cyrilzakka/clinical-trials huggingface dataset:
Surgical Field Bacterial Contamination in Primary Total Hip (THA) and Knee (TKA) Arthroplasty

In Denmark, approximately 13,000 operations are carried out every year. Prosthetic infection is a very serious condition and despite extensive prophylactic measures, prosthetic infections appear in 1-2 percent of the operated patients.

It is difficult to diagnose prosthetic infection with the techniques applied so far and incorrect diagnosis might imply unnecessary reoperations as well as unnoticed infections might lead to prolonged pain and invalidity.

The purpose of this study is to examine the value of these three techniques applied as a supplement to the existing technology and on this basis to prepare an algorithm for the examination of joint prosthesis infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been through an alloplastic operation in hip og knee.

Exclusion Criteria:

* Patients with cancer or a bilateral disease
* Former patients who have been through an operation with implants in hip or knee.
* Patients who might be infected in the joint due to operation in hip or knee.
* Lack of informed consent or inability to read/understand Danish
Epidemiological Analysis of Ambulant Patients in a COVID-19 Outpatient Clinic

There is insufficient knowledge about transmission routes and the effectiveness of general protective measures to prevent infection, such as the closure of schools or the wearing of mouthguards. This will be illustrated using the example of the COVID-19 outpatient clinic in Solingen and the positive COVID-19 tests registered there.

Another aspect we would like to address in this study is the number of COVID-19 tests performed against the background of political events or dramatic accumulations of COVID-19 cases in other parts of Germany or Europe. Do speeches by political leaders about the COVID-19 situation or a very strong regional spread of infection elsewhere have an impact on the frequency with which people react sensitively to suspicious symptoms and undergo testing for infection?

The aim of this study is to analyse the frequency of positive COVID-19 tests and the infection chains in Solingen since February 2020:

1. a prospective survey (telephone contact) of the positively tested patients is done to analyze the social environment and thus provide information about possible transmission routes. Is transmission mainly within the family through visits from relatives or rather through large extra-familial gatherings, such as in the case of the open huts and après-ski bars in Ischgl? Are there age- or gender-specific transmission routes (personal habits, travel)?
2. analysis of the number of positive tests in connection with general measures to contain the infection (closure of schools, mouthguards obligation, etc.)
3. characterization of positively tested patients based on anthropometric data and medical history.
4. the effect of political events and developments in world affairs on the daily visitor frequency in the COVID-19 outpatient clinic will be retrospectively investigated. Is there an accumulation of tests after speeches by politicians or public figures (Angela Merkel, Armin Laschet, Queen Elizabeth II, etc.) or after dramatic infection numbers in other parts of Germany or Europe (Heinsberg, Ischgl, etc.)?

Eligibility Criteria:
Inclusion Criteria:

* positive COVID-19 test result

Exclusion Criteria:

* negative COVID-19 test result
* Any medical, psychological or other condition which restricts the ability to provide information or consent of the patient for voluntary participation in this examination
Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique

The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR with 2D PC flow measurement.

Measurement of blood flow in vessels leading to or arising from the heart is one of the key features of Cardiac Magnetic Resonance (CMR). With standard 2D phase contrast (PC) flow measurements, each vessel is measured separately at a predefined location. Planning and scanning can be time consuming while the patient is inside the scanner. In addition, when the scan time is long, the hemodynamics may be assessed at different physiological states. In contrast to a 2D PC acquisition 4D PC captures all the information about blood flow velocities within a 3D anatomical volume. Once this predefined volume has been acquired, the flow within the heart and vessels of interest can be measured at any desired location offline, i.e. after the patient has left the scanner. This is especially advantageous in cases where multiple 2D PC MRI scans are needed such as in congenital heart disease (CHD). In addition to standard measurements, 4D PC provides flow patterns, which might change our current understanding of pathologic flow conditions. Although there has been increasing interest in this new technique, only a few papers have proved its accuracy in adult population. The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR with 2D PC flow measurement.

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients under 18 years of age undergoing CMR with 2D PC flow measurements as a clinically indicated component of the examination at The Hospital for Sick Children, Toronto, ON.
* Ability to undergo an MRI examination without anesthesia or sedation.
* Ability to undergo an MRI examination using 'Feed-and-Sleep' technique39

Exclusion Criteria:

* Refusal of consent / assent by parent / legal guardian / patient
* General contraindications for an MRI examination such as non-MRI compatible metallic implants, claustrophobia.
* Patients who require anaesthesia or sedation for MRI
Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss

Online visit and online counseling via telemedicine technology is a new service for obese people who wish to lose weight but because of their active lifestyle and time limitation cannot come to clinic. The purpose of this study was to examine the efficacy this technology-based intervention on weight loss in obese and overweight female adults.


Eligibility Criteria:
Inclusion Criteria:

* Must be female
* Must be 18-45 years of age.
* Must have Body mass index (BMI) between 27-35 kg/ m².
* Must be able to have moderate exercise.
* Must be interested to have weight loss.
* Have access to the internet via broad- band ADSL or Mobile 4G

Exclusion Criteria:

* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medications that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A

This randomized trial aims to compare the euploid rate of blastocysts between PPOS (progestin-primed ovarian stimulation) and GnRH (gonadotrophin releasing hormone) antagonist protocols in patients with PCOS (polycystic ovary syndrome) undergoing PGT-A (preimplantation genetic testing for aneuploidy). Infertile women with PCOS will be recruited for study after explanation and counseling if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups:

Antagonist group: Women will receive antagonist once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

PPOS group: Women will receive oral MPA (medroxyprogesterone acetate)10mg qd from Day 3 till the day of ovulation trigger.

The primary outcome is the euploidy rate of blastocysts.


Eligibility Criteria:
Inclusion Criteria:

* Women age between 20 and 37 years.
* Women diagnosed with PCOS according to the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with the presence of ≥12 antral follicles (≤9 mm) and/or ovarian volume \>10 mL on transvaginal ultrasonographic scanning, and/or clinical/ biochemical hyperandrogenism. Other causes of hyperandrogenism and ovulation dysfunction-including tumours, congenital adrenal hyperplasia, hyperprolactinaemia and thyroid dysfunction-were excluded

Exclusion Criteria:

* Presence of a functional ovarian cyst with E2\>100 pg/mL
* Endometriosis grade 3 or higher
* Repeated implantation failure (\>=4 embryos replaced or \>=2 blastocysts replaced without success)
* Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)
* Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease;
* Recipient of oocyte donation
* Presence of hydrosalpinx which is not surgically treated
Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19

SINGLE CENTER PHASE III INTERVENTIONAL RANDOMIZED CONTROLLED TRIAL comparing efficacy and safety of enoxaparin at prophylactic dose (standard treatment) and enoxaparin at therapeutic dose (OFF-LABEL treatment) in 300 COVID-19 infected patients with moderate-severe respiratory failure (PaO2/FiO2\<250) and/or increased D-dimer levels enrolled in different Units (Infectious disease, Internal Medicine, Emergency Medicine, Pneumology) of Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco (ASST-FBF-SACCO).

Patients with COVID-19 are at high risk of developing a venous thromboembolism (VTE) and it is essential that effective thromboprophylaxis with parenteral drugs (LMWH, UFH) is considered for all patients admitted to hospital especially in case of severe pneumonia.

The aim of the study is the evaluation of efficacy and safety of enoxaparin at prophylactic dose (standard treatment) as compared to enoxaparin at therapeutic dose (OFF-LABEL treatment) in 300 COVID-19 infected patients with moderate-severe respiratory failure (PaO2/FiO2\<250) and/or increased D-dimer levels.

After the admission to different Units (Infectious disease, Internal Medicine, Emergency Medicine, Pneumology), enoxaparin at prophylactic dose (standard of care) will be prescribed to all patients.

The randomization of the single patient will be made when the the inclusion criteria (PaO2/FiO2 \<250 and/or D-dimer \>2000 ng/) will be satisfied. Patients with increased bleeding risk will be excluded (exclusion criteria).

Patients will be divided into two arms:

* arm A: enoxaparin at prophylactic dose (standard 4.000 IU; 6000 UI if body weight\>100 kg)
* arm B: enoxaparin at therapeutic dose (70 U/Kg b.i.d. every 12 h)

In both arms, enoxaparin treatment will be monitored clinically and with first and second line laboratory tests Venous compression ultrasound (CUS) will be performed at admission and after 7 days in case of a first negative exam and elevated D-Dimer levels, to rule out deep vein thrombosis.

Enoxaparin at prophylactic dose (4000 IU) will be maintained in all patients for 4 weeks after discharge.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 related pneumonia with moderate-severe respiratory failure (PaO2/FiO2\<250) and/or markedly increased D-dimer level (\>2000 ng/mL)
* Signed informed consent

Exclusion Criteria:

* age \< 18 and \> 80 yrs
* history of bleeding (peptic ulcer, esophageal varices, cerebral aneurysm, cancer at high risk of bleeding, cirrhosis, hemorrhagic stroke \< 1 year)
* thrombocytopenia (\<100 x109/L)
* anemia (Hb \< 8 g/dl)
* coagulation abnormalities (PT e/o aPTT \> 1.5; fibrinogen \< 150 mg/dl)
* consumption coagulopathy (ISTH criteria) \[15, 16\]
* deep vein thrombosis or pulmonary embolism
* dual antiplatelet therapy
* ongoing anticoagulant therapy
* allergic reaction to LMWH
* previous heparin-induced thrombocytopenia
* major surgery \< 1 month; neurosurgery \<3 months; eye surgery \<3 months
* pregnancy
* arterial hypertension (SBPS\>160 mm Hg; DBP\>100 mm Hg)
* renal failure (creatinine clearance 30 ml/min)
* ICU admission or endotracheal intubation
A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints

It is well recognized that physical activity/exercise is an effective intervention to improve sleep, reduce pain and improve function in a variety of pain conditions. Traditional interventions to increase physical activity are challenging in older adults due to extensive staffing requirements and low adherence. The investigators plan to conduct a pilot trial in a cohort of older adults (without dementia) with both chronic musculoskeletal pain and nocturnal sleep complaints to test the effectiveness of a 12-week personalized behavioral intervention (compared to a control group) embedded within a smartwatch application in older adults. 27 cognitively intact elders were enrolled and randomly allocated to intervention or control group. Participants in the intervention arm received a 2-hour in person education session, and personalized, circadian-based activity guidelines, with real time physical activity self-monitoring, interactive prompts, biweekly phone consultation with the research team, and financial incentives for achieving weekly physical activity goal. The control group received general education on physical activity in older adults and continue routine daily activity for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Intact cognition
* Poor sleep quality
* Self-reported presence of pain
* Capacity for mild to moderate physical activity.

Exclusion Criteria:

* Non-ambulatory or have severely impaired mobility,
* Visual or hearing impairment that interfered with assessments, and
* An acute or a terminal illness
* Neuropathic pain
Role of Endothelin- and Nitric Oxide-system in the Regulation of Optic Nerve Head Blood Flow During Changes in Ocular Perfusion Pressure

Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. The existence of an effective autoregulation in the optic nerve circulation has been shown in animals and humans. The exact mechanism behind this autoregulation is still unknown. The motive for the investigation of optic nerve head (ONH) blood flow autoregulation is to enhance the understanding of pathologic eye conditions associated with ocular vascular disorders. To clarify the regulatory mechanisms of ONH microcirculation is of critical importance to understand the pathophysiology of glaucoma because there is evidence that glaucoma is associated with optic nerve head ischemia. Several studies indicate that a disturbed autoregulation might contribute to glaucomatous optic neuropathy. Previous findings suggest endothelial dysfunction in glaucomatous optic neuropathy, in particular alterations in endothelin- and nitric oxide- system, which both play an important role in local regulation of vascular tone.

In the present study, changes in ocular perfusion pressure will be performed during administration of drugs, which may potentially alter the pressure-flow relationship. These drugs include endothelin-1 and the nitric oxide synthase inhibitor NG-monomethyl-L-arginine (L-NMMA).


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 18 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy \< 1 Dpt

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of systemic or pulmonary hypertension, or other cardiac or pulmonary diseases
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
Impact of Time Intervals of Preparation on Quality and Tolerance of the Bowel Preparation

The purpose of this study is to determine optimal time intervals for preparation before colonoscopy using different formulas.

Different formulas are used for bowel preparation before colonoscopy. Present guidelines are based on conventional polyethylene glycol. Their validity for other preparations were not evaluated. Relationship between length of preparation, interval to colonoscopy and bowel preparation quality, tolerance are assessed.

Eligibility Criteria:
Inclusion Criteria:

- subjects referred to diagnostic or therapeutic colonoscopy.

Exclusion Criteria:

* ileus
* known or suspected bowel obstruction
* active bowel inflammation
* pregnancy
* any presence of serious medical conditions ( esp. cardiac, renal, liver diseases)
* history of prior colonic or rectal surgery
* inability to obtain valid data from
A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects (MK-0000-159)(COMPLETED)

This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral or better than placebo in lowering ambient glucose levels during a graded glucose infusion (GGI) and that a single dose of OXM will lead to a statistically significant increase in the sum of the plasma βOHB + AcAc levels compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests
* Subject has a Body Mass Index of ≥27 kg/m\^2 and ≤35 kg/m\^2 and weighs ≥70 kg at the prestudy (screening) visit
* Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
* Subject is willing to avoid strenuous physical activity (weight lifting, running, bicycling, etc.) for the duration of the study

Exclusion Criteria:

* Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit
* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Subject has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, or abdominal pain
* Subject has a history of hypertension requiring treatment
* Subject has a history of cancer
* Subject has history of diabetes, or family history of diabetes mellitus
* Subject has a history of hypersensitivity to OXM or hemaccel
RE-BLEED: A Digital Platform for Identifying Bleeding Patients - a Feasibility Study

The RE-BLEED feasibility study aims to develop and test a real-time digital platform, whereby bleeding patients in-hospital can be identified and approached for their consent to participate in future research studies.

Bleeding affects up to 40% of all trauma patients, up to 30% of all surgery patients and is one of the commonest causes of death for women giving birth. The presentation and features of bleeding are different between patients - in some cases bleeding is very obvious to recognise, but in other cases bleeding is more "hidden", for example in the stomach. Bleeding must be stopped promptly to prevent severe illness or death.

Many studies have shown differences in how patients who bleed are treated. There is also variation in how individual patients respond to the same treatment, with some patients doing better than others. Understanding how variation in practice and patient characteristics affect outcomes will help researchers and clinicians design and test improvements in care.

Patients in hospital have regular tests that measure levels of the different types of cells in their blood and its ability to clot. For example, a drop in red blood cells can indicate that patients have suffered bleeding. More advanced blood tests are available that can provide more detailed information on why patients are bleeding and what treatments might be most effective.

This study aims to develop a real-time, hospital-wide digital system to identify patients in hospital who have suffered from bleeding and test whether this system could be used in the future to potentially identify patients to recruit into trials of new treatments or blood tests.

To do this, the investigators will:

* Assemble a panel of experts to identify criteria (for example, specific blood test results and drug prescriptions) that could indicate a patient has suffered from bleeding
* Use historical electronic patient records to test how well these criteria identify patients who have received treatments for bleeding (blood transfusion)
* Develop and refine a web-based digital system where the most useful criteria can be applied in "real-time" to identify bleeding patients
* Test how well the digital platform identifies bleeding patients
* Test whether a significant number of patients identified by the digital platform are willing to allow their routine blood samples tested for blood clotting and endothelial factors.

Eligibility Criteria:
Inclusion Criteria:

Retrospective cohort:

* Adults aged between 16 and 110
* Admitted to hospital (Oxford University Hospitals NHS Foundation Trust) or attended the emergency department between 1/3/2011 to 31/8/2023

Prospective cohort:

* Adults aged between 16 and 110
* Admitted to hospital (Oxford University Hospitals NHS Foundation Trust) or attended the emergency department between 1/10/2021 to 31/8/2023

Exclusion Criteria:

Both retrospective and prospective cohorts:

* Patients who inform us directly that they do not wish their records used in this research study
* Patients who have completed the NHS Opt-out.
Ganglion Cell Thickness in Enuresis Nocturna

The precise role of the intrinsic circadian regulatory mechanism behind the pathogenesis of enuresis is not fully understood, but in theory, circadian rhythm irregularity may be the primary pathogenic mechanism not only for urinary outflow mechanisms but also for nocturnal bladder function. The proximity between SCN centers that control AVP release, sleep/arousal, voiding, and baroreregulation may provide the basis for circadian rhythm disturbance in one or more of these biological functions. Ganglion cells containing melanopsin pigment in the retina transmit the information they receive from the outside world about the light-dark state to the SCN via the retinohypothalamic pathway. Peripapillary retinal nerve fiber layer (RNFL) thickness, optic nerve head and macula are examined most frequently for the diagnosis of glaucoma and the detection of progression with optical coherence tomography (OCT). If differences in ganglion cell thickness can be detected using OCT in these children, a new avenue in Enuresis Nocturna may be opened.


Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 5-18
* have enuresis

Exclusion Criteria:

* have any eye conditions