cyrilzakka/clinical-trials huggingface dataset:
Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction

To compare the different effect of conservative pharmacotherapy and Staged Percutaneous Coronary Intervention (SPCI) on significant non-culprit lesions in patients with ST-segment elevation myocardial infarction (STEMI) at presentation remains controversial


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 75 with continuous ischemic chest pain for ≥ 30 minutes and ST-segment of electrocardiographic leads between V2 and V3 elevated ≥ 0.2 mV (or ≥ 0.1 mV in ≥ 2 other continuous electrocardiographic leads), cardiac troponin I (cTn I) elevation of \> 0.05 ng/ml, coronary arteriography within 12 hours after the onset of symptoms indicating lesion in culprit vessel with thrombolysis in myocardial infarction (TIMI) flow grade 0 to 1, merely underwent PPCI. Additionally, coronary arteriography corroborates lesions in non-culprit vessel (Besides the culprit vessel, there are ≥ 70% stenoses in one or more coronary vessels in which diameters were ≥ 2 mm).

Exclusion Criteria:

* left main coronary artery disease, cardiogenic shock, complete left bundle branch block (CLBBB) PPCI treated culprit and non-culprit vessels, PPCI failure patients with postsurgical haemodynamic instability or spontaneous ischemia, ≥ 70% stenoses of vessels remained during the hospitalization after staged PCI, history of PCI or Coronary Artery Bypass Grafting (CABG), history of chronic cardiac failure, bleeding diathesis, prior administration of thrombolytic therapy, known thrombopenia or leucopenia, sever liver and kidney dysfunction, active infection, immune system and connective tissue diseases, known contraindications to aspirin or heparin, life expectancy \< 1 year, had major procedure within 3 months, uncontrolled hypertension, ischemic stroke within 30 days, hemorrhagic stroke, intracranial diseases including and arteriovenous malformation, extensive traumatic cerebral infarction within 6 weeks, oral anticoagulant therapy, severe myocardial infarction related complications and perioperative death
The PREFORM Study: Rotational Fractional Resection for Submental Contouring

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. Rotational fractional resection is used to remove loose skin and fat.

This is a prospective, single-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection and focal lipectomy) in patients with moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* At least 30 years old
* Moderate to severe submental laxity
* Up to moderate submental lipodystrophy
* Agree to maintain weight (±5%) for the duration of the study

Exclusion Criteria:

* Previous intervention to treat submental fat or skin laxity
* Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
* Severe acne, cystic acne or acne scars on neck
* Trauma of chin or neck area
* Skin infection or rash on neck
* Psoriasis, hyperpigmentation, eczema, rosacea or vitiligo
* History of scarring
* Body mass index (BMI) \>30
* Clinically significant bleeding disorder
* Anemia, kidney disease, or liver disease
Comparison of Soft and Hard Tissue Thickness in the Anterior Regions of the Upper and Lower Jaws Taken From CBCT Versus Clinical Measurements

Hypothesis: there is a positive correlation between tissue thickness measured from CBCT and clinical measurements.


Eligibility Criteria:
Inclusion Criteria:

* 100 subject who have done a CT

Exclusion Criteria:

* periodontal surgery in anterior regions, medications which effect the gingiva
The Adaptation, Usability, and Feasibility of a Mobile Health (mHealth) System to Improve Type 2 Diabetes Self-management in Thailand

This project explores the feasibility of using automated telephone calls to adult patients with type 2 diabetes to improve diabetes self-management in Thailand. This line of work could significantly extend Thai nurses' ability to manage this growing epidemic, and ultimately reduce the suffering and costs caused by diabetes in Thailand.

There is a serious shortage of community nurses to address Thailand's significant and expanding burden of poorly controlled type 2 diabetes. However, mobile health (mHealth) strategies are likely to significantly improve and extend Thai nurses' ability to monitor and manage these patients. This study aims to:

1) investigate the feasibility and acceptability of a culturally- and clinically-adapted mHealth intervention with adult Thai diabetic patients and their community nurses, and 2) estimate the intervention's effect upon glycated hemoglobin (HbA1c), fasting blood glucose, self-management behaviors, and diabetes-related distress in uncontrolled type 2 diabetes. Thirty-six patients with poorly controlled type 2 diabetes (along with their regular nurses) will be recruited through an established community clinic network. After baseline clinical and behavioral assessment, patients will receive 12 weeks of automated 10-minute weekly Interactive Voice Response (IVR) calls to provide monitoring and self-management support related to glycemic symptoms, medication adherence, and several self-care behaviors. Patients' clinical nurse will receive weekly summaries of each IVR call by text message and email with guidance on Thai-appropriate best practices. Principal investigator will receive email whenever patients report a potentially urgent issue by IVR, i.e., symptoms of hypoglycemia, or inadequate supply of medication. Immediately after the 12-week intervention concludes, clinical and behavioral variables will be reassessed and a mixed-methods process evaluation will be performed.

Eligibility Criteria:
Inclusion Criteria:

For patients:

1. poorly controlled type 2 diabetes as indicated by HbA1c ≥ 7.5% recorded within past 6 months
2. aged 20 years and older
3. currently being treated by oral antihyperglycemic
4. communicates and reads in Thai
5. has access to and able to use a touch-tone phone (either a land line or a mobile phone)
6. free of major physical, cognitive, or psychiatric impairment (per medical records and PI discretion) that would prevent them from participating meaningfully in the intervention.

Inclusion criteria:

For nurses:

1. works in a non-communicable disease clinic.
2. can access email
3. has a mobile telephone.

Exclusion Criteria:

For patients:

1. have participated in other mHealth interventions within 3 months
2. have baseline HbA1c \< 7.5%
3. are hospitalized or otherwise at risk for hospitalization
4. are prescribed injected insulin
5. patients and nurses who participated in the usability trial will be ineligible to participate in the pilot trial.

Exclusion criteria:

For nurses: None
TSPO PET in the Evaluation of Neuroinflammation in Patients with Multiple System Atrophy

The aim of this study was to apply PET/MR techniques targeting TSPO to explore the temporal and spatial alterations characterizing neuroinflammation in MSA patients, and to assess its value as a biomarker for diagnostic typing, disease severity, and prognosis of MSA disease.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 35 years old, gender is not limited;
* Clinically confirmed MSA and clinically probable MSA according to the 2022 MDS MSA diagnostic criteria;
* all patients had been ruled out of polyQ disease by genetic testing;
* Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

* pregnancy or breastfeeding;
* contraindications to MRI examination or inability to cooperate in completing neuroimaging examination;
* previous history of other neurological disorders or presence of other organic intracranial lesions on neuroimaging that cannot be interpreted by MSA, such as epilepsy, trauma, tumors, or high-grade cerebral white matter degeneration (Fazekas grade 2 and above);
* History of alcohol or drug abuse
A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab

The main objective of this project is two-fold

1. to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity
2. to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment.

Specifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet.

Expected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments.


Eligibility Criteria:
Inclusion Criteria (group of SMC):

* \> 65 years old
* self-reported memory complaints
* score on Mini-Mental State Examination greater than or equal to 27/30 (normal range)

Exclusion Criteria:

* no evidence of objective impairments on the neuropsychological testing, scores on the Clinical Dementia Rating \< 0.5

Inclusion Criteria (group of MCI):

* \> 65 years old
* a self-reported (or reported by a caregiver) cognitive decline
* an objective impairment on the neuropsychological testing
* scores on the Clinical Dementia Rating \< 0.5.

Exclusion Criteria:

* no dementia
Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation

Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return of normal gut function Chewing gum has recently been used as a form of sham feeding to stimulate acceleration of gut function after abdominal surgery.

The investigators hypothesize that sham feeding with chewing gum will accelerate return of gut function after liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* elective liver transplantation surgery
* an ability to chew gum

Exclusion Criteria:

* emergency surgery
* age less than 18 years,
* inability to provide written informed consent
* an inability to chew gum
* hepaticojejunostomy
* sedated patients
* reintubated patients
* Glasgow Coma Scale \<13
* reoperation before gas out
* previous bowel surgery
Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome

The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).

After being informed about the study and potential risks, all participants will complete validated IC/BPS symptom questionnaires for baseline screening. Once participants meet eligibility requirements and give written informed consent they will be randomized in a 1:1 ratio to peppermint oil (200mg TID) or placebo (also TID). Participants will complete validated IC/BPS questionnaires and follow up surveys over 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 18-65 years old
* Diagnosed with IC/BPS for at least one month prior to study enrollment

Exclusion Criteria:

* Culture proven urinary tract infection within 1 month of randomization
* Gross hematuria
* Currently pregnant or breastfeeding
* Unable to speak and read English
* History of allergic reaction to peppermint, coconut or enteric coating
* History of malabsorption syndrome
* History of gastroparesis
* History of gastric bypass surgery
* History of gastrointestinal, genitourinary or pelvic cancer in the last 5 years
* History of insulin dependent diabetes
* History of active urinary stone disease
Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis

The aim of this study was to assess the effect of a specific protocol of sEMG-BFB in upper limb hemiparesis added to conventional physical therapy on changes in upper extremity functionality, motor recruitment pattern and range of motion (ROM) compared to the single application of conventional physical therapy. It aims to find a 22.22% difference between both interventions.

Upper limb hemiparesis is a common consequence after brain damage.

Objective: To evaluate the effect of a specific protocol of surface electromyographic biofeedback (sEMG-BFB) and conventional physical therapy in upper limb functionality, muscle recruitment changes, and glenohumeral range of motion compared to the single application of conventional physical therapy.

Design: randomized controlled clinical trial.

Sample: 40 participants from State Center of Attention to Brain Injury were recruited.

Interventions: Patients were randomly assigned to 2 groups where the experimental group received sEMG-BFB for the upper trapezius and middle deltoid muscles of the upper limb with hemiparesis and the control group received a placebo of the same technique. Both treatments were applied for 6 weeks. The score of the Fugl-Meyer Assessment-Upper Extremity" for functionality and shoulder range of motion were objectified. Root mean square (RMS) value was assessed as a secondary measure Data were collected before and after intervention.

A protocol of sEMG-BFB in upper limb may have an important role in the recovery of subjects with upper limb hemiparesis.

Eligibility Criteria:
Inclusion Criteria:

* acquired brain injury after two months of medical evolution at least;
* suffer paretic upper limb;
* spasticity no greater than 3 in the modified Ashworth scale;
* minimum active ROM of 20º of glenohumeral abduction.

Exclusion Criteria:

* peripheral nerve injury, fractures of upper limb, cervical radiculopathy, complete luxation of the shoulder and severe cognitive impairment.
Patient INformation About Options for Treatment - PINOT

This prospective observational study is designed to find out what treatment options new patients with chronic kidney disease learn about from their renal unit.

Aims: To determine the proportion of new CKD patients who receive information about treatment options prior to commencing dialysis, pre-emptive transplantation or conservative management. To determine the timing (i.e. patient's stage of disease) when information is given. To find out whether patients have a friend or family member with them when information is given.

Research Design and methods: This study is an assessment of CKD education practices. Nephrologists and pre-dialysis coordinators from each renal unit will complete questionnaires about information that was given to each new dialysis, pre-emptive transplant or conservatively managed patient that started treatment during a 3 month period.

Study hypothesis: Approximately one third of CKD patients will receive information after starting treatment. There will be a positive association between in-centre haemodialysis and later referral, non-English speaking background, and advancing age. Significance: The results from this national audit will provide Australian nephrologists and renal nurses with evidence about CKD education practices and compliance with clinical practice guidelines. The results may highlight opportunities for improvement in practice.

Additional research objectives and key research questions:

1. To determine the proportion of patients who receive information about: pre-emptive transplantation; peritoneal dialysis; home haemodialysis; centre based haemodialysis; supported non-dialytic care or conservative management.

3. To determine the proportion of incident patients that have a non-English speaking background (NESB) requiring an interpreter or translated materials.

4. To examine associations between age, gender, health insurance status, NESB, CKD stage and information provided on initial treatment commenced.

5. To determine the proportion of patients who choose not to dialyse.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending Australian adult or pediatric renal units
* Patients with Stage 5 chronic kidney disease commencing dialysis or having a pre-emptive transplant or with decision made for conservative care and eGFR \< 15ml/min/1.73m2 between 1st July and 30th September 2009

Exclusion Criteria:

* Patients with acute kidney injury not requiring chronic renal replacement therapy
* Patients with a failing kidney transplant returning to dialysis
Same Day Diagnosis of Extrapulmonary TB (TB Serositis and TB Meningitis).

Extrapulmonary TB (EPTB) accounts for nearly 30% of TB cases in HIV endemic settings, such as South Africa. The diagnosis of extrapulmonary TB is complicated by the poor performance of Gene Xpert and TB Culture in extrapulmonary fluid (30-50% sensitive), as well as the poor specificity of ADA. We can therefore not reliably use these tests to diagnose EPTB as effectively as we use them in sputum samples. The current best practice for diagnosing pleural TB is to perform a pleural biopsy, which is both invasive and costly. A rapid, easy to use test is needed to allow accurate and fast diagnosis of EPTB. Interferon-gamma is released at high concentrations in extrapulmonary fluid in active EPTB. Antrum Biotech has developed the IRISA-TB assay (validated and SAHPRA licenced) for the diagnosis of EPTB.

The study will assess the real-world performance of IRISA-TB compared to ADA, Gene Xpert, and TB Culture when used to diagnose EPTB. We will evaluate IRISA-TB's performance in the following patient groups:

* Suspected TB pleural effusion (n= 650)
* Suspected TB pericardial effusion (n= 280)
* Suspected TB peritonitis (n= 200)
* Suspected TB meningitis (n = 1040) As part of our evaluation, we will ask clinicians who treat these patients to provide their feedback on IRISA-TB. We will ask them to indicate to what extent the IRISA-TB test helped them to make treatment decisions. Finally, we will conduct an economic assessment to determine the true cost of diagnosing and treating EPTB to the health system and patients, and we will determine how IRISA-TB could potentially result in cost savings.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants 18 years and over attending health care facility with symptoms of TB.
2. Serosal or CSF fluid sample provided to NHLS with sufficient volume to perform SOC tests + 1ml.
3. Patients in whom extrapulmonary TB is part of the treating clinicians' differential diagnosis.

Exclusion Criteria:

1. Volunteers who refuse to sign informed consent and/or provide clinical details (Proxy consent will be obtained for participants who are incapacitated, with a follow up consent when they have recovered their capacity to consent)
2. Patients with current significant history of substance or alcohol abuse that may impact study visits.
3. Patients who are unable to communicate by telephone or who do not have a current active traceable contact number.
4. Patients not willing to undergo an HIV test.
5. Patients whose fluid sample volumes are insufficient to perform standard of care testing in addition to IRISA-TB
6. Positive sputum GXP within 2 weeks prior to serosal fluid or CSF sampling.
Assessment of Prevalence of Stress Urinary Incontinence During Pregnancy

Stress urinary incontinence is the most common type of incontinence during pregnancy.our study aims at determining the prevalence in the first and third trimesters and the associated risk factors.

The required sample size has been calculated using IBM© Sample Power© version 3 .The primary outcome measure is the prevalence of stress urinary incontinence (SUI) in the 1st and 3rd trimesters.

Accordingly, it is estimated that a sample of 240 patients in either study group would have a power of 80% (beta error, 0.2) to detect a statistically significant difference of 9% between the two groups as regards the incidence of SUI.

The incidence of SUI is assumed to equal 10% in the 1st trimester. The prevalence of SUI in the 3rd trimester is assumed to equal 10% under the null hypothesis and to equal 19% under the alternative hypothesis.

This calculation used a two-sided z test with a confidence level of 95% (alpha error, 0.05).

Data will be collected, tabulated, then analyzed using IBM© SPSS© Statistics version 22.

Normally distributed numerical data will be presented as mean and SD, and skewed data as median and inter-quartile range.

Qualitative data will be presented as number and percentage.Comparison of normally distributed numerical data will be done using the unpaired Student t test. Skewed data will be compared using the Mann-Whitney U test.

Categorical data will be compared using the chi-squared test, or Fisher's exact test when appropriate.

A two-sided p-value \<0.05 will be considered statistically significant .

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in first and third trimesters

Exclusion Criteria:

* Communication problems.
* Mental disturbances.
* Previous surgery for incontinence or other pelvic procedures.
Study of OT-101 in Treating Myopia

This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multicenter safety, tolerability, and efficacy study of atropine sulfate 0.01% (OT-101) as an investigational treatment for myopia in pediatric subjects

This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multi-center study to evaluate the safety tolerability and efficacy of OT-101 (Atropine 0.01%) Ophthalmic Solution in treating the progression of myopia in pediatric subjects that will enroll approximately 678 pediatric subjects with myopia in total. Subjects will be stratified by age and refractive error.

This study consists of 11 visits over the course of approximately 4 years and can be broken down in the 3 stages: Screening (Days -14 to -1), Stage 1 (Day 1 to Year 3), and Stage 2 (Year 3 to Year 4). In stage 1, subjects will be randomized in a 2:1 manner to OT-101 Ophthalmic Solution: Placebo. Subjects will be dosed with one drop of study treatment per eye once daily at bedtime for 3 years. In stage 2, subjects will be re-randomization 1:1 will occur at Visit 9 (Month 36). At re-randomization, subjects who had been assigned to OT-101 Ophthalmic Solution will be randomized in a 1:1 ratio to continue on OT-101 Ophthalmic Solution or switch to placebo. Subjects who had been assigned to placebo will continue with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of:

  1. myopia greater or equal to -1.00D of spherical equivalent
  2. astigmatism less than or equal to 1.50DC
  3. progression of at least -0.50D of spherical equivalent in the last 12 months;

     Exclusion Criteria:
* Have active or a history of chronic or recurrent episodes of ocular inflammation (e.g. moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis) in either eye;
* Have undergone any myopia control treatment including orthokeratology, rigid gas-permeable contact lenses, bifocal contact lenses, progressive addition spectacle lenses, or other lenses to reduce myopia progression in the previous 6 months. Myopic correction in the form of single-vision eyeglasses and/or single-vision soft contact lenses are allowed;
* Have undergone any form of refractive eye surgery including incisional keratotomy, photorefractive keratectomy \[PRK\], laser in situ keratomileusis \[LASIK\], laser-assisted sub- epithelial keratectomy \[LASEK\]), corneal inlay procedures, conductive keratoplasty, small incision lenticule extraction (SMILE), cataract extraction, or any form of intraocular lens implantation;