cyrilzakka/clinical-trials huggingface dataset:
Pelvic Alignment Level (PAL) Instrument Evaluation

The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL) instrument in achieving desired acetabular position, desired leg length and offset after Total Hip Replacement (THR) reconstruction.

Total hip replacement (THR) has been a sucessful treatment for cases of degenerative joint diseases. However, post operative complications such as dislocations, osteolysis, component wear and migration are still a concern. It has been noted in the scientific literature that precise acetabular cup position helps reduce such post operative complications. The Pelvic Alignment Level (PAL) offers this solution by assessing pelvic motion and optimizing implant position without the need for intra-operative fluoroscopy or a large capital expenditure. The focus of this study is to evaluate the clinical outcomes (acetabular cup placement, femoral offset, and leg length) of using the PAL instrument to those without using PAL instrument during total hip replacement. This will be a prospective, post market, randomized multi-center clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Patient has signed an IRB approved, evaluation specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female age 18 years or older at time of enrollment.
* Patient clinically qualifies for total hip arthroplastic surgery, based on physical examination and medical history.
* Patient must have a diagnosis of: osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, failed fracture fixation or rheumatoid arthritis.

Exclusion Criteria:

* Patient's anatomy precludes a cup placement of 45° inclination and 20° anteversion.
* Patient has an active infection within the affected hip joint.
* Patient is a prisoner.
* Patient has plans to relocate to another geographic area before the completion of the evaluation.
Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants

Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates.

The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants \< 30 weeks gestational age at birth.

Specific Aims:

* To determine whether there is a sustained difference in the level of respiratory support during the first 3 days of life in extremely premature infants treated with Curosurf versus Survanta
* To determine whether Curosurf is associated with a higher incidence of hemodynamically significant PDA, compared with Survanta
* To determine whether there is a difference in the cerebral blood flow response to Curosurf versus Survanta
* To determine whether there is a difference in morbidity in very premature infants treated with Curosurf versus Survanta

We reasoned that if Curosurf was primarily responsible for improved survival rates, compared with Survanta, then there should be a sustained improvement in respiratory function in the first three days of life, when the direct pulmonary effects of the surfactant preparations would be most easily detected. It was also possible that Curosurf and Survanta could have effects on other systems that could secondarily affect long-term survival of the infant. These other organ systems would include, but not be limited to, the development of a hemodynamically significant Patent Ductus Arteriosus, Intraventricular Hemorrhage or Periventricular Leukomalacia, or Necrotizing Enterocolitis. We propose to examine how surfactant administration affected the hemodynamic precursors of these common morbidities of very premature infants.

Eligibility Criteria:
Inclusion Criteria:

* \<29 6/7 and \>24 0/7 weeks gestational age
* Inborn at the participating institution enrolling the patient
* FIO2 \>25% and Intubated with mean airway pressure \> 5 cm H20
* \<8 hours age at randomization
* Signed informed consent from parent(s)

Exclusion Criteria:

* \<500 g birth weight
* \<24 0/7 weeks gestational age (best estimate)
* Prolonged Premature Rupture of membranes \>3 weeks (21 days)
* Apgar score \< 3 at 5 minutes
* Impending death anticipated within the first 3 days of life, moribund
* Severe congenital anomalies
New Predictive Marker for Pancreatic Cancer Using CA19-9 and Fecal Elastase

Background Carbohydrate antigen 19-9 (CA19-9) is used as a marker to predict recurrence and survival of patients with Pancreatic cancer(PDAC). Recently, fecal elastase-1(FE-1), a marker of pancreatic exocrine function, has been shown to correlate with prognosis in patients with PDAC. However, there have been no studies that have predicted prognosis by combining these two factors. In this study, investigators developed a predictive strategy for prognosis of PDAC using data on preoperative CA19-9 and FE-1 levels.6

Methods The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Investigators conducted a retrospective study using data from 857 patients with pancreatic cancer enrolled in two hospitals in the Republic of Korea (179 from Gangnam Severance Hospital and 678 from Seoul National University Hospital) from January 5, 2010 to December 31, 2019.

Exclusion Criteria:

* Investigators excluded patients without information about preoperative tumor marker levels (n = 45), those who received neoadjuvant (n = 169), those with preoperative CA19-9 levels \< 9.0 \[Lewis antibody-negative patients\] (n = 98), those with missing covariates (n = 3) and R2 resection (n = 6).
Acute Effects of Squat Protocols in Muscular Power, Postural Sway and Tendinous Thickness.

The objective of this study is to know the acute effects of a squat protocol in: 1- lower limb muscle power analyzed by countermovement jump on force platform and upper limb through a bench press with encoder test; 2 - the unipodal postural equilibrium by force platform; 3 - the patellar tendinous thickness measured by ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Males, with at least a year of experience in heavylift exercises, age between 20 and 35 years.

Exclusion Criteria:

-
GPIAG and Leicester Asthma and Dysfunctional Breathing (GLAD) Study: a Randomised Controlled Study

Breathing retraining supervised by a physiotherapist will result in improvements in the quality of life and asthma control of patients treated for asthma in the community with symptoms suggestive of dysfunctional breathing.

To investigate the effects of breathing retraining on clinical and physiological parameters of asthma control, to identify the characteristics of patients who benefit, to perform a health economic evaluation.

Objectives:

* To assess the effect of breathing retraining on asthma-related health status, asthma control and objective indices of asthma severity (bronchial hyper-reactivity (BHR), sputum eosinophilia and nitric oxide production) in patients with symptomatic asthma.
* To compare the relationship between symptoms of dysfunctional breathing (Nijmegen Questionnaire screening score), changes in asthma-related health status and other parameters resulting from breathing retraining
* To explore the relationship between dysfunctional breathing, baseline asthma symptoms, treatment and asthma-related quality of life.
* To estimate the cost effectiveness of the breathing retraining intervention

Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosis in medical records
* Age 17-70 yrs.
* One or more prescription for asthma medication in previous 12 months
* Impaired asthma related quality of life (AQLQ score \<5.5)

Exclusion Criteria:

* COPD
* Unstable or under-treated asthma at enrollment.
Efficacy of Web-Based Social-Cognitive Interventions in Right Hemisphere Stroke and Frontotemporal Dementia

This study is being done to test the feasibility and effectiveness of web-based social-cognitive training exercises in treating social-emotional deficits in patients with stroke or frontotemporal dementia (FTD).

Although deficits in empathy and social interaction are relatively common in certain forms of FTD and stroke, there are currently no proven treatments for these symptoms. Spouses and caregivers often cite these symptoms as a major concern, and these deficits can have a negative impact on the quality of life that patients experience. The purpose of this study is to evaluate whether or not web-based social training exercises can improve social-cognitive impairments in patients with FTD or right hemisphere stroke. These training exercises have been shown to improve social skills and empathy in other disorders. This study will be the first to examine if these exercises can be effective and feasible for treating social deficits in stroke and FTD.

The study will be based out of the Johns Hopkins Hospital where patients will be assessed three times in total. Patients will be assessed upon enrollment in the study and after each of the two treatment conditions. The training itself will be completed at home on a provided laptop, with monitoring and support by the study team. This study uses a crossover design, which means that all patients will receive the training treatment and a control treatment during their participation in the study. The approximate timeline for the study is 9 weeks total.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of right hemispheric stroke or behavioral variant frontotemporal dementia.
* Able to give informed consent.
* Premorbid proficiency in English (by self-report).
* Age 18 or older.
* Score of 21 or higher on the mini-mental state examination.

Exclusion Criteria:

* Prior history of neurological disease affecting the brain other than stroke or frontotemporal dementia (e.g., brain tumor, multiple sclerosis, traumatic brain injury)
* Known uncorrected hearing loss
* Known uncorrected vision loss
* Prior history of severe psychiatric illness, developmental disorders, or mental retardation (e.g., schizophrenia, autism spectrum disorders) other than FTD
* Score of 20 or lower on the Mini-Mental State Examination.
Consumer Motivation for Disease Prevention

The purpose of this study is to examine (1) how the causal structure of a disease influences people's disease prevention decisions; and (2) how the causal structure of a disease interacts with people's regret anticipation in determining their disease prevention decisions.

People sometimes have to deliberate on whether or not to remove a risk factor that may potentially cause a disease in the future. When a controllable risk factor (say, X) is the only factor that causes a disease, the decision to remove it may simply depend on the probabilistic relationship between X and an outcome, as well as the cost of removing X. However, little is known when other factors that are out of the decision-maker's control are also present. The main question being asked here is how does the presence of such uncontrollable factors change people's decision to remove X.

Specifically, the investigators consider two cases: a disease caused by a single controllable risk factor (say X) and a disease caused by two risk factors -- a controllable factor (X) and an uncontrollable factor (Y). In both cases, the removal of X can result in a meaningful reduction in overall disease risk. It is hypothesized that even when the magnitude of overall risk reduction brought by the removal of X is the same in the two cases, people would have a lower motivation to remove X in the latter case.

The investigators also examine how the presence of an uncontrollable risk factor interacts with the respondents' regret anticipation to influence their decision to remove X. In the context of the current research, regret anticipation could take one of the following forms: (a) feel regretful if one decides not to remove X and later develops the disease (b) feel regretful if one decides to remove X but still develops the disease. The investigators expect (a) to moderate the effect of uncontrollable risk factor on motivation to remove X.

Eligibility Criteria:
Inclusion Criteria:

* students enrolled in marketing courses at the Chinese University of Hong Kong

Exclusion Criteria:

* None
The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes mellitus
* HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
* Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
* Body Mass Index (BMI) below or equal to 40 kg/m\^2

Exclusion Criteria:

* Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (Visit 1)
* Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
* Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
* Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
* Screening calcitonin above or equal to 50 ng/l
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
* Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary,carotid or peripheral artery revascularisation procedures
* Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
* Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes Mellitus),neurological, genitourinary or haematological system that in the opinion of the Investigator,may confound the results of the trial or pose additional risk in administering trial product
* History of chronic pancreatitis or idiopathic acute pancreatitis
Trial on Impact of HealthPROMISE Mobile App on Inflammatory Bowel Disease Care and Quality of Life

HealthPROMISE is a mobile application (app) for patients that allows regular tracking of symptoms by patients and communicates them to physicians. The purpose of this randomized controlled trial is to determine the impact of the HealthPROMISE application on improving patient outcomes. The trial will look at how much patients use the application, whether physicians change treatment in response to new information from patients, and how the patients quality of life change over the span of the study. The investigators hypothesize that HealthPROMISE will enhance physician-patient communication and improve clinical outcomes.

This study will prospectively enroll about 300 patients with Crohn's Disease or Ulcerative Colitis presenting at the Mount Sinai Health System.

Eligible participants who complete the informed consent will fill a Tablet or Web-based questionnaire at the end of which they will be given a pin and offered to download the HealthPROMISE app or an education app. Patients who download HealthPROMISE app will then be requested to provide updates on quality metrics, a quality of life questionnaire, and emergency visits and hospitalizations.

Data will be collected continuously throughout the study using the mobile health app. Study endpoints will primarily be assessed using "intention to treat" analysis. Additionally, per protocol analysis of data will be performed for patients who have logged into the application at least 4 times in 12 months. The total study duration will be 2 years (104 weeks). At 1 year (52 weeks), an interim analysis will be done to determine if study needs to be continued for full 104 weeks. Furthermore, patients in either arm who login using PIN but not completing week 52 (or week 104) exit survey will be considered as "lost to follow up".

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years,
* Internet or Smartphone access
* Ability to complete a Tablet or web-based questionnaire in English language.

Exclusion Criteria:

* Presence of short bowel syndrome, stoma or pouch.
* Presence of a condition or disease that, in the opinion of the investigators, may make it exceedingly difficult for the patient to use HealthPROMISE App, including, but not limited to, advanced dementia.
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)

This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing multiple sclerosis (RMS) (McDonald Criteria 2010)
* Active disease
* Expanded disability status scale (EDSS) 0 - 5.5 (inclusive) at screening

Exclusion Criteria:

* Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed treatment
* Treatment with the following therapies at any time prior to randomization: alemtuzumab, natalizumab, teriflunomide, leflunomide and Stem cell transplantation
* Diagnosed with primary progressive multiple sclerosis (PPMS)
* Pregnant or nursing
Silent Myocardial Ischemia in Patients Undergoing Non-oncological Abdominal Surgeries

Perioperative mortality in non-cardiac surgical procedures is 1-2 % with half of these cases attributed to cardiovascular events. Silent myocardial ischemia, which typically occurs within 72 hours to 30 days after surgery is the most common. The only diagnostic criterion is troponin T, which should ideally be measured before the operation. In addition to troponin, blood samples can be taken for N terminal-pro BNP. Genetic factors can also contribute to the development of myocardial infarction. Methylenetetrahydrofolate reductase (MTHFR) is an important enzyme in homocysteine metabolism. The two most investigated variants of the MTHFR gene are C677T and A1298C single nucleotide polymorphisms (SNPs). As new biomarkers of cardiovascular diseases, non-coding RNAs, especially microRNAs (miRNAs) and circulating extracellular vesicles (EVs) are of interest. On the other hand, EVs were shown to reduce myocardial autophagy, leading to death during MI or ischemic-reperfusion injury. Methods: The investigators will enroll approximately 200 patients aged 18 and older. The first study of silent myocardial ischemia, will include patients without cardiovascular disease undergoing urgent or elective surgery for benign abdominal diseases. The second group will include patients with STEMI undergoing primary coronary angiography. Patients will also complete a questionnaire on folate intake. Subsequently, the investigators will collect blood for standard laboratory tests as well as troponin T, N terminal-pro BNP, homocysteine, and folic acid. Blood will be also collected for biomarker analysis. On the third day of hospitalization, blood will be collected again for troponin T, NT-proBNP and biomarkers. After that, the investigators will follow up the patients for another year every three months for the possible occurrence of major adverse cardiovascular events (MACE). Peripheral blood and blood from the coronary sinus will be collected in patients from the second study group for biomarker research. Expected results and significance for science and medicine: the investigators anticipate that the study will improve the understanding of clinical, biochemical, and biological markers of silent ischemia and cardiovascular complications following non-oncological abdominal surgeries. Knowledge of these factors would enable early identification of patients at higher risk of such complications, leading to more targeted preoperative preparation for non-oncological abdominal surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-oncological abdominal disease and without cardiovascular disease
* Patients with STEMI

Exclusion Criteria:

* Patients with active cancer
* Pregnant women
* Psychiatric patients
* Patient with dementia
* Patients who do not understand basic instructions
* Alcohol and illegal drug addicts