cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Effect of Age and Injury Severity on Short-term Intra-hospital Outcomes After Surgical Stabilized Rib Fractures

The study aims to investigate the effect of surgical stabilisation of rib fractures (SSRF) on clinical outcomes measured during the hospital stay (mortality, days on a mechanical ventilator, intensive care unit and hospital length of stay, rate of complications). Furthermore, the effect of the patients age and overall injury severity on the outcomes after SSRF will be investigated. We hypothesise that the combination of high age and high injury severity will lead to worse outcomes after SSRF.


Eligibility Criteria:
Inclusion Criteria:

* Patients of the University Hospital Muenster
* Coded serial rib fractures (ICD S22.4 and S22.5)
* Treatment for the rib fractures between 2019 and 2023

Exclusion Criteria:

* pathological rib fractures (due to suspected malignancy)
Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

Repeated and untreated pain can lead to long-term consequences in preterm infants, such as pain hypersensitivity and impaired motor and intellectual development. Studies on the pharmacological and non-pharmacological interventions for pain management in preterm infants are limited. Thus, we investigated an intervention based on olfactive stimulation with mothers' milk. The aims of this study are: a) Evaluate the effectiveness of an olfactive stimulation intervention with mothers' milk odor on preterm procedural pain; b) Evaluate the effectiveness of adding a period of familiarization previous to the olfactive stimulation intervention with mothers' milk odor on preterm procedural pain. Preterm infants will be recruited and randomly assigned to three groups 1) mothers' milk odor during the nine hours before and during heel-prick, 2) mothers' milk odor during heel-prick, 3) standard care. Pain will be measured using a scale of pain adapted for preterm infants. This procedure with mothers'milk odor is inexpensive and easily performed.This study will significantly contribute to the advancement of knowledge on preterm infants pain management.


Eligibility Criteria:
Inclusion Criteria for mothers

* 18 years or older,
* speak, understand and write French or English
* express their milk

Exclusion Criteria for mothers

- pathology or condition that contraindicates the use of their breast milk (HIV, drugs...)

Inclusion Criteria for preterm

* 29 to 36 weeks of gestation
* APGAR \> 6 at 5 minutes
* less than 21 days

Exclusion Criteria for preterm

* intubated, under Continuous Positive Airway Pressure or nasal oxygen,
* surgery in the first day of life
* congenital disease
* intraventricular hemorrhage \> grade II
* leukomalacia
* sedation within 48 hours prior to heel prick
* pharmacologic treatment for pain within 12 hours prior to heel prick
* being under phototherapy treatment during the familiarization stage
Intervention Study: Genetic Risk Communication and Wearables

This study aims to determine the effects of communicating genetic risk for type 2 diabetes (T2D) alone or in combination with goal setting and prompts from a wearable device on objectively measured physical activity (PA) and sedentary behavior (SB) in East Asians. It is hypothesized that this combination will lead to significant favorable changes in objectively measured PA and SB, and that such changes will be more likely to be sustained over 6-month follow-up.

This study aims to recruit 150 healthy East Asian adults in Hong Kong. At baseline, participants will be invited to visit the research laboratory for measurement of a series of variables including height, body weight, blood pressure and grip strength. Participants will also be invited to complete a set of questionnaires to assess their self-reported PA and SB, fruit and vegetable consumption, smoking status and psychological variables. Blood samples will be collected to analyze key diabetes and cardiovascular disease biochemical markers as well as their estimated genetic risk of T2D. Each individual's unique genetic risk for T2D will be estimated on the basis of established genetic variants associated with T2D specifically for East Asians. Each participant will be asked to wear a Fitbit Charge 4 tracker, an objective activity monitoring device, throughout the entire trial.

Participants will be randomly allocated into 3 groups: 1 control and 2 intervention groups. A control group will receive an e-leaflet containing general lifestyle advice for prevention of T2D. An intervention group will receive an estimated genetic risk of T2D, in addition to the e-leaflet. The other intervention group will have a Fitbit step goal set 10% higher than their baseline step count and use prompt functions of the Fitbit tracker, in addition to the genetic risk estimate and e-leaflet.

Activity data from the Fitbit will be collected at 4-week post-intervention; information about lifestyle and psychological variables will be assessed through the questionnaires at both immediate and 4-week post-intervention. To determine the longer-term effect of the intervention, participants will be asked to visit the research laboratory 6 months after the intervention to repeat the same set of assessments as baseline, except the blood samples collected at 6-month follow-up are used only to analyze cardiometabolic risk profiles (not genetic risk). Activity levels will also be objectively measured using the Fitbit for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* East Asian ancestry
* Aged 40-60 years
* Able to perform daily-living physical activity
* Able to use English to communicate
* Use a smartphone

Exclusion Criteria:

* have been diagnosed with any type of diabetes
* pregnant or lactating
* unable to perform daily-life physical activities (determined through Physical Activity Readiness Questionnaire \[PAR-Q\])
* participating in another research study or exercise programs
* had experience of genetic testing
* cannot use English
Phase II Double Blind Controlled Trial of Nigral Grafting in Patients With Parkinson's Disease

OBJECTIVES:

I. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's disease.

PROTOCOL OUTLINE: This is a placebo controlled, randomized, double blind study. Patients are randomly assigned to 1 of 3 treatment groups. All patients receive 2 separate operations in which the substantia nigra from either 4 fetuses (Group A) or 1 fetus (Group C) is implanted into the striatum of each side.

Group B patients receive 2 separate placebo operations without fetal transplantation.

The second surgical procedure begins approximately 1 week after the first operation.

After 2 years, treatments are compared. If transplant is shown to benefit Parkinson's disease, then patients who received placebo operation will be offered transplant surgery in the final year of the study.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Advanced Parkinson's disease Hoehn-Yahr stage IV or worse during "off" periods Hoehn-Yahr stage III or better during "on" periods Predictable motor fluctuations with at least 20% of waking day in the "off" stage No atypical parkinsonism or secondary parkinsonism --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Stable doses of levodopa/carbidopa or any other antiparkinson therapy for 2 months prior to study Surgery: No previous intracranial/neurosurgical procedures --Patient Characteristics-- Renal: Creatinine clearance at least 70 mL/min or creatinine no greater than 1.8 mg/dL Protein no greater than 300 mg/dL Other: Not pregnant or nursing Adequate contraception required of fertile patients Prior history of good response to levodopa No sensitivity to cyclosporine Not HIV positive (e.g., HIV I or II) No human T-cell leukemia/lymphoma virus (HTLV-1) No tremors interfering with stereotactic surgery No clinically significant medical, neoplastic or infectious disease No clinically significant laboratory abnormality No dementia that precludes signing informed consent or score of less than 24 on Mini-Mental status examination
Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A

The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Male, age above or equal to 18 years at the time of signing informed consent,(part A).
* Male, age above or equal to 12 years at the time of signing informed consent,(part B).
* Diagnosis of congenital haemophilia A based on medical records (FVIII activity \<1%).
* History of more than 150 exposure days to any FVIII containing products.

Exclusion Criteria:

* Previous participation in this trial. Participation is defined as signed informed consent.

(Patients who have completed part A are allowed to also participate in part B. If so, a separate informed consent covering part B must be signed.)

* Immune compromised patients due to human immunodeficiency virus (HIV) infection (defined as viral load greater than or equal to 400.000 copies/mL and/or cluster of differentiation 4+ (CD4+) lymphocyte count less than or equal to 200/μL performed at screening or defined by medical records no older than 6 months)
* Any history of FVIII inhibitors (defined by medical records within 8 years of randomisation)
* Inhibitors to FVIII (greater than or equal to 0.6 Bethesda unit (BU)) at screening, measured by Nijmegen modified Bethesda method at central laboratory.
Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients

This study is to collect human activity and electrocardiogram (ECG) data from heart failure (HF) patients to aid in the development of a novel chronotropic incompetence (CI) algorithm designed to diagnose CI in patients with HF.

The Investigation of the Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients (CI Algorithm Study) is an acute data collection study using market released actigraphy devices (wGT3X-BT) and holter devices (DR 180) to measure study subjects' daily activities and surface ECG data simultaneously. The data will be analyzed to develop an algorithm to diagnose CI in patients with HF.

Eligibility Criteria:
Inclusion criteria for the case group:

* Patient is greater than 18 years of age and less than 70 years of old.
* Patient is willing and able to give informed consent.
* Patient has been diagnosed with stable chronic HF according to European Society of Cardiology 2012 HF guidance.
* New York Heart Association class I- III, including with HF with preserved ejection fraction and HF with reduced ejection fraction patients.
* Patients can perform moderate exercise.
* Left ventricular ejection fraction less than 55% but greater than 35%.

Inclusion criteria for the control group:

* Subject is greater than 18 years of age and less than 70 years of old.
* Subject is willing and able to give informed consent.

Exclusion criteria for the case group:

* Patient is unable or unwilling to sign the patient informed consent.
* Patient has implantable pacemaker, Implantable cardiovert defibrillator (ICD) or cardiac resynchronize therapy (CRT) device.
* Patient has at least one pacemaker, ICD or CRT indications.
* Patients has persistent atrial fibrillation (AF).
* Patient whose hear rate baseline at the rest is greater than 95 beats per minutes (BPM).
* Patient has contraindications for cardio-pulmonary exercise testing, including but not limited to, unstable angina, decompensated heart failure, active pericarditis or myocarditis and ECG ST-segment shift \> 2mm at the resting.
* New York Heart Association Class IV.
* Less than 45 days after myocardial infarction.
* Less than 3 months after acute heart failure.
* Patient has uncontrolled hypertension.
* Patient is pregnant.
* Patient has a medical condition that would limit study participation.
* Patient is enrolled in a concurrent study that may affect the outcome of this study.
Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin

The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 years or above
* Patients scheduled for elective total hip replacement

Exclusion Criteria:

* Planned, staged total bilateral hip replacement
* Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
* Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
* Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
Neurologic Physiology After Removal of Therapy (NeuPaRT)

The purpose of this study is to determine when brain function stops compared to when the heart stops by monitoring electrical brain activity in patients who are taken off life support and progress to death in the intensive care unit.

There are many Canadians who need an organ transplant and who will never get one. In the past, people could only be organ donors after being declared brain dead.

The dead donor rule serves this purpose by ensuring that death determination precedes organ retrieval. In Canada, death determination occurs in one of two ways. In neurologic determination of death (NDD), death is declared upon completion of a standardized neurologic assessment that confirms permanent loss of brain activity. In donation after circulatory determination of death (DCDD), death is declared 5 minutes after circulatory arrest. By confirming permanent loss of brain activity, the current NDD process protects donors from suffering and maintains stakeholder trust. In contrast, the current DCDD process assumes, but does not explicitly confirm, permanent loss of brain activity when death is declared 5 minutes after circulatory arrest. While this assumption is rooted in a strong physiologic rationale, lack of compelling evidence regarding cessation of brain activity in humans contributes to ongoing mistrust of the DCDD process among healthcare and public stakeholders.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Plan for the withdrawal of life sustaining measures (WLSM)
3. Attending physician anticipates patient will die within 24 hours of the withdrawal of life sustaining measures
4. Patient has an indwelling arterial cannula for monitoring blood pressure

Exclusion Criteria:

1. Brain death or plan for Neurologic Determination of Death (NDD)
2. Injuries that anatomically preclude the use of neurologic monitoring
Effects of Exercise Training on Cardiovascular Health in Middle-aged Women

The hypothesis of the present study is that physical training can oppose detrimental changes in cardiovascular and metabolic health associated with estrogen loss after menopause.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal (45-53 years) OR postmenopausal 50-57 years
* BMI\> 18.5 and \<30
* Sedentary (no regular physical activity the last 2 years)
* Plasma measurements
* Premenopausal: estradiol\> 0.20 nmol/l, Follicle stimulating hormone \< 22 IU/l and progesterone \>2.5 nmol/l
* Postmenopausal: estradiol \< 0.20 nmol/l, Follicle stimulating hormone \> 22 IU/l and progesterone 0.3-2.5 nmol/l

Exclusion Criteria:

* Smoking
* Excessive alcohol intake
* Regular medication including hormone replacement treatment
* Chronic disease
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)

The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females between 45 to 80 years of age
* Postmenopausal females
* Low bone mineral density, defined by bone mineral density (BMD) T-scores between -1.0 and -2.5, inclusive, for the lumbar spine \[L1-L4\] or total evaluable vertebrae \[if fewer than L1-L4\] or total hip)
* 25-hydroxyvitamin D ≥ 20 ng/mL
* Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)

Exclusion Criteria:

* Osteoporosis defined by bone mineral density (BMD) T-scores \< -2.5 for the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4) or total hip
* Diagnosed with any condition that would affect bone metabolism
* Previous exposure to AMG 785
Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis


Eligibility Criteria:
Inclusion Criteria:

* Healthy, males or females, 21 to 55 years old.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Condition affecting drug absorption. Blood pressure or ECG abnormalities. Recent treatment with an investigational, prescription, or non-prescription drug
Outcomes of Total Arterial Coronary Artery Bypass Grafting

"real-life" retrospective multicentric database for the analysis of the long term outcomes of total arterial CABG in comparison to saphenous vein based CABG

This aim of this registry is to create a multi centric database for the analysis of basic long term outcomes and immediate postoperative outcomes of total arterial CABG in comparison to saphenous vein based CABG. The registry will include both on pump and off pump surgery. The registry is intended to capture the "real-life" picture of the CABG scenario among centers worldwide

Eligibility Criteria:
Inclusion Criteria:

* elective CABG patients (on pump or off pump surgery; pedicles of skletonized internal mammary artery harvesting technique; open or endoscopic vein harvesting technique)

Exclusion Criteria:

* urgent or emergent CABG
* concomitant procedures
* redo cases
Guanfacine Extended-release for Adolescents With Cannabis Use

A randomized controlled trial to assess the efficacy of extended-release guanfacine to reduce cannabis use frequency in young people with cannabis use disorder following a period of monitored abstinence.


Eligibility Criteria:
Inclusion Criteria:

1. 12-25 years of age (inclusive) at consent;
2. Seeking treatment for cannabis use;
3. DSM-5 Cannabis Use Disorder, mild, moderate or severe;
4. Self-reported cannabis use on average at least 5 days/week during the 28 days prior to screening with a THC positive urine drug screen on the day of screening; and
5. Able to provide informed consent (both adequate IQ and English fluency; \<18-year-olds will provide consent themselves in addition to parent/guardian consent).

Exclusion Criteria:

1. DSM-5 substance use disorder (moderate or severe) except cannabis or nicotine;
2. Any unstable medical, psychiatric or neurological condition or medical contraindicating study participation;
3. Diagnosis of a psychotic or bipolar illness;
4. Acute suicidality as assessed by clinician;
5. Prescribed antipsychotics, benzodiazepines or other sedative medications, or other medications for the treatment of ADHD. If prescribed antidepressants, the participant must have been on a stable dose for more than 2 weeks at screening;
6. A history of heart disease or cardiac risk factors (e.g. arrhythmias);
7. Abnormal liver or thyroid function as indicated by clinically-significant findings on blood tests;
8. Pregnancy, breast feeding or, if sexually active and able to become pregnant, no effective contraception.
9. Intention to enter residential rehabilitation after treatment in the YSAS residential withdrawal facility.
Effect of Single Oral Dose BIRB 796 BS on Endotoxin-induced Inflammatory Responses in Healthy Human Subjects

Study to determine the effect of a single dose BIRB 796 BS on systemic inflammatory responses induced by endotoxin in healthy humans


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice and local legislation
* Age ≥18 and ≤ 35 years
* Broca ≥- 20 % and ≤ + 20%
* Able to communicate well with the investigator and to comply with study requirements

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and EKG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections within 14 days of enrolment
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial (\< 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\< 3 months prior to administration or during trial)
* Smoker (\> 10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation or loss \> 400 ml (\< 2 month prior to administration or during the trial)
* Excessive physical activities (\< 24 hours prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance
* History of any familial bleeding disorder
* Weight \> 150 kg
* Prior confirmed or suspected receipt of a monoclonal antibody