cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Impact of Reining in Anxiety

The purpose of this pilot study is to evaluate the impact of Reining in Anxiety for children with anxiety and their caregivers. A total of up to 80 child/caregiver dyads will be enrolled in the study, anticipating that 40 dyads will complete the 10 week intervention. The intervention will be delivered at Fieldstone Farm Therapeutic Riding Center, which is one of the largest therapeutic riding centers in the US.

Reining in Anxiety is a manualized equine assisted therapy (EAT) for childhood anxiety. The manual and associated materials are being tested in this pilot study, and, if found to be successful, will be available for public consumption. This EAT, which is delivered in a group setting, combines therapeutic horseback riding with cognitive behavioral strategies for anxiety. The group meets weekly over the course of ten weeks, with each session lasting 45 minutes. Each session is delivered in a group format with up to four children between 6 and 17 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver/child dyads where the children are between six and 17 years of age and their caregivers will be enrolled in the study.
* Children must have a score of 3 or higher as measured by the GAD-2,
* Children must have a minimum level of functioning as measured by the CGAS of 41 or higher.

Exclusion Criteria:

* An inability to provide informed consent
Comparing Safety and Efficacy of Dexmedetomidine and Propofol

This is a prospective, open label randomized study. The purpose of this study is to compare propofol with dexmedetomidine for pediatric monitored anesthesia care for MRI, specifically identifying important patient demographics and looking at important outcomes including adverse events.

Patients will be randomized to either arm of the study. Throughout the sedation and recovery period, all study patients will have careful, routine documentation of hemodynamics (blood pressure, heart rate, plus oximeter, respiratory rate) as well as sedation depth. Patients will remain in recovery room until they have maintained discharge criteria for 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 3 - 11 years
* Patient is scheduled for MRI at Children's Hospital Boston.
* Patient meets criteria to receive either dexmedetomidine or propofol sedation
* Patient's guardian provides written consent

Exclusion Criteria:

* Patient does not meet established sedation criteria
* Patient has history of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity
* Patient has current, repaired, or risk for Moya-Moya disease
* Patient has had a stroke within the past six months
* Patient has uncontrolled hypertension
* Patient currently uses beta antagonist, alpha 2 agonist or calcium blocker
* Known soy, Lecithin, or egg allergy
Self-Management Using Smartphone Application for Type2 DM in Real siTuation (SMART-DM)

The purpose of this study is to evaluate the effectiveness of smartphone application for management of type 2 diabetes mellitus (DM).

Type 2 DM is an almost incurable chronic disease and continuous management is important for long-term prognosis. However, patient's compliance to conventional medical intervention is generally unsatisfactory and many patients feel difficult to access to the detail medical advice for type 2 DM.

Thus, the investigators developed a smartphone application for giving programed medical intervention to patients according to patients data; blood pressure, fasting blood sugar, body weight, calorie intake,exercise amount, etc.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 DM using oral hypoglycemic agent
* 6.5% \< HbA1c \< 10%
* systolic blood pressure \> 130 mmHg or diastolic blood pressure \> 80 mmHg
* BMI over 23.0
* 20 \< age \< 70
* smartphone user (android OS based)

Exclusion Criteria:

* Serum fasting glucose \> 250 mg/L or post prandial 2 hour serum glucose \> 350 mg/L
* systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg
* Diabetes mellitus patient using insulin
* severe chronic diabetic complications (diabetic foot ulcer, severe diabetic retinopathy, diabetic nephropathy with severe proteinuria)
* congestive heart failure (NYHA III-IV or left ventricular ejection fraction \< 30%)
* Aspartate aminotransferase (AST) or alanine transaminase (ALT) over 3 times of upper normal limit
* Serum creatinine \> 1.5 mg/dL
* refusal to participate in the study
* drug addiction or alcohol addiction
* major psychiatric illness
* steroid treatment or hormonal treatment with changing the drug or drug dosage in 1 month
* changing dosage of antihypertensive agent, oral hypoglycemic agent or lipid lowering agent in 1 month
* malignant cancer
* pregnancy
Cytokine Profile in Children With Celiac Disease

Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption of gluten and related prolamines in genetically susceptible individuals. Not only genetic but also environmental factors play an important role in CD pathogenesis. CD patients have imbalance in the gut microbiota, they have reduced number of Bididobacterium species in feces and biopsies.

Up till now, only effective treatment for CD is life long adherence to gluten free diet. If gluten free diet is not strict that leads over the years to complications of disease, such as autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by continuous recirculation of activated immune cells between the inflamed organ and the periphery. To avoid complications of disease in long term the investigators want to test specific probiotic bacteria from Bifidobacteria genus, that has has been in vitro studies recognized as anti-inflammatory.

Hypothesis

1. Children with celiac disease on gluten free diet have a higher level of pro-inflammatory cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in comparison with healthy controls.
2. 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level increase.

In the investigators research will be selected 70 children, age from 2 to 18 years, divided in different groups:

1. Group: 25 children with celiac disease on GFD for at least 3 months and will receive probiotic for 3 months.
2. Group: 25 children with celiac disease on GFD for at least 3 months and will receive placebo for 3 months.
3. Group: 20 healthy children


Eligibility Criteria:
Inclusion Criteria:

* celiac disease on gluten free diet

Exclusion Criteria:

* acute or chronic diseases,
* permanent use of medication and
* ingestion of antibiotics at least one month prior to study
Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement

I. To investigate whether patient characteristics, exercise therapy characteristics, local metabolic exercise response, endothelial function, autonomic function or atherosclerotic lesion location can predict the walking response to a successfully completed semi-supervised exercise intervention in patients with intermittent claudication (WP I) II. To assess the effect of a home-based exercise intervention with remote monitoring and coaching on cardiovascular risk factors in patients with intermittent claudication (WP II)


Eligibility Criteria:
The study population will comprise patients diagnosed with lower-extremity artery disease (ABI ≤0.9 and/or 20% decrease after a maximal treadmill test) suffering from intermittent claudication (Rutherford 1-3) presenting with new complaints (at least 6 months after previous revascularization) at the Vascular Center of university hospitals Leuven will be included if according to current guidelines their initial treatment should be conservative

Inclusion Criteria:

* age \> 17 yrs
* ABI ≤0.9 and/or 20% decrease after a maximal treadmill test
* intermittent claudication (Rutherford 1-3)
* ability to undertake an exercise test and read and understand Dutch questionnaires

Exclusion criteria

* exercise test induced signs of complex arrhythmias or significant ischemia during baseline testing
* other comorbidity limiting participation in the exercise group
CRP/Albumin Ratio as a Predictive Inflammatory Marker for Postoperative SIRS and/or Sepsis

The goal of this observational study is to determine the value of CRP/Albumin Ratio as an inflammatory marker for predicting the development of postoperative Systemic Inflammatory Response Syndrome and/or Sepsis in polytraumatized patients admitted to Intensive care unit.

The main question it aims to answer is whether CRP/Albumin Ratio can be used as predictive inflammatory marker for postoperative Systemic Inflammatory Response Syndrome and/or Sepsis or not.

The development of postoperative Systemic Inflammatory Response Syndrome (SIRS) or Sepsis is a very serious complication that has been associated with high morbidity, mortality, and increased length of inpatient stay.

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection.

As surgical interventions lead to well-understood metabolic, neuroendocrine, and immune responses, the stress responses to surgery contribute to increased postoperative complications mostly caused by increased levels of Pro-inflammatory cytokines in response to surgical injury, which leads to changes of circulating acute phase proteins, such as albumin and C-reactive protein (CRP).

The CRP to albumin ratio (CAR) is a new index calculated by dividing CRP by the albumin level. It has been assumed to have predictive value in determining morbidity and mortality in many critical diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients classified by American Society of Anesthesiologists physical status (ASA) as I to III.
* Both sex.
* Aged ≥ 18 years old.
* Polytraumatized patients (fulfilling the 'New Berlin definition' of Polytrauma patient which includes Abbreviated Injury Scale (AIS) ≥3 for two or more different body regions with one or more of the following five physiological variables: Disturbed level of consciousness, hypotension, coagulopathy, acidosis and age \>70y).
* Admitted to Intensive Care Unit preoperatively or postoperatively. • Surgical intervention within 48 hours of the onset of Trauma.

Exclusion Criteria:

* Patients who used immunosuppressive therapy and chemotherapy.
* Patients with known hematological disorders or malignancy.
* Patients with known liver cirrhosis classified as Child- Pugh C ( serum Albumin \< 2.8 mg/dl or International Normalized Ratio \> 2.2 ) (Tsoris , et al.,2023) or liver cell failure.
* Patients receiving Albumin Supplementation during the period of the study.
* Age \< 18y.
Thigh Pain After Total Knee Arthroplasty (TKA)

The purpose of this research study is to evaluate the cause of thigh pain after knee replacement. Different surgical techniques will be used to help determine the cause of thigh pain, and all surgical techniques are accepted and produce good clinical results.

This research study will be a randomized study in which patients volunteer participate. "Randomized" means the patients who received the new treatment are chosen at random, similar to flipping a coin. Several factors have been identified as possible sources of thigh pain after surgery: use of a tourniquet around the thigh to control bleeding during surgery; use of an intramedullary rod during surgery or quadriceps muscle strain. Participants will be randomized into surgical groups that use/do not use a tourniquet and use/do not use intramedullary rod during surgery. A subset of participants in all surgical groups will have a MRI to look for quadriceps muscle strain.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing total knee arthroplasty for osteoarthritis
* Adult patients (age 18 years or older)
* Written informed consent
* Ability to speak, read and write English or Spanish

Exclusion Criteria:

* Inability to speak, read and write English or Spanish
* Evidence of malignant disorder/neoplasm in past 60 months
* Contraindication for removal of infrapatellar fat pad
* History of smoking and not committed to give up
* Chronic skin conditions
* Connective, metabolic or skin disease
* Evidence of active infection
* Pregnancy or lactating for female subjects
* Current corticosteroid use
* Immunosuppressive medication
* Renal failure (creatine \> 1.8 mg/dL)
* Hepatic failure (AST, ALT \> 2x normal values; bilirubin \> 2 mg/dL)
* Inflammatory joint diseases of the knee that indicate additional, conflating therapies
* Joint infection within the past 6 months
* No prisoners or mentally disabled persons
* No Workers' Compensation cases
The Asthma Bronchial Challenge Study

This is a randomised, controlled, cross-over study to determine the effect of indirect bronchial challenge testing upon volatile organic compounds (VOCs) in the exhaled breath of adults with well-controlled, mild-to-moderate asthma.

Participants will undergo baseline evaluation including clinical history, spirometry, exhaled nitric oxide measurement (FeNO), phlebotomy (blood eosinophil count), and sampling of exhaled breath VOCs. Participants will be randomised to receive either an indirect bronchial challenge test using mannitol dry powder (MDP) or a sham bronchial challenge, followed by further sampling of breath VOCs. The study will consist of a consent visit and two assessment visits with participants allocated to receive one of the two challenges (MDP or sham) at each assessment. Data will be analysed to determine the effect of bronchial challenge upon exhaled breath VOC profiles.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18 or over
* Able to provide informed consent
* Self-report of asthma diagnosis from health professional
* Diagnostic confirmation meeting British Thoracic Society guidelines will be sought from primary care
* Non-smokers; or ex-smokers of at least two years duration with less than a ten pack year history
* Asthma Control Questionnaire score \< 1.0
* Asthma treated according to level-1 to level-2 of British Thoracic Society treatment guidelines

Exclusion Criteria:

* Respiratory tract infection, asthma exacerbation or change in treatment step within the previous four weeks
* Major chronic cardiorespiratory disease other than asthma
* Significant comorbid condition
* Condition that may be compromised by repeated spirometry manoeuvres or induced bronchospasm
* Asthma Control Questionnaire score \>1.0
* Asthma treated at level 3 of the treatment guidelines or higher
* Pregnant or nursing mothers
* Current smokers or 'vapers'
* Ex-smokers of \< 2 years duration or \> 10 pack years.
* Participating in a clinical trial of an investigational medicinal product (CTIMP).
* Unable to speak English.
* Low baseline lung function (FEV1 \<1.50 litres or \< 70% predicted value)
* Known hypersensitivity to mannitol, gelatin or strong anaphylactic response in the past.
Return to Play Checklist

This study will try to develop and determine objective and validated criteria for our athletes to safely return to sports after labral repair.


Eligibility Criteria:
Inclusion Criteria:

- Males and non-pregnant females aged 15 years or older with a capsulolabral tear undergoing arthroscopic capsulolabral repair surgery at the Rothman Institute with one of the investigators

Exclusion Criteria:

* Patients with an labral repair
* Patients only undergoing debridements with no repair
* Patients undergoing revision shoulder surgery or those with a history of multiple shoulder surgeries
* Concomitant severe glenohumeral arthritis or adhesive capsulitis
* Patients with a worker's compensation claim
* Patients diagnosed with psychological disorders
* Patients with a history of alcohol or drug abuse -Patients on preoperative narcotic therapy -
To Study the Safety and Efficacy of Disposable Cyclone Ring in Artificial Abortion

The purpose of this study is to compare the two surgical methods of surgical rotation abortion and surgical negative pressure uterine aspiration with the termination of pregnancy. which one can better protect female fertility; To understand the impact of both surgical approaches on the long-term prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* 1) Age: 20-40 years old, planning to terminate pregnancy; 2) Menopause time≤ 56 days (8 weeks); 3) Ultrasound examination showed early pregnancy in utero, and the average diameter of the fetal sac was 1-3cm; 4) According to the requirements of clinical operation standards, the preoperative examination, laboratory results and surgical indicators are normal 5) The subject was conscious, had good compliance, agreed to participate in the trial, and voluntarily signed the informed consent form

Exclusion Criteria:

* 1) According to the requirements of clinical practice, there are contraindications to induced abortion; 2) The number of previous induced abortions ≥2 times; 3) Diseases affecting uterine cavity morphology such as uterine malformations and uterine fibroids; 4) History of uterine surgery: such as submucosal myomectomy history, mediastinal resection history, uterine adhesion-separation history; 5) Unable to sign the informed consent; 6) Other conditions that the investigator considers inappropriate to participate in this clinical study.
Genetics, Brain Structure and Thinking Skills in Autism

The purpose of this research is to better understand the genetic, biochemical, cognitive and behavioral symptom abnormalities that contribute to autism spectrum disorders. The investigators anticipate recruiting at least 100 participants with autism spectrum disorder and large head size, at least 100 participants with autism spectrum disorder without large head size and at least 40 healthy siblings. Biological parents are expected to be recruited only as genetic changes are identified in individuals with autism spectrum disorders to better understand the nature of these genetic changes. Participants are asked to complete cognitive testing, a blood draw, urine collection and measurement of his/her height, weight and head circumference. Parents or caregivers may be asked to complete a diagnostic evaluation and will complete questionnaires that examine the participant's medical and family history as well as his/her current symptoms, functioning, and quality of life. A brief report simply listing and giving a basic description of any behavioral diagnostic information, autism symptoms, adaptive functioning, and a listing of results from cognitive testing will be provided as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of autism
* Consent from parents or guardians or an adult with or suspected of having an autism spectrum disorder that does not require a legal guardian or an adult who is the healthy sibling of an individual with an autism spectrum disorder.
* Youth ages 2-17 and adults ages 18-50. Youths and adults who are able (some young or severely impaired participants may not be able to provide assent) will be asked to provide assent.
* Families with multiple children who meet the above inclusion criteria will be permitted to have as many children participate as they wish.
* Youth ages 2-17 and adults ages 18-50 who do not have an autism spectrum disorder or are not suspected of having an autism spectrum disorder and who have a sibling with an autism spectrum disorder who has participated in the present study.

Exclusion Criteria:

* Clinically significant medical disease that would prohibit participation in the study procedures.
* Children younger than 2 years old and adults older than 50 years old.
Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery

This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in adult patients undergoing cardiac surgery. The study will include adult patients undergoing coronary artery bypass grafting and/or valve surgery with concomitant sleep disorders, as assessed by the Pittsburgh Sleep Quality Index. All participants will be randomly assigned to placebo, placebo + cognitive behavioral therapy, and melatonin + cognitive behavioral therapy in a 1:1:1 ratio. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative cognitive function, sleep quality, and severity and duration of delirium. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Scheduled for elective coronary artery bypass grafting and/or valve surgery.
3. Preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 5.

Exclusion Criteria:

1. History of neurosurgery, cerebral hemorrhage, cerebral infarction, delirium, dementia, or other neurological diseases.
2. History of mental illness.
3. Habitual heavy drinking.
4. American Society of Anesthesiologists (ASA) grade IV or above.
5. Severe hepatic dysfunction (Child-Pugh Grade C) or renal dysfunction (chronic kidney disease stages 3-4).
6. Contraindications to melatonin use, such as allergies to melatonin-related ingredients.
7. Currently taking melatonin, melatonin receptor agonists, sleep-related medications, sedatives, antipsychotic medications, or opioids.
8. Inability to communicate due to hearing or speech impairment, or refusal to provide informed consent.
Organization of the Dietetic Service in a Hospital

In Denmark the dieticians can be organized centrally and called upon if needed, or locally in larger units, or very locally related to bed-units. The organization form is based on tradition not on measurements of quality. We wanted to compare the very local form with the traditional centralized.

Methods: Randomized, unblinded, parallel design. The intervention group (IT) was nutritionally handled by the dietician, and the control group (C) by the nurses as previously with the possibility for dietetic help from the center.

All patients were screened by NRS-2002 and had their estimated needs calculated (equations in IT, tables in C). The IT was in addition assessed for adapted weight-loss, counseled with a plan for nutrition and followed-up daily by the dietician if at nutritional risk. All patients were re-screened weekly and had their intake registered. Hand-grib-strength (HGS) was measured in both groups at admittance and discharge, and weight three times weekly.

The primary endpoint was re-admission rate to hospital within 2 months.

Eligibility Criteria:
Inclusion Criteria:

* adult
* acutely admitted to hospital

Exclusion Criteria:

* dementia
* unable to comply with the protocol