cyrilzakka/clinical-trials huggingface dataset:
A Study in Healthy Men to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food

Single-rising dose (SRD) part The main objectives of the SRD part of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1815368 in healthy male subjects following oral administration of single rising doses.

Bioavailability (BA) part The main objective of the BA part is to investigate the relative bioavailability of a tablet formulation versus oral solution and to assess the influence of food on the relative bioavailability of the tablet formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP),pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation- Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply
Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture

Femoral neck fracture is very common in the elderly and can produce severe to moderate pain. As this pathology is not life-threatening, waiting time in the emergency department may be prolonged due to the high number of unforeseen cases with patients remaining in pain.

Fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca, resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves, with effective analgesia.

The objective of this trial is to compare the fascia iliaca block with a sham injection on patients arriving in the emergency department with a femoral neck fracture.

The fascia iliaca block will be performed with an anatomical landmark technique and a volume of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL will be injected.

Eligibility Criteria:
Inclusion Criteria:

- patients with femoral neck fracture in the emergency department

Exclusion Criteria:

* presence of demencia
* body weight less than 40kg
* presence of a cancer or patients receiving chemotherapy
* allergy to local anaesthetics
Benefits of Digital Dance Game by Older Adults

This study aims to examine the clinical efficacy of dancing somatosensory videogames in improving physical health, cognitive performance, happiness, laboratory biomarkers, and structural brain imaging (magnetic resonance imaging, MRI) by a randomized controlled trial design, and hopefully to expand the scope of healthy aging intervention activities with strong scientific evidence.

This randomized controlled trial followed the CONSORT guidelines to compare the clinical efficacy of the intervention group with the control group. The intervention group and control group were randomly allocated (1:1) with no stratification. The intervention group received the dance somatosensory videogame (DSG) training program at the community health center, which consisted of two 30-minute sessions per week for 6 months. The control group were provided with health education for healthy aging and were followed by telephone survey for their daily activities every month during the study period.

The primary outcome of the trial was changes of gray matter volume of the brain done by 3T brain magnetic resonance imaging during the study period. The secondary outcomes included cognitive performance, quality of life, physical activities, resilience, and demoralization. For all outcome variables, the measurements at the baseline and 6-month follow-up were examined by a random intercept and a fixed slope, and the effect of the intervention was estimated by using the Generalized Estimating Equation.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 55 years old.
2. More than 6 years of formal education.
3. Can communicate in Mandarin and Taiwanese.
4. Can accept MRI examination without claustrophobia.
5. Can understand the research process, meet the requirements of the research, and can sign the consent form and participate in the subject.

Exclusion Criteria:

1. Have engaged in any video dancing games in the past three months.
2. Engaged in video dancing games more than three times per year in the past three years.
Assessment of Geriatric Evaluations Impact on New AML Guidance

The goal of the study is to measure physiologic age (there is no current formal definition but is meant to imply that patients should be evaluated holistically rather than on age alone) at baseline in newly diagnosed AML patients over 50 years receiving either intensive or non-intensive treatment. This information will be used to evaluate toxicity, early mortality, remission rates and long term survival.


Eligibility Criteria:
Inclusion Criteria:

* AML diagnosis by peripheral flow cytometry and/or bone marrow aspirate and biopsy
* New diagnosis being considered for new line of treatment
* Age ≥ 50 years.
* Performance status 0,1, and 2

Exclusion Criteria:

* Inability to understand or unable to sign a written informed consent
* Unable to fill out questionnaires on their own and/or do not have someone to help complete them
Training Parents of Children With ADHD by Mindfulness-based Stress Reduction for Reducing Stress

The study aimed at comparing the effects of 8-week MBSR programme intervention group with usual care group in reducing parental stress and improving quality of life of parents of children with ADHD in Chinese culture.

This study aimed at comparing the effects of 8-week mindfulness-based stress reduction (MBSR) intervention with usual care in improving the parental stress, quality of life, and the feasibility and acceptability of MBSR of parents of children with Attention Deficit Hyperactivity Disorder (ADHD) in Chinese context after the coronavirus disease pandemic.

This study was designed as a pilot randomised controlled trial with single-blind repeated measures. By using convenience sampling, 36 parents of children with ADHD were recruited from the Parent Resource Centre of The Salvation Army (Centre), a Non-government Organization in Hong Kong, between July to August 2022. Centre staff invited parents of children aged 3-12 diagnosed with ADHD who can communicate and understand Cantonese to participate. Parents who had physical or severe intellectual disabilities, mental disorders or received any form of psychological intervention or psychiatric services were excluded from this study. All eligible parents were randomized to either the intervention group (n=18) or the usual care group (control) (n=18).

Parents assigned to the intervention group received the MBSR programme and usual services from the Centre. MBSR had eight weekly sessions of 2.5 hours each, plus a whole day retreat in small groups between session 6 and 7. The usual care group remained with usual support from the Centre, with interest activities such as cooking classes or calligraphy classes, but without any other form of intervention during this period.

Eligibility Criteria:
Inclusion Criteria:

* parents who have a child aged 3-12 with a confirmed diagnosis of ADHD with or without medications
* able to communicate and understand Cantonese

Exclusion Criteria:

* having physical disabilities or severe intellectual impairments
* any forms of mental disorders
* receiving any other form of psychological intervention, behavioural treatment, or psychiatric services
Motivating Quitline Use Among Smokers in Treatment for Substance Use Disorders

The long-term goal of this program of research is to disseminate an effective, brief computer-based intervention that can be readily integrated into Substance Use Disorders (SUD) treatment programs to motivate tobacco quitline use in patients who smoke. The overall objective of this application, which is the first step in the attainment of this long-term goal, is to fully develop this computer-based intervention, modify it based on initial piloting and feedback to insure its feasibility and acceptability, and obtain preliminary data supporting the efficacy of the intervention. This will be accomplished by pursuing three specific aims: 1) to develop and conduct preliminary pilot testing (n=20) of a brief, computer-based intervention intended to motivate tobacco quitline use among cigarette smokers in SUD treatment (TIME-TQ; Tablet computer Intervention to Motivate Engagement in Tobacco Quitline use) and to develop and pilot test a computer-based, time matched control intervention (CON), 2) to conduct a preliminary randomized controlled trial (RCT) with 60 smokers in SUD treatment, comparing TIME-TQ vs. CON, with predictions that TIME-TQ relative to CON will result in increased readiness, higher rates of tobacco treatment engagement, more quit smoking attempts and higher rates of 7-day point prevalence abstinence rates at 1- and 3-month follow-ups. Substance use outcomes over the course of the 3-month follow-up period will also be examined, and 3) to examine TIME-TQ's effects on key mechanisms during the computer session and their associations with tobacco treatment engagement and smoking outcomes at 1- and 3-month follow-ups.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 70 years of age
* current smoker (i.e., at least 10 cigarettes per day)
* current DSM-IV alcohol or drug abuse or dependence per SCID-P.

Exclusion Criteria:

* history of psychotic disorder or current psychotic symptoms per the Structured Clinical Interview for DSM 4R - Patient version
* cognitive impair-ment sufficient to impair provision of informed consent or study participation
* current suicidality or homicidality
* use of NRT or other pharmacotherapy for smoking cessation
* use of other tobacco products
Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)

The aim of this study is to measure effects of the combined treatment with GH and IGF-I on glucose sensitivity and body composition in patients with GHD and IGT or diabetes.

The study was a 6 months randomised placebo controlled trial of adults with GHD and type 2 diabetes. All receive GH (0.15 mg/day for 1 month, 0.3 mg/day for 5 months) and are randomised to IGF-I or placebo (15 µg/kg/day for 1 month and 30 µg/kg/day for 5 months). Glucose metabolism is evaluated with euglycemic hyperinsulinemic clamp and body composition by computed tomography (CT) and bio impedance;.

Eligibility Criteria:
Inclusion Criteria:

1. Verified profound GH deficiency. If the patient is already on GH replacement therapy this must have been commenced at least 6 months prior to study entry.
2. Impaired glucose tolerance test or diabetes (stable on oral antidiabetic medication for at least 3 months)
3. HbA1C\<7.5%
4. Age 18-70 years
5. Each patient must sign an informed consent document before inclusion in the study
6. Women of childbearing potential must provide a negative pregnancy test before study start, and they must agree to use an effective method of contraception such as double barrier contraception, an injectable or implanted hormonal contraceptive, combined oral contraceptive or an intra-uterine device (IUD). The patient must agree to continue to use the contraceptive for two weeks after the last injection of IMP. Women without childbearing potential are defined as being postmenopausal for at least 1 year, or permanently sterilised at least 3 months before study entry.

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Exclusion Criteria:

1. Known or suspected allergy to GH or IGF-I preparation
2. Insulin treatment
3. Proliferative retinopathy
4. Previous malignancy or other serious diseases (ex severe cardiovascular diseases, severe infections). Patients with a history of cancer can be included if they have been treated with curative therapy and have been disease free for more than 5 years. Patients with cardiac failure are not included.
5. Increased liver enzymes (ASAT or ALAT\>2.5 normal range)
6. S-creatinine above 120 umol/L
7. Patients with active hyperthyroidism and untreated hypothyroidism
8. Pregnancy
9. Lactation
Double-blinded, Randomized, Placebo-controlled Study Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection

Urinary tract infections (UTIs) are the most common bacterial infections in women, with about 50% of women experiencing at least one UTI in their lifetime.

The main pharmacological treatments of cystitis usually involve the use of antibiotics, in particular quinolones (such as ciprofloxacin and levofloxacin), fosfomycin, second-generation and third-generation cephalosporins, and b-lactam antibiotics associated with b-lactamase inhibitors.

This is a double-blinded, randomized, placebo-controlled, parallel-group study evaluating the effect of the probiotic on recurrent urinary tract infection (UTI) in adult women recently treated for UTI.

Primary objective The primary objective is to evaluate the effect of oral supplementation with probiotic on the frequency of UTI during six months from start of intervention in adult women with recurrent UTI.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to give informed consent for participation in the study.
2. Woman aged 18-50 years old at screening.
3. BMI ≥18 at screening.
4. Currently on antibiotic treatment for UTI, at the time of screening. Antibiotic treatment must stop within three days prior to first IP dose.
5. Recurrent UTI defined as at least two UTIs during the last six months or at least three UTIs during the last 12 months, according to information given by the subject.
6. Able and willing to comply with the restrictions defined for the the study period (see Section 10.6).
7. Access to Bank ID and ability to use the e-health platform (i.e. Internet access).
8. Ability to understand and comply with the requirements of the study, as judged by the Investigator.

Exclusion Criteria:

1. Postmenopausal (defined as 12 months of amenorrhoea).
2. Pregnant or breastfeeding.
3. Planning to become pregnant during the study.
4. Irregular menstruations combined with perimenopausal symptoms.
5. Known hypersensitivity or allergy to any of the components of the test product, or to the comparator (placebo).
6. Use of spermicide contraceptives including spermicidal condom within three days prior to first IP dose.
7. History of complicated cystitis, urgency incontinence, recent pyelonephritis, urological and/or gynaecologist abnormalities, immunocompromised, as judged by the Investigator.
8. Unstable bowel disorder such as diarrhoea, Crohn's disease, ulcerative colitis.

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Regional Analgesia After Cesarean Section

All patients will be anaesthetized with spinal technique. Each patient will be treated with intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total morphine consumption and time to the first demand will be noted. 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).

Written consent will be obtained before the cesarean section. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

All patients will receive PCA (patient controlled analgesia) pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit). In PACU vital signs will be monitored.

Each patient will be randomly assigned to one of three groups. In the first group of patients no additional regional analgesia will be performed. In the second and the third group, ultrasound-guided transversus abdominis plane or quadratus lumborum block will be done with 0.375 % ropivacaine (0.2 ml per kg on each side).

Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of operation.

Paracetamol, metamizol, ketoprofen may be given as required.

1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Eligibility Criteria:
Inclusion Criteria:

* obtained consent
* singleton pregnancy
* subarachnoid anaesthesia

Exclusion Criteria:

* coagulopathy
* allergy to morphine and local anesthetics
* depression, antidepressant drugs treatment
* epilepsy
* usage of painkiller before surgery
* addiction to alcohol or recreational drugs
Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology

Interventional Neuroradiology replaces surgery. This technology requires various exposition to X rays : number of X rays photographs, radioscopy, distance between patient and detector, speed of acquisition of X-rays photographs, high tension and intensity.

The manipulator must find the right balance between quality of photographs and dose delivered to the patient (optimization).

Children are particularly exposed to these risks of irradiation (sensitivity to X-rays and long life expectancy with risks. So, it is fundamental to optimize the dose delivered during the procedures.

The investigators propose to analyse a study comparing two protocols of optimization of doses. The investigators' hypothesis is that the protocol experimented in this trial allows less radiation of the children, compared to the usual protocol.


Eligibility Criteria:
Inclusion Criteria:

* malformation or occlusion of a cerebral vessel requiring interventional Neuroradiology

Exclusion Criteria:

* opposition ot the parent(s) to the participation of their child in the trial and/or no social security.
Availability and Advice on Test Uptake During the COVID-19 Pandemic: a Vignette Study.

Lateral Flow Testing (LFT) use for COVID-19 related symptoms continues to rise, despite governmental advice to test at a test facility. In this study we investigate whether 1) adjusting the governmental testing advice will lead to a collective increase of people who test with COVID-19 symptoms and if this leads to a higher strategy sensitivity.

In an online randomised multi-factorial survey (vignette study) participants are randomised to assess four scenario's. Between subject testing advise is randomised (IV1; 2 levels) and the availability of LFT (IV2; 2 levels). Within subject we asked participants to assess their most likely behaviour on day 1 of symptoms and day 3 of unchanged symptoms (IV3; 2 levels). Corona-related symptoms are randomly presented (IV4; 4 levels) and new incidences of symptoms are presented in additional vignettes describing new months (IV5; 4 levels).

Subjects are asked to immerse themselves in the scenario's before answering what their most likely behaviour would be: a) go to a test facility b) use a LFT c) wait and see or 4) no test. Participants who didn't choose the test facility on day 1 were presented with the same vignette on day 3 with unchanged symptoms, and were asked their most likely behaviour again.

After assessing the scenario's, participants fill in a questionnaire assessing demographics, behavioural determinants related to test behaviour, vaccine status, current symptoms and previous experience with Corona and testing.

The primary outcomes is defined as the average strategy sensitivity over time and therefore the chance of detecting a Covid-infection. Average strategy sensitivity is calculated by converting the choice of testing behaviour into the corresponding sensitivity score (PCR =1, LFT day 1 = .8, LFT day 3 = .7, wait and see and no test = 0), averaged over four scenario's.

Our primary hypothesis is:

1. Adjusting the governmental testing advice will lead to a higher strategy sensitivity.

   In follow-up analysis we will explore the following hypothesis:
2. Availability of LFT at home will lead to a higher strategy sensitivity.
3. The type of corona related symptoms (mild or severe) are predictive of the type of test used.
4. When confronted with a new incidence of corona-related symptoms over time, strategy sensitivity will decline.

Eligibility Criteria:
Participants were recruited from an online research panel representative for the Dutch population.

Inclusion Criteria:

* non

Exclusion Criteria:

* non