cyrilzakka/clinical-trials huggingface dataset:
Relationship Between HbA1c Level, Sleep Quality and Sleep Duration

The study will be conducted during the period of, January 2019 - August 2019 with pre-diabetic participants on a NHS England funded National Diabetes Prevention Program (NDPP) with a clinically diagnosed Haemoglobin A1c (HbA1c) referral reading of between 42mmol/mol - 47mmol/mol within the last 12 months. The term pre-diabetic can all be used to explain blood glucose levels that are higher than normal, but not high enough for participants to be diagnosed with Type 2 diabetes. Having high blood glucose levels can increase a participant's risk of developing Type 2 diabetes and other health complications, although this is not inevitable.

100 participants will take part in the study. Participants will be eligible if they are aged between 18 and 65 years and have an HbA1c referral reading of between 42-47mmol/mol within the last 12 months.

The participants will be given a written consent form to sign to take part in the study, after receiving both written and verbal information beforehand on the study protocol from the researcher. Health screening to determine eligibility for the NHS funded program will be undertaken directly by the intervention provider.

Study design and procedures:

The study will be delivered in a controlled format and will be designed to assess the relationship between the elevation of HbA1c level, sleep quality and sleep duration in clinically diagnosed pre-diabetic participants referred and registered to join the NHS NDPP. Participants will receive a pre-program information pack in conjunction with a sleep quality and sleep duration questionnaire at the end of their 1:1 initial appointments for the NHS NDPP.

Participants will be given prepaid envelopes to send their anonymised questionnaires back to the researcher once completed after their appointments. The researcher will ensure confidentiality by keeping all questionnaires in a securely combination coded locked cupboard that only the researcher has access to. Participants will be instructed to not write their names on the questionnaires but to only state their gender, age, and referral HbA1c reading received from the relevant health care professional.


Eligibility Criteria:
Inclusion Criteria:

* Participants were eligible if they were aged 18 years - 65 years
* Had an HbA1c referral reading of between 42-47mmol/mol within the last 12 months
* Registered on the NHSE NDPP

Exclusion Criteria:

* Participants with a severe debilitating disease which may have interfered with the study participation
* Under the age of 18 years or over the age of 65 years
* Pregnant
Breathe Anew for Lung Cancer Survivorship

Survivorship programs have become an integral component of modern cancer care programs. In Canada, there has been tremendous success for survivorship programs for breast, prostate, and colorectal cancer, however lung cancer survivorship programs have not been widely developed. The complexity of the disease, high mortality, short survival times, high cost of surveillance, and patient habits have traditionally been barriers against the success of lung cancer survivorship programs. The investigator proposes a feasibility study to pilot a novel intervention titled Breathe Anew, which will aim to identify and overcome the barriers to the design and implementation of a lung cancer survivorship program. The investigator has assembled a multi-disciplinary team of experts and lung cancer survivors who will develop the Breathe Anew survivorship intervention. The intervention will be vetted using an integrated knowledge translation approach, which will involve members of the target population, primarily patients who previously underwent lung resection, to modify the intervention and ensure acceptability. After Breathe Anew has been designed, it will be tested in a pilot study of 50 patients to ensure its feasibility and determine its cost. The ultimate goal of this feasibility study is to lay the groundwork for a subsequent comparative trial to evaluate the impact of Breathe Anew on patient-important outcomes including health related quality and length of life and postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* All patients at St. Joseph's Healthcare Hamilton who received lung resection for Stage I, Stage II, or Stage IIIa Non-Small Cell Lung Cancer are eligible to enroll.
* Owns a smart device

Exclusion Criteria:

* Patients who received lung resection for Stage IIIb or IV Non-Small Cell Lung Cancer
* Patients with affected mobility (walker, wheelchair)
* Patients who use oxygen at home
Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy

The study hypothesis: Valsartan as an angiotensin II receptor blocker treatment has beneficial effects on both midwall mechanics and myocardial functions in hypertensive patients with Left ventricular hypertrophy.


Eligibility Criteria:
Inclusion Criteria:

* hypertension with left ventricular hypertrophy

Exclusion Criteria:

* clinical or laboratory evidence of secondary hypertension
* heart failure
* ischemic heart disease
* valvular heart disease
* arrhythmias
* peripheral vascular disease
* chronic obstructive pulmonary disease
* neurologic disorders
* diabetes mellitus
* renal dysfunction
* notable systemic disease
Chicago Parent Program for Foster and Kinship Caregivers

The primary objective of this study is to test the effects of an evidence-based prevention intervention (CPP) adapted for foster and kinship caregivers of young children (FC; foster care) on caregiver competence and child behavior problems for children in foster care compared with an active comparator group that receives standard supports through the child welfare and healthcare systems (i.e., usual care).

The purpose of the study is to evaluate the impact of an evidence-based parenting program, The Chicago Parent Program (CPP) adapted for foster and kinship caregivers of young children (CPP-FC). A parallel, two-arm, randomized controlled trial of 300 caregiver-youth dyads will be conducted, comparing the impact of CPP-FC versus a usual care control on caregivers and foster youth. Quantitative and qualitative data about CPP-FC will be collected from foster and kinship caregivers and through observations of caregivers and youth. The findings from this study will demonstrate whether CPP-FC is effective in reducing behavior problems in young foster children and whether that contributes to reduced caregiver stress, increased caregiver confidence, increased positive parenting behavior, and longer lengths of time that children remain with foster and kinship caregivers, preventing unnecessary moves from one caregiver to another and improving child wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Must be a licensed foster caregiver or kinship caregiver to a foster child between the ages of 2 and less than 9 years of age
* Must be a licensed foster caregiver or kinship caregiver to a foster child in Ohio and in the custody of Hamilton County Job and Family Services, Butler County Children Services, or Montgomery County Children Services
* Must be in good standing with the foster care agency
* Must be English-speaking

Exclusion Criteria:

* Not having a foster child between the ages of 2 and less than 9 years
* The foster child not being in the custody of Ohio counties: Hamilton County Job and Family Services, Butler County Children Services, or Montgomery County Children Services
* The foster child was placed in the home more than 45 days prior to enrollment
* The foster child being moved out of the placement prior to the start of the intervention
* The foster child having been previously enrolled with another caregiver
* The caregiver having been previously enrolled with another child
* The caregiver unable to commit to completing all study activities
* The foster child is not enrolled in the study
Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.

Based in an embodied approach of cognition, several studies have highlighted a direct link between perception of an object or an emotion and the associated motor responses. This study investigated in patients suffering from bipolar affective disorders whether the perception of emotional words involves an automatic sensorimotor simulation of approach and avoidance behaviors, and whether the perception of an object involves an automatic sensorimotor simulation of object prehension (affordance). We hypothesize that, in this pathology, low level (sensorimotor) cognitive processes are preserved whereas high-level (attentional) are altered. 20 patients suffering from bipolar affective disorders and 20 healthy controls will be recruited. The main objective is the emergence of sensorimotor compatibility effects in approach-avoidance task with emotional stimuli (gain between compatible vs incompatible conditions).


Eligibility Criteria:
Inclusion Criteria:

For patients:

* Affiliated or entitled to a social security
* Aged between 18 and 55
* Patients of both sexes suffering from bipolar disorders (DSM V criteria) whatever the subtype
* Stabilized from a point of view clinical and therapeutic
* Euthymic (score \<7 at the Hamilton scale, and score \<8 at Young's scale)
* Must have given their informed consent before their participation in the study
* Be right-handed (score\> 14 on the laterality scale)

For control group:

* Affiliated or entitled to a social security
* Must have given their informed consent before their participation in the study
* Be right-handed (score\> 14 on the lateral scale)
* Aged 18 to 55 matched by age (± 5 years), sex, and on the study level of patients (years of schooling after primary school ± 2 years)

Exclusion Criteria:

For patients:

* Thymic acute decompensation
* Hamilton scale \> 8, Young's scale \> 9
* Montreal Cognitive Assessment (MOCA) \<26
* History neurological pathology with cerebral impairment or serious somatic disease
* Disorders related to the use of a psychoactive substance, as defined by the DSM-V (abuse, dependence or withdrawal) within 6 months.
* IQ \< 70
* History of head trauma

For control group:

* History of head trauma
* Neurological pathology with cerebral impairment or serious somatic disease
* Psychotropic treatment
* Disorders related to the use of a psychoactive substance, as defined by the DSM-V (abuse, dependence or withdrawal)
* IQ \< 70
Requests for Euthanasia and Assisted Suicide

This study take place in the palliative care units of Burgundy-Franche-Comté regions and at the Maison Médicale Jeanne Garnier. The main aim of this project is to analyze and understand the meaning of explicit requests to hasten death (euthanasia and assisted suicide).

This involves conducting interviews with patients, carers to whom the request has been expressed and a relative chosen by the patient. This study aims to describe the request over time. This will be done through two series of interviews, one as soon as it is first expressed, then one week later.


Eligibility Criteria:
Inclusion Criteria:

* Adult not under guardianship or curatorship,
* Hospitalized in palliative care units of Bourgogne-Franche-Comté region and in the Maison Médicale Jeanne Garnier in Paris,
* At the end of life due to advanced stage disease or a major change in the state of health of an elderly person,
* They have made an explicit request for euthanasia or assisted suicide,
* They are in capacity to meet researchers for interview,
* Having consented to interviews,
* They are covered by the French social security system.

Exclusion Criteria:

* Adult under guardianship or curatorship,
* They are underage,
* They are not hospitalized in Palliative Care Unit of Bourgogne-Franche-Comté region and in the Maison Médicale Jeanne Garnier,
* The request was expressed by another person or not explicit,
* They didn't consent to interviews,
* The request appears in the context of a situation other than illness or a general change in state of health
* They are not in capacity to meet researchers for interviews.
Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery

Research questions:

1. What is the absolute risk reduction for in-hospital major adverse cardiac events (MACE) associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population?
2. What is the absolute risk increase for clinically significant bleeding during the same period associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population?

In brief the design of the study is as follows:

* We will study patients undergoing non-cardiac surgery within four years of coronary stenting.
* We will record the anti-platelet agents taken by patients before, during and after surgery.
* We will record cardiac and bleeding events that occur whilst the patient is in hospital.
* We will use the statistical technique of propensity scoring to match patients who have similar risk factors and who received different anti-platelet regimens.
* We will compare the incidence of cardiac events and bleeding in the matched groups.

This study will compare the use of aspirin alone with dual antiplatelet therapy (i.e. aspirin and clopidogrel) in patients presenting for elective non-cardiac surgery who have undergone PCI with either bare metal stent or drug eluting stent placement in the four years prior to surgery. The absolute risk reduction in major adverse cardiac events (MACE) with dual antiplatelet therapy and the absolute risk increase for clinically significant bleeding events with dual therapy will be determined. This will allow the number needed to treat (NNT) for the prevention of MACE and the number needed to harm (NNH) for bleeding to be determined and the optimal antiplatelet therapy in this setting to be identified.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing non-cardiac surgery within four years of percutaneous coronary intervention (PCI) with the placement of a bare metal or drug eluting stent will be included in the study.

Exclusion Criteria:

* Patients maintained on anticoagulant therapy e.g. heparin infusion before and after surgery will be excluded. (Patients receiving prophylactic doses of heparin for prevention of thromboembolic events will be eligible for inclusion.)
* Patients receiving bridging therapy with full anticoagulant does of heparin or other drugs to compensate for the withdrawal of antiplatelet drugs will be excluded.
* Patients who are anticoagulated with warfarin (INR\>1.5 at the time of surgery) will be excluded.
* Patients receiving full anticoagulation with heparin for a known recent a known thromboembolic event (APPT ratio \> 1.5) be excluded. -
Efficacy Study of Ultrasound-Assisted Debridement to Influence Wound Healing

The UltraHeal Study is a randomized controlled trial to compare healing response of low frequency contact ultrasonic-assisted debridement in addition to best practice wound care to best practice wound care alone in a Vascular Surgery Clinic patient population with wounds of the lower extremity.

The study will also investigate the bacterial tissue burden and protease activity to provide further insight into the infection and inflammation aspects of healing barriers in a challenging population.

Eligibility Criteria:
Inclusion Criteria:

* Persons with lower extremity wound referred to vascular surgery service.
* Full thickness wound below the knee with surface area of at least 1cm2.
* Age \>18 years
* English speaking
* Ulcer of known etiology including diabetic foot wounds, and arterial or venous leg ulcers
* Willing and able to adhere to 12 week study protocol that includes attending weekly clinic appointments, and wearing prescribed footwear or compression therapy

Exclusion Criteria:

* Leg wounds due to inflammatory conditions (e.g. pyoderma gangrenosum, vasculitis), malignancy, or other unknown etiologies.
* Severe arterial insufficiency: Absence of pedal pulses combined with Ankle Brachial Index ≤ 0.3, Toe Pressure ≤20, or Trans Cutaneous Oxygen Measure ≤20
* Presence of acute limb threatening infection
* Vascular surgery planned within next 3 months
* Exposed vascular graft or blood vessel, bone or tendon in the base of the wound.
* Currently receiving advanced wound therapy treatments: Hyperbaric therapy, biological dressings \[collagen or extracellular matrix dressings\].
* Increased likelihood of an adverse reaction to ultrasonic debridement due to:
* Excessive wound pain (\>5 VAS scale) or patient described intolerable
* Allergy to topical anesthetic (lidocaine)
* Individuals who have factors/circumstances that are known to limit their ability to demonstrate healing in 4 weeks.

For example:

* medically unstable or palliative medical status
* poor nutritional status (low serum albumin \< 15),
* anemia (Hb \< 75 mg/dl),
* taking immunosuppressant medication (prednisone, chemotherapy; transplant anti-rejection medication),
* Individuals with medical conditions that contraindicate the use of ultrasound energy
* Cardiac pacemaker or defibrillator
* Excessive bleeding tendency (\> 5 mins post debridement) or identified coagulopathic disorders
* Exposed bone in the wound base
* Untreated osteomyelitis
A Safety Study on Posterior Pedicle Screw System

The goal of this study is to assess the MUST MINI system safety in patient who will undergo a posterior cervical spine fusion intervention. Patients will be invited to partecipate during preoperative visit and follow the postoperative visits according to the standard practice.

Patient who will undergo a posterior cervical spine fusion intervention, will be invited during preoperative visit to take part to the study.

The study is an observational multicentric study with an enrolment period of 12 months with the aim to assess the safety of MUST MINI system.

All adverse events will be collected for all study duration, classified as device and not device related. Screw failure rate is calculated considering screw loosening, breakage, lost-reduction events.

Standard radiological investigations are previewed at preoperative visit, before discharge and at 6 weeks and 12 months follow-up after surgery visits; the risk of any further exposure to radiation other than it's routine use in a diagnostic manner within the follow-up period can be excluded.

A final visit at 12 months level index fusion will be evaluated clinically as well as radiographically, with a confirmation CT scan as per standard of care. Screw placement accuracy will be evaluated during this visit.

A functional cervical x-ray is considered also during last follow-up (12 months after surgery) in order to assess cervical spine functionality.

Eligibility Criteria:
Inclusion Criteria:

* those affected by degenerative disc disease needing a posterior surgical instrumented treatment aimed at segmental fusion,
* those who will undergo posterior fixation due to traumatic lesion or tumor,
* Patients with BMI ≤ 35 kg/m2,
* those who signed the consent form to participate to the study.

Exclusion Criteria:

* Patients \<18 years,
* Patients who are pregnant or intend to become pregnant during the study.
Biomarkers in Tumor Tissue Samples From Younger Patients With Rhabdomyosarcoma

This research trial studies biomarkers in tumor tissue samples from younger patients with rhabdomyosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

PRIMARY OBJECTIVES:

I. To demonstrate CRKL expression at the protein level in rhabdomyosarcoma tumors by tissue microarray (TMA).

OUTLINE:

Archived tumor tissue samples are analyzed for CRKL expression.

Eligibility Criteria:
Inclusion Criteria:

* Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma specimens from the Children Oncology Group (COG) tumor microarrays (TMAs)
Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study

Total hip arthroplasty is amongst the most painful procedures postoperatively, and pain management can be a challenge. Different measures have been introduced to manage severe postoperative pain in these patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reduced postoperative pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated for total joint arthroplasty patients.

The study was submitted to Health Canada and has received the letter of no objection. A randomized, double-blind, placebo-controlled trial will be conducted. The randomization scheme will be prepared and done by the pharmacy department at McMaster University. Ninety patients undergoing primary hip arthroplasty will be recruited from the preoperative clinic. Forty-five patients in each population will be allocated to a gabapentin group and the other forty-five patients will be allocated to a placebo group.

Eligibility Criteria:
Inclusion Criteria:

* participants aged 19-90
* elective single joint, primary total hip arthroplasty
* use of PCA with morphine for postoperative pain control has been discussed and agreed upon between patient and anesthetist

Exclusion Criteria:

* bilateral total hip arthroplasty
* revision hip arthroplasty
* underlying diseases of epilepsy, seizure, or chronic pain syndrome
* active gastrointestinal bleeding within the last 6 months
* history of non-steroidal anti-inflammatory drug (NSAID) induced asthma
* known or suspected history of drug or alcohol abuse
* participate currently takes gabapentin or pregabalin for any reason
* participant currently takes pain medication that is more potency than codeine or oxycodone (morphine, hydromorphone, meperidine, methadone, fentanyl, including any long acting narcotics)
* known allergy to study medications: gabapentin, morphine, NSAID, acetaminophen
* unable to tolerate morphine
* liver impairments
* kidney impairment or calculated creatinine clearance by Cockcroft-Gault formula is \<=60ml/min
* pregnancy or breast-feeding
* participant currently receives associated worker's compensation benefits (WSIB)
* participant unable or unwilling to give written or informed consent
* unable to use PCA
Impact of a Mobile Geriatric Team With a Pharmacist on the Optimisation of Prescriptions in Elderly Inpatients

In patients aged 75 years and older, polypathology is frequent and often associated with polypharmacy. This polypharmacy coupled with a lack of proactive elderly care can sometimes lead to hospitalisation. Due to comorbidities and complex problems, management of geriatric patients usually requires a multidisciplinary approach. In Toulouse University Hospital, elderly inpatients can benefit from a geriatric assessment by a Geriatric Mobile Team. Whether this team improve the prescriptions through the advice of a clinical pharmacist has not been demonstrated yet.

All participants will be identified via the geriatrician of the mobile geriatric team with the following inclusion criteria: age ≥ 75 years, ≥ 5 medications per day and being hospitalised either in emergency room, short-stay medicine unit or in a surgery department. For each patient, the pharmacist will detect potentially inappropriate prescribing (based on explicit criteria and an implicit approach) and liaise with the geriatrician for drug optimisations. The pharmaceutical advice will be added to the geriatrician's written report, and then addressed to the relevant physician. The implementation of the proposals will be evaluated immediately at the end of hospitalisation, and then reassessed three months later by calling the patient and/or his community pharmacist. A total of 250 patients will be enrolled over a 12 month-period. The evolution of potentially inappropriate prescribing will be assessed and their cost evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 75 or older
* Having 5 medications or more per day
* Being hospitalised either in emergency room, short-stay medicine unit or surgery department

Exclusion Criteria:

* Patient refuses to participate
* Patient already included in another study