cyrilzakka/clinical-trials huggingface dataset:
Urodynamics: Prone Vs. Seated Position

To demonstrate the feasibility of a pressure-flow study using a urinary condom with drainage tube in the sitting and lying position in everyday clinical practice and the comparability of the measured values with the "conventional" pressure-flow studies according to the ICS standard with regard to the diagnosis of outlet obstruction in men.

The study aims to investigate a change in the measured values of a pressure-flow measurement in male patients between the sitting and lying position using a urinary condom. This offers enormous added value for science, as both a technique for carrying out the measurement and the effect of positioning can be evaluated. Due to anatomical conditions, this project will only be carried out with male patients. By carrying out the individual measurements in different examination positions on the same patient, influences caused by the change in position can be verified. It enables direct comparison of the criteria for outlet obstruction in the same patient and thus leads to confirmation or rejection of the hypothesis that the outlet obstruction criteria can be used for measurements in the supine position in the same way as for the measurement in the sitting position described by ICS. This project is therefore based on the question of whether the known analysis criteria for outlet obstruction are equivalent to the measurements recommended by ICS in the sitting position in male patients in whom pressure-flow studies can only be performed in the supine position. In addition, the use of a urinal condom with a drainage line as an aid or technique during the measurement is being investigated.

Eligibility Criteria:
Inclusion Criteria:

* Genotype and phenotype XY
* Age between 18 and 90 years
* Signed informed consent form
* Ability to understand and follow the study procedures and understand the consent form
* possibility ti carry out out the necessary urodynamics as part of the regular clinical examination
* assessment of neurogenic and/or non-neurogenic (idiopathic) bladder dysfunction
* Spontaneous micturition in a sitting position is possible

Exclusion criteria:

* Patients with assistance/patients under guardianship
* Patients with latex allergy or cross-allergy (banana, kiwi, fig, avocado)
* No spontaneous movement possible in a sitting position
* Sitting position not possible due to lack of trunk stability/circulatory problems
* Intravesical Botox injection during the last 9 months
An Intervention Study: Shaping a Healthier Child

The aim of this study is to identify parent-children communication in relation to health risk behaviors (smoking, drinking and illegal drug taking) in adolescents, and to enhance better parental skills in preventing these behaviors in children.

Previous research found that parent-children communication is the best predictor of health risk behaviors among adolescents. However, longitudinal studies of parent-adolescent communication on the subject of health risk behavior such as alcohol, tobacco and other drug use (ATOD) remain relatively scarce, and none of this kind of work has been done among Chinese sample. Such information is urgently needed given the increasing trend of drug use among adolescents in Hong Kong, and the severe burden of morbidity and mortality related to ATOD.

The study aims to examine parent-children communication in relation to health risk behaviors and to explore the potential efficacy of a brief intervention which is designed to assist parents of primary school children to communicate with their children about issues in the prevention of health risk behaviors. The efficacy of the intervention will be compared with a waiting-list control group using a randomized controlled trial. There will then be two telephone follow-ups to reinforce learnt strategies and skills for home practice in between the two workshops. There will also be assessments post-intervention and at 1 year follow-up. Evaluation focus groups will also be conducted after the intervention program.

Eligibility Criteria:
Inclusion Criteria:

* Parent of a child in primary five or six
* Cantonese-speaking
* Consent to their participation in the program and the inclusion of their children in the assessments

Exclusion Criteria:

* none
A Study of a Lifestyle Program on Recurrent Atrial Fibrillation

The purpose of this study is to examine the impact of a comprehensive lifestyle intervention, including cardiac rehabilitation, prior to catheter ablation (a procedure to stop abnormal electrical signals in the heart), on Atrial Fibrillation (AF)-related symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal or persistent atrial fibrillation.
* Planned elective catheter ablation of AF.

Exclusion Criteria:

* Prior catheter ablation.
* Presence of pacemaker/ICD.
* Longstanding persistent AF.
* Uncontrolled AF (including poor rate control or tachycardia-mediated cardiomyopathy requiring urgent cardioversion/ablation at the clinician's assessment).
Pulmonary Fibrosis Biomarker Cohort - a Prospective Cohort of Incident Patients With IPF

Incident patients with idiopathic pulmonary fibrosis (IPF) in Denmark will be offered inclusion and followed up for up to 5 years with measurements of blood biomarkers and measurements of disease progression.

IPF pathogenesis is complex, including epithelial injury, resident fibroblast-myofibroblast transformation, recruitment of fibrocytes, macrophage activation, and release of numerous cytokines and chemokines. Several of these processes release potential biomarker proteins into the blood stream or onto the epithelial surface where they can be measured. Biomarkers have mainly two potential roles in IPF. Firstly, a diagnostic biomarker would distinguish IPF from other diseases with similar symptoms, facilitating diagnosis and possibly decreasing the need for risky procedures, such as surgical lung biopsy. Secondly, a prognostic biomarker would distinguish rapid progressors from slow progressors, which is difficult today.

This study will prospectively include patients at the two largest centres in Denmark where patients are treated for IPF and has thus a good opportunity to include the majority of incident cases of IPF in Denmark. The blood levels of several promising biomarkers will be measured at baseline and during up to 5 years follow-up. Patients will also be followed up through regular clinical examination and by querying national registries to determine disease progression, mortality, healthcare utilization and selected co-morbidities. The database will be used for determination of risk factors for the outcomes listed above. Sub-group analyses are planned in respect to sex, treatment, radiologic imaging, smoking status, clinical data such as pulmonary function tests, co-morbidities (both pulmonary disease and extra-pulmonary disease), and disease severity at baseline.

A research biobank with blood samples is established from the study population. This biobank, and the database of newly diagnosed IPF patients, will be used for future research in IPF.

The prospectively created database will also be used for future research in IPF.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic pulmonary fibrosis according to the 2011 guidelines by the American Thoracic Cosicety (ATS) and European Respiratory Society (ERS)

Exclusion Criteria:

* Age lower than 18 years
* Unable to provide informed consent to participation
Pilot Trial for Implementation of a MPA PK Monitoring Strategy

This study is a prospective interventional trial of de novo renal transplant recipients, aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a clinically applicable fashion.

Mycophenolate mofetil or MMF (CellCept® by Roche) is the mofetil ester of mycophenolic acid (MPA), the active immunosuppressant.

MMF significantly decreases the episodes of acute rejection in kidney transplant patients; but as with any medication without adequate pharmacokinetic drug monitoring, the issue of under or over immunosuppression arises. For this reason, the biggest challenge lies with establishing a feasible mean of MPA pharmacokinetic monitoring. Thus far no study has shown that measuring MPA trough levels alone correlates with rejection, unlike MPA Area Under the concentration time Curve (AUC), due to the large incidence of inter- and intra-patient variability.

This is the first prospective blinded trial set up to analyze the correlation between individualized MPA AUC and trough levels of kidney transplant patients in hopes of establishing a more efficacious way of monitoring MPA. MPA target trough levels that correspond to AUC greater than 30 mg x h/L could then be utilized as maintenance measurements.

Eligibility Criteria:
Inclusion Criteria:

* primary or secondary cadaveric or living donor kidney recipients
* On Cellcept

Exclusion Criteria:

* Multi organ recipients
* Documented non-compliance
* Not on a calcineurin inhibitor
* GFR \<25 ml/min by Cockcroft Gault equation
* Serum albumin \<2.5 mg/dl
* Pregnant
* Active serious digestive disorder
Ultrasound to Check the Position of the Nasogastric Tube

The main objective of this study is to evaluate whether the use of ultrasound as a method of checking the normal positioning of the NGT is reliable, without requiring other diagnostic tests. Clinical trial that will include patients who had the NGT placed intraoperatively. 114 patients (57 with NGT and 57 without NGT) will be examined by ultrasound in the immediate postoperative period to diagnose the normal positioning of the NGT or its absence.

Can ultrasound quickly and effectively diagnose the normal positioning of the NGT? Can chest X-ray be avoided by introducing ultrasound in the verification of the normal positioning of the NGT in the immediate postoperative period?

The nasogastric tube (NGT) is an essential element of our daily clinical practice, commonly used for the administration of enteral nutrition and medication or for gastric decompression and diagnostic procedures. Despite its common use, it is still an invasive procedure with potential complications. Ultrasound is a noninvasive, inexpensive, widely available and rapid method that can speed up the proper verification of these devices. The main objective of this study is to evaluate whether the use of ultrasound as a method of checking the normal positioning of the NGT is reliable, without requiring other diagnostic tests. Clinical trial that will include patients who had the NGT placed intraoperatively. 114 patients (57 with NGT and 57 without NGT) will be examined by ultrasound in the immediate postoperative period to diagnose the normal positioning of the NGT or its absence. Patients who have had the NGT placed will have had their NGT placed correctly by chest X-ray. The upper part of the patient will be covered for the examiner, who will only have access to the patient's abdomen and will not know which patients have NGT or not.

Eligibility Criteria:
Inclusion Criteria:

* Patients classified as ASA I-IV according to the American Society of Anesthesiologists
* Patients over 18 years old.
* Informed consent signed by the patient or their family representatives

Exclusion Criteria:

* Patients classified as ASA V.
* Patients under 18 years old.
* Refusal to participate in the study.
* Contraindication for nasogastric tube placement: ingestion of caustics, nasal or skull fractures, and cervical surgery.
* Patients with anatomical abnormalities at the cervical or pharyngoesophageal level.
The Effect of Tracleer® on Male Fertility

The objective of the study is to evaluate the effects of chronic TRACLEER® treatment on testicular function via semen analysis in male patients with primary pulmonary arterial hypertension (PAH).


Eligibility Criteria:
Inclusion Criteria:

* Male patients age 18-65 years.
* Bosentan-naïve.
* PPH, WHO functional class III/IV, in need of TRACLEER
* Patients pulmonary arterial hypertension (PAH) secondary to congenital heart disease.
* Written informed consent.

Exclusion Criteria:

* Female
* Patients with PAH secondary to connective tissue vascular diseases or HIV.
* Patients who have undergone a vasectomy.
* Patients with an average baseline sperm concentration \< 15 x 10\[6\]/mL, or any sample with a sperm concentration \<= 7.5 x 10\[6\]/mL.
* Patients with an average baseline sperm motility \<20% or normal sperm morphology \<5%.
* Body weight \< 50 kg.
* Hypotension, defined as systolic blood pressure less than 85 mm Hg.
* AST and/or ALT plasma levels greater than 3 times ULN.
* Hypersensitivity to bosentan or any of the components of the formulation.
* Treatment with glyburide, cyclosporine A or tacrolimus at inclusion or planned during the study.
* Treatment with hormone suppressive agents, including androgens, estrogens, anabolic steroids or glucocorticoids within the past 6 months or planned during the study.
* Current treatment less than 3 months prior to inclusion or planned treatment with prostacyclin or prostacyclin analogues (e.g., Flolanâ or Remodulin).
* Patients who received an investigational drug in the month preceding the study start or who are due to be treated with another investigational drug during the study period.
* Known drug or alcohol dependence or any other factors that will interfere with conduct of the study.
* Any illness other than PPH that will reduce life expectancy to less than 6 months.
* Active cancer.
* Prior treatment with an anti-neoplastic agent or ionizing radiation.
* Hot tub/Jacuzzi use.
* Uncontrolled diseases including diabetes, liver or kidney disease.
* Patients receiving spironolactone (aldactone) less than 3 months prior to inclusion or dose \>25 mg/day at baseline or anytime during the study.
Hypopituitarism After Aneurismal Subarachnoid Hemorrhage

Introduction:

Almost 50% of patients die after aneurismal subarachnoid hemorrhage (aSAH). 30% of the survivors suffer from neurological handicap and need permanent care (Suarez et al.). Even when neurological outcome is good, neuropsychological deficits are frequently observed (Ogden et al., Anderson et al.) The incidence rate of aSAH is almost 8 of 100.000 per year. Due to similar clinical symptoms to patients with hypopituitarism, several studies have analyzed the incidence of hypopituitarism after aSAH. Dysfunction of the anterior pituitary gland was found in up to 47% (Schneider et al.). GH deficiency was demonstrated in almost every fourth patient and an association with poor recovery was postulated. In Germany, the investigators would therefore expect as many as 1200 patients with incident GH deficiency. The KIMS-study is an observational GH-treatment study in adult onset growth hormone deficiency. Within the epidemiological data of KIMS, aSAH is not known as a relevant contributing cause (Brabant et al.). This resembles much of the investigators clinical experience that there is no huge prevalence of hypopituitarism after aSAH.

Objective: Evaluation of the frequency of hypopituitarism and neuropsychological dysfunction of any degree in patients with aSAH in a prospective approach.

Methods:

The investigators conduct a prospective study for the evaluation of endocrine deficiency with aSAH. The investigators study patients 3, 6 and 12 month after aneurismal bleeding. Patients diagnosed with aSAH with a clinical grade of I-IV according to Hunt and Hess are included in the study. The investigators perform basal testing for the pituitary by measuring: TSH, LH, FSH, IGF-1, GH, prolactin and ACTH. For evaluation of the adrenal function the investigators perform an ACTH-stimulation test (Lindholm et al.). Subjects with evidence for adrenal or GH insufficiency are further analyzed by insulin-induced hypoglycemia testing (GH Research Society). In the neuropsychological examination, the investigators screen for verbal comprehension (Token Test, short form) and visual neglect (line bisection). Verbal and visual short term memory (digit and spatial span), visuospatial construction and figural memory (Rey Osterrieth Complex Figure Test), psychomotor speed, attention and concentration (Trail Making Test Part A and B, d2) as well as mental flexibility (word fluency) are assessed. Patients additionally fill out a questionnaire measuring actual depressive symptoms and anxiety (Hospital Anxiety and Depression Scale).


Eligibility Criteria:
Inclusion Criteria:

* aSAH grade I-IV Hunt und Hess
* bleeding CCT Fisher grade 3-4
* therapy within 48h after aSAH
* preoperative angiography as well as control angiography
* Glasgow Outcome Scale 4 to 5 after therapy

Exclusion Criteria:

* known intra-, peri- or suprasellar neoplasia
* preexisting hypopituitarism of any degree
* previous hormonal substitution
* previous radiation
* for the neuropsychological examination: difficulties with German language
Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis

This study is a Phase 1, first-in-human single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single ascending dose (SAD) in participants with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) without advanced hepatic fibrosis. This dose-escalating strategy will test the safety of OA-235i when given as a single subcutaneous dosage using up to five successive cohorts. Each cohort will have three non-randomized participants receiving the active medication. One (1) planned multiple dose (MD) expansion dose cohort with 8 NAFLD/NASH subjects will be enrolled for a 7-day dosing regimen at a dose level to be determined from the SAD portion of the study.

Eligibility Criteria:
Main Inclusion Criteria:

1. Male and female subjects between the ages of 18 and 70 years, inclusive, at Screening.
2. Body mass index (BMI) of ≥25 and \<40 kg/m2 with a total body weight 50-150 kg (inclusive) at Screening and Day 1 Pre-dose.
3. Suspected or confirmed diagnosis of noncirrhotic NAFLD/NASH without advanced hepatic fibrosis by one of the following:

   1. Histologically with liver biopsy within 2 years prior to Screening (documentation with pathology report); or
   2. Radiologically with ≥5% steatosis measured by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF), or controlled attenuation parameter (CAP) \>288 dB/m via FibroScan assessment, or presence of hepatic steatosis on abdominal ultrasound within 1 year prior to Screening; or
   3. Clinically with a diagnosis of Metabolic Syndrome (MetS) reflecting the presence of at least 3 of 5 factors/criteria (ie, abdominal obesity, elevated triglycerides, reduced HDL-C, elevated blood pressure, and/or elevated fasting glucose \[IFG or type 2 diabetes mellitus\]) as defined by the National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) \[Grundy 2005\]; and fatty liver on imaging within 1 year prior to Screening.

Key Exclusion Criteria:

1. History or presence of cirrhosis as assessed by Investigator following review of diagnostic measures (clinical, imaging, histopathology, or laboratory).
2. Clinical evidence of hepatic decompensation (laboratory or clinical abnormalities- ascites, variceal bleeding, etc.).
3. History or presence of other concomitant liver disease (eg, hepatitis B \& C, alcoholic liver disease, autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin (A1AT) deficiency, bile duct obstruction, liver primary or metastatic cancer, drug-induced liver disease.
Effect of Virtual Reality on Dental Patients

Clinicians should appreciate the effectiveness of virtual reality (VR) headsets for managing both the anxiety and the behaviour of dental patients. The aim of this study was to assess the effectiveness of using a VR headset as a distraction for managing the anxiety and behaviour of patients during their dental treatment related to underlying psychological factors.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with dental needs.
* Children with parental consent

Exclusion Criteria:

* patients with cognitive impairments
Complex Molecular Etiology and Cellular Landscape of Hip Osteoarthritis

The purpose of this study is to cast light on the highly complex etiology and cellular landscape of hip osteoarthritis by utilising single-cell and spatial omics.

The specific objectives of this project are:

1. Using the latest single-cell RNA sequencing (scRNAseq) techniques the investigators aim to A) characterize what kind of cell populations are found in different synovial tissues and blood derived samples of OA patients, B) determine how the cell composition differs between arthritic and corresponding non-arthritic tissues, C) map the transcriptional and regulatory landscape of the cells mentioned in A and B focusing on the inflammatory responses, D) determine what are the key molecular pathways activated in OA.
2. To determine if some of the blood-derived immune cell populations or their products could be used as biomarkers for OA.
3. To map the whole transcriptome and proteome of OA and non-arthritic control tissue while keeping the morphological context with spatial omics technologies.
4. Further differentiation and identification of OA endotypes utilizing the single-cell and spatial omics data.

The project includes a Rheumatoid sub-study where the main objective is to compare arthritic tissue and peripheral blood constituents between OA and rheumatoid arthritis patients to explore the differences in the disease mechanisms.

Eligibility Criteria:
Inclusion Criteria for the main (OA) study:

Cases: Adult patients with osteoarthritis in the hip joint and who are going through an elective total hip arthroplasty.

Controls: Non-arthritis adult patients who are going through a trauma-based emergency total hip arthroplasty.

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Inclusion Criteria for the Rheumatoid sub-study:

Adult patients with rheumatoid arthritis in the hip joint and who are going through an elective total hip arthroplasty.

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Exclusion Criteria:

* The body mass index must be below 35
* Age \< 18 or \> 74
* The OA patients may not have diabetes, rheumatoid arthritis (RA), or metabolic syndrome.

For the Rheumatoid sub-study, the exclusion criteria are the same as above except for the RA.