cyrilzakka/clinical-trials huggingface dataset:
Role of PET/CT With Fluorine-18 Tracers of Bone Metastases in Prostate Cancer

Compare PET/CT and MRI for the early detection of bone metastases of prostate cancer: diagnostic performance and impact on the patient management.Determine the lowest cost strategy according to the precise clinical circumstances.

In patients with high risk prostate cancer and high PSA levels, PET/CT with fluoride (18F) and FLUOROCHOLINE (18F) and whole-body MRI will be performed within one month.

Data of a 6 month follow-up after those examination will be made available to a panel of independent experts. They will determine the standard of truth (SOT) concerning the invasion of the skeleton and also of soft tissue by prostate cancer tissue, the impact of each imaging modality on patient management and the adequacy of the decisions. In some cases (anti-hormone treatment without histology), it will not be possible to determine the SOT.

By comparison of the results of blind readings for each imaging modality with the standard of truth, the diagnostic performance will be determined.

By simulation, several strategies will be constructed concerning the best examinations to be performed and the sequence according to the precise clinical circumstances. Their cost and effectiveness will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Histologically proven prostate cancer.
* Abnormal plasmatic level of prostate specific antigen dating less than 3 months, initial Gleason score available
* Written informed consent.

Exclusion Criteria:

* Other active cancer or bone infection.
* Chemotherapy or change in hormone therapy since the last PSA assay
* Contraindication to MRI without contrast agent (claustrophobia, pace maker, metallic foreign body, some cardiac valves). Metallic joint prostheses are NOT a contraindication.
* Allergic reaction to radiopharmaceuticals that will be used.
* Patient who seems not capable of staying in the gantry of the machines during the examinations without moving.
Real-world Daptomycin Use in Chinese ICUs

Analyze the effectiveness and safety of Daptomycin(Jiangsu Hengrui Medicine Co., Ltd) in Gram-positive infections in Chinese Intensive Care Units by using the real-world data platform, https://rws.scccmqc.com. Patients who received at least one dose of Daptomycin between 2016 to 2021 are eligible.


Eligibility Criteria:
Inclusion Criteria:

* Patient who received at least one dose of daptomycin

Exclusion Criteria:

* No
Oxygen in Migraine Treatment

IIn this study, the investigators planned to investigate effectiveness of supplemental oxygen in patients (18-65 years) who were diagnosed as headache related to migraine without aura in the emergency department (ED).

Patients who will be ordered standard migraine therapy (50 mg dexketoprofen and 10 mg metoclopramide HCl in 100 cc normal saline IV) by the physician blind to research, will be evaluated by the researchers before the treatment and patients met the study criteria will be included. Included patients randomly divided to two group, study group will receive supplemental oxygen with face mask for 1 hour.

Patients' visual analog score (VAS) will be measured at 0th, 15th, 30th and 60th minute of treatment. If there will not be a 50% decrease at VAS score from the beginning, patients will be examined again by the physician again. Patients who will be ordered 100 mg tramadol as rescue therapy by the physician, will be continued to observed, VAS scores will be measured at 120th minute again.

To avoid drug related bias, patients who will be ordered any other drug for primary care or rescue treatment other than mentioned above will not be included into the study.


Eligibility Criteria:
Inclusion Criteria:

with their medical history and ED evaluation being diagnosed as migraine related headache according to HIS 2018 classification, having VAS \>40 at the beginning of the treatment, accepting to participate patient group who received standard migraine therapy (50 mg dexketoprofen and 10 mg metoclopramide HCl in 100 cc normal saline iIV).

patient who received 100 mg tramadol as rescue therapy

Exclusion Criteria:

Taking any analgesic in 6 hours before admission, patients who were diagnosed with all other types of primary headaches (migraine with aura, migraine status, TTH, trigeminal autonomic cephalgia etc), patients using anticoagulants or have bleeding diathesis, pregnant and breastfeeding patients, patients had fever, patients diagnosed as secondary headaches, patients had focal neurologic findings, patients had heart, liver, or kidney failure, patients had peptic ulcer, patients had chronic obstructive pulmonary disease, patients had acute coronary syndrome, patients who were not stable hemodynamically patients who had history of acute dystonia or akathisia due to metoclopramide.

-
Leo Study Unstable Asthma

This is a prospective, observational study to investigate the agreement of the Leo device signal derivation with gold standard asthmatic testing in recently exacerbated asthmatic children.

This study is designed for engineering validation of a wireless, wearable device (Leo) for assessing clinical control of children recovering from acute respiratory event such as asthma attack. The Leo device will monitor chest impedance, ECG and body position to calculate parameters such as respiration rate, heart rate, lung volume, tidal breathing flow and volume curves, and body position. These parameters will then be used to train and algorithm to assess clinical control of asthma.


Eligibility Criteria:
Inclusion Criteria:

* Children aged ≥2 years old and \<18 years old at time of consent
* Children with a legal guardian able to sign consent for study participation
* Children and caregivers able to read and understand English or Spanish
* Children who are currently hospitalized with acute exacerbation of asthma
* Child's caregiver is able to communicate using SMS
* Child has an asthma inhaler

Exclusion Criteria:

* Children with complex medical conditions which may hinder their ability to complete protocol assessments
* Children with an active skin condition involving the area on the chest wall where the Leo device will be attached. E.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment
* Children with any implanted medical devices, E.g. cardiac pacemaker
* Children with any history of known allergic reaction to adhesives or hydrogels, as the ones used with the Leo device
Cross-linking for Corneal Ulcers Treatment Trial

The primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal cultures immediately after the procedure than patients who received medical therapy alone.

The secondary purpose of this study is to determine if patients randomized to corneal collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who receive medical therapy alone.

The proposed study is a randomized controlled trial to determine whether collagen cross-linking improves outcomes in microbial keratitis. Patients presenting to the Aravind Eye Hospitals in Madurai, India for treatment of microbial keratitis will be recruited for the proposed study. Approximately 266 patients will be enrolled in the study. Subjects presenting with bacterial keratitis will be randomized to receive medical therapy plus corneal collagen cross-linking at presentation or to receive medical therapy alone. All subjects with bacterial ulcers will receive standard topical antibiotic medications as required after the procedure.

Subjects with fungal keratitis will be randomized into one of four groups:

1. collagen cross-linking + amphotericin;
2. collagen cross-linking + natamycin;
3. amphotericin alone;
4. natamycin alone.

All study subjects will be followed for 12 months to evaluate response to treatment.

Investigators from the University of California, San Francisco (UCSF) will assist Aravind Eye Hospital with the study design, implementation, and analysis of the research, and will help fund the study. The investigators plan to visit Aravind to help with the study implementation. UCSF will play an important role in this study by assisting with the study design, implementation, analysis, and funding.

Eligibility Criteria:
Inclusion criteria:

* Corneal ulcer that is smear positive for either bacteria or filamentous fungus
* Pinhole visual acuity worse than 20/70 in the affected eye
* Not treated already with antimicrobial medications at presentation
* Age over 18 years
* Basic understanding of the study as determined by the physician
* Commitment to return for follow up visits

Exclusion criteria:

* Evidence of concomitant infection on exam or gram stain (i.e. herpes, both bacteria and acanthamoeba on gram stain)
* Impending or frank perforation at recruitment
* Involvement of sclera at presentation
* Non-infectious or autoimmune keratitis
* History of corneal transplantation or recent intraocular surgery
* No light perception in the affected eye
* Pinhole visual acuity worse than 20/200 in the unaffected eye
* Participants who are decisionally and/or cognitively impaired
Progressive Splinting Status Post Elbow Fractures and Dislocations

The purpose of this study is to help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function.

Fractures and dislocations about the elbow are high energy injuries which are often comminuted and associated with extensive soft tissue damage and are very difficult to treat. The most problematic complication for these fractures is the potential development of a cosmetic defect and functional disability due to the loss of 20 degrees to 30 degrees of terminal extension of the elbow. It has been found imperative that early motion and physical therapy be implemented to help produce the best results in terms of a patient's range of motion and decreases secondary surgeries.

We intend to examine a group of patients with distal humerus and elbow fracture/dislocations who use static stretching braces along with physical therapy (PT) within 3 weeks after surgery, in contrast to physical therapy treatment alone after surgery. The static stretching brace group will have a small electronic circuit attached to the brace that will record patient's usage.

Improvement of patient's overall functional outcome will also be measured by a standard functional outcome instrument, the Disabilities of Arm, Shoulder and Hand (DASH) form. The DASH Form is a standard functional outcome instrument specific to upper extremity injuries. In addition, a more general measure, the Visual Analog Scale (VAS), will be used to assess pain.

The use of the static motion brace may help eliminate the necessity of additional treatments, saving both pain and suffering, as well as monetary costs for the patient, while simultaneously producing a better long term functional and cosmetic outcome.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Extra or intraarticular distal humerus or elbow fracture or fracture/dislocation
* Agrees to participate and signs informed consent
* English Speaking (outcome questionnaires are validated for English only)

Exclusion Criteria:

* Less than 18 years of age
* Closed Head Injury
* Burn Injuries
* Ipsilateral upper extremity fracture(s) requiring surgery
* Nonunion of prior distal humerus fracture or fracture dislocation
* Type 3 open distal humerus fracture dislocation
* Insufficient fracture fixation to allow early range of motion
* Transient population with no fixed address
* Not willing to sign informed consent
* Does not speak English
Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction

This study aims to find out whether taking antibiotics to prevent a urinary tract infection after a medical procedure called percutaneous nephrostomy (placement of a catheter directly into the kidney to keep it working after the urinary tract has been blocked by a malignant tumour) actually prevents a urinary tract infection, compared to not taking antibiotic prophylaxis.

The medical records of cancer patients who underwent percutaneous nephrostomy between January 2013 and July 2020 were reviewed. Procedures were excluded if the nephrostomy was used for other procedures (e.g. double-J passage) or for non-malignant urinary tract obstruction (e.g. kidney stones). The association between antibiotic prophylaxis and UTI was assessed using association tests such as Pearson's chi-squared or Fisher's exact test. A significant level of 5% was adopted.

Definitions:

Urinary tract infection - occurs when there are signs and symptoms consistent with a local infection (fever, chills, dysuria, lower back pain, and costovertebral angle tenderness), such as cystitis (bladder or lower UTI) or pyelonephritis (kidney or upper UTI), combined with a positive urine culture (more than 104 colony-forming units of microorganisms per millilitre of urine with a catheter present or more than 105 colony-forming units of microorganisms per millilitre of urine without a catheter present).

UTI related to percutaneous nephrostomy procedure - occurs until seven days after the percutaneous nephrostomy procedure, both for first placement and/or catheter replacement.

UTI related to the nephrostomy catheter - occurs at another time, usually within 90 days of the procedure, in the presence of the nephrostomy catheter, and in the absence of another focus that would justify the infection.

Antibiotic prophylaxis was administered before percutaneous nephrostomy. If there was no record of antibiotics in the cost centre of the institution's database, it was considered that antibiotic prophylaxis was not given.

For the first percutaneous nephrostomy catheter placement, antibiotic prophylaxis was given empirically.

For catheter replacement, antibiotic prophylaxis was both empirical and targeted, based on the result of a pre-procedure urine culture to guide the antibiotic choice.

Percutaneous nephrostomies (first placement and/or catheter replacement) were excluded from analysis if patients were treated for UTI up to 7 days before or during the procedure. However, they were included in analysis outside the period of antibiotic prophylaxis for future UTIs.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated for cancer who required percutaneous nephrostomies

Exclusion Criteria:

* Patients and/or procedures if percutaneous nephrostomy was used to perform other procedures;
* Patients and/or procedures if percutaneous nephrostomy was used to treat clinical conditions other than malignant ureteral obstruction
* Patients and/or procedures if percutaneous nephrostomy was used to clear the urinary tract of non-malignant causes
Effect of High-quality Pre-operative Videos on Patient Anxiety Levels Prior to Ambulatory Hand Surgery

Previous research has shown that YouTube is a poor source of high-quality medical information. This is likely because there is no regulation of the content on YouTube and relatively little of the content is posted by qualified medical professionals. It is known that up to 30% of patients use the internet to research the procedure they will be having and given the increasing popularity of YouTube we suspect many patients are using YouTube or similar sites as a source of information prior to elective surgery. There are likely a number of patient factors that contribute to patients seeking out videos as a source of pre-operative medical information. Patient age, which is generally inversely correlated to computer literacy, may have a role. Patient anxiety and pre-operative worrying may cause a patient to turn to the internet to search for information, and the poor overall quality of the content available may worsen pre-operative anxiety.

The primary objective of this study is to determine if providing patients with a reliable, high-quality video about their condition and operation prior to surgery reduces pre-operative anxiety. Secondary aims are to determine the percentage of patients that independently seek out videos online as a source of medical information prior to elective hand surgery, identify patient attributes that are associated with this behavior, and understand if introducing high quality pre-surgical videos has an impact on post-operative patient outcomes and/or patient engagement. The investigators hypothesize that providing patients with high-quality pre-operative videos will reduce pre-operative anxiety. Its is also expected that patients who seek out videos on their own for pre-operative medical information will be younger and have higher anxiety levels and pain catastrophizing scores. Additionally, the investigators hypothesize that patients who watch high-quality pre-operative videos may have better short term post-operative outcomes and greater engagement in their care than their counterparts that did not watch videos or who sought out videos on their own.


Eligibility Criteria:
Inclusion Criteria:

* undergoing a primary routine elective hand procedure (Carpal tunnel release, trigger finger release)
* age \> 18 years

Exclusion Criteria:

* revision procedure
* prior debilitating upper extremity injury
* surgery not being performed on ambulatory basis
* special populations (pregnant patients, prisoners or other institutionalized patients, cognitive impairment)
* non-english speaking patients (videos only available in english language)
* age \< 18 years
Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma

Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin, ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in first line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of soft tissue.

The trabectedin is a new cancer drug that has obtained marketing authorization after failure of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe. It has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.

This study aims to evaluate the usefulness of the combination of trabectedin with doxorubicin in first-line treatment of uterine or soft tissue leiomyosarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic leiomyosarcoma (uterus or soft tissue) in inoperable relapse with no previous chemotherapy
* At least one measurable lesion according to RECIST criteria before inclusion. At least one of the target is in a none irradiated area
* Aged \>/= 18 years and physiological age \</= 70 years
* PS \</= 2
* Normal hematological function (Polymorphonuclear Neutrophils \>/= 1500/mm3, platelets \>/= 100 000/mm3)
* Normal kidney function (creatinine \< 1.5xN)
* Creatinine phosphokinase \</= 2.5xN
* Normal hepatic function (total bilirubin \</= 1xN; transaminase \</= 2.5xN and alkaline phosphatase \</= 1.5xN)
* Cardiac function: normal echography and/or isotopic ventriculography (FR\>30%, FEVG \> 50%)
* Patients able to procreate must use a birth control device during treatment and during 3 months after treatment for women; 5 months for men
* Signed informed consent
* Patient under affiliated to a system of care

Exclusion Criteria:

* Any other histological type of uterus sarcoma (carcinosarcoma...) or soft tissue
* Specific contraindication to the treatment
* Previous or evolutive mental disease
* Previous cancer
* Symptomatic or known brain metastasis
* Previous radiotherapy ont he only measurable lesion
* Previous allograft or autograft
* Known positive serology (HIV, HbC, HbS)
* Pregnant or breastfeeding women
* Impossibility to follow the treatment for geographical, social or mental reason
* Patients under legal protection
Trial of Immediate vs. Delayed Cord Clamping in the Preterm Neonate

To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation.

This study is intended to be a randomized controlled trial comparing immediate cord clamping which represents the current standard of care at Oklahoma University Medical Center with delayed cord clamping among preterm neonates born between 24 weeks and 34 weeks 0 days weeks' gestation. Allocation sequence will be generated by simple randomization using random number table in the stratum 24-28 weeks 6 days and 29 weeks to 34 weeks 0 days weeks' gestation stratum.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies
* Signed consent to participate in the trial

Exclusion Criteria:

* Major fetal anomaly or known fetal chromosomal abnormalities
* Multiple gestation
* Mothers with pregestational and gestational diabetes
* Refusal to participate in the trial
Clinical Outcomes of Laser Prostatectomy

Benign prostate obstruction (BPO) can be treated with a range of laser treatments using different laser systems and applications. Transurethral laser treatment is considered to be an alternative treatment to transurethral resection of the prostate (TURP). The latest guidelines of the European Association of Urology recommend 532-nm GreenLight laser vaporisation of the prostate and thulium laser enucleation as alternatives to TURP. For further investigation of the efficacy of GreenLight and thulium laser in treating BPH, the investigators organize a prospective randomised control study. The investigators will enrol 100 patients with BPO, treated with either GreenLight laser or thulium laser prostatectomy, and compare their safety and efficacy.

80 patients with symptomatic benign prostate obstruction (BPO) will be assigned under randomization to treat with GreenLight laser or thulium laser. Randomization is performed by free randomization software.

Inclusion criteria are patient age greater than 50 years, maximum flow rate (Qmax) \< 15 ml/second and an International Prostate Symptom Score (IPSS) ≥ 10. The data for the quality-of-life questionnaire (QoL) and transrectal ultrasound measurement of the prostate (TRUS) are obtained preoperatively.

Exclusion criteria are known prostate cancer, bladder cancer, previous transurethral surgery, interstitial cystitis and neurogenic bladder confirmed after urodynamic studies. The use of anticoagulants or platelet aggregation inhibition and urinary retention under catheterization is not a criterion for study exclusion. The local institutional review board committee has approved the study as well as the data analysis.

Sample size The sample size was determined based on an expected mean IPSS of 5.8 ± 2.6 at 1-year followup. The investigators considered a change of deference of IPSS ≤ 2 as an accepted equivalence between the two groups. The sample size was calculated to be at least 21 patients in each group with α=0.05, β=0.80 and a desired statistical power level of 80%. Considering the possibility of patients drop out or lost to followup, 40 patients will be enrolled in each arm. All measurement data will be presented as mean ± standard deviation.

Statistical analysis StataCorp Stata 15 was used for statistical analysis. The Fisher's exact test was applied to compare categorical variables; and the Student's t-test was used to compare quantitative variables between the two treatment groups. A mixed model with random effect and Bonferroni correction was applied to compare IPSS, QoL, Qmax, and PVR between two groups. A two-sided P-value of \< 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are patient age greater than 50 years, maximum flow rate (Qmax) \< 15 ml/second and an International Prostate Symptom Score (IPSS) ≥ 10.

Exclusion Criteria:

* Exclusion criteria are known prostate cancer, bladder cancer, previous transurethral surgery, interstitial cystitis and neurogenic bladder confirmed after urodynamic studies.