cyrilzakka/clinical-trials huggingface dataset:
Glycemic Control and Iron Status in Diabetic Pregnancies - a Study of New Markers

This is an observational study at the Obstetrical outpatient clinic at Stavanger University Hospital. The main goal is to compare the current marker of glycemic control (glycated hemoglobin A1c, HbA1c) with glycated albumin in pregnancies with pregestational diabetes mellitus.

Women with diabetes are at increased risk for adverse pregnancy outcomes. With improved glycemic control, the risk decreases. Glycated albumin is suggested to be a better marker for monitoring glycemic control in pregnancies because it reflects blood glucose for a shorter period than HbA1c (3 versus 8-12 weeks). Other studies have shown that HbA1c increases in pregnancy because of iron deficiency. The investigators want to investigate HbA1c, glycated albumin and iron status in diabetic pregnancies. The investigators will compare HbA1c and glycated albumin throughout pregnancy with the patient's own blood glucose measurements or data from CGM (continuous blood glucose monitoring). Blood samples for HbA1c and glycated albumin will be taken 6 times during pregnancy (week 12, 20, 24, 28, 32, 36).


Eligibility Criteria:
Inclusion Criteria:

* pregestational diabetes mellitus
* singleton pregnancy
* follow-up at Stavanger University Hospital in pregnancy

Exclusion Criteria:

* gestational diabetes
* twin pregnancies
Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).


Eligibility Criteria:
To be eligible for the study, a child must meet the following criteria:

1. Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria
2. Time since diagnosis of at least six months
3. Age between 2 and 6 years at enrollment
4. Parental consent to participate in the study
5. No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.
6. If current use of CGM, A1c has to be above 7.5%; value obtained within 3 months of enrollment
7. Own and use an iPhone, or be willing/able to carry a study-supplied wi-fi enabled iPod

To be eligible for the study, a parent must meet the following criteria:

1. Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above
2. Age of 18.0 years or older
3. Parent comprehends written English
4. Parent understands the study protocol and signs the informed consent document
5. Parent has access to a personal computer to upload diabetes devices and send to research team

The presence of any of the following is an exclusion for the study:

1. Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application).
2. Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
3. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
4. Child is unable to completely avoid acetaminophen for duration of study
Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy

Cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. Fatigue is frequently identified as one of the most troublesome symptoms in pediatric cancer patients. Fatigue affects children with cancer throughout the trajectory of their disease. Treatment interventions for cancer-related fatigue have been largely unsuccessful. Homeopathy involves treatment of patients with diluted natural substances aimed at stimulating the body's healing system. In the efficacy trial literature, individualized homeopathy shows the most promise over other forms of homeopathic intervention. Individualized homeopathic treatment involves a unique yet established method of case taking. During the consultation, the homeopath asks a series of broad questions to elicit subjective symptoms related to the patient's disease, their medical history, as well as particular characteristics (physical or psychological) related to the individual. This study will recruit children receiving chemotherapy to undergo homeopathic remedies to treat their fatigue. This study hypothesizes that homeopathic treatment will effectively treat fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with any type of cancer. Patients may have newly diagnosed, relapsed or a second malignant disease.
* Receiving any type of chemotherapy administered intermittently (i.e. not continuous administration) with or without radiation treatment
* Discharge from SickKids is anticipated to occur following completion of the current inpatient chemotherapy or chemotherapy is being administered as an outpatient
* Between 2 and 18 years of age (age range for which instruments are available and children may be able to comply with homeopathy) A score on the Symptoms Distress Scale (SDS) of 2 or higher
* Able to ingest medications in lactose/sucrose globule or liquid form
* Reside within Greater Toronto area or willing to travel to the Riverdale Homeopathic Clinic. Participants living outside of the Greater Toronto area who wish to receive home visits may be eligible provided that permission is granted by the homeopath investigator
* A parent or caregiver must be able to read and write in English.
* Patients who are currently receiving CAM including homeopathy are eligible.

Exclusion Criteria:

* Previous history of allergy to the homeopathic products
Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine

The overall aim of this study is to further understand the memory response to HPV vaccination in subjects who have received 2 versus 3 doses of quadrivalent HPV vaccine. Although memory responses can be detected shortly after immunization, the best approach to measure the long-lasting anamnestic response is to challenge with a booster dose years (\> 5) after the original exposure.

This is a single center, interventional study to evaluate long term memory response to Q-HPV vaccination and to natural infection. Memory response will be assessed by measuring seroprotection 8-10 years post Q-HPV vaccination and to challenge with a booster dose years after the original exposure to measure the long-lasting anamnestic response.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent provided by the participant.
* Participant whom the investigator believes can and will comply with the requirements of the protocol.
* General good health.
* Immunized with Q-HPV vaccine between the ages of 9-13 or 16 to 26 years on the BCGov01 study or the BC provincial program.
* Participant who is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study. Examples of effective methods of birth control include:

  * Abstinence (no sexual activity)
  * Hormonal contraceptives including oral, injectable, implants \& skin patches
  * Intrauterine device (IUD)
  * Male partner sterilization
  * Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository)
  * Male condom combined with a female diaphragm, whether with or without a vaginal spermicide (foam, gel, cream, or suppository)
  * Adequate contraception does not apply to participants with same sex partners, when this is their preferred and usual lifestyle

Exclusion Criteria:

* Received more than 3 doses of Q-HPV vaccine
* Received any doses of HPV9 vaccine
* Systemic hypersensitivity to Q-HPV vaccine or HPV9 vaccine or severe reaction to any previous dose of Q-HPV vaccine.
* Receipt of blood or blood product within 3 months prior to Visit 1.
* Receipt of a live vaccine within 28 days or an inactive vaccine within 14 days of Visit 1
* Immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months prior to Visit 1.
* Inadequate participant fluency in English to provide fully informed consent.
* Participant who is currently pregnant or planning a pregnancy during the course of the trial
Physiological Benefits of High-intensity Interval Training for Individuals With Parkinson's Disease

Aerobic exercise is recommended for individuals with Parkinson's disease (PD) and can improve quality of life, both physically and mentally. The most efficacious program to achieve these exercise benefits is unknown. Recently, high-intensity interval training (HIIT) has been shown to be safe and more effective in many high-risk populations with limited exercise tolerance. Shorter bouts of exercise are likely better tolerated in PD due to difficulty sustaining muscle contractions. The goal of this project is to determine whether HIIT produces superior cardiorespiratory, neuromuscular, biomechanical, and clinical adaptations than conventional continuous moderate intensity training (CMIT) in PD.

The specific research aims are to compare, in PD, the effects of HIIT or CMIT on: 1) maximal exercise capacity; 2) neural and non-neural factors contributing to muscle strength, power and fatigability; 3) biomechanical measures of postural stability and gait; and 4) Clinical markers (Mini-BESTest and Unified Parkinson's Disease Rating Scale (UPDRS)). The investigators hypothesize that, HIIT will produce greater improvements in: 1) exercise capacity; 2) muscle strength, power and reduced fatigability; 3) stability and gait velocity; and 4) clinical markers.

Methods: This pilot project will involve a randomized trial of 30 individuals with PD comparing the effects of HIIT and CMIT. Training will be completed thrice weekly for 10 weeks. Participants will include men and women between 50-85 years of age, who are able to stand unsupported for 1 min, walk 18m without use of an aid, and mount a stationary bike. Participants will be randomized to either HIIT (10, 1-minute cycling intervals at 90% of peak power output, each separated by 1-min at 10% peak power output) or CMIT (30-50min cycling at 60% of peak power output). Participants will undergo the following pre- and post-training assessments: Cardiovascular testing will examine hemodynamic and efferent muscle sympathetic responses to static handgrip exercise and post-exercise circulatory occlusion; Neuromuscular testing will examine muscle activity (electromyography) during voluntary and electrically stimulated contractions of the knee extensors; Biomechanical testing will examine whole-body stability, gait, and balance patterns; and Clinical risk assessments (Mini-BESTest and UPDRS).

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 45-85 years of age
* Clinical diagnosis of Parkinson disease
* Able to stand unsupported for 1 minute
* Able to walk 18 metres without aid
* Able to mount a stationary bike

Exclusion Criteria:

* History of dementia
* History of stroke
* Type 1 diabetes
* Autonomic neuropathy
* Currently involved in formal exercise training (\>3 day per week).
Comparison the Effectiveness of Mirror Therapy VS Music Therapy for Training in Post Stroke Hemiplegic Patients

A randomized clinical trial was performed on hemiplegic post-stroke patients with a sample size of 50 (25 in each group).

It was a single-blinded study. Mirror therapy was given to group A and music therapy was given to group B. Our findings support the alternate hypothesis. This indicates the small effect size for BBS in group A and the moderate effect size for the gait assessment scale in favor of group A.

Eligibility Criteria:
Inclusion Criteria:

* ischemic and hemorrhagic post stroke hemiplegic patients
* patients of age 40-60 years
* no visual perception dysfunction

Exclusion Criteria:

* patients with fracture of upper or lower limb
* patient with comorbidities
* patients with hearing issues
* patients with cognitive disabilities
* patient with other neurological disease
Physical Activity Levels and Functional Improvement in Breast Cancer Survivors

The main objective of our project is to describe what characteristics (e.g., age, current physical activity level) women present when starting the exercise program are potentially associated with an improvement in functional abilities measured with different tests such as the distance you can cover while walking for six minutes.

The main research objective is to investigate the relationship between baseline physical activity and improvement in physical function, quantified using changes in 6-minute walk test (6MWT) results over the course of the 12-week program. An association is hypothesized to exist between the two variables even when adjusted for weeks into treatment. The goal of the 6MWT is to cover as much distance as possible in six minutes, using as many breaks s necessary. The test is often performed using a 20-meter hallway but requires no specific equipment. A recent study reported that the result of the 6MWT could be used as a measure of the major components of global health in women with breast cancer, making its use in our research especially relevant. Aside from physical functions, baseline characteristics will also be used to determine what characteristics, if any, are associated with health and psychosocial outcomes such as quality of life, social connectedness/support, and mental well-being. The data collected is certain to fill a gap in the literature, and will therefore be likely published in an important journal in the field.

Eligibility Criteria:
Inclusion Criteria:

* Have received a diagnosis of breast cancer in your lifetime
* 19 years of age and older
* Cleared by medical team to participate in the study
* Have the intention to exercise at the facility for the duration of the study

Exclusion Criteria:

-
The Efficacy of Oral Dissolution Therapy (ODT), Extracorporeal Shock Wave Lithotripsy (ESWL), and Combined ESWL and ODT as Non-Invasive Modalities for Treating Small and Medium-Sized Radiolucent Renal Stones

This study aimed to compare oral dissolution therapy (ODT), extracorporeal shock wave lithotripsy (ESWL), and a combination of ESWL and ODT as noninvasive modalities for treating small and medium-sized renal radiolucent.

Various methods exist for managing small and medium-sized radiolucent renal stones. These range from observation to oral dissolution therapy (ODT), percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and extracorporeal shock wave lithotripsy (ESWL).

Oral dissolving therapy diminishes the recurrence rates of stones. It positively influences the medical management of stone activity following ESWL in cases with residual calculi. By integrating oral dissolution therapy with extracorporeal shock wave lithotripsy, cases may experience the advantages of both non-invasive techniques. The combination of oral dissolution therapy and ESWL is an efficient therapeutic modality for radiolucent renal stones, dramatically reducing the overall stone volume. It also reduces the frequency of necessary extracorporeal shock wave lithotripsy sessions compared to treatment with ESWL alone

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* Patients with a single radiolucent renal stone 0.5-2 cm at largest diameter diagnosed by non-contrast MSCT of the urinary tract (CTUT) ≤ 500 HU (Hounsfield Unit) and not seen on kidney, ureter, and bladder (KUB) X-ray.

Exclusion Criteria:

* Patients with Coagulation disorders, a pacemaker, severe deformity of the skeletal system, anatomical obstruction distal to the stone, and obesity (Body Mass Index more than or equal to 35 kilograms per meter square).
* Patients with renal insufficiency (creatinine more than 1.7 mg/dl).
* Patients with active urinary tract infections.
Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease

Patients with Thyroid Eye Disease (TED) often have enlarged extraocular muscles and higher orbital fat contents due to their disease process. The confined space of the orbit cannot hold the enlarged orbital contents creating a forward displacement and/or compression of the globe with a rise in intraocular pressure (IOP). Many of these patients undergo surgical decompression, a procedure that fractures orbital bones, in order to allow more space for the enlarged orbital contents to occupy. To date, there is no data that shows intraocular patterns over a 24-hour period in patients with mechanical compression on the globe as in TED. It is not know if the pattern of IOP is more consistent with normal IOP patterns, glaucomatous patterns, or perhaps completely different then either. The goal of this project is to investigate patterns of IOP in patients requiring orbital decompression because of orbital congestion. Changes in IOP during a 24-hour period will be studied with a contact-lens embedded sensor that provides continuous data. This device has previously been investigated and shown to be safe and well-tolerated. Monitoring the pattern in these patients will allow us to compare Thyroid TED patterns of IOP with those of normal and glaucomatous patients. Also, testing these patients before and after orbital decompression surgery will allow characterization of how intraocular pressure changes once the mechanical compression on the globe is relieved.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to comply with the study procedures
* 18-80 years old
* Subjects diagnosed with Thyroid Eye Disease based on both endocrinology studies showing autoimmune dysfunction consistent with Graves' Disease as well as orbital imaging studies manifesting characteristics consistent with Thyroid Eye Disease.
* Ability to understand the character and individual consequences of the study
* Subject has consented to be in the trial

Exclusion Criteria:

* Subjects with contraindications for wearing contact lenses
* Severe ocular surface disease
* Keratoconus or other corneal abnormality
* Severe ocular inflammation
* Full frame metal glasses during SENSIMED Triggerfish® monitoring
* Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
* Simultaneous participation in other clinical studies
* Diagnosis of glaucoma
Does Tourniquet Use in Total Knee Replacement Improve Fixation

Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.

The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration.

We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not.

Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis.

Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years

Eligibility Criteria:
Inclusion Criteria:

* primary or secondary osteoarthritis without other severe disease (ASA 1-2).

Exclusion Criteria:

* were inability to give informed consent,
* rheumatic arthritis,
* malignancy,
* coagulation disorder or medical treatment influencing the coagulation,
* liver disease,
* severe heart disease or bilateral operation.
Cognitive Behaviour Therapy for Patients With IBS

Irritable bowel syndrome (IBS) affects approximately 10-15% of the adult population. This condition is characterized by abdominal pain, altered bowel habit, abdominal bloating and reduced quality of life. Options for treating IBS include pharmacotherapy, psychotherapy, hypnotherapy and cognitive behavior therapy (CBT). Available data on the effectiveness of CBT in IBS patients in Israel are scarce.

The aim of the present study is to assess effectiveness of CBT as compared with standard therapy for IBS patients in Israel The course of CBT consisted of up to six 40 min sessions, and included education about IBS and techniques to reduce focusing on symptoms and to manage stress.Standard therapy includs life style modifications.

The primary outcome measure was the score on a symptom-severity scale specific to IBS.

Symptomatic treatment of patients would not be modified

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* IBS

Exclusion Criteria:

* Malignancy
* Known psychiatric disorders
Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion

The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.

Background: Dysphagia is a serious post-operative concern in patients following anterior cervical surgery. Although many experts have acknowledged that dysphagia is often incompletely understood and defined, there is a significant amount of literature to support the significance of this clinical entity. This is the first randomized study to examine the use of topical steroids for the prevention of dysphagia postoperatively after anterior cervical discectomy and fusion.

Study Design: This study is a single site, double blinded randomized control trial. All individuals undergoing 2-4 level ACDF that meet the inclusion criteria will be randomized to either:

1. treatment arm or
2. control arm.

Both arms will undergo their planned surgeries and will receive the exact same procedure and standard of care as if they were not enrolled in a study. The only difference is that the treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with one Hemostatic Matrix Kit injectable delivery vehicle prior to closure in the prevertebral soft tissues. The control group will receive only Hemostatic Matrix Kit prior to closure in the prevertebral soft tissues.

Outcomes: Patients will be asked to fill out questionnaires that assess dysphagia, general swallowing difficulty, and how neck pain impacts their quality of life. Additionally Radiographic images will be obtained at set time points to evaluate soft tissue inflammation and bony fusion.

Eligibility Criteria:
Inclusion Criteria:

* Any patient \> 18 years undergoing a 2-4 level Anterior Cervical Discectomy and Fusion

Exclusion Criteria:

* Patients undergoing revision surgery
* Pediatric patients
* Trauma patients with cervical spine fractures
* Patients with cancer
* Patients with active infection
* Patients with a known allergy to Methylprednisolone Acetate
* Patients who refuse to participate
* Non English speakers
Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma

The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when administered in combination with ipilimumab.


Eligibility Criteria:
Inclusion:

* Male and female subjects ≥ 18 years of age with a histologic or cytologic diagnosis of Stage III or Stage IV (unresectable) melanoma
* Enrollment to cohort expansion will be limited to only those subjects whose tumors demonstrate the B-Raf V600E mutation
* ECOG ≤ 1
* Adequate organ \& marrow function

Exclusion:

* Uncontrolled or significant cardiovascular disease
* Cohort expansion: Prior therapy with a RAF inhibitor