cyrilzakka/clinical-trials huggingface dataset:
Health Surveillance at Constructor University Bremen (CUB) 2025

The aim of Health Surveillance 2025 is to analyze and describe the state of health of students at Constructor University, key influencing factors and individual resources.

The aim of Health Surveillance 2025 is to analyze and describe the state of health of students at Constructor University (CU), key influencing factors and individual resources. In areas where there is a need for action, the Health Surveillance can provide detailed insights and/or in-depth analyses. The Health Surveillance thus provides information on health-related topics and delivers scientifically sound information as a basis for health-promoting discussions in the subsequent follow-up process at various levels (e.g. faculties and departments). In addition, the Health Surveillance 2025 at CU contributes to comparability with surveys at other German universities through the use of validated and standardized measuring instruments.

Main hypotheses are

1. The Health Surveillance 2025 gives insights into state of health of students at CU, key influencing factors and individual resources.
2. With the Health Surveillance 2025 the health-promotion at CU can be guided and promotion of mental health (including the reduction of loneliness and discrimination) can be strengthened.
3. The health of students, their perceived loneliness and discrimination/minorization (disadvantage) interrelates with participation in health promoting activities?
4. Recommendations can be derived for qualification and skills training of multipliers for health-promoting behavior (e.g., J-peers)?

Eligibility Criteria:
Inclusion Criteria:

* English language skills
* Reading and writing skills
* Internet access
* Student status
* Consent to participate in the study

Exclusion Criteria:

* Illiteracy
* Massively limited cognitive abilities i.e. linguistic components of the digital offerings must be able to be used, and questionnaires completed, or interviews participated in)
Adolescent Mood During Puberty and Testosterone

Starting at puberty, female adolescents are nearly three-times more likely to develop internalizing disorders, like depression, while male adolescents are two-times more likely to develop externalizing disorders, like attention deficit hyperactivity disorder (ADHD). This divergence between the sexes during puberty suggests sex-specific pathways of risk and differential effects of sex hormones. The purpose of this research is to determine: 1) sex-specific neural and endocrine features of the pubertal transition that may mediate sex differences in adolescent mood disorders, and 2) the neurophysiological basis of susceptibility to hormone change during puberty.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 11 and 14
* Have their own personal mobile device and capability to download the MyCap and Healthy Minds apps
* Experienced a stressful life event within the last year, or endorse moderate depression (defined by a CES-DC score 16 or higher)

Exclusion Criteria:

* Previous experience with the Healthy Minds Program
* Regular meditation practice
* Current or history of manic episodes, psychotic symptoms, or current suicidal intent
* Taking any form of exogenous hormones or intrauterine device (IUD) within one month of participation in the study
* Taking medications that directly alter cardiovascular or neurological function
Testosterone Therapy in Hypogonadal Men Treated With Opioids

The purpose of this study is to evaluate the efficacy of testosterone replacement therapy in men with low testosterone due to opioid treatment on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.

Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40 patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20 patients per arm

A double blinded randomized placebo controlled trial

The study duration is 24 weeks. Patients are treated with Testosterone Undecanoate 1000 mg/4 ml, intramuscular (i.m.) or placebo at 0, 6 and 18 weeks.

Outcome measures will be evaluated at 0 and 14 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male patients 18-75 years
* Treatment with opioid for \>3 months, daily dose \>50-100 mg
* Total testosterone \< 12 mmol/L
* Follicle Stimulating Hormone (FSH)/Luteinizing Hormone (LH) levels normal og below normal laboratory values
* Normal prolactin levels

Exclusion Criteria:

* Hematocrit\> 54% at screening
* Prostate Specific Antigen (PSA) \> 3 ng/ml
* Severe organic and mental disease
* current or present cancer diagnosis
* Previous venous thrombotic embolism and cerebrovascular disease
* Uncontrolled hypertension
* Epilepsy or migraine not adequately controlled by therapy
* Severe benign prostate hypertrophy with symptom score \>19
* Sleep apnea
* Alcohol or drug abuse
* Implantation of sustained action sex hormone in the last 12 months
* Use of oral, buccal or transdermal testosterone in the last two weeks
* Treatment with glucocorticoids \> 5 mg/day or 5 alfa reductase inhibitors
* Hypersensitivity to Nebido
Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice

In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed active head lice infestation

Exclusion Criteria:

* Allergy to pediculicides or hair care products
* Scalp conditions other than head lice
* Previous head lice treatment within the past 4 weeks
* Current antibiotic treatment
TEXTBOOK OUTCOMES OF EMERGENCY CHOLECYSTECTOMIES IN ELDERLY PATIENTS

Textbook outcome is a measure used to assess the quality of surgical practice. The goal of this observational study is to compare textbook outcomes of elderly patients (≥65 years) in emergency cholecystectomies with younger patients(\&lt;65 years ) via using aforementioned criteria

Textbook outcome is a measure used to assess the quality of surgical practice and has been implemented in various areas of surgical literature. It is defined as an uneventful operative and postoperative period that leads to successful surgery without negative outcomes. There is still no consensus on the textbook outcome concept for emergency cholecystectomy. SPRIMACC Collaborative Study has presented and offered a list of textbook outcome criteria.

Their proposal was: no 30-day mortality, no 30-day postoperative complications (any CD≥I is considered non-TO), no readmission within 30 days, and hospital stay≤7 days (75th percentile) and full laparoscopic surgery.

The goal of this observational study is to compare textbook outcomes of elderly patients (≥65 years) in emergency cholecystectomies with younger patients(\&lt;65 years ) via using aforementioned criteria

Eligibility Criteria:
Inclusion Criteria:

* All patients underwent emergency cholecystectomy with a diagnosis of acute choleystitis

Exclusion Criteria:

* Patients underwent open surgery directly. Patients diagnosed as malignant postoperatively in the pathology report
Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System

An objective assessment of that part of the spectrum of ophthalmic eyelid surgeries that focuses on correcting the position of entropy (e.g. ectropion, ptosis surgery) is very difficult - although it is possible to use different measuring parameters (distance of pupillary reflexes from the edges of the eyelid), comparing different distances on the face, exophthalmometry or the lid laxity test - the so-called snap-back test, but all these methods are based either on the subjective assessment of the examiner or on the correctness of the attached ruler, and their objectivity is therefore very low.

The goal of the project is to develop a methodology for evaluating the results of operations using a stereo photographic system, to objectively evaluate the functionality and results of various eyelid operations, and subsequently to expand the use of the device in other ophthalmological indications.

Different files will be created where the effect of different operations will be monitored in parallel.

Lateral canthal hinge surgery will be evaluated in the pilot group, and ptosis surgery through an anterior approach will be evaluated in the second group.

In all patients, the position of the eyelids, their change before and after surgery, the periorbital volume, and the relation of the eyelids to the periorbital landscape will be assessed metrically.

The Vectra M3 device will be used for the measurement.

The expected cohort size is 40 patients in each group.

Eligibility Criteria:
Inclusion Criteria:

* Eyelid ptosis
* Eyelid entropion
* Eyelid ectropion

Exclusion Criteria:

* Refusal to participate in the study
* Not signing the Informed Consent Form
* Inability/reluctance to cooperate in the study
Assessment of Performance of [18F]-FES for Endometriosis Diagnosis

Endometriosis is a benign chronic disease responsible for infertility and pelvic pain. One of the main problem of endometriosis is the significant delay of diagnosis.This delay has significant consequences for patients. Currently the definitive diagnosis of endometriosis and the evaluation of its lesional extension require performing laparoscopy and a histological analysis of biopsy and pathologic areas. Lesions of endometriosis whose development and growth are estrogen-dependent, express estrogen receptor (ER). \[18F\]FES (16α-\[18F\]Fluoro-17β-estradiol) is an analog of estrogen, used in positron emission tomography (PET), and a specific tracer of ER. We propose to evaluate the performance of this functional imaging as a diagnostic tool for endometriosis.

The aim of this multicenter, prospective, open study is to assess sensitivity of PET with \[18F\] -FES for diagnosing endometriosis compared to the gold standard (histological confirmation on biopsy or excision of lesions performed during laparoscopy) in women care for suspected endometriosis and for whom laparoscopy is already scheduled.


Eligibility Criteria:
Inclusion Criteria:

* First planned coelioscopy (therapeutic indication) for suspected endometriosis
* Patient aged from 18 to 50 years
* Absence of treatment with GnRH (gonadotropin-releasing hormone) analogue for at least 3 months
* Patient affiliated to a social security system
* No hormonal treatment for at least 3 months

Exclusion Criteria:

* History of abdominal pelvic surgery for endometriosis
* Current treatment with GnRH (gonadotropin-releasing hormone) or stopped for less than 3 months
* hormonal Drug ongoing
* Patient pregnant, may be or during lactation
* Patient under guardianship or trusteeship
* Patient unable to understand the purpose of the study
* Patient already included in another clinical trial with an experimental molecule.
AZD9833 China PK Study

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Chinese patients with ER Positive, HER2 Negative, Metastatic Breast Cancer

This study is designed to investigate and characterize the safety, tolerability and PK of AZD9833 monotherapy (Part A, Part B-cohort 1) or in combination with palbociclib (optional Part B cohort 2) or everolimus (optional Part B cohort 3) and to explore the preliminary anti-tumour activity in Chinese patients

Eligibility Criteria:
Inclusion Criteria:

1. Any menopausal status:

   1. Pre-menopausal women must have commenced treatment with an LHRH agonist at least 4 weeks prior to the start of study intervention and must be willing to continue to receive LHRH agonist therapy for the duration of the study.
   2. Post-menopausal defined according to standard criteria in the protocol.
2. Histological or cytological confirmation of adenocarcinoma of the breast.
3. Documented positive ER status and HER2 negative status of primary or metastatic tumour tissue.
4. ECOG performance status 0 to 1.
5. Metastatic disease and radiological or objective evidence of progression on or after the last systemic therapy prior to the start of study intervention.
6. At least one lesion as per RECIST Version 1.1 that can be accurately assessed at baseline and is suitable for repeated assessment by CT, MRI, or plain X-ray or clinical examination.
7. Recurrence or progression on at least one line of endocrine therapy in the metastatic disease setting.
8. For Part A and Part B cohort 1, patients should be eligible for SERD monotherapy treatment.
9. For Part B Cohort 2, patients should be eligible for SERD treatment and CDK4/6 inhibitors, and prior treatment with CDK4/6 inhibitors is not permitted.
10. For Part B Cohort 3, patients should be eligible for SERD treatment and mTOR inhibitors, and prior treatment with mTOR inhibitors is not permitted.

Exclusion Criteria:

1. Previous treatment with AZD9833.
2. Presence of life-threatening metastatic visceral disease, uncontrolled CNS metastatic disease or life-threatening extensive hepatic involvement.
3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, or infection requiring intravenous antibiotic therapy, which makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
4. Inadequate bone marrow reserve or organ function.
5. Any clinically important and symptomatic heart disease.
6. Any concurrent anti-cancer treatment.
7. Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9833 (and palbociclib and everolimus).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Men 45 years of age or older
* Documented bladder outlet obstruction

Exclusion Criteria:

* History of urinary retention
* Symptomatic and recurrent urinary tract infection (UTI)
Empagliflozin as a Novel Therapy in Refractory Ascites

The aim of the present study is to investigate the safety, efficacy and cost-effectiveness of empagliflozin, a sodium glucose transporter 2 inhibitor, as an add on therapy to the standard care for refractory ascites in patients with liver cirrhosis

Midodrine will be added if the blood pressure less than 100/70 mmHg during the follow up period (start by dose 5 mg three times daily and up titrate the dose according to the blood pressure monitoring to maximum dose 12.5 mg three times daily.

* Treatment of empagliflozin will be stopped if patient developed any of the following (attack of symptomatic hypoglycemia, hypotention not responding vasopresser agent, complicated urinary tract infection or attack of diabetic ketoascidosis) .
* The dose of diuretics will be reduced if marked weight reduction occurred (more than 0.5 kilogram/day in patient with ascites only or more than 1 killogram /day in patients with ascites and lower limb edema).
* The diuretics will be stopped temporally if any of the following (renal impairment, attack of hepatic encephalopathy, severe electrolyte imbalance) and permanently if the urine sodium \< 30 mEq per day or there are intolerable side effects.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age older than 18 years old. 2. Ability to give a written informed consent. 3. Decompensated liver cirrhosis complicated with ascites. 4. Diagnosis of refractory ascites has made 3 months before informed consent which defined as one of the following(6)

  1. Ascites that cannot be mobilized or the early recurrence of which cannot be prevented despite moderate salt restriction and maximum dose of diuretics ( furosemide 160 mg or equivalent and spironolactone 400mg)
  2. Ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of the development of diuretic-induced complications that preclude the use of an effective diuretic dosage.

Exclusion Criteria:

* 1. History of any attack of hypoglycemia (defined as serum glucose less than 70 mg/dl) either symptomatic or a symptomatic.

  2. Blood pressure below 90/60 or History of Hypotension requiring high dose of vasopressor therapy (more than 15mg midodrine /day) 3. Patients who receive non-selective B-blockers. 4. History of recurrent urinary tract infection defined as more than 2 infections in last 6 months 5. Pregnancy and breast feeding 6. History of hypersensitivity to any SGLT2 inhibitor 7. Presence of hepatocellular carcinoma or any other malignancy. 8. eGFR below 30 ml/min using Modification of Diet in Renal Disease study (MDRD) 9. Patients with history of diabetes mellitus complicated with diabetic ketoacidois (DKA) or patients have any risk factors for DKA 10. History of alcohol intake 11. Modified Child-Pugh score 12 or more.
Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs

The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).

In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric and duodenal ulcers and this ulcer leads to the gastrointestinal bleeding which may be cause of death.

The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily nonsteroid anti-inflammatory medication.

Eligibility Criteria:
Inclusion Criteria:

* The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
* The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion Criteria:

* Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
* Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
* Current or past history of aspirin-induced asthma or hypersensitivity to NSAIDs.
* Past or planned surgery affecting gastric acid secretion.
* Clinically significant hepatic or renal disorder.
* Serious cardiac dysfunction, hypertension, or hematological disorder.
Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy

The purpose of this study is to determine whether ketamine or propofol, drugs used for procedural sedation during paediatric bronchoscopy, results in higher operator satisfaction and better side effect profile.

Pediatric bronchoscopy requires moderate to deep sedation in order to maintain patient comfort and safety, while optimizing the working environment for the physician performing the procedure. There is a paucity of pediatric research in the field of pediatric flexible bronchoscopy and data are often extrapolated from adult studies.

Propofol is often used as the sedation drug for this procedure due to its rapid sedative effect and favorable emergence profile. Propofol's major limitation is its tendency to cause apneas, which can occur in a relatively narrow therapeutic window. Apnea risk decreases with the patient's age and administering physician's familiarity and experience with the drug.

Ketamine is a drug often used for pediatric procedural sedation. Its pharmacologic safety profile is very wide, allowing a wide spectrum of dosing with a significantly reduced risk of apnea when compared to propofol. Known adverse effects of the drug include its emergence profile which may be accompanied by hallucinations, bronchorrhea and laryngospasm. Hallucinations may be prevented by using benzodiazepines concurrently and are possibly more pronounced in teenaged children compared to infants, although post-sedation irritability in the latter group might be an expression of this. Bronchorrhea, while usually not of significant concern during procedural sedation, has the potential to play a more noteworthy role during bronchoscopy. Significant airway secretions can create a difficult working environment for the pulmonologist performing the procedure. Patient safety may also be affected, as increased airway secretions reduce visibility in pediatric airways that are narrow to begin with and further compromised by placement of the bronchoscope. Potentially, this might also impact on the child's air flow and gas exchange. Laryngospasm during the procedure potentially hinders passage of the scope beyond the vocal cords and might extend the duration of the procedure.

In the investigators' center, propofol has most often been the sedative drug of choice for bronchoscopy. Yet, ketamine has been used at times due to its safety profile and the administering physicians level of comfort with each drug.

Aim:

To compare operator satisfaction and adverse effects in children presenting for flexible bronchoscopy using ketamine versus propofol as the primary sedative agent.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing flexible bronchoscopy

Exclusion Criteria:

* Failure to acquire parental consent
* Bronchoscopies performed outside of the bronchoscopy suite
* Bronchoscopies performed under general anesthesia with a protected airway
* Bronchoscopies performed by personnel outside of the study group
* Known allergies to either of the sedation drugs used