cyrilzakka/clinical-trials huggingface dataset:
The Impact of Structured Patient Education Material (SPEM) in Improving Clinical and Behavioural Outcomes in Home-based Cardiac Rehabilitation Program Participants: A Pilot Study

This study aims to examine the impact of providing a digital education material to participants of home based cardiac rehabilitation in improving clinical and behavioural outcomes

This is a pilot study aiming to assess the impact of providing a structured patient education material in a digital form to participants of home based cardiac rehabilitation program in University Malaya Medical Centre.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-70 years
* Fulfills the low to moderate exercise participation risk criteria for Cardiac rehabilitation program phase 2 as per the American Association of Cardiovascular and Pulmonary Rehabilitation standards
* Able to participate in a treadmill exercise program
* Cognitively able to give consent, and able to read and utilize the digital education material

Exclusion Criteria:

* Stratified as high risk to participate in an aerobic exercise program as per the American Association of cardiovascular and Pulmonary Rehabilitation standards
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650

Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.


Eligibility Criteria:
Inclusion Criteria:

* HBA1c \> 6.5%
* History of coronary, cerebrovascular or peripheral artery disease

Exclusion Criteria:

* history of pancreatitis
Biomolecular Analysis for Predicting Response to Regorafenib

The study envisages NGS analysis on tumor tissue from patients treated with regorafenib for recurrent glioblastoma as per standard care, with the aim to identify predictive biomarkers for response.


Eligibility Criteria:
Inclusion Criteria:

1. recurrent glioblastoma after surgery and chemoradiation with temozolomide;
2. indication to treatment with regorafenib per standard of care;
3. written informed consent.

Exclusion Criteria:

None.
Lidocaine for Pain Control During Intrauterine Device Insertion

Despite being the most common method of contraception, the use of intrauterine devices (IUDs) is limited by the associated pain during insertion. Many pharmacologic interventions had been studied for their efficacy to reduce IUD insertion pain, of them, lidocaine was found to be superior over NSAIDs or other local anesthetics. This work aims at comparing the safety and efficacy of different lidocaine formulations to optimize selection in reduction of IUD associated pain.


Eligibility Criteria:
Inclusion Criteria:

1. Multiparous women.
2. Over 18 years of age and eligible for IUD insertion.
3. Application of IUD will be done in postmenstrual period.

Exclusion Criteria:

Null parity. 2. History of failed intrauterine device insertion (uterine perforation, acute expulsion).

3. Copper allergy. 4. Uterine anomaly. 5. Post-partum endometritis or septic abortion in the past three months. 6. Untreated cervicitis/vaginitis, including bacterial vaginosis. 7. Immunosuppression. 8. History of lidocaine ,prilocaine allergy. 9. Analgesic or anxiolytic use within the last 24 hours before the procedure. 10. Wilson's disease. 11. Suspicion of pregnancy. 12. Untreated abnormal uterine bleeding.
Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor

Preterm birth continues to be a major public health problem with lasting family and societal repercussions. Despite tremendous research effort, prevention strategies have failed, and the prevalence of preterm birth in the United States reached 12.3% in 2003.

Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at \< 37 weeks' gestation. The rate of prematurity increases dramatically with the number of fetuses - singletons 10%; twins 54.9%; and triplets 93.6%


Eligibility Criteria:
Inclusion Criteria:

1. singleton fetus less than 37 weeks of gestation
2. women diagnosed to having Threatened preterm labor.

   1. presence of uterine contraction (at least 4 in 20 min or 8 in 60 min )
   2. cervical effacement \<80 %
   3. cervical dilatation \<1 cm

Exclusion Criteria:

1. suspected fetal growth restriction,
2. maternal medical complications,
3. presence of fetal heart rate abnormalities at enrollment.
4. Preterm Premature rupture of membranes
5. Placenta previa
6. Lower urinary tract infection or genital infection
7. Fetal congenital anomaly
A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD)

The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the study. No efficacy and tolerability of pharmacological treatments will be assessed. Patients matching inclusion and exclusion criteria will be enrolled consecutively; each investigator will include the first 10 to 40 patients that will be visited as treatment resistant MDD.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent form
* Male and Female age: 18-65 years
* Diagnosis of MDD according to DSM-IV TR (296.3 x Major Depressive Disorder, recurrent)
* Treatment resistance defined as non-response to at least 2 antidepressants given in an ade

Exclusion Criteria:

* Patients already participating in clinical trial or any other interventional study
* Patients unable to understand HCL-32 item meaning
An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo

TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine Zhongfengxingnao formula (ZFXN) in reducing haematoma and bleeding after acute intracerebral hemorrhage (ICH) from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study is designed to evaluate the blinding and physical consistency between the investigational drug and placebo in RCT, taking the trial named Chinese herbal medicine in patients with acute intracerebral hemorrhage (CHAIN) as an example. Therefore the blinding of placebo as well as and physical consistency with investigated TCM in CHAIN trial will be determined. In addition, an assessment method for blinding and physical consistency could be developed for subsequent placebo evaluations.

A total of 48 subjects will be divided into two parts for manual scoring, which includes not only the proportion of the discrimination to ZFXN, which is the primary outcome in this study, but also the physical (odor, taste) consistency of the two drugs. The primary outcome was the percentage of ZFXN response. The secondary outcomes included artificial sensory score and intelligent sensory attributes of testing drug.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years old;
* 2. No visual, olfactory, taste, cognitive impairment;
* 3. Provide written informed consent by patient (or approved surrogate);

Exclusion Criteria:

* 1. Evaluation personnel involved in the clinical trial about ZFXN;
* 2. Subjects with severe history of heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders or metabolic disorders;
* 3. Subject with history of food, drug allergies, or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) or is known to be allergic toZFXN;
* 4. Known definite contraindication to the Chinese herbal medicine;
* 5. Women who are known to be pregnant or lactating;
* 6. Subjects not fit to participate in this study judged by responsible treating clinician.
When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy?

Objective: The aim of this study is to evaluate if direct removal of the urine catheter after an laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery, which is the current treatment. In addition, we want to investigate patient's experience on this subject.

Study design: Randomized Controlled trial, non-inferiority study.

Study population: Women older than 18 years old, who are a laparoscopic hysterectomy for benign indication or low-grade malignancy.

Intervention:

* Group A (treatment group): the patients in this group will have their catheter directly removed in the OR after LH.
* Group B (control group): the patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place).


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Scheduled for LH for benign indication or low-grade malignancy (with or without salpingo-oophorectomy)

Exclusion Criteria:

* Concomitant procedures such as prolapse surgery, severe endometrioses and/or bowel resection
* Preoperative known urinary voiding problems (incontinence)
* Preoperative known urinary tract infection
* Patients suffering from diseases potentially associated with inability to void (e.g. MS)
* A Gravid or postpartum hysterectomy
Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome

Magnesium is the second most abundant ion in human cells and plays fundamental roles in several enzymatic reactions: it is involved in ATP production, in the phosphorylation of proteins, in glucose metabolism and in the contraction of cytoskeleton.

Several epidemiological studies demonstrated that low dietary magnesium intake is inversely associated with diabetes mellitus, hypertension and metabolic syndrome.

Magnesium could be related to important haemodynamic and metabolic anomalies: at vascular level it acts as an antagonist of calcium, especially in vascular smooth muscle cells, thus its deficit could enhance vascular contraction; with regard to glucose metabolism, magnesium is involved in the physiopathological mechanism of insulin resistance, through a reduction in cellular uptake of glucose. This condition and the subsequent compensatory hyperinsulinemia can ultimately lead to increased synthesis of proinflammatory cytokines and to endothelial dysfunction. Thus, magnesium depletion and subsequent alterations can increase the risk of developing vascular disease such as atherosclerosis and has been associated with cardiovascular events.

Several clinical trials have explored the possible beneficial effect of magnesium supplementation on blood pressure, plasma lipids and insulin resistance but the results are often contradictory. One of the possibilities for these unclear results could be that in some of them the interventions started too late when haemodynamic and metabolic changes are more difficult to revert.

The investigators hypothesis is that magnesium supplementation in a population at increased genetic risk of developing metabolic syndrome but without it could improve blood pressure and the other metabolic syndrome related components.

Thus, the aim of the present study is to evaluate the effect of oral supplementation of magnesium (16.2 mmol/day of magnesium pidolate) on metabolic syndrome's components in a sample of 15 subjects who are at increased risk of developing metabolic syndrome since have a positive familiar history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI criteria).


Eligibility Criteria:
Inclusion Criteria:

* positive family history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI criteria).

Exclusion Criteria:

* any therapy related to metabolic syndrome (that is antihypertensive, anti diabetic, antilipemic drugs);
* age \< 18 years or \>50 years;
* previously diagnosed hypertension or immediate need for antihypertensive therapy (BP≥160/100);
* diabetes mellitus (ADA criteria);
* obesity (BMI\>30Kg/m2);
* Continuative use of NSAIDs, magnesium or vitamin supplements;
* Hypermagnesaemia;
* Previous cardio- or cerebrovascular events;
* chronic kidney or liver or inflammatory or neoplastic disease;
* gastrointestinal dysfunction with hypomotility;
* active smoke (\>5 cigarettes per day);
* Impossibility to give informed consent.
Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD

The purpose of the study is to compare atomoxetine hydrochloride and methylphenidate hydrochloride in pediatric patients with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 6 years of age and not more than 16 years of age at Visit 1
* Must meet DSM-IV criteria for ADHD
* Must be of normal intelligence (that is, without a general impairment of intelligence and likely, in the investigator's judgement, to achieve a score of greater than or equal to 70 on an IQ test)
* Must be able to swallow capsules
* Must have laboratory results that show no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)

Exclusion Criteria:

* Weigh less than 20 kg or more than 60 kg at study entry
* Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
* Meet DSM-IV criteria for an anxiety disorder
* Have a history of any seizure disorder (other than febrile seizures)or prior ECG abnormalities related to epilepsy, or subjects who have taken or are currently taking anti-convulsants for seizure control
* Have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions,including a hypersensitivity to methylphenidate
Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship

The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.

The clinical investigation is designed to be prospective to ensure that the population is representative of the type of population for which the Freedom Total Knee® System with the revision components is intended to treat. Subjects with a primary diagnosis of end-stage symptomatic revision knee who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a revision total knee arthroplasty, by the Investigator, will be invited to take part in this clinical investigation. Patients will be drawn from hospital clinics focusing on this type of treatment.

The treatment period of 36 months is considered sufficient to monitor the safety and clinical performance of the device. However, the patients will be contacted annually for 10 years or as long as the patient is willing to monitor their long-term progress.

An interim report will be issued when at least 120 patients will complete the 12-month follow-up.

No treatments will be withheld as part of this clinical investigation although any other treatments that need to be administered during the clinical investigation will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 40 years of age or older and less than 80 years of age (\>40 and \<80 years).
* Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.
* Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and the prescribed rehabilitation.
* Subjects who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
* Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

Exclusion Criteria:

* Primary knee replacement of the affected knee joint
* Other significant disabling problems from the muscular-skeletal system than in the knees (i.e muscular dystrophy, polio, neuropathic joints)
* Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living.
* Patients who are found to be non-compliant by their physician
* Patients with or having; malignancy - active malignancy, active or suspected systemic infection, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia, and systemic lupus erythmatosus.
* The patient has a neuromuscular or neurosensory deficit.
* Female patients planning a pregnancy during the course of the study.
* Patients, who are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
* Varus or valgus deformity \> 20 degrees
* Bilateral TKR
The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal

Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. Our objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* VUMC patients age 18 or older with a penicillin allergy reported in their chart, and are medically stable, currently admitted to stepdown unit or regular floor bed.

Exclusion Criteria:

* Patients with a penicillin allergy reported in their chart, but who are currently medically unstable.
* Pregnant patients
A Single and Multiple Ascending Dose Study of COR588

The study is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety and tolerability of COR588 HCl in healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between 18 to 55 years of age, inclusive (at the time of consent) for Part A;
* Body mass index between 18 and 32 kg/m2, inclusive, at screening and Day -1;
* Participants with no clinically significant abnormal screening results in the opinion of the investigator;
* All screening laboratory parameters (chemistry, hematology, coagulation, urinalysis) within normal limits or considered not clinically significant in the opinion of the investigator. If necessary, in the investigator's opinion, screening labs may be repeated once to confirm the results if error is suspected.
* Women of childbearing potential (WOCBP) must have a negative blood or urine pregnancy test within 24 hours prior to the start of investigational product and must not be breastfeeding, lactating or planning pregnancy during the study period. WOCBP must agree to use an acceptable form of contraception during the treatment period and for at least 30 days after the last dose of investigational product.
* A male subject with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period and for at least 90 days after the last dose of study treatment and refrains from donating sperm during this period;
* Agree to comply with study-specified diet and consume the high-fat breakfast in its entirety (food effect cohort) while confined in the study site;
* Provide signed informed consent prior to any study procedures commencing, understand and comply with the requirements of the study, and be able to communicate with the investigator.

Exclusion Criteria:

* Presence of significant neurological, cardiovascular, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease;
* History or presence of malignancy within the past 2 years prior to Day -1 with the exception of adequately treated basal cell or squamous cell carcinoma of the skin;
* History of conditions (e.g., chronic diarrhea or prior abdominal surgery) known to interfere with the absorption, distribution, metabolism, or excretion of drugs;
* Clinically significant acute illness or infection within 14 days prior to Day -1;
* Any surgical procedure within 3 months prior to Day -1, that may interfere with the performance in the study in the judgment of the investigator;
* History or presence of cardiac abnormalities or congenital long QT syndrome;
* Subjects with a QTcF interval \>450 msec for males and \>470 msec for females at screening or Day -1;
* Any dietary restriction, intolerance, or food allergy that would prohibit the consumption of a high fat breakfast (food effect cohort only);
Dose Enhancement of Vancomycin IN Everyday Patients

Current Australian guidelines for vancomycin commonly underdoses individuals particularly in the first 48 hours.

The aim of the trial is to compare two dosing regimens; the current Australian guidelines versus a more appropriately modeled pharmacokinetic based regimen with the overall aim of developing a new vancomycin dosing strategy that will enable patients to have more individualised and therapeutically efficacious treatment.

The hypothesis is that dosing vancomycin according to a pharmacokinetically modeled regimen increases the likelihood of achieving therapeutic trough levels of vancomycin within the first 48 hours (or at steady state, whichever is sooner) compared to dosing vancomycin according to the current Antibiotic guidelines.

DEVINE will be a randomised controlled trial of a new vancomycin dosing regimen against a control.

The control group regimen will receive the doses recommended by Therapeutic Guidelines - Antibiotics 2010. The intervention group will receive a dosing regimen that has been devised by modelling the antibiotic properties within the body over a large range of renal function and weight that will be more specific for the individual patient. They will receive this regimen for approximately 36-60 hours at which point they will have a vancomycin level blood test (a routine practice as part of their normal care). After this time the treating team will determine further dosing requirements.

All patients will be randomised at commencement of vancomycin with consent being obtained for the trial prior to the first dose of vancomycin

Eligibility Criteria:
Inclusion Criteria:

* All patients in general wards requiring routine treatment with vancomycin

Exclusion Criteria:

* GFR \< 30mL/min(as measured by Cockcroft Gault equation)
* Age \< 16 yrs
* Weight \> 200kg
* Patients dosing with Vancomycin other than BD according to national guidelines (ie continuous infusions, q6h etc)
* Vancomycin infused at a rate other than 500mL/min