cyrilzakka/clinical-trials huggingface dataset:
Use of Continuous Passive Motion in the Post-Operative Treatment of Intra-articular Knee Fractures

Decreased range of motion is common after fractures around the knee and can impact a patient's ability to perform activities of daily living such as rising from a seated position or getting in and out of a bathtub. A continuous passive motion (CPM) machine is a machine that continuously moves a joint (such as the knee) without the patient having to use the muscles in his/her leg. A goal of this therapy is to maintain as much motion as possible following this injury. This study is a randomized, prospective study to evaluate the effectiveness of CPM in maintaining knee range of motion following open reduction and internal fixation (ORIF) of fractures around the knee


Eligibility Criteria:
Inclusion Criteria:

* If the patient has an intra-articular distal femur or proximal tibia fracture
* Independent ambulatory prior to injury
* No previous knee injury limiting motion

Exclusion Criteria:

* If the patients range of motion was decreased prior to injury (ex. Osteoarthritis, previous knee fracture or injury)
* Any contraindication to CPM (concomitant hip or ankle fracture)
* Open physis of tibia or distal femur
* Pathological Fracture
* Compartment Syndrome
* Neurovascular injury
* Fracture due to gunshot wound
* Greater than 21 days from fracture to definitive open reduction and internal fixation
* Fractures treated with definitive external fixation
* Open fractures
* Extensor mechanism injuries
* Likely problems in the judgment of the investigator with maintaining follow-up
A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Volunteers Who Receive Long-term Prophylaxis Against Pandemic Influenza: PIPET B

This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as prophylaxis against pandemic influenza infection in patients who are prescribed a long term course in the context of a place of employment or profession. The study is observational only. The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. This project will commence upon pandemic influenza being declared in Australia, Hong Kong or Singapore. Data will be analysed as quickly as possible to help inform the continued use of neuraminidase inhibitor therapy as a cornerstone of the public health agency response to pandemic influenza.

The aim of this study is to

1. Describe the incidence of symptomatic pandemic influenza infection in participants receiving neuraminidase inhibitor prophylaxis in the context of a place of employment or a profession
2. Describe the incidence of seroconversion to pandemic influenza
3. Describe the incidence of adverse events in volunteers taking long term antiviral prophylaxis
4. Compare the effectiveness of oseltamivir and zanamivir prophylaxis

The study is an open label prospective cohort study. Participants in this study will be health care and other essential workers receiving long term neuraminidase inhibitor prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Intention to commence, or already commenced prophylaxis with a neuraminidase inhibitor in the context of a place of employment or profession

It is anticipated that participants in this study who are subsequently clinically diagnosed with pandemic influenza will be enrolled in the Index Case protocol (PIPET-A) with follow-up as specified.

Exclusion Criteria:

* none
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis

The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in participants with multiple sclerosis.

The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 (dextromethorphan \[DM\]/quinidine \[Q\]) capsules containing either 45 mg DM and 10 mg Q (AVP-923-45) or 30 mg DM and 10 mg Q (AVP-923-30) or 20 mg DM and 10 mg Q (AVP-923-20) compared to placebo, for the treatment of central neuropathic pain in a population of participants with multiple sclerosis (MS) over a 12-week period. The MS participant population enrolled includes participants with relapsing-remitting multiple sclerosis (RRMS) and participants with secondary progressive multiple sclerosis (SPMS).

Eligibility Criteria:
Main Inclusion Criteria:

Multiple Sclerosis (relapsing-remitting multiple sclerosis \[RRMS\] or secondary progressive multiple sclerosis \[SPMS\]), Clinical history and symptoms of central neuropathic pain (dysesthetic pain) for at least 3 months prior to screening, pain rating scale (PRS) baseline score = or \> 4, No MS relapse within previous 30 days.

Main Exclusion Criteria:

Personal history of complete heart block, QT interval corrected for heart rate (QTc) prolongation, or torsades de pointes, family history of congenital QT interval prolongation syndrome, Myasthenia Gravis, Beck Depression Inventory Second Edition (BDI-II) score \> 19
Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.

The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 1 or 2
* Subjects with severe non-proliferative or early proliferative diabetic retinopathy (according to the Alfediam classification)
* Subjects with central macular thickness less than or equal to 350 µm according to spetralis OCT
* Subjects registered with a social security agency
* Subjects who have provided written informed consent
* Subjects aged 18 or above

Exclusion Criteria:

* Pregnancy
* Breastfeeding women
* Patients presenting a contra-indication to Mydriaticum and Neosynephrine
* History of glaucoma or non-controlled ocular hypertension
* Blindness in one eye
* History of renal insufficiency requiring dialysis, or kidney or pancreas transplantation
* Unbalanced diabetes requiring, in the previous 4 months, intensive insulin therapy.
* Central macular thickness greater than 350 µm
* Visual acuity less than 20/32 measured using an ETDRS chart
* Proliferative diabetic retinopathy associated with "high risk factors" (extensive prepapillary neovessels and/or preretinal or prepapillary neovessels associated with preretinal of intravitreal hemorrhage)
* Macular edema due to causes other than diabetic retinopathy (venous occlusion, uveitis) or occurring in a context of vitreomacular traction
* Already started PRPC
* History of eye surgery or YAG laser capsulotomy performed during the preceding 6 months
* Subjects under legal supervision or guardianship
Noninvasive Study of Brain Connectivity With EEG and NIRS

Background:

- Different regions of the brain are activated when a person performs a task. Electroencephalograms (EEGs) and near-infrared spectroscopy (NIRS) are tests that detect changes in the brain. EEG looks at changes in electrical signals, and NIRS looks at changes in blood flow. These tests can detect local changes in brain activity in a safe and noninvasive way. Researchers want to study brain activity more closely by combining these tests.

Objectives:

- To use EEG and NIRS to study brain activity during specific tasks.

Eligibility:

- Healthy volunteers at least 18 years of age.

Design:

* Participants will be screened with a physical exam and medical history.
* Participants will have between one and five testing sessions. Each session will be 1 to 2 hours long. The tests given at each session will be determined by the researchers.
* Participants will have EEG and NIRS tests, given either separately or together. During these tests, participants will perform tasks of thinking and reasoning.
* Participants may also complete optional tests of thinking and reasoning. These tests will be given on paper or on a computer.

Objective: To record near-infrared optical signal (NIRS) simultaneously with EEG signal and correlate hemodynamic and neuronal responses, and to understand brain connectivity associated with cognitive functions using combined EEG/NIRS technology

Study population: 40 healthy volunteers

Design: The study will aim to capture the dynamics of brain interactions on two different scales by combing EEG (neuronal) and NIRS (hemodynamic) techniques. We will then correlate the two responses to study the brain connectivity in a more comprehensive way.

Outcome Measures: graded changes in blood flow and blood oxygenation, measured with NIRS, along with electrical signals recorded by EEG in response to different functional tasks.

Note: This study is sponsored by the Center for Neuroscience and Regenerative Medicine (CNRM). De-identified data including imaging data sent to CNRM may be shared with outside investigators or collaborators. This data may be used for a variety of research purposes. The Henry M. Jackson Foundation for the Advancement for Military Medicine (HJF), USUHS, or DOD representatives may also access data for audit purposes.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Age 18 years or greater.

EXCLUSION CRITERIA:

* Healthy volunteers with any skin disease.
* Past or present hematologic abnormality of Hgb \< 9.0 gm/dl.
* Healthy volunteers with any past or present vascular disease.
* Have a history of substance abuse, psychiatric, or neurological disorders
* Any medical condition that, in the opinion of the Principal Investigator, would preclude the inclusion of a patient onto this research study.
* Unable or unwilling to give informed consent.
Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies

The purpose of this clinical trial is to evaluate the effectiveness and safety of oncolytic viruses H101 intra-tumor injection combined with or without radiotherapy in refractory or recurrent gynecological malignancies. And further research the mechanism of oncolytic viruses H101.

Patients with recurrent, radiation/chemotherapy-resistant gynecological cancer carry a poor prognosis. H101 is a recombinant human type-5 adenovirus (Ad5), in which the E1B and E3 gene have been deleted. Previous studies have shown that H101 has anticancer activity and safety in some solid tumors, but has little report in gynecological oncology. In this clinical trial, 60 recurrent or refractory gynecological cancer patients will be enrolled. Based on individual conditions, all eligible patients are intra-tumor injected oncolytic viruses H101 within 5 consecutive days combined with or without radiotherapy in sequential, three weeks for a cycle (1-4 cycles totally). Simultaneously, the tumor sample, peripheral blood, and urine specimen were collected on day1 and day5. Local control rate and side effects are recorded respectively.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained.
* Age ≥ 18 years at the time of study entry.
* Histological or Cytologically diagnosed gynecological malignancies.
* Failure to prior standard treatment (surgery, chemotherapy, radiotherapy);
* Refractory/recurrence/metastasis gynecological cancer
* At least one measurable lesion according to the RECIST1.1.
* Cooperative Oncology Group-Status (ECOG Status) 0-3.
* The last treatment should be over 2 weeks.

Exclusion Criteria:

* History or evidence of active autoimmune disease that requires systemic treatment.
* Participated in other anti-tumor clinical trials within 4 weeks.
* Patients who have a contraindication to similar drugs.
* That failure to follow up regularly.
The Effectiveness of Mindfulness Practices in the Recovery of Burnout

The aim of this study is to examine the effectiveness of intervention based on mindfulness and acceptance-commitment therapy (ACT) in the recovery from job burnout. The 8-week intervention is delivered using jointly face-to-face group meetings and web-based program. The study hypothesizes that the Muupu-program is more effective than the normal practices when promoting work well-being in Finland. The participants are recruited from Finland.

Mindfulness-ACT-based interventions aren't widely used in Finnish work health care a the moment. This study examines the possibility of using this kind of intervention for reducing job burnout and stress and also promoting well-being at work. Muupu-program is standardized and can be administered in varying settings. If intervention is effective, it can have an impact on Finnish practices when treating job burnout and work-related stress.

Eligibility Criteria:
Inclusion Criteria:

* Currently working
* Daily internet connection available
* Belongs to the group of most exhausted workers in Finland (BBI cut-off is set on the top 25%)

Exclusion Criteria:

* No psychological or somatic conditions or other practical reasons that hinder the possibility to participate to the program
* Acute medicine changes
* Regular psychotherapy
* Not willing to inform employer and/or work health care of participation to the study
PERFECT Project - Part 1 - Study 1

The objectives are to test the acute effects of different extruded pulse snacks on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products.

The investigators hypothesize that snack products containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse snack products.


Eligibility Criteria:
Inclusion Criteria:

* Normoglycemic (\<5.6 mmol/L) and normotensive (systolic blood pressure \<140 mm Hg and diastolic blood pressure below \< 90 mm Hg)
* BMI of 18.5-29.9 kg/m2

Exclusion Criteria:

* Restrained eaters
* Regularly skip breakfast
* Smokers
* Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year
* Competitive sports or athletic training at a high intensity
* Those unable to walk for an hour continuously
Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

This is a randomized, placebo controlled study in cancer patients reporting fatigue persisting for at least two months following completion of chemotherapy. Subjects will receive 6 weeks of either acupuncture or placebo treatment as a means of evaluating whether acupuncture reduces chronic fatigue after chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-64 diagnosed with a malignancy (solid tumor or hematologic malignancy).
* Patients must have received chemotherapy.
* Patients must complain of fatigue following chemotherapy buy not prior to chemotherapy.
* At least 60 days must have elapsed between the last chemotherapy infusion and completion of the first baseline questionnaire.
* Mean baseline fatigue as measured by the Brief Fatigue Inventory must be four or above.

Exclusion Criteria:

* Anemia, defined as Hb\<9 or active treatment for anemia. Iron supplementation is allowed as long as the dose has been stable for at least six weeks.
* Platelets less than 50,000/microliter or an Absolute Neutrophil Count less than 1,000/microliter.
* Baseline depression score on the Hospital Anxiety and Depression Scale of 11 or above, indicating clinical depression.
* Thyroid disorder, defined as either thyroid stimulating hormone or free T4 out of normal range, is excluded as it is a possible cause of fatigue unrelated to cancer therapy.
* Surgery under general anesthesia; immunotherapy; radiotherapy; or initiation of hormonal therapy within the three weeks prior to enrollment.
* Acupuncture in the previous six weeks.
* Change in use of any of the following drugs in the prior three weeks: opiates, antidepressants (other than selective serotonin reuptake inhibitors \[SSRIs\])/anxiolytics; OR change in use of SSRIs in the prior six weeks. "Change in use" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen: changes in actual amounts of PRN medication taken are allowed.
Accuracy of Prediction Equations to Calculate Maximum Strength

Resistance exercise training (RT) is a key component of health related exercise programs. However, an accurate specification of RT load prescription is essential for effective and safe achievement of training aims. Proper specification of exercise intensity might be the most critical issue when designing RT protocols for adults. One repetition maximum tests (1RM) have been considered the "gold standard" of dynamic maximum strength evaluation. Although the argument of increased risk of injuries and adverse effects with 1RM testing in older people has been rejected by several studies , limited motivation to lift maximum loads, requirement for high test effort, time constraints, and interruption of the continuity of the training process aggravate the frequent application of 1RM tests particularly in non-athletic RT. 1RM prediction equations that use the load and number of repetitions completed to fatigue (RTF) to predict repetition maximum might be a reliable and feasible option to 1RM testing. Thus, the primary aims of this study were to evaluate the predictive accuracy of current RTF equations and to develop an equation that more accurately predicts 1RM from RTF tests.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 years old
* 60 to 85 years old

Exclusion Criteria:

* Contraindication for one repetition maximum tests
* musculoskeletal injuries that may prevent a reliable and safe assessment of the 1RM and RTF tests
Emotional Brain Processes in Recreational Cannabis Users

This fMRI study investigates neural correlates of emotion regulation, emotion processing and craving in recreational cannabis users.


Eligibility Criteria:
Inclusion Criteria:

* Recreational cannabis use
* 72 hours of abstinence

Exclusion Criteria:

* neurological disorders
* psychiatric disorders according to DSM-4
Comparison of Postoperative Recovery Between TIVA and Inhalation Agent

This prospective, randomized, single-blinded study is designed to compare the postoperative quality of recovery between propofol based total intravenous anesthesia and desflurane in patients undergoing minimally invasive nephrectomy. We hypothesize that propofol based total intravenous anesthesia can significantly improve the quality of recovery after surgery in patients with minimally invasive nephrectomy.

Adult patients undergoing elective laparoscopic or robotic assisted nephrectomy are randomly allocated to receive propofol based total intravenous anesthesia (n=75) or desflurane (n=75). The quality of recover after surgery using the QoR-15K was assessed by a investigator at postoperative day (POD) 1, 2, and 3. The primary outcome is the QoR-15K at POD 1, 2, and 3 after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective laparoscopic or robotic assisted nephrectomy under general anesthesia
* American Society of Anesthesiologists (ASA) physical classification I-II
* Willingness and ability to sign an informed consent document

Exclusion Criteria:

* Do not understand our study
* American Society of Anesthesiologists (ASA) physical classification III or more
* Allergies to anesthetic or analgesic medications
* Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
* Medical or psychological disease that can affect the treatment response
* Patients who receive mechanical ventilation more than 2 hours after surgery
A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients

The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women with metastatic breast cancer who are completing planned course of chemotherapy with planned treatment break
* On stable hormone therapy for at least 2 months are also eligible for the study
* Estimated survival of at least 3 months
* No platelet inhibitor therapy within 1 month of study entry
* Platelets ≥ 100,000
* Coagulation screening tests within normal range (INR between 0.81 and 1.20)
* Normal kidney and liver function as defined by:

  * Aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase (SGOT))/alanine aminotransferase(ALT) ≤ 2 x Institutional Normal
  * Creatinine ≤ 2 x Institutional Normal
* Able to provide signed, informed consent.

Exclusion Criteria:

* Patients going on to surgery
* Patients with a serious bleeding disorder that make them inappropriate candidates for NSAID therapy
* Patients with history of significant bleeding related to peptic ulcer disease
* Patients on standing doses of NSAIDS or platelet function inhibitors
* Patients on standing doses of anti-coagulants
Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion

A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged \>= 18 years
* Hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of unknown duration
* Scheduled for cardioversion (electrical or pharmacological) of nonvalvular atrial fibrillation
* Women of childbearing potential and men must agree to use adequate contraception when sexually active

Exclusion Criteria:

* Severe, disabling stroke (modified Rankin score of 4- 5, inclusive) within 3 months or any stroke within 14 days prior to randomization
* Transient ischemic attack within 3 days prior to randomization
* Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
* Acute Myocardial infarction (MI) within the last 14 days prior to randomization
* Cardiac-related criteria: known presence of cardiac thombus or myxoma or valvular atrial fibrillation
* Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
* Concomitant medications: indication for anticoagulant therapy other than atrial fibrillation, chronic aspirin therapy \> 100 mg daily or dual antiplatelet therapy, strong inhibitors of both cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) if used systemically
* Concomitant conditions: childbearing potential without proper contraceptive measures, pregnancy, or breast feeding; hypersensitivity to investigational treatment or comparator treatment; calculated creatinine clearance (CrCl) \< 30 mL/minute; hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk; any severe condition that would limit life expectancy to less than 6 months; planned invasive procedure with potential for uncontrolled bleeding; inability to take oral medication; ongoing drug addiction or alcohol abuse
* Any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
* Participation in a study with an investigational drug or medical device within 30 days prior to randomization