cyrilzakka/clinical-trials huggingface dataset:
Androgen Deprivation Therapy Prior to Prostatectomy for Patients with Intermediate and High Risk Prostate Cancer

Degarelix is an approved drug that is used to treat prostate cancer by lowering testosterone levels in the body.

Degarelix is commonly given with radiation for prostate cancer, but less frequently with surgery since there has been no proven benefit with this approach.

The investigators do not expect the patient to benefit directly from treatment with degarelix since their prostate will be removed shortly after the drug is given. Instead, the investigators hope to learn about how degarelix and other treatment that lowers your testosterone effects prostate cancer cells and use this information to develop better treatments in the future.


Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of prostatic adenocarcinoma by MSKCC inclusive of the following:
* 3 or more positive biopsy cores or equivalent tumor specimen as confirmed by pathologist
* At least 2 cores containing ≥3 mm of tissue with carcinoma or equivalent tumor specimen as confirmed by pathologist
* A primary tumor Gleason score ≥ 7
* Adequate primary biopsy tissue or equivalent tumor specimen as confirmed by pathologist available for protocol required analysis (i.e. bladder or TURP specimen)
* Planning to have or have had a radical prostatectomy (RP) at MSKCC
* Candidates may have a history of deep vein thrombosis, pulmonary embolism, and/or cerebrovascular accident, or require concomitant systemic anticoagulation, if otherwise deemed to be suitable for RP
* Karnofsky performance status \>70% (Appendix A)
* Sexually active fertile subjects, and their partners, must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the dose of study drug(s) for Cohorts 1 , 2 and 4, and for 3 months after the surgery for Cohort 3
* For cohorts 1,2 and 4 only:, non-castrate testosterone level (\>100 ng/dL)
* For cohort 3 only:, 1-6 months of androgen deprivation therapy (gonadotropin hormone releasing analogs with or without an anti-androgen) prior to prostatectomy with a castrate testosterone level of \<50 ng/dL within 1 month prior to prostatectomy.

Exclusion Criteria:

* Histologic variants in the primary tumor (histologic variants other than adenocarcinoma)
* Current or prior chemotherapy
* The use of the 5-alpha-reductase inhibitor dutasteride must be discontinued within 4 weeks of degarelix injection for Cohort 1, 2 and 4, and within 4 weeks of surgery for Cohort 3.
* Saw palmetto administered with the intent to treat the patient's malignancy within 1 week of degarelix injection for Cohorts 1, 2 and 4, and for within 1 week of surgery for Cohort 3
* Current or prior radiation therapy to the prostate
* Active infection or intercurrent illness
* Concomitant therapy with any other experimental drug
* For cohorts 1, 2 and 4 only:, current or prior hormonal therapy (e.g., gonadotropin hormone releasing analogs, megestrol acetate, or antiandrogens) are exclusionary
Multidisciplinary Care Program to Secure MEdication Therapy for HematoLOgy Patients Receiving Injectable Anticancer Drugs

Several experiences of multidisciplinary care pathways associating oncologists, pharmacists and nurses have been reported for cancer patients, with positive results on medication management safety, reduction of Drug-Related Problems (DRPs), and re-hospitalizations.

This study aims to evaluate the impact of a multidisciplinary city-hospital follow-up program on medication management safety in haematological oncology patients receiving intravenous chemotherapy in onco-haematology. Additional aspects will be evaluated, such as the impact of the follow-up on the city-hospital link, satisfaction of patients and professionals involved in the follow-up and the use of telecare


Eligibility Criteria:
Inclusion Criteria:

Adult patients aged 18 years or older With hematological malignancy at any stage Initiating R-CHOP or G-CHOP chemotherapy Who do not object to participation in the study and use of collected data

Exclusion Criteria:

* Patients already enrolled in a clinical trial evaluating any drug product
* Patients living in an institution
* Patients protected by law

  * Adults subject to a legal protection measure (curatorship, guardianship) (article L1121-8 of the CSP)
  * Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and persons admitted to a health or social establishment (article L1121-6 of the CSP)
Development of UP2UTobacco for High School Youth

Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco cessation programs for youth is limited. The current study seeks to adapt and evaluate a universal group-based youth brief tobacco intervention for 9th grade students.

This study will use a sequential, multi-method research design beginning with qualitative roundtable discussions with 9th grade students to adapt an existing young adult brief tobacco intervention for youth. Roundtable discussions with students will identify salient intervention themes and strategies for targeting the intervention and developing the text messages. The second phase of the study evaluates the brief intervention, UP2UTobacco, through a cluster randomized controlled trial that compares UP2UTobacco to a no treatment control. It is hypothesized that the UP2UTobacco will produce greater abstinence at the 6-month follow-up compared to the no treatment control.

Roughly 90% of daily smokers started before the age of 18, and 2,000 youth smoke a cigarette for the first time each day in the U.S. Additionally, e-cigarette use is on the rise among youth, and is linked to cigarette initiation among tobacco naïve youth. In order to curb the rise of tobacco use among youth, interventions that are easily implemented and easily disseminated need to be developed for youth addressing currently available products and contemporary patterns of use. If the interventions in the current study are proven efficacious, they can easily be disseminated to other schools to continue reducing youth tobacco use.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the selected physical education or health class selected for participation in the study.

Exclusion Criteria:

* None
Defining Optimum Cup Orientation for Hip Replacements Taking Into Account the Individual's Anatomy and Movement Patterns

The purpose of this study is to investigate and determine the optimal zone for implanting the cup component (the ball that sits in the joint socket) in a total hip replacement. Enrolled participants will have a series of X-rays analyzed before surgery to identify their individual optimal zone or cup orientation. This information will be provided to the operating surgeon, who may use this information to influence the placement of the cup implant. Follow-up X-rays taken after surgery will determine if the cup is within the suggested optimal zone. Questionnaires will be completed before and after surgery, and data on complications or issues with the surgery (including incidents of dislocation) will be collected after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Signed up for primary total hip arthroplasty procedures at the General Campus at The Ottawa Hospital.

Exclusion Criteria:

* Unwilling or unable to complete study requirements (either X-rays or questionnaires)
* Unwilling or unable to sign the informed consent form
Influence of Assistive Device Use While Performing Dual Task in Patients With Stroke

The primary purposes of the this three-year research proposal are to investigate the influence of assistive device use on dynamic balance and the associated attentional demands during standing and walking in patients with stroke

Research has shown the effectiveness of using ambulatory assistive devices to increase standing stability of patients with stroke in clinical practice (Maeda et al., 2001). However, literature has also suggested that manipulation of ambulatory assistive devices in dynamic motor tasks, such as walking, inevitably requires additional attention, even in healthy adults (Wright \& Kemp, 1992). Given that the majority of patients with stroke suffer from balance control difficulty, which subsequently increases their attentional demands associated with maintaining balance (Brown et al., 2002), it remains an important question as to whether the use of ambulatory assistive devices would take away some attentional resources that would otherwise be used for maintaining balance.

Eligibility Criteria:
Inclusion Criteria:

Healthy adults

* between 50 and 75 years old
* having no neuromuscular or musculoskeletal disorders that would jeopardize their balance control abilities
* being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital

Stroke patients

* between 50 and 75 years old
* hemiplegic or hemiparetic as a result of a single cerebral vascular accident
* medically stable with no ongoing complications
* independently walking without using any assistive device for at least 10 meters, and have the exercise endurance for at least 30 minutes
* having no serious hemianopsia, hemi-inattention or any obvious cognitive problems as evaluated with the Mini-Mental State examination
* being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital

Exclusion Criteria:

* unable to follow the order of the experimenters, and having serious comprehension and expression impairment
A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIP Study)

Spontaneous bacterial peritonitis (SBP) is a common complication of end-stage liver disease due to various causes. The initial anti-infective medication is appropriate and the patient's survival rate is closely related. Ascitic fluid bacterial culture takes a long time, the positive rate is low, it is difficult to guide the timely use of antimicrobial drugs, empirical medicine based on evidence-based medicine for SBP in patients with end-stage liver disease is essential. The American College of Hepatology and the European Society of Hepatology recommend the use of third-generation cephalosporins as the first choice of empirical therapy in patients with end-stage liver disease associated with community-acquired SBP. Patients with merger of hospital-acquired SBP with piperacillin / tazobactam or carbapenem +/- glycopeptide antibiotics is the first choice for empirical medication. There is no clear recommendation in China. In recent years, the conclusions of international clinical research in this area have been in disagreement with the recommendations. As a key factor in the selection of empirical antibiotics is local bacterial resistance data, these findings are difficult to evidence-based medicine for Chinese doctors. This project intends to observe the efficacy of different initial anti-infective regimens in Chinese patients with end-stage liver disease with SBP and 30-day and 60-day non-liver transplant survival rates, providing evidence-based medical evidence for the empirical use of such patients.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the end-stage liver disease part of the type of standard (including slow plus acute liver failure, chronic liver failure, cirrhosis decompensation);
2. age\> 18 years old
3. ascites nucleated cell count\> 250 × 106 / L;
4. Unable to obtain ascites specimens or ascites nucleated cells count does not meet the conditions of 3) are required abdominal examination tenderness (+), rebound tenderness (+), abdominal ultrasound can detect ascites, and procalcitonin (PCT) \> 0.5ng / ml, hs-CRP\> 10ng / ml

Exclusion Criteria:

1. history of abdominal surgery within 4 weeks;
2. secondary peritonitis;
3. tuberculous peritonitis;
4. Malignant tumor;
5. patients who use hormones or immunosuppressants;
6. AIDS patients;
7. heart failure or respiratory failure;
8. merge other parts of the infection;
9. died within 48h;
10. liver transplantation during observation;
11. Diagnosis of spontaneous bacterial peritonitis is the use of carbapenems or third-generation cephalosporins / enzyme inhibitors, piperacillin / enzyme inhibitor antibiotics
Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement

Salivary duct stent placement is a common practice to maintain duct patency after salivary duct repair or interventional sialoendoscopy; procedures performed to manage salivary duct pathology such as stenosis, traumatic injury or most commonly salivary duct stones. It is common practice for patients to receive perioperative antibiotics while undergoing interventional sialoendoscopy and postoperative oral antibiotic therapy with Clindamycin or Augmentin for 10-14 days, if a short term (2 week) salivary duct stenting was considered necessary due to the nature of the intervention. However, In reviewing the literature, there are controversial trials that indicate post-operative antibiotics may not be best practice in all surgical scenarios, as the adverse events ie. gastrointestinal disturbances, nausea, Clostridium difficile (C.diff) infection and antibiotic resistance over time surrounding overuse of antibiotics may outweigh the clinical need for the antibiotic regiment and the chances of post-operative infection.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (18 years of age or older) who are undergoing salivary duct surgery and stent placement at Our Lady of the Lake Regional Medical Center

Exclusion Criteria:

* Patients who are unwilling to consent to the study and/or to being placed in a randomized arm of either receiving post-operative antibiotics or not receiving post-operative antibiotics
* Patients with acute infections at the time of surgery
* Patients who are immunocompromised
* Patients who are recruited but then have early dislodgement of the stent
* Patients who do not complete their postoperative antibiotic therapy due to intolerance or antibiotic side effects. However, data on these patients will be recorded to provide an observational results that will support the need for this investigation on antibiotic use.
* Patients who are in the non-post operative antibiotic arm but choose to put themselves on antibiotics without consultation from the physician
Itraconazole to Prevent Recurrent Barrett's Esophagus

Recurrent Barrett's esophagus (BE) that occurs at the rate of 12.4%/year is the Achilles heel of the endoscopic treatment of high-risk BE. Over time, after eradication, BE ultimately recurs in as many as 30-50% of the patients putting them at risk for esophageal adenocarcinoma (EAC), thereby undoing the benefits of an effective initial therapy. Also, recurrences need retreatments that increase costs and complications including strictures and refractory ulcerations. A therapy to prevent recurrent BE does not currently exist. Itraconazole with its ability to inhibit important molecular pathways related to BE development could enhance the long-term effectiveness of endoscopic eradication of high-risk BE, thereby promoting a long-term cure


Eligibility Criteria:
Inclusion Criteria:

* Patients with Barrett's esophagus with either confirmed low-grade dysplasia or high grade dysplasia or intramucosal/T1 adenocarcinoma (see histologic review) being considered for endoscopic treatment. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

* Inability to provide informed consent, New York Heart Association class III or IV congestive heart failure (CHF), liver function tests (LFT)\>3X upper limit of normal, drug allergy to itraconazole, pregnancy, prolonged QTc (\>450 ms for men and QTc\>470 ms for women) or critical drug interactions with other medications metabolized by cytochrome P450(CYP)3A4.
The Effect of Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome in Aged 60 or Older

The Effect of Feedback on Physical Activity Surveillance using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome in Aged 60 or older; a 12-Week Randomized Control Study

Research on whether wearable device interventions can effectively prevent metabolic syndrome remains insufficient. This study aimed to evaluate the effect of feedback on clinical indicators in patients with metabolic syndrome aged 60 or older on activities measured using wearable devices, such as smartphone apps. Patients aged 60 or older diagnosed with metabolic syndrome were recruited and prescribed to survive for 12 weeks using wrist-worn devices (B.BAND, B Life Inc, Korea). The block randomization method was used to distribute the participants between an intervention group (n=20) and control group (n=20). In the intervention group, an experienced study coordinator provided feedback on physical activity to individuals through telephone counseling every other week.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with metabolic syndrome by a doctor.
* Aged 60 or older.
* A person who understands the clinical trial process and signs the consent form
* Possession of a smartphone and a daily mobile phone user for the past 3. months and expected to use for more than 3 months.
* A person who agrees to provide the data on the amount of physical activity measured and collected by a wearable device.
* A person who can exercise at an intensity more than walking for 12 weeks.

Exclusion Criteria:

* Under the aged 60.
* A person who does not agree to provide data on physical activity.
* Those who who are judged to have difficulty in exercising such as walking due to uncontrolled diabetes, high blood pressure or serious cardiovascular disease.
* A person who is not used to or is reluctant to use a smartphone app.
* Those who have difficulty wearing wearable devices due to skin diseases around their wrists.
* A person who is expected to have an unintended change in weight over the next three months due to current pregnancy and planning, thyroid disease, cancer, etc.
FLX475 Combined with Pembrolizumab in Patients with Advanced or Metastatic Gastric Cancer

This clinical study is a Phase 2, open-label study to assess the efficacy, safety profile of FLX475 combined with pembrolizumab in patients with advanced or metastatic gastric cancer. This study is designed to assess the potential anti-tumor activity when administered at the 100mg QD of FLX475 with pembrolizumab and will be conducted (2) cohorts as detailed below.

* Cohort 1: EBV negative / CPI naïve gastric cancer subjects who have progressed on at least 2 prior systemic treatments for advanced or metastatic gastric cancer
* Cohort 2: EBV positive / CPI naïve gastric cancer subjects who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer

Approximately 90 subjects may be enrolled across two cohorts to examine the safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* All patients must have histologically or cytologically confirmed, advanced, relapsed or metastatic gastric or gastroesophageal junction adenocarcinoma
* Patient must have one of the following diagnoses to be eligible for enrollment into cohorts:

  * Cohort 1: Checkpoint inhibitor naïve Epstein-Barr Virus negative (EBV-) gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer
  * Cohort 2: Checkpoint inhibitor naïve Epstein-Barr virus positive (EBV+) gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Patient must have at least one measurable lesion at baseline by computed tomography(CT) or magnetic resonance imaging (MRI)
* Tumor available for biopsy

Exclusion Criteria:

* Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), any history of discontinuing from that treatment due to Grade 3 or higher immune-related adverse event (irAE)
* Patient with MSI-H status
* Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or clinical symptoms of active pneumonitis
* Significant cardiovascular disease. New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or chronic Grade 3 hypertension.
* Significant screening electrocardiogram (ECG) abnormalities
* Has had an allogenic tissue/solid organ transplant
Ozonated Water Irrigation as an Adjunct to Periodontal Therapy

The use of chlorhexidine or ozonized water in periodontal pockets accompanying NPT can provide a significant improvement in probing pocket depths compared to conventional treatment. However, the effect of subgingival ozonized water applications on VEGF and IGF levels, which are thought to play a role in the pathogenesis of periodontal disease and periodontal regeneration, should be examined.

Background: This study aims to evaluate the effects of subgingival ozonated water irrigation as an adjunct to non-surgical periodontal treatment on clinical and biochemical parameters of patients with moderate and severe periodontitis.

Methods: A total of 72 stage II and Stage III periodontitis patients were included in the study. The systemically healthy patients which were between the ages of 19 and 58 were treated non-surgically. At the end of each visit concerning periodontal treatment, the pocket of each tooth was irrigated with a sterile plastic syringe (10 mL per quadrant) with a blunt tip containing ozonated water (OW; ozone groups), 0.12% chlorhexidine digluconate (CHX groups) or saline (C; control groups) for 30-60 s. Periodontal clinical parameters, gingival crevicular fluid (GCF) vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) levels were evaluated at baseline and 8 weeks after periodontal treatment. All statistical data were analyzed using SPSS software.

Eligibility Criteria:
Inclusion Criteria:

* good general health without a history of systemic disease (hyperthyroid, diabetes, etc.)
* ≥ 20 teeth
* having not received periodontal treatment within the past 6 months
* no contraindication for periodontal therapy and ozone application
* presenting moderate-to-severe periodontitis according to criteria outlined by 2017 World Workshop.

Exclusion Criteria:

* smoking
* use of anti-inflammatory and antibiotic drugs within the past 6 months
* pregnancy, lactation or use of oral contraceptives