cyrilzakka/clinical-trials huggingface dataset:
The Tele-Taking Charge After Stroke Randomized Controlled Feasibility Trial

Take Charge is a novel, community-based treatment for stroke developed to harness a person's self-determination. Two prior clinical trials with 572 stroke survivors showed that Take Charge improves quality of life, independence, and social participation up to a year after stroke. Take Charge has also been shown to be overall cost-saving to the health system and is a useful adjunct to standard care after stroke.

Because of the COVID-19 pandemic, a lot of healthcare has moved into a telehealth approach. The simplicity of Take Charge may lend itself to being effective if delivered by telehealth, allowing greater access for people with stroke in rural communities. Improving the care we provide in underserved regions of the country is important to help the health of Canadians.

We are proposing a new study, working closely with the researchers who ran the previous Take Charge studies.

The goal of this feasibility clinical trial is to learn about Tele-Take Charge in adults with stroke who live in Southern Alberta. The main questions it aims to answer are:

* is delivering Take Charge by telehealth feasible?
* is Take Charge by telehealth acceptable to this population?

Participants will meet with facilitators online via Zoom at 4 to 16 weeks after stroke, and be randomized to receive either:

* two Tele-Take Charge sessions six weeks apart
* one control tele-education session.

Researchers will compare the Tele-Take Charge and control groups to see if there are any differences in outcome measures. these differences will help researchers to estimate the number of participants that will be needed for a larger, multi-centred effectiveness trial.

For adults diagnosed with acute stroke who are discharged to community living (non-institutionalized), we wish to evaluate whether delivering two Take Charge sessions by telehealth is (1) acceptable to the population of Southern Alberta, and (2) feasible to do.

Subjects will be randomly assigned to receive either two Tele-Take Charge sessions or one tele-education session (Life After Stroke video) by telehealth (the active control).

The primary feasibility outcome will be recruitment rate. Secondary outcomes will be measured by a blinded outcomes assessor at 6 and 12 months, either by e-questionnaire or by telephone.

Those who received Tele-Take Charge will also be asked to complete an acceptability questionnaire, and will be invited to take part in an in-depth interview about their experience as part of a qualitative substudy.

Eligibility Criteria:
Inclusion Criteria:

* Discharged with diagnosis of stroke to non-institutionalised community living situation
* Answering 'No' to the question 'Are you fully recovered from your stroke?' (i.e., modified Rankin score \[mRS\] must be \> 0)
* Able to access video calling with a smartphone, computer, or other device

Exclusion Criteria:

* Major comorbid illness that would dictate functional outcome at 12 months or life expectancy \< 12 months
* Pre-stroke dependency (mRS \> 2 before index stroke)
Enhancement of Emmetropization in Hyperopic Infants

To determine if wearing a moderate spectacle under-correction (3.00D) and performing activities designed to stimulate accurate accommodation during a 15-month period will enhance emmetropization in highly hyperopic (between +5.00D and +7.00D) 3-month old infants.

The purpose of the project is to determine if emmetropization can be enhanced in very farsighted babies. We will give them glasses with a partial correction, an amount that is less than their full degree of farsightedness but enough to put them in the zone of effective emmetropization. This 'boost' is meant to enable very farsighted babies to use their eyes in a normal way and emmetropize as normal infants. This partial correction would be given at 3 months of age for a period of up to 15 months. A program of visual engagement is also provided in order to encourage the normal development and use of accommodation. As changes in farsightedness occur, the power of the glasses will be reduced at follow up appointments to keep the farsightedness within the zone of effective emmetropization. Once an infant reaches a normal amount of farsightedness, the glasses would be discontinued.

Eligibility Criteria:
Inclusion Criteria:

* 3 months of age (between 8 weeks and 20 weeks)at the baseline examination
* Either gender, any ethnicity
* Birthweight greater than 2500g
* Normal pregnancy and delivery (including Cesarean section delivery but excluding serious complications or conditions such as eclampsia or rubella)
* Hyperopia of +5.00D or more but less than +7.00D spherical equivalent refractive error in each eye by cycloplegic retinoscopy using cyclopentolate 1%
* Currently under the care of a pediatrician

Exclusion Criteria:

* Anisometropia greater than 1.00D (difference in spherical equivalent)
* Strabismus
* Previous history of difficulty with pupillary dilation
* History of cardiac, liver, asthma, or other respiratory disease
* History of ocular disease or active ocular inflammation
Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy

The purpose of this study is to determine the antiperistaltic effect and safety of glycopyrrolate and whether the use of glycopyrrolate is beneficial for colonoscopy and colonoscopic polypectomy.

Colonic spasm is a major adverse event affecting colonoscopy.The current mainstay for the prevention of colonic spasm is the use of antispasmodic.Glycopyrrolate is a long-acting quaternary ammonium anticholinergic drug.The study is designed as a randomized, double-blind, placebo-controlled study of the efficacy and safety of glycopyrrolate in participants receiving colonoscopy and colonoscopic polypectomy. Patients at our center who met the inclusion criteria were randomized into the glycopyrrolate group and the placebo group, and then statistically analyzed whether there was any difference in the incidence of spasticity, spasticity scores, polyp treatment time, and satisfaction with endoscopist operation between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old.
* Outpatients and inpatients with lesions to be resected under colonoscopy.
* Participants voluntarily participated and signed informed consent forms.

Exclusion Criteria:

* Pregnancy status and lactating women.
* With glaucoma, myasthenia gravis, hyperthyroidism, chronic renal insufficiency, and inflammatory bowel disease.
* With obstructive gastrointestinal diseases such as pyloric obstruction, paralytic ileus, and achalasia of the cardia.
* With obstructive urinary tract diseases such as prostatic hyperplasia and dysuria.
* With heart disease such as arrhythmia (bradycardia, tachycardia, ventricular fibrillation, atrial fibrillation, etc.), coronary heart disease, congestive heart failure.
* With a history of previous abdominal or intestinal surgery.
* Anticholinergic drugs were administered 48 hours before surgery.
Oxytocin and Fetal Heart Rate Changes

The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%. This variability may be due to fluid and oxytocin management prior to and during the initiation of neuraxial analgesia. The study hypothesis is that decreasing the oxytocin infusion rate by 50 % prior to initiation of combined spinal epidural analgesia will cause a reduction in the incidence of adverse fetal heart rate changes.

Oxytocin is used in labor and delivery to increase the frequency of contractions and augment uterine contractile strength, thereby establishing a regular pattern of labor. However, the administration of exogenous oxytocin in the presence of an uncoordinated labor pattern confers a risk for an increase in uterine contraction frequency, resulting in inadequate relaxation periods. This leads to an increase in the basal tone of the uterus, which may lead to a tetanic contraction with the risk of decreased uteroplacental blood flow and fetal hypoxemia. Previous studies investigating low- versus high-dose oxytocin for induction or augmentation of labor have had conflicting results on the effect on fetal heart rate abnormalities. One of the limitations of these studies is that the labor analgesia was not standardized. The combination of low-dose combined spinal epidural analgesia and the high/low dose oxytocin have not been evaluated. One of the proposed mechanisms for nonreassuring fetal heart a tracing after initiation of analgesia is that the pain relief from neuraxial analgesia causes a decrease in catecholamine release by the sympathetic nervous system. The subsequent decrease in the circulating epinephrine concentration contributes to an increase in uterine tone, as epinephrine is a potent tocolytic agent. The increased tone, in turn, leads to a decrease in placental blood flow, and eventually fetal bradycardia. The primary outcome of this study is the incidence of non-reassuring fetal heart rate tracings within the first 60 minutes after the placement of combined spinal epidural analgesia

Eligibility Criteria:
Inclusion Criteria:

* Healthy nulliparous or multiparous women at term (37 \> weeks' gestation)
* Singleton pregnancy
* Request for neuraxial analgesia
* Oxytocin used for induction of labor or augmentation of labor per institutional protocols

Exclusion Criteria:

* Use of chronic analgesic medications
* Prior administration of systemic opioid labor analgesia
* Non-vertex presentation
* Contraindication to neuraxial analgesia
* Category 3 fetal heart rate tracing prior to the initiation of combined spinal epidural analgesia
Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans

This randomized clinical trial uses an educational brochure and online tutorial program to assess sun-protective behavior and skin self-examination among African Americans. Skin cancer is very common among African Americans, with a disproportionately high mortality rate. Providing a brochure and an online educational program about sun-protective behaviors may encourage African Americans to take preventative measures against skin cancer, help improve early skin cancer detection, determine how far the disease has spread, and plan the best treatment.

PRIMARY OBJECTIVES:

I. To assess whether an educational brochure and online program will increase sun-protective behaviors among African-American patients who present at the general dermatology clinic.

SECONDARY OBJECTIVES:

I. To assess whether the educational brochure and online program will improve skills for skin self-examinations among African-American patients who present at the general dermatology clinic.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Participants receive a skin cancer educational and preventive brochure distributed by the National Cancer Institute and watch a 30-minute online tutorial video called X-Plain about skin cancer, preventative behaviors, and skin self-examinations.

ARM II: Participants receive an educational brochure as in Arm I.

After completion of study, participants are followed up at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified African-Americans who are literate and fluent in English

Exclusion Criteria:

* Non-African-Americans
* English illiteracy
* non-fluency in English
Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)

This is a clinical study where patients with diabetes and a vision threatening eye condition called "Diabetic Macular Edema" receive four injections into the eye at monthly intervals. The patients will already have tried the standard of care without complete success. The patients will be randomized to receive either a high dose, a low dose or a sham control treatment. The study will evaluate whether the new treatment improves vision and whether it changes the underlying course of the disease in the eye.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Type I or Type II diabetes mellitus (DM).
* BCVA of ≥19 letters (\~20/400) and ≤73 letters (\~20/40) in the study eye and ≥34 letters(\~20/200 or better) in the fellow eye.
* Presence of ciDME in the study eye defined as CST ≥305 μm in women and ≥320 μm in men
* Subjects first anti-VEGF injection in the study eye occurred ≤36 months.
* Subjects have received at least 3 anti-vascular endothelial growth factor (VEGF) injections in the study eye within a 6-month period.
* The last anti-VEGF injection in the study eye is ≥ 8 weeks.

Exclusion Criteria:

* Evidence of ocular pathology (e.g. visually significant cataract) that impacts subject's vision in the study eye from any cause other than DME.
* Evidence/presence of amblyopia, vitreomacular traction, epiretinal membrane, foveal atrophy, or foveal ischemia, or any other condition in the macula that is thought to impair the subject's vision (other than DME).
* Prior treatment with panretinal photocoagulation or focal grid macular photocoagulation in the study eye within the previous 3 months.
* Prior treatment with intravitreal (IVT) steroid in the study eye (in the previous 3 months for triamcinolone, previous 6 months for Ozurdex and at any time for Iluvien).
* Prior treatment with topical NSAIDs or topical steroids in the study eye within 1 month.
* Prior treatment with systemic corticosteroids or systemic anti-VEGF therapy within 3 months.
* Prior vitrectomy in the study eye.
* Prior intraocular surgery in the study eye except for cataract surgery. Cataract surgery within the previous 6 months in the study eye is excluded.
* Intraocular pressure (IOP) of \>22 mmHg in the study eye or use of \>2 antiglaucoma agents (combination agents count as 2 agents) in the study eye.
* Evidence of infectious dacrocystitis, significant blepharitis, active conjunctivitis, infectious keratitis, or scleritis in either eye, or any other condition that might affect the safety of the IVT injection.
* Current active proliferative diabetic retinopathy (PDR), active anterior segment neovascularization (ASNV), active retinal neovascularization, or the presence of vitreous hemorrhage in the study eye.
* Poorly controlled DM.
* Uncontrolled hypertension
* Prior treatment with ocriplasminin the study eye within 3 months
Green Exercise for Cancer - Creating Opportunities for Survivors

The purpose of this study is to assess feasibility and acceptability for a trial to evaluate exercise behaviors, fatigue and exercise motivation in adolescent and young adult survivors of childhood cancer who participate in an outdoor exercise intervention compared to survivors who participate in an indoor exercise intervention. A pilot randomized cross over design will allow participants to be compared to traditional controls as well as self-controls.

Title: Green Exercise for Cancer - Creating Opportunities for Survivors (GECCOS)

Rationale: Exercise is related to lower rates of late effects like fatigue, heart disease and second cancers among survivors of childhood cancer. Yet levels of exercise remain low among survivors. The context where exercise occurs - indoors or outdoors - may affect motivation to exercise and sustained exercise behavior. Yet the effects of exercise context on motivation and maintained behavior remain unexamined. This study aims to pilot test an outdoor exercise intervention for cancer survivors compared to attention controls receiving an indoor exercise intervention.

Target Population: Adolescent (13 to 17 years) and young adult (18 to 30 years) survivors of any cancer or hematopoietic cell transplantation for non-malignant disease.

Number of Participants :

16 to 20 participants (8 to 10 adolescents, 8 to 10 young adults).

Objective:

Pilot test, for feasibility and acceptability, a novel outdoor exercise intervention to motivate and maintain exercise in adolescent and young adult survivors of childhood cancer. Using a randomized cross-over design, participants will randomly receive both indoor and outdoor exercise sessions.

Study Design:

Randomized Cross-over Pilot Trial

Measures of Interest:

Primary Outcome - Accelerometer measured moderate to vigorous physical activity.

Secondary Outcomes - Self-Determination Theory based measures of motivation to exercise from validated survey questions. Fatigue, measured with validated survey questions.

Semi-structured qualitative exit interview will be used to assess acceptability and feasibility of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Survivors of childhood cancer or hematopoietic cell transplantation for non-malignant diseases
* Between the ages of 13 and 30
* Able to speak English
* More than 3 months out from the completion of cancer treatment and/or 6 months out from hematopoietic cell transplantation with no evidence of recurrent or residual cancer
* Must be off of all immune suppressing therapies

Exclusion Criteria:

* Anyone not meeting the inclusion criteria
A Trial to Evaluate the Superior Mesenteric Vein (14V) Lymphadenectomy for Distal Advanced Gastric Cancer

This trial is going to evaluate the advantage of D2 radical gastrectomy plus 14v lymph node dissection in 3-year survival rates of advanced gastric cancers.

Radical surgery is still the only possible way to cure gastric cancer. In Japan, South Korea and other countries, due to the popularity of screening and Improved surgical procedures, there has been great improvement in overall survival. Standard D2 Gastrectomy has been the standard operation for advanced gastric cancer. However, there is no unanimous consensus whether Standard D2 Gastrectomy plus 14v lymph node dissection is needed.Till now, it is difficult to stage the 14V lymph node as regional lymph nodes metastasis or distant metastasis. And it is urgent to explore the necessity of 14v lymph node dissection in advanced gastric cancer.So a prospective randomized controlled study will to carry out to evaluate the effects of D2 radical gastrectomy plus 14v lymph node dissection compared with D2 radical gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

* Curative D2 or D2+ operation had been performed;
* Physical condition and organ function allows to tolerable abdominal surgery;
* Willing and able to comply with the program during the study period;
* Aged 18 to 70 years, preoperative gastric cancer patients with pathologically confirmed;
* With more than a 6-month life expectancy;
* No other serious concomitant diseases;
* No adjuvant chemotherapy before recurrence;
* Karnofsky performance status scale ≥ 60;
* All patients accept 6 cycles XELOX chemotherapy regimen

Exclusion Criteria:

* Pregnancy or breast feeding;
* Women of childbearing age do not take contraceptive measures;
* Organ transplantation patients need immunosuppressive therapy;
* Five years after the trial begin,other malignant tumor occur;
* While using other experimental drug or other clinical trials are being;
* Can not take oral medications;
* Mentally disordered;
* Severe recurrent infections were not controlled or with other serious concomitant diseases;
The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy

Many studies have shown that inflammation has an important effect on the development, progression, and also response to treatment of tumors. Dexmedetomidine is a potent and selective alpha 2 receptor agonist, known to have a sedative, analgesic and immune-controlling effect. The purpose of this study is to investigate the effect of dexmedetomidine during surgery on postoperative inflammatory response and surgical recovery in gastric cancer patients undergoing robot or laparoscopic gastrectomy.

* Experimental group (Dexmedetomidine group) Continuous IV Precedex™ using infusion pump (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery (from immediately after induction to before starting peritoneum closure) Infusion rate 0.4μg/kg/hr
* Control group (normal saline group) Continuous IV normal saline using infusion pump (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery Infusion rate 0.4μg/kg/hr

Eligibility Criteria:
Inclusion Criteria:

* 1. 20-70 yrs old patients
* 2. Scheduled for robot or laparoscopic gastrectomy
* 3. Body weight under 90kg and BMI under 32

Exclusion Criteria:

* 1. Emergency operation
* 2. Reoperation
* 3. Co-operation with other surgery department
* 4. Co-operation with other organs (except cholecystectomy)
* 5. Patients with history of heart failure (unstable angina, congestive heart failure)
* 6. Patients with history of arrhythmia (specially AV nodal block), ventricular conduction problem
* 7. Patients with history of uncontrolled hypertension (diastolic BP \>110mmHg), extremely bradycardia (HR \<45 bpm on ECG)
* 8. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia
* 9. Patients who is steroid user
* 10. Patients who is beta blocker user
* 11. Patients with history of liver failure, renal failure, allergic to medicine
* 12. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
* 13. Patients who cannot read the consent form (examples: Illiterate, foreigner)
* 14. Patients who withdraw the consent
A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

This study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Is obese with a Body Mass Index (BMI) \>=30 kg/m\^2 to \<=50 kg/m\^2 or overweight with a BMI \>=27 kg/m\^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions)
* Has been obese or overweight for at least one year prior to study start
* Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: \*hormone replacement therapy; \*oral contraceptives; \*lipid-lowering agents; \*thyroid replacement therapy; \*metformin

Exclusion Criteria:

* Is currently enrolled in or is planning to enroll in a formal weight-loss program
* Is unwilling or unable to participate in a lifestyle intervention program as part of the study
* Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: \*prescription or over the counter antiobesity agents (within the 6 months prior to study start); \*psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); \*steroids that are known to result in high systemic absorption; \*calcitonin; \*ketoconazole; \*antidiabetic medications
* Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study
* Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start
* Has previously used pramlintide either by prescription or as part of a clinical study
* Has used sibutramine or phentermine (either by prescription or as part of a clinical study) within 2 years before study start
* Has donated blood within 2 months before study start, or is planning to donate blood during the study