cyrilzakka/clinical-trials huggingface dataset:
Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer

This study will primarily compare the effectiveness of surgery and radiation for localized prostate cancer, the most common male cancer. It will focus on modern technologies and control for differences in patients and treatments that may affect both cancer-related and patient-reported outcomes (such as impotence and incontinence). By figuring out what treatments "work best, in which patients and in whose hands", it will help men with prostate cancer make better decisions regarding their care.

Prostate cancer is the most common solid tumor and the second leading cause of cancer death among American men. While surgery, radiation and observation have all been deemed appropriate for newly diagnosed men, tremendous uncertainty remains regarding the optimal treatment. AHRQ's 2008 evidence report on the comparative effectiveness of therapies for localized prostate cancer concluded that "no one therapy can be considered the preferred treatment for localized prostate cancer due to the limitations in the body of evidence as well as the likely tradeoffs an individual patient must make between estimated treatment effectiveness, necessity and adverse effects." The existing literature is limited by its focus on older therapeutic modalities and failure to control for individual patient characteristics and provider/hospital characteristics that may influence outcomes (quality of care). To fill these evidence gaps, we propose to expand a network of state tumor registries and a national observational disease registry to establish a new population-based cohort of men newly diagnosed with localized prostate cancer. We will prospectively measure key patient-reported outcomes, such as health-related quality of life and side-effects of therapy at diagnosis and 6 and 12 months later. We will also collect detailed medical record information, including clinical data, technical details of the interventions, complications, short-term cancer recurrence rates, and quality-of-care indicators.

By using this approach, we will overcome limitations of the extant literature and achieve the following specific aims:

1. To compare the effectiveness of contemporary surgical and radiation techniques for localized prostate cancer in the cohort described above in terms of the 6- and 12-month patient-reported outcomes, side-effects and complications of treatment.
2. To identify patient level characteristics that may influence comparative effectiveness.
3. To assess how the comparative effectiveness of the various therapies varies by quality of care received.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of adenocarcinoma of the prostate
* Clinically localized stage
* PSA \<50ng/ml
* age 18-79

Exclusion Criteria:

* diagnosis of other malignancy (excluding squamous or basal cell carcinoma of the skin) within 3 years of diagnosis of prostate cancer
* age 80 or greater
* clinically locally advanced or metastatic disease
* PSA equal to or greater than 50 ng/ml
* pathologic diagnosis of prostate cancer greater than 6 months prior to baseline recruitment interview
Segmental Exclusion of the Upper Limb and Peri-personal Space

This study is based on previous studies on the search of the limit of the peri-personal space. In a previous study, Gouzien et al. (2017) evaluated the peri-personal space of action of patients with upper limb amputations and sought a link between this space and the level of integration of their myoelectric prosthesis. We have decided to implement part of this protocol to evaluate the peri-personal space for another population with upper limb patholog: segmental exclusion of the upper limb.

Exclusion is a phenomenon that is very little studied but known to orthopedic surgeons and physical medicine and rehabilitation physicians. It is characterized by the non-use or underuse of a limb segment in the absence of central nervous system involvement. This phenomenon is compared to peripheral neglect. Most of the time, the patient is unaware of his disorder "he forgets his finger without realizing it", but this phenomenon can be reversible under verbal exhortation from a third party.

The aim of this study is to observe if there is a change in peri-personal space in patients with unilateral segmental exclusion.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age greater than or equal to 18 years old).
* Person with a symptom of unilateral exclusion.
* Person with no contraindication to hard work in activities of daily living due to the lesions.
* Person who has given informed consent.

Exclusion Criteria:

* Person under 18 years of age.
* Person with visual impairment
* A person with a central neurological pathology.
* A person with cognitive impairment related to a brain injury, psychiatric illness or intellectual disability.
* A person who has difficulty understanding instructions.
* A person of full age who is subject to a legal protection measure or who is unable to give consent.
Optimization for Laryngeal Mask Removal Strategy and Evaluation of Transitional Criteria From PACU in Children

Laryngeal mask airway(LMA) is now a widely accepted airway device in general anesthesia for children. LMA removal after operation is always practiced in post-anesthesia-care-unit(PACU). The removal timing depends on recovery of spontaneous respiration and wash-out of inhalation anesthetics. This study focuses on the optimization for LMA removal strategy. Moreover, this study also discusses the transitional criteria from PACU to the ward.

The study recruits 180 children aged under 6-year-old undergoing elective general anesthesia. Laryngeal mask is used in procedure. The children are carried into PACU to get monitored and removal the LMA. The children are randomized into 4 groups.

Eligibility Criteria:
Inclusion Criteria:

* Children aged under 6 years old undergoing selected eye surgery
* Scheduled for general anesthesia

Exclusion Criteria:

* With systemic disease
* Respiratory system deformity
* Respiratory infection in 4 weeks
Imatinib as Pre-operative Anti-Colon Cancer Targeted Therapy

In this proof-of-concept trial the investigators will study the effects of imatinib treatment on the biology of mesenchymal-type colon cancers.

Tumor biopsies from patients with newly diagnosed colon cancer will be pre-screened with an RT-qPCR test to identify tumors of the mesenchymal subtype. Patients with mesenchymal-type tumors that meet the in- and exclusion criteria will be treated with imatinib during the "window period" that normally precedes surgery. Immediately following tumor resection, biopsies will be taken from the surgical specimen. Gene and protein expression of the pre- and post-treatments biopsies will be compared to assess the effects of imatinib therapy on PDGFR- and cKIT-signalling and on the mesenchymal gene expression profile.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥18 years
2. Histologically proven adenocarcinoma of the colon;
3. Completed cancer staging with CT-abdomen and CT-thorax/X-thorax according to hospital's standard of care;
4. Confirmed eligibility for surgery with curative intent as deemed by the hospital's multidisciplinary board (MDB) review;
5. An intratumoural gene expression profile of PDGFR-α, PDGFR-β, PDGF-C and KIT, indicative of the mesenchymal phenotype, according to our diagnostic RT-qPCR test (i.e. more than 50% chance of having the mesenchymal phenotype);
6. Minimum of four properly stored pre-treatment biopsies for gene expression analysis/ELISA;
7. WHO performance status 0 or 1;
8. Adequate haematology status and organ function, defined as:

   * Normal creatinine clearance (≥60 ml/min (MRDR))
   * ALAT within 2.5x upper limit of normal (ULN)
   * PT-INR \< 1.5
   * Leukocytes \> 1,5\*10\^9/L; Hb \> 6.0 mmol/L; platelets \> 100\*10\^9/L
9. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests;
10. Written informed consent.

Exclusion Criteria:

1. The presence of synchronous distant metastases;
2. Current hospital standard of care dictates that subject should undergo any neoadjuvant therapy;
3. Concurrent participation in another clinical trial using any medicinal product, or participation in such a trial in the period of three months prior to the current trial;
4. Women who are pregnant, plan to become pregnant or are lactating during the study or for up to 30 days after the last dose of imatinib;
5. Known HIV or Hepatitis B/C infection;
6. Known symptomatic congestive heart failure;
7. Co-morbidity requiring concomitant treatment with drugs that act as strong inducers of CYP3A4 or with drugs with a narrow therapeutic range influenced by imatinib
Frozen-thawed Embryo Transfers and Hormone Substitution on Thrombotic Risk Markers

The study focus on the impact of estrogen/progesterone substitution during artificial cycle frozen embryo transfer (AC-FET) in women undertaking assisted reproductive technology treatment (ART).

The aim is to investigate whether the coagulation is activated in women undergoing estrogen/progesterone substitution during artificial cycle frozen embryo transfer (AC-FET) in assisted reproductive technology treatment (ART). An activation of the coagulation might induce an increased thromboembolic risk in these women. Thus, the present study may lead to improvement of the current treatment protocol for women receiving AC-FET and ultimately prevent thromboembolic complications for woman in fertility treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women receiving FET with or without estrogen/progesterone substitution

Exclusion Criteria:

* Known bleeding disorder
* Indication for thromboprophylaxis during ART treatment
* Treatment with anti-platelet medication including non-steroid-anti-inflammatory drugs (NSAIDs) within the last week
* Donor recipients
Thromboelastometry in Liver Transplantation

Thromboelastometry better assess coagulation than standard coagulation test in patients undergoing ortothopic liver transplantation. In a post-hoc analysis from a randomized study recently conducted by our group, presurgical values of MA10 Extem \< 35 mm are highly predictive of RBC administration , with no further improvement over MA10 Extem \>40 mm ; suggesting that MA10 Extem between 35-40 would be the optimal range to manage blood product administration. The aim of the study is to validate this result in a prospective cohort of patients submitted to ortothopic liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Presurgical hemoglobin \< 13 d/L and clot firmness at 10 minutes Extem \< 35 mm

Exclusion Criteria:

* Previous thrombosis
* Antithrombotic treatment
* No consent
Neostigmine For Snoring During DISE

The study team is seeking a novel treatment for snoring involving local application of a nerve stimulant medication, neostigmine. In this study, neostigmine will be injected into 5 sites of the soft palate during a standard procedure, drug-induced sleep endoscopy, to evaluate the effect on snoring.

Snoring is a major problem, affecting 40 million Americans. The disease affects patient and partner sleep quality as well as daytime function. Snoring treatment is limited by device compliance (mouth appliance, positive airway pressure) and insurance does not regularly pay for these devices. Surgical treatment for snoring has mixed results. As a result, there is an important need to develop new treatments for snoring.

The study team is seeking a novel treatment for snoring involving local application of a nerve stimulant medication, neostigmine. In this study, neostigmine will be injected into 5 sites of the soft palate during a standard procedure, drug-induced sleep endoscopy, to evaluate the effect on snoring. If successful, development of a topical (non-injectable) version of this drug will be considered, so that the patient can apply him/herself before bedtime.

Eligibility Criteria:
Inclusion Criteria:

* Snoring or mild obstructive sleep apnea
* English-speaking
* Greater than 18 years old
* Able to give informed consent

Exclusion Criteria:

* On active anti-coagulation medication
* Pregnant women
* Hypersensitivity to neostigmine
* Peritonitis or mechanical obstruction of the intestinal or urinary tract
* Coronary artery disease
* Cardiac arrhythmia
* Recent acute coronary syndrome
* Myasthenia gravis
Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients

The aim of this work is to evaluate efficacy and tolerability of preservative containing 0.0015% tafluprost and preservative-free 0.0015% tafluprost. Both preservative containing and preservative-free 0.0015% tafluprost will reduce intraocular pressure significantly. In addition, preservative-free 0.0015% tafluprost might improve tolerability of glaucoma patients.


Eligibility Criteria:
Inclusion Criteria:

* 1. Primary open angle glaucoma and normotensive glaucoma patients who came to the outpatient clinic for regular glaucoma check-ups were enrolled.
* 2. Glaucoma was defined as the patients who had open angle confirmed by gonioscopy, optic nerve cupping (a vertical cup-disc ratio of \>0.6) and or notching of the neuroretinal rim and or retinal nerve fiber defects characteristics of glaucoma, and visual field defect(i.e., a glaucoma hemi-filed test result outside normal limits, a pattern standard deviation probability of \<5%, or a cluster of three or more non-edge points in location typical of glaucoma, all of which were depressed on a pattern deviation plot at a P level of \<5%, and at least one of which was depressed at a P level of \<1% on two consecutive visual field tests).
* 3. Normal tension glaucoma included criteria: repeated measurements of untreated IOP values of \< 21mmHg. Primary open angle glaucoma included criteria: repeated measurements of untreated IOP values of ≥ 22mmHg.

Exclusion Criteria:

* 1. Phakic and pseudophakic eyes.
* 2. eyes that had been taken vitrectomy, trabeculectomy, or surgery influenced IOP
Human Papillomavirus Infection and Knowledge and Attitudes About HPV Vaccines Among Men Who Have Sex With Men (MSM)

This is a observational study aims to assess anal and genital human papillomavirus (HPV) infection status among men who have sex with men (MSM) in China, and their knowledge and attitude about HPV vaccine.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old;
* Ever had homosexual behaviors in the past 12 months;
* Willing to take tests for HIV/HPV infection;
* Physically able and willing to provide written informed consent.
The Early Diagnosis of Gestational Diabetes Mellitus Study

The main purpose of the study is to evaluate an OGTT at 18 to 20 gestational weeks as an early diagnosis method of GDM in low risk pregnant women. By investigating maternal and neonatal outcomes that are associated with the early OGTT and regular OGTT results, the study will provide a evidence for the most appropriate time to perform an OGTT in pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnant women will be invited to participate in this study if they are between 18 and 40 years of age, and have had their first prenatal visit in our center before 18 weeks 0 days of gestation.

Exclusion Criteria:

* Previous history of GDM or preexisting DM
* Family history of diabetes mellitus (first degree relative with diabetes or a sister with GDM)
* Body mass index\>30 kg/m2
* Previous macrosomia (baby with birth weight \>4,000 g) or a history of stillbirth
* Polycystic ovary syndrome
* Medications: corticosteroids, antipsychotics
* Participant not willing to take OGTT twice (at 18-20 gestational weeks and 24-28 gestational weeks), or not willing to have a series of prenatal care visits and deliver in our center.
Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours

This study will evaluate the insertion of double balloon device (DBD) for cervical ripening for 12 h vs 6 hours.

This randomized controlled study is designed to:

1. To assess and compare the Bishop score when removing the DBD 12 hours' vs 6hours' after insertion.
2. To compare the efficacy (vaginal delivery rate and time to VD) in the two arm groups

200 women are expected to be randomized in to two arms. One will be randomized to DBD removal after 12 hours and the other to DBD removal after 6 hours.

Each patient will sign an informed consent.

The following screening will be completed: medical and gynecological history, general physical and gynecological examination, ultrasonography to exclude contraindication to vaginal delivery or insertion if the DBD and non stress test (NST) for baseline. Bishop score will be assessed.

After confirming eligibility for study, randomization into the following groups will take place.

Insertion of the DBD and removal 6 hours following its insertion. Insertion of the DBD and removal 12 hours following its insertion.

Eligibility Criteria:
Inclusion Criteria:

1. Parous patients 18 years of age or older.
2. Diagnosed to be parous pregnant women with an indication for induction of labour.
3. Having a Bishop score of 5 or less.
4. Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of 37 completed gestational weeks or more.
5. Willingness to comply with the protocol for the duration of the study.
6. Have signed the informed consent.

   -

Exclusion Criteria:

1. A non -vertex presentation
2. Placenta previa
3. Ruptured membranes
4. Documented labour
5. Foetal distress necessitating immediate intervention
6. Proven malignancy of the cervix
7. Active inflammatory or purulent condition of the lower genital tract
8. Twin pregnancy
9. Any other contraindication for vaginal delivery
Brain Perfusion and Hemodynamic Stability in Patients Undergoing Radiofrequency Ablation of Ventricular Tachycardia

Ventricular tachycardia (VT) is a life-threatening, fast heart rhythm that starts in the lower chambers of the heart (the ventricles). This fast heartbeat is caused by abnormal electrical pathways located in the heart tissue. A standard procedure called a catheter ablation has been used for several years to help correct these abnormal pathways and, in some cases, improve or even eliminate the ventricular tachycardia.

During a VT ablation it is routine to monitor your vital signs (blood pressure, heart rate, and oxygen saturation in your blood). If you choose to participate in this study we will also monitor your cerebral oximetry, the amount of blood flow and oxygen saturation to your brain during the ablation.

By doing this study, we hope to have a better understanding of patients' blood and oxygen flow to their brain during an episode of Ventricular Tachycardia (VT).


Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Have implantable defibrillator in-situ and are undergoing ablation procedure for ventricular tachycardia

Exclusion Criteria:

* Patients who have been hypotensive with systolic blood pressure of \< 80mm Hg prior to procedure
* Cerebral event as defined by Cerebrovascular Accident or Transient Ischemia Attack within six months prior to procedure
CPAP or BiPAP for Motion Mitigation During Radiotherapy

When using highly conformal radiotherapy techniques, such as proton therapy, a controlled breathing pattern and a minimal breathing amplitude could greatly benefit the treatment of mobile tumors. This reduction in tumor motion may be achieved with the use of a ventilator that is able to regulate and modulate the breathing pattern. CPAP provides a constant level of positive airway pressure. Compared to spontaneous breathing, the use of CPAP increased lung volume and can result in a significant decrease in tumor movement and a significant decrease in both mean lung and mean heart radiation dose. These results were found in patients treated for limited stage disease, it is not clear if this approach is feasible for patients with more advanced stage of disease that undergo radiotherapy with curative intent.

With Bilevel Positive Airway Pressure (BiPAP), tidal volume excursions are determined by the pressure difference between the set inspiratory positive airway pressure (IPAP) and the set expiratory positive airway pressure (EPAP). This mode of ventilation increases lung volume comparable to CPAP, but also to control tidal volumes and breathing frequency. However, BiPAP has never been studied in the setting of motion mitigation during radiotherapy and BiPAP might be more difficult to adjust to for patients compared to CPAP. Therefore, the current study is proposed to evaluate whether or not CPAP or BiPAP is of benefit in patients that undergo radiotherapy for larger intra-thoracic tumor volumes.

The study will follow a 2-step approach.

First (Phase 1, n=10), the feasibility of short-term use of CPAP and BiPAP and its effects on (regional) lung volumes, tidal volumes and breathing frequency will be investigated in patients with intra-thoracic tumors who are planned for radiotherapy. This is necessary to select the best setting of CPAP or BiPAP with which minimal tumor motion is expected (and that is feasible for the patient).

In the second phase (n=21), the particular setting found in fase 1 is investigated: weekly repeated radiotherapy planning (4D) CT scans with and without CPAP/BiPAP will be aquired to evaluate the influence on tumor motion and dose to the target and organs at risk. Radiotherapy will be deliverd according to local protocol without the use of CPAP/BiPAP.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Stage III/IV (N)SCLC, esophageal cancer or malignant lymphoma that will be treated with curative intent
* WHO 0-2.
* Written informed consent

Exclusion Criteria:

* Facial deformations so that facial mask is impossible to fit
* Noncompliance with any of the inclusion criteria.
* Planned for radiotherapy with fraction dose ≥3 Gy.
* Severe heart failure (LVEF\<30%)
Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures

The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures.

Displaced distal radius fractures treated with closed reduction and plaster cast fixation are radiographed 10 days (range 8-13 days) after reduction and randomized to one of two study arms; immediate removal of plaster cast or continued fixation in plaster cast for another 3 weeks. Radiographic and Clinical outcome measurements at 1, 4 and 12 months

Eligibility Criteria:
Inclusion Criteria:

* Distal radius fracture with intact ulna (except for processus styloideus ulnae)
* Dorsal angulation 5-40 degrees
* Axial compression \< 4 mm
* Intra articular step-off \< 1 mm
* Low energy trauma
* Closed fracture
* Suitable for treatment with closed reduction and plaster cast fixation

Exclusion Criteria:

* Fracture older than 3 Days
* Previously fractured ipsi- or contralateral wrist
* Dementia
* Inflammatory joint disorder