cyrilzakka/clinical-trials huggingface dataset:
Testing and Development of a Sleep Training Mobile Health Application

The specific aims of this study are : 1) To pilot test the alpha build prototype of the sleep training smartphone application using a sample of parents looking for sleep training advice online. 1a) To assess the efficacy of the application in helping parents with the sleep training process 1b) To assess the 'workability' of the application 2) Use feedback to guide the next round of development with the goal of building out the applications functionality and increasing usability.

Problems with bedtime and night-wakings are common in early childhood. Behavioral interventions to address these sleep problems are commonly referred to as "sleep training" and are effective but difficult for some parents to perform. The investigators have developed a prototype of a novel smartphone application designed to assist parents throughout this process.

The smartphone application first collects basic information from the parents, including: first name of child, number of caregivers participating in bedtime, tolerance of caregivers for crying, and basic information about timing of sleep and wake, as well as information about the usual order of events at bedtime. At each step, a brief (2-3 paragraph) is provided to explain the rationale for the next step, as well as concrete advice on how to succeed. It then walks parents through proven techniques to improve sleep in children in a stepwise fashion.

Eligibility Criteria:
Inclusion Criteria:

* english speaking
* parent of child age 6-24 months
* target child sleeping in crib in his or her own room (not the same room as the parents or a sibling)
* actively looking to sleep train their child
* own an iOS or Android smartphone

Exclusion Criteria:

* bedsharing/cosleeping with child
* target child has a known developmental delay
* target child has a significant health issue affecting his/her sleep (failure to thrive, congenital heart disease, etc).
Communication Skills Intervention to Promote Transition Into Survivorship

The purpose of this study is to improve the communication skills of physicians who transition lymphoma cancer patients from the end of treatment to survivorship.


Eligibility Criteria:
Inclusion Criteria:

Physicians:

* who treat patients with DLBCL and HD as per self report

Patients of Physicians:

* have a new diagnosis of Hodgkin's or Diffuse Large B-cell Lymphoma as per pathology report or physician assessment in medical record and/or clinical judgment of the treating physician treated with curative intent.

For part 1 - have scans indicating remission and completing planned chemotherapy and/or radiation therapy. The treating physician will determine that clinical remission has been achieved based on their best judgment.

For part 2 (longitudinal phase): - have new scans indicating remission and completing planned chemotherapy and/or radiation therapy. The treating physician will determine that clinical remission has been achieved based on their best judgment.

* be at least 18 years old
* speak English well enough, in the judgment of the consenting professional, to be able to understand all aspects of the study, provide informed consent, and be able to complete all study measures.

Exclusion Criteria:

Physicians:

* who do not have adequate patients in their clinical practice to meet the 8 patient enrollment requirement for patients with either DLBCL or HD as per self report

Patients of Physicians:

* show evidence of cognitive impairment severe enough to preclude giving permission to the study staff, or completing the survey instruments of the study.
* as per physician judgment, patient's prognosis and/or co-morbidities make them inappropriate for participation in a survivorship study.

For Part 2 ONLY (longitudinal phase):

* those who consented to part 1, consult recording, of the study.
The Success of Lumbar Sympathetic Ganglion Block Using Lower Extremity Perfusion Index

The patient, who is experiencing chronic pain in the lower extremities persisting for more than three months, is scheduled to undergo lumbar sympathetic ganglion block. To evaluate the technical success of the sympathetic blockade, temperature and perfusion index (PI) will be measured at one-minute intervals over a 20-minute period before and after the procedure on the treated side and the opposite side foot. Additionally, other variables related to the procedure will be assessed before the procedure, after the procedure, before discharge, and during follow-up outpatient visits or phone surveys at 1 week and 1 month after the procedure.

Patients aged 19 to 85 experiencing lower limb pain and scheduled to undergo lumbar sympathetic ganglion block at the Seoul National University Hospital Pain Center will be directly informed about the study, and their participation will be sought and registered. Continuous monitoring of electrocardiography, blood pressure, and pulse oximetry will be conducted before and after the procedure.

Upon admission to the pain center's operating room, the patient will assume a prone position. Thermometers will be attached to the soles of both feet, and perfusion index probes will be attached to the second toe on both sides. Using fluoroscopy guidance, a needle will be inserted at the painful side, either right or left, at the L3. After confirming the needle's position in front of the desired vertebral body using contrast medium in lateral and anteroposterior (AP) views, 7 mL of 0.5% ropivacaine will be injected. Baseline temperature and PI values will be recorded before drug administration, followed by recording every minute for 20 minutes after injection.

Other variables related to the procedure will be assessed before and after the procedure, before discharge, and through outpatient visits or phone surveys at one week after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Lower extremity pain
* Pain for more than 3 months
* 19 - 85 years

Exclusion Criteria:

* If the patient refuses to undergo the procedure
* In the presence of vascular disorders in the lower extremities
* If the patient has previously undergone lumbar sympathetic ganglion removal or neurolysis
* When there are abnormalities in blood coagulation tests
* If there is a systemic infection or infection at the injection site
* In the presence of anatomical deformities at the injection site
* If the patient has allergies to the injected medication
* In other cases where the researcher deems the patient unsuitable for participation
Dietary Wild Blueberries and Joint Health

The goal of this proposed study is to examine the effects of dietary wild blueberries on gut microbiome, serum markers of inflammation, and joint function in adults. Each participant will consume 25g freeze-dried blueberries or matched placebo powder for 12 weeks, with a 2-week washout phase between.


Eligibility Criteria:
Inclusion Criteria:

* Adults with documented multi-joint/knee arthritis

Exclusion Criteria:

* inability to give informed consent
* pregnancy or lactation
* planned knee replacement surgery
* allergy or contraindication to berries
* recent trauma of the knee responsible of the symptomatic knee
* intra-articular injection in the target knee/hip in the last 3 months
* oral corticosteroid therapy ≥ 5 mg/day (prednisone equivalent) at baseline
* use of berry extracts in the last 3 months
* special diets
* cancer treatment
* bone diseases
Acceptability of Hepatitis B Vaccination in General Practitioners and Paediatricians

The present study is conducted in order to assess the acceptability of Hepatitis B vaccination in French general practitioners and peadiatricians before and after reimbursement of the paediatric vaccine InfanrixHexa. Two data measurement time points are planned, first before reimbursement and after reimbursement.

The aim of the study is to assess the acceptability of Hepatitis B immunization among general practitioners and open-care paediatricians. This is a national, repeated transversal epidemiological study with two data measurement time-points over a period of two years (T1 in 2009, T2 in 2011, two different samples of physicians) in order to assess immunization practices before introduction of the reimbursement of InfanrixHexa®, during the transition period and then during the period following reimbursement of the vaccine. At each collection time-point, two patient age groups will be investigated: 12-15 months and 24-27 months, thus providing measurements before/after reimbursement.

Eligibility Criteria:
Inclusion Criteria:

• Children on the eligibility register complying with the investigator's immunization policy (children followed by the investigator since their birth, whose immunization regimen has been managed by the investigator).

Exclusion Criteria:

* Children on the eligibility register not complying with the investigator's immunization policy.
* Refusal of the patient.
Health Care Associated Infection Surveillance in NICU

Healthcare - Associated Infection Surveillance In Neonatal Intensive Care Unit of Assiut University Children's Hospital.The objective of study is to determine the incidence, infection sites, causative organisms and risk factors related to healthcare-associated infections in NICU in Assiut University Children hospital.

Nosocomial infections (NIs) are a major public health problem worldwide . Nosocomial infections are those acquired in or associated with hospitals. They are also known as hospital-acquired or healthcare-associated infections. The usual deﬁnition of a hospital-acquired infection is one that was not present or incubating when the patient was admitted to a hospital or healthcare facility; where there is doubt, a cut-off period of 48 hours after admission is used.The terms hospital-acquired and healthcare-associated are often used interchangeably, but 'healthcare-associated' also has the wider meaning of any infection acquired as a result of healthcare in any setting.

Nosocomial infections are common, and may be serious or fatal. Some are unavoidable but doctors' duty of care to their patients extends to fundamental matters such as basic hygiene, which may prevent patients becoming infected, and avoidance of unnecessary antibiotics, to discourage development of resistance Health care-associated infections (HC-AIs) are a major cause of morbidity and mortality in neonatal intensive care units (NICUs) and lead to increases in hospital length of stay and treatment cost. Higher nosocomial infection incidence in NICUs was related to longer duration of hospital stay, and invasive interventions and medical treatments. HC-AIs, especially device-associated health care-associated infections (DA-HAIs), were also common in newborns because of their insufﬁcient immune system and mechanical barriers, as well as lack of protective ﬂora

Eligibility Criteria:
Inclusion Criteria:

1. Age at admission ( 0-28 DAY )
2. Neonates who admitted for more than 48 hours

Exclusion Criteria:

1. Age:more than 28days
2. Neonates who admitted for less than 48 hours.
3. Neonates who admitted for infection reasons as (pneumonia, MAS, AGE and skin infection).
4. Neonates with potentially infection (PROM, chorioamnionitis, TOF)
5. Neonates with congenital infections
Thrombosomes for Expanded Access Use

Expanded use of Thrombosomes where a clinical trial with Thrombosomes is not an option, Cellphire may elect to provide the Sponsor/Investigator (S/I) expanded access to its investigational product, Thrombosomes.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has presented with WHO Grade 2 or higher bleeding which requires treatment with platelet therapy and there is limited availability of platelets or no other approved clinical alternative.
2. Evidence from the facility blood bank/Medical Director that there are no approved platelet products available for transfusion, or the patient is refractory to platelet transfusion.

   Exclusion Criteria:
3. Clinical circumstances of a history of thrombosis, thromboembolism, or vascular occlusion/ischemia in the prior six months such as defined by a past history of current diagnosis of one or more of the following:

   * arterial or venous thromboembolic disease including acute coronary syndrome
   * peripheral vascular disease
   * arterial or venous thrombosis (except when a prior history of central line thrombosis has resolved)
   * myocardial infarction (MI)
   * stent placement
   * valve replacement and/or repair
   * sinusoidal obstruction syndrome (veno-occlusive disease)
Hemoglobin Levels for Blood Transfusions During and After Surgery

The goal of this pilot clinical trial is to learn if it is achievable to conduct a large-scale clinical trial whereby, the investigators will compare two ways of deciding when to give a blood transfusion during surgery. Participants in this study are adults undergoing surgery with a risk of significant blood loss.

The main question it aims to answer is:

* Is a trial designed to definitively test and compare two different red blood cell transfusion strategies feasible?

Participants will:

* Receive blood transfusions during surgery based on a higher (less than 90 g/L) or a lower (less than 70 g/L) hemoglobin value.
* Complete questionnaires at 30 and 90 days after surgery.

During some surgeries, there is a risk of significant blood loss. To manage this, blood transfusions may be needed to replace lost blood.

Transfusion strategies during surgery vary among physicians and hospitals. Current guidelines are broad and suggest it is okay to limit blood transfusions during surgery. However, some anesthesiologists worry that not giving enough blood might cause problems for patients. On the other hand, many cancer surgeons are concerned that giving too much blood could lead to worse outcomes for cancer patients. This difference in opinions shows why clinical trials are needed to guide future practices.

The purpose of this study is to test a new protocol that is designed to definitively test and compare two different red blood cell transfusion strategies. It is hypothesized that this trial will be deemed feasible.

TOPGUN-Pilot is a pragmatic, individually randomized, parallel-arm, vanguard, randomized controlled trial. If feasibility is demonstrated, patients enrolled in the vanguard pilot will be rolled into the definitive TOPGUN trial. This trial is meant to be pragmatic in nature, whereby the study protocol is simple to implement, outcomes are relevant to patients, physicians, and healthcare administrators, and data collection is limited. Management of patients prior to, during, and after the intraoperative transfusion strategies will be at the discretion of individual practitioners. A total of 384 patients will be randomized across 3 hospitals (4 sites) in Ontario and Quebec.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age ≥18.
* Elective or urgent surgery.
* Risk of red blood cell transfusion of at least 10 percent.
* Preoperative hemoglobin of less than 130 g/L.
* Intraoperative hemoglobin of ≤ 100 g/L at any time during surgery.

Exclusion Criteria:

* Active major hemorrhage as indication for surgery (e.g. ruptured aneurysm, polytrauma, etc.).
* Acute coronary syndrome or myocardial infarction within the past 6 weeks.
* Cardiac surgery.
* Liver transplantation.
* Surgery for moderate to severe (Glasgow Coma Scale (GCS) score ≤ 12) traumatic brain injury.
* Pregnancy or obstetrical surgery.
* Patient refusal of blood products.
* Inability to provide consent.
Vitamin B12 Supplement to Prevent Cognitive Decline

Background: Older diabetic people are at greater risk of cognitive decline than non-diabetic people. Vitamin B12 deficiency in older people is associated with cognitive impairment and Alzheimer's disease. Vitamin B12 deficiency may therefore contribute to cognitive decline in older diabetic people.

Objective: To determine whether the correction of mild vitamin B12 deficiency in cognitively normal older diabetic people reduces the incidence of cognitive decline.

Design: randomized, double blind, placebo controlled trial Subject: Cognitively normal diabetic outpatients aged 70 years or older with plasma vitamin B12 150-300 pmol/L in medical and family medicine/ general outpatient clinics.

Procedure: After excluding those with clinical manifestations of vitamin B12 deficiency and without family member who can reliably inform on cognitive functioning (personal contact at least once a week), eligible patients will be invited to participate in this clinical trial. After obtaining written consent, research assistant (RA) will record demographic and clinical information from the subjects and perform neuropsychological tests - 1. Clinical dementia rating scale (CDR), 2. neurocognitive test battery (see below) 3. Chinese Mini mental state examination (MMSE), 4. Geriatric depression scale (GDS). Fasting blood will be taken for serum methylmalonic acid (MMA). Those with cognitive impairment and significant comorbidities will be excluded.

264 eligible subjects will be randomly assigned to take either two Vitamin B12 500 microgram or two identical looking placebo tablets once daily for 27 months.

All subjects or family caregivers are reviewed in the research clinic every 12 weeks in which the research assistant performs a pill count and dispenses the trial tablets. At 9 monthly intervals, the subjects will have neurocognitive test battery repeated at research clinic. CDR will be repeated at month 18 and 27. At month 9 and 27, fasting serum MMA and vitamin B12 will be repeated.


Eligibility Criteria:
Inclusion Criteria:

* \>/= 70 years old
* B12: 150 - 300 pmol/L
* Caregiver (personal contact at least once a week)

Exclusion Criteria:

* Dementia
* Peripheral neuropathy
* Anaemia (Hb\<10 g/dl)
* Renal failure (creatinine \> 150 µmol/L
* Stroke
A Comparison of Post-Operative Analgesia Requirements In Recreational Cannabis Users Versus Cannabis Naïve Inflammatory Bowel Disease Patients

Cannabis is a drug that is widely used for recreational purpose. In most patients undergoing surgery, opioids are the most widely used mode of pain relief, during and following surgery. Anecdotally it has been observed that cannabis users required unexpectedly high doses of opioids. The purpose of this study is to compare opioid requirements between cannabis users and non- users after the surgery. Currently, post-operative opioid doses are determined based on various patient factors such as pre-operative opioid use, patient weight, age and sensitivity to opioids during surgery. Patients' requirements may be underestimated and opioid regimens need to be escalated in the first 24 hours in order to alleviate uncontrolled pain in cannabis users. Better understanding of the impacts of cannabis use on post-operative opioid requirements would help the Acute Pain Service optimize post-operative pain management for patients who use cannabis pre-operatively.


Eligibility Criteria:
Inclusion Criteria:

1. Consent to participate and signed consent form.
2. Age: 18-65 years.
3. Elective IBD bowel surgery under general anesthesia.
4. PCA use.
Automated Analysis of EIT Data for PEEP Setting

First: to develop a computerized algorithm for automated analysis of the electrical impedance tomography (EIT) data. The algorithm calculates the "optimal" positive end-expiratory pressure (PEEP) and inspiratory pressure defined as the "optimal" balance between stretch, ventilation distribution and collapse.

Second: to compare the results of the algorithm with the current standard of care clinical judgement of an experienced ventilation practitioner.

The study will be performed at the Intensive Care Unit, Maastricht University Medical Centre. The investigators routinely apply EIT (Pulmovista, Dräger, Lübeck. Germany) in mechanically ventilated patients to optimize the ventilator settings .

An algorithm will be developed by the Institute of Technical Medicine, Furtwangen University, Germany. The algorithm will automatically detect changes in both PEEP and inspiratory pressures. For each PEEP step and/or changes in inspiratory pressure the difference in regional alveolar overdistension and alveolar collapse will be calculated. This makes it possible to select the optimal ventilator setting depending on the best compromise between alveolar overdistension and alveolar collapse.

The algorithm will be tested in 40 EIT guided mechanically ventilated patients. EIT measurements will be performed during an incremental and decremental PEEP trial. The EIT measurement will be performed in the same way as during standard clinical care. EIT data will be analysed offline by a ventilation practitioner with experience in EIT and with the newly developed algorithm. The resulting advice on optimal ventilator settings will be compared for inter-observer variability.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated in a volume or pressure controlled mode
* ventilator settings guided by EIT

Exclusion Criteria:

* Participants who specifically opt-out regarding the use of the data for research purpose
* Internal pacemaker, Implantable Cardioverter Defibrillator
* Skin lesions, dressings at the thorax, hindering belt placement
* Thoracic circumference \< 70 cm
* Thoracic circumference \> 150 cm
* BMI \> 50
Testing Effect and Schizophrenia

When people are tested on a previously learned material, they will latter remember it better even when compared to a condition where they can re-study it. This phenomenon is called retrieval practice and is supported by an extensive research literature mostly carried out in normal students. This paradigm begins to be used in cognitive remediation programs in patients suffering from memory difficulties.

The objective of this study is to investigate whether retrieval practice is spared in patients with schizophrenia.

If effective, this method could be used in cognitive remediation programs.

Since episodic memory difficulties are supposed to be secondary to deficits in the initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that retrieval practice is spared in schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* French is the native language, or acquired before 5 years old
* People must be able to understand and follow the trial instructions

Specific inclusion criteria (for patients) :

* Diagnostic of schizophrenia, according to the DSM -5, clinically stable
* The treatment must remain unchanged during the trial

Exclusion Criteria:

* Severe or acute cerebral disease
* Other actual psychiatric disorder
* Use of drugs with high anticholinergic effect
* Irregular use of benzodiazepines medication, or high dose of benzodiazepin (more than 2 mg of lorazepam per day or equivalent)
* Inappropriate use of drugs

Specific exclusion criteria (for healthy subjects) :

- Diagnostic of schizophrenia of a relative up to the third degree
Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent, including authorization to release health information
* Male or female subjects 18 to 65 years of age with diagnosis of plantar fasciitis
* Persistent heel pain for more than three months
* Women of child bearing potential must have negative pregnancy test at Screening and Injection Visits and must use an effective method of birth control during the course of the study

Exclusion Criteria:

* Previous surgery on the midfoot or hindfoot
* Neuromuscular disease
* Systemic muscle weakness
* Planning a pregnancy during the study
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit