cyrilzakka/clinical-trials huggingface dataset:
Parkinson's Disease Registry

The purpose of the Parkinson's disease Registry (PDR) is to develop a nation-wide database of persons with Parkinson's disease (PD) in Taiwan.

Among degenerative neurological disease, PD is the second most common disorder. Although a wide range of incidence and prevalence rate exist in reviewed literatures due to a consequence of variation in study methodologies, the crude prevalence rate above 60 year-old is 1%. Increase in aging population will lead to an increase in PD patients. The PDR will be used to facilitate the understanding of basic epidemiological features of the disease, genetic and non-genetic risk factors, co-morbidity, the up-to-date treatment strategies and the related economic burden from medical and surgical treatment (deep brain stimulation), to develop new therapeutic protocols as well as healthcare policies, and ultimately, to improve the quality of life of PD patients. PDR will also be served as data bank for investigators in the field of PD to quickly identify and notify research subjects about other research studies for which they are eligible. Patient who registered can also sign their consent for a future brain donation after they passed away.

Methods:

The 4 main Tzu Chi Hospitals from Hualien, Da Lin, Taichung, and Taipei will serve as representative of pilot study for National registry. This will be a record-based, multi-center, nation-wide, cohort study. A user-friendly, yet, encrypted registration platform will be provided through internet for authorized personnel. The contents of PDR will be as follow: demographic features, risk factors, clinical profiles of diagnostic criteria, co-morbidity, images profiles, treatment regimens in details, prognosis, health-related quality of life, and neuropsychological assessment batteries.

Expected results:

1. To facilitate the understanding of demographic epidemiological features of PD.
2. To find the risk factors of PD and the possible intervention toward disease prevention in Taiwan.
3. To find the comorbidity of the disease, and the solution toward better treatment and related outcome.
4. Assess current treatment approaches and develop best-practice guidelines.
5. Tracking the health-related quality of life of PD patient as well as care-givers and the economic impact from different treatment regimens of best medications versus surgical interventions (neuromodulation / neuro-regeneration) from time to time.
6. Drive the development of innovative research projects.
7. Accelerate the process of informing patients of research projects for which they may be eligible.

Key words: Parkinson's disease, Registry, Epidemiology, Treatment, Prognosis

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease

Exclusion Criteria:

* None
Clinical Trial on Anti-inflammatory Effect of Low-Molecular Weight Heparin in Pediatric Cataract Surgery

The purpose of this study is to determine if intraocular infusion of low-molecular weight heparin (enoxaparin) influences postoperative inflammation following pediatric cataract surgery with intraocular lens (IOL) implantation.

Despite advances in cataract surgery in children, postoperative inflammation is a significant complication following pediatric cataract surgery. Any drug that prevents or decreases this inflammation would be beneficial.

Heparin has anti-inflammatory and antiproliferative effects as well as anticoagulant properties. Several studies on animal and adult human eyes show that adding heparin to the irrigating solution during cataract surgery results in less disturbance of the blood-aqueous barrier and helps prevent posterior capsule opacification (PCO).

A prospective, randomized, controlled and masked study is mandatory to evaluate the anti-inflammatory effect of Low-molecular weight Heparin for pediatric cataract surgery

Eligibility Criteria:
Inclusion Criteria:

* Children (0-15 years) with congenital cataract scheduled for surgery with IOL implantation and informed consent from the parents/legal guardian

Exclusion Criteria:

* Preoperative: Associated ocular anomalies (uveitis, microphthalmos, persistent fetal vasculature, aniridia, glaucoma, iris coloboma), traumatic cataract
* Intraoperative: Inability to implant IOL in the capsular bag, intraoperative complications- iris trauma, vitreous disturbance, descemet's detachment
Patient -Ventilator Interaction in Chronic Respiratory Failure

To evaluate a novel advanced physiological monitoring system to improve nocturnal non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD), Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn, will improve ventilatory failure, quality of life and reduce length of admission during initiation of therapy. We aim to incorporate this technology into routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over the age of 16 years.
2. Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome.
3. Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of \>6.0 kPa in the morning.
4. Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of \>6.0 kPa during the day.
5. No prior domiciliary ventilation.

Exclusion Criteria:

1. Patients with other co-morbidities e.g. cancer or cardiac failure.
2. Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease.
3. Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation.
4. Patients who have an abnormal bleeding tendency (INR or APTTr \>1.4 or platelets \<100).
5. Patients with a psychological, social or geographical situation that would impair compliance with the project.
Long Term Safety Study of PRALUENT

The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682).

The secondary objectives of the study were:

* To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C)
* To evaluate the effect of PRALUENT on other lipid parameters
* To evaluate the effect of PRALUENT on gonadal steroid hormones


Eligibility Criteria:
Key Inclusion Criteria:

Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug.

Key Exclusion Criteria:

1. Significant protocol deviation in the parent study (neurocognitive function study R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance
2. Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study R727-CL-1532 (NCT02957682).
3. Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study
4. Known hypersensitivity to monoclonal antibody or any component of the drug product
5. Pregnant or breastfeeding women

Note: Other inclusion/ exclusion criteria apply
Dabigatran Study in the Early Phase of Stroke. New Neuroimaging Markers and Biomarkers Study (SEDMAN STUDY)

SEDMAN study is a prospective multicenter investigator initiated study (IIS). The main idea is to look by Genome Wide Association (arrays that determine more than 1 million polymorphisms) genetic risk factors associated with response to dabigatran. To conduct the study, the goal is to recruit 300 patients with ischemic stroke with cardioembolic etiology treated with dabigatran and 200 treated with Acenocoumarol to determine if genetic risk factors are associated with the occurrence of any bleeding or vascular event in a year follow-up.

Data will be analyzed through GWAS analysis. The results will be analyzed by experienced genotypic bioinformatics: Plink, Haploview, STATA, IMPUTE2, SNPtest, GTOOL, Galaxy management. In addition, the investigators have support of Spanish Consortium for Genetics of Stroke (Genestroke). The PLINK software is the main program for the analysis of GWAS. Using this software we can clean the raw results of genotyping platforms and determine the presence of risk alleles associated with resistance to the study drugs. Haploview software will be used for data management and graphics for significance analysis. STATA statistical software is a data management and very useful for the creation of Q_Q plots graphs that assist in the interpretation of genotypic results. GTOOL, SNPtest and IMPUTE2 are software for data imputation and analysis of imputed data through the information available in the 1000 Genomes Project.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes who are ≥ 18 years of age
* Patients with stroke or TIA in last 14 days and a diagnosis of non-valvular atrial fibrillation who initiate treatment with dabigatran or classical ACOs (acenocoumarol) to prevent stroke or non-CNS systemic embolism.
* Patients with mild/moderate strokes (i.e. strokes less than 2/3 of vascular territory with initial ASPECTS on first CT/MRI \> 6 and NIHSS \<25).
* Patients who have an overall condition which allow the 12 months' follow-up.

Exclusion Criteria:

* Patients with an indication of oral anticoagulants for primary prevention or with an indication other than cardioembolic etiology.
* Patients with contraindications to use anticoagulants.
* Patients who do not wish to participate in the study and have not signed informed consent.
* Patients with non-controlled hypertension or hypertensive crisis will be also excluded.
* Patients with a life expectancy of less than one year.
* Patients with psychological or social factor which not allow a correct follow-up.
* Patients with severe/disabling strokes (i.e. more than 2/3 of vascular territory, NIHSS≥25).
Energy Expenditure in Weaning From Mechanical Ventilation

During weaning from mechanical ventilation process, the energy expenditure in T tube is greater than pressure support ventilation.

The energy expenditure (EE) was measured during the two periods of 30-minutes, with the 10 first minutes being discarded for analysis purposes. The other variables were recorded and monitored during the 10th and the 30th minute, in both pressure support (PS) and t-Tube (TT) modes. Patients were randomized in terms of sequence selection: PS - TT or TT - PS. In the baseline period, patients were receiving mechanical ventilation (Servo 900C and Servo 300; Siemens-Elema, Solna, Sweden), with PS ranging from 10 to 15cmH2O. During the PS mode, patients received assisted pressure ventilation of 10 cmH2O, 5 cmH2O of final positive expiratory pressure, the sensitivity of -1cmH2O and FiO2 of 0.4. During TT mode, oxygen flow was delivered in order to keep the same FiO2 that was provided in PS (0.4) as controlled by monitor screen (Datex Ohmeda S/5 - Compact Airway Module, M-COVX model, Finland). In this mode, an extensor was employed, one end of which was connected to the oxygen-enriched and the other end was secured to a 3-output ("T") connector, which was attached to the patient's ventilatory prosthesis. During the rest period (30 minutes), patients returned to the mechanical ventilation parameters utilized in the baseline period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute respiratory failure receiving MV for over 24 hours, in the ICU of the Hospital de Clínicas de Porto Alegre

Exclusion Criteria:

* Patients with chest drainage, hemodynamic instability (characterized by the use of vasoactive drugs), renal failure, mental status change, agitation, sudoresis, tachycardia, axillary temperature above 38°C and inspiratory oxygen fraction (FiO2) over 0.6.
The Effect of Sound Stimulation on Hearing Ability

In the late 1990s, researchers discovered that acoustic stimuli slow progressive sensorineural hearing loss and exposure to a moderately augmented acoustic environment can delay the loss of auditory function. In addition, prolonged exposure to an augmented acoustic environment could improve age-related auditory changes. These ameliorative effects were shown in several types of mouse strains, as long as the acoustic environment was provided prior to the occurrence of severe hearing loss.

In addition to delaying progressive hearing loss, acoustic stimuli could also protect hearing ability against damage by traumatic noise. In particular, a method called forward sound conditioning (i.e., prior exposure to moderate levels of sound) has been shown to reduce noise-induced hearing impairment in a number of mammalian species, including humans.

Interestingly, recent report has suggested that low-level sound conditioning also reduces free radical-induced damage to hair cells, increases antioxidant enzyme activity, and reduces Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically, increased cochlear sensitivity was observed when distortion product otoacoustic emissions (DPOAEs) and compound action potentials (CAPs) were measured.

In addition to forward sound conditioning, backward sound conditioning (i.e., the use of acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing ability against acoustic trauma and to prevent the cortical map reorganization induced by traumatic noise.

In this study, the investigators examine the effect of sound stimulation on hearing ability in human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Age between 20 and 70 years
* Subjects should be able to use an mp3 player

Exclusion Criteria:

* Hearing loss more than 70 dB HL at any frequency
* More than 10 dB of air-bone gaps at more than 3 frequencies in pure-tone audiometry
* Ear infections, chronic middle ear disease or any abnormality of the ear canal or ear drum
* Temporary hearing loss
* Hearing aid user
* Pregnant females
Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis Patients in Turkey

Development, feasibility testing and validation of a Survey Set to Measure Patient-Reported Outcomes among Hemodialysis Patients in Turkey: Creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in Turkish dialysis patients in clinical as well as in home care settings.

Individuals with chronic kidney disease represent a growing population in adult and pediatric practices. This has resulted in a drive to optimize patient care and outcomes. Historically, healthcare outcomes focused on morbidity, mortality or complication rates, but failed to provide meaningful data on the value of medicine to patients and the quality of life gained or lost. Several studies have revealed that treatments aimed at minimizing morbidity and mortality in end-stage renal disease (ESRD) have very often been ineffective. Therefore, attention to HRQOL among ESRD patients is crucial.

The aim of this pilot study is creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in Turkish dialysis patients. This questionnaire consists of the PROMIS Cognitive Function and Abilities Subset, the PROMIS-29, a new post-dialysis recovery time module, the MOS-Social Support Scale (MOS-SSS), Subscales of the KDQOL SF 1.3 (sexual function \& cognitive function), the General Self-Efficacy Scale and the Health Services Utilization And Productivity Loss Survey which are to be delivered together on a tablet computer.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated by study patient and investigator/authorized physician
* Age of 18 -80 years
* Ability to understand the nature and requirements of the study
* Literacy in Turkish including the ability to read with regards to visual acuity and the ability to understand what is read
* General ability to use a tablet (the study nurse will instruct the patient how to use the study-tablet during the conduct of the study)
* To be on stable maintenance hemodialysis (HD) for over 3 months (prevalent patients)

Exclusion Criteria:

* Any conditions which could interfere with the patient's ability to comply with the study
* Previous participation in the same study
* Participation in an interventional clinical study during the preceding 30 days
* Serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease, which causes life-expectancy less than a year,
* Acute cardiovascular events including myocardial infarction, stroke and unstable angina pectoris requiring hospitalization within the last 6 months,
* To have cognitive or mental co-morbidities which prevent reliable answering of questions
Bacterial Colonization After Tunneling in Femoral Perineural Catheters

Background: Bacterial colonization of peripheral nerve catheters is frequent, although infection is relatively rare. With central venous catheters, the tunneling of catheter into the subcutaneous tissue significantly decreases catheter colonization and catheter-related sepsis.

Purpose: The aim of this study is to evaluate the incidence of bacterial colonization in adult patients with femoral tunnelized perineural nerve catheters.

Methods: A total of 338 patients with femoral catheter will be included in the study. The patients will be randomized to be included in the control group (without tunnelling) or in the group with catheter tunneled 2-3 cm subcutaneously. After removal, catheter will be analyzed for colonization (primary outcome). Quantitative culture will be used as described by Brun-Buisson for intravascular catheters. The site of insertion will be monitored daily for any signs of infection (secondary outcome).

Perspective: To show the incidence of femoral perineural catheter colonization is low with subcutaneous tunneling


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo scheduled orthopaedic surgery performed with a femoral perineural catheter

Exclusion Criteria:

* Age under 18 years
* Local nerve pathology
* Refusal to regional anaesthesia
* Major psychological disorder
* Major cardiac conduction disease
* Infection at the puncture site
Impact of COX2 on Sera Biomarkers From Obese Subjects

Obesity promotes worse outcome for post-menopausal breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Post-menopausal as confirmed by medical history
* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee

Exclusion Criteria:

* Evidence of active cancer (patients with a prior history of malignancy are encouraged to participate, but due to cytokine levels associated with malignancy there must be no evidence of disease)
* Cachexia
* Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
* Chronic use of aspirin of omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
* Known hypersensitivity to aspirin and/or omega-3 fatty acids
* Actively receiving a physician-directed regimen of aspirin and/or receiving herapeutic/prophylactic anticoagulation
* Any aspirin or omega-3 free fatty acid supplementation within the last 14 days
* Subjects who are pregnant
* History of medical noncompliance
Drug Drug Interaction (DDI) Between Supaglutide and Digoxin or Metformin

This is a study of a drug drug interaction between Supaglutide and Digoxin or Metformin.

This is a single-centre, open labeled, fixed-sequence study designed to assess the pharmacokinetic effects of multiple subcutaneous injections of Supalutide on a single oral dose of digoxin or multiple oral doses of metformin. 32 healthy subjects are planned to be enrolled and allocated to 2 parallel trial groups, Digoxin combined with Sulpalutide injection (Group A) and Metformin combined with Sulpalutide injection (Group B), with 16 cases in each group, of which no less than 4 were of a single sex.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Chinese subjects.
2. Age between 18 and 45 years, inclusive.
3. Body mass index \[BMI = weight (kg)/height2 (m2)\] of between 20 and 28 kg/m2 (including thresholds), with male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg.
4. Subjects with no plan of pragnancy within the screening period up to 3 months after the last dose and who are voluntarily using contraception.

6. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Subjects with a previous or existing history of serious cardiac, hepatic, renal, gastrointestinal, neurological, psychiatric abnormalities and metabolic abnormalities.
2. Subjects with a previous or existing disease affecting the absorption, distribution, metabolism or excretion of drugs, such as active peptic ulcers or bleeding, history of ulcers or bleeding, acute and chronic pancreatitis, etc.
3. Subjects with a history or family history of C-cell tumours/carcinoma of the thyroid gland, or a previous history of thyroid insufficiency or thyroid hormone abnormalities
4. Subjects who have undergone major surgery within 4 weeks prior to screening which, in the judgment of the investigator, may affect this trial, such as gastric and duodenal surgery, cholecystectomy, nephrectomy, or removal of malignant tumours (except for previous appendectomy), or those who are scheduled to undergo major surgery during the trial
5. those with existing symptoms of unexplained infection.