cyrilzakka/clinical-trials huggingface dataset:
Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19

Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors for thrombosis.

Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors for thrombosis.

Randomization 1:1 - Group 1 will receive Apixaban 2.5mg twice daily vs. matching placebo (Group 2) for 30 days.

Primary Objective: To evaluate the clinical impact of a strategy of oral anticoagulation with apixaban comparing with placebo on the number of days alive and out of the hospital/emergency department (DAOH) through 30 days in outpatients with symptomatic SARS-CoV2 infection and risk factors for thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with symptomatic laboratory-proven diagnosis of COVID-19 (any exam that shows acute infection as positive PCR or IgM in a context of acute symptoms ≤ 10 days) AND
* Negative pregnancy test for women in child bearing period AND
* D-dimer level ≥ 2x ULN or
* C-reactive protein (CRP) ≥ 10 mg/L or
* At least two of the following risk factors:

  * d-dimer level ≥ULN
  * CRP ≥ULN
  * age ≥65,
  * diabetes,
  * chronic kidney disease stage 3
  * cardiopulmonary disease (for example, peripheral arterial disease, coronary artery disease, heart failure, chronic obstructive pulmonary disease),
  * history of PE/DVT,
  * nursing home/SNF resident or severely restricted mobility
  * Body mass index ≥30 kg/m2.

Exclusion Criteria:

* Age \< 18 years-old
* Patients with indication for full anticoagulation during inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis)
* Platelets \< 50,000 /mm3
* Use of acetylsalicylic acid \> 100 mg per day
* Use of P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor)
* Chronic use of NSAIDs
* Hypersensitivity to apixaban
* Creatinine clearance \< 30 ml/min
* Pregnancy or breastfeeding
* Patients contraindicated to anticoagulation (active bleeding, recent major surgery, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator)
* A history of hemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (AV) malformation, or aneurysm
* Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) (e.g. protease inhibitors, ketoconazole, Itraconazole) and/or use of P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort)
Tart Cherry Supplementation and Women's Bone Health Study

In spite of aggressive approaches to prevent and treat osteoporosis, it remains one of the most costly and debilitating diseases associated with aging. The pursuit of alternative approaches for preventing bone loss has included the investigation of a number of promising plant-based foods that can be incorporated into the diet. This project is an extension of our pre-clinical studies with tart cherry, designed to determine whether the findings from our animal study can be extended to humans. Thus, the purpose of this project is to investigate the dose-dependent effect of tart cherry juice consumption on biomarkers of bone metabolism in women, aged 65-80 years. The hypothesis to be tested is that three months of tart cherry supplementation will improve bone biomarkers in a dose-dependent manner. Moreover, these improvements in bone metabolism will correspond to a decrease in markers of inflammation and oxidative stress.

Tart cherries are an excellent course of phenolic compounds and anthocyanins, and in pre-clinical studies have been shown to prevent age-related bone loss. Based on these findings, this pilot study was designed to investigate the effects of three months of tart cherry juice supplementation on improving markers of oxidative stress and bone metabolism in older women. Women (n=30), aged 65-80 yrs, will be recruited for the study and randomly assigned to one of two doses of tart cherry juice (8 or 16 fl oz) per day prepared from a Montmorency cherry concentrate (King Orchards, Central Lake, MI). Study participants will complete two study visits to the Nutritional Sciences Clinical Research Center. At the first visit, informed consent will be obtained and relevant medical history and anthropometric measures will be taken by the research team. A blood draw will be performed to assess baseline, biochemical markers of bone metabolism and inflammation as well as indicators of oxidative status. A physical activity and food frequency questionnaire will be completed by each study participant. Whole body, hip and spine bone density (DXA) scan will be performed by certified bone densitometrist. A 3-month final visit will be scheduled for all study participants in which most of the procedures described at baseline (except DXA) will be repeated. Change in primary and secondary outcome measures (i.e., bone, inflammation and oxidative stress biomarkers) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Women, 65-80 years of age
* Capacity to give informed consent

Exclusion Criteria:

* Hormone replacement therapy in the 3 months prior to starting the study
* Bisphosphonates in the 3 months prior to starting the study
* Raloxifene in the 3 months prior to starting the study
* Intermittent parathyroid hormone in the 3 months prior to starting the study
* Growth hormone or steroids in the 3 months prior to starting the study
* Osteoporosis
* Renal disease
* Cancer
* Cardiovascular disease
* Diabetes
* Respiratory disease
* Gastrointestinal diseases
* Liver disease
* Other chronic conditions that could affect bone metabolism
Procedural Learning in Participants With ADHD

Skill acquisition refers to the process of improvement of performance following practice experience. This process is the basis for generation of a long-lasting memory. Individuals with Attention Deficit Hyperactivity Disorder (ADHD) have been shown to be impaired on some performance aspects of previously learned skills, an impairment that is often ameliorated, at least temporarily, by psychostimulant medication (the standard therapy in ADHD). The proposed study aims to define the course of learning and of generation of long-term memory consolidation in individuals with ADHD, and to essay the effectiveness of psychostimulant medication on both the learning and retention of the skills.

Skill Acquisition and the Evolution of Long Term Procedural Memory in participants with ADHD: The Effect of Methylphenidate

Eligibility Criteria:
Inclusion Criteria:

* Full scale IQ score of 85 or above
SLMAP and EPO Genetic Polymorphism in Diabetic Retinopathy

A case-control study to assess the association between the risk of diabetic retinopathy in Egyptians and genetic polymorphism of both EPO and SLMAP genes.

Traditional environmental risk factors, such as glycemic control and duration of diabetes, failed to fully explain why some individuals remain protected while others progress to severe diabetic retinopathy.

Several studies suggest variations in diabetic retinopathy prevalence depending on racial background and genetic polymorphism.

Eligibility Criteria:
Inclusion Criteria:

* Age \>30-60
* Type 2 DM
* Duration of diabetes from 5-10 years
* Egyptian patients

Exclusion Criteria:

* Other ophthalmic diseases not related to diabetes
The Correlation of Myodural Bridges to Biomechanical Parameters in Patients Suffering From Primary Chronic Neck Pain

In recent years, an anatomical connection of suboccipital muscle fibers to the dura has been found in pathological studies. The physiologic function of these fibers is still unknown. Using Magnetic Resonance Tomography (MRI), this study will investigate whether these fibers undergo changes in patients suffering from primary chronic neck pain. In addition, the biomechanical parameters of neck movements in these patients will be correlated with the imaging findings.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Neck Pain

Exclusion Criteria:

* Have undergone cervical spine surgery
* Known cerebral vascular disease of the carotid or vertebral arteries
* Malignant disease of the cervical spine
CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact

The eCMP Pilot aims to study the feasibility and potential effectiveness of an electronically-mediated CardioMetabolic Program (eCMP) for therapeutic lifestyle change among adults with or at high risk for type 2 diabetes, heart disease, and/or stroke.

The eCMP is an evidence-based lifestyle intervention using a holistic, mind-body-spirit-based, and multidisciplinary approach, and it will be delivered using existing web and mobile technologies. In this pragmatic randomized controlled trial, participants will be recruited from primary care patients of an integrated ambulatory care system. They will be randomly assigned to receive the eCMP upon completion of baseline data collection (the Immediate Intervention group) or after 3 months (the Delayed Intervention group). All participants will be assessed at 0, 3 and 6 months. Outcomes include common cardiometabolic risk factors (e.g., weight, blood pressure, and fasting plasma glucose), health behaviors (e.g., dietary intake and physical activity), and indicators of eCMP engagement and adherence (e.g., attendance and self-monitoring).

Eligibility Criteria:
Inclusion Criteria:

* English-speaking adults aged 18+ years
* High-risk primary prevention: BMI 35+ and prediabetes (including hx of gestational diabetes) and/or metabolic syndrome
* Secondary prevention: BMI 30+ and type 2 diabetes and/or cardiovascular disease
* Able and willing to provide written informed consent

Exclusion Criteria:

* Medical determination that the study is inappropriate or unsafe for the patient
* Type 1 diabetes
* Safety concerns related to significant physical or mental health issues or life expectancy of less than 12 months
* Currently pregnant or lactating
* No regular telephone or broadband Internet access or otherwise unable to participate in the intervention
Bacterial Transmission Dynamics Study

Infections with multiply antibiotic-resistant bacteria represent a major cause of preventable morbidity and mortality amongst hospitalized neonates worldwide. In Southeast Asia, where antibiotic-resistance is a major problem, Gram-negative bacteria account for the majority of such infections. The most common pathogens are Acinetobacter spp., Pseudomonas aeruginosa, Enterobacter spp., Escherichia coli and Klebsiella pneumonia. The great majority of infections with these pathogens represent asymptomatic carriage, though in the absence of routine screening for asymptomatic carriage reliable estimates of the prevalence, rates of transmission between patients, and rates of importation from the community are lacking. Moreover, current understanding of the degree and manner in which different antibiotics act to select for such resistant organisms is rudimentary.

Objectives: To quantify the prevalence of drug-resistant Gram-negative pathogens on admission to a neonatal intensive care unit and during subsequent days of hospital stay. To quantify rates of patient-to-patient transmission for key organisms, to characterize how patient antibiotic use impacts on the ward-level dynamics of such organisms.

Methods: All infants admitted to the unit over a period of one year for whom the parent/guardian gives informed consent will be included. In addition to routine demographic and clinical data for included patients, full patient-level data on antibiotic use within the ward will also be recorded. Carriage of resistant Gram-negative organisms will be determined though rectal swabs, tracheal aspirates (for ventilated patients) and stool samples taken on admission and at twice weekly intervals. Antibiotic-resistant Gram-negative bacteria will be cultured and their resistant patterns determined. Selected environmental surfaces will also be sampled to detect contamination with such organisms. For the most important organisms (Acinetobacter spp. and Klebsiella spp.) whole genome sequencing will be used in conjunction with Bayesian data augmentation techniques to determine transmission pathways and the impact of antibiotic use on the transmission and persistence of such organisms within the hospital ward.

Eligibility Criteria:
Inclusion Criteria:

* All neonates admitted to QSNICH NICU
* Parent/legal guardian gives written informed consent

Exclusion Criteria:

• There are no exclusion criteria for this study
Effect of Nurse-Led Individualized Follow-Up Intervention on Patients With Nasopharyngeal Carcinoma

The incidence of nasopharyngeal carcinomas (NPCs) is highly unbalanced around the globe, primarily concentrated in East and Southeast Asia.There is no well-conducted, larger randomized controlled trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of recurrence, good management of symptoms and cost-effectiveness. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored symptom management program will significantly reduce reported symptoms among NPC patients following primary treatment compared to physician-led scheduled follow-up. Additionally, the investigators will assess patient activation (self-management), anxiety, depression, fear of recurrence, work abilities, recurrence times, changes in health behavior, and health care utilization and costs for the two arms of the study.

A nurse-led education program focused on symptom management is provided to patients, along with an electronic platform to report symptoms to nurses and support in symptom management.

It is planned to recruit 250 primary NPC patients from Fujian Cancer Hospital's Oncology Departments during an 18-month period, after completing the chemoradiotherapy for NPC. You will participate in a five-year study in which you are randomly assigned to either the nurse-led intervention or the physician-led intervention. Regardless of group assignment, you will follow the national nasopharyngeal carcinoma screening program.

Both the control and intervention arms will use questionnaires, clinical databases, and national registers to collect data for 5 years after inclusion both in the control and intervention groups. The primary and secondary outcomes are measured using questionnaires in both groups, whereas Patient Reported Outcomes (PRO) are collected only in the intervention group. Relapsed patients will not be asked to complete the remaining outcome questionnaires or PROs since they quit the follow-up program to pursue recurrent treatment. If PROs reveal a need, or if the patient requires consultation, the nurse or project physician will be consulted.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent;
2. Have completed radiotherapy treatment for loco-regional nasopharyngeal carcinoma without clinical sign of distance metastatis;
3. Aged 18 years and above;
4. Expected survival ≥6 months;
5. Read, understand Chinese characters and speak Mandarin.

Exclusion Criteria:

1. Previous history of other malignancies, mental illness or cognitive impairment (MMSE score \< 27 points);
2. Unstable medical or psychiatric conditions
3. Inability to communicate effectively in mandarin
4. Pregnant women or lactating women.
Night-time Compression Systems for Breast Cancer Related Lymphedema

Women who have undergone breast cancer surgery may develop swelling of the arm on the side the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This study will examine night-time compression system garments for lymphedema. Our objective is to determine if breast cancer survivors are willing and able to use the garment overnight to help control their lymphedema. Thirty breast cancer survivors from Alberta will be enrolled in the 24-week long study. Measurements will be taken of each arm to assess the extent of lymphedema and to measure changes over the study period. We will also examine other outcomes such as the impact of the night-time compression system garment on sleep. The study will provide important information on the feasibility of night-time compression system garments as a self-management strategy for lymphedema.


Eligibility Criteria:
Inclusion Criteria:

1. Women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 10% and maximum 40% increase in arm volume over the unaffected arm (mild to moderate lymphedema).
2. Patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization.
3. Patients must have their own fitted compression garment for daytime maintenance.
4. No past or current use of a night-time compression system for maintenance. Those patients who have trialed a night-time compression system in the past year must observe a six-month washout period before entering the trial.

Exclusion Criteria:

1. Clinical or radiological evidence of active disease, either local or metastatic.
2. History of contralateral breast cancer and axillary surgery.
3. Serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow-up.
4. Patients for whom compression is contraindicated.
5. Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
6. Unable to comply with the protocol, measurement and follow-up schedule.
Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases

Elderly people usually have systemic diseases and take medications that can cause dry mouth. The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in geriatric population with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.

A pre-post test trial was conducted in 120 elders with xerostomia. All subjects received a total of 50 ml (10ml x 5 times) OMJ per day. Subjective and objective dry mouth scores, salivary pH, buffering capacity and satisfaction were monitored at 2 weeks and 1 month use, compared to baseline. The data were analyzed by Repeated Measure ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Have systemic diseases such as hypertension or diabetes mellitus and take medications that can cause dry mouth
* Report symptoms of dry mouth

Exclusion Criteria:

* Subjects with uncontrolled systemic diseases
* Subjects who aspirate upon eating
* Subjects who smoke
* Subjects who are allergic to component of the intervention
Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients

This is a prospective phase II study of peri-operative docetaxel plus laparoscopic radical prostatectomy in patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate and a risk of relapse after radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years and less than 70 years
* Histologically-proven Gleason 7 adenocarcinoma of the prostate
* pT2a or pT2b disease based on biopsies of the prostate
* More than 2/3 of positive biopsies or 15 ≤ serum PSA \<20
* No previous carcinoma, except basal-cell carcinoma of the skin
* Adequate renal function: measured or calculated creatinine clearance\> 60 ml/min
* Absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value
* Signed informed consent.

Exclusion Criteria:

* Patients infected by the Human Immunodeficiency Virus (HIV)
* Contra-indication to general anesthesia or surgery
* Patients who do not fit inclusion criteria
Lateralization After IntraMedullary Nailing of InterTrochanteric Hip Fractures, Clinical and Radiographic Outcomes

Intertrochanteric fractures are commonly stabilized using an intramedullary nail with a lag screw that enters the lateral cortex of the femur. This lag screw commonly protrudes during the healing process and may cause implant related pain. This study will help determine if implant related pain is different depending to the lag screw design.

This study compares cephalomedullary fixation of intertrochanteric femur fractures using the Arthrex Hip Nail System with a telescoping lag screw compared to the Zimmer Natural Nail and the Smith and Nephew InterTan. This pilot study will evaluate radiographic outcomes and lateral sided hip pain related to different lag screw designs used for patients with intertrochanteric femur fractures by comparing outcomes of patients receiving 3 different lag screws The primary objective of this study is to compare pain at the level of the lag screw of patients with collapsible lag screws compared to patient who received a standard lag screw using a numeric rating scale on a 0-100 scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal to 22 years of age who undergo treatment of an intertrochanteric hip fracture with an intramedullary nail.
* Fluoroscopic views of the final fixation construct or a post-operative radiograph taken within 24 hours must be available.

Exclusion Criteria:

* Non-ambulatory prior to injury (patient must do more than only transfers)
* Cognitive deficiencies that prevent the patient from providing their own informed consent
* Inability to follow-up at the discretion of the investigator (incarceration, moving out of area, no permanent housing)
* Prior fracture to injured hip
* Prior surgery to injured hip
* Basi-cervical fracture pattern (fracture that begins above the lesser trochanter and exits medial to the greater trochanter)
* Patients not treated within 48 hours of admission
* Chronic or acute infection at site of surgery
* Language barrier preventing completion of study forms in English
* Open fracture
* Fracture related to neoplasm