cyrilzakka/clinical-trials huggingface dataset:
Knee Osteoarthritis Care: A Quality Improvement Intervention in General Practice

The aim of this study is to improve the referral rates to physiotherapy of patients with knee osteoarthritis. The intervention consists of one academic detailing visit directed to general practitioners (GPs)

In Belgium, referral rates to physiotherapy of patients with knee osteoarthritis are low. A surveys shows that only 11% of the patients with knee osteoarthritis are referred for physiotherapy in an early stage of the disease process. Referral to physiotherapy is common after arthroplasty for revalidation, but not in early stage of the disease process. The aim of this study is to increase the referral rate for physiotherapy in an early stage of the disease process.

One to three times a year, a large part of Belgian GPs receive an academic detailing visit by an independent medical visitors of Farmaka. Farmaka is a non-profit organization, which is sponsored by the government. Each year, three medical and medication-related themes are developed to provide evidence-based and independent information for primary care management. A visit takes about 20 minutes.

The medical visitors of Farmaka will spend 5 minutes of their standard visit to inform GPs about the evidence-based conservative management of knee osteoarthritis with physiotherapy. The information will focus on the referral of patients with knee osteoarthritis to a physiotherapist in an early stage of the disease. To optimize the effect of the referral to physiotherapists, GPs are asked to specify their prescription by adding a clear therapy description 'exercise therapy with aerobic, muscle strengthening and functional exercises'.

This information will be summarized on a flyer. This flyer will be distributed to the GPs at the end of the academic detailing visit. The flyer gives more extended information about the approach and treatment of knee osteoarthritis. The information and flyer will only be distributed to the intervention group.

For the sample size calculation we want to optimize the referral rate to physiotherapists with 15%.

To detect an absolute difference of 15% in referral rate to physiotherapists we need 100 patients in each group ( with significance level of 5%, 1 on 1 allocation and power of 80%). The control group is composed of GPs, visited by Farmaka, who will not receive the additional information on knee osteoarthritis management.

After 6 months the GPs of the intervention and control group will receive two case vignettes on the management of knee osteoarthritis.

The number of referrals to a physiotherapist of the intervention group and the control group will be compared, as well as the number of specified well-directed prescriptions.

Eligibility Criteria:
Inclusion Criteria:

* active GP setting
* visited by independent medical visitors for academic detailing

Exclusion Criteria:

* not willing to participate
* not visited by independent medical visitors for academic detailing
Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study

It has been demonstrated that allergic rhinitis (AR) reduces sleep quality by some components such as nasal obstruction. Pollution and allergen exposure worsening AR, sleep quality is deteriorated.

Sleep is associated to physical and mental health, alterations in sleep could explain the link between AR and work productivity diminution, impairment in daily activities or emotional problems.

However, interactions between air pollution, sleep and allergic diseases are insufficiently understood.

The main objective of this study is to determine the impact of pollution and pollens on sleep parameters.

Over 150 million people have allergic rhinitis (AR) in Europe and around 30% have uncontrolled AR during allergen exposure. It has been demonstrated that AR reduces sleep quality by some components such as nasal obstruction. Pollution and allergen exposure worsening AR, sleep quality is deteriorated.

Sleep is associated to physical and mental health, alterations in sleep could explain the link between AR and work productivity diminution, impairment in daily activities or emotional problems.

However, interactions between air pollution, sleep and allergic diseases are insufficiently understood.

Moreover, the prevalence of OSA in patients with AR is higher than in subjects without AR. Nasal obstruction could explain the increased risk of OSA.

This prospective, open study will compare sleep quality in 2 different groups: AR patients and patients without AR during the pollen season and outside the pollen season.The main objective is to determine the impact of pollution and pollens on sleep parameters for subjects with AR

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Be able to use an application on a personal smartphone
* Patient non treated for OSA
* Be legally able to give consent
* Person affiliated to social security

Exclusion Criteria:

- Being unable to understand, follow objectives and methods due to cognition or language problems Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.
Blood Flow Index as an Indicator of Successful Peripheral Nerve Block

Laser speckle contrast imaging (LSCI) allows real-time, non-invasive, quantitative measurements of regional blood flow. The aim of this prospective observational study was to evaluate the blood flow changes by LSCI after peripheral nerve block and determine whether this novel optical technique can be used as a reliable indicator of successful blocks.

Methods: One hundred adult patients scheduled for elective upper or lower limb surgery with peripheral nerve block will receive LSCI measurements and pinprick sensory tests before the block and at 5-min intervals till 30 min after the block. The sensitivity, specificity of LSCI as a diagnostic method will be determined by receiver operator characteristic analysis.

Clinical Implications: LSCI with quantitative data could be used as an indicator of successful blocks.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* American Society of Anesthesiologists physical statusⅠ-Ⅱ
* Undergo elective upper or lower limb surgery with peripheral nerve block

Exclusion Criteria:

* refusal to participate in the study
* peripheral vascular disease
* digit injury or deficiency
* colored or infected fingernails/toenails
* BMI\>35
* those who had taken vasodilatory drugs before surgery
* preoperative analgesic medications
* Any contraindications to peripheral nerve block such as coagulation abnormalities, allergy to local anaesthetics, peripheral neuropathy.
Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder

This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day observation period. The study is being conducted in order to assess safety and tolerability of the probiotic (BB-12 with LGG) at 2 different doses of BB-12 with LGG. Identifying effects on behaviors in healthy children with ASD using SRS-2 and ABC, GI symptoms using GI symptom severity index, and relevant biomarkers of inflammation, microbiota, and metabolites. Primary testing and procedures will be conducted at the University of Texas Health Science Center at Houston and Memorial Hermann.

Biomarker identification includes Integrative analysis of plasma metabolome and stool microbiota will be conducted with the collaboration of Dr. Ruth Ann Luna and Dr. Jim Versalovic at Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology \& Microbiology of Baylor College of Medicine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children with autism spectrum disorders (4 - 16 years old) and gastrointestinal symptoms, based on the GI Severity Index, with no other recognized illness will be enrolled in this study. There will be no selection on the basis of age, race, or gender. Although the investigators anticipate the majority of subjects will be male and/or pre-pubertal, in females of childbearing potential, a pregnancy test (urine) will be performed on females participating (at each visit).

Exclusion Criteria:

* Pregnancy or breastfeeding
* Subjects taking immunosuppressive medications, including oral corticosteroids
* A History of Positive result of HIV, Hepatitis B, and/or Hepatitis C test
* Abnormal lab test results (Section 5.2)
* Gastrointestinal diseases such as celiac disease, inflammatory bowel disease
* Subjects with an allergy to antibiotics
* Presence of fever or a pre-existing adverse event monitored in the study
* Use of probiotics in the last 30 days
* Acute diarrheal illness within the past 30 days
* Recent (within 2 weeks) or current use of oral antibiotics /anti-fungals Current use of oral laxatives
* Subjects with implanted prosthetic devices including prosthetic heart valves
* The investigators will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the study period.
Music Therapy for Speech and Prosody in Autistic Children (MTSPAC)

This research is a single-blind randomized controlled trial, where the investigators plan to recruit 40 children with autism, randomly divided into two groups. The music therapy intervention group will receive an hour of group music therapy in addition to traditional language therapy. The control group will receive only traditional language therapy. The trial will last for 8 weeks, and participants in both groups will be assessed before and after the trial.

During the study, the investigators will use professional recording equipment to record their speech and use the speech analysis software to objectively compare whether there are significant differences in prosody between the two groups of children with autism before and after the intervention. Besides the acoustic measurement the investigators also assess the language abilities autism trait performance, adaptive function, emotional behavior, and parent-child stress levels.

This research is a single-blind randomized controlled trial, where the investigators plan to recruit 40 children with autism, randomly divided into two groups. The music therapy intervention group will receive an hour of group music therapy in addition to traditional language therapy. The control group will receive only traditional language therapy. The trial will last for 8 weeks, and participants in both groups will be assessed before and after the trial.

During the study, the investigators will use professional recording equipment to record their speech and use the speech analysis software to objectively compare whether there are significant differences in prosody between the two groups of children with autism before and after the intervention. Besides the acoustic measurement the investigators also assess the language abilities autism trait performance, adaptive function, emotional behavior, and parent-child stress levels.

The study hypothesizes that music therapy can contribute to improving language development delays in children with autism and may enhance their language development further by ameliorating prosody abnormalities. The investigators hope that this research can propose more diversified therapeutic methods for language development in children with autism.

Eligibility Criteria:
Inclusion Criteria:

* children with autism
* aged 3-5 y/o
* children with speech delay (T-score of Preschool Language Scale \< 40)
* Mandarin as first language

Exclusion Criteria:

* children with other neurological diseases
* children without verbal output
* children with articulation or voice disorder
Comparing Effects of Patient-specific Versus Non-patient-specific Computerized Reminder System

The investigators hypothesize that a Clinical Decision Support System (CDSS) designed with "Patient-Specific" reminders yields superior performance than that with "Non-patient-specific" reminders in preventing contrast-induced nephropathy.

We hypothesize that a clinical decision support system (CDSS) designed with "Patient-specific" reminders yields superior performance than that with "Non-patient-specific" reminders in preventing contrast-induced nephropathy.

A 3-arm randomized controlled trial (RCT) will be performed by cluster randomization using physicians as the unit of allocation. Physicians in 3 university medical centers will be randomly assigned into 1) patient-specific arm with Anti Contrast-Induced-Nephropathy(Anti-CIN) reminder, 2) non-patient-specific reminder arm, and 3) the control arm without any reminders, respectively.

The patient-specific alert, Anti-CIN system, is designed as a real-time CDSS implementation on CPOE for monitoring physician's contrast-enhanced CT and IVP orders. Computerized pop-up reminders provide the patient-specific encounters with optimal decision options when patients are at a high CIN risk or patients with unknown risk factors are encountered. Non-patient-specific reminders always pop up no matter whether the patient is at a high risk or not.

Eligibility Criteria:
Inclusion Criteria:

* Our intervention targets are physicians but not patients. All physicians working in the hospital may join this trial.

Exclusion Criteria:

* The physician who never orders a CT scan or IVU study will be excluded
* The physician who never operates the CPOE by himself or herself will be excluded
My Health Coach Study

The "My Health Coach Study" seeks to determine if health coaching by a medical assistant can help patients have better sleep, a better diet, be more physically active or lose weight, according to the recommendation of their health care provider.

The aim of the study is to determine whether medical assistants (MAs) can assist primary care providers to achieve healthier lifestyles via better sleep, food choices, weight loss and/or increased physical activity in their patients. The hypothesis driving this research is that health coaching can be done by existing medical support staff to facilitate healthy lifestyles in a primary care setting. Coaching can maximize the health of the patient population in a cost-effective way if the coaching service is integrated into primary care clinics with minimal capital investment at the outset. A major focus will be on behaviors associated with weight management since this is the most common health issue in the U.S. today. This method, if successful, should be easily adaptable to other health behaviors and in most any medical practice that seeks to improve the health of its patient base in a cost-effective way.

In order to achieve a change in health behaviors, and especially weight loss, regular follow-up contacts are needed. Previous research has shown health coaching to be effective, but this has utilized programs that "add on" to the existing clinic structure. This type of coaching model is difficult to sustain. Utilizing existing staff for health coaching is a method we propose to more fully integrate this service into primary care clinics.

Eligibility Criteria:
Inclusion Criteria:

* adults age 21 and over
* referred by primary care physician for health coaching
* have telephone for follow-up
* English speaking

Exclusion Criteria:

* pregnant or trying to become pregnant
What To-be-discard Biomaterials From ART Cycles Can Tell us About the Treatment Cycle Outcome?

Various to-be-discard material from IVF treatment cycle will be collect and examined, aiming to identify potential reasons of successful outcome or cycle failure.

Usually around 2/3 of IVF material will be discarded at the end of each treatment cycle, including immature oocytes, abnormal fertilized zygotes, poor grading embryos, spent culture medium, etc. Next generation sequencing will be performed for DNA / RNA analysis including the length and the quantity, RNA-seq will be applied for transcriptome profiling, and protein profile will be investigated in a pool sample. By applying various diagnostic tools against those to-be-discard biomaterials, we aim to identify potential underlying reasons of indicating either for an IVF failure or a successful cycle, and try to develop a non-invasive testing method for embryo quality check; better detection of the embryo implantation potential and eventually further increase the IVF clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending the Assisted Reproductive Technology (ART) Unit of the Chinese University of Hong Kong for ART treatment.
* Participant able to give voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* Patient using donor gamete in IVF treatment
* Patient refuses to join and failed to giving consent for any reasons
Routine Post-Operative Supplemental Nutrition

Patients undergoing an esophagectomy will be randomized to receive either (1) routine post-operative tube feeding for 1 month post-operative or (2) usual practice, which is tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at POD#8, or upon discharge.

Specific Aim 1 is to determine the occurrence of common complications and readmissions post-operatively between the two patient groups. The investigators hypothesize that routine use of tube feeding may reduce the occurrence of post-operative complications.

Specific Aim 2 is to determine if routine dietary supplementation with enteral tube affects recovery and QOL after esophagectomy. The investigators hypothesize that routine post-operative supplementation will enhance patients recovery and QOL.

For esophagectomy specifically, there is very limited literature evaluating the complication rate and QOL associated with the length of post-operative tube feeding and adequate nutritional requirements. Small randomized studies have not shown a benefit to routine tube feeding, although the numbers were very small, ranging from 12-70 per group. The investigators will randomize 200 patients for the purpose of this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an elective esophagectomy
* Jejunal feeding tube placed at the time of surgery

Exclusion Criteria:

* Emergent esophagectomy procedure
* Inability to provide informed consent or to complete testing or data collection
* Unwillingness to be randomized
* Tube feeding dependent on discharge
Collection of Endometrial Cancer-derived Organoids to Evaluate the Efficacy of PARP Inhibitors: PENDOR Pilot Study

This study comprises 3 stages:

1. Collection of tumor and blood samples.
2. Creation of organoid models based on tumor samples.
3. Development of functional tests to predict clinical response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or more
* Patient with histologically confirmed, localized endometrial cancer, candidate for surgical treatment.
* Patient with localized endometrial cancer, presenting:

  * A high-grade endometrioid histological type and/or
  * P53 mutation and/or
  * a non-endometrioid histological type regardless of P53 status.
* Patient affiliated to a social security scheme
* Information and signature of informed consent prior to any specific study procedure

Exclusion Criteria:

* Other active cancer less than 6 months old (with the exception of treated basal cell carcinoma of the skin).
* Patient deprived of liberty, under guardianship, or subject to a legal protection measure, or unable to express consent.
14 g vs. 16 g in Breast Biopsy

Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Informed consent available
* Palpable and non-palpable breast findings
* Tumor size 5-20 mm
* Findings of sonographic BI-RADS® classification 2-5.
* Guideline-oriented indication for bioptic clarification

Exclusion Criteria:

* No reliable sonographic demarcation of the finding
* Pregnancy
Effect of High Caloric Diet on Brain Insulin Sensitivity and Inflammation

Obesity if known to be associated with brain insulin resistance in humans and evidence is rapidly accumulating that brain insulin resistance influences peripheral metabolism, eating behavior and cognition. A reduced insulin response in the brain is found mainly in people with a metabolically unfavorable fat distribution - high visceral fat. Visceral fat produces inflammatory mediators and elevated inflammatory levels are closely linked to insulin resistance. Inflammation of the brain (i.e., neuroinflammation) has been proposed as a possible cause of brain insulin resistance. Interestingly, rodent models of a high calorie diet show that these inflammatory mechanisms occur rapidly in the brain, even prior to weight gain of the animals. Among other things, it has been shown in humans that a short-term increase in calories, especially carbohydrates and fats, reduces insulin sensitivity in the body and increases inflammatory parameters in the blood. Whether a high-calorie diet triggers insulin resistance or inflammation in the human brain is currently unknown.

Aim of study:

The aim of the study is to investigate the effects of a five-day high calorie diet in healthy young male volunteers on peripheral and brain insulin sensitivity as well as on eating behavior, mood and cognition. Brain insulin sensitivity, peripheral metabolism and different behavioral assessments will be evaluated before, 1 week and 2 weeks after high caloric diet.


Eligibility Criteria:
Inclusion Criteria:

* BMI 19-24 kg/m2

  * Non smoking
  * normal glucose tolerance during 75g oral glucose tolerance test (OGTT)
  * Exercise less than 2h per week

Exclusion Criteria:

* Vegetarians and Vegans
* Food allergies
* Working at night
* Professional Athletes
* Not removable metal parts in or on the body
* manifest cardiovascular disease
* claustrophobia
* recent surgery (less than 3 months)
* Simultaneous participation in other studies
* Acute disease or infection within the last 4 weeks
* neurological and psychiatric disorders
* treatment with centrally acting drugs
* hemoglobin Hb \<13g / dl
* Hypersensitivity to any of the substances used
Outcomes After Visceral Aortic Coral Reef Surgery

Coral reef aorta is defined by a calcified stenosis of the visceral aorta which can cause leg claudication, renal failure and visceral ischemia depending the type and localisation of the stenosis.

This pathology is rare and is usually treated by open surgery with aortic endarteriectomy. Little is know about the outcomes after such aggressive surgery with short series and short follow up.

The authors propose a retrospective study from their institution to explore the post operative and long term outcomes after this surgery.

Coral reef aorta is defined by a calcified stenosis of the visceral aorta which can cause leg claudication, renal failure and visceral ischemia depending the type and localisation of the stenosis.

This pathology is rare and is usually treated by open surgery with aortic endarteriectomy.

Little is known in the literature regarding the outcomes of this aggressive surgery.

The authors propose a retrospective study from their institution describing the type of surgery realised. They describe the post operative outcomes of this surgery in term of cardiologic, respiratory, renal complication a,d surgical complication.

Moreover they follow the patients to present long term outcomes of this pathology with a description of the post operative recurrence of a coral reef, the permeability of the different target vessel and the cardiologic, respiratory and renal evolution of the different patients.

Eligibility Criteria:
Inclusion Criteria:

* Coral reef surgery
* Urgent intervention
* Claudication, renal, visceral involvement
* Thoracic aortic cross clamping (above coeliac trunk)

Exclusion Criteria:

* "simple" visceral aorto thrombectomy without opening laterally the aorta
* Pregnant