cyrilzakka/clinical-trials huggingface dataset:
Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment

Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.

We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.

Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for especially recurrent urinary tract infection. Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies.

We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical, placebo-controlled, double-blind trial at Odense University Hospital.

Claim to be investigated:

* The non-pathogenic bacterial strain (ABU) E.coli can overcome the most common pathogenic E.coli (UPEC) in humans.
* ABU can be used for preventive treatment in patients with recurrent urinary tract infections.

Clinical effect of preventive treatment (prophylactic treatment) with the non-pathogenic bacterial strain (ABU) in a selected group of patients with recurrent cystitis: A clinical, placebo-controlled, triple-blinded study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with recurrent cystitis including 2 times of rUTI within the last 6 months or 3 times in the last 12 months, where at least 2 cultures show the same bacteria.
* Normal investigation for lower urinary tract diseases (LUTD) including voiding diary, symptom scores, flexible cystoscopy, voiding diagram and test for residual urine.
* Failed previously treatments.
* Patients with native bladder with both spontaneous voiding, the need for clean intermittent catheter (CIC) or indwelling catheter.
* Patients with neurogenic and non-neurogenic bladder dysfunction.
* Patients with urostomy, kidney transplantation or another complicated genesis.
* Written consent.

Exclusion Criteria:

* Malignancy in the urinary tract, kidney-, ureteral- or bladder stones, age \< 18 years, pregnancy, breastfeeding. Patients in ongoing orally antibiotic treatment. Not able to speak or understand Danish.
Rapid Pancreatic and Ovarian Screening MR Imaging With Motion Corrected T1, T2, and Advanced Diffusion Weighted Imaging for Patients With BRCA Mutation Who Undergo Screening Breast MRI

The purpose of this study is to create a rapid scan of the pancreas and ovaries that could be used in the future to screen patients at risk for pancreatic or ovarian cancers. Currently, Magnetic Resonance Imaging (MRI) examinations of the pancreas and ovaries can last 30-45 minutes each. The investigators hope to create a rapid pancreatic and ovarian MRI evaluation that can be used as a screening tool that is completed in approximately 15 minutes. They will compare different tools available on modern MRI scanners to see which one reliably offers high quality images of the pancreas and ovaries.


Eligibility Criteria:
A minimum of 5 and maximum of 60 evaluable patients will be imaged on this study. Description of the subject inclusion and exclusion criteria are listed below.

Inclusion Criteria:

* BRCA 1 or 2 mutation
* Age ≥ 30
* Patients scheduled to undergo screening breast MRI with contrast

Exclusion Criteria:

* Patients with known breast cancer
* Patients unable to complete their scheduled breast MRI
* Patients with prior pancreatic surgery or cancers
* Patients with prior ovarian cancer or surgery involving removal of one or both ovaries
* Patients with prior abdominal or pelvic surgery
Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different associations of drugs in the treatment of patients diagnosed with tensional-type headache in accordance with International Headache Society guidelines.

* Open-label, non-inferiority, prospective, parallel group, intent to treat trial.
* Experiment duration: 56 days.
* 04 visits (days -7, 0, 28 and 56).
* Efficacy will be evaluated for 10 episodes of tension-type headache.
* Adverse events evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Tensional-type headache patients according to the International Headache Society criteria.
3. Corporal body indices \< 40.

Exclusion Criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy.
4. Use of immunosuppressive drugs.
5. Alterations of laboratory selective tests.
6. Drugs or alcohol abuse
Efficacy of Neoadjuvant Endocrine Therapy Compared to Chemotherapy in Breast Cancer Patients

Eligible patients will be divided into two groups; one will receive neoadjuvant endocrine therapy and the other one will receive neoadjuvant chemotherapy.

Patients will be randomized into two groups:

The first group (Arm A) will receive NCT; (Any approved Chemotherapy protocol by guidelines.

The second group(Arm B) will receive NET; GnRH analog Goserelin acetate 3.6 mg every 4 weeks with tamoxifen 20 mg daily for premenopausal patients or an aromatase inhibitor for postmenopausal patients.

* Before and during treatments (every 3 weeks for the NCT group, and every 4 weeks for the NET group), the clinical assessment will be performed for all patients.
* All patients will undergo breast magnetic resonance imaging (MRI) before the start of treatment, after 12 weeks (3 months) of treatment, and after the end of treatment before surgery.
* We will determine the objective tumor response with every measurement method and assess the response according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1.
* Treatment will be continued for 19-21 weeks before surgery for the chemotherapy group and 24 weeks for the endocrine therapy group.
* Ki-67 will be assessed using a sample of the core biopsy before treatment and a surgery specimen after treatment.
* Adverse events will be recorded at every patient visit and will be assessed according to the Common Terminology Criteria for Adverse Events Version 5.0.
* Surgery will be performed between the 24th and 26th week.
* Arm B Patients who will develop PD or SD after 6 months of treatment will be shifted to arm A.

The primary endpoint will be;

* The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements.
* A clinical response included either a complete response (CR), a partial response (PR), Progressive Disease (PD), or Stable Disease (SD) according to the (RECIST) version 1.1.

Secondary endpoints will be;

* The rate of pathological complete response (pCR).
* The rate of breast conservation surgery.
* Ki-67 changes.
* The length of time to maximum response within a treatment period.
* The Adverse events associated with each treatment arm.

Eligibility Criteria:
Inclusion Criteria:

* Any histological type of invasive breast cancer. All grades of breast cancer (I, II, III). ER-positive and/or PR-positive, HER2-negative breast cancer. ER and/or PR level of positivity ≥34 % (score 4 according to modified Allred score).

Clinical Stages: any T N1-3, or T2-4 any N, M0.

Exclusion Criteria:

* Hormone receptor positivity \< 34%. inflammatory breast cancer Metastatic breast cancer. Recurrent breast cancer. Other malignancy. Unfit patients for chemotherapy.
What Effect Does Intubation Have on Regional Lung Ventilation?

During any general anaesthetic which involves muscle relaxation artificial breathing is required. This is most commonly provided by pushing air under pressure (positive pressure ventilation) into the lungs via a tube in the airway (the tracheal tube). It has been observed for many years that with this form of breathing the distribution of gas within the lungs differs from that seen during 'natural' breathing: more of the gas goes to the upper parts of the lung than lower parts. This change in how the gas is distributed can lead to problems with how well oxygen is taken up by blood and carbon dioxide removed from the body. Previous work using mathematical modelling has found that the position of the tracheal tube might affect air distribution, but this has previously been difficult to study in 'real life', requiring the use of radioactive dyes and computerised tomography (CT). However a bedside test is now available which allows us to study these changes rapidly and non-invasively, using electrical impedance tomography (EIT). The EIT device is commercially available (PulmoVista®, Draeger UK) and is used in hospitals worldwide as a bedside monitor of lung ventilation.

This study aims to investigate the effect of tracheal intubation on regional ventilation of the lungs by comparing measurements before and after the patient is anaesthetised and intubated. The investgiators aim to show whether altered patterns of ventilation are caused by patients simply being asleep and ventilated, or whether these changes are due to the use of a tracheal tube itself. The exact effect of tube position will also be studied by measuring ventilation as the tube is deliberately advanced until it enters one of the lungs. This will give us information about the ideal position for a tube within the trachea to promote optimal ventilation patterns within the lungs


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to consent
2. undergoing a surgical procedure for which the anaesthetic technique includes muscle relaxation, intubation and ventilation for clinical care.

Exclusion Criteria:

1. Unwilling or unable to consent
2. co-existant respiratory disease associated with known abnormalities of ventilation/perfusion matching. This includes chronic obstructive pulmonary disease, asthma, or abnormalities of the chest wall or abdomen affecting ventilation e.g. morbid obesity
3. Requirement for double-lumen tracheal tube for clinical care
4. increased risk of regurgitation/aspiration e.g. pregnancy, symptomatic acid reflux, structural abnormalities of the gastro-intestinal tract (e.g. hiatus hernia)
Effects of SMART VS FIRE Training in Chronic Ankle Instability

The study was a randomized clinical trial with the sample size of 26. The study was conducted at Sports Club Sheikhupura. Subjects were enrolled according to eligibility criteria. Patients were divided into two groups, each with 13 patients. Group A received SMART training intervention and warm-up exercises, while group B received Foot intensive rehabilitation exercises (FIRE) and warm up exercises. The session was around 45 to 60 min on each patient with three sessions per week on alternate days. A total of Three weeks treatment regime was given to the patients and assessment of patient's strength (CAIT) and performance (FAAM) was done at the baseline, after the completion of treatment at three weeks and after six weeks to observe the long-term effects.

Ankle sprain is one of the most common sports injuries in physically active individuals and causes a high financial burden on the healthcare system. Seventy-four percent of patients with an acute ankle sprain suffered from residual symptoms lasting 29 months after the initial ankle sprain, such as pain, perceived instability, weakness and swelling. Lateral ankle sprains (LASs) are a common injury sustained by individuals who participate in recreational physical activities and sports. After LAS, a large proportion of individuals develop long-term symptoms, which contribute to the development of chronic ankle instability (CAI).The aim of this study to determine the comparative effects of SMART training intervention versus foot intensive rehabilitation (FIRE) on strength and performance in athletes with chronic ankle instability.

The study was a randomized clinical trial with the sample size of 26. The study was conducted at Sports Club Sheikhupura. Subjects was enrolled according to eligibility criteria. Patients was divided into two groups, each with 13 patients. Group A received SMART training intervention and warm-up exercises, while group B received Foot intensive rehabilitation exercises (FIRE) and warm up exercises. The session was around 45 to 60 min on each patient with three sessions per week on alternate days. A total of Three weeks treatment regime was given to the patients and assessment of patient's strength (CAIT) and performance (FAAM) was done at the baseline, after the completion of treatment at three weeks and after six weeks to observe the long-term effects.

Eligibility Criteria:
Inclusion Criteria:

* Athletes 18-45 years of age,
* 2 repeated episodes of giving way, feelings of instability
* Core training not less than 4 week.
* Chronic ankle instability more than 6 months.
* Repeated ankle sprain more than twice and patients with \<24 points based on CAIT.
* Athletes with single side ankle instability

Exclusion Criteria:

* Acute concomitant injuries of the ankle.
* Individuals who were able to return to pre-injury levels of activity
* Serious lower-extremity injuries of the last 6 months
* Lower-extremity surgery, and neurological diseases
* Simultaneous severe sprain of both ankle joints
NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants

The NIRS (near infrared spectroscopy) sensor will be applied to the abdomen of the study population. To ensure good skin contact the sensor will be placed underneath the diaper. If that should not provide enough measurement stability, additional fixation will be given by employing aforementioned flexible bandage routinely employed in neonatal care. Once good skin contact is ensured, the sensor will measure aStO2 (abdominal tissue oxygen saturation) for up to seventy-two hours. The presence of this sensor will not disturb daily clinical activities or medical treatment in any way. Should good skin contact be endangered by movements, clinical interactions or such, the sensor will be removed and re-attached to the infants' abdomen as a consequence.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with GA less than 35 0/7 weeks
* Start of measurement earliest at day of life 2 for preterm infants with GA \>=30 0/7 weeks and day of life 4 otherwise. The measurement will not start after day of life 5 for all GA.
* Signed Informed consent of the legal representative(s) is received after being informed. It is sufficient, if the consent form is signed by one legal representative, which is in majority of cases either the mother or the father.
* Clinically stable condition. The clinical stability is to be reconfirmed before the start and checked during the measurement.

Exclusion Criteria:

* Injured, hypersensitive or bruised skin present on the belly,
* Existence of clinical instability at any time during the investigation leads to exclusion, if ordered so by the physician entrusted with the investigation,
* Any medical care equipment, e.g. patches, dressing, umbilical arterial or venous catheter, blood supply, etc., prohibiting correct placement of the sensors,
* Dark skin pigmentation or dense hairiness on the belly absorbing too much light in the near infrared region to allow for NIRS,
* Congenital malformations,
* Severe metabolic disorders,
* Early onset sepsis,
* Inability of legal representatives to understand the purpose of the clinical trial due to language barriers such as the insufficient ability to understand the spoken or written language,
* The treatment of newborn jaundice with light during the intended measurement time,
* Previous enrolment into the current study,
* Family members, employees and other dependent persons of the investigator,
* Participation in another study with investigational drug/device within the preceding days and during the present study which may influence aStO2.
The Effect of Direct Referral for Fast CT Scan in Early Lung Cancer Detection in General Practice

Background: The primary investigation of lung cancer (LC) is for 85% of the cases conducted through General Practice, sadly it tends to take a relatively long time from first time the patient is seen by their General Practitioner and until they are diagnosed. LC symptoms are common, but usual because of benign diseases. Only 33% of LC patients presenting with alarm symptoms. On average a General Practitioner in Denmark sees only one patient with newly diagnosed lung cancer a year and the doctor will therefore get the clinical experience that when they refer a patient, test often come out negative and they therefore fail to refer and delay will increase - with a poorer prognosis as a result. Centrally in the diagnosis is conventional chest X-ray, which unfortunately is inefficient in many cases, while CT scanning has proven effective even for small tumors.

Hypothesis and aims: The project has three main hypotheses to be tested 1) the GP's use of cancer fast-track and detection of suspected lung cancer can be optimized in relation to interpretation of symptoms and subsequent referral practices and radiological investigation. 2) General Practitioners with special training can change the referral routines and 3) direct access to fast CT scanning leads to earlier diagnosis of lung cancer.

Methods: The first part of the study is a register-based study of lung cancer patients' road to diagnosis, based on a database of newly diagnosed cancer patients in a year. Second part of the study is a clinical, randomized study of the effect of referral directly to fast chest CT scan. Primary endpoint is delay, secondary endpoints are referral pattern (use of fast-track packet), primary use of CT and 1-year mortality. Furthermore side effects, including patient groups with increased delay.

The study will contribute new knowledge to the way GP's interpret symptoms, the way they refer their patients when they suspect cancer, their use of diagnostic imaging and cancer fast-track pathways. It will then provide a unique opportunity to create the necessary knowledge about the effects of direct referral to fast CT scan and it might be a decision aid whether to open for direct CT scan in General Practice for a group of patients.


Eligibility Criteria:
Inclusion Criteria:

* all practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital.

Exclusion Criteria:

* former lung cancer patients.
Enhanced Vascular Function Following Intake of Feruloyl Esterase-processed High Fibre Bread.

This study evaluates the impact of a high phenolic acid intake from wholegrain wheat bread on human vascular function and plasma phenolic acid concentrations in healthy adults. All participants received a high fibre flatbread with enzymatically released free FA (14.22 mg), an equivalent standard high fibre bread (2.34 mg), or a white bread control (0.48 mg).

Clinical trial data have indicated an association between wholegrain consumption and a reduction in surrogate markers of cardiovascular disease. A number of components of wheat have been suggested to contribute to the cardiovascular health benefits associated with wholegrain consumption, most notably the fiber component. However, phenolic compounds that are bound to arabinoxylan fibre, particularly the hydroxycinnamate ferulic acid, may also contribute, in part, to vascular health effects. These phenolics may be more active when released enzymatically from the fiber prior to ingestion.

The aim of the present study was therefore to determine whether the intake of high fibre bread containing higher free ferulic acid levels (enzymatically released during processing) enhances human endothelium-dependent vascular function to a greater extent than that of traditional wholegrain bread and/or a white bread control.

Eligibility Criteria:
Inclusion Criteria:

1) fasting lipids in the upper half of the normal range (triacylglycerol 0.8-3.2 mmol/l and total cholesterol 6.0-8.0 mmol/l); 2) BMI 25-32 kg/m2; 3) non-smoker; 4) not diabetic (diagnosed or fasting glucose \< 7 mmol/l) or suffer from endocrine disorders; 5) hemoglobin and liver enzymes levels within the normal range \[Alanine Transaminase (ALT): 0-55 IU/L; Alkaline Phosphatase (ALP): 38-126 U/L; Aspartate Transaminase (AST): 0-45 IU/L; Gamma Glutamyl Transferase (GGT): 12-58 IU/L\]); 6) not having suffered a myocardial infarction/stroke in the past 12 months; 7) not suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis; 8) not on drug treatment for hyperlipidemia, hypertension, inflammation or hyper-coagulation; 9) not taking any fish oil, fatty acid or vitamin and mineral supplements; 10) no history of alcohol misuse; 11) not planning, or on a weight reduction regime; 12) not having taken antibiotics in the 6 months prior to the study; and 13) being able to consume the study interventions.

Exclusion Criteria:

* Gluten sensitive
Prevalence of DVT or PE in Patients Infected With COVID-19 Admitted to Hospital

The main objectives are:

* To establish the prevalence of deep venous thrombosis through ultrasonography in Patients infected with COVID-19 admitted to hospital.
* To identify patients with higher risk of deep venous thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients infected with COVID-19.
* Admission to hospital.

Exclusion Criteria:

* Patients treated with ECMO (Extracorporeal membrane oxygenation).