cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Efficacy and Safety of General Anesthesia Using Dexmedetomidine With Sevoflurane in Patients Undergoing Arthroscopic Shoulder Surgery: Preliminary Study

Patients undergoing shoulder arthroscopy in the beach chair position may be at risk for adverse neurologic events due to cerebral ischemia.

Dexmedetomidine, a potent alpha adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response in the perioperative period.

dexmedetomidine has an effect of peripheral vasoconstriction thus it is theologically appropriate for reducing bleeding for arthroscopic operation field.

The aim of this study is to evaluate the efficacy and the safety of dexmedetomidine on cerebral oxygen saturation, cognitive function, hemodynamic stability and operative field in patients undergoing arthroscopic shoulder surgery in the beach-chair position.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Aged between 20 and 70 year
* general anesthesia for arthroscopic shoulder surgery in the beach-chair position

Exclusion Criteria:

* Congestive heart failure, coronary artery occlusive disease
* Bradycardia \< 50 BPM, 2nd degree \< AV block
* Poorly controlled hypertension
* ß blocker medication
* Coagulopathy
* Pregnancy, nursing
Iron and Vaccine Response

Vaccines often underperform in Africa compared to high-income countries. Why vaccines do not work as well in Africa remains uncertain. Malnutrition likely plays a role. Our study objective is to assess whether iron deficiency anaemia in young women impairs their immune response to viral vaccines, and whether iron treatment improves their response.

Group 1 (immediate iron treatment) will receive iron treatment before vaccination. Women in both groups will receive two intramuscular vaccines (influenza and yellow fever). Vaccine response will be measured 28 and 56 days after vaccine administration in both groups. Group 2 (delayed iron treatment) will receive iron treatment at study end.

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years old
* Zinc protoporphyrin \> or equal 40 mmol/mol heme
* hemoglobin \< or equal 109 g/L
* no malaria
* no known HIV infection
* no medical condition that precludes study involvement
* no iron supplementation 1 week prior to study start
* no recent tuberculosis infection
* no vaccination of yellow fever or influenza prior to enrolment
* not pregnant

Exclusion Criteria:

-
Effects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain

This is a prospective case series study.There were 20 individuals with chronic neck pain accompanied by myogenous temporomandibular disorders(mTMD) from Linkou and Taoyuan Chang Gung hospitals, and Chang-Gung university. The purpose of this study was, first, to investigate the effects of muscle energy technique (MET) or strain-counterstrain (SCS) applied on the tender or trigger points of neck muscles on improving pain and pressure pain sensitivity in neck and masticatory muscles, the maximal mouth-opening range of motion, chewing endurance, and head-neck-shoulder posture in patients with chronic neck pain accompanied by mTMD. Second, whether the significant effects could be reached within the four-week intervention duration.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20\~65
* Self-report neck pain ≥3 months (pain occurs between superior nuchal line and 1st level of thoracic spine)
* At least one tender point at both Upper trapezius and Sternocleidomastoid muscles
* Diagnosed as mTMD according to the Diagnostic Criteria for Temporomandibular Disorders(DC/TMD)

Exclusion Criteria:

* Cognitive deficit
* Malignancy, infection, cervical or orthognathic surgery, acute pain, and history of trauma in craniocervical region
* Neurological problem or cervical radiculopathy/myelopathy
* Cervical instability with positive rotational alar ligament stress test and transverse ligament stress test, jaw dislocation
* Tooth implantation or extraction a week before study
* Vertebrobasilar insufficiency
Effect of Catheter on Postoperative Urinary Retention

To determine if indwelling Foley placement at the onset of the procedure, straight catherization at the conclusion of the procedure, or no catheterization produces the lowest rates of postoperative urinary retention after transforaminal lumbar interbody fusions (TLIFs).

Post-operative urinary retention (POUR) is one the most common post-operative complications after elective spine surgeries. Common causes of postoperative urinary retention (POUR) include bladder stenosis, distension, trauma due to catheterizations, age, and prostate hyperplasia. The incidence of POUR increases with age, gender, types of surgery conducted, any comorbidities such as cerebral palsy or multiple sclerosis, use of drugs such as anticholinergic agents, beta blockers, or sympathomimetics, and use of IV fluids.

This condition has been associated with the development of UTIs and sepsis, increased post-operative length of stay (LOS), and 90-day readmission after surgery. In the field of spine surgery, the reported incidence of POUR is highly variable, and there is no consensus on effective methods of prevention. We set out to assess POUR from patients catheterized compared to non-catheterized following a transforaminal lumbar interbody fusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a primary single-level MIS TLIF (Diagnosis: radiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, spondylolysis, spondylolisthesis)
* Patients able to provide informed consent

Exclusion Criteria:

* Patients with baseline urinary dysfunction requiring manual bladder emptying via intermittent straight catheterization, suprapubic catheters, or other indwelling catheters. -Allergies or other contraindications to medicines in the post- operative urinary retention protocol
* Lack of consent
Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic

The purpose of this study is to assess whether the short-term use of professional continuous glucose monitoring (Pro-CGM) at the Parkland Diabetes Clinic in selected patients with poorly-controlled diabetes due to hyper- and/or hypoglycemia leads to improvements in patients' glycemic control within 3-6 months, subjective understanding of how food, activity, and medications affect blood sugar levels, and diabetes self-care practices. The study will be a prospective cohort study that assesses patients glycemic control and diabetes self-care practices before and 3-6 months after utilization of a Pro-CGM for 10 days. Glycemic control and diabetes self-care practices will be assessed based on hemoglobin A1c measurements and glucose data download from glucometer and Pro-CGM. A short survey will be administered at the end of the 10 days Pro-CGM use to assess whether the Pro-CGM use had a positive impact on patients' understanding of how different activities affect their blood sugar and diabetes self-care practices.

Parkland Diabetes Clinic serves an ethnically diverse, low socioeconomic patient population, the majority of whom do not have access to diabetes technology like continuous glucose monitoring. CGM measures sugar levels every 5 to 15 minutes and have been shown in clinical studies to improve glycemic control. Establishing a professional CGM program at the clinic will provide short-term access to this technology. One of the main reason for conducting this study is to determine if Pro-CGM would be a useful intervention to integrate into the clinic's routine practice in the future.


Eligibility Criteria:
Inclusion Criteria:

Patients of the Parkland Diabetes Clinic who meets one or more of the following criteria:

* Patients with inaccurate HgbA1c due to conditions that affect red blood cell turnover (examples include but not limited to: anemia, hemoglobinopathies, chronic kidney disease)
* Patients with suspected recurrent hypoglycemia and/or hypoglycemia unawareness
* Patients with persistently elevated HgbA1c \>8% despite reported adherence to medications and lifestyle modifications and after assessment by a Certified Diabetes Care and Education Specialist (CDCES)
* Patients with inability to do frequent fingersticks for blood glucose checks due to physical limitations (examples include but not limited to: vision loss, dexterity problems)

Exclusion Criteria:

* Patients who already have their own personal continuous glucose monitoring device
PSMA-PET and MRI for Detection of Recurrent Prostate Cancer After Radical Treatment

Approximately one third of prostate cancer patients experience biochemical relapse following initial radical prostatectomy or curative radiotherapy. To determine further treatment, it is of utmost importance to accurately differentiate local and regional recurrence from distant metastatic disease. Unfortunately, the currently used medical imaging methods (MRI and bone scan) lack sensitivity for detection of nodal and skeletal metastases, which can lead to over-treatment of patients with occult metastatic disease. PET imaging with prostate specific membrane antigen (PSMA)-ligands has shown a promising potential for improving the detection accuracy in recurrent prostate cancer, especially when combined with the excellent soft-tissue contrast of MRI. However, evidence is mostly based on retrospective single center studies so far, including patients with a wide variety of PSA levels.

Improving the sensitivity for detection of metastatic disease is a crucial step in reducing over-treatment of prostate cancer patients with biochemical relapse following radical treatment. The purpose of this prospective multi-center study is to standardize PSMA PET/CT and PET/MRI imaging across three university hospitals in Norway, and investigate its merit for detection of recurrent prostate cancer. The long-term overall goal is offering prostate cancer patients a more personalized treatment plan aiming to improve the chances of survival and quality of life.


Eligibility Criteria:
Inclusion Criteria (surgery cohort):

* Prostate cancer patients with biochemical relapse in accordance with the European Association of Urology (EAU) guidelines on prostate cancer; two consecutive measurements with PSA ≥ 0.2 ng/ml following radical prostatectomy or PSA \> 2.0 ng/ml above the nadir following definitive radiotherapy
* Potential candidates for loco-regional pelvic salvage treatment based on age and co-morbidity

Exclusion Criteria:

* Previous salvage therapy for recurrent prostate cancer
* General contra-indications for an MRI exam (pacemaker, aneurysm clips, any form of metal in the body, or severe claustrophobia)
* Serious concomitant systemic disorders or reduced cognitive functioning that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
* Impaired renal function defined as estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2
* Hormonal treatment during the last three months
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition

This study is design to assess the effects of an increase in nutritional intake on the bone mineral density of children with sickle cell disease, for 12 months.

* Sickle cell disease is the most common inherited disease of the red blood cell
* During sickle cell disease, the decrease in Bone Mineral Density (BMD) in children is very common: 19 and 56% depending on the studies
* children with sickle cell disease have an increase in resting energy expenditure of 15-20%
* children with sickle cell disease have a significant decrease in muscle mass
* there are no specific nutritional recommendations for sickle cell disease in children

Our main purpose is to assess the effects of an increase in nutritional intake on the bone mineral density of children with sickle cell disease, for 12 months

Our secondary objectives are :

1. / Evaluate the effects of an increase in nutritional intake on: body composition, height and weight growth, frequency of complications of sickle cell disease, school absenteeism, cardiac function, cerebral vasculopathy, biological parameters follow-up, and the relationship with the treatment started
2. / Creation of a sero-type blood bank for future research

Eligibility Criteria:
Inclusion Criteria:

* Following genotypes of sickle cell disease: SS, SC, SE, Sbeta + or Sbeta0
* Ages 3 to 16 years old

Exclusion Criteria:

* Overweight at the start of the study
* Child for whom one of the 2 parents refuses his child's participation in the study
Kinect Equations for Body Indices and Body Composition

This perspective observational study will recruited 240 participants for investigating the feasibility of using Microsoft Azure Kinect developer kit as a method for body indices and body composition. Reference methods will be dual energy X-ray absorptiometry and bioelectrical impedance analysis.

The purpose of this research is to validate the precision and accuracy of Microsoft Azure Kinect Developer Kit in the application of body anthropometric index and body composition measures. This study assumes that depth camera along with skeletal tracking package can estimate the 3D joint position and skeletal length. A dual energy X-ray absorptiometry scanner, a medical device with a daily background dose of radiation will be used as the gold standard.

This study aims to investigate the correlation and agreement of using Kinect in estimating skeletal length and body composition in human.A total of 240 participants including children and adults will be recruited for measurements in a 3-year period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children and adult
* Age 6-65 years

Exclusion Criteria:

* Chronic illness or chronic medication use (\> 3 months)
* Pregnant
* Metal implant(s) or splint(s)
* Pacemaker implantation
* Limb defect(s) or injury
The Effectiveness of TECH: Tablet Enhancement of Cognition and Health

This study assess the effectiveness of novel cognitive intervention utilizing tablet apps (TECH protocol: Tablet Enhancement of Cognition and Health) to improve cognitive abilities, daily function and health-related quality of life of older adults with MCI. Older adults with MCI will be randomly allocated to the TECH protocol (experimental group) or standard care (control group). Assessments will be administered pre and post the 6-week TECH protocol and at 6-month follow-up by assessors blind to group allocation.

A single-blind randomized controlled trial (RCT) will be conducted, by assessors blind to group allocation. Participants will be referred to the study from 'Maccabi Healthcare Services' by family physicians and geriatric physician of 'Maccabi Healthcare Services Central District'. The majority of TECH protocol training will take place in the participants' home as self-practice. The assessment and weekly group meetings will take place at clinics of Maccabi Healthcare Services in the Central District. A Helsinki approval (#2016009) has already been obtained. Participants will receive information regarding the study and if eligible will sign a consent form, undergo the screening and then the pre-intervention assessments. Then they will be randomly allocated into experimental or control group by a computer program (stratification of the severity of the cognitive decline according to the Montreal Cognitive Assessment (MoCA) scores of above or below 23 points). The experimental group participants will receive the TECH protocol, while participants in the control group will continue to receive standard care. Following the intervention a second assessment will be performed, as well as six-months follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 and above.
* Have MCI (as determined by the following four criterions: A. a score of 19-25 on the MoCA, B. subjective memory complaints, and report from an informant of the same memory complains (the informant should be a person who interacts with the participant three or more times a week), C. Informant report of the cognitive decline as newly acquired, D. independence in Basic Activities of Daily Living (BADL) and Instrumental Activities of Daily Living (IADL), as reported by the participants and the informant, excluding motor difficulties which are not caused due to neurological conditions or lack of performance with no changes compared to the past.
* Have normal or corrected vision and hearing.
* Speak, write and read Hebrew.
* Able to understand and follow use of the touchscreen of a tablet after initial demonstration.

Exclusion Criteria:

* Experience severe depressive symptoms (10 points or more in The Geriatric Depression Scale)
* Are diagnosed with dementia, or other neurological or psychiatric condition (such as stroke, Parkinson's disease).
Molecular Typing of Community-acquired Pneumonia Based on Multiple-omic Data Analysis

Community-acquired pneumonia (CAP) is a heterogeneous disease causing great morbidity, mortality and health care burden globally. Typing methods for discriminating different clinical conditions of the same disease are essential to a better management of CAP. Traditional typing systems based separately on clinical manifestations (such as PSI and CURB-65), pathogens(bacterial types, virulence, drug resistance, etc) or host immune state (immunocompetent, immunocompromised or immunodeficiency). Thus, they are barely able to represent the real disease status nor to precisely predict the mortality.

As the development of multi-omic technologies, the relatedness of different phenotypes at a molecular level have revolutionized our ability to differentiate among patients. Our study is aimed at establishing a novel molecular typing method of CAP. Multi-omic (including genomics, transcriptomes, and metabolisms) data obtained from enrolled CAP patients and isolated pathogens would be integrated analyzed and interpreted. Tthe investigators believe that an appropriate molecular typing method would lead to revolutionary changes in current arrangements of CAP.


Eligibility Criteria:
Inclusion Criteria:

* adult (aged \> 16 years)
* diagnosed as community-acquired pneumonia

Exclusion Criteria:

* being immunocompromised, including history of glucocorticoid taken for more than 1 month, history of immunosuppressive therapy, history of human immunodeficiency virus (HIV) infection, solid tumor or hematological malignancy
* history of long-term nursing home stays
* history of recently hospitalized (\<90 days)
Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease

Comparison of femtosecond small incision lenticule extraction (FS-SMILE) versus Femtosecond laser Insitu Keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal sensitivity (CS) after those refractive surgeries.


Eligibility Criteria:
Inclusion Criteria:

* bilateral eyes with spherical correction range from -2 to -6 diopters and cylinder range from 0 to - 3.5 diopters

Exclusion Criteria:

* sign or symptom of dry eye disease (tear film breakup time (TBUT) \>10 seconds
* Schirmer I test \>10 mm /5 minutes)
* corneal or conjunctival staining
* Meibomian gland dysfunction
* Previous ocular and or eyelid medical or surgical treatment
* pregnancy
* Chronic systemic disorder
Prevention and Intervention of Externalizing Problem Behavior in School: Development and Evaluation of a Teacher Coaching.

Children with externalizing problem behaviour are at risk of developing educational impairment, because of their problems in rule following, social behaviour and attention. This behaviour represents a great challenge for teacher. In addition, time pressures and conflicts with colleagues are the most common sources of stress for teachers. Till now teachers receive no evaluated training which in particular regards externalizing problem behaviour. Therefore we develop and evaluate an indicated prevention program for elementary school teachers with children with externalizing problem behaviour. All teachers of a participating school are given a general overview of externalizing problem behaviour (etiology, diagnosis) and information on evidence-based treatments for children with externalizing problem behaviour in school settings. Single teachers will then participate in a 12 week coaching in which they learn to apply classroom management techniques, strategies to improve their relationships with children, behaviour modification techniques and cognitive interventions to specific target children. The coaching intervention is based on functional behavioural analysis and provides teachers with evidence-based strategies which focuses on one target child.

Longitudinal data will be collected in a within-subject control group design. Dependent measures include teacher and observer reports.


Eligibility Criteria:
Inclusion Criteria:

* age between 6 and 11 years, externalizing behavior problems

Exclusion Criteria:

-
Contamination of Ovarian Tissue by RT-PCR in Participants With Solid Tumors

For prepubertal patients, cryopreservation of ovarian tissue is the only option available to preserve their fertility before cancer treatment. But ovarian autograft raises the issue of the risk of reintroduction of potentially malignant cells. The aim of our study is to develop a specific and sensitive method for residual disease detection in the ovarian tissue from patients treated for a solid tumor during infancy, whose fertility may have been compromised by treatments and who benefited of ovarian tissue cryopreservation.

Some solid tumors have high risk of metastatic localization including in ovaries. There is concern over the possible presence of malignant cells in ovarian tissue that could cause a recurrence of the primary disease after reimplantation. Thus, the possibility of ovarian tissue involvement needs to be evaluated with sensitive molecular methods. Those techniques are now available for leukaemia but histology is still the only way for solid tumors.

Based on our experience in detection by RT-PCR of minimal residual disease (MRD) in neuroblastoma since 1994 \[Tchirkov et al. 2003\] and in ovarian tissue cryopreservation since 1995 \[Schubert et al. 2005, Chambon in press\], we want to develop a specific and sensitive method for residual disease detection by RT-PCR in order to evaluate the tumor contamination of ovarian harvested tissue.

Study population: We chose 3 models of pediatric solid tumors with high risk of metastases and which often require sterilizing treatments (chemo and/or radiotherapy): neuroblastoma, Ewing tumor and alveolar rhabdosarcoma. We will use four tumor cells lines: IMR32 and SK-NSH for neuroblastoma; RD-ES for Ewing tumor; RH-30 for rhabdosarcoma. We plan to use 20 fragments per line.

Study duration: 12 months Study design: Ovarian tissue without known malignancy but with a condition warranting laparoscopy (benign cysts) will be harvested during kystectomy (perikystic tissue).

The harvested ovarian cortex will be cut: one half will be frozen according to our routine protocol \[Schubert et al. 2005\] and the other half will be contaminated with tumor cells lines. Then, detection of the specific transcript will be done by RT-PCR in fresh tissue and after freeze/thaw. Total RNA will be extracted with the TRI-reagent and qRT-PCR will be performed using the "TaqMan" technology.

Primary endpoint: to reach a sensitivity about 1/106 cells.

Eligibility Criteria:
Inclusion Criteria:

* Women of any age, diagnosed with a benign cyst that needs a laparoscopy may be included

Exclusion Criteria:

-