cyrilzakka/clinical-trials huggingface dataset:
Smartwatches to Manage Stress and Anxiety in Residential Settings

The purpose of the study is to conduct a prospective evaluation of a smartwatch technology and an associated application (developed by Awake Labs) in a clinical cohort from Centre for Addiction and Mental Health (CAMH) Adult Neurodevelopmental Services (ANS) and adults with developmental disabilities in the community who have received a watch.

Tools that help predict the onset of anxiety and agitation can not only help a person learn to self-monitor their emotions, but can may also help others feel more efficacious in understanding the internal state of the person they are supporting (especially if not able to communicate), and help them respond in a way that keeps the individual and others safe.

The purpose of the study is to conduct a prospective evaluation of the smartwatch technology with modifications recommended by the researchers (based on a previous retrospective study) in a clinical cohort at CAMH Adult Neurodevelopmental Services (ANS) and in adults with developmental disabilities in the community.

Specifically, this study seeks to evaluate the utility and validity of the smartwatch and associated mobile application as a clinical tool by gathering behavioral data when the applications gives a notification. The person wearing the watch or those in their environment will be asked to report the following in the application after the smartwatch gives a notification: 1) the valence of the emotion of the person wearing the smartwatch, 2) what events were occurring prior to notification (e.g., potential triggers for behaviours that challenge), and 3) what happened after the notification (e.g., how the person or others in their environment responded to the notification).

Results will be used to inform future iterations of the technology and make recommendations for clinical use.

Eligibility Criteria:
Inclusion Criteria:

* individuals with an intellectual and/or developmental disability
* living in the community or receiving services from CAMH ANS department

Exclusion Criteria:

* Under 18 years old
TeleCare North Diabetes

This feasibility study will evaluate the feasibility of two telemonitoring designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial.

Background: Maintaining optimal glycaemic control in type 2 diabetes (T2D) is difficult. Telemedicine has potential to support poorly controlled people with T2D in the achievement of glycaemic control if the telemedicine solution includes a telemonitoring component. However, only few telemonitoring solutions for non-insulin treated T2D exist. Therefore, the aim of this feasibility study is to evaluate the feasibility of two telemonitoring intervention designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial.

Method: The trial will be conducted as a three-month randomized feasibility study in four municipalities in North Denmark with 15 participants from each municipality. Two different telemonitoring intervention designs will be tested. One intervention will include self-monitoring of blood glucose (SMBG) together with monitoring of sleep and mental health. The second intervention will include an identical setup but with the addition of blood pressure and activity monitoring. Two municipalities will be allocated to one intervention design, whereas the other two municipalities will be allocated to the second intervention design. Qualitative interviews with participants and clinicians will be conducted to gain insight into their experiences with and acceptance of the intervention designs and trial procedures (e.g., blood sampling and questionnaires). In addition, differences in direct intervention costs between the two alternative interventions will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Women and men ≥ 18 years
* Poorly controlled T2D, i.e. HbA1c \> 58 mmol/mol
* Diagnosis of T2D for at least 12 months
* General Practitioner responsible for diabetes treatment
* Residence in Hjørring, Morsø, Jammerbugt, or Rebild municipality
* Ability and willingness to use a smartphone/tablet along with the other devices to be used in the trial
* Signed informed consent
* Ability to understand and read Danish

Exclusion Criteria:

* Pregnancy or breastfeeding
* Insulin treatment
* Prednisolone treatment
* Severe diabetes complications such as severe neuropathy or nephropathy (dialysis treatment)
* Participation in diabetes rehabilitation courses
* Participation in other intervention trials
* Terms that, in the opinion of the sub-investigator or investigator, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate
Strengthening Women's Agency During Pregnancy

This research aims to address the feasibility and acceptability of a brief empowerment counselling intervention (ECI) among pregnant women and girls receiving antenatal care (ANC) who have experienced intimate partner violence (IPV), in humanitarian healthcare settings.

This research aims to address the feasibility and acceptability of a brief empowerment counseling intervention (ECI) among pregnant women and girls receiving antenatal care (ANC) who have experienced intimate partner violence (IPV), in humanitarian healthcare settings. This 3- year study will take place in two IRC-managed health posts in a refugee camp in Kigoma, Tanzania. The objectives of the study are to: 1) Adapt, as needed, for use in the context of ANC in a humanitarian setting, a brief ECI to address women's and girls' exposure to sexual and/or physical IPV during pregnancy, by improving their mental health, self-efficacy, safety, and coping strategies; 2) Test the ECI through a pilot randomized controlled trial, determining whether the intervention is feasible/acceptable and whether it improves women's self-efficacy, reduces mental distress and increases uptake of longer-term IPV services; 3) Test the feasibility of integrating such an intervention into pre-existing ANC service delivery in humanitarian settings and make recommendations for future intervention research and development, including effectively linking routine enquiry of IPV in ANC settings with support service use.

Eligibility Criteria:
Inclusion Criteria:

* Women or girl aged 15 years or older:
* Pregnant (any trimester);
* Attending their 2nd or later ANC visit;
* Have experienced physical and/or sexual and/or severe psychological IPV in the past 12 months;
* Consent to participate.

Exclusion Criteria:

* At their first ANC visit or accompanied by their partner (or anyone else) at the ANC visit;
* Under age 15;
* Unable to provide informed consent/assent;
* Suicidal or at risk of severe violence or of being murdered; and/or
* In a high-risk situation or medically high risk.
A New Scoring System Improves Diagnostic Accuracy of Intestinal Dysganglionosis --a Prospective Study

1. The investigators previously reported a simple diagnostic scoring system to differentiate Hirschsprung disease (HD) from Hirschsprung disease allied disorders (HAD) in the patients with suspected intestinal dysganglionosis. In the retrospective study, the investigators concluded that the patients with a predicting score of more than 5 are more likely to be diagnosed with HD, whereas a score less than 5 is mostly indicative of HAD.
2. Since it is essential to confirm the accuracy and efficacy of the scoring system in a prospective manner before it is used as a standard procedure, this prospective study is designed and performed.

1. Patients have hard or firm stools for 2 or less per week, and with ages from newborn to 3 years old are recruited in this study.
2. The recruited patients is undergoing preoperative work-up including barium enema (BE), anorectal manometry (ARM) and histochemical acetylcholinesterase (AChE) staining of rectal mucosa. Known risk factors for intestinal dysganglionosis (IDs) are recorded. The predicting score is calculated by summing the scores of the risk factors and 3 preoperative tests.
3. The patients with a predicting score of more than 5 are diagnosed with HD, and are performed surgery to remove the aganglionic bowel.
4. The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.

Eligibility Criteria:
Inclusion Criteria:

* Hard or firm stools for 2 or less per week
* Age are from newborn to 3 years old

Exclusion Criteria:

* Children\>3 years of age
* Patients presented severe inflammation or malnutrition, unconsciousness or perforation of intestine
Effect of Pneumoperitoneum and Neuromuscular Block on Renal Function in Diabetes Patients

In this single center, double-blind, randomized controlled clinical trial, we will include 648 diabetes patients aged 18-70 undergoing laparoscopic pelvic tumor resection. They will be randomized to the following four groups: high-pressure pneumoperitoneum (10mmHg)+ deep neuromuscular block group, high-pressure pneumoperitoneum (15mmHg)+moderate neuromuscular block group, low-pressure pneumoperitoneum + deep neuromuscular block group and low-pressure pneumoperitoneum+moderate neuromuscular block group. Deep neuromuscular block is defined as post tetanic count (PTC) 1-2, and low neuromuscular block is defined as train-of-four (TOF) twitch 1-2. The outcomes will be indicators for acute kidney injury and surgical condition.

In this single center, double-blind, randomized controlled clinical trial, we will include 648 diabetes patients aged 18-70 undergoing laparoscopic pelvic tumor resection under general anesthesia. They will be randomized to the following four groups: high-pressure pneumoperitoneum (10mmHg)+ deep neuromuscular block group, high-pressure pneumoperitoneum (15mmHg)+moderate neuromuscular block group, low-pressure pneumoperitoneum + deep neuromuscular block group and low-pressure pneumoperitoneum+moderate neuromuscular block group. Neuromuscular block will be induced by rocuronium bolus and maintained by a continuous infusion of rocuronium. Deep neuromuscular block is defined as PTC 1-2, and low neuromuscular block is defined as train-of-four TOF twitch 1-2. The primary outcome will be serum Cystatin C level, and the secondary outcomes will be serum creatine level, urinary sediment, intraoperative urine output, duration of surgery, surgical space condition and occurrence bucking and body movement.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-70;
2. American Society of Anesthesiologist physical status (ASA) II-Ⅲ;
3. Diagnosed of diabetes;
4. Undergoing elective laparoscopic pelvic tumor resection under general anesthesia;
5. Estimated duration of operation \>2h;

Exclusion criteria:

1. Not willing to participate in the study or not able to sign the informed consent；
2. Diagnosed of other kidney diseases except diabetic nephropathy;
3. Severe renal insufficiency defined as serum creatine level \> 2 times the upper limit of normal, or urine output \< 0.5ml/kg/h, or estimated glomerular filtration rate \< 60ml/h;
4. Severe liver, lung or heart dysfunction;
5. Known or suspect neuromuscular disease;
6. Use of drugs that may affect neuromuscular block monitoring;
7. Severe diabetic neuropathy or other peripheral neuropathy；
8. Known or suspect allergy to general anesthetics；
9. Family history of malignant hyperthermia；
10. Previous history of pelvic surgery.
Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

The purpose of this study is to determine hypofractionated conformal proton beam radiation therapy of prostate cancer can achieve similar treatment benefits as our current institutional standard with conventional fractionation.

Radiation therapy has a long and established role in the curative treatment of organ-confined prostate cancer. However, the optimal radiation dose and treatment schedule remain unknown. The use of hypofractionation has a long and generally successful history in conformal proton beam therapy. Several reports detailing the efficacy and safety of hypofractionated conformal radiation therapy (with x-rays) of prostate cancer can be found in the literature. Hypofractionated conformal proton beam radiation therapy has become our institutional routine for the treatment of numerous solid tumors. The purpose of this study is to determine if a shortened overall treatment schedule will result in equivalent tumor control rates and no increased side effects as compared to our current institutional standard treatment of an equivalent dose given over a longer period of time.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma within 180 days of registration
* History \& Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration
* Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment
* Clinical stage, Tumor Stage (T1-T2C)
* Prostatic Specific Antigen (PSA) less than 10 ng.ml within 180 days prior to registration

Exclusion Criteria:

* Prior or concurrent invasive malignancy
* Evidence of distant metastasis
Observational Study Of Donepezil In Routine Clinical Practice

To characterize the comorbidities and medications of patients treated with donepezil in a routine clinical practice and to verify the therapeutic response of these patients.

This trial was terminated prematurely on December 31, 2007 due to difficulties in enrolling patients in the study. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for the clinical diagnosis of mild to moderate Alzheimer's Disease with or without other etiologies of dementia
* Mini Mental Status Examination score of 10-26

Exclusion Criteria:

* Contraindication as stated in the Canadian label for donepezil
* Subjects treated with medication for dementia within 30 days prior to baseline
Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia

People under stress, such as those caring for an ill family member, often have trouble with their sleep. The aim of this study is to see if reducing stress and changing a caregiver's sleep and wake patterns will improve his/her sleep. The investigators also will see whether improvements in sleep result in improved mood, health, and general functioning.

The general aim of this study is to characterize stress-related sleep disturbances in spousal caregivers of patients with progressive dementia and to test the efficacy of an intervention designed to reduce stress and sleep disturbances. We will compare the efficacy of a Stress Management Plus Health Sleep Practices (SM+HSP) intervention to an attention-only control condition in spousal caregivers of patients with progressive dementia.

Specific Aims for this study are:

Aim 1: To characterize stress-related sleep disruptions in spousal caregivers of patients with progressive dementia.

Aim 2: To test the short-term efficacy of a Stress Management Plus Healthy Sleep Practices (SM+HSP) intervention versus an attention-only control for improving sleep and health outcomes in caregivers of patients with progressive dementia.

Aim 3: To test the durability of the SM+HSP intervention among spousal caregivers of patients with progressive dementia.

Aim 4: To characterize:

1. the impact of stress-related sleep disruptions on health in older adults, and
2. the effects of sleep interventions on health and functioning.

Eligibility Criteria:
Inclusion Criteria:

* Ages 60 or older
* Spousal caregivers of patients with progressive dementia
* Patients have a diagnosis of possible or probable Alzheimer's disease or other progressive dementia
* Affirm that it is a physical and emotional strain to care for spouse
* Pittsburgh Sleep Quality Index score of 5 or above or a polysomnographically determined sleep efficiency of 90% or worse.

Exclusion Criteria:

* Psychotic disorder or substance abuse disorder
* Apnea-hypopnea index of greater than 30
* Score of less than 24 on Mini-Mental State Exam
Stem Cell Isolation From Femoral Heads Post Total Hip Arthroplasty

Femoral heads will be collected at University Hospital (London, ON, Canada) from individuals with type-2 diabetes, obesity, and no T2D/no obesity controls. The femoral head will be taken to the Robarts Research Institute (London, ON, Canada) for lineage-restricted progenitor cell expansion and analyses. There the femoral heads will be used to isolate three stem cell types - Multipotent Stromal Cells, Endothelial Colony Forming Cells, and Hematopoietic Progenitor Cells. The yield and cell surface markers expressed on these cells will be measured using flow cytometry. These cell types will then undergo further analyses of the secretome, tubule forming assays, vascular regenerative cell exhaustion assays, and will be transplanted into immune deficient mice with with femoral artery ligation. These experiments are to assess the differences in function and expression of these cell types between individuals with type-2 diabetes and/or obesity and/or healthy controls.

Femoral Heads will be extracted by Dr. Lanting (Department of Surgery - Division of Orthopaedics) at University Hospital, they will then be transferred to Robarts Research Institute where they will undergo cell isolation and analyses. Multipotent Stromal Cells, Endothelial Colony Forming Cells, and Hematopoietic Progenitor Cells will be extracted from the bone marrow of the femoral heads. These cells will be used to characterize the difference in regenerative progenitor cell number and potential dysfunction in individuals with type 2 diabetes and/or obesity compared to controls. Analysis will include growth kinetics, flow cytometry, Bio Luminescent Imaging and Laser Doppler Perfusion Imaging using a FAL mouse model.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18+ years of age

Exclusion Criteria:

* Diagnosis of bone cancers
* Diagnosis of Rheumatoid arthritis
* Diagnosis of hematopoietic conditions
* Diagnosis of avascular necrosis of the hip
* does not fall within BMI requirements for experimental groups
* Cannot read and/or speak in english
Laparoscopic Recurrent Inguinal Hernia Repair

Laparoscopic management of recurrent inguinal hernia in children has been recently introduced in surgical practice. One of the most important advantages of using the laparoscopic approach in cases with recurrent inguinal hernia (RIH) is that it avoids the previous operation site thus avoiding injuries to the vas and vessels \[19\]. Some authors designed a study to compare laparoscopic hernia repairs with classical open repairs for pediatric RIH following the ﬁrst open repair. They stated that avoiding the scarred tissue the former operation area with the laparoscopic approach facilitates the procedure and decreases both the operative time and complication rate. \[5\]. Further, it is as simple as a fresh hernia repair because the time taken for the repair of recurrent hernia laparoscopically was the same as the fresh laparoscopic repair with no added complication \[5,20\]. In laparoscopic surgery, approaching the hernia defect from within the abdomen, makes the area of interest bloodless, and the magnification renders anatomy very clear, making surgery precise \[6,7\].

Abstract: Background: Open repair of recurrent inguinal hernias \[RIH\] in infancy and childhood is difficult and there is definite risk of damaging the vas deferens and testicular vessels. Laparoscopic repair of RIH has the benefit of avoiding the previous operative site. The aim of this study is to present the investigator's experience with laparoscopic repair of RIH either after open or laparoscopic hernia repair with stress on technical refinements to prevent recurrence. Patients and methods: This is a retrospective study of laparoscopic repair of recurrent inguinal hernia. Records of patients that have been subjected to laparoscopic inguinal hernia repair for RIH were reviewed and evaluated. All patients were subjected to laparoscopic repair of 42 recurrent hernial defects. The primary outcome measurements of this study include; operative time. The secondary outcomes include; hydrocele formation, iatrogenic ascent of the testis and testicular atrophy.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent inguinal hernia

Exclusion Criteria:

* complicated inguinal hernia
Coxib-inhibition of Duodenal Polyp Growth in FAP

Preliminary data indicate a protective effect on the development of duodenal polyps by coxib treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib for 1 year would stop or reverse the development of premalignant adenomatous lesions in the duodenal mucosa of FAP patients.


Eligibility Criteria:
Inclusion Criteria:

* FAP patient with previous colectomy and confirmed polyposis

Exclusion Criteria:

* Pregnancy
* Malignancy
* NSAID hypersensitivity
An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advance Refractory Cancer

When a patient with advanced cancer consults with a member of the Phase I drug development team, the investigators utilize all information possible to try to select a therapy for that patient which has the best chance of working for them. This information includes:

1. Past published information
2. Clinical experience and judgement
3. Immunohistochemistry for specific targets (e.g., ER)
4. Standard sequencing (e.g., for K-Ras) and other methods now available.

The investigators have a new tool which warrants early exploration for what role it might eventually play in the process of selecting the best therapy for an individual patient. The basis of the current ancillary exploratory study is to gain initial experience with the operational aspects of this whole genome sequencing in this setting.

1. To measure the time from biopsy to completion and final analysis of Whole Genome Sequencing (WGS) on patient tumor and non-tumor samples.
2. To examine the frequency with which useable sequence data is obtained as a function of tumor volume received and percent tumor involvement in the biopsy
3. To identify the frequency with which potential targets and pathways for therapy are discovered.
4. To observe for any evidence that if anti-tumor activity from treatment is noted how would the genome sequencing have correlated with that activity.

Eligibility Criteria:
Inclusion Criteria:

* Have a life expectancy of greater than 3 months.
* Patients must have a diagnosis of histologically or cytologically confirmed advanced incurable cancer which has progressed on one or more prior chemotherapeutic, hormonal or biological regimens for advanced disease.
* Be a good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.

Exclusion Criteria:

* Patients with symptomatic CNS metastasis.
* Known HIV, HBV or HCV infection requiring antiviral therapy.
* Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.
* Inaccessible tumor for biopsy
Pseudodrynaria Coronana (Wall) Ching

The Study to evaluate the clinical effect of "Gusuibu" lasts for 3 years. It aims to evaluate its effect on bone density of postmenopausal osteoporosis. Besides, its effects on the liver, kidney and the hematological influence will be evaluated, too.

Research of the this traditional chinese medicine clinucal, Gusuibu, curative effect is plan three years time. The entire studyaims to evaluated the effect of the traditional chinese medicine on postmenpausal osteoporosis as well as the possible side effects on the experimental animal and the human body. All subjects were postmenopausal woman with established osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal osteoporosis

Exclusion Criteria:

* Insulin dependent diabetes