomized controlled experimental study.

The data will be collected using the Individual Descriptive Information Form, Information Questions on Reproductive Health and Sexual Life, Questions on Cervical Cancer and Screening, Questions on HPV Knowledge, Cervical Cancer and Pap Smear Test Health Belief Model Scale. The statistical data obtained as a result of the research will be analyzed using the SPSS package program. It is expected that the rate of having HPV-DNA test and Pap smear test is higher in the experimental group in which the nurse navigation program is applied compared to the control group in which the intervention is not applied, and the mean score of benefit perception of cervical cancer screening behaviors (HPV DNA and/or Pap smear) is expected to be significantly different in the group in which the nurse navigation program is applied compared to the group in which it is not applied.

Eligibility Criteria:
Inclusion Criteria:

* 30-65 years old,
* With health insurance,
* No history of gynecologic cancer,
* Current or past active sexual life
* Women who agreed to participate in the study

Exclusion Criteria:

* Diagnosed with gynecologic cancer,
* The one who had a hysterectomy,
* Who do not want to be involved in the study,
* No previous sexual experience,
Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation

Aim of the study is to investigate the prognostic value of right ventricular contractile reserve in patients with functional tricuspid regurgitation undergoing tricuspid valve repair or replacement.

Chronic volume overload in patients with severe tricuspid regurgitation (TR) leads to right ventricular (RV) dilatation, fibrosis and eventually failure. RV dysfunction is an important determinant of mortality in patients undergoing tricuspid valve surgery.

Aim of the current study is to investigate the prognostic utility of right ventricular contractile reserve in patients with severe TR undergoing surgical or interventional tricuspid valve repair or tricuspid valve replacement.

RV contractile reserve will be assessed using semi-supine bicycle stress echocardiography.

Echocardiographic parameters are prone to altered loading conditions, such as volume overload. Load independent RV contractility can only be measured using invasive pressure-volume-loop (PVL) analysis. Therefore RV PVL analysis will be done using conductance catheter in a subset of patients who undergo right heart catheterization for clinical evaluation of pulmonary hypertension. Aim of this sub study is the validation of non-invasively derived RV contractile reserve with load independent markers of intrinsic RV contractility.

Eligibility Criteria:
Inclusion Criteria:

* Severe functional tricuspid regurgitation.
* Planned surgical or interventional tricuspid valve repair or replacement.
* Able to cycle on a semisupine tilting exercise table.
* Informed consent.

Exclusion Criteria:

* Coronary artery disease with significant ischemia.
* Unstable Angina.
* Myocardial infarction \<4 month prior to inclusion.
* Concomitant valvular heart disease (aortic, mitral or pulmonary valve) \> mild-moderate.
* Constrictive pericarditis.
* Malignant disease with a life expectancy \< 12 months.
* Pregnancy.
* Insufficient image quality on echocardiography.
Mindfulness for Adolescents With Type 1 Diabetes

Adolescents with Type 1 Diabetes will be invited to the Mindfulness study. They will be randomly assigned to a Control or Active Group. The Active Group will learn Mindfulness Based Stress Reduction (MBSR) through an online website designed to teach the basic principles of MBSR in six week-long modules. They will be measured in three main areas: before learning the intervention, directly after learning it and 3 months after learning it to determine any changes in their Mindful attention awareness, Diabetes Quality of Life and HbA1c. The Control Group will also take the questionnaires at the beginning of the study, 6 weeks after it begins and then 3 months from the beginning to obtain data for all three time points when they have not received access to the modules/intervention.

Research Design and Procedures This study will utilize a between group repeated measures design to measure the effects of the learned MBSR intervention over time. MBSR will be the independent variable. Dependent variables include mindfulness, diabetic quality of life and HbA1c. Adolescents with Type 1 diabetes will be randomly assigned to an intervention group or a wait list/control group that will be taught MBSR after all data has been collected. The study will utilize a 2 (experimental versus wait-list control group) by 3 (pretest \[Time 1\], posttest \[Time 2\], and 3 month follow-up \[Time 3\]) to examine within and between group differences overtime on two psychosocial measures including mindfulness and quality of life. The physiological measure understudy, HbA1c, reflects glucose control over the previous three month period and will be measured at Time 1 and Time 3. MBSR training will be provided via an online website and secure data collection site called MySweetMind.org.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between the ages of 12 - 19
* Diagnosis of Type 1 Diabetes
* Fluent in English
* No diagnosed cognitive impairments
* 6th grade education completion
* Access to a Computer
* Access to the internet

Exclusion Criteria: under 12, over 19 - no access to a computer/internet

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Comparability of Keratometry of VERION Image Guided System With Established Measuring Devices

The purpose of this study is to determine if the keratometric functions of the VERION Image Guided System are comparable to those of established keratometric devices (IOLMaster 500, Pentacam HR, LenStar LS900). Calculated intraocular lenses (IOLs) are compared as a clinical consequence of the biometric measurement for IOLMaster 500, LenStar LS900 and VERION Image Guided System.

In addition the comfort and duration of examination in the different devices is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* All interested individuals
* Full legal capacity

Exclusion Criteria:

* Pre-existing or actual ocular disease or pathology, history of ocular surgery
* Contact lens wear 2 weeks before examination
Safety and Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-Abdominal Collections in Children - A Prospective Study

The objective of this study is to establish the efficacy of tPA when used in pediatric intra-abdominal abscesses immediately after percutaneous drainage, irrespective of the ultrasound appearance or consistency of the drained fluid.

The use of tPA in pediatric abdominal abscesses is poorly defined. The indications are somewhat subjective and the dosage guidelines vary between institutions. Some studies have suggested that it be administered at, or soon after, the time of drainage if the ultrasound appearance of the collection is complex and/or septated, or if the initial aspirated contents are thick and viscous. Both criteria are difficult to accurately define and implement. In many instances, when there is minimal ongoing drainage despite follow-up ultrasound appearances suggesting a significant residual collection, tPA is administered several days following the initial procedure.

The purpose of this study is to establish the efficacy of tPA in the initial treatment of all pediatric intra-abdominal abcesses and a standardized manner in which it can be used. This may eventually lead to a change in practice in the management of this patient population.

Eligibility Criteria:
Inclusion Criteria:

1. All patients under the age of 18 years with intra-abdominal bacterial abscesses requiring percutaneous drain insertion (including transrectal drains).
2. Drain(s) must be inserted within the 23hrs prior to enrollment in the study.
3. The underlying diagnosis of the condition will not affect the enrollment of the patient unless it is detailed within the exclusion criteria (section 4.1.2).
4. Patients and parents must have signed informed consent to participate in the study.

Exclusion Criteria:1.

1. Pancreatic abscess (not bacterial in nature)
2. Known coagulation impairment
3. Known central nervous system tumor or abscesses
4. Arteriovenous malformation
5. Aneurysm or history of central nervous system bleeding
6. Hypersensitivity to tPA
7. Recent administration of an investigational drug (within previous 30 days)
8. Pregnancy
9. Breast-feeding
10. Fulminant hepatic failure
11. Proven fistula (as it will alter the drainage time) or any abscess secondary to Crohn's Disease (because fistula existence cannot be excluded)
12. Necrotizing enterocolitis
13. Children requiring 4 or more drains
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer

This study will prospectively collect airway, stool, and blood samples on 80 subjects with lung cancer undergoing immunotherapy. Investigators will evaluate airway/stool microbial signatures associated with local (lower airway) and systemic (blood) immune tone.They will then study whether microbiota and/or host signatures predict subjects' response by longitudinal assessment of the progression free survival. They will also repeat sampling after 8 weeks of immunotherapy to expand our mechanistic understanding of the response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a diagnosis of advanced stage unresectable Non-Small Cell Lung Cancer and indication for PD-1 blockade treatment (either as monotherapy or combined with chemotherapy)

Exclusion Criteria:

* Antibiotic, steroid, or chemotherapy received within the prior month since these are possible confounders that may impact the microbiome and the host immunity.
* Brain metastasis (as evaluated by MRI obtained as part of standard of care staging evaluation)
* FEV1\<50% predicted
* Cardiovascular disease (defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure)
* Renal disease
* Coagulopathy
* Liver disease
Monitoring the Effect of Red Blood Cell Transfusion on Cerebral Oxygen Saturation With Near Infrared Spectroscopy (NIRS) in Critically Ill Patients

Critically ill patients are frequently transfused with red blood cell (RBC) units with the predominant intention to increase arterial oxygen content and thus oxygen delivery to the tissues.

To date, RBC transfusions have been proven effective in patients with profound anaemia or circulatory shock. However, the impact of the storage process and the so-called storage lesion on oxygen-carrying properties and, hence, the efficacy of RBC transfusion regarding tissue oxygenation are much debated at present. Alterations of RBC physiology have been comprehensively described ex vivo. Reduced deformability, increased adhesiveness and aggregability of stored RBC impair their rheological properties; anaerobic cellular metabolism with reduced contents of 2,3 bisphosphoglycerate and adenosine triphosphate (ATP) increases oxygen affinity and impairs oxygen release to the tissues.

This study aims to monitor the effect RBC transfusion has on the regional cerebral oxygen saturation (rSO2) of critically ill patients. rSO2 will be measured indirectly, using near infrared spectroscopy (NIRS) . Patients will be monitored once it looms that they might require RBC transfusion. The monitoring is continued for the time of transfusion and the hours afterwards.


Eligibility Criteria:
Inclusion Criteria:

* expected requirement of RBC transfusion
* 18 yrs and older

Exclusion Criteria:

* severe traumatic brain injury (Glasgow coma scale \< 9), subarachnoid hemorrhage (Hunt and Hess scale ≥ 3) or intracranial hemorrhage
* cerebral ischaemia
* active bleeding
* patients necessitating ongoing resuscitation
* deficient signal of rSO2 impeding its proper valuation
North American Mitochondrial Disease Consortium Patient Registry and Biorepository (NAMDC)

The North American Mitochondrial Disease Consortium (NAMDC) maintains a patient contact registry and tissue biorepository for patients with mitochondrial disorders.

Mitochondrial diseases comprise a group of relatively rare (\~1 in 5000 adults) but very serious genetic disorders. Mitochondria are often called the "powerhouses of the cell" because they provide the energy our cells need to live. Mitochondria have their own DNA (mtDNA), but they also rely on DNA from the nucleus (nDNA). Mitochondrial diseases are caused by mutations in either mitochondrial or nuclear DNA that result in poorly functioning mitochondria. This can cause a variety of symptoms including muscle weakness, seizures, mental retardation, dementia, hearing loss, blindness, strokes, diabetes, and premature death. Most mitochondrial diseases are progressive, and we are unable to cure most of these diseases with currently available treatments.

Research into mitochondrial diseases has been hampered by the low frequency of these disorders and by under-diagnosis by clinicians. This has hindered patient recruitment for research studies and clinical trials. The North American Mitochondrial Disease Consortium (NAMDC) was established to help surmount these issues. Led jointly by Drs. Michio Hirano and Salvatore DiMauro, NAMDC is a consortium of several clinicians and researchers with an interest in mitochondrial disease research in the United States and Canada.

By creating a mechanism for the sharing of patient samples with researchers, data and patient contact information, NAMDC will make it easier to conduct clinical and basic laboratory research.

Patient information will be shared through the use of the "Patient Data Registry," a specially-designed database, and patient tissue samples will be shared through the use of the "Patient Sample Biorepository", a storage facility in which patient-derived biological samples will be maintained. The Registry and the Biorepository will hopefully accelerate progress in the understanding and treatment of mitochondrial disease.

Patients can enroll at any of the NAMDC member sites. A web-based remote enrollment is also available at www.namdc.org for eligible patients who reside far from any of the NAMDC participating sites.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with or suspected to have a mitochondrial disorder
* Adult carriers of known mitochondrial DNA mutations
* Patients with laboratory analysis indicative of a mitochondrial disorder.
* Medical information and tissue samples are also accepted from deceased individuals who fulfill the above criteria.

Exclusion Criteria:

* Patients not suspected of having a mitochondrial disorder
* Patients not suspected of carrying a mitochondrial DNA or nuclear DNA mutation that affects mitochondrial function.
Oxytocin Effects on Self and Other Processing

To determine whether the neuropeptide oxytocin (OXT) influences self-processing by investigating whether it increases the endowment effect in relation to both self and others.

In a double-blind, between- subject placebo (PLC) controlled design, investigator aimed to measure the effect of intranasal OXT on the endowment effect. All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety before self-administration: Positive and Negative Affect Schedule (PANAS) , State-Trait Anxiety Inventory (STAI) , Beck Depression Inventory (BDI), self-esteem scale (SES). Subjects were asked to decide whether to buy or sell their own or others' (their mothers'/ fathers'/ classmate'/ strangers') possessions at various prices. Indifference point and brain activation were inluded into analysis as dependent variables.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* claustrophobia;
* medical or psychiatric illness.