cyrilzakka/clinical-trials huggingface dataset:
Functional Outcomes Following Shoulder Surgery: A Prospective Database

The purpose of this prospective database is to investigate the long-term functional status of patients who have undergone various types of rotator cuff repair surgery. Patients are asked to respond to questionnaires prior to surgery and at various post-operative visits in an attempt to quantify their functional outcomes. Responses are then linked to other data such as symptoms, prior treatments, previous surgery, complications, radiographic results, etc. These data may then be used as a basis for devising guidelines for future patients and surgeons. This particular project is interested in investigating long term results of arthroscopic rotator cuff repair techniques.

The purpose of the prospective database is to initiate data collection for a group of patients undergoing surgery of the shoulder. Long-term data collection will include information on the functional status of the patients' shoulder as well as quality of life information and radiographic results.

For the purposes of this study, we are interested in the long-term outcomes of participants who underwent a double row versus single row fixation in arthroscopic rotator cuff repair procedures.

Eligibility Criteria:
Inclusion Criteria:

* arthroscopic rotator cuff repairs that occurred between 2007-2009
* enrolled in previous study comparing single vs double-row fixation

Exclusion Criteria:

* withdrew from original study
* unable or unwilling to provide written informed consent
* excluded from original study
Psychosocial Outcomes and Transition Readiness in Uveitis

It is widely acknowledged that the transition from paediatric to adult health services should be a multidimensional and multidisciplinary process that addresses the medical, psychosocial, and educational needs of adolescents and young adults (AYA). Despite this, there is currently a scarcity of research examining the relationships between psychosocial factors (e.g., anxiety, social support) and transition readiness in AYA with uveitis. This study therefore aims to examine the relationships between psychosocial factors and transition readiness in pre-transfer adolescents and post-transfer young adults aged 10-25 years diagnosed with JIA at a single centre.

In total, 25 adolescents aged 10-16 years, together with a parent/guardian, will participate at Sheffield Children's Hospital and 10 young adults aged 16-25 years will participate at Sheffield Teaching Hospitals. Participants completed a battery of self-report questionnaire measuring psychosocial factors (anxiety/depression, social support, family functioning, health-related quality of life) and transition readiness (transition knowledge and skills, self-efficacy). Uveitis disease severity was also measured during clinic appointments. A subset of participants will also be asked to take part in a focus group. This study received full ethical approval, and all participants will give their written informed assent or consent before taking part.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of uveitis
* Uveitis managed by either Sheffield Children's NHS Foundation Trust or Sheffield Teaching Hospitals NHS Foundation Trust
* Fluent in English

Exclusion Criteria:

* No diagnosis of uveitis
* Uveitis not managed by either Sheffield Children's NHS Foundation Trust or Sheffield Teaching Hospitals NHS Foundation Trust
* Not fluent in English
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis

The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.

Diabetic men with clinical symptoms attributed to diabetic gastroparesis and documentation of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized to Metoclopramide Nasal Spray 10 mg or placebo administered as a single intranasal spray four (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects between the ages of 18 and 75 years
* Willingness and ability to give written informed consent
* The ability to read, understand and speak English
* Prior diagnosis of Type 1 or Type 2 diabetes
* Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying
* A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization
* Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study

Exclusion Criteria:

* Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility
* A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product
* A history of, or physical findings suggestive of, tardive dyskinesia
* A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening
* Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening
* Renal dysfunction calculated as creatinine clearance (CrCl) \<40 mL/min at screening
* Hemoglobin A1c \>11.5% at screening
Effectiveness of Social Skills Training Group for Children With Autism Spectrum Disorder

Socio-communicative impairments are core deficits in individuals with autism spectrum disorder (ASD). Individuals with ASD have difficulty understanding eye contact, facial expressions, body language, and different tones of voice when communicating with others. They can't interpret the thoughts and feelings of others, or predict social events, and the impaired social skills may lead to rejection of peers and poor participation in school.

Social skills training targets the core symptoms of ASD. Empirical support is building for cognitive-behavioral intervention approach, social skills training group for verbally fluent, school-aged children with ASD. Several studies have shown the efficacy of the social story intervention. It is usually provided individually, but we want to use it in the group.

Many different intervention program have been used throughout the world. One alternative method used to teach children is the social stories method, which was created by Gray (1993) to address the social difficulties of children with ASD. The theoretical framework of the social stories is based on theory of mind (TOM) hypothesis. Difficulties associated with the impaired TOM was addressed by explaining the complex social concepts in simple words and often include the description of perspectives of others. Several studies have shown the efficacy of the social story intervention. It is usually provided individually, but we want to use it in the group.

In this study, we plan to randomly assign thirty-six 5-7-year-old children with ASD to one of two kinds of social skills groups: the social skills group or the play activities group (control condition). Group met for 16 weeks, one time per week, one hour each time. Participants were recruited between October 2020 and September 2023. Assessment were conducted at baseline and endpoint (16 weeks). To empower parents, we would also ask parents of participants to attend our treatment and lecture.

Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of Autism spectrum disorder
* Must be able to understand 3-steps verbal commands

Exclusion criteria:

* Mental retardation
* Seizure
A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants

The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays.

The primary objective of this study is assess the efficacy of motavizumab compared to placebo when administered monthly by intramuscular (IM) injection during the first RSV season for the reduction of the incidence of serious early childhood wheezing in preterm infants between their 2nd and 3rd birthdays.

Eligibility Criteria:
Inclusion Criteria:

* Male or female infants born at 32 \& 1/7 - 35 \& 0/7 weeks GA, determined according to available medical records
* Chronological age of \<6 months of age at randomization
* In good health, in the opinion of the investigator
* Not more than one of the following AAP-defined risk factors:

  1. Childcare attendance
  2. School-aged siblings
  3. Exposure to environmental air pollutants (not including passive exposure to tobacco smoke)
* Ability and willingness of the subject's parent/legal guardian to complete all protocol-mandated follow-up telephone contacts, visits and procedures
* Written informed consent obtained from the subject's parent(s) or legal guardian

Exclusion Criteria:

* Diagnosis of CLD of prematurity (also referred to as BPD) or other chronic pulmonary diseases
* Diagnosis of hemodynamically significant CHD, defined as requiring medication or supplemental oxygen for their CHD
* Congenital abnormalities of the airways
* Severe neuromuscular disease, as determined by the investigator
* Previous or concurrent treatment with palivizumab or intravenous immunoglobulin (IVIG)
* Eligible for prophylaxis based on local medical standards and guidelines at participating sites
* Known immunodeficiency
* Previous or current diagnosis of an upper or lower respiratory infection by a medical professional
* Previous or current diagnosis of wheezing, asthma, or other wheezing-related diagnoses
* Hospitalization at the time of enrollment (in case admitted to nursery as part of routine care, infant should only be randomized immediately prior to being discharged)
* Any illness or condition that would preclude long-term survival
* Participation in a trial or an investigational agent for RSV prophylaxis or therapy
* Inability to be followed through their 3rd birthday
Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison

Aim of this study is to evaluate whether the length of coronary segments, assessed by an experienced operator, using the "optimal view" of standard 2-dimensional coronary angiography, is over/underestimated with respect to the one evaluated automatically with the help of a 3-dimensional coronary reconstruction model. Moreover, both techniques are compared with an "in-vivo" surrogate of the real length of the coronary segment under evaluation, i.e. an intra-coronary marker guide-wire, which is a wire with markers placed at fixed and known distance along its length in its distal (intra-coronary) part. Two hypotheses are tested: (1) the length of a coronary segment evaluated with a standard 2-dimensional "optimal view" over/underestimates the length assessed by a 3-dimensional coronary model that automatically detects the least foreshortened length of the segment under evaluation, and (2) the 3-dimensional model approximates more closely than standard 2-dimensional angiography, the real length of the segment detected by the marker guide-wire.

The potential to improve the accuracy of the assessment of the coronary tree by means of 3-D modeling reconstruction may lead to an evaluation of the coronary artery anatomy that approximates more correctly the real anatomy, thus subsequently leading to a more tailored diagnosis and therapy for the patients with ischemic heart disease.

Aim of the current study is to assess whether a 3-D model of the coronary tree offers a less foreshortened and less operator-dependent evaluation of the length of the coronary arteries with respect to standard coronary angiography. Furthermore, for the first time "in-vivo", a comparison with the "real" length of the vessel will be performed using as "gold standard" an intra-coronary guide-wire with radiopaque markers at fixed and known distance one from the other along its distal part.

Eligibility Criteria:
Inclusion Criteria:

Clinical

* Age \> 18 years.
* Ability to give informed consent.
* Clinical evidence of coronary artery disease:

  * recent (\< 72 hours) acute myocardial infarction,
  * stable angina with documented positive stress test,
  * unstable angina with documented ischemia (positive ECG or troponin test or documented positive stress test).

Angiographic

* Eligibility for PCI in at least one de-novo stenosis in a native coronary artery, after the index angiogram.
* Planned PCI according to a previous coronary angiogram.

Exclusion Criteria:

Clinical

* Pregnancy.
* Chronic or acute renal failure (serum creatinine \> 1.8 mg/dL or hemodialysis).
* Urgent procedure (a procedure carried out before the next referring day, for example for acute myocardial infarction, unstable angina refractory to medical therapy or cardiogenic shock).
* Contraindications or known hypersensitivity to contrast media.
* Enrollment in another study protocol.

Angiographic

* Significant left main coronary artery disease.
* PCI for a total occlusion of a major coronary vessel (LAD, LCX or RCA).
* Extensive thrombotic burden in a coronary lesion (thrombus grade 3/4).
* TIMI flow \<3 distal to the lesion.
Validation of a Brain-Computer Interface for Stroke Neurological Upper Limb Rehabilitation

The study's main goal is to determine if clinical and physiological effects of a brain-computer interface intervention for the neurorehabilitation of stroke patients' upper limb are greater than the effects of a sham robotic feedback. For this purpose a randomized controlled trial will be performed to compare somatosensory sham robotic feedback with the same somatosensory feedback controlled with the brain-computer interface output.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of first ischemic stroke
* Time since stroke onset higher than 3 months and lower than 24 months
* Hand paresis
* Normal or corrected to normal vision
* Without previous diagnosed neurological diseases

Exclusion Criteria:

* Clinical diagnosis of severe aphasia
* Clinical diagnosis of severe depression
* Clinical diagnosis of severe attention deficits
* Previous diagnosis of traumatic brain injury
* Previous diagnosis of spinal cord injury
* Previous diagnosis of peripheral nerve injury
Prediction of Block Height of Spinal Anesthesia

Spinal anesthesia is one of the most used techniques for surgery. Anesthesiologists usually check the block height (dermatome) of spinal anesthesia before surgery start. More than 20 factors have been postulated to alter spinal anesthetic block height. We would like to use machine learning to comprehensively consider various factors such as physiological parameters and different drug characteristics to establish a predictive model to evaluate the sensory blockade of spinal anesthesia.

This is an observational study of the retrospective collection of patient data.

The investigators retrospectively collected the electronic medical record of patients receiving spinal anesthesia from July 1, 2018, to Dec 31, 2018. Anesthesia-related factors such as anesthesiologist's expertise, injection site, patient position, the dosage of local anesthetics, needle size, the direction of needle bevel, and basic demographic information of the patients were used for data analysis. Patients less than 18 years old were excluded from this study. Twenty percent of the dataset was used as a testing dataset, and the remaining were used for model training. The investigators will utilize four machine learning algorithms as XGBoost (Extreme Gradient Boosting), AdaBoost (Adaptive Boosting), Random Forest (RF), and support vector machine (SVM). Model performances were evaluated visually with a confusion matrix.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving spinal anesthesia from July 1, 2018, to Dec 31, 2018, with available electronic medical records.

Exclusion Criteria:

* Age \<18 years
Reduction of Adverse Events of Anticholinergic Drugs by Multidisciplinary Medical Reviews in Norwegian Nursing Homes

Thesis: Is drug-induced anticholinergic activity additive resulting in a total anticholinergic load causing harmful side effects in old, fragile patients? Is it possible to reduce the anticholinergic load by multidisciplinary medical review including a pharmacist and a physician? The effects of the medical reviews are measured by cognitive tests (MMS and CERADS word lists), a measure of mouth dryness, serum levels of anticholinergic activity, activity of daily living and neuropsychiatric symptoms.

Design: A randomized, controlled, single blinded interventional study in Norwegian nursing homes.

Several studies have claimed that drugs showing anticholinergic activity in vitro cause high levels of serum anticholinergic activity in vivo that might cause impaired cognitive and functional functions in elderly. Pathophysiological changes in Alzheimer's dementia makes these patients particularly vulnerable for anticholinergic cognitive impairments. The PRADA-study is the first interventional study evaluating the clinical effects of reducing drug-induced anticholinergic load in patients with dementia. This is also the first interventional study in the Nordic countries evaluating the clinical effects of clinical pharmacy.

Eligibility Criteria:
Inclusion Criteria:

* Long-term nursing home patients with none, mild or moderate dementia (evaluated by CDR9,using drugs with a total anticholinergic burden that might lead to adverse events.

Exclusion Criteria:

* Not able to perform the testes because of physical or psychiatric illnesses.
Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer

The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent;
* Men, 18 years of age or older;
* Histologically or cytologically confirmed adenocarcinoma of the prostate;
* Ongoing androgen deprivation therapy

Exclusion Criteria:

* Severe concurrent disease;
* Known or suspected brain metastasis;
* History of another malignancy within the previous 5 years;
* Prior treatment with docetaxel-based chemotherapy
The Relationship Between Salt Restriction and Taste Sensitivity in Patients With Chronic Kidney Disease

The compliance of salt restriction in patients with CKD may be associated with taste sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* stage 3-5 CKD patients
* clinical stable

Exclusion Criteria:

* renal replacement therapy
* cancer
* systemic infection
* Alzheimer's disease
* acute cardiovascular events, active hepatitis
* all other study-obstructive conditions
Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study

The EINSTEIN program showed that oral rivaroxaban is effective and safe treatment for prevention of recurrent venous thrombosis and pulmonary embolism in deep vein thrombosis patients and FDA approved the rivaroxaban for prevention and treatment of deep vein thrombosis (Nov 2 2012).

Recently, catheter-directed thrombolysis can significantly reduce post-thrombotic syndrome, and more and more centers introduce catheter-directed thrombolysis to treat proximal (i.e, iliofemoral) DVT. However, the EINSTEIN program excluded patients with deep vein thrombosis if they had been treated with a vena cava filter or a fibrinolytic agent for the current episode of thrombosis.

Although catheter-directed thrombolysis (CDT) or pharmacomechanical thrombolysis has now been accepted as a treatment of choice in iliofemoral DVT, thrombolysis has an inherent risk of bleeding. Therefore, patients who have completed CDT and have been stabilized at least 24 hours after thrombolysis will be included in this study.

Also, the investigators want to explore the efficacy and safety of rivaroxaban in patients with iliofemoral DVT after catheter-directed thrombolysis and/or a vena cava filter insertion and/or venous stent insertion and compare these outcomes with warfarin treatment alone.

This study will be a pilot study to establish the safety and efficacy parameters for further studies.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Onset of symptoms within the past 21 days
* Objectively verified (by CT venography) deep vein thrombosis localized in the iliofemoral segment
* Complete catheter-directed thrombolysis and/or a vena cava and/or venous stent insertion
* Informed consent

Exclusion Criteria:

* Incomplete catheter-directed thrombolysis
* If patients received more than a single dose of a warfarin before randomization
* contraindicating anticoagulant treatment
* another indication for a warfarin
* an estimated glomerular filtration rate by MDRD equation \<30ml/min
* clinically significant liver disease (acute hepatitis, chronic active hepatitis, cirrhosis)
* Alanine aminotransferase \> 3-time higher than upper limit of the normal range
* Bacterial endocarditis
* Active bleeding or high risk of bleeding
* Pregnancy or breast-feeding
* Concomitant use of strong cytochrome P-450 3A4 inhibitors or inducers
Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity

The primary objective of this study is to test the feasibility of a digital therapeutic to address comorbid binge eating and obesity in adults.

This single-arm, open-label clinical trial will test the feasibility, usability, acceptability, and preliminary efficacy of a digital therapeutic in reducing binge eating and weight in 30 adults with comorbid recurrent binge eating and obesity.

Eligibility Criteria:
Inclusion Criteria:

1. English speaking male or female patients, 18-70 years
2. Patients with recurrent binge eating (≥12 episodes in 3 months) and obesity (BMI ≥30)
3. Understand written and spoken English
4. Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
5. Willing and able to complete enrollment procedures
6. Able to understand the nature of the study and provide written informed consent

Exclusion Criteria:

1. Patients with active psychosis
2. Patients who are acutely intoxicated at the time of enrollment
3. Currently enrolled in other treatment studies for the symptoms and behaviors targeted
4. Patients who are cognitively impaired
5. Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit profile with respect to the digital therapeutic