cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Nelfinavir and Chemoradiation for Pancreatic Cancer

This study is designed to evaluate if nelfinavir works as a radiation sensitizer in combination with gemcitabine (a chemotherapy). We are also looking to establish the maximum dose of gemcitabine that is tolerated with the nelfinavir and radiation therapy, so the dose of gemcitabine is increased based on how previous trial participants tolerated their dose of gemcitabine.

This trial utilizes gemcitabine (a chemotherapy agent commonly used for pancreatic cancer) and nelfinavir (an anti-retroviral agent FDA-approved for use in HIV+ patients) in addition to radiation therapy for treatment of borderline resectable pancreatic cancer. The trial seeks to determine the maximum tolerated dose of gemcitabine when administered concurrently with radiation therapy and 1250 mg nelfinavir twice daily.

The gemcitabine and radiation is standard; the dose of gemcitabine does vary nationally and internationally as to what the 'best dose' is. Administered weekly, doses can range from 400 mg/m2 to 1000 mg/m2. Thus, this is why the proposed clinical trial escalates the gemcitabine.

The gemcitabine will be administered weekly during radiation therapy for a total of 6 cycles. After completion of radiation therapy, the subjects will be evaluated by the surgeons for resectability. This ends the active portion of the clinical trial; the subjects will be followed for long-term progression free survival and for overall survival.

Primary endpoints for this trial are identifying the maximum tolerated dose of gemcitabine when administered concurrently with nelfinavir and radiation therapy (the phase I portion of this study) and the rate of resectability (typically, utilizing gemcitabine plus radiation therapy will convert up to 30% of patients from borderline resectable to resectable) for the phase II portion of the study.

Interim analyses and stopping rules are in place if an effect size is not observed in the therapeutic group compared to published reports of response to standard chemoradiation for borderline resectable cases.

Eligibility Criteria:
Closed to accrual.
Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice

Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent.

Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent use in real-world percutaneous coronary intervention

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* PCI and stent implantation indication according to ESC Myocardial Revascularization Guidelines
* 1 or more stenosis at native coronary anatomy, in a 2-4mm vessel size, where 1 or more ihtDEStiny® drug eluting stent were implanted (or attempted to be implanted).
* Informed consent signed after PCI

Exclusion Criteria:

* Patient refusal to participate in the study
* Pregnancy
* Other DES implantation during index PCI, or 30 days before of after index PCI
* PCI at surgical grafts
* PCI for in-stent restenosis
* Killip class 3-4 Acute Coronary Syndromes (ACS)
* High bleeding risk with dual antiplatelet intolerance for at least 3 months (or 6 months for ACS PCI)
* Allergy or hypersensitivity to sirolimus
* Patients requiring surgery (cardiac or non-cardiac) in the next 3 months after index PCI
* Patients with life expectancy \<2 years
* Patients included in other trials or clinical studies
Efficiency of Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures

The purpose of this study is to determine whether laser internal urethrotomy (IU) is as efficient as cold knife internal urethrotomy for treatment of anterior urethral strictures regarding post operative urination outflow, stricture recurrence rate and possible post- operative complications

The current surgical treatment for anterior urethral stricture includes internal urethrotomy (IU) by cold knife. Recurrence rate after such procedure is quoted as 35-70% in 2 to 5 years follow-up. Possible surgical alternative procedures include: open surgical urethral re-construction, urethral stents usage \& laser IU. According to existing data (Nd-YAG laser- retrospective) the recurrence rate after laser IU is far better comparing to cold knife urethrotomy. The current research intends to address this question using prospective randomized methods.

Eligibility Criteria:
Inclusion Criteria:

* Men over 18 years old with urethral stricture

Exclusion Criteria:

* S/P urethral reconstruction
* Posterior urethral strictures
* Children
Neurorehabilitation of the Hand

Stroke is the number one cause of adult disability in the world. Due to the neurological damage from stroke, a vast majority of individuals suffer from hand function disability (\~70%). To improve hand function and overcome challenges from this disability, IRegained has developed the MyHandTM system, a connected mechatronic device with programmed proprietary hand function training protocols developed through deep research in neuroplasticity that provide targeted hand function therapy. When these therapeutic protocols are provided in a gamified format, it enhances the patient engagement and motivation, thereby enabling effective therapy administration with the required intensity and repetition to improve hand function. Participants who have sustained a stroke 6 months or earlier will be eligible to participate in this study, and will undergo hand function therapy for one 1-hour/session, 5 times/week, over a 3-week duration, for a total of 15 sessions. Therapy will be administered through with specific hand functions in a gamified format to enhance greater function in the hand and thereby help patients gain greater independence in performing activities of daily living. This research project will aim to understand the extent to which this approach to therapy impacts patient motivation and engagement in order to develop the most efficient and effective mode of therapy.


Eligibility Criteria:
Inclusion Criteria:

* sustained a single stroke
* aged between 30-85 years of age.

Exclusion Criteria:

* Participants with severe spasticity or contractures,
* have other musculoskeletal or neuromuscular disorders that compromises sensation or other neuromuscular parameters
* participants who are unable to provide consent to participate
Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer

Primary objective:

To correlate the blood/urine metabolomic biomarkers with PET/MR imaging.

Secondary objectives:

1. To evaluate the sensitivity and specificity of the PET/MR in diagnosis of prostate cancer.
2. To examine the diagnostic performance among subgroups of defined high-risk and low-risk subjects.
3. To interrogate the metabolomic alterations with the molecular PET/MR to develop workable panel biomarkers.

According to 2015 National Comprehensive Cancer Network (NCCN) guideline, medical imaging plays important roles for detection and staging for PCa, in addition to blood or urine biomarkers. Although there are a number of very different diagnostic imaging methods, e.g. transrectal ultrasound (TRUS), computed tomography (CT), magnetic resonance (MR) imaging and spectroscopy, or 18F-FDG positron emission tomography (PET), none of these have gained a dominant role as the optimum method for all clinical scenarios.The recently added armamentarium, PET/MR, might improve diagnosis in this regard.

Therefore, we conduct this trial to identify the ability of \[11C\]Choline PET/MR to evaluate the patients with prostate cancer, especially under the circumstance of elevated PSA level.

Eligibility Criteria:
Inclusion Criteria:

* Males
* 40-85 years of age
* Patients with a biopsy-proven or clinically highly suspected prostate adenocarcinoma, or benign prostatic hyperplasia
* Able to tolerate \[11C\]Choline PET scan and MRI scan
* Written informed consent from the patient

Exclusion Criteria:

* Acute prostatitis or non-urologic bacterial infection requiring medical treatment within the last 3 months.
* History of AIDS in the period prior to the screening.3
* Contraindications to \[11C\]Choline PET/MR scans

  1. Surgical implants including pacemaker implants, cochlear implants, dentures held in place by magnets imbedded in the gums and aneurysm clips except those inserted at CGMH
  2. Metallic prosthesis of the hip or pelvic region
  3. Renal function impairment with estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2
  4. Claustrophobia
  5. Medical drugs with choline
  6. Previous allergy to carbon-labeled radionuclide
* Active other malignancy within the last 2 years
* Subject which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety.
* Prisoners or patients with mental illness
Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design

The overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (IntelliCare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital health interventions to improve outcomes. To achieve these goals, an innovative experimental study design, known as a Sequential, Multiple Assignment, Randomized Trial (SMART), will be used to test the effects of the IntelliCare apps on symptoms of depression and anxiety, as well as the added value of human support to improve participant engagement. 313 breast cancer survivors diagnosed within the past 5 years and who screen positive for elevated symptoms of depression and/or anxiety will be recruited. Participants will initially be randomized to receive the IntelliCare apps or app-delivered patient education (control) for 8 weeks, and the impact of the IntelliCare apps on reducing symptoms of depression and anxiety in breast cancer survivors relative to control will be tested (Aim 1). We will monitor the app usage data of participants who receive the IntelliCare apps. Those who are high-engagers will continue to use the apps with no change. Those who are low-to-moderate engagers will be rerandomized after 1 week to either receive added coaching vs. not (i.e., no change) in addition to the apps. The hypothesis is that added coaching to address barriers to app usage will lead to greater engagement with the apps (Aim 2), for low-to-moderate engagers. Finally, semi-structured exit interviews will be conducted with participants that receive the IntelliCare apps and coaching. Interviews will capture survivors' perceptions about the extent to which, and how, tailoring the apps and coaching specifically for breast cancer survivors may improve intervention outcomes and engagement (Aim 3).


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years (age 19 if in Nebraska, given age of consent);
2. 0-5 years post-diagnosis of Stage I, II, or III female breast cancer;
3. elevated symptoms of depression as measured by the Patient Health Questionnaire-8 (PHQ-8) score ≥ 10 and/or symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) score ≥ 8.

Exclusion Criteria:

1. Taking antidepressant medication and have had an appointment to adjust the dosage over the past 2 weeks;
2. mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care;
3. do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later);
4. cannot read and speak English (current intervention only available in English).
Efficacy and Safety of Saussurea Involucrata Liquid Tonic in Patient With Postpartum Rheumatism

This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The study aims to evaluate the efficacy and safety of Involucrata Liquid Tonic in patients with Postpartum Rheumatism.


Eligibility Criteria:
Inclusion Criteria:

* Women experience joint and muscle pain, soreness, heaviness, numbness, etc. within 1 year after childbirth, miscarriage or induction of labor; with or without sensitivity to external stimuli such as wind, cold, moisture, etc., which may be induced or aggravated by emotional fluctuations
* Meets the diagnostic criteria for Yang Qi deficiency and cold-dampness syndrome.
* Age 18-50
* Pain VAS score ≥4cm

Exclusion Criteria:

* Those in the puerperium (within 42 days after delivery).
* Those who have rheumatoid arthritis, ankylosing spondylitis, osteitis density, polymyalgia rheumatica, reactive arthritis, myofasciitis, fibromyalgia syndrome and other rheumatic immune diseases before pregnancy.
* Severe abnormalities in blood routine and electrocardiogram, active liver disease or abnormal liver function, AST, ALT or GGT higher than 1.2 times the upper limit of normal value; abnormal renal function, serum creatinine (sCr) higher than 1.2 times the upper limit of normal value. Patients whose white blood cell count \< 3.0×109/L, or hemoglobin \< 90 g/L, or platelet count \< 100.0×109/L in routine blood examination
* Combined with serious underlying diseases, primary diseases and postpartum diseases, such as uncontrollable hypertension, heart disease, kidney disease, puerperal fever, mastitis, moderate to severe postpartum depression diagnosed by a psychiatric department, etc.
* Those who have a history of using glucocorticoids, immunosuppressants and other drugs within 4 weeks.
* Those who are allergic to the ingredients of the test drug or have a high-sensitivity constitution.
* Existing or past history of cancer.
* Those who have participated in other clinical drug studies in the past 2 months.
* Those who do not use the medication as prescribed, or who have incomplete information that affects the judgment of efficacy.
A New Treatment Protocol for Paediatric Mandibular Condylar Fractures

This study aim to evaluate the clinical and radiographic outcomes of mandibular condylar fractures in pediatrics treated simply with a mandibular manipulation technique accompanied by mouth opening training.

There is a consensus on nonsurgical approach is a priority for paediatric condylar fractures, but a recognized nonsurgical method for treating children with condylar fractures is still a highly debated theme. The purpose of this study is to investigate the effect of a new nonsurgical method simply using a mandibular manipulation technique and mouth opening training in managing children with condylar fractures.

Spiral computed tomography (CT) or Cone beam computed tomography (CBCT) will be taken before treatment when the patients present to the department. Condylar fracture classification is defined according to SPIESSL \& SCHROLL.

These patients are then treated termly with a mandibular manipulation technique reported by Farrar, which is an effective treatment method to reset the physiological positional relationship between condyle and disc. Neither intermaxillary fixation nor guiding elastics will be used after hand manipulation. Then patients are told to persist in mouth opening training at home everyday. The mouth opening training is performed as follow: patients are told to try to close his mouth in intercuspal position at first, then open their mouth as wide as possible(the reference maximal mouth opening is as wide as the mouth opening after treatment in last time), then closed back to the intercuspal position again. Patients are recommended to follow up at every week at first two months, then every 2 weeks at third months, 6th months, 1 year after first treatment, then yearly afterward. The mandibular manipulation is performed at every follow-up. Meanwhile, the maximal mouth opening (MMO) is recorded before and after hand manipulation treatment. So do the occlusion status, deviation during opening, as well as subjective symptoms of temporomandibular joints. At first moth, 3rd month, 6th month, 1 year, then every year after first treatment, CBCT is performed.

Eligibility Criteria:
Inclusion Criteria:

* suffer mandibular condylar fracture
* voluntary Patient
* with no concomitant displaced jaw fractures
* the fracture-treatment interval time is less than 2 months

Exclusion Criteria:

* Life-threatening Patient
* Patient can not do the Guide Line
Colorectal Cancer Awareness, Research and Education and Screening - Rural Expansion, Access and Capacity for Health

This study is to assess the impact of the CARES-REACH intervention on colorectal cancer screening rates.

This study will not accrue individual patients. Instead, the investigators are collecting process data from health care providers to determine the procedures that impact or help to increase colorectal cancer screening rates.

Eligibility Criteria:
Inclusion Criteria:

* Staff and providers working in a clinic within one of the two participating systems
* Involved in adult patient care

Exclusion Criteria:

* Staff and providers who are not engaged in directing or decisions related to colo-rectal cancer screening
A Study to Assess Learning Performance in Patients With Schizophrenia and Young and Elderly Healthy Volunteers

The purpose of this study is to measure and contrast implicit and explicit learning performance in patients with schizophrenia relative to young and elderly healthy volunteers.

This is an exploratory study involving schizophrenic patients (Group 1) and young and elderly healthy volunteers (Group 2 and 3 respectively). No investigational medicinal product will be administered. For all participants enrolled (Group 1 to 3) the study will consist of an eligibility screening examination (from Day -21 up to and including Day 1) and 3 cognitive assessment days. Cognitive assessments will be made on 2 subsequent days (Days 1 and 2) which are separated by overnight sleep. In addition, a session will be performed on Day 7. Completion of the cognitive test batteries can occur at any time during the day provided that the completion time is comparable on all test days. For each participant, the maximal study duration will not exceed 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Group 1 (patients with schizophrenia):
* Be a man or woman between 18 and 55 years of age, inclusive
* Has a known history of schizophrenia of at least 12 months by the referring psychiatrist
* Receives stable antipsychotic drug therapy (maximally 2) for at least 6 weeks prior to screening
* Medically stable on the basis of clinical judgment by the investigator
* Group 2 (young healthy volunteers): be a healthy man or woman between 18 and 55 years of age, inclusive
* Group 3 (elderly healthy volunteers): be a healthy man or woman between 65 and 85 years of age, inclusive
* All participants (Group 1 to 3) must be capable of completing the cognitive test battery

Exclusion Criteria:

* Receives treatment with benzodiazepines, tricyclic antidepressant or anticholinergics
* Has a positive urine screen for drugs of abuse or alcohol breath test
* Has a recent history (within previous 6 months) of alcohol or drug abuse
* Has psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the participant to comply with the study requirements
* Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the participant or the study or prevent the participant from meeting or performing study requirements
* Group 1 only: a diagnosis of substance dependence within 3 months prior to screening evaluation (patient with a positive drug screen at screening may be included provided use does not lead to a diagnosis of substance dependence and patient consents to abstain from illegal drugs at any time during the study)
Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.

Multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.

Eligibility Criteria:
Inclusion Criteria:

* Post menopausal women,
* Ages 35 or older,
* Frequent moderate to severe hot flushes,
* Qualifying general medical health

Exclusion Criteria:

* Disqualifying gynecological disorders,
* Disqualifying dermatological disorders,
* Disqualifying concurrent conditions
The Application of a Mask in Patients With Severe Covid-19 Already Treated With High-flow Nasal Cannula.

Patients with severe hypoxemic respiratory failure due to Covid-19 are often treated with oxygen delivered through a high-flow nasal cannula (HFNC). This is according to guidelines. We have made the clinical observation that oxygenation sometimes improves when a mask (e.g. oxygen mask or inhalation mask) is applied on top of the HFNC. This has quickly become a clinical routine at intermediary care units at our hospital, where patients with HFNC are offered to test the intervention (mask + HFNC) as part of clinical routine.

This study aims to evaluate this new routine in a standardised way.

Patients with severe covid-19, treated with HFNC, will be approached for consent. If inclusion critera and no exclusion criteria are fulfilled, baseline measurements will be taken without mask, including arterial blood gas analysis (ABG)

Then a simple oxygen mask will be applied covering nose and mouth, without providing supplemental oxygen. After 30 minutes with mask + HFNC, new measurements will be taken, including ABG.

After 30 minutes, the mask is removed and when steady state occurs, new measurements will be taken, without ABG. Then, the patients could continue using the mask as part of clinical routine

Eligibility Criteria:
Inclusion Criteria:

* Verified Covid19 infection
* treatment with HFNC
* Estimated P/F ratio of ≤ 13 KPa

Exclusion Criteria:

* language barrier
* unable to provide consent
* risk of deterioration due to study
Randomized Controlled Trial Comparing Postoperative Pain Following TAH With GA vs. Combined GA + SAB

The investigators hypothesize that a spinal anesthetic administered prior to the induction of general anesthesia will result in reduced need for pain medication and reduced postoperative pain, as well as reduced hospital stay following a total abdominal hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists' (ASA) I and II patients undergoing elective Total Abdominal Hysterectomy at the Saskatoon City Hospital
* Lower transverse abdominal incision

Exclusion Criteria:

* BMI \> 40
* The TAH is treatment for cancer
* A history of regular opioid use
* Any medical condition that would make a spinal inadvisable,
* An allergy or medical condition that would make it inadvisable to receive the drugs used in this study (eg. Peptic ulcer disease), or
* If you will also be having a salpingo-oophorectomy).