cyrilzakka/clinical-trials huggingface dataset:
Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.

Many patients may face long-term urinary side effects following stereotactic body radiation therapy (SBRT), including increased urinary frequency, dysuria, and nocturia. The investigator hypothesizes that Urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and side effects of radiation therapy (SBRT).

Urolift is a standard of care treatment for BPH. It involves the placement of a stainless-steel urethral end piece tethered to a capsular tab to the left and right side of the prostatic urethra approximately 1.5cm distal to the bladder neck. It pulls and maintains the opening of a continuous channel through the prostatic urethra. A previous study examined the effect of Urolift on urinary symptoms and urinary medications at six months post-procedure.Urolift was associated with significant urinary improvements measured by IPSS and quality of life questionnaires and a reduction in the use of total medication as well as alpha-blockers and beta-3 agonists.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 50 - 99 years of age
* Subject has provided informed consent
* Subject has diagnosis of prostate cancer requiring SBRT
* Subject is able to complete self-administered questionnaires
* Subject is a surgical candidate for Urolift
* Subject has a diagnosis of BPH
* Medical record documentation of prostate volume from 30-80 ml by TRUS
* Absence of a middle lobe

Exclusion Criteria:

* Life expectancy \&amp;lt; 2 years
* Currently enrolled in or plans to enroll in any concurrent drug or device study
* Concurrent androgen deprivation therapy
* Has an active infection (e.g., urinary tract infection or prostatitis)
* Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
* Subject has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
* Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years
* Diagnosis of lichen sclerosis
* Neurogenic bladder or other neurologic disorder that affects bladder function
* Diagnosis of polyneuropathy (e.g., diabetic)
* History of lower urinary tract surgery
* Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
* Subject has been catheterized or has a PVR \&amp;gt; 400 ml in the 14 days prior to the surgical procedure
* Current diagnosis of bladder stones
Low-dose Aspirin Therapy for Esophageal Cancer

The aim of this study is to evaluate the survival benefit of low-dose aspirin use for stage II-III esophageal cancer patients.

The investigators aimed to evaluate the hypothesis that low-dose aspirin can improve survival in stage II-III esophageal cancer patients, and to evaluate whether this effect is influenced by PIK3CA, KRAS, BRAF mutation and COX-2 expression. Eligible participants will be randomized to either aspirin treatment arm (100 mg aspirin OD for 3 years), or non-aspirin user arm in 1:1 ratio. After randomization, participants will receive 3 monthly assessments during treatment and follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects with an age of 18 years or older.
2. Subjects with Stage II-III histological proven esophageal cancer.
3. Subjects with performance status (PS) of 0-1 or ECOG performance status 0-2.
4. Subjects must have signed an approved informed consent prior to any study procedures.
5. Subjects with adequate bone marrow, hepatic and renal functions, with a) neutrophils ≥ 1.5x109/ L; platelets ≥ 100x109/L; hemoglobin ≥ 9g/dL; b) Total bilirubin ≤ 2.0 x the upper limit normal; ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastasis); c) creatinine clearance \> 50 ml/min;
6. Subjects undergone complete resection of primary tumor;
7. Subjects with life expectancy ≥ 3 months.
8. Completed standard therapy ( at least 3 months of chemotherapy ± radiotherapy )
9. Within 120 days of completion of standard therapy (surgery, chemotherapy ± radiotherapy)

Exclusion Criteria:

1. Subjects with haemorrhagic diathesis (i.e. haemophilia).
2. Subjects with prior malignant tumors except for esophageal cancers in the past 5 years.
3. Subjects with documented or suspected central nervous system metastases.
4. Subjects with serious, nonhealing wound, ulcer, or bone fracture.
5. Subjects with a history of stroke, coronary arterial disease, angina, or vascular disease.
6. Subjects who are pregnant, lactating, or not using adequate contraception.
7. Subjects who have known allergy to NSAID or Aspirin.
8. Subjects receiving other antiplatelet agents (i.e. clopidogrel, ticlopidine) or anticoagulants (i.e. warfarin, low molecular weight heparins).
9. Subjects receiving current long term treatment (≥ 1 month) with Aspirin or other NSAIDs.
10. Subject unwilling or unable to comply with study requirements.
Treatment for Migraine and Mood

The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).

This study aims to set the stage for a future definitive large-scale Phase III trial in patients with migraine and depressive symptoms. This pilot is aimed at evaluating the feasibility and acceptability of the Telephone and Video MBCT and EUC in people with migraine (defined by the International Classification of Headache Disorders - 3) and depressive symptoms (defined by empirical cut-offs on the Patient Health Questionnaire - 9).

Eligibility Criteria:
Inclusion Criteria:

* Currently meets ICHD-3 (International Classification for Headache Disorders - 3rd Edition) criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
* Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
* Score between 5-14 on the PHQ-9 (Patient Health Questionnaire)
* Age ≥ 18
* Ability to read and speak English
* Capacity to consent
* Prospective diary-confirmed 4-14 headache days per month, with at least one attack meeting migraine criteria
* ≥1 year of migraine

Exclusion Criteria:

* Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the American Migraine Prevalence and Prevention Diagnostic Module
* Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake
* Changes in longer-term migraine prevention (onabotulinum toxin A, injectable or oral anti-calcitonin gene related peptide treatment; neuromodulatory device) within 3 months of intake
* Changes in acute migraine treatment started within 4 weeks of enrollment
* Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities; bipolar disorder; obsessive-compulsive disorder, drug use
* Prior history of engaging in formal mindfulness-based interventions including: MBSR (Mindfulness-based stress reduction), MBCT (Mindfulness-based cognitive therapy), Acceptance and Commitment therapy, Dialectical Behavior Therapy
* Current daily meditation practice
* Inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days)
* Unwilling to maintain stable current acute or preventive medication dosages for study duration
* Any condition that would prevent being a suitable candidate or interfere with medical care needs
A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses

This study aims to compare the short-term clinical performance of the two study contact lenses.

The aim of this study is to evaluate the short-term clinical performance of two multifocal toric soft contact lenses after 15 minutes of daily wear each.

Eligibility Criteria:
Inclusion Criteria:

1. They are aged 35 years or over and have capacity to volunteer.
2. They understand their rights as a subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They agree not to participate in other clinical research for the duration of this study.
5. They are currently wearing soft contact lenses or have done so within the past 12 months.
6. They have a spherical prescription between +10.00 and -10.00DS inclusive, (based on the ocular refraction).
7. They have astigmatism of between -0.75 and -5.75DC (based on the ocular refraction) in each eye.
8. They have a reading addition component to their spectacle refraction of between +0.75 and +2.50DS.
9. They can be satisfactorily fitted with the study lenses.
10. They own a wearable pair of spectacles.

Exclusion Criteria:

1. They have an ocular disorder which would normally contraindicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medications such as eye drops or ointment.
4. They have had cataract surgery.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
8. They have eye or health conditions including immunosuppressive or infectious diseases which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
9. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions

Recently, a new category classification (NICE classification) using non-magnified NBI has been proposed. We design this multicenter study to evaluate the reliability and validity of the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both image and real-time process.

Many reports have demonstrated the efficacy of narrow band imaging (NBI) with magnification in predicting the histology and invasion depth of colorectal polyps. In China, however, the magnifying endoscope is not used in some medical centers. Even in centers equipped with this technique, the magnifying colonoscope is not sufficiently used in daily practice. Recently, a simple category classification (NICE classification) using non-magnified NBI has been proposed, which classifies colorectal tumors into types 1-3 based on different characteristics of color, surface pattern, and microvessels. Type-1 is considered an index for hyperplastic lesions, type-2 is an index for adenoma or mucosal/SM scanty invasive carcinoma and type-3 is an index for deep SM invasive carcinoma. The new classification has soon arouse attention and been validated in some centers on the efficacy of differentiating adenomatous and hyperplastic polyps. However, most studies enrolled diminutive polyps less than 5mm and the efficacy of non-magnified NBI in differentiating type-2 and type-3 lesions has not been reported. To promote this simple classification, we design this multicenter study to evaluate the predictive validity and performance characteristics of the non-magnified NBI in diagnosing polyps during both image and real-time process.

Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal lesions during colonoscopy examination
* Informed consent available

Exclusion Criteria:

* Suspect of advanced colorectal cancer
* History of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
* Poor bowel preparation
* Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc
Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15 patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the study with the primary objective of assessing the feasibility and safety of the knee articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary objectives are to assess the efficacy by imaging procedures and clinical questionnaires.

MSC obtained from each patient's bone marrow will be isolated and expanded "Ex-Vivo" under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36) at 3, 6 and 12 month.

The working hypothesis proposes that the expected regenerative articular cartilage effect of the MSC will be produced to a measurable degree by imaging procedures and clinical questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1. Gonarthrosis grade II-III of Kellgren and Lawrence assessed by two observers
2. Chronic knee pain with mechanical characteristics
3. Absence of local or systemic septic process
4. Haematological and biochemical laboratory tests without significant alterations that contraindicate treatment.
5. Informed Consent form signed by the patient
6. The patient is able to understand the nature of the study

Exclusion Criteria:

1. Patients \< 18 years or legally dependent
2. Patients \>65 years
3. Previous surgery of the knee
4. Intraarticular treatment in the past 6 month
5. Knee ligament or meniscus rupture observed by MRI
6. Any sign of infection
7. Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) and syphilis.
8. Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results.
9. Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
10. Pregnant women or intend to become pregnant or breast-feeding
11. Neoplasia
12. Immunosuppressive states
13. Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
14. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy

This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glaucoma or ocular hypertension
* Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks

Exclusion Criteria:

* None
Avoiding Postinduction Hypotension: the Clinical ZERO-HYPOTENSION Proof-of-concept Study

In this clinical proof-of-concept study, the aim is to investigate the efficacy of a hypotension avoidance strategy to prevent post-induction hypotension. Specifically, it will be investigate how much postinduction hypotension occurs when using a hypotension avoidance strategy - combining continuous intraarterial blood pressure monitoring, careful administration of anesthetic drugs, and continuous administration of norepinephrine to treat hypotension - in high-risk patients having elective non-cardiac surgery.

Hypotension is common in patients having non-cardiac surgery with general anesthesia and is associated with organ injury. About one third of hypotension occurs "postinduction" - i.e., after the induction of general anesthesia but before surgical incision. Unmodifiable risk factors for postinduction hypotension include age, male sex, and a high American Society of Anesthesiologists physical status. However, postinduction hypotension is mainly driven by modifiable factors - specifically, anesthetic drugs that cause vasodilation. Vasodilation can be effectively treated with vasopressors, e.g. norepinephrine.

It is reasonable to assume that postinduction hypotension is largely avoidable by careful anesthetic and hemodynamic monitoring and management during anesthetic induction. A hypotension avoidance strategy could include continuous intraarterial blood pressure monitoring, careful administration of anesthetic drugs, and continuous administration of norepinephrine to treat hypotension. However, it remains unknown to which extent a hypotension avoidance strategy actually can avoid postinduction hypotension. Before testing the effectiveness of hypotension avoidance strategies in large-scale randomized trials it is important to investigate their efficacy.

In this clinical proof-of-concept study, the aim is to investigate the efficacy of a hypotension avoidance strategy to prevent post-induction hypotension. Specifically, it will be investigate how much postinduction hypotension occurs when using a hypotension avoidance strategy - combining continuous intraarterial blood pressure monitoring, careful administration of anesthetic drugs, and continuous administration of norepinephrine to treat hypotension - in high-risk patients having elective non-cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status classification III or higher, and in whom intraarterial blood pressure monitoring is planned for clinical indication

Exclusion Criteria:

* Emergency surgery
* Transplant surgery
* History of organ transplant
* Sepsis
* Pregnancy
* Contraindications for the use of propofol
* Rapid sequence induction
Temozolomide, Nedaplatin, Vincristine, and Radiotherapy as First-line Treatment in Newly Diagnosed Primary CNS Lymphoma

In this trial, we will treat newly diagnosed PCNSL with temozolomide, nedaplatin, vincristine (TNV) as the replacement of high-dose methotrexate to combine with concurrent chemoradiotherapy. Our objective was to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.

The best reported outcomes of PCNSL treatment are high-dose methotrexate-based chemotherapy combined with whole-brain radiation therapy (WBRT). Despite aggressive therapy, however, nearly 50% of patients will relapse within 24 months of diagnosis. Furthermore, the application of high-dose methotrexate-based regimen is complex, needing be hydrated, alkalified and detoxified, and treatment-related toxicity mortality is severe\[3,4\]. In an attempt to improve upon these poor results and reduce treatment-related side effects, we will treat about 15-20 PCNSL patients with temozolomide concurrent chemoradiotherapy at the outset and then adjuvant chemotherapy for 6 cycles with temozolomide, nedaplatin, vincristine, as part of front-line therapy. Our objective is to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary CNS lymphoma.
* Newly diagnosed.
* ECOG (Eastern Cooperative Oncology Group) Performance status of 0-1.
* Relevant hospital examination including laboratory examination and physical examination (Chest X-ray, electrocardiogram, abdomen B ultrasonography, magnetic resonance imaging (MRI) of head and neck) must to be done, in order to exclude other system fatal diseases.
* Must have adequate organ function as defined by the protocol: Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min; Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT \& ALST ≤ 1.5 x ULN.Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl.
* Age \>/= 18 and \</= 75 years
* Signed written informed consent prior to study entry.

Exclusion Criteria:

* Patients with human immunodeficiency virus seropositivity and systemic lymphoma manifestation.
* Serious uncontrolled concurrent illness.
* Previous brain radiotherapy, systemic chemotherapy.
* Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol.
* Any evidence of prior exposure to Hepatitis B virus.
* Unable to comprehend the study requirements or who are not likely to comply with the study parameters.
* Pregnant (confirmed by serum or urine β-HCG) or lactating.
Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women

A multicenter prospective interventional comparative study that investigate pain management during Jaydess insertion in nulliparous women that will be tested by the analgesic affects of oral tramadol or 'verbal anesthesia' on the patients.

Most intrauterine contraception (IUC) insertions do not require pain management. However, small proportions of nulliparous women experience substantial pain that needs to be proactively managed No prophylactic pharmacological intervention has been adequately evaluated to support routine use for pain reduction during or after IUC insertion. Women's anxiety about the procedure may contribute to higher levels of perceived pain, which highlights the importance of counselling, and creating a trustworthy, unhurried and professional atmosphere in which the experience of the provider also has a major role; a situation frequently referred to as 'verbal anaesthesia'.

It has been proven in the past that the use of oral Tramadol can reduce the pain in the insertion.

In the study investigators will compare the analgesic affects of oral Tramadol and verbal anesthesia on pain relief during Jaydess insertion in nulliparous women.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women aged 18-48 years, interested in a long acting, reversible contraception method. Each read and signed the informed consent.

Exclusion Criteria:

Women suffering from:

* Acute or recurrent pelvic inflammatory disease.
* Acute cervicitis or acute Vaginitis.
* Current cervical intraepithelial lesion.
* Current any genital malignancy.
* Progesterone hypersensitivity.
* progesterone-sensitive tumours (e.g. breast tumours).
* Abnormal vaginal bleeding.
* Congenital or acquired uterine anomaly.
* Distorted uterine cavity e.g. fibroid or polyp.
* Impaired liver functions, or liver tumour.
* Known hypersensitivity to the active substance or to any of the excipients of Jaydess.
* Contraindications to Tramadol according to approved product information:

  * In hypersensitivity to tramadol or any of the excipients.
  * In patients who are receiving monoamine oxidase inhibitors or within 2 weeks (14 days) of their withdrawal.
  * In patients with epilepsy not adequately controlled by treatment.
* Vaginismus.