cyrilzakka/clinical-trials huggingface dataset:
FemVue and Tubal Patency

A thorough infertility evaluation commonly involves determining whether a woman's fallopian tubes are patent. The two most often utilized methods of evaluating the fallopian tubes are hysterosalpingogram (taking an X-ray of the pelvis after injecting dye through the uterus and fallopian tubes) and laparoscopic chromopertubation (a surgical procedure in which dye is visualized passing through the fallopian tubes).

The FemVue Saline-Air device is a new method of assessing tubal patency. The device utilizes a mixture of saline and air bubbles that can be seen passing through the fallopian tubes by ultrasound. FemVue can be efficiently performed in a physician's office and is minimally invasive. Unlike hysterosalpingogram and laparoscopic chromopertubation, it does not carry the risks of anesthesia or surgery, and doesn't expose the patient to radiation or contrast. It does, like the other two methods, carry a small risk of infection.

This study will involve using the FemVue device on patients under anesthesia in the operating room before they undergo scheduled laparoscopic chromopertubation, the gold standard for evaluating tubal patency. The two methods will be compared to determine the accuracy of the FemVue device.

Subjects who agree to participate will have their tubes evaluated by using the FemVue Saline-Air device and laparoscopic chromopertubation.

Eligibility Criteria:
Inclusion Criteria:

* Pts ages 18-45 undergoing planned diagnostic laparoscopy with chromopertubation.

Exclusion Criteria:

* Adnexal mass \> 3.5cm or uterine size greater than 10 wks
Impact Study of Workplace Mental Health Education on Early Intervention for Healthcare Workers With Mental Health Issues

The purpose of this study is to compare the impact of a new workplace-based mental health peer education program with standardized mental health literacy training on early intervention and support for healthcare employees with mental health issues. Participants are healthcare workers who volunteer to participate in one of the two twelve-hour group education programs. It is hypothesized that the customized "Beyond Silence" peer education program led by trained staff members with personal experience of mental ill-health will be more effective in reducing the stigma associated with help-seeking and help-outreach regarding mental ill-health in the workplace. The comparison group is a standardized mental health literacy training program that has been widely implemented in both Canada and around the world. Change in help-seeking/help-outreach behavior, mental health knowledge and beliefs of participants will be assessed at three-month intervals; before, after and three months following the educational intervention.

The target sample of 200 employee participants will be recruited from two healthcare organizations. The Beyond Silence program is based on principles of contact-based education, and will include six 1.5-2 hour in-person sessions conducted every other week, interspersed with five online resource sessions. The Mental Health First Aid training is a standardized, 12-hour evidence-based mental health literacy training program that has been implemented in a range of national and international settings. This program is typically offered over two full days.

Eligibility Criteria:
Inclusion Criteria:

* Employee (full-time, part-time or contract) in the participating healthcare organization
* Willing and able to participate in 12 hours of training outside of paid work hours
* Able to understand and speak English

Exclusion Criteria:

* Prior training in either of the two educational approaches
Geriatric Head Trauma Short Term Outcomes Project

This prospective observational study will examine the incidence of intracranial hemorrhage. The investigators will compare patients on anticoagulant and/or antiplatelet therapy with head trauma compared to patients not on these medications. While many studies have sought to quantify the incidence of intracranial hemorrhage in these patients, there is considerable controversy regarding their care and what to do after an initial negative head CT in anticoagulated geriatric patients who have experienced head trauma.


Eligibility Criteria:
Inclusion Criteria: Patients seen in the emergency department for head trauma

Exclusion Criteria: Penetrating head trauma
Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy

This study will measure the activity of natural killer (NK) cells using the in vitro diagnostic device NK Vue in high risk subjects (Quebec risk categories P2, P3 and P4) scheduled for colonoscopy.

In Quebec, subjects in risk category P2 are scheduled for colonoscopy due to high suspicion of cancer based on imaging, sigmoidoscopy or clinical exam. Subjects in categories P3 and P4 are scheduled for colonoscopy for one of the following reasons: suspicion of having an inflammatory bowel condition, rectal bleeding, presence of occult blood in stool, unexplained iron deficiency anemia, recent change in bowel habits, family history of CRC or adenomatous polyps or other hereditary colorectal diseases. Often, colonoscopy is not performed within the government-prescribed recommended delays, leading to waiting lists for the procedure. Analysis of NK cell activity may help identify those at risk for the presence of CRC and therefore help prioritize subjects on these waiting lists, help manage resources and help convince subjects to have a colonoscopy. Furthermore, all subjects will undergo a FIT, allowing a determination of the ability of each test alone, as well as a combination of NK Vue and FIT, to predict outcome on colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 40 and over who are scheduled to undergo colonoscopy at the research site and who are classified in category P2, P3 or P4.
2. Subjects who provide informed consent to participate in the trial

Exclusion Criteria:

1. Lack of understanding and/or participation due to illiteracy or inability to comprehend English or French
2. Subjects in category P3 who are there due to knowledge or suspicion of an inflammatory bowel disease
3. Previous history of cancer (any type) or active infection (as declared by the subject at the time of enrolment)
4. Currently participating (or participated within the previous 120 days) in an investigational therapeutic study (in case of interference of the drug with the immune system)
5. Subjects who underwent their colonoscopy and

   1. the colonoscopy preparation was judged insufficient
   2. the colonoscopy itself was judged insufficient or incomplete by the doctor
   3. the biopsy sample was lost and cancer could not be pathologically confirmed
   4. the colonoscopy detected an inflammatory bowel disease
6. Female who is pregnant, nursing, or of child-bearing potential while not practicing effective contraceptive methods.
Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study

The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are:

* The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests.
* The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria.
* The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes.
* The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients.

Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.
* Glycated hemoglobin (HbA1c) \< 11.0%.

Exclusion Criteria:

* Insulin dependent diabetes;
* Active infections, antibiotics-using, inflammatory bowel disease, irritable bowel syndrome, or other severe gastrointestinal organic disease;
* Severe diabetic complications;
* Thyroid disease, malignancies, severe cognitive impairment and mental disease;
* Alcohol or substance abuse;
* Pregnancy or lactation.
Egg Donor Recipient Characteristics Preferences

To identify the characteristics in an egg donor that are important to a recipient and to see if those characteristics change over time.

No study has explored how recipients' attitudes and reactions change over time regarding the selection criteria for their donors. Consequently, programs have no guidance in how to counsel prospective recipients as to whether their donor preferences will change over time. Participants will complete a survey at 4 points in time as they go through the process of selecting an egg donor and pursuing a pregnancy using that egg donor.

Eligibility Criteria:
All patients planning to undergo an egg donor cycle are eligible- there are no specific inclusion or exclusion criteria beyond that.
Experimental Biomarker Study for Pain Thresholds

The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by UVB (ultraviolet B) irradiation and topical capsaicin.


Eligibility Criteria:
Inclusion Criteria include:

1. Signed informed consent obtained.
2. Males aged 18 to 45, inclusive.
3. Body weight ranging from 50 to 100 kg and BMI ranging from 18 to 32 (kg/m2), inclusive.
4. Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.

Exclusion Criteria include:

1. Current or recent (within 5 years) history of drug or alcohol abuse.
2. History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
3. Any history of frequent nausea or emesis regardless of etiology.
4. Any history of allergic-type reactions to sulfonamides, or any experience of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDS.
5. Subjects who do not develop erythema at the maximum dose of the UVB source (MED determination for UVB model) will be excluded from the study.

Other protocol-specific inclusion/exclusion criteria may apply.
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as first-line endocrine therapy in postmenopausal patients with metastatic or recurrent hormone receptor-positive, HER2-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with postmenopausal metastatic or recurrent breast cancer
2. Patients with ECOG Performance Status 0 to 1
3. ER-positive, PgR-positive and HER2-negative patients

Exclusion Criteria:

1. Patients are unable to swallow oral medications
2. Patients with severe complication
Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees

The Implantable Myoelectric Sensors (IMES) system is an investigational device intended to improve signal quality and consistency of myoelectric signals for prosthetic control in individuals suffering from an above elbow (transhumeral) amputation. The sensors pick up myoelectric signals intramuscularly and therefore signal quality is not affected from electrode replacement, perspiration, or artefacts.

Implantable Myoelectric Sensors (IMES), the surgical tools implantation, and the external equipment used to control an electromechanical prosthetic device, together comprise the IMES System (investigational product, medical device).

Each IMES acts as an independent differential amplifier consisting of custom electronics housed within a biocompatible, hermetically sealed ceramic cylinder with metal end caps. The end caps serve as electrodes for picking up EMG activity during muscle contraction. Reverse telemetry (via a coil around the arm) is used to transfer data from the implanted sensor, and forward telemetry is used to transmit power and configuration settings to the sensors. The coil and associated electronics are housed within the frame of a prosthesis. A control system that sends data associated with muscle contraction to the motors of the prosthetic joints is housed in a belt-worn, battery-powered device. A cable attaches the control unit to the prosthetic frame.

An IMES is implanted into each targeted muscle that will be used to control a function of the prosthetic arm. Two IMES devices are needed for each DOF. For example, one device would control fingers opening and another device would control fingers closing.

Eligibility Criteria:
Inclusion Criteria:

* unilateral transhumeral amputation
* can speak and comprehend German
* undergone amputee rehabilitation, including being trained to wear and use a conventional myoelectric prosthesis
* residual upper limb meets the criterions for TMR surgery

Exclusion Criteria:

* Known genetic neuromuscular disorder
* bleeding or clotting disorder
* active implant
* any metal fragments or metal implants located within the residual upper limb stump
* Female patients if pregnant or breast-feeding
Clinical Learning Study for a Mobile Smoking Cessation Program

The purpose of this study are to obtain learnings regarding the Digital Therapeutic (DTx) experience of Clickotine, including acceptability and preference of the overall program and specific DTx components, as well as to obtain learnings related to adult participants' use of the DTx for smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Age 18 and older.
* For cigarette smokers: Smokes at least 5 cigarettes a day. For dual-users: Smokes cigarettes AND uses e-cigarettes, with the following additional criteria:

  * Smokes at least 5 cigarettes a day
  * Vaping sessions, when they occur, must be for at least 10 minutes (15 puffs)
* Fluent in written and spoken English (confirmed by ability to read and comprehend the informed consent form)
* Lives in the United States.
* Is the solo user of an iPhone with iPhone operating system (iOS)13 or greater capabilities or a smart phone with an Android operating system (OS) 9 or greater capabilities.
* Has an active email address.
* Willing and able to receive SMS text messages on their smartphone and email messages.
* Have access to internet connection during the study duration.
* Able to confirm download of installed DTx on baseline date.
* Willing and able to comply with study protocol and assessments.
* Is willing and able to self-identify sessions of cigarette smoking (1 or more consecutive cigarettes) or vaping (approximately 15 puffs or around 10 minutes in duration) and log those sessions.
* Self-reported comfort with and ability to use smartphone apps/programs.

Exclusion Criteria:

* Prior use of Clickotine.
* Currently using a software app for smoking cessation.
* Lifetime diagnosis of schizophrenia, psychotic disorder, or pervasive developmental disorders, as per participant self-report.
* Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrine, neurologic (including history of severe head injury with loss of consciousness), immunologic, or hematologic disease, as per participant self-report.
* Other significant medical condition that, in the opinion of the Investigator or study sponsor, may cofound the interpretation of device efficacy, safety, and tolerability.
* Current use of tobacco-containing products other than cigarettes or e-cigarettes (e.g. snuff, chewing tobacco, cigars, or pipes).
* Does not have or is unwilling to create a PayPal account
Effect of Vitamin D Supplementation on Infliximab Response in Patients With Crohn's Disease

Background: It remains uncertain whether vitD3 supplementation is beneficial for remission of Crohn's disease (CD). The influence of vitD3 supplementation on Infliximab (IFX) efficacy was retrospectively analyzed in Chinese CD patients. Methods: Patients with moderate-to-severe CD, who were bio-naïve and prescribed with IFX treatment for at least 54 weeks were recorded. VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period. Disease activity was assessed using Harvey-Bradshaw Index (HBI). Serum cytokine profiles were quantitatively analyzed in a subset of all patients at baseline and 54-week after intervention.


Eligibility Criteria:
Inclusion Criteria:

* moderate-to-severe CD
* Treated with Infliximab
* bio-naïve at the time of diagnosis

Exclusion Criteria:

* had recent supplementation of vitD3
* had prior or concomitant use of other biologic agent, glucocorticoid and/or immunomodulators at the time of enrollment
* pregnant
* had cognitive/developmental disorders that affected their ability to complete the study procedures
* had medical illness or therapies potentially affecting bone, nutrition or growth status
Effects of Implementing a High Potassium Diet in Heart Failure Patients

This study evaluates the safety and physiologic effects of increasing dietary potassium intake in individuals with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* All patients classified as having HF, both systolic and diastolic.
* New York Heart Association class II-III symptoms.
* Treatment with an beta blocker, ACE inhibitor, or angiotensin receptor blocker without any adjustment over the previous month
* Intake at baseline of ≤ 3 servings of fruits and vegetables per day. Servings defined by Health Canada's food guide.

Exclusion Criteria:

* Patients with an episode of decompensated heart failure, acute coronary syndrome, or revascularization within the previous 3 months of study inclusion.
* Patients receiving insulin therapy
* Glomerular filtration rate \< 40mL/min/1.73 m2
* Pregnancy and lactation (women of childbearing potential will be included but will have to have a negative pregnancy test prior to inclusion).
* Inability to provide informed consent.
Bortezomib (Velcade) + Pemetrexed (Alimta) in Advanced NSCLC

Pemetrexed is an FDA-approved treatment for advanced lung cancer but the response rate is still very low. Bortezomib is currently approved to treat myeloma in patients who have already been treated. Currently, multiple studies are actively investigating how well bortezomib works with other drugs. This study is testing how much bortezomib can be given to advanced lung cancer patients who have already received one treatment. This study will also see how well bortezomib and pemetrexed work together to treat lung cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC who have received one prior platinum-based chemotherapy regimen.
* One prior treatment with any biologically targeted agent is acceptable
* Stable, previously treated, brain metastases are allowed if clinically stable without steroid treatment for 10 days.
* ECOG performance status of 0 or 1.
* Measurable and/or evaluable indicator lesion(s).
* Adequate hematologic, renal and hepatic function
* Patient is of a legally consenting age
* Patient has a life-expectancy \>2 months.
* Voluntary written informed consent before performance of any study-related procedure
* Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.
* Male patient agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:

* Prior treatment with pemetrexed (Alimta) or Bortezomib (Velcade).
* Patient was treated for another cancer within 3 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
* Peripheral neuropathy NCI grade \> 2.
* Symptomatic or uncontrolled brain metastasis.
* Radiation therapy to major bone marrow (\> 10% of bone marrow) areas or to target lesions within 30 days prior to study entry.
* Patient has received other investigational drugs with 14 days before enrollment.
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Any systemic therapy within 21 days prior to study entry.
* Patient known to be human immunodeficiency virus (HIV)-positive.
* Patient had a significant cardiac event within 6 months of enrollment
* History of arrhythmia
* Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
* QT prolongation with other medications that required discontinuation of that medication.
* Presence of left bundle branch block (LBBB).
* QTc ≥480 msec or greater on screening ECG.
* Patient has hypersensitivity to bortezomib, boron or mannitol.
* Female patient is pregnant or breast-feeding.
Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

Measurement of residual peritoneal fluid after laparoscopic surgery

Primary endpoints

* to evaluate whether the clearance rate of peritoneal fluid is exponential or linear over time. (absorption rate expected for Adept \~30-60 ml/h)
* to evaluate the role of the mesothelial barrier in this clearance rate.

Knowing that diffusion to and from peritoneal fluid decreases with increasing molecular weight (MW), our hypothesis is that clearance rate will decrease following peritoneal conditioning. Indeed a decreased mesothelial trauma (either through hypoxia or through denudation) and retraction will expose less the basal membrane

Secondary endpoints:

-To confirm the decrease in post-operative pain as measured by VAS-score and inflammation as measured by CRP and leucocytosis with the full conditioning of the pneumoperitoneum.

Eligibility Criteria:
Inclusion Criteria:

* Women planned to undergo a total or subtotal laparoscopic hysterectomy and having signed the informed consent.
* No limitation in body mass index or uterine size is made.

Exclusion Criteria:

* pregnancy
* immunodeficiency
* refuse or unable to sign informed consent
* chronic disease (i.e. COPD, Crohn, cardiac...)
* known allergy for Adept©
Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium Using Mitomycin C

The purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence

Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the bare sclera will efficiently reduce postoperative longstanding epithelial defect.

Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival autograft .The patients will be followed at least 12 months. Corneal recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous pterygium excision.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent pterygium
* Willingness to participate in research project and to attend research time
* At least 6 months after last pterygium surgery

Exclusion Criteria:

* Pregnant,breast-feeding women or poor general health
* Patients with significant ocular or lid pathology, such as Sjogren's Syndrome ,infection, exposure keratitis,glaucoma and trauma
* Patients with allergy to mitomycin C,tobramycin or local anesthetics