cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Virtual Reality- Based Rehabilitation Program in Individuals With Adolescent Idiopathic Scoliosis After Posterior Fusion Surgery

The aim of this clinical study is to investigate the effect of virtual reality based rehabilitation program on kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life after posterior fusion surgery in individuals diagnosed with Adolescent Idiopathic Scoliosis (AIS). The main questions it aims to answer are:

* Does a virtual reality based rehabilitation program after posterior fusion surgery have an effect on kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life in individuals diagnosed with AIS?
* Is the virtual reality-based rehabilitation program after posterior fusion surgery more effective for individuals diagnosed with AIS than the routine physiotherapy and rehabilitation program applied in the clinic?

They will compare it with the \[routine physiotherapy and rehabilitation program\] to see if the virtual reality-based rehabilitation program is effective in individuals with AIS after posterior fusion.

Participants :

After being evaluated in terms of kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life, the Virtual Reality-Based Exercise Group will be given an exercise program via the games in Kinect Sports Ultimate for 30 minutes a day for a total of 6 weeks, 2 days . At the end of the 6 week, the participants will be re-evaluated and the results will be compared according to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with AIS December 10-18
* Underwent posterior spinal fusion surgery
* Post-operative (post-op) 6.during the week and after
* Absence of vision, speech and hearing problems
* Regular participation in the program to be implemented
* Volunteering of individuals

Exclusion Criteria:

* Have a history of previous spinal surgery
* Have any contraindications to exercise
* Have a mental problem
* Have a neuromuscular, mesenchymal, rheumatic disease
* Have pulmonary and cardiac complications
Feasibility of an App to Measure Patient Stressors in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after Study

This study examines the feasibility and efficacy of a mobile application (app), which enables critically ill patients to report perceived patient stressors to their caregivers.

For many critically ill patients, treatment in an intensive care unit (ICU) is very stressful, and for some of the patients it is a traumatic experience. The domains of patient stressors encompass physical stressors, mental health stressors, communication stressors, and environmental stressors. The experience of stressors during ICU is associated with a higher risk of worse outcomes including delirium, delayed recovery, and post-intensive care syndrome (PICS). In the context of inpatient intensive care medicine, health care professionals (HCP) have problems to correctly rate the extent of their patients' stress.

In this study, we examine the feasibility and efficacy of a stressor-reporting system based on a mobile application (app), which allows critically ill patients to evaluate by themselves the intensity of their stressors, and thus, to communicate their stress experience to HCPs.

In the first assessment phase of this study, outcome data of a cohort of n=20 patients will be collected (cohort A). Participants of cohort A will not use the ICU Feel Better App. In the second phase, outcome data of another n=20 patients (cohort B) will be collected. Participants of cohort B will have the opportunity to use the ICU Feel Better App from the second day after admission to the ICU until the day of discharge from ICU.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated in an ICU
* Duration of treatment ≥48h
* Age: 18 years and older
* Male, female, or divers gender

Exclusion Criteria:

* Poor language skills
* Statement in patient letter or living will that excludes participation
* Participation in another prospective treatment study with indication delirium
* Refusal of participation
Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia

The concept of Enhanced Recovery After Surgery(ERAS) has been prevalent in recent years. In the ERAS guideline, short-acting anesthetics, instead of long-acting opioid anesthetics, were recommended during surgery to decrease post-operative complication and length of hospital stay. Propofol-remifentanil based total intravenous anesthesia (TIVA) can provide quicker emergence and decreased post-operative nausea and vomiting. However, the prescription of opioid (especially remifentanil) may induce opioid-induced hyperalgesia (OIH) and increase the requirement of analgesics. Previous studies provided some strategies to prevent OIH. The purpose of this study is to investigate the effect of adding remifentanil(1 mcg/kg) after emergence and endotracheal extubation in breast cancer females receiving breast surgery under propofol-remifentanil based TIVA for the prevention of OIH.

1. After obtaining informed consent, patients will be randomized into two groups.
2. All patients receive remifentanil-propofol based TIVA and Bispectral index (BIS) monitor during breast surgery. In the end of surgery, intravenous NSAID(keto) 30mg and local anestehsia (Marcaine) infiltration around the surgical wound will be prescribed to reduce post-operative pain.
3. group R(intervention): remifentanil 1mcg/kg diluted with 0.9% saline to 50ml and drip for 30 minutes after emergence and extubation of endotracheal tube
4. group N(no intervention): 0.9% saline 50ml drip for 30 minutes after emergence and extubation of endotracheal tube
5. In post-anesthesia room: record the numerical rating scale (NRS); requirement of additional analgesics (rescue medication), blood pressure, heart rate, pulse oximeter, degree of nausea, vomiting
6. In ward: record the numerical rating scale (NRS) and total analgesics consumption

Eligibility Criteria:
Inclusion Criteria:

* Subject's ASA (American Society of Anesthesiologists) Physical Status Classification: I (A normal healthy patient)\~III(A patient with severe systemic disease)
* Subject has breast cancer and scheduled for breast surgery using total-intravenous anesthesia(TIVA)

Exclusion Criteria:

* Subject's ASA (American Society of Anesthesiologists) Physical Status Classification \>3
* Subject doesn't receive total-intravenous anesthesia(TIVA) during surgery
* Subject has psychiatric disease
* allergic to opioid or propofol
* History of alcoholism
* History of drug abuse
Improving the Accuracy of Revised Cardiac Risk Index With HbA1C:Hemoglobin Ratio (HH Ratio)

Retrospective observational study on the effects of altering components of RCRI to improve the predictive capacity.

The current Lee's Revised cardiac risk index (RCRI) was created in 1999. Validation studies have found RCRI to be only moderately discriminant. The "Diabetes Mellitus on insulin" component of the score does not accurately reflect the severity of the disease. A previously studied HbA1C:Hemoglobin ratio shows an improved association with outcomes than individual components alone and could be potentially used as a new marker for severity of the disease.

A retrospective cohort study was performed in consecutive diabetic patients undergoing non-cardiac surgery. Ethics approval was obtained. The objective of the study is to compare the predictive value of RCRI and substitution of the "DM on insulin" component with HH ratio for 30- and 90-day mortality, and postoperative acute myocardial injury(AMI) and acute kidney injury(AKI).

Eligibility Criteria:
* Above 18 years old
* Past medical history of Diabetes Mellitus or preoperative HbA1C \> 6.5% (within 3 months of surgery)
* Had HbA1C done within 3 months prior to date of surgery
* Undergoing non cardiac surgery
* Emergency and elective surgery

EXCLUSION:

* If patient is below 18 years old
* no History of DM
* No HbA1C done within 3 months prior to date of surgery
Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula

The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.

This is a multicenter, open label, observation study; 500 formula fed infants are planned to be enrolled from a network of general pediatricians in the Gulf countries (UAE, Kuwait, Qatar, and KSA). Eligible infants will consume a high sn-2 palmitate infant formula for 12 weeks. All enrolled infants will be evaluated at enrollment and at 4 weeks and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Formula fed healthy full term infants with normal birth weight (2500g 4000g)
* Partially breast and formula fed infants who drink at least 2 formula feedings per day; each to be at least 30ml
* Infants of both genders at age of 2 weeks to 12 weeks
* Infants of parents providing written informed consent before any study related activities are carried out

Exclusion Criteria:

* Preterm or IUGR babies
* Contraindication of standard infant formula
* Infants who have allergy of cow's milk protein
* Infants with Serious medical or surgical GI disease
* Infants with multiple congenital anomalies
* Infants with suspected chromosomal or metabolic disorder
* Infants of mothers with a health condition or socioeconomic problems that may interfere with their ability to take care of their infants
* Infants of parents who refuse to participate in the study
Efficacy of Silver Diamine Fluoride and Its Parental Perception

This randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols, namely 38% silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in arresting dental caries in children.

The present randomized clinical study is aiming to evaluate the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions when compared to MI Varnish a 5% sodium fluoride varnish which also contains RECALDENT™\* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. For this, healthy children aged 4-8 years with at least one active dentin carious lesion will be allocated randomly to one of two treatment groups: Group (1) SDF and Group (2) MI Varnish. Each participant will be assigned to one treatment group to avoid the possible synergistic effect of the different agents.

Parents/ guardians of each child will be fully informed regarding the study design, objectives and probable advantages and side effects especially the black discoloration of SDF before their involvement by written consent. The International Caries Detection and Assessment System (ICDAS II) will be used to determine caries diagnosis and activity.visual and tactile examination will be done with a WHO probe to assess the primary outcome. the secondary outcome will be conducted by a questionnaire given to the parents.

Eligibility Criteria:
Inclusion Criteria:

1. Normal healthy children without any systemic disease ASA 1 physical status.
2. Children with at least one carious dentin lesion in their primary teeth, code 5 (ICDAS II)

Exclusion Criteria:

1. Children who suffer from major systemic diseases and require long term medications.
2. Children refuse the study intervention.
3. Children with silver or milk product sensitivity.
4. Presence of any gingival or perioral ulceration or stomatitis.
5. Tooth with abscess, fistula or severe pain.
Effect of Snapshot Freeze on Cardiac CT Image Quality

The aim of this study was to investigate the effect of a new motion correction algorithm on image quality and diagnostic utility in unselected patients undergoing coronary cardiac computed tomography, and to investigate if this motion correction algorithm can compensate for the usual use of intravenously medication (beta-blockers) before the scan.

Aims:

To investigate the motion correction algorithm Snapshot-Freeze(SSF) compared to standard reconstruction(STD) in patients randomized to receive beta-blockers(BB) or no beta-blockers(non-BB) before coronary CT angiography (CCTA), and to investigate if SSF can replace BB.

Methods:

The study included 140 consecutively recruited patients scheduled to CCTA to rule out coronary artery disease.

The inclusion criteria were: age ≥ 18 years, Glomerular filtration rate ≥ 60 mL/min, Heart Rate between 60 and 85 bpm before the scan. The exclusion criteria were: irregular heart rhythm or history of allergic reaction to contrast agents. Patients were randomized to the BB group or the non-BB group. The trial complied with the Declaration of Helsinki and was approved by the local ethics committee. Written informed consent was obtained from all patients.

Image quality score:

The evaluation was performed according to the Likert score as follows: 1: excellent, no motion artifacts, clear delineation of the segments; 2: good, minor artifacts, mild blurring of the segment; 3: adequate, moderate artifacts, moderate blurring without structure discontinuity; and 4: poor and non-diagnostic, with doubling or discontinuity in the course of the segments, preventing evaluation or producing vessel structures that were not differentiable. In cases where the image quality was less than excellent (Likert score 2-4), the readers noted the reason(s) for the observed artifact.

Statistical analyses:

Quantitative variables were expressed as mean ± standard deviation, and categorical values as frequencies or percentages. Values from the Likert score were dichotomized to excellent vs. non-excellent (Likert score 1 vs. 2-4), and diagnostic vs. non-diagnostic (Likert score 1-3 vs. 4). McNemar's test was performed to test categorical variables separately per-vessel and per-patient level. Analyses for all segments were calculated by the Wilcoxon signed-rank test.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years,
* glomerular filtration rate ≥ 60 mL/min,
* heart rate between 60 and 85 bpm before the scan

Exclusion Criteria:

* irregular heart rhythm
* history of allergic reaction to contrast agents
Phase I/IIa Study of BR790 in Combination With Tislelizumab in Adult Subjects With Advanced Solid Tumors

This study is a Phase I/IIa, multi-center, open-label study of BR790 in combination with Tislelizumab with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors.

These treatment to characterize the safety, tolerability, PK, PD and preliminary antitumor activity.

The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

Phase 1 (Dose Escalation Phase of BR790 Tablets Combined with Tislelizumab Injection): According to the incidence of DLT in BR790 Tablets Combined with Tislelizumab Injection Monoclonal Antibody in the Treatment of Advanced Solid Tumors, MTD and the Phase 2 clinical trial dose (RP2D) combining PK , efficacy and safety data were determined.

Stage II (BR790 Tablets combined with tislelizumab injection dose expansion stage): Evaluate the objective response rate (ORR) of BR790 Tablets combined with tislelizumab injection according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 .

Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent voluntarily.
2. Age ≥18 and ≤75 years old.
3. Subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment.
4. Had at least one measurable lesion.
5. ECOG≤1.
6. Expected survival period ≥ 3 months.

Exclusion Criteria:

1. Any previous treatment with SHP-2 inhibitor.
2. Symptomatic brain metastases.
3. Subjects with thoracic/ascites fluid that need drainage or intervention.
4. Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC\<1.5×10\^9/L PLT\<100×10\^9/L Hb\<90g/L TBIL\>1.5×ULN ALT, AST\>2.5×ULN (without liver metastases) or ALT, AST\>5×ULN (with liver metastases), Cr \>1.5×ULN.
5. With uncontrolled severe disease.
Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments

French health insurance data indicate that approximately 15% of ambulatory antibiotic consumption is generated by hospital prescriptions. This extra-hospital consumption represents a greater volume than intra-hospital consumption. To date, hospital indicators of good antibiotic use do not include this outpatient dimension. This study will provide a snapshot of the proportion of ambulatory antibiotics generated by emergencies and analyze compliance with management recommendations.This study will serve as a basis for developing indicators of outpatient antibiotic consumption generated by hospital activity and for identifying specific intervention targets aimed at the misuse situations that have been highlighted.

This study will be carried out in the form of a repeated survey on a given day (4 days, one across each season), carried out by the local mobile antibiotic therapy team, using a standardized grid. The survey will concern all the medical records of the patients visiting any emergency department on the days of the survey.

The evaluation of antibiotic therapies prescribed in discharge orders will be carried out in accordance with local management recommendations by the site investigator (infectious disease and/or emergency medicine specialist), who will assess whether the prescription is in accordance with the recommendations or not.


Eligibility Criteria:
Inclusion Criteria:

* Visit on emergency department on one of the survey days
* Age ≥18

Exclusion Criteria:

* Patient opposed to the collection of his/her data
* Patient under guardianship or curatorship
Quality of Life in Breast Cancer Patients and Survivors

The purpose of this study is to determine how physical activity, other lifestyle factors, and psychosocial factors are related to quality of life and other health outcomes across the breast cancer survival spectrum from diagnosis to long term survival in a nationally representative sample of breast cancer patients and survivors across a 6 month period of time.

Participants in this study will be asked to sign an informed consent, wear an activity monitor (similar to a pedometer) for 7 consecutive days and complete a packet of questionnaires. The questionnaires will take about 45 minutes to complete. All materials will be sent to participants via the US Postal Service and will need to be mailed back in the provided self-addressed stamped envelopes within 2 weeks. Participants will be asked to repeat these same assessments again in 6 months. NO lab visits will be required for participation. Women from all across the U.S. who have been diagnosed with breast cancer at any point in their lives are being sought. There is no limit on time since diagnosis or treatment status.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Have received a breast cancer diagnosis and consider self a breast cancer patient or survivor
* Aged 18 years and older
* English speaking
* No limit on time since diagnosis

Exclusion Criteria:

* Under the age of 18
* Male
* Have never been diagnosed with breast cancer
Altered MAstication Contribute to TMJ PAin

The cause of temporomandibular joint disorders remains unknown. It is considered multifactorial and includes physical (peripheral) and psychosocial (central) factors. It has been showed an association: a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the symptomatic side. This finding argues the possibility of causation of some of these characteristics. This double blind longitudinal study aims to assess if the presence of one habitual chewing side could contribute to temporomandibular joint disorders over time.

Method. Young adults with no signs or symptoms of TMD will be assessed. Participants with one chewing side (observed and interview); with steeper condylar path and lower lateral guidance angles will be considered consistent one side chewers, and this side will be considered more susceptible to suffer TMD. Mouth opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD.


Eligibility Criteria:
Inclusion Criteria:

* healthies
* full dentates
* normal occlusion
* One habitual chewing side

Exclusion Criteria:

* Severe malocclusion, dental decay, severe periodontal disease.

Pains from other origins or Orthodontics are not criteria for exclusion
Minimal Invasive Surgery Versus Interlaminar Decompression in Lumbar Canal Stenosis

Conventional open surgery has been shown to be an effective procedure for LCS decompression. Minimally invasive surgery (MIS) through tubular retractors is a recently introduced alternative procedure for decompression of LCS.

The current study aims at evaluating the efficacy of minimally invasive surgery as a decompressive procedure in comparison to conventional open surgery for the treatment of patients with LCS.

Lumbar canal stenosis (LCS) is defined as narrowing of the spinal canal, the vertebral foramina, and/or the lateral recesses, causing compression on the nearby neurologic structures. Degenerative LCS is one of the most common reasons for old patients to undergo spinal surgery. Neurogenic claudication is the most common symptom for LCS patients. The patients complain of pain or discomfort that radiates to the buttock, thigh and lower limb after walking for a certain distance, therefore leading to functional disability and decreased walking capacity. Conservative management is the first line of treatment in the absence of progressive neurologic deficit or intractable pain, consisting of physical therapy, medications (analgesics, steroids) and pain management procedures. Surgical intervention is recommended if the symptoms are persistent or worsening.

Various techniques are currently used for direct decompression of LCS. Conventional open surgery involves laminectomy that has been shown to be an effective procedure for LCS decompression. However, wide laminectomies disturbs the stability of bony and ligamentous structures and may exacerbate preexisting spondylolisthesis. Minimally invasive surgery (MIS) through tubular retractors is a recently introduced alternative procedure for decompression of LCS. This technique avoids detachment of the paraspinal muscles and may promote preservation of stabilizing ligamentous and bony spinal structures.

The current study aims at evaluating the efficacy of minimally invasive surgery as a decompressive procedure in comparison to conventional open surgery for the treatment of patients with LCS.

Eligibility Criteria:
Inclusion Criteria:

* all patient with lumbar canal stenosis From 18_70 years old

Exclusion Criteria:

* instability Infection Tumours of vertebrae