cyrilzakka/clinical-trials huggingface dataset:
Mentalization-based Training for Adolescents With Conduct Disorder (MBT-CD)

A feasibility and pilot trial to investigate the feasibility of a newly manualized psychotherapy "Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD)"

Background: Conduct Disorder is a severe and complex mental disorder with the highest incidence in adolescence. Previous studies have shown that family-oriented interventions are effective in the treatment of Conduct Disorder. However, most therapies focus rather on symptom management and less on etiological causes without inclusion of the family in the therapeutic process. Previous research has linked specific symptoms of Conduct Disorder with deficits in mentalization ability. Mentalization is the ability to perceive one's own and other's behavior as the product of affective and cognitive mental states. Low or missing mentalization abilities are regarded as a risk factor for the development and chronification of Conduct Disorder.

Aims: The study aims to investigate the feasibility of a newly manualized psychotherapy "Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD)" that strives to decrease symptoms associated with Conduct Disorder by increasing mentalization in adolescents and their families.

Methods: The study is feasibility and piolot trial, carried out in Heidelberg (Germany), and Mainz (Germany). Adolescents aged between 11-18, who meet the DSM-5 criteria for Conduct Disorder will receive MBT-CD. Times of measurement: t0 (Screening), T1 (Baseline, at the beginning of therapy), T2 (3 months after the beginning of therapy), T3 (at the end of therapy, after 6 months), T4 (follow-up, after 9 months).

Eligibility Criteria:
Inclusion Criteria:

* main diagnosis conduct disorder (DSM-5 312.81,312.82)
* written informed consent

Exclusion Criteria:

* acute substance dependence
* sexual offenses
* acute psychotic symptoms, early or early-onset schizophrenia
* neurological impairments and low intelligence (IQ \<80)
* non-German-speaking
* other clinical contra indication for outpatient psychotherapy (e.g. acute suicidality)
Aromatherapy for Upper Respiratory Health

The purpose of this study is to confirm and quantify the effects of aromatherapy on respiratory health.

Participants will inhale the scent from an aroma stick every waking hour for the entire duration of a period of respiratory symptoms or 14 days, whichever is shorter. As it is a randomized, placebo-controlled study, some participants will inhale the scent from an aroma stick containing active essential oils while other participants will inhale from an aroma stick containing no essential oils.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness and demonstrated ability to comply with all study procedures and availability for the duration of the study
* Gender expression: female
* Aged 20-65
* In good general health
* Exhibiting routine upper respiratory symptoms such as: sneezing, coughing, running nose, headache, general fatigue, or dry or sore throat, etc.
* Ability to utilize the inhaler and be willing to adhere to the regimen

Exclusion Criteria:

* Current use of bronchodilators or asthma medications
* Presence of asthma diagnosis or other severe breathing disorder
* Pregnant or trying to conceive
* Known allergic reactions to components of the inhaler, specifically plants in the following families: rutaceae, pinaceae, labiatae, and myrtaceae.
* Treatment with another investigational drug or other intervention within 30 days
* Current smoker
* COVID-19 diagnosis
Diet and Exercise for Elevated Risk (DEER)

To determine the effect in men and postmenopausal women with elevated LDL-cholesterol and low HDL-cholesterol of an exercise regimen with or without the National Cholesterol Education Program (NCEP) Step Two diet compared to usual care control group on HDL- and LDL-cholesterol.

BACKGROUND:

The NCEP is a major public education program providing advice to physicians and the public on management and prevention of coronary heart disease. However, data supporting the advice are derived primarily from middle-aged men, with less data available for women and older individuals. Furthermore, there have been recent reports that when low saturated fat diets such as the NCEP Step One and NCEP Step Two diets, are followed, HDL-cholesterol is lowered as well as LDL-cholesterol.

DESIGN NARRATIVE:

Randomized, controlled, factorial design powered for men and women separately. One hundred eighty postmenopausal women, 45 through 64 years of age, and 197 men, 30 through 64 years of age, who had low high-density lipoprotein (HDL) cholesterol levels (\< or =59 mg per deciliter in women and \< or =44 mg per deciliter in men) and moderately elevated levels of low-density lipoprotein (LDL) cholesterol (\>125 mg per deciliter but \<210 mg per deciliter in women and \>125 mg per deciliter but \<190 mg per deciliter in men) were enrolled. The subjects were randomly assigned to aerobic exercise, the NCEP Step 2 diet, or diet plus exercise, or to a control group, which received no intervention. The four interventions were delivered for one year: usual care (written dietary materials only with delayed intervention optional), exercise only (supervised, progressive aerobic exercise program at least three times per week), diet only (group and individual dietary instruction on the NCEP Step One/Step Two diet delivered by registered dietitians), and diet plus exercise. At baseline and at the end of one year, measurements were made of blood lipids and lipoproteins, plasma glucose and insulin, glucose tolerance, blood pressure, body composition through hydrostatic weighing and waist and hip circumterences, aerobic fitness (VO2 max), and five unannounced 24-hr. recalls. The primary outcomes measured was HDL-cholesterol, major secondary endpoints included LDL-C, LDL-C/HDL-C ratio, and triglycerides.

Eligibility Criteria:
Men with with LDL-cholesterol of 125-189 mg/dL and HDL-cholesterol below or equal to 44 mg/dL, and postmenopausal women, age 45 to 64, with LDL-cholesterol of 125 to 209 mg/dL and HDL-cholesterol below or equal to 59 mg/dL.
A Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis

The objective of this study is to demonstrate the safety and efficacy of IC14 in the treatment of hospitalized patients with community-acquired pneumonia and sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of community-acquired pneumonia.
* Evidence of systemic inflammatory response to infection.

Exclusion Criteria:

* Atypical or viral pneumonia based on clinical or epidemiologic suspicion by the investigator.
* Presence of organ failure.
Vit D3 for Early Symptoms of COVID-19

This study is aimed to investigate the treatment vitamin D3 as complementary therapy with routine care for early mild symptoms of COVID-19 in outpatients setting.

There is currently no specific early-stage therapeutic treatment available for COVID-19.

Vitamin D3 is a strong antioxidant, and anti-inflammatory/immunomodulatory agent.

The present study is aimed to investigate the treatment benefits of vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older, of either gender
* Patients must be tested positive for SARS-CoV-2 by RT-PCR
* Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes withshaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
* Patients must be in the early stage of COVID-19 disease who do not require hospitalization at the time of screening
* Patients must be under the care of a Physician for diagnosis of COVID-19
* Patients who have signed informed consent

Exclusion Criteria:

* Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin
* Patients with known chronic kidney disease with estimated creatinine clearance \< 50 mL/minute or need for dialysis
* Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
* Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.
* Patients with gallstone obstruction
* Hypothyroid suppering patients
* Patients with moderate or severe thrombocytopenia (platelet count \<100 ×10⁹/L);
* Pregnant patients
Relining Assessment of Digital and Conventional Fabricated Complete Denture Base

The bond between the resilient denture liner material and the denture base is essential to improve complete denture accuracy and retention to the underlying ridge. The bonding characteristics between resilient denture reline materials and conventional Polymethyl methacrylate (PMMA) denture base polymers have been evaluated extensively. But with the introduction of digital fabricated complete denture, the bond characteristics between digitally fabricated dentures and denture liner is sparse.

Dental prostheses fabricated using different digital technology have become popular in recent years. Computer-aided design and computer-aided manufacturing (CAD-CAM) technology provides two techniques, milled or 3D printed technique which simplified the complex dental laboratory procedures by digitalizing the prosthetic design and automating the manufacturing process. Digitally fabricated prostheses have been reported to have excellent accuracy factor that has been related to favorable clinical performance. However, bone resorption underneath any mucosa supported prosthesis is not avoidable. Resilient liners are required for most complete dentures after 6 to 12 months to improve adaptation to the underlying tissues and to reduce the force transmitted to the edentulous ridge during functionThe bond between the resilient denture liner material and the denture base is essential to improve complete denture accuracy and retention to the underlying ridge. The bonding characteristics between resilient denture reline materials and conventional Polymethyl methacrylate (PMMA) denture base polymers have been evaluated extensively. But with the introduction of digital fabricated complete denture, the bond characteristics between digitally fabricated dentures and denture liner is sparse.

Therefore, the aim of this project is to evaluate the bond strength and effectiveness of denture reline of CAD/CAM (milled and 3D printed ) fabricated complete dentures compared to conventional heat-polymerized denture base.

Eligibility Criteria:
Inclusion Criteria:

* Patients are free from any systemic diseases that might affect neuro-muscular control.
* Patients having class I maxilla-mandibular relationship
* Patients having healthy mucosa and normal salivary flow

Exclusion Criteria:

* Patients have severe bony undercut.
* Uncooperative patients.
* Patients having radiation to the head and neck region.
* Smoker patients.
Intradialytic Resistance Training in Haemodialysis Patients

The study will investigate the effects of an intradialytic resistance training on miRNA´s expression and muscle strength in haemodialysis patients.

Chronic kidney disease (CKD) is accompanied by distortions of immune functions and acceleration of inflammation processes. Regular exercise has shown great potential for improving the health-related parameters of CKD patients. Moreover, muscle strength is considered to be an important predictor of protein- and energy- wasting, inflammation, quality of life and mortality in CKD patients. The behaviour and individual variability of adaptation to regular, controlled, supervised physical activities in CKD patients are not well defined and understood. The understanding of molecular adaptation mechanisms, represented by the epigenetic impact of exercise on renal specific miRNA´s expression, is necessary for future improvements in clinical practice. Monitoring pro- and anti-inflammation genes activity, their transcription factors and expression of miRNA molecules (influencing the signalling pathways of specific genes) will enable us to draft a new transcription and translation model for exercise-induced adaptation in CKD patients. Additionally, our results will indicate the clinical value of selected markers for the diagnostics and prognostics of disease.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 30 years of age, diagnosed with chronic kidney disease, treated with haemodialysis are eligible for our study.

Exclusion Criteria:

* Lower extremity amputation, severe dementia or retardation, acute intercurrent disease and probability of one year mortality higher than 25 % according to Charlson Comorbidity Index (CCI) are the exclusion criteria for participation in the study.
Correlation Between Smartphone Use and Text Neck Posture in Asymptomatic Subjects

This study will be conducted to investigate the correlation between the number of hours of smartphone usage and severity of text neck posture, cervical ROM, DNF endurance and resting head posture among asymptomatic 18 to 25 years old adults

Smartphone use has increased significantly globally, with 79% of adults aged 18-44 carrying a smartphone constantly. This can cause excessive anterior curves in the neck vertebrae and increase the mechanical load on cervical spine joints. Overuse syndrome, spinal damage, and other side effects can result. This study aims to investigate the correlation between time spent using smartphones and text neck posture and its association with head and neck posture, cervical ROM, and DNF endurance among asymptomatic 18-25-year-olds.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals who are willing to participate at the time of data collection.
2. Individuals aged 18 - 25 years old.
3. Individuals who use a smartphone to report the duration of weekly usage (at least one year of using a smartphone and minimum duration of smartphone use of ≥1 h per day

Exclusion Criteria:

1. Previous history of an accident or severe injury.
2. Any neurological or cardiovascular problem.
3. Spinal surgery or any disease that prevents the individual from adopting an unsupported orthostatic posture.
4. Congenital cervical problem.
5. Pregnant women.
A Multidimensional Study of Premenstrual Syndrome and Body Image

The goal of this cross-sectional study is to investigate the influencing factors of body image in women of reproductive age. The main question\[s\] it aims to answer are:

* Is there a connection between physical activity, body mass index and body image?
* Is there a connection between body image, premenstrual syndrome and sleep quality? Participants will fill out a complex online questionnaire.

During the research, the researchers use a quantitative method, in which the participants fill out the Knowledge of the Female Body Scale, the Global Physical Activity Questionnaire, the Body Appreciation Scale, the Sleep Quality Scale and the Premenstrual Assessment Form Short Form, as well as a general health status questionnaire. and a self-made questionnaire containing socio-demographic questions. In the course of the research, we form a sub-sample, on which we carry out further instrumental tests to monitor body composition and physical activity. The number of participants is approx. There will be 500 women between the ages of 18 and 45, who will be selected through targeted sampling. During the research, the data are processed in the SPSS v28.0 program and the following statistical methods are used: Kolmogorov-Smirnov and Shapiro-Wilk normality tests, Spearman and Pearson correlation analysis, Pearson chi-square test, linear regression analysis. During the research, the safety of the participants and the ethical rules are strictly observed.

Eligibility Criteria:
Inclusion Criteria:

* women
* between the ages of 18-45 years
* regular menstruation

Exclusion Criteria:

* older than 45 years
* pregnancy
* amenorrhoea
* premature ovarian failure
Inter- and Multidisciplinary, Cross-sectoral Feto-neonatal Pathway

Due to the fetoneonatal pathway it is possible to identify pregnant women with an increased risk of fetal growth restriction or pre-eclampsia in early stages (from 10th week of pregnancy). Women whose pregnancy is considered high-risk receives risk-adapted prenatal treatment as well as certain treatments for their newborn and infant until 1 year of age. The tasks of all involved persons are defined by standard operating procedures (SOP)

By implementing a preventive feto-neonatal pathway, healthcare for pregnant women with high risk of fetal growth restriction (FGR) or pre-eclampsia will be improved and, therefore the occurence of children's health problems may be prevented.The pathway allows healthcare to be structured, ross-sectoral, inter- and multidisciplinary in consideration of medical and psychosocial imensions. The feto-neonatal pathway transfers scientific findings, which already determine international routine care, in the project region into clinical routine care. The anamnestically increased risk for FGR or pre-eclampsia is validated by ultrasound and the identified high-risk pregnancy is attended risk-adapted from birth until the end of the first year of life of the child.As a result, the mothers' pregnancy-related risks (death, premature delivery, traumatic stress disorders) as well as risks for the child (prematurity and associated problems, childhood growth restriction with the risk of metabolic syndrome, developmental neurological problems) are reduced and the sustainability of the interventions is ensured in the long term through improved health competence of the families. The feto-neonatal pathway shows how highly specialised fetoneonatal care of high-risk pregnancies can be ensured while ensuring primary care in a health region, and offers the possibility of being extended to other indications.

Eligibility Criteria:
Inclusion Criteria:

* Female, minim. 10 weeks of pregnancy, maximum 36 weeks of pregnancy
* anamnestic risk of preeclempsia or fetal growth restriction
* being part of the project region

Exclusion Criteria:

* none
Patient Registry of Blind Subjects With Sleep-related Problems

Non-24-hour sleep-wake disorder (Non-24) is a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness. This is a research protocol to develop a patient registry of subjects who may suffer from Non-24 and who are blind. Subjects participate in the study through a phone survey. This registry will be used to better understand, sleep related problems in blind individuals, including the investigation of a potential treatment, recruitment for future clinical studies, and to provide a forum for raising awareness about Non-24. The survey consists of questions regarding the degree of vision impairment and sleep problems that the subjects may be experiencing.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects or legal guardians must be at least 18 years of age to participate in the telephone survey. Parents or legal guardians may represent children from 0 through 17 years who meet the following criteria.
2. Subjects must be blind.
3. Subjects must have some self-described problem with sleep or daytime sleepiness.
The Measurement of Bladder Impedance and Heart Rate During Urodynamic Study

Purpose To measure the impedance of the bladder during the urodynamic study to see if changes in the impedance value occur as the bladder volume changes in pediatric patients aged 5-12 years along with its leg time.

In addition, during the urodynamics test, the heart rate is measured at the same time to confirm the pulse change due to the filling of the bladder.

-Background of the study (Method of identifying urinary bladder using impedance) In order to overcome the limitation of the method of checking the urinary volume in the bladder using ultrasound, the measurement of the impedance in the bladder is proposed as an alternative. Impedance measurement is non-invasive, very low cost, easy to measure and has a great advantage that it can be continuously measured in everyday life. In fact, early studies suggest that impedance measurement in the bladder is helpful in identifying urinary bladder capacity.

On the other hand, there are two disadvantages to the urinary bladder identification method using impedance. One is the relative aspect that the impedance value changes according to the patient, and the other is the time lag time from the measurement point to the point when the impedance change appears.

* In order to overcome this problem of impedance-based urinary bladder identification method, we measured impedance change according to real-time change of urinary volume in bladder during urodynamic study.
* Background of the Invention (Pulse changes due to changes in urinary volume in bladder) It is known that when the urine enters the urinary bladder, the autonomic nervous system detects and regulates the heart rhythm, and the change of heart rate has not been reported in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* 1. Children aged 5-12 years
* 2. Children in whom urodynamic evaluation is required due to voiding dysfunction
* 3. Children who agreed to participate in clinical trials

Exclusion Criteria:

* 1. If there is a previous history of bladder surgery
* 2. If there is a scar on the upper part of the pubic bone