cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program

This study will evaluate baby box ownership and safe sleep practices (sleep location, sleep position, use of bedding) among families provided a free baby box and standardized safe sleep education compared to families provided a safe sleep pamphlet and information on how to obtain a free box in the community.

The proposed study is a randomized controlled trial with two arms: the intervention group (n=110) will be provided a baby box and standardized face to face education regarding the box and its contents, safe sleep, and infant health promotion; the control group (n=110) will be provided information on how to obtain the same baby box at a community site in Winnipeg, and will receive a safe sleep pamphlet, baby box pamphlet and a guide to online resources for prenatal ad infant health promotion. An additional comparison group will be parents who already have a baby box at the time of recruitment. This group will also receive the safe sleep pamphlet. Families will be interviewed at recruitment and 2-4 months of age to measure box ownership and self-reported safe sleep and infant health promotion practices. Administrative data will be used to evaluate the impact on infant immunizations and hospitalizations in the first year of life, and to evaluate the impacts of prenatal care visits and neonatal length of stay on the outcomes.

Families will be asked to participate in a face to face interview at baseline (enrolment) and one follow-up interview coordinated with a scheduled routine healthcare visit for the infant at 2 months of age and conducted face to face or by telephone, according to family preference.

PHIN will be requested for both mother and infant in order to explore the relationship between adequacy of prenatal care and the study outcomes, and to evaluate the impact on infant immunizations and hospitalizations in the first year of life. Postal code will be requested to analyze differences related to place of residence and neighbourhood income quintile.

Eligibility Criteria:
Inclusion Criteria:

* Mothers who are 32 weeks or more gestation
* Infants less than 3 months of age (or post-conceptional age 44 weeks)
* Able to consent freely and complete face to face and/or telephone interviews in English
* Will be residing in Winnipeg until the infant is 2-4 months of age or able to complete a telephone interview at 2-4 months of age

Exclusion Criteria:

* Parent/guardian/client less than 18 years of age (unless emancipated minor)
* Parents who cannot consent due to intellectual capacity, medical condition, etc.
* Infant is discharged from hospital in the care of Child and Family Services or a birth alert is in place
Injection of Lymphocytes From Haplo-identical Donor Following Chemotherapy in Patients With High-risk Acute Myeloblastic Leukemia Not Eligible for an Allogeneic Hematopoietic Stem Cell Transplantation

Patients with high risk AML non eligible for an intensive treatment and for an allogeneic transplantation will be treated with azacitidine and venetoclax. The fourth, fifth and sixth injection of azacitidine will be followed by injection of haplo-identical lymphocytes (HLI). This is a single-center phase I study to identify the dose of HLI with the most tolerable toxicity. TheBayesian continuous reassessment method (CRM) will be used


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* patients with de novo or secondary AML, with an unfavorable or intermediate karyotype (according to the 2017 ELN classification), or patients with relapsing AML who may receive second-line treatment
* not candidates for intensive induction, for the following reasons

  * 75 years or ≥ 18 to 74 years and at least one of the following comorbidities: PS ≥ 2 or a history of heart failure requiring treatment or LVEF ≤ 50% or chronic stable angina or FEV1 ≤ 65% or DLCO ≤ 65% or creatinine clearance \<45 ml / min; or liver damage with total bilirubin\> 1.5 N or other comorbidities that the hematologist considers incompatible with intensive treatment
* ineligible for a classic allogeneic hematopoietic stem cell transplant due to the presence of co-morbidities or too high a risk of toxicity \>70 years old or at least one of the following comorbidities: PS ≥ 2 or a history of heart failure requiring treatment or LVEF ≤ 50% or chronic stable angina or FEV1 ≤ 65% or DLCO ≤ 65% or creatinine clearance \<45 ml / min; or liver damage with total bilirubin\> 1.5 N
* may receive chemotherapy with hypomethylating agents have a partially compatible (haplo-identical) major family donor (≥18 years old) eligible for lymphocyte donation.

Exclusion Criteria:

* AML with favorable karyotype (according to ELN 2017) in RC1
* Patient with refractory or progressive AML
* Other progressive cancer in progress
* Karnosky index \<60% or PS\> 2
* Severe hepatic function disturbance: transaminases\> 5 N, hyperbilirubinemia\> 30 µm / L
* Severe infection requiring hospitalization.
* Psychiatric illness compromising the understanding of the information or the carrying out of the study.
* woman of childbearing potential and refusing an effective method of contraception.
* Minor
* Adult under tutorship or curatorship, under legal protection or under family authorization
* Minor family donor (\<18 years old)
Efficacy of Ubiquitous SR-based Memory Advancement and Rehabilitation Training (U-SMART)

The purpose of this study is to examine the efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild cognitive impairment (MCI) by an open-label, controlled, crossover Trial.

The Spaced Retrieval-based Memory Advancement and Rehabilitation Training (SMART) which consisted of 24 one-hour face-to-face sessions (Lee, Park et al. 2009) was developed based on the spaced retrieval training (SRT), which was effective in improving memory retention span of very mild to mild Alzheimer's disease patients. The Ubiquitous SMART (U-SMART) by transforming the current SMART to a self-administered program using an application working on IPAD was developed, and showed its feasibility and efficacy in the elderly individuals with mild cognitive impairment in the preliminary study. (ClinicalTrials.gov ID: NCT01628653) To validate the efficacy of the U-SMART, an open-label, controlled, crossover design of clinical trial were planned in this study.

Eligibility Criteria:
Inclusion Criteria:

* Aged 55-90
* Educational level above 1 year and confirmed literacy
* Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment
* Clinical Dementia Rating (CDR) of 0 or 0.5

Exclusion Criteria:

* Diagnosed to dementia by DSM-IV
* Evidence of delirium, confusion
* Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
* Evidence of severe cerebrovascular pathology
* History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity
* History of substance abuse or dependence such as alcohol
* Presence of depressive symptoms that could influence cognitive function
* Presence of medical comorbidities that could result in cognitive decline Use of medication that could influence cognitive function seriously
The Effect of Metformin on Fecundability in an ART(Assisted Reproductive Technology) Setting - the Correlation to Uterine Flows

The basis for obesity's impact on reproduction is not well characterised and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.

Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to determine if Metformin helps to increase fecundability by affecting the uterus in women undergoing ART. As a surrogate marker- flows in the uterus will be tested during the treatment.

Obesity has been long implicated in reduced reproductive potential and it has been shown to impair conception and implantation. However, the basis for this adverse effect is still obscure and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.

It is well established that insulin resistance is one of the main mechanisms of obesity's negative influences on the reproductive organs in females. Insulin sensitizers ameliorate insulin resistance in obese patients.

This study seeks to determine if Metformin ,an oral antidiabetic and insulin sensitizer, helps to increase fecundability by affecting the uterus in women undergoing frozen-thawed embryo transfer compared to the control group. As a surrogate marker- flows in the uterus will be tested during the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age: from 18-40 years old.
* BMI \> 30
* Infertile women undergoing frozen-thawed embryo transfer in an ART setting
* Women with at least one Top graded embryo
* Normal uterine Doppler indices at time of recruitment.

Exclusion Criteria:

* Diabetes mellitus - uncontrolled.
* Hyperprolactinemia- uncontrolled.
* Hypothyroidism- uncontrolled.
* women who are already treated with Metformin
* women with endometrial factor as the cause for infertility
A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia

The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation（PFA） Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia（PSVT）

The primary endpoint of this sutdy is the actue ablation success rate for all subjects, other endpoints include treatment success rate within 6 months after surgery, evaluation of equipment and cather. The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PFA ablation procedure) primary adverse events (AEs), ohter satety endpoints are incidence of AEs associated with the study devices and serious adverse events(SAEs).

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old ≤ age ≤ 80 years old, regardless of gender
2. Patients with symptomatic paroxysmal supraventricular tachycardia PSVT (AVNRT or AVRT) documented by ECG, Holter or electrophysiological examination
3. Recurrent episodes of disease prior to enrollment
4. Fully understand the treatment protocol and voluntarily sign an informed consent form, willing to undergo the tests, procedures and follow-ups required by the protocol

Exclusion Criteria:

1. Previous failure or recurrence of radiofrequency ablation
2. Left ventricular ejection fraction (LVEF) ≤ 40%
3. Combined with atrial flutter or atrial fibrillation
4. Combination of thromboembolic disease
5. Women who are breastfeeding, pregnant or planning to become pregnant during the study period
6. Carrying active implants in the body (e.g., pacemakers, ICDs, etc.)
7. Patients with second-degree (type II) or third-degree atrioventricular block
8. NYHA Class III-IV cardiac function \[Appendix 1\]
9. Patients with congenital heart disease (excluding atrial septal defect and patent foramen ovale)
10. Patients with definite acute cerebrovascular disease (including cerebral hemorrhage, stroke, transient ischemic attack) within the last 1 month
11. cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)
12. Acute or severe systemic infection
13. Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases
14. Patients with significant bleeding tendency, hypercoagulable state and serious hematologic disorders
15. Patients who have participated or are participating in other clinical trials within 3 months before enrollment
16. Patients who have other conditions that the investigator considers inappropriate for participation in this trial.
Board Games Among Mild Cognitive Impairment Patients Experience (GAME Project)

Nowadays, on geriatric centres, cognitive decline used to be prevented by pen and paper exercises (Calero García \& Navarro Gonzalez, 2006). However, as Lampit et al. (2014) suggest, studies based on the efficacy and effectiveness of new cognitive-based interventions in order to improve these cognitive processes are fundamental (Lampit et al., 2014). Cognitive-based interventions are interventions that directly or indirectly try to improve cognitive processes (Chiu et al., 2017). Between the different kinds of cognitive-based interventions, cognitive training permits stablish randomized controlled trials. Cognitive training consists of repeating during a concrete time a standardized set of tasks in order to maintain or improve one or some cognitive processes. Meta-analysis studies have shown that computerized cognitive training can improve in a moderate size some cognitive processes in elderly people with mild cognitive impairment or dementia (Hill et al., 2017) and without those diagnoses (Lampit, Hallock, \& Valenzuela, 2014; Chiu et al., 2017). Although it seems that computerized training is effective, safe and secure, it is important to note the social component of the definition of health (OMS, 1948). Chang, Wray \& Lin (2014) found that social relationships predict the use of leisure activities and this predict a better physical health and wellbeing psychological. In fact, a comparative study found that those elderly people that have played board games have a 15% lower risk of having dementia diagnose and problems related with memory (Dartigues et al., 2013). To sum up, the aim of this research project is to test the effectiveness of a cognitive training based on modern board and card games in elderly people with a diagnose of mild-cognitive impairment in comparison to do cognitive paper and pencil tasks or in a wait-list comparison group.


Eligibility Criteria:
Inclusion Criteria:

* Participation in cognitive disease center
* Amnestic MCI diagnoses (clinical diagnoses following the guidelines of Petersen et al. 2011)
* Global deterioration scale (GDS) 2-3 values
* Participation assessing outcomes of the caregivers in the study

Exclusion Criteria:

* Participation in another cognitive training program
* Dementia, neurologic or other disease non-neurodegenerative, which could affect cognitive change over time (medical-reported)
* Severe visual impairment, language impairment or motoric impairment of the upper extremity which significantly affects ability to solve jigsaw puzzles (medical-reported)
Effects of Inspiratory Muscle Training in Elders

Aging causes anatomical and physiological changes in the respiratory system and respiratory muscle strength with decline in its maximum function. This study aimed to evaluate the effects of inspiratory muscle training on respiratory muscle strength, thickness of the diaphragm and diaphragmatic mobility in older women. The investigators' hypothesis is that inspiratory muscle training improves respiratory muscle strength, the thickness of the diaphragm and diaphragmatic mobility in older women.


Eligibility Criteria:
Inclusion Criteria:

Elderly women are able to walk without aid and cognitive integrity.

Exclusion Criteria:

* Participation in other training or rehabilitation protocol;
* Contraindication or difficult to perform the evaluation;
* Difficulty adapting or adherence in training protocol;
* Smoking;
* Hemodynamic instability;
* Degenerative neuromuscular disease;
* Pulmonary comorbidities;
* Heart disease;
* Users of drugs that interfere in bone metabolism or muscle strength.
Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain

This study evaluates the acute effect of aerobic exercise and yoga on pain, plasma levels of endocannabinoids, and mood (i.e., mood disturbance and anxiety). Participants will complete three separate sessions on different days. The first session is a familiarization session in which participants complete questionnaires and are familiarized with the experimental protocols. During the second and third sessions, outcomes are measured before and after the participants complete either 44 minutes of moderate aerobic exercise (i.e., walking on a treadmill) or 44 minutes of yoga.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of breast cancer (stage 0-III),
* no evidence of active disease (i.e., recurrence, bone metastases, etc),
* presence of painful polyneuropathy, with onset coinciding or developing after receiving chemotherapy agents that in the opinion of the research team is likely to have caused such symptoms,
* at least six months since last active cancer treatment, with no further planned treatment (Note. active treatment is defined as surgery, chemotherapy, or radiation),
* the participant agrees to use the safety stop feature on the treadmill if needed,
* at least 18 years of age,
* and their physicians has provided consent for them to participate in yoga and aerobic exercise sessions.

Exclusion Criteria:

* Undergoing current chemotherapy or radiation treatment for cancer,
* taking anticoagulant therapy,
* uncontrolled medical conditions (i.e., uncontrolled hypertension, heart disease, stage 4 liver disease, end-stage renal disease, end-stage pulmonary disease, etc),
* stroke or myocardial infarction in the past 6 months,
* being pregnant or planning to become pregnant,
* severe mobility constraints (e.g., confined to a wheelchair),
* having a history of light headedness or fainting during blood draws or physical activity.
Modified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study

the purpose of this study is to assess functional and radiological outcome of open reduction and internal fixation of isolated displaced greater tuberosity fractures (more than 5mm displacement) in adults advocating modified hook wiring with a follow-up period of one year.

after being informed about the study and potential risks, all enrolled cases giving informed consent will undergo fixation of their fractured greater tuberosity, then physiotherapy. patients will be followed up till full union, clinical and radiological follow up for at least one year utilizing approved clinical scores and radiological criteria for healing. any complication will be recorded.

Eligibility Criteria:
Inclusion Criteria:

Patients presented and admitted at Mansoura Trauma, emergency hospital affiliated to Mansoura university, with acute isolated displaced GT fractures ( more than 5mm displacement), with/without glenohumeral dislocations, with age between 18years to 50 years.

Exclusion Criteria:

1. Skeletally immature patients (less than 18 years), age more than 50 years.
2. Open and pathological fractures
3. Associated proximal humeral fractures
4. History of previous GH dislocations
5. History of previous shoulder injuries or surgeries
Evaluation of Preoperative N1539 in Total Knee Arthroplasty

The primary objective of this study is to assess the effect of preoperative administration of N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily provide written informed consent.
* Be planned to undergo an elective, primary (no repeat arthroplasties) open unilateral total knee arthroplasty (TKA), and be expected to require IV analgesia, remain in an inpatient setting for ≥24 hours, and receive at least two doses of study drug.
* ASA physical status category 1, 2, or 3.
* Female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study.
* Have a body mass index \<40 kg/m\^2

Exclusion Criteria:

* Have a known allergy or hypersensitivity to any study treatment.
* Have a history of previous TKA.
* Has plans for a concurrent surgical procedure (eg, bilateral TKA).
* Has TKA planned to be performed under general anesthesia.
* Have a history of myocardial infarction within the preceding 12 months.
* Have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant condition that would preclude participation.
* Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.
* Have a known bleeding disorder which may be worsened with the administration of an NSAID.
* Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within 48 hours prior to surgery.
* Have previously received N1539/IV meloxicam or received any investigational product within 30 days before dosing with study medication.
* Have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening through last follow-up.
Temporal Pattern of Circulating DNA for Patients Receiving Irradiation

The purpose of the research study is to test a measurement tool that will determine the radiation dose people receive when they have been accidentally exposed to radiation. This test will be done using a small amount of blood and known dose of radiation.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be scheduled to undergo Total Body Irradiation (TBI) as part of a conditioning regime for a Bone Marrow Transplant. OR, Be scheduled to undergo Radiation Therapy treatment for a malignancy or other disease and have a radiation treatment field that contains at least 2 liters of tissue receiving at least 2 Gy radiation dose over the first 5 days of treatment.
* Patient must be willing to have blood draws as defined below.
* Patient must provide study-specific informed consent prior to study entry.
* Hemoglobin≥8.
* Age ≥ 18, but not older than age 60.

Exclusion Criteria:

* Patients not meeting the above inclusion criteria.
Comparing Personalized and Adaptive Cognitive Training Methods Following Stroke

This study aims to assess the efficacy of two cognitive training programs - one tablet-based (NeuroAIreh@b) and one in paper-and-pencil format (Task Generator) - in improving cognitive and noncognitive outcomes among community-dwelling stroke survivors.

This study will include a waiting-list control group to assess the impact of these interventions and provide further insights into their potential for stroke survivors.

The investigators plan to conduct a multicentric clinical trial with 45 participants randomly assigned to one of three groups. The study will have three arms, with each group receiving one of the following interventions: table-based cognitive training (NeuroAIreh@b), paper-and-pencil cognitive training (Task Generator) or no intervention (waiting-list control group). The latter group will not receive intervention during the study but will be offered the opportunity to participate in one of the cognitive training programs after completing the study. Additionally, the investigators will assess participants at three different time points: before the intervention (pre-intervention), immediately after the intervention (post-intervention), and three months after the intervention (follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Stroke diagnosis;
* Maximum age: 75 years old;
* Education: at least three years of formal education;
* Relatively preserved language abilities (expressive and receptive language);
* Residing in the community;
* Availability to go to the hospital 2x/week;
* Preserved visual and auditory acuity;
* Physically able to operate the tablet and perform the paper-and-pencil training;
* Motivation to participate.

Exclusion Criteria:

* Diagnosis of concomitant neurological and/or psychiatric disorders;
* Hemianopsia;
* Unilateral neglect;
* Aphasia syndromes.