cyrilzakka/clinical-trials huggingface dataset:
Dashboards for Clinician Monitoring of Patients Through a Mobile Sensing Platform

The purpose of this study is to determine whether the use of a mobile sensing platform in a primary care setting has an effect on provider workflows, patient outcomes, patient engagement, patient self-help behavior, health research, and total cost of care.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 70 years of age.
* Speak, understand, and read conversational English.
* Be a current patient of South Huntington Clinic recommended for behavioral health care.
* Have a smartphone and cell service plan, including voice and data, that meets the device requirements of the Mobile Sensing Platform.

Exclusion Criteria:

* Planning on permanently leaving Boston during the study period.
A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612

This phase 2a randomized double blind placebo controlled, in 30 Parkinson's disease (PD) subjects who are treated with oral levodopa/carbidopa (LD/CD) and suffer from motor fluctuations. The aim of the study is to determine the safety, tolerability, the levodopa pharmacokinetics, the need for oral LD dose adjustment and the usability of the ambulatory drug delivery pump following repeated dosing of ND0612 in a conventional home setting in Parkinson's disease patients. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa, pump usability and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women with idiopathic Parkinson's disease
2. Subjects must experience motor fluctuations associated with LD/CD dosing
3. Modified Hoehn and Yahr stage \< 5
4. Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
5. Subjects who are treated with dopaminergic agonists and other anti-PD drugs should be on stable doses
6. Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
7. Subjects must be age 30 or older.
8. Subjects must be willing and able to give informed consent

Exclusion Criteria:

1. Subjects treated with entacapone, tolcapone, stalevo or controlled release formulation of levodopa/carbidopa.
2. Subjects with a clinically significant or unstable medical or surgical condition
3. History of melanoma or significant skin disorders
4. Subjects with significant cognitive impairment
5. Subjects treated with unstable doses of dopaminergic agonists, anticholinergics, Monoamine oxidase (MAO)-B inhibitors, or antipsychotics
6. Subjects with clinically significant psychiatric illness
7. Subjects with a history of alcohol or substance abuse
8. Subjects who have taken experimental medications within 60 days prior to baseline.
9. Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
10. Subjects with severe disabling dyskinesias.
11. Subjects with hearing, visual or motor impairments that prevent them from using the pump or reacting effectively to errors
Paroxysmal Nocturnal Hemoglobinuria (PNH), Level of CD59 on Red and White Blood Cells in Bone Marrow Failure Syndromes

Examine red and white blood cells of PNH patients with bone marrow failure syndromes.


Eligibility Criteria:
Inclusion Criteria:

* At least 10 years of age.
* Has aplastic anemia, myelodysplastic syndromes or other bone marrow failure syndromes

Exclusion Criteria:

* Has any condition that might interfere with the patient's participation
A Study of Using Parenchymal Blood Volume(PBV) for Endovascular Treatment of Renal Arterial Stenosis

This study will use PBV technique to quantitatively assess the improvement of renal perfusion before and after endovascular treatment (EVT) of renal artery stenosis.

BACKGROUND: Renal artery stenosis (RAS) is one of the main reasons for secondary hypertension and renal failure, which etiologies include atherosclerosis, fibromuscular dysplasia and takayasu arteritis. Endovascular treatment under digital subtraction angiography (DSA) is an option to treat this disease. However, the technical success of this procedure is mainly based on morphology of its targeting renal artery without any quantified data towards renal blood perfusion. Thus, this study will try to solve how renal blood perfusion changes before and after endovascular treatment of renal artery stenosis.

DESIGN NARRATIVE:

This prospective cohort study will recruit patients with renal artery stenosis. PBV data will be obtained before and after their endovascular treatments. The volume of target kidney and its mean density of contrast from PBV data will be calculated as indicators for renal perfusion. And the relation between the percentage of stenosis and renal perfusion will be analyzed. The follow-up will last for one year. At 6-month and 12-month follow-up, DSA and PBV acquisition protocol will be undertaken again to evaluate renal blood perfusion in the long term.

Eligibility Criteria:
Inclusion Criteria:

Patients should meet all of the following criteria:

1. Age ≥ 18.
2. Renal artery stenosis is greater than or equal to 80% and less than 100% by duplex, CT angiography or magnetic resonance angiography.
3. The target kidney remains functional(tested by radionuclide imaging)
4. Documented history of hypertension on two or more anti-hypertensive medications OR estimated glomerular filtration rate (eGFR) less than 60 mL per minute per 1.73 m\^2, calculated by the modified Modification of Diet in Renal Disease formula.
5. The length of target kidney is \>8cm.

Exclusion Criteria:

Patients meet any of the following criteria should be excluded.

1. Unable or willing to comply with study protocol or procedures.
2. Pregnancy or lactation.
3. History of kidney transplant.
4. Currently in acute pulmonary edema OR systolic ejection fraction of heart \<30% OR respiratory failure due to hypertension or acute coronary syndrome or cerebrovascular accident in past 3 months.
5. The eGFR is less than 15 mL per minute per 1.73 m\^2 OR serum Cr is greater than 3.0 mg/dl on the day of randomization.
6. Other known reason nonischemic kidney injure(e.g. nephritis). If it is diabetic nephropathy, 24h urinary protein should be more then 3g.
7. Aorta has stenosis(greater than 30%).
Understanding Women's Contraceptive Expectations at the Time of a First Trimester Surgical Abortion

The investigators will conduct a voluntary anonymous survey at four separate Sacramento area family planning clinics. The investigators will ask the staff at each facility to offer a survey to all women 18 and older presenting to the clinic to have a first trimester (\<12 weeks gestation) surgical abortion. Gestational age will be based on what the woman believes is her gestational age at presentation, before any evaluation in the clinic. Women who cannot understand or read the survey will be excluded. The investigators hope to implement the survey at these clinics for 3-4 months reaching a minimum of 200 women (based on a target population of 600 women receiving surgical first trimester abortions at these two clinics over a 3-4 month period with a 95% confidence interval).

We will conduct a voluntary anonymous survey at four separate Sacramento area family planning clinics. We will introduce the research project to clinic staff, recruiting their support and participation, as they will be the main implementers. The survey will be offered to women in the waiting room before any pre-procedure counseling. We will include all women presenting to the clinic who are 18 years and older and planning to have a first trimester (\<12 weeks gestation) surgical abortion. Gestational age will be based on what the woman believes is her gestational age at presentation, before any evaluation in the clinic. Women who cannot understand or read the survey will be excluded. We hope to implement the survey at these two clinics for 3-4 months reaching a minimum of 200 women so as to obtain an adequate power for our study. The brief survey will include a cover letter explaining the study and stressing the anonymity and confidentiality. The surveys will include an envelope in which to place completed surveys; the envelope can be sealed by the participant and dropped in a collection bin. This process will allow the data to be collected anonymously. The survey data will then be synthesized first by descriptive analysis, followed by chi-square and multiple regression analyses. A statistician in the University of California Davis Department of Obstetrics and Gynecology will help when necessary.

Eligibility Criteria:
Inclusion Criteria:

* seeking first trimester surgical abortion

Exclusion Criteria:

* Women who cannot understand or read the survey
Implementation of the Caregivers-Patients Support Coping with Advanced-Cancer (CASA) Intervention.

This pre-pilot aims to prepare the PI to receive hands-on experience in implementation and dissemination and design and lead pilot studies in palliative care. The catchment area communities experience lower cancer health outcomes and are more likely to be diagnosed with advanced cancer when compared to other surrounding areas. The PI's catchment area experiences advanced cancer, and their caregivers are at an increased risk for unmet psychosocial needs; this pre-pilot will allow the PI to focus on this critical gap in equal healthcare. The research goal of this proposal is to refine and pre-pilot an intervention titled Caregivers Patients Support to Cope with Advanced Cancer (CASA), a five-session, 60-minute telehealth series for patient-caregiver dyads. The rationale for this project is that it will lay the groundwork for a Randomized Control Trial (RCT) testing the efficacy of CASA. It will also assess the implementation of an innovative method to deliver the CASA intervention. This study aims to use the collaborative intervention planning framework and ORBIT model to modify and assess the feasibility and preliminary effect of the CASA intervention. The overall impact of this study is to improve access to psychosocial, culturally adapted interventions in the proposed catchment area.


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients must be stage III and IV solid tumor patients who report distress \>4 on the Distress Thermometer
* Caregivers. Identified caregivers by distressed patients.

Exclusion Criteria:

* (1) diagnosed with a major disabling medical or psychiatric condition, (2) unable to understand the consent procedure, or (3) too ill to participate, all as reported by the participant and/or determined by the investigator's judgment.
Bevacizumab Versus Docetaxel/Erlotinib on Tumor Metrics in Patients With Previously Untreated Advanced Non Small Cell Lung Cancer

To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer.

In 2008, the Hellenic Co-operative Oncology group (HeCOG) initiated a randomized phase II study to determine the comparative efficacy of intermittent docetaxel/erlotinib chemotherapy, with erlotinib given for twelve consecutive days either before (group A) or after (group B) docetaxel, in chemotherapy-naive patients with advanced non small cell lung cancer. Docetaxel chemotherapy was considered one of the valid non-platinum containing therapeutic options at that time and today represents one of the approved second-line treatment options after failure of first-line platinum based chemotherapy. The trial was terminated early due to slow accrual after enrollment of 51 patients and was published in 2014, showing no clinically meaningful difference between the two treatment arms.

Based on the aforementioned trial population,a parallel radiological study was conducted, evaluating sequential tumor metrics on computed tomography performed at baseline and after each cycle of treatment in patients receiving either bevacizumab or docetaxel/erlotinib. Given the differential mechanism of action of these agents, it was hypothesized that the different parameters of radiological tumor response evaluation, namely the maximum diameter, tumor volume and tumor density, would respond differently for each therapeutic category (a chemotherapeutic agent, a molecular agent and and an anti-angiogenic agent). For bevacizumab, in particular, it was hypothesized that its unique mechanism of action, inducing central tumor necrosis and subsequent shrinkage, would lead to completely different tumor metrics as compared to the other two agents. Herein the final results of this analysis are presented, showing the comparison of the three agents in terms of tumor response metrics, as evaluated in CT scans performed at baseline and after each cycle of treatment

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic non small cell lung cancer will be enrolled.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
3. Presence of measurable or evaluable disease (lesions that are present but do not fulfil the criteria for measurable disease).

Exclusion Criteria:

1. Patients who have undergone complete tumor resection after responding to platinum based chemotherapy.
Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Sevoflurane Inhalation.

In humans and animals, circadian rhythm sleep cycle is an important function to maintain and regulate basic physiological homeostasis, such as cognitive function, glucose metabolism, memory consolidation, immune function and growth hormone secretion. The induction of general anesthesia leads to a state of reduced responsiveness, which is often described by anesthesiologists and patients as "sleep". However, previous studies have shown that in the case of patients under general anesthesia, besides surgery trauma and general anesthetics may change sleep function and sleep cycle perioperatively, the postoperative complications such as pain, nausea and vomitting etc after general anesthesia may also reduce postoperative sleep quality.Meanwhile, there is a mixed literature linking sleep and markers of systemic inflammation that greater sleep disturbances were associated with higher levels of circulating IL-6 and CRP but not TNF-α. And the effects of inflammatory cytokines may also cause changes in sleep patterns. Flurbiprofen axetil is a new non-steroidal anti infection analgesic(NSAIDs), which is widely used for analgesia to reduce the dose of opioids. It not only has a high affnity for infammatory tissues to achieve targeted drug therapy and prolonged duration of action, but causes analgesia effect through decreasing the biological production of prostaglandins, reducing the reactivity of peripheral nerves to endogenous infammatory factors, and inhibiting the sensitization of central as well as peripheral nervous systems.Furthermore, it could also inhibite the occurrence of adverse reactions, such as declined sleep quality, respiratory depression, nausea and vomiting. Preemptive analgesia is an analgesic intervention that begins before surgery to prevent the nervous system from becoming sensitive to subsequent stimuli that may aggravate pain. A large number of experimental studies have shown that the use of local anesthetics and/or analgesics in advance can prevent central nervous system hyperplasia, thereby reducing postoperative pain. The aim of our study was to investigate the effect of preemptive analgesic with flurbiprofen axetil on postoperative pain, inflammatory markers and sleep quality among patients under general anesthesia. We hypothesized that use flurbiprofen axetil preoperatively would effectively relieve postoperative pain, inhibite inflammtory reaction and improve postoperative sleep quality.


Eligibility Criteria:
Inclusion Criteria:

age: 18-75 ASA: I-II Receive operation under general anesthesia

Exclusion Criteria:

* ①Patients with mental illness;

  * Severe sleep disorders in the past;

    * A history of taking opioids;

      * Patients who are allergic to the drug

        * Patients who have difficulty communicating and refuse to participate in the trial.
Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine.

Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication.

The alpha2-adrenoceptor agonist, dexmedetomidine, was originally developed as a sedative and analgesic drug for use in intensive care. However, it has a number of unique pharmacodynamic properties, which also make it useful in anesthesia including; decreased MAC, analgesia without respiratory depression and a significant reduction in catecholamine secretion. Also it has been used off-label as an adjunctive agent for sedation and analgesia in patients in the critical care unit and for sedation during non-invasive procedures in radiology. It also has a potential role as part of anesthesia care to prevent emergence delirium and post-anesthesia shivering.

Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication.

The current literature is focused in studying the sedative and analgesic effects of intravenously administered dexmedetomidine. Pharmacodynamics and pharmacokinetic studies undertaken on alternative routes of dexmedetomidine administration are lacking. The pharmacokinetic properties of trans-mucosal administration of dexmedetomidine have been demonstrated in one study only, and the clinical effects of non-parenteral administration of dexmedetomidine have been described in anecdotal case reports.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I - II.
* Aged between 20 and 60 years.
* Scheduled for modified radical mastectomy

Exclusion Criteria:

* Cardiac disease.
* Hepatic disease.
* Renal disease.
* History of alcohol or drug abuse.
* Patients with a known allergy to the study drug
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS

This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4 weeks. Anticipated time on study treatment is 96 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Active moderate to severe rheumatoid arthritis
* Inadequate response to \>/=3 DMARDs (non-biologic and/or biologic)
* Current treatment at stable dose for \>/=8 weeks
* Etanercept discontinued \>/=2 weeks, Anakinra \>/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab \>/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab \>/=16 weeks, and must have proven B-cell repletion

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
* Rheumatic autoimmune disease other than RA
* Functional class IV (American College of Rheumatology Classification)
* Prior history or current inflammatory joint disease other than RA
* Oral corticosteroids at a dose of \>10 mg/day prednisone equivalent
* Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody
* Current or history of recurrent bacterial, viral, fungal or mycobaterial infection
* History of or currently active primary or secondary immunodeficiency
Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery

Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Elective Cesarean section

Exclusion Criteria:

* Diabetes severe anaemia allergy
U-LABA/ICS Effects on Exercise Performance, Formoterol

The purpose of the project is to investigate exercise performance in well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* Physically active \>5 hours a week
* Maximum oxygen uptake classified as high or very high

Exclusion Criteria:

* Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
* ECG abnormality
* FEV1/FVC ratio \< 0,7 determined with spirometry
* Chronic illness determined to be a potential risk for participant during the study
* In chronic treatments with medication that may interfere with study results
* Pregnancy
* Smoker
* Blood donation during the past 3 months
Comparison of M-TAPA Block and ESP Block İn Laparoscopic Cholesystektomy

After cholecystectomy, modified-thoracoabdominal nerve block (M-TAPA) is a newly applied technique in upper abdominal surgery for postoperative analgesia. In recent years, block methods such as erector spina plane (ESP), paravertebral (PVB), transverses abdominis plane (TAP) have also been applied in these surgeries. MTAPA has been defined as a technique that is performed in the supine position and is easier to apply than the other mentioned blocks. In our study, we aimed to investigate the effectiveness of this block.

After laparoscopic cholecystectomy, most patients experience moderate to severe pain, especially in the first 24 hours. The cause of the pain is the skin incision, the carbon dioxide insufflation given into the abdomen for laparoscopy, and the visceral peritoneum.

This pain that occurs in the postoperative period negatively affects the patient's early mobilization, wound healing, and patient comfort. While the toxic effects of nonsteroids used for pain control on the liver and kidneys are known, narcotic analgesics have side effects such as nausea, vomiting, and addiction. In recent years, trunk blocks have begun to be used frequently for pain control in abdominal surgery. Although blocks such as erector spina plane (ESP), paravertebral (PVB), and transverses abdominis plane (TAP) are frequently applied, there are differences in terms of their effectiveness and duration. On the other hand, it is important to give the patient a suitable position for the application.

Modified-thoracoabdominal nerve block (M-TAPA), which is applied especially in the supine position and is easier to apply compared to other blocks, has started to be applied as an alternative method.

In our study, we aimed to compare the effectiveness and duration of the MTAPA block compared to other trunk blocks such as ESP.

Eligibility Criteria:
Inclusion Criteria: ASAI-III , 18-70 yaş, elective surgery -

Exclusion Criteria: pregnancy, patient with emegency, patients allergic to local anesthetics, patient with coagülopaty, uncooperative, mentally retarded patients

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Attidutes and Understanding of Oat Fibre Claims on Food Labels

Oat fibre consumption has been shown to lower blood cholesterol, which is advantageous for heart health. Oat and fibre claims on food labels should help people find heart healthy food choices; however consumer attitudes and understanding of such claims are unknown.

The objective of this study was to evaluate the attitudes and understanding to different types of permitted oat fibre claims.


Eligibility Criteria:
Inclusion Criteria:

* Primary grocery shoppers
* Canadian adults between the ages 20 to 69 years

Exclusion Criteria:

* Did not have an email address or have access to internet