cyrilzakka/clinical-trials huggingface dataset:
Sensitivity of Extended Cultures in Diagnosing Urinary Tract Infections

There is some evidence to suggest standard urine cultures may not be adequate in identifying patients with low grade urinary tract infections. Therefore, there are patients with symptoms of frequency and urgency, being misdiagnosed with overactive bladder due to negative urine cultures. If this is true, could extended cultures be used to identify the false negative patients?

In 2014, Hilt, Evann et al published a study called "Urine is not sterile," in which it was found via PCR and extended urine cultures, there is a microbiome that exists within the urinary bladder. In this study, 92% of the bacteria failed to be identified by a standard urine culture but 80% were identified with extended urine cultures. In further explorations of the significance of this microbiome, Pearce, Meghan et al. found that the female bladder consists of increased abundance of bacteria in patients with UUI; including Gardnerella and Lactobacilus gasseri. Then in 2015, a study by Thomas-White, Krystal et al. found that patients with urge urinary incontinence (UUI) who responded to treatment with Solifenacin had fewer and less diverse communities of bacteria when evaluated by PCR and extended urine cultures.

The clinical significance of the bacteria identified is not well understood. However, these studies show that the presence of bacteria is being missed by standard cultures. Dune et al. found that of patients with UTI symptoms, 27.5% were standard culture negative but extended quantitative urine culture positive. This demonstrates that practitioners may be overlooking urinary tract infections in patients with frequency and urgency. Therefore, if bacteria within the urine can be detected with extended cultures, can this technique be used to improve detection and treatment of urinary infections in patients with symptoms of frequency and urgency?

The hypotheses states that extended urine cultures are more sensitive in the identification of urinary tract infections in patients with symptoms of urgency and frequency. The secondary hypothesis is that treatment of the uropathogen identified on extended urine cultures will improve patient symptoms.

Eligibility Criteria:
Inclusion Criteria:

* 18 y/o-70 y/o
* Able to consent
* Urgency /Frequency
* Urge incontinence
* PUF score ≤ 4
* Bother questionnaire #2 or #3 answered either "a moderate amount" or "a lot"

Exclusion Criteria:

* Pregnant
* Pelvic radiation
* Chronic pelvic pain
* Urinary retention
* Greater than Stage 2 prolapse
* Renal calculi
* Recurrent UTI (2 in 6 months)
* Immunosuppressed
* Neurologic disorder
* No antibiotics in the past 4 weeks
Total Versus Subtotal Abdominal Hysterectomy

319 Women undergoing hysterectomy for benign (not cancer) indications were randomly allocated to 2 types of surgery (Total (TAH) and Subtotal (SAH)) abdominal hysterectomy 15 years ago. They were followed by questionnaire at time of surgery and up to 5 years (not yet published) after the surgery and evaluated regarding following outcomes: Urinary incontinence, pain, bowel problems, per and postoperative complications, sexuality, quality of life, pelvic organ prolapse and vaginal bleeding. Now the investigators are conducting a 15 year follow up with the same out-come measures but also including physical examinations regarding Urinary incontinence, voiding difficulties, pelvic organ prolapse and problems with the cervix. The investigators' hypothesis is that several of the out-come measures will be present in more cases than earlier due to age and menopausal changes. The investigators expect more urinary incontinence in the subtotal group as this was seen at earlier follow ups. The investigators expect to find more women with pelvic organ prolapse with the physical examination than by questionnaire alone, possibly with a higher incidence in the subtotal group.

The study included women who were offered a hysterectomy for benign uterine disease such as: metrorrhagia, menorrhagia, fibroids, endometriosis,and pelvic pain. Women in need of hysterectomy for malignant disease or because of prolapse of the uterus were not included. They were followed up by a questionnaire covering all outcome measures as described above. Background information was registered in a second questionnaire prior to surgery. All gynaecological departments in Denmark were invited to join the trial. 11 departments contributed randomized patients to the trial.

the results up to 1 year after surgery have been published, links can be found in the citation list. The results from the 5 year follow up have not yet been published.

The questionnaire used in this trial consists of the validated SF-36 (Short Form 36) quality of life questionnaire as well as a thorough questionnaire regarding the outcome measures described elsewhere. The entire questionnaire was validated prior to the beginning of the trial.

A second questionnaire has been added in the 15 year follow up: PFDI-20(Pelvic Floor Distress Inventory 20). The investigators included this, as it is more thorough regarding pelvic organ prolapse and in particular a "bother" measure than the original questionnaire.

The 20 min. pad-weighing test has been tested against the 1 hour gold-standard used by the ICS (International Continence Society) and has been found to give comparable results.

Eligibility Criteria:
Inclusion Criteria:

-Women undergoing abdominal hysterectomy for benign uterine disease at a gynaecological department in Denmark (15 years ago)

Exclusion Criteria:

* malignant disease
* mental disease
* diabetes
* neurological disease
* not able to read and write Danish
* pelvic organ prolapse as the reason for hysterectomy
* prior surgery for urinary incontinence
Serum Markers in Preeclamptic Women

Could possible markers in serum obtained in the first trimester predict the human-pregnancy specific disorder pre-eclampsia?


Eligibility Criteria:
Inclusion Criteria:

* previous healthy

Exclusion Criteria:

* Previous inflammatory diseases
Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room

Package of mentholated measures for the relief of thirst in the anesthesia recovery room: Randomized clinical trial

Perioperative thirst is intense and has a high incidence. There is evidence that strategies using cold and menthol could be viable alternatives to reduce thirst and the discomforts arising from it. For that reason, this study evaluated the efficacy of a mentholated package of measures (lip moisturizer and ice popsicle) compared to a non-mentholated package of measures in alleviating thirst in the anesthesia recovery room.

Eligibility Criteria:
Inclusion Criteria:

* Possess aged between eighteen and sixty-five years
* To be fasting for more than four hours
* Verbalizing headquarters spontaneously or after questioning, with greater than or equal to three intensity in numerical verbal scale
* Receive opioids or anticholinergic during surgery duration of greater than one hour anesthesia
* Being in anesthetic recovery in anesthesia recovery room
* Have been approved in the evaluation Headquarter Insurance Management Protocol which was applied to both groups
* Accept participate and sign the consent form Clarified

Exclusion Criteria:

* Being allergic to menthol
* Have continuity of injury in the oral mucosa
* Having suspended the anesthetic-surgical procedure after acceptance of participation
* Receive High operating room directly to another healthcare sector than the anesthetic recovery room, and intensive care unit or hospital unit
Healing of Rectal Anastomosis Sealed With a Concentrate Derived From the Patient's Blood, After Rectal Cancer Surgery

Rectal cancer is one of the most frequent cancer diseases, with more than 1500 new cases per year in Denmark. Fortunately, if the tumor is discovered early, surgeons can remove the part of the intestine that is afflicted, and they can often sew the intestine-ends back together, forming what is known as an anastomosis. However, in 10-15% of cases, this anastomosis doesn't heal completely, leading to anastomotic leakage. This is a serious complication, with detrimental effects for the individual patient. Previous measures to avoid this complication, have proven unsuccessful.

Obsidian is a mixture derived from the patients' own blood, that contains components of blood normally responsible for stopping bleeding and kickstarting the healing process. It is already used in other clinical settings and preliminary, yet unpublished, results from a pilot study have shown its promise in decreasing the risk of anastomotic leakage in rectal anastomosis. However, its use has not been examined when performing surgery for rectal cancer with minimally invasive technique, which is today's standard.

The main clinical hypothesis of this feasibility study is that it is possible for colorectal surgeons to apply Obsidian successfully on the anastomotic area with minimal invasive technique, as a supplement during rectal cancer resection with anastomosis.

This study will be conducted at the Department of Surgery, Aarhus University Hospital. 50 patients will be included, who will undergo minimally invasive rectal cancer surgery with an anastomosis. Right after the onset of anaesthesia, 120 ml of blood will be collected from the patient and will be processed, making a 5-6 ml Obsidian concentrate. When the tumor-bearing part of the rectum has been removed, Obsidian will be applied, according to a pre-specified protocol.

If the application is deemed successful (based on predefined assessment criteria) in at least 90% of our included patients, then this study will serve as a stepping stone for a bigger study, the aim of which will be to assess if this method can indeed bring down the rate of anastomotic leakage in such patients.


Eligibility Criteria:
Inclusion Criteria:

* Primary rectal cancer (adenocarcinoma) with the lower boarder within 15 cm from the anal verge assessed by rigid proctoscopy
* Clinical UICC stage I-III at time of rectal cancer diagnosis
* Deemed suitable for intended curative rectal cancer resection at MDT either by total mesorectal excision (TME) or partial mesorectal excision (PME)
* Scheduled for elective, minimal invasive surgery
* ECOG performance status 0-2
* Age at least 18 years
* Written and orally informed consent

Exclusion Criteria:

* Distant metastatic disease
* Locally advanced rectal cancer requiring extended resection
* Open surgery
* Benign lesions of the rectum
* Inflammatory bowel disease
* Another malignant disease within previous 2 years
* Inability and unwillingness to give informed consent
* Pregnant (positive pregnancy test) or breast feeding women
Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)

To define the pharmacokinetic characteristics of Nystatin LF IV (intravenous) in human subjects with AIDS-related complex (ARC) after administration of a single IV dose at each of 4 dose levels.


Eligibility Criteria:
Inclusion Criteria

Patients must have the following:

* Positive HIV antibody test.
* Diagnosis of AIDS-related complex (ARC).
* CD4+ cell count between 100 and 300 cells/mm3.
* Estimated life expectancy of at least 6 months.
* Normal neurological status.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Active opportunistic infection requiring ongoing therapy except patients being treated topically for oral thrush.

Patients with the following are excluded:

* Active opportunistic infection.
* Known hypersensitivity to polyene antibiotics.
* Unwillingness to sign an informed consent or to be in compliance of protocol requirements.

Prior Medication:

Excluded within 72 hours of study entry:

* Biologic response modifier agents.
* Corticosteroids.
* Cytotoxic chemotherapeutic agents.
* Potential nephrotoxins.
* Potential neutropenic agents.
* Rifampin or rifampin derivatives.
* Systemic anti-infectives.
* Phenytoin or barbiturates (inducers of microsomal enzymes).
* All systemic medications.

Prior Treatment:

Excluded within 72 hours prior to study entry:

* Radiation therapy.

Active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks prior to start of study.
Effect of Local Pamidronate in Preventing Bone Loss After Total Hip Arthroplasty

The aims of the study are to determine whether pamidronate applied locally causes diminished periprosthetic bone loss and decreased rate of bone turnover compared to patients receiving placebo after cemented total hip arthroplasty (THA). The study design will be prospective, randomized, and blind. Periprosthetic bone mineral density (BMD) will be measured with dual energy X-ray absorptiometry (DXA) at the total periprosthetic area as well as at seven Gruen zones or regions of interest. DXA scans will be performed at one week (baseline), three months, and six months postoperatively. Mean values of biochemical markers of bone turnover, BMD, and baseline-normalized BMD values will be compared between the bisphosphonate and placebo groups at each time point. For all temporal measurements including bone markers, BMD and normalized BMD, mean values will be compared across each time point within a given group.


Eligibility Criteria:
Inclusion Criteria:

* patients with hip arthritis scheduled for total cemented hip arthroplasty

Exclusion Criteria:

* pregnancy
* endoprosthesis on contralateral hip
Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange

Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon.

All of the procedures will be recorded and stored as digital files.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colonoscopy performed by the participating endoscopists

Exclusion Criteria:

* obstructive lesions of the colon known before colonoscopy
* massive ascites
* past history of partial colectomy
* refusal to provide written informed consent
SP16 Inflammatory Response Inhibition Trial

This study will evaluate the potential benefit of blocking inflammation during a heart attack using an investigational anti-inflammatory medicine called SP16. The study will enroll 10 patients and all 10 patients will receive a standard dose of SP16.

The main hypothesis of this study is that a single subcutaneous administration of SP16 0.2 mg/kg is safe and well tolerated in patients with ST segment elevation myocardial infarction (STEMI) and associated with a reduction in the acute inflammatory response to STEMI, as measured as area-under-the-curve (AUC) for C reactive protein (CRP), the preferred inflammatory marker for cardiovascular risk prognostication.

SP16 will be administered subcutaneously as this route has greater ease of administration than intravenous injection. A single dose administration has been selected based upon pre-clinical data and expected clinical use of SP16.

Eligibility Criteria:
In order to be eligible for this study, patients must meet all the 3 criteria:

1. Presentation to the hospital with acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and electrocardiogram (ECG) evidence of ST segment elevation (\>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new (for intermittent pain lasting more than 12 hours, the time from the when the pain became severe and constant);
2. Coronary intervention planned and/or completed within 12 hours of symptom onset, and enrollment in the study within 6 hours of angiogram (max 18 hours from symptom onset)
3. Age\>21 years

In order to be eligible for this study, patients must meet none of the Exclusion criteria.

* Inability to give informed consent
* Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump)
* Pregnancy or breastfeeding
* Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)
* Preexisting severe left ventricular dysfunction (LVEF\<20%)
* Preexisting severe valvular heart disease
* Known active infections (acute or chronic)
* Recent (\<14 days) or active use of immunosuppressive drugs (including but not limited to high-dose corticosteroids \[\>1 mg/kg of prednisone equivalent\], tumor necrosis factor-alpha blockers, cyclosporine) not including non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids used for intravenous (IV) dye allergy only)
* Recent (\<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only)
* Known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
* Known active malignancy of any type, or prior diagnosis in the past 10 years
* Neutropenia (absolute neutrophil count\<1,800/mm3 \[or \<1,000/mm3 in African American patients\])
* Severe impairment in renal function (estimated glomerular filtration rate \<30 ml/kg\*min)
* Anticipated need for cardiac or major surgery
* Known Allergy to SP16
Fluid Status and T1-mapping by CMR

It is unclear to what extent systemic fluid overload has an impact on T1-mapping results by cardiovascular mangetic resonance imaging.

In this study, patients will undergo body composition monitoring assessing systemic fluid overload and T1-mapping using MOLLI by cardiovacular magnetic resonance imaging in order to investigate a possible association with each other.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* patient undergoing cardiovascular magnetic resonance imaging

Exclusion Criteria:

* Unwillingness to participate
* pregnancy
Administration of High-Dose Intravenous Proton Pump Inhibitor for Upper Gastrointestinal Bleeding Prior to Endoscopy

To evaluate if intravenous PPI infusion, when administered prior to endoscopy, hastens resolution of bleeding stigmata and thereby facilitates endoscopic examinations and reduces the need for endoscopic treatment. Clot stabilization may itself sustain control of bleeding before endoscopy. These may translate into improved patients'outcome and survival.

To determine the therapeutic effect of high-dose PPI infusion in upper gastrointestinal bleeding from causes other than peptic ulcers.

A placebo-controlled randomised study is being proposed. We hypothesize that early administration of intravenous omeprazole infusion stabilizes clots overlying arteries and hastens resolution of bleeding stigmata in peptic ulcer, and facilitates subsequent endoscopic examinations and reduces the need for endoscopic treatment. This may translates into clinical benefits in those who receive early intravenous omeprazole.

Consecutive patients with overt signs of upper gastrointestinal bleeding will be randomised to receive omeprazole or its equivalent placebo (80mg i.v. bolus followed by 8mg/hr) until next scheduled endoscopy. Patients with circulatory instability or fresh hematemesis will undergo endoscopic examinations urgently after initial stabilisation. The infusion will continue until endoscopic examination with or without therapy. Next scheduled endoscopy is performed within 24 hours from admission by experienced endoscopists with expertise in therapeutic endoscopy. At endoscopy, actively bleeding ulcers or ulcers with non-bleeding visible vessels are to be treated by endoscopic therapy. Omeprazole infusion 8mg/hr is to be continued for 72 hours after endoscopic hemostasis.

Patients will be followed-up for 30 days from the time of admission or if patients stay longer than 30 days, the time to hospital discharge or death.

Eligibility Criteria:
Inclusion Criteria:

* Patients with overt signs of upper GIB; fresh hematemesis and/or melena with or with circulatory compromise

Exclusion Criteria:

* Chronic aspirin user,
* Pregnancy,
* Age\<16,
* Allergy to PPI,
* No consent
ESPB and ACB in Knee Arthroplasty

Total knee arthroplasty surgery is preferred in the treatment of osteoarthritis and causes severe postoperative pain. In this study, we aimed to investigate the effects of lumbar erector spina plan block and adductor canal block on postoperative pain and quadriceps muscle strength in patients who underwent total knee arthroplasty with spinal anesthesia.

In a prospective, randomized study; Medeniyet University Faculty of Medicine Göztepe Prof. Dr. Forty patients who underwent total knee arthroplasty surgery at Süleyman Yalçın City Hospital were divided into two groups. After the surgery was completed, erector spina plane block was applied to Group E (n=20) patients with 20 ml of 0.25% bupivacaine from the operated side L3-L4 level, while in Group A (n=20) patients, in the area where the sartorius muscle crosses the adductor magnus muscle, it was lateral to the superficial femoral artery. Adductor canal block was applied to the adductor canal with 20 ml of 0.5% bupivacaine. All patients were administered 1 gr paracetamol and 75 mg diclofenac sodium when their pain started in the orthopedic ward. Numerical pain score and quadriceps muscle strength were evaluated during the 48-hour follow-up of the patients. When the pain score was 4 and above, 50 mg pethidine hydrochloride was administered.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent total knee arthroplasty surgery
* ASA I-III patients

Exclusion Criteria:

* Patients with coagulopathy
* Patients history with local anesthetic allergy or toxicity
* Patients with long hospital stay
* Patients with advanced organ failure
* Mental retarded patients
* Presence of infection at the injection site