cyrilzakka/clinical-trials huggingface dataset:
The Dutch Asymptomatic Mitral Regurgitation Trial

The purpose of this study is to compare early mitral valve repair versus a watchful waiting strategy in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function.

Severe asymptomatic organic mitral valve (MV) regurgitation with preserved left ventricular (LV) function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and conflicting, which is reflected in current guidelines. European guidelines advocate a more conservative strategy i.e. watchful waiting, with yearly echocardiography, whilst American guidelines are more in favour of early surgery to reconstruct the MV, i.e. MV repair (in contrast to MV replacement) in order to prevent future LV dysfunction and complaints.

A number of non-randomised trials show a favourable outcome of early surgery and the early surgery strategy has shown to be associated with improved long-term survival, decreased cardiac mortality and decreased morbidity compared with the conservative management \[citations 1-3\]. On the other hand, non-randomised trials describe also that a conservative strategy (i.e. watchful waiting) can be safely accomplished. If facilitated surgery is performed in this population it has proven to be eventually associated with good perioperative and postoperative outcome in 50% of the patients at 10 years when careful follow-up is being carried out \[citation 4\]. Non-randomised trials inherently have a number of drawbacks. A randomised trial comparing both strategies and objectivising the best treatment strategy has never been performed.

The Dutch AMR (Asymptomatic Mitral Regurgitation) trial is a multicenter, prospective, randomised trial comparing early MV repair versus watchful waiting in asymptomatic patients with severe organic MV regurgitation and preserved LV function \[citation 5, 6\].

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic
* Severe organic mitral valve regurgitation.
* Preserved left ventricular function (left ventricular ejection fraction \>60% and left ventricular end-systolic dimension ≤45 mm)
* The likelihood of MV repair should be more than 90% determined by the local heart team with a cardiologist and cardiothoracic surgeon

Exclusion Criteria:

* Pulmonary hypertension (\>50 mmHg at rest)
* Atrial fibrillation
* Physical inability as determined by the heart team to undergo surgery
* Other life-threatening morbidity
* Higher expected surgical risks in advance, according to the dedicated heart team
* Moderate to severe kidney disease (eGFR less than 30 mL/min)
* Flail leaflet together with a left ventricular end systolic diameter (LVESD) \>40 mm
Pilot Study Using Radiostereometric Analysis (RSA) to Evaluate the Fixation of the Tibial Components in the DePuy M.B.T. Revision Knee System

Motivated by the growing number of revision total knee arthroplasty (TKAs) and the interest among surgeons to quantify the effectiveness of specific implant designs, the goal of the current project is to use Radiostereometric Analysis (RSA) to provide conclusive and clinically relevant results on fixation of the tibial component with the DePuy M.B.T. Revision TKA system using Metaphyseal Sleeves.

Does the tibial component of the M.B.T. Revision Knee System achieve adequate fixation to the underlying bone (proximal tibia) as measured by migration? • Null Hypothesis: The maximum total point motion (MTPM) value of migration of the M.B.T. Revision Knee System component between postoperative years one and two does not exceed 0.2 mm indicating adequate long-term fixation at the bone-implant interface.

• Alternative Hypothesis: The MTPM value of migration of the M.B.T. Revision Knee System component between postoperative years one and two does exceed 0.2 mm indicating inadequate long-term fixation at the bone-implant interface.

b) In what proportion of patients is adequate fixation achieved?


Eligibility Criteria:
Inclusion Criteria:

* Revision TKA is indicated and it is the opinion of the investigator that the PFC Sigma M.B.T. Tibial component with metaphyseal sleeves and a stem is a suitable treatment
* Contained bone defects in the proximal tibia that allow for contiguous contact between metaphyseal sleeves and cortical bone
* Use of tibial stem
* Ability to give informed consent

Exclusion Criteria:

* Revision TKA due to infection
* Patellar revision only
* Polyethylene liner exchange only
* Revision requiring hinged TKA
* Uncontained defects in the proximal tibia that preclude contiguous contact between metaphyseal sleeves and cortical bone
CPR Prescription Program

In this study we hope to show that prescriptions provided for CPR Anytime™ to patients who are at risk for or have heart disease at three key locations, can motivate families to learn the skill. We will use our ED sites, an office based primary care setting, and an office based cardiology practice. Participants will be given the pharmacy locations where they can be purchased. Optimally they will complete the program at home with their family.

Research Hypothesis:

1. Families of patients at risk for coronary artery disease can be motivated to learn CPR by receiving a prescription for a CPR Anytime ™ self learning kit.
2. As part of the multiplier effect, an additional 1.5 family members per participant are projected to be trained to perform CPR.
3. Families may experience a "teachable moment" when their loved one is in the emergency department. In comparison to the office settings, this may increase the likelihood that they fill the prescription for CPR Anytime® and complete the learning kit.

This will be a prospective study of patients presenting to one of three recruiting sites (emergency department and office based primary care/cardiology settings). Physicians at all settings will agree to be a part of the Physician CPR Prescription program. Participating physicians are provided with a description of the Physician CPR Prescription program and pre-printed CPR prescription pads. The front side of the prescription is preprinted with the information needed to obtain CPR Anytime ™ for Friends and Family. The back of the prescription is preprinted with "Quick Facts" to assist the physician in delivering a consistent and persuasive CPR message to patients and their families.

After consent, participants will be randomized to one of two groups. The control group will be advised to take a traditional CPR class and be offered a list of local classes. Phone follow up at approximately 3 months will assess their participation. The study group will be asked to fill the CPR Anytime ™ prescription and complete the program. They will be encouraged to include other friends and family members in the program. Follow up phone survey at approximately three months will assess compliance with physician recommendations to fill the prescription, as well as actual completion of the materials (and possible multiplier effect).

Comparisons between the sites regarding efficacy of prescribing will be performed. Results will be reported as mean +/- standard deviation, % or frequencies to summarize patient characteristics. One way ANOVA will be used to compare the three groups for continuous data and chi-square for categorical data.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* 45 or older
* Competent outpatient.
* Have DVD access in home.
* Willing to fill prescriptions at Spectrum pharmacy.
* Never had CPR, or CPR greater than 1 year ago.
* Have a risk factor for heart disease or have heart disease.

Exclusion Criteria:

* Non English speaking
* Minors
* Incompetent or significantly ill/distressed
* No DVD access
* Unwilling to fill rx at spectrum.
* CPR less than 1 year ago.
The Effect of Bispectral Index Monitoring on Recovery From Deep Sedation

The purpose of this study was to compare BIS (bispectral index) monitoring and clinical sedation scale assessment on the recovery time and propofol usage from deep propofol sedation in children with cerebral palsy who received botulinum toxin injection.

After arrival in the preoperative holding area, children were randomly allocated into two groups using a computer-generated random assignment scheme. Five minutes before propofol sedation, remifentanil is administered intravenously at 0.025 μg / kg / min for analgesic effect and continued throughout the sedation process until just before the end of the procedure. Five minutes after remifentanil administration, 2 mg / kg of propofol mixed with 1 mg / kg of lidocaine was administered over 30 seconds, followed by continuous infusion at 100 μg / kg / min. Group C is monitored using UMSS(University of Michigan Sedation Scale) scores every three minutes, and group B is monitored using BIS score until deep sedation. Deep sedation is defined based on UMSS score of 3-4 and BIS score of 65 ± 5. If the sedation score is determined to have reached a deep sedation, a botulinum toxin injection is given by a practitioner blind to how to assess the depth of sedation. Independent investigator who is blind to group assignement assesses the oxygen saturation, respiration, and blood pressure, recovery time from sedation, and adverse events during and after sedation.

Eligibility Criteria:
Inclusion Criteria:

* 3-12 years old children with spastic cerebral palsy receiving botulinum toxin injection with deep sedation
* American Society of Anesthesiologists Physical Status 1-2

Exclusion Criteria:

* Body mass index \> 30 kg/m2
* unstable heart disease
* Anticipated difficult airway including congenital facial or airway anomaly
* Recent upper respiratory tract infection ( \< 2 weeks)
* Gastroesophageal reflux
* Allergy history to propofol, remifentanil or any drug used during procedure
A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects

This is a single-center, randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, PK profile, and immunogenicity of multiple SC administraion of CM326 at different doses in healthy subjects.

40 healthy male subjects will be enrolled in the study. The drug will be administered by dose-escalating principle at 4 dose levels: 55 mg Q2W, 110 mg Q2W, 220 mg Q2W, 220 mg Q4W.


Eligibility Criteria:
Inclusion Criteria:

* Male healthy volunteers, aged between 18 and 65 years of age inclusive, with a body mass index (BMI) within 18-26 kg/m2 (inclusive);
* Medical history, vital signs, physical examination, 12-lead Electrocardiogram, chest X-ray and abdominal color ultrasound are normal or abnormal with no clinical significance;
* All variables of clinical laboratory tests are normal or abnormal with no clinical significance;
* Subjects and partners agree to take effective contraception throughout the study (from screening to 3 months after the end of treatment);
* Capable of understanding the nature of the study and voluntarily signing the Informed Consent Form.

Exclusion Criteria:

* Known allergy to monoclonal antibody drugs or other related drugs, or allergy to excipients of CM326 injection;
* History of any clinically serious disease or history of circulatory, endocrine, neurological or hematological, immune, psychiatric, and metabolic diseases;
* History of asthma and allergic reactions;
* Use of any prescription drugs within 2 weeks prior to dosing, use of traditional Chinese medicine or over-the-counter drugs within 1 week prior to dosing;
* Received any marketed or investigational biologics within 5 half-lives (if known) or 12 weeks (whichever is longer) prior to dosing, or any investigational non-biologics within 5 half-lives (if known) or 4 weeks (whichever is longer) prior to dosing.
A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service

Asthma is a common lung condition that causes occasional breathing difficulties and affects around 5.4 million people in the UK of all ages. Common symptoms can include wheezing when breathing, breathlessness, a tight chest and coughing. However, these symptoms can get worse and lead to an asthma attack which can be fatal.

There is currently no cure for asthma but there are treatments that can help keep the symptoms under control. The main types of treatment include reliever inhalers used when needed quickly to reverse asthma symptoms for a short time, and preventer inhalers that are used everyday to prevent symptoms for starting. Unfortunately, not all patients are able to control their asthma on these treatments alone. Biologic treatments, also known as monoclonal antibodies, have been introduced to treat certain types of severe asthma over recent years. These specialist treatments use antibodies produced from cells in a laboratory to help reduce inflammation and might offer the possibility of higher levels of disease control including the reduction or absence of symptoms and normal lung function. This higher level of disease control is called remission.

This study aims to understand whether or not remission is possible in patients with severe asthmas treated with biologics in the NHS. This study will take place a 4 specialist asthma centres in the UK and seeks to include retrospective data from approximately 450 adult patients that were treated with biologics as part of routine care between 01 October 2021 and 30 September 2022. Data will be collected directly from medical records and entered into the study database in a pseudonymised format by members of the direct care team ready for analysis.


Eligibility Criteria:
Inclusion Criteria:

* Initiated on a biologic treatment for SA between 1st October 2021 and 30th September 2022
* Patients who received ≥1 dose of biologic treatment
* Patients aged ≥18 years at index

Exclusion Criteria:

* Patients who were involved in any interventional clinical trial during the study period (+/- 12 months from index).
Acute and Chronic Pulmonary and Renal Complications Following Contracting Severe Respiratory Distress Syndrome Coronavirus-19

Tracking post- corona virus infection pulmonary and renal complications

Mortality from pulmonary and renal system is highly noticable with COVID-19 pandemic . We trying to monitor compliction

Eligibility Criteria:
Inclusion Criteria:

* All COVID 19 patients admitted to ICU

Exclusion Criteria:

* Refusal to participate
Positive Assurance and MTBI

This study will develop and validate a new ED/Urgent Care discharge educational video that provides positive assurance about mild traumatic brain injury (mTBI) recovery for patients with mTBI.

The research team will investigate the effect of this new ED/Urgent Care Positive Assurance discharge intervention video on state anxiety and clinical recovery outcomes in pediatric patients with mTBI. A sample of adolescent and young adult patients (13-21yrs) will be recruited for participation that present to the IFH Pediatrics ED (PED) and/or Inova GoHealth Urgent Care sites with confirmed mTBI diagnosis and receive specialty referral to the Inova Sports Medicine Concussion Program for follow-up care. Investigators will employ a randomized controlled trial (RCT) to enroll two groups of mTBI patients: 1) a group that receives the video intervention (EDUC), and 2) a group that receives standard discharge instructions (i.e., treatment as usual: TAU).

Eligibility Criteria:
Inclusion Criteria:

1. 13-21 years
2. Has sustained an external force to head or body resulting in neurological symptoms and at least one reported symptom is attributed to the mTBI (e.g., dizziness, confusion, headache, postural instability, light/noise sensitivity, nausea)
3. Has receive a medical diagnosis of mTBI from an emergency physical at the IFH Pediatrics ED or Inova GoHealth Urgent Care clinic within 72 hours of injury
4. Is able to provide informed written consent (parent) and assent

Exclusion Criteria:

1. Loss of consciousness \&gt; 30 minutes in conjunction with the injury
2. Glasgow Coma Scale (GCS) score \&lt; 13
3. Has sustained a previous mTBI within the past 6 months
4. Has a neurological disorder (e.g., epilepsy)
5. Has a positive finding on brain imaging (e.g., CT, MRI) that suggests a severe closed head or open injury involving any structural damage or abnormality (e.g., fracture, subdural hematoma)
6. Has a previous history of neurosurgery
7. Does not speak English as a primary language
8. Requires admission to the hospital
9. Has developmental delays
10. Prisoner
11. Pregnant\*
12. Has been previously enrolled in the study
13. Members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups.
Nutrients and Hormones: Effects in Boys With Disordered Growth

The purpose of the study is to find out if patients with constitutional delay of growth have a mismatch between energy intake and utilization (as measured by doubly labeled water) and to compare the improvement in growth and energy balance between a group of boys treated with growth hormone (GH) alone versus those given GH plus added nutritional supplements for one year.

Two groups of boys 7-10 years old who are very short and below average in weight but otherwise healthy will be studied. One group will be observed initially for 6 months and then receive GH injections every day for the subsequent 12 months. Another group of boys will get a high-calorie drink every day for 6 months, and then receive GH injections plus the supplement every day for the next 12 months. We will compare how well boys grow in height, weight and the changes in body composition. We will compare diet and energy usage using the doubly labeled water technique. A battery of hormonal and nutritional tests will be performed, as well as body composition assessment.

Eligibility Criteria:
Inclusion Criteria:

* Boys 7-10 years old who are very short and below average in weight but otherwise healthy.
* Delay in skeletal maturation \> 1 year.

Exclusion Criteria:

* Growth hormone deficiency
* Chronic illness
* Participation in high endurance athletics
Behavioral Lifestyle Intervention Study (BLIS) in Patients With Type 2 Diabetes in UAE: A Randomized Controlled Trial in Real Life Setting

The primary purpose of this study is to develop a behavioral lifestyle intervention and evaluate its effectiveness in improving the glycemic control in patients with type 2 diabetes in real life setting. This is because ambiguity still exists on the effectiveness of behavioral lifestyle interventions in routine clinical practice despite of the efficacy of large randomized controlled trials, suggesting the need for more research in this area.


Eligibility Criteria:
Inclusion Criteria:

Females or males. Type 2 diabetes. BMI (kg/ m²) ≥ 25. Age 18-60 years old. HbA1c \> 7%.

Exclusion Criteria:

major physical activity disability that restricts participation in moderate physical activity.

serious heart condition like heart failure, heart attack, stroke within the last 3 months.

participating in a weight management or lifestyle program. presence of proliferative retinopathy or kidney failure.
The Influence of Sedation for Endoscopy on Cognitive Function

It is commonly recommended that patients should refrain from driving for 24 hours after sedation for endoscopy，however，this recommendation has been queried recently．To investigate the effect of sedation on early postoperative cognitive function in patients undergoing endoscopy.

One hundred adult patients undergoing sedative esophagogastroduodenoscopy ( EGD) were randomly recruited，and another 100 adult patients undergoing conventional（without sedation） EGD were served as controls． All patients had an education level more than 9 years． Cognitive function was assessed by Montreal Cognitive Assessment（MoCA）1 week before EGD exam, 10 mins before propofol sedation or the beginning of endoscopic procedure, 30mins after EGD exam, and 2 week after exam.

Eligibility Criteria:
Inclusion Criteria:

1. The scores of MMSE are more than 26.
2. The AHA grade I and II.

Exclusion Criteria:

1. The AHA grade III, IV or V.
2. binge drinking.
3. Take sedatives, sleeping agents and some drug which may affect the study in a month.
4. Psychiatric disorders.
5. The dysfunction of heart, lung, liver and kidney.
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study

This is a prospective longitudinal study that evaluates Platelet Function Analyzer-100 (PFA-100) CT-ADPs (closure time-ADP) and incidence of bleeding using the Neonatal Bleeding Assessment Tool - Neo-BAT in preterm neonates \<32 weeks gestational age or with a birth weight \<1500 grams and with different degrees of thrombocytopenia.

The investigators hypothesized that PFA-100 CT-ADP, a global in vitro test of primary hemostasis, will be a better predictor of clinical bleeding in neonates than platelet count alone. A bleeding risk assessment marker could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in neonates with thrombocytopenia.


Eligibility Criteria:
Inclusion Criteria:

* \<32 weeks gestation or with a birth weight \<1500 grams;
* Have confirmed moderate-to-severe thrombocytopenia, defined as a platelet count \<100x109/L;
* Have a parent/guardian willing to comply with the protocol and provide written informed consent.

Exclusion Criteria:

* Are not expected to survive by the Attending Neonatologist;
* Are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. associated congenital malformations, platelet morphology);
* Have a major chromosomal anomaly such as Trisomy 13, 18, or 21.
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

This is a single center,prospective,no-controlled clinical trial

1. The complete remission of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients
2. The safety of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients

Eligibility Criteria:
Inclusion Criteria:

* Female or male patients aged between 18 to 65 years
* Renal biopsy was used to diagnose IgA nephropathy
* Patients with 24h proteinuria 3.5g and serum albumin concentration lower than 30g/L

Exclusion Criteria:

* Patients with serum creatinine ≥ 3 mg/dl or eGFR \< 30ml/min per 1.73 m2
* urine RBC \> 1 million/ml
* Patients who have received treatment of enough steroids for more than 12 weeks
* patients with secondary IgA
* Patients who have impaired liver function,with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis
* Patients with 2 type diabetes or obesity, whose BMI is more than 28kg/m2