cyrilzakka/clinical-trials huggingface dataset:
Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation

This is a prospective, randomized, open-label, blinded end-point evaluation trial. The patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and end-stage renal disease (ESRD) .

This is a multicenter study in adult patients with AF and ESRD who are on hemodialysis and who have stroke risk factors making them candidates for oral anticoagulation. Patients will be randomized to apixaban versus warfarin, and will be treated for up to 15 months.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age at least 18 years, or the local age of consent, whichever is greater.
* Patients with AF defined as AF on ECG at enrollment or two or more reports of AF from separate monitoring events at least 2 weeks apart (report of ECG, Holter monitor, event monitor or implantable loop recorder).
* CHA2DS2-VASc score of ≥ 2.
* End-stage renal disease treated with hemodialysis for ≥ 3 months.
* Considered by the treating physician(s) to be candidate for oral anticoagulation.
* If of childbearing potential, be willing to avoid pregnancy during the study.

Exclusion Criteria:

* Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin \< 8.5g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban)
* Moderate or severe mitral stenosis
* Conditions other than AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism
* Need for aspirin at a dose \> 81 mg a day or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)
* Life expectancy \< 3 months
* Anticipated kidney transplant within the next 3 months
* Prisoners or others who are involuntarily incarcerated or detained
* Pregnant, breastfeeding, or considering pregnancy.
* Participation in a clinical trial of an experimental treatment within the past 30 days
Propensity Score Matched Comparison of HMP vs. SCS in Kidney Transplantation

Hypothermic machine perfusion (HMP) is considered superior to static cold storage (SCS) in kidney transplantation, but the true benefit in the real-world experience remains incompletely understood.

The aim of our study is to investigate the real-world impact of HMP on kidney graft function after deceased donor kidney transplant in an HMP cohort propensity score matched with SCS.

Propensity score matching will be based on CIT, ECD, gender mismatch, CMV mismatch, re-TX and ET-senior program with a caliper of 0.05


Eligibility Criteria:
Inclusion Criteria:

* single kidney transplantation from a deceased donor at Medical University of Innsbruck between 08/2015 and 12/2019

Exclusion Criteria:

* combined kidney transplantation with an other organ
* living donor kidney transplantation
Rapid Improvement of Depression of Fluoxetine Combined With ATP

The clinical study is a randomized (1:1:1), double-blind, placebo-controlled clinical study. Recruit patients with moderate to severe depression. After signing the informed consent, patients who meet the inclusion criteria will be randomly assigned to the ATP group (fluoxetine combined with ATP) or phosphocreatine group (fluoxetine combined with phosphocreatine) or control group (fluoxetine combined with 0.9% sodium chloride) to received treatment. Then accessed scale, cognitive function and brain function before treatment and at one, two, and four weeks after treatment to initially explore the safety and efficacy of ATP combined with fluoxetine to rapidly improves moderate to severe depression.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-V diagnostic criteria for moderate to severe depression.
* HAMD-24 scores ≥ 20.
* 18-65 female or male.
* Subjects who have not used any antipsychotic drugs, antidepressants, mood stabilizers (sodium valproate, lithium carbonate) or fluoxetine treatment within the first month prior to the start of this study
* Written informed consent.

Exclusion Criteria:

* Sufferring from various major mental disorders other than depression (such as bipolar disorder, schizophrenia, personality split, etc.).
* Individuals with neurological disorders such as dementia.
* Individuals with a high risk of suicide.
* Pregnant and lactating women.
* Individuals with alcohol or drug abuse or dependence within one year prior to the start of this study.
* Contraindications to MRI.
* Physician evaluation was not suitable for participants in this study.
Full-scale Intervention Study: Genetic Risk Communication and Wearables

Background: Communication of information about risk of type 2 diabetes (T2D) alone has not been associated with changes in habitual behaviors among individuals of European ancestry. In contrast, the use of wearable devices that monitor physical activity (PA) has been associated with changes in behavior in some studies. It is uncertain whether risk communication might enhance the effects of wearable devices. We aim to assess the effects on wearable-device-measured PA of communicating genetic risk for T2D alone or in combination with goal setting and activity prompts from a wearable device among overweight or obese East Asians.

Methods: In a parallel group, randomized controlled trial, a total of 355 overweight or obese East Asian individuals aged 40-60 years will be allocated into one of three groups: 1 control and 2 intervention groups. Blood samples will be used for estimation of T2D genetic risk and analysis of metabolic risk markers. Genetic risk of T2D will be estimated based on 113 SNPs associated with T2D among East Asians using an established method. All three groups will receive a Fitbit device. Both intervention groups will be given T2D genetic risk estimates along with lifestyle advice, but one of the intervention groups will additionally use Fitbit's step-goal setting and prompt functions. Questionnaires and physical measurements will be administered at baseline, immediately after intervention delivery, and 6 and 12-month post-intervention following standard operating procedures. The primary outcome is time spent in moderate-to-vigorous PA measured through the Fitbit. Secondary outcomes include other parameters of wearable-device-measured PA, sedentary time, and sleep, body mass index, systolic and diastolic blood pressure, five intermediate metabolic risk markers, hand grip strength, self-reported PA, self-reported fruit and vegetable consumption and smoking status, and a list of psychological variables.

Discussion: This study will be the first randomized controlled trial using the combination of communication of T2D genetic risk with standard functions of wearable devices in any population. Findings will inform strategies to prevent T2D through lifestyle modification.


Eligibility Criteria:
Inclusion Criteria:

* East Asian ancestry
* Aged 40-60 years
* overweight or obese (i.e. measured BMI ≥23 kilograms/meters2 according to the WHO BMI-defined cut-offs for Asians)
* Able to perform daily-living physical activity
* using English/Chinese and a smartphone in Hong Kong

Exclusion Criteria:

* have been diagnosed with any type of diabetes
* pregnant or lactating
* unable to perform daily-life physical activities (determined through Physical activity Readiness Questionnaire \[PAR-Q\])
* participating in another research study or exercise programs
* had experience of genetic testing
* and/or cannot comprehend English/Chinese (i.e., sole language medium for the study).
Effectiveness of Adjuvant Supplements Prior to in IVF

To investigate the effect of combined DHEA, CoQ10 and tocotrienol on IVF cycles in poor ovarian responders

Background There is a trend for delayed marriage and childbearing worldwide. Women undergoing in vitro fertilization (IVF) cycles are getting older. Women with advanced age are more likely to be poor ovarian responders (PORs) who have poor prognosis in IVF cycles. Numerous studies have shown that DHEA supplementation may improve IVF outcomes in PORs. Additionally, due to poor prognosis of PORs, it is quite common to combine multiple therapies instead of just one treatment. Some studies showed that CoQ10 and tocotrienol are beneficial for fertility. Thus, the aim of this study is to investigate the effect of combined DHEA, CoQ10 and tocotrienol on IVF cycles in PORs.

Objective To investigate the effect of combined DHEA, CoQ10 and Tocotrienol on PORs undergoing IVF cycles

Methods The study will be conducted from March 1st, 2022 to December 31st, 2023 in our reproductive center. We plan to enroll 120 PORs undergoing IVF cycles and divided them into four groups: (1) DHEA (n=30): 75 mg DHEA supplementation per day for three months; (2) DHEA + CoQ10 + Tocotrienol (n=30): 75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for three months; (3) Control: no supplementation. Basic characteristics, infertility history, hormone profiles and ovarian reserve will be recorded. We will recheck serum levels of DHEA-S, FSH and AMH after DHEA supplementation. Then, during the IVF cycles, cumulus cells will be collected after oocyte retrieval to analyze genes expression and mitochondrial function. We will follow reproductive outcomes after embryo transfer.

Outcome The effect of combined DHEA, CoQ10 and Tocotrienol on cumulus cells and IVF outcomes in PORs

Eligibility Criteria:
Inclusion Criteria:

* Age 35\~44
* BMI18\~30 kg/m2
* Diminished ovarian reserve (AFC\<5, AMH\<1.2 ng/ml)

Exclusion Criteria:

* Primary ovarian insufficiency
* Congenital uterine anomaly
* Severe intrauterine adhesion
* Severe male factor
* Chromosome anomaly
* Malignancy
* Donor cycle
* having supplementation within 3 months
Clinical and Biological Strokes Collection in Reunion Island

Cross-sectional regional multicenter hospital study of all neurological events (stroke, AIT and mimics) for diagnostic and prognostic purposes. Cost of illness study.


Eligibility Criteria:
Inclusion Criteria:

* affiliated to a social security scheme
* clinical signs suggestive of stroke : hemiparesis or hemiplegia, unilateral sensory disorder, language disorder, balance disorder, dizziness, loss of total or partial bilateral or monocular vision, sudden neurological deficit

Exclusion Criteria:

* current pregnancy
* Recent clinical history of head trauma
* patients aged \< 18 years old
* patient under guardianship or curatorship
* Person deprived of liberty
1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis

Background: Statins are the recently evolved agents that aid in periodontal regeneration and ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2% SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic periodontitis.

Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV, SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic defect depth reduction was evaluated using computer-aided software at baseline, 6 months and 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe CP subjects with PD ≥ 5 mm or clinical attachment level (CAL) ≥ 4 mm and vertical bone loss ≥3 mm on intraoral periapical radiographs and no history of antibiotic or periodontal therapy in the preceding 6 months

Exclusion Criteria:

* Individuals with systemic diseases known to alter the course of periodontal disease and treatment outcome, known or suspected allergy to the SMV/ATV/statin group, those on systemic SMV/ATV/statin therapy, individuals with aggressive periodontitis, use of tobacco in any form, alcoholics, individuals with diabetes, immunocompromised individuals, and pregnant or lactating females
Prediction Frozen Shoulder Validation

Background: Few studies have examined the predictors of the clinical course of subjects with frozen shoulder syndrome or explained the persistence of symptoms after appropriate therapy. Altered shoulder kinematics may predispose subjects to subacromial impingement, rotator cuff tendonitis, altered shoulder joint forces, and possible degenerative changes. Subsequently, a more difficult and chronic course of frozen shoulder syndrome may develop.

Objective: The purposes of this study are: (1) to develop a prediction method for determining altered shoulder kinematics and associated muscular activities which are associated with the chronicity of frozen shoulder dysfunction, and (2) to validate this prediction method and analyze the impact of the method on clinical behavior.

Design: For the first year, a prospective study will be conducted to develop a prediction method that will identify impaired shoulder kinematics associated with the degree of symptom-related functional disability in patients with frozen shoulder syndrome. For the second and third years, validation of the proposed prediction method will determine whether altered shoulder kinematics and associated muscular activities subject to intervention meet the prediction criteria and demonstrate improvement in their follow-up, which will be shown to improve decision making in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* 50% loss of passive movement of the shoulder joint relative to the nonaffected side, in 1 or more of 3 movement directions (i.e., forward flexion, abduction in the frontal plane, or external rotation in 0° of abduction);
* 13-15 and duration of complaints of at least 3 months.

Exclusion Criteria:

* a history of stroke with residual upper-extremity involvement,
* diabetes mellitus,
* rheumatoid arthritis,
* rotator cuff tear,
* surgical stabilization of the shoulder,
* osteoporosis, or
* malignancies in the shoulder region.
* subjects who had pain or disorders of the cervical spine, elbow, wrist, or hand, or who had pain radiating from the shoulder to the arm, were also excluded.
Walking With Overground Robotic Exoskeletons to Improve Arrousal in Individuals With Disorders of Consciousness

This proposed study will examine a walking intervention to promote changes in conscious state in individuals with disorders of consciousness (DoC) due to acquired brain injury (ABI). Recent practice guidelines highlight the need to develop interventions to arouse patients with DoC, as current treatment options are scarce with limited to low-quality pharmaceutical and electrical stimulation approaches to improve outcomes. New data indicates patients with chronic DoC may benefit from therapeutic intervention prioritizing repeated multimodal sensory (i.e., simultaneous vestibular, proprioceptive, and visual) input, but likely not attain comparable functional recovery to those who demonstrate early command following ability. Interventions activating pathways of the cerebral consciousness network may leverage a substrate for recovery. We hypothesize that walking in an overground robotic exoskeleton (ORE) is safe, feasible, and will simultaneously stimulate endogenous cognitive and automatic pathways associated with walking5 to promote changes in behavioral performance in individuals with DoC.

The objective of this study is to evaluate the safety, feasibility and tolerability of using ORE therapy with individuals who meet criteria for DoC during inpatient rehabilitation while evaluating changes in behavioral performance, neurophysiology, and physiologic response to training. DoC numbers are very small so our goal is to gather this pilot data to support a future multi-site efficacy study with other TBIMS Center partners.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with DOC who are receiving inpatient rehabilitation

Exclusion Criteria:

-
Impact of Mobile Phone Texting Service to Support Weight Loss

This study evaluates the efficacy of a mobile telehealth short message service as a facilitator for weight management. Half of the participants will receive a standard care weight management group intervention, while the other half will receive daily text messages via their mobile phone to help facilitate weight loss. It is hypothesized that the intervention group receiving text messages will be as successful as the control group at achieving weight loss over a 3-month period.

Obesity, a chronic progressive disease, has become a major public health concern due to its increasing prevalence and association with many adverse health conditions including type 2 diabetes, many cancers and heart disease. The number of individuals requiring weight management intervention is increasing necessitating the need to explore other initiatives.

Developments in health technology are growing in popularity and there is increasing evidence that this type of intervention for obesity can significantly improve clinical outcomes. Mobile phones are a popular means of communication that provide a convenient, inexpensive means to deliver a health technology intervention.Short message service (SMS) by mobile phone has the potential to serve as an intervention medium to promote weight loss that is accessible and easy to use.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \> 35kg/m requiring to lose weight for an operation or having a co-morbidity including diabetes, osteoarthritis, high cholesterol, asthma, heart disease, high blood pressure or sleep apnoea or with a body mass \>40kg/m with no co-morbidities.
* Own a mobile phone
* Have the ability to use short message service
* Have access to weighing scales
* Mentally capable of informed consent
* Have the ability to read and speak English

Exclusion Criteria:

* Uncontrolled Hypothyroidism
* Poorly controlled psychiatric illness
* Current alcohol or drug abuse
* Learning disability
* Do not own a mobile phone
* Do not have access to weighing scales
* Does not have the ability to read or speak English
Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices

The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.This study is a randomized controlled trial. The purpose of the study is to evaluate the efficacy and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Eligibility Criteria:
Inclusion Criteria:

* 18 y.o. ≤age≤75 y.o.;
* Diagnosis of esophageal gastric varices by gastroscopy;
* Cirrhotic gastroesophageal variceal bleeding underwent endoscopic injection of tissue adhesive;

Exclusion Criteria:

* age \<18 y.o. or age \> 75 y.o.;
* Never had the variceal bleeding episode before;
* Do not have endoscopic injection of tissue adhesive;
* The cefotiam contraindications: such as allergies, pregnancy etc;
* combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment);
* Known infection before endoscopic treatment (Fever, microbial cultures positive, et al.);
* Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics;
* Acute variceal bleeding within 5 days;
* Refuse to participate
Contrast-enhanced 3D T1-weighted Gradient-echo Versus Spin-echo 3 Tesla MR Sequences in the Detection of Active Multiple Sclerosis Lesions

Gadolinium-enhanced magnetic resonance imaging (MRI) is currently the imaging gold standard to detect active inflammatory lesions in multiple sclerosis (MS) patients. The sensitivity of enhanced MRI to detect active lesions may vary according to the acquisition strategy used (e.g., delay between injection and image acquisition, contrast dose, field strength, and frequency of MRI sampling). Selection of the most appropriate T1-weighted sequence after contrast injection may also influence sensitivity. Several clinical studies performed at 1.5 Tesla have shown that conventional 2D spin-echo (SE) sequences perform better than gradient recalled-echo (GRE) sequences for depicting active MS lesions after gadolinium injection. As relates to MS, 3.0 Tesla systems offer some advantages over lower field strengths, such as higher detection rates for T2 and gadolinium-enhancing brain lesions, an important capability for diagnosing and monitoring MS patients. Recent studies have shown that at 3 Tesla, 3D GRE or 3D fast SE sequences provide higher detection rates for gadolinium-enhancing MS lesions, especially smaller ones, than standard 2D SE, and better suppress artefacts related to vascular pulsation. However, the comparison of the performance of 3D GRE versus 3D SE sequences has not been investigated yet.

Objectives To compare the sensitivity of enhancing multiple sclerosis (MS) lesions in gadolinium-enhanced 3D T1-weighted gradient-echo (GRE) and turbo-spin-echo (TSE) sequences.


Eligibility Criteria:
Inclusion Criteria:

* Equal or more than 18 years of age
* Able to provide written informed consent.
* Known central nervous system inflammatory disease
* Magnetic Resonance exam needed for evaluation after a clinical event in the last 3 weeks

Exclusion Criteria:

* Current treatment with dimethylfumarate (Tecfidera®), natalizumab (Tysabri®) or fingolimod (Gilenya®)
* Contraindications either to 3 Tesla Magnetic Resonance Imaging (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency).
A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy

The objective of the SAMISEN study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral).

The main objective of this registry is to collect data on the safety and performance of the new motorized PowerSpiral device during Post-market Clinical Follow-up. It is assumed that the new device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes.

As clinical performance and efficacy is equally important for the user this study also collects efficacy and handling data of the new device.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Patients with small bowel disease indicated for deep enteroscopy

Exclusion Criteria:

1. Age under 18 years
2. Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
3. Any contraindication to standard enteroscopy
4. Concurrent participation in another competing clinical study
Microcirculatory Assessment in Patients With Trauma and Severe Burns

Predict the development of multiple organ failure in patients with trauma and severe burns.

Microvascular alterations are frequently seen in patients with sepsis, trauma, burns and those who are hemodynamically uncompensated(Shock).

The use of the Microscan is a non-invasive approach to visualize and assess impaired mucosal microcirculation in order to identify early on patients who are predisposed for MOF (multiple organ failure)

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe burns/trauma ages 19-80. Patients undergoing elective abdominal or cardiothoracic surgery ages 19-69 years old

Exclusion Criteria:

* Patients undergoing elective surgery \< 19 years old.