cyrilzakka/clinical-trials huggingface dataset:
Impact of Olfactory Odour StimulatioN on Energy EXpenditure

In this preliminary short-term study it is investigated, whether a short olfactory stimulation with distinct odours impacts energy expenditure in patients with obesity and lean patients.


Eligibility Criteria:
Inclusion Criteria:

* • Age 18-55 years

  * Obesity (BMI ≥30 kg/m2) and Lean (BMI 18-25 kg/m2)
  * Written informed consent
  * Normosmia (defined by sniffing Sticks test)

Exclusion Criteria:

* • Chronic or acute sinusitis

  * Surgical intervention of the nasal cavity or the paranasal sinus
  * Known allergy to odors used in the study
  * Smokers
  * Current illicit drug abuse including daily marijuana and cannabidiol (CBD) consumption (alcohol ≤2 drinks per day allowed)
  * Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
  * Diabetes mellitus
  * Treatment with insulin sensitizing drugs including Glucagon-like Peptide (GLP)-1 analogues within the last 3 months
  * History of neurodegenerative diseases, severe head trauma
  * Severe renal impairment (e.g. estimated glomerular filtration rate \<30 ml/min/m2)
  * Known liver cirrhosis or other severe liver impairment
  * Use of any kind of decongestant more than twice a week
  * Use of cortisone-containing nasal spray within the last 3 months
  * Acute upper respiratory tract infection
  * Uncontrolled dysthyroidism
  * Uncontrolled hypertension
  * Regular use of psychopharmaceutic drugs
  * Study participants aims to start a new diet or exercise program during the study
  * Bariatric surgery
  * Pregnancy/Lactation
  * Onset of climacteric symptoms within one year (e.g. hot flashes and/or diaphoresis) OR initiation of hormonal replacement therapy in the last three months
  * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
  * Participation in an interventional study within the last 3 months
" Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD "

The treatment of adult patients with congenital heart disease (ACHD) and heart failure (HF) represents a great challenge since, to date, there is no standardized guideline for this specific population. Although new treatments for HF have been proposed, such as Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors and neprilisin and angiotensin receptor inhibitors, the benefit of these drugs in patients with HF associated with congenital heart disease in adults has not yet been demonstrated. For this reason, this study pretends to evaluate the efficacy of empagliflozin and sacubitril/valsartan in this population.

A 12-week randomized, open label, active-controlled trial to explore the effects of once-daily empagliflozin 10 mg and/or sacutril/valsartan 49 mg/51 mg in the reduction of systemic ventricular volumes (end-diastolic and end-systolic) in adult patients with HF associated with congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

* NYHA functional class II-IV
* Diagnosis of CHD: repaired, palliated or without previous treatment
* Systemic ventricular ejection fraction \<40%
* Without unplanned hospital admissions within 3 months prior to randomization
* The participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Pregnant and postpartum women
* Breastfeeding women during the study
* History of drug allergy to any SGLT-2 inhibitor and/or sacubitril/valsartan
* Previous administration of a drug regimen including an SGLT-2 inhibitor and/or sacubitril/valsartan
* Intellectual or physical disability that impedes the subject to perform the 6 minute walk-test
* Patients with any contraindication to SGLT-2 inhibitor and/or sacubitril/valsartan
* Medical history of myocardial infarction, cardiac surgery or fulminant myocarditis within the last three months
* Medical history of type 1 diabetes mellitus
* Medical history of hypertensive crisis in the previous 6-months
* Medical history of cardiogenic shock or heart failure decompensation in the previous 6-months
* Medical history of heart transplantation
Targeted Letters to Reduce Avoidable Emergency Department Attendances

The study aims to test whether it is possible to reduce pressure on Emergency Departments by sending a personal feedback letter to people who have recently attended an Emergency Department and whose health issues could likely have been dealt with elsewhere. These attendances clearly have many causes. However, it is likely that some attendances are due to behavioural factors - in other words, the various ways in which users interact with services. This study focuses on one particular behavioural factor: lack of feedback to users making avoidable visits.

The study will take place in collaboration with an NHS hospital trust. Each week during the trial, the hospital trust will identify those Emergency Department attendances in the last seven days which, according to clinical judgement, could have been dealt with elsewhere. Patients will then be randomly selected to receive a letter containing information on alternative healthcare options for non-emergency health concerns. Patient records will be analysed to determine whether the patients who received the letter are less likely to make an avoidable repeat visit to the Emergency Department in the future, compared with patients who received no letter.


Eligibility Criteria:
Inclusion Criteria:

* Adults who attended a participating Emergency Department during the trial period and whose attendance was codes as 'No Investigation No Significant Treatment'

Exclusion Criteria:

* Children under the age of 18
* All departments and hospitals other than participating Emergency Departments.
Empowered With Movement to Prevent Obesity and Weight Regain

This study will help determine the appropriate type, amount and intensity of physical activity most beneficial for preventing weight regain after weight loss in older adults.

The investigators will use a 3-group design in 180 older (65-85 years), obese (BMI=30-45 kg/m2), sedentary men and women, all of whom will undergo a 9-month Weight Loss (WL) intervention (6-mo intensive phase and 3-mo reduced contact phase), followed by a 9-month self-managed follow-up phase with minimal contact, to test our overall hypothesis that intervening on Sedentary Behavior (SitLess) will enhance long-term Weight Loss in this age group. The diet element of the intervention is identical across groups, but groups differ by activity intervention: 1) structured, moderate-intensity, aerobic exercise (EX) (WL+EX); 2) intervening on SB throughout the day (WL+SitLess); or 3) (WL+EX+SitLess).

Eligibility Criteria:
Inclusion Criteria:

* 65-85 years
* BMI=30-45 kg/m2
* Weight stable-no loss or gain (±5%) in past 6 mo
* Sedentary
* No contraindication for safe and optimal participation in exercise training
* Approved for participation by Medical Director
* Willing to provide informed consent
* Agree to all study procedures and assessments
* Able to provide own transportation to study visits and intervention

Exclusion Criteria:

* Dependent on cane or walker
* Reported unintentional or intentional weight loss or gain of \>5% in past 6 mo Participation in regular resistance training and/or \> 20 mins/day of aerobic exercise in past 6 months
* Cognitive impairment (MoCA score \<22)
* Low bone density (T-score \< -2.3 on hip or spine scan)
* Severe arthritis, or other musculoskeletal disorder
* Joint replacement or other orthopedic surgery in past 6 mos
* Joint replacement or other orthopedic surgery planned in next 2 years

  * Uncontrolled resting hypertension (\>160/90 mmHg);
  * Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease other than asthma or COPD, any disease requiring oxygen use, neurological or hematological disease; cancer requiring treatment in past year, except non-melanoma skin cancers
  * Serious conduction disorder, new Q waves or ST-segment depression (\>3 mm), or uncontrolled arrhythmia
  * Room air SpO2 (oxygen saturation) at rest or with exercise qualifying for supplementary oxygen (SpO2≤88%)
  * Abnormal kidney or liver function (2x upper limit of normal);
  * eGFR \<45 mL/min/1.73m2
  * Anemia (Hb\<13 g/dL in men/ \<12 g/dL in women);
  * Uncontrolled diabetes (fasting glucose \>140 mg/dl);
  * Deficient levels of vitamin D (25 hydroxyvitamin D level \< 20 ng/mL) in those not taking a vitamin D supplement;
  * Smoker (No nicotine in past yr)
  * No heavy alcohol use (\>14 drinks/week)
  * Unstable severe depression
* Regular use of: growth hormones, oral steroids, weight loss medications or prescription osteoporosis meds
* Current participation in other research study
Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer

Prostate cancer patients diagnosed with a biochemical recurrence and limited metastases are conventionally treated with androgen deprivation therapy. However, in patients with limited metastatic load, the time to progression might be. Subsequently, active surveillance of these patients until progression might defer the start of androgen deprivation therapy (ADT) for several months to years. As an alternative, salvage treatment of the limited number of metastases with either surgery or radiotherapy might postpone the start of ADT even longer. The current trial hypothesizes that ADT might be deferred longer following salvage treatment as compared to active surveillance.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of prostate cancer (PCa)
* Biochemical relapse of PCa following radical local prostate treatment
* N1 and M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.
* World Health Organization (WHO) performance state 0-1
* Exclusion of local relapse
* Age \>=18 years old
* Signed informed consent

Exclusion Criteria:

* Serum testosterone level \<50ng/ml
* Symptomatic metastases
* PSA rise while on active treatment with luteinizing hormone-releasing hormone (LHRH)-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen
* Previous treatment with cytotoxic agent for PCa
* Treatment during the past month with products known to influence Prostate Specific Antigen (PSA) levels (e.g. fluconazole, finasteride, corticosteroids,...)
* Disorder precluding understanding of trial information or informed consent
Primary Care Evidence-based Approach for Improving Lifelong Health

This study investigates the implementation and effectiveness of the Family Check-Up 4 Health (FCU4Health) intervention in primary care settings for reducing cardiovascular disease risk in children. Through a hybrid type 3 cluster randomized factorial trial and innovative technology-based strategies integrated with Electronic Health Records, the study aims to enhance intervention fidelity and engagement. Results will inform scalable approaches to promote child and family health behaviors, improve parenting skills, and potentially reduce child BMI, contributing to significant public health impacts in addressing cardiovascular health disparities.

The proposed implementation trial is a hybrid effectiveness-implementation type III design, with a primary focus on implementation strategies and outcomes. Eligible families include children aged 2-17 who are patients at Denova Integrated Healthcare. All families (n = 900-1200) will receive FCU4Health services from a Denova staff member trained in the intervention and supervised by FCU4Health experts. Following guidance from the ongoing Community Advisory Board, investigator's previous trials, and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, implementation barriers were identified to scale-up and implementation strategies adopted for the trial: Lyssn fidelity support and Short Message Service (SMS) text messaging to promote program engagement.

Randomization to these strategies will occur at the care team level (n = 11-12) using a factorial design. Parent/caregivers and children at least 6 years of age will complete assessments at baseline, 6 months, 12 months, and 18 months.

Primary outcomes are fidelity and engagement (Aim 1a) and child health behaviors (Aim 1b). Investigators will also examine secondary outcomes including family health routines and parenting; conduct economic analyses (Aim 2); and examine the link between trajectories of improvement in health behaviors and improvements in BMI for subgroups related to baseline BMI, child developmental age group, race/ethnicity, language, and gender (Aim 3).

Eligibility Criteria:
Inclusion Criteria:

* BMI at or above 85 percentile for age and gender.

Exclusion Criteria:

* N/A
Intraoperative Detection of Lesions Using PET (Positron Emission Tomography) Probe During Secondary Cytoreductive Surgery for Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer

The purpose of this study is to see if Positron Emission Tomography (PET) probes make it easier for your surgeon to find cancer and remove it during your surgery. A PET probe is a wandlike device that can detect radioactivity.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven diagnosis of ovarian carcinoma, fallopian tube, or primary peritoneal not to include tumors of low malignant potential (all stage, grade, and histology)
* First recurrence
* Platinum sensitive as defined by disease free interval ≥ 6 months
* Radiological evidence of recurrent disease on preoperative PET/diagnostic CT
* Planned surgical secondary cytoreduction via laparotomy
* \>18 years old

Exclusion Criteria:

* Secondary cytoreduction via laparoscopy or robotically assisted laparoscopy
* Tumors of low malignant potential
* Beyond first recurrence
* With the exception of non-melanoma skin cancer, subjects with other invasive malignancies, who had (or have) any evidence of the other cancer present within the last 5 years, are excluded
* Active infection requiring parenteral antibiotics
* For subjects with diabetes mellitus, a blood sugar will be checked preoperatively and must be \<200 for participation in the study
Towards a Food Ingredient Clinically Proven to Benefit Gut Health: Novel RG-I Variants

The aim of this study is to determine, quantify and understand the potential prebiotic effects of RG-I variants via microbiota modulation. The anti-inflammatory potential effects of these variants will also be investigated.

The plant cell wall derived RG-I (from chicory or carrot) and maltodextrin (placebo) in capsuled form will be provided by the food company NutriLeads B.V (Wageningen, The Netherlands), which has run tests of safety of the products and warranties their food grade quality and safety. The administration of RG-I will be done via a human intervention study of parallel arms, randomized, placebo - controlled, double blinded design (proof of concept study).

The dietary fibre from different RG-I sources will be tested for its prebiotic and immunomodulatory potential. Thus, the effects of these fibres on short chain fatty acid (SCFA) profile, microbiota composition, microbiota-associated metabolites and intestinal inflammatory markers will be investigated from fecal material obtained from the study participants.

The dietary fibre from different RG-I sources will be tested for their immunomodulatory and lifestyle related effects. The effects of fibres on immune activation markers will be investigated from blood samples collected from the study participants.

Eligibility Criteria:
Inclusion Criteria:

1. Signed consent prior to any study related procedures
2. Age 18-70 years
3. Willing to abstain from regular consumption of prebiotics/probiotics/synbiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits
4. Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg m-2

Exclusion Criteria:

1. Previous complicated gastrointestinal surgery
2. Presence of gastrointestinal disorder or any disorder which the principal investigator considers to affect the results of the study
3. Current diagnosis of psychiatric disease
4. Current and past diagnosis inflammatory gastrointestinal disease (e.g. Inflammatory Bowel Disease)
5. Systemic use of antibiotics or steroids medications in the last 3 months prior to study visits
6. Frequent use of NSAID (Non-Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
7. Abuse of alcohol or drugs
8. Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 3 months prior to study visits
9. Pregnancy and breast-feeding
10. Vegan dietary habits or consumption of dietary fibers ≥ 25 g per day according to the food frequency questionnaire
11. Smoking or usage of snus within last 3 months prior to study visits
12. No recent weight loss or gain 5% of their normal weight in the last month
Eyelid Crush for Marginal Eyelid Surgery

Surgery involves eyelid margin asscocited with intraoperative bleeding. Proper intra-operative homeostasis is essential for good intraoperative procedure and postoperative results.

baseline and postoperative full ophthalmic examination was done.Procedure include all surgeries involving eyelid margin

Eligibility Criteria:
Inclusion Criteria:

* All surgeries involving eyelid margin

Exclusion Criteria:

* bleeding tendency
A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL)

The purpose of this study is to compare the pharmacokinetics (PK) of both lyophilized and liquid S95014 formulations during the induction phase after a single IV dose in newly diagnosed paediatric patients with ALL


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 1 to \< 18 years
* Patients with cytologically confirmed and documented newly diagnosed ALL according to National Comprehensive Cancer Network guidelines 2020 (see Appendix 2), excluding B-cell Burkitt ALL
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2 (see Appendix 3)
* Highly effective contraception method
* Signed informed consent and assent, when appropriate

Non-inclusion Criteria:

* Unlikely to cooperate in the study
* Pregnant and lactating women
* Participation in another interventional study at the same time; participation in non-interventional registries or epidemiological studies is allowed
* Participant already enrolled in the study (informed consent signed)
* Women of childbearing potential tested positive in a serum pregnancy test within 7 days prior to the treatment period
* Inadequate hepatic function (bilirubin \> 1.5 times upper limit of normal (ULN), transaminases \> 5x ULN)
* Inadequate renal function defined as serum creatinine \> 1.5 x ULN
* Prior treatment with chemotherapy or radiotherapy (except steroids and intrathecal therapy)
* Prior surgery or bone marrow transplant related to the studied disease
* Down Syndrome
* Psychiatric illness/social situation that would limit compliance with study requirements
* Known history of pancreatitis
* Known history of significant liver disease
* Known carriers of HIV antibodies
* Significant laboratory abnormality likely to jeopardize the patients' safety or to interfere with the conduct of the study, in the investigator's opinion
* Pre-existing known coagulopathy (e.g. haemophilia and known protein S deficiency)
* History of previous or concurrent malignancy
* History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs
* Severe or uncontrolled active acute or chronic infection
* Uncontrolled intercurrent illness including life-threatening acute tumor lysis syndrome (e.g. with renal failure), symptomatic congestive heart failure, cardiac arrhythmia
GDNF Gene Therapy for Parkinson's Disease

The objective of this Phase 1b investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a recent or a long-standing diagnosis of PD.


Eligibility Criteria:
Key Inclusion Criteria:

* Male and female adults 35-75 years of age (inclusive)
* Diagnosed with Parkinson's disease
* Modified Hoehn and Yahr stage I-III OFF medication
* Time since receiving a clinical diagnosis of PD and disease severity consistent with one of the following:

  1. EITHER: Less than 5 years since clinical diagnosis of PD and mild to moderate UPDRS III OFF score
  2. OR: At least 4 years since clinical diagnosis of PD and moderate to severe UPDRS III OFF score
* Responsiveness to levodopa

Key Exclusion Criteria:

* Atypical parkinsonism
* Severe dyskinesia
* Presence of dementia, psychosis, substance abuse or qualify as "severe depression"
* Prior brain surgery (i.e. deep brain stimulator or DBS implantation) or other brain imaging abnormalities
* Receiving an investigational drug
* History of cancer or poorly controlled medical conditions that would increase surgical risk
* Inability to tolerate laying flat in an MRI or allergy to gadolinium
Comparison of Gamma Nail Versus Dynamic Hip Screw for the Treatment of Unstable Intertrochanteric Fractures

The objective of the study is to examine the treatment of unstable Intertrochanteric fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS).

This is a prospective study. Sixty patients with unstable Intertrochanteric fractures will be randomized to be treated using either Gamma nail or DHS. The patients will be followed for 12 months. The primary endpoint is the clinical outcome as measured by the Merle d'Aubigne and Postelhip score.


Eligibility Criteria:
Inclusion Criteria:

* Acute Intertrochanteric fracture - A1-32 AO/OTA
* Abbreviated mental score \>6
* Community ambulator (pre-fracture state)

Exclusion Criteria:

* Previous arthritis
* Pathological fracture
* Chronic corticosteroid use
* Concomitant lower extremity fractures
Frequency of Parasite Infestation in Patients With Chronic Spontaneous Urticaria

The goal of this study is to describe the prevalence and the type of parasite in patients with a chronic spontaneous urticaria as well as to describe the associations between parasitic disease and the characteristics of the patients, for example eosinophilia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a chronic spontaneous urticaria
* Age: 17 years old and up

Exclusion Criteria:

* No diagnosis of a chronic spontaneous urticaria
* Age: younger than 17 years
Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?

The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.


Eligibility Criteria:
Inclusion Criteria:

* Age 0-15 years
* All patients accepted for primary fundoplication at Oslo University Hospital

Exclusion Criteria:

* Age over 16 years
* Parents not speaking Norwegian or English well
* Prior fundoplication
* Patients with comorbidities considered as unsuited for laparoscopic surgery (diaphragma hernia, several previous abdominal operations etc)