cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients

This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous and subcutaneous doses of CFZ533 in healthy subjects and intravenous doses in rheumatoid arthritis patients.

This was a Healthy Volunteer only study originally, but after an amendment to protocol, rheumatoid arthritis patients will be starting 7-Mar-2014 and thus, the protocol is now registered.

Eligibility Criteria:
Inclusion Criteria (for healthy volunteers):

1. Healthy male and surgically sterilized or post-menopausal female subjects 18 to 55 years of age (for Cohort 9 only, subjects must be of Chinese descent)
2. Vital signs (systolic and diastolic blood pressure and pulse rate) should be within normal limits
3. Weight 50-150 kg and a body mass index (BMI) 18-32 kg/m2

Inclusion Criteria (for rheumatoid arthritis patients):

1. Healthy male and surgically sterilized or post-menopausal female subjects 18 to 55 years of age
2. Fulfilled 2010 ACR/EULAR classification criteria for RA per Investigator
3. Treatment with a stable oral RA treatment regimen for ≥ 4 weeks before randomization
4. Systemic corticosteroids allowed if on a stable dose (≤ 10 mg/day of prednisone or equivalent) ≥ 4 weeks prior to randomization
5. Subjects taking NSAIDs (COX-1 or COX-2 inhibitors) as part of their RA therapy must be on a stable dose for at least 4 weeks before randomization

Exclusion Criteria (for healthy volunteers):

1. History of hypersensitivity to vaccines, the study drug, or to drugs of similar chemical classes (i.e., biologic agents)
2. Abnormal hematology, coagulation or inflammatory lab results
3. History or evidence of tuberculosis.

Exclusion Criteria (for rheumatoid arthritis patients):

1. Use of anti-TNF or other biologics in previous 3 months
2. Any intra-articular injection therapy (e.g., corticosteroid, hyaluronan) required for treatment of acute RA flare within 4 weeks before randomization
3. Previous treatment with a B cell-depleting biologic agent or any other immunomodulatory biologic agent within 5 half-lives (experimental or approved)
4. Current treatment with cyclophosphamide
5. Autoimmune disease other than RA
6. Adult juvenile rheumatoid arthritis
7. RA functional status class IV according to the ACR 1991 revised criteria

Other protocol-defined inclusion/exclusion criteria may apply
COPing With Shift Work - Web Based Program for Police Officers

This study is a clinical trial in which 300 Police Officers who currently work midnight shifts in the participating police departments will be recruited to test the effectiveness of a new web-based program to address sleep and associated problems related to shift work, particularly night shift work. Recruitment letters will be sent to all officers currently working midnight shift, with the goal of recruiting 300 officers willing to participate in the study. The 300 participants will be randomly assigned to either the experimental group (receiving the web-based program) or the waitlist control group. Participants in the experimental group will be given access to the program site (COPing with Shift Work) and the mobile application (Sleep Tracker). Following completion of the field test, participants in the control condition (as well as all other interested officers) will have access to the web-based COPing with Shift Work program.

All participants will be asked to complete a baseline questionnaire containing multiple measures of sleep, dietary practices, physical activity and job performance. Participants will be asked to complete the posttest approximately three months following initial access to the intervention.

Primary and secondary outcome measures: The Primary outcome measures are "sleep quality" as measured by the Pittsburgh Sleep Quality Index (PSQI) and "sleepiness" as measured by the sleepiness subscale of the widely used Karolinska Sleep Questionnaire (KSQ). The investigators have adapted the sleep measures to apply to individuals who work nights and may sleep during the day.

Secondary outcome measures include the Nutritional Patterns Scale, a 13-item modification of the Block Self-Administered Diet History Questionnaire assessing the nutritional value of the respondent's diet; Attitudes Toward a Healthy Diet, a 17-item scale, based on the Health Belief Model and developed and validated by Trenkner and associates assessing perceived benefits and barriers to eating a healthy diet; the Godin Leisure-Time Exercise Questionnaire, a brief 4-item query of usual leisure-time exercise habits; and work productivity measured with the Work Limitations Questionnaire (WLQ), developed and validated by Lerner and associates.

It is expected that the program group participants will have significantly better outcomes than the control group at three months.


Eligibility Criteria:
Inclusion Criteria:

* Police officer with participating Police Departments
* Access to a computer or mobile device with Internet access

Exclusion Criteria:

* None
Evaluation of Electrocardiography Performed With Mobile ECG Devices in Cardiac Patients and Healthy Volunteers

Electrocardiography is one of most basic laboratory tests in cardiology. Novel mobile ECG are becoming popular. The investigators aim to compare typical electrocardiographic measurements obtained with mobile ECG devices (Alivecor Kardia and Alivecor Cardia 6L) and 12-leads standard ECG (gold standard). The recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ECG curve and quality of recording.

Electrocardiography is one of most basic laboratory tests in cardiology. Novel mobile ECG are becoming popular. The investigators aim to compare typical electrocardiographic measurements obtained with mobile ECG devices (Alivecor Kardia and Alivecor Cardia 6L) and 12-leads standard ECG (gold standard). The recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ECG curve and quality of recording.

ECG evaluation will include: rhythm description, measurements of mean RR, PR, QRS, QT, QTc and ST-T description. Additionally inter/intraventricular conduction abnormalities are to be determined from 12-leads ECG and approximate from mobile ECG recordings.

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for electrocardiography
* Informed consent to participate in the study
* The possibility of self-registration of a mobile ECG (no physical and mental restrictions)

Exclusion Criteria:

* Not willing or incapable to give written informed consent.
* Lack of willingness to cooperate
The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease

The purpose of this study is to see if patients with chronic kidney disease have endothelial cells that don't function properly, which is thought to be a marker for cardiovascular risk. Endothelial cells line the heart and blood vessels. The investigators will treat your high cholesterol with a cholesterol-lowering drug (atorvastatin, or Lipitor). They will determine if this cholesterol lowering drug improves subjects' cholesterol as well as the function of endothelial cells.


Eligibility Criteria:
Inclusion Criteria:

* Stage 3, 4 and 5 chronic kidney disease (not on dialysis)
* Hyperlipidemia requiring cholesterol lowering therapy
* Aged 18 to 80 years old
* Ability to provide informed consent

Exclusion Criteria:

* Patients requiring multiple cholesterol reducing agents
* Patients with neovascularization present, such as neoplasm, active wounds, or significant retinopathy
* Patients with contraindications or allergy to statins
Study of LY3074828 in Healthy Participants

The purpose of this study is to evaluate different concentrations and formulations of LY3074828 compared to placebo ("dummy drug").

The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. For each participant in Part A and Part B, the total duration of the clinical trial will be approximately 16 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

- Have venous access sufficient to allow for blood sampling and administration of investigational product

Exclusion Criteria:

* Must not have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females)
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening or intend to receive during the study
* Must not be immunocompromised
* Must not have known hypersensitivity to hyaluronidases
* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
* Must not have significant allergies to humanized monoclonal antibodies
* Must not have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Must not have had breast cancer within the past 10 years
Diet and Depression

This study is a pilot open label crossover trial to assess the feasibility and acceptability of reducing ultra- processed foods (UPF) in a personalized manner from the diets of patients with major depressive disorder who eat a large percentage of UPF.

There is a need for additional treatment or augmentation strategies for people who have depression. Epidemiological and observational studies show that an increased consumption of ultra-processed food (UPF) is associated with an increased risk of developing depression. This study will test the hypothesis that that reducing UPF intake from the diets of patients with major depressive disorder who eat a large percentage of UPF is a feasible and acceptable intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 year olds (inclusive), all race/ethnic groups
* Willing to not change psychotropic medication or psychotherapy regimen during the study
* Willing and able to come to UCSF for in person visits two times
* Ability to speak and read English and answer participant surveys

Exclusion Criteria:

* Psychiatric hospitalization in past 3 months
* Active suicidal ideation with intent and plan or scoring a 3 or higher on the Columbia suicide severity rating scale (C-SSRS)
* In a current severe mood state when entering the study that would prohibit compliance with study visits or dietary program
* Known GI abnormalities or known GI medical problems (diarrhea, chronic intestinal disease, toxic megacolon, ileum) or known swallowing or chewing disorders or issues
* Anticipating or planning any major changes in physical activity or sleep during the study
* Pregnant or planning to be pregnant during the study
* Breastfeeding or planning to breastfeed during the study
Extended Application of Intraoperative Parathyroid Scores System(IPSS) in Thyroidectomy

after established the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy we further extented the clinical value of Intraoperative Parathyroid Scores System in Treatment decisions of calcium treatment time and improve recognition skills of parathyroid in Clinicians

IPSS includes transplantation Parathyroid Scores and in situ Parathyroid Scores, the investigators will establish the Intraoperative Parathyroid Scores System by parathyroid size and Blood supply, and recording IPSS, according to certain rules. We expand IPSS, including the description of the location of parathyroid after postoperative.Parathyroid hormone and calcium were test in d0, d1, d14, d60 post operation. The correlation between Intraoperative Parathyroid Scores and PTH calcium were calculated, and ROC curve and logistic regression were tested for the prediction value.and after that we further evaluate the relationship Between IPSS and calcium supplement time.and Whether IPSS enhance ability of parathyroid recognition for clinical doctors.

Eligibility Criteria:
Inclusion Criteria:

1. postoperative pathology confirmed as thyroid papillary carcinoma;
2. for the first time to undergo thyroid surgery, no history of neck surgery and external radiotherapy;
3. preoperative serum calcium, parathyroid hormone levels were normal;
4. intraoperative and postoperative clinical data integrity, standardized follow-up patients;
5. parathyroid is a tumor violation.

Exclusion Criteria:

1. serious underlying disease;
2. age greater than 60 years of age or combined with arteriosclerotic disease;
3. patients with postoperative loss;
4. patients with parathyroid disease.
Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan

The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with rheumatoid arthritis(RA) in Jordan where no visits or intervention(s) additional to the daily practice will be performed

A multi-center, observational, prospective, cohort study to assess the safety and effectiveness of biosimilar Infliximab (Remsima®) in patients with rheumatoid arthritis in Jordan. Biologic naïve patients will receive Remsima® in accordance with standard medical care and the approved label and will be followed over a period of 34 weeks (8.5 months). Outcomes including occurrence of adverse events (AEs), mean changes in disease activity and health assessment in each cohort will be measured and compared

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥18 years)
* Biologic naïve patients with active RA diagnosed according to the revised 1987 American College of Rheumatology (ACR) (Arnett et al. 1988) or 2010 ACR / European League Against Rheumatism (EULAR) Rheumatoid Arthritis classification criteria (Aletaha et al. 2010)
* Patients should be receiving a stable dose Methotrexate (MTX) for at least 3 months prior to enrolment, and still have active disease defined as erythrocyte sedimentation rate (ESR) ≥28 mm/h and swollen and tender joints ≥ 6
* Absence of tuberculosis demonstrated by negative chest X-ray

Exclusion Criteria:

* Patient \<18 years
* Previous treatment with biologics
* Patients who meet any of the contraindications to the administration of infliximab
* Previous or concurrent malignancies
Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke

This study will assess the potential efficacy and safety of TSC as early treatment for both ischemic and hemorrhagic stroke when administered while subject is in ambulance being transported to hospital.

This is a multicenter, randomized, placebo-controlled, double-blind, parallel group trial of intravenous trans sodium crocetinate (TSC) initiated by emergency medical service (EMS) responders in the field within 2 hours of symptom onset in 160 subjects with acute stroke. The primary objectives of the study are to evaluate the efficacy and safety of field-initiated TSC in improving the long-term functional outcome of subjects with acute stroke.

Subjects with acute stroke will be identified and screened in the ambulance by (EMS) responders who have received training in basic and advanced cardiac life support, stroke recognition, and specific procedures relevant to the proposed study. The EMS responders will contact a Study Neurologist, who will enroll eligible stroke patients into the study. Effort will be made to obtain prospective informed consent in the ambulance when deemed to be feasible. If not feasible, subjects will be enrolled under regulations for exception from explicit informed consent (EFIC) in emergency research circumstances, after public disclosure and community consultation. Written informed consent to continue in the study is obtained from subjects or their legally authorized representatives as soon as possible after hospital arrival.

EMS responders will deliver the single, field, bolus dose of study agent, TSC at 0.25 mg/kg or matched placebo, followed after hospital arrival by standard of care (SOC). No additional study drug will be administered in the hospital. Follow-up assessments will be performed at Emergency Department (ED) arrival, 24 hours, 48 hours, Day 4, Day 30, and Day 90. The study will be performed at up to 30 receiving hospital sites in Los Angeles County, CA, and central Virginia.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40-85, inclusive
2. Last known well time 15-120 minutes before anticipated study drug injection
3. Suspected stroke identified by the LAPSS
4. Moderate to severe motor deficit, with Los Angeles Motor Scale (LAMS) 2 or higher
5. No seizure

Exclusion Criteria:

1. Coma
2. Rapidly improving neurologic deficit
3. History of seizures or epilepsy
4. Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
5. SBP \< 90 or \> 220
6. Major head trauma in the last 24 hours
7. Recent stroke within 30 days
8. Known to be pregnant or lactating
Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice

This study is conducted in Europe. The aim of this study is to investigate Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of age above 18 years as per Victoza® SmPC par.4.2 and 5.1 diagnosed with type 2 diabetes receiving the first prescription of liraglutide in 2011

Exclusion Criteria:

* None. Available data from all eligible patients for each center, will be included
Assessment of the Prescriber's and the Pharmacies Overview of Patient Medication by Use of the Fidelity Coefficient.

The purpose of this study is to twofold. The investigators wish to introduce a new patient-descriptive parameter, the 'Fidelity Coefficient', and use it to assess and compare the overview of patient's medication possessed by the general practitioners and the pharmacies.

The fidelity coefficient, FC, is a measure of what proportion of individual patients' medication that are accounted for by the most used prescriber and the most used pharmacy. Each patient therefore has two values, one describing his fidelity towards his most used prescriber, FCPresc, and one describing his fidelity towards his most used pharmacy, FCPharm.

The investigators intend to assess this parameter in an observational population scale database study, using standard descriptive statistics, and subsequently compare the obtained average FCPresc and FCPharm.

Furthermore, the investigators will analyze the two obtained FCs for dependency of a predefined list of variables: age, gender, number of prescriptions, whether the most frequent prescriber was a GP and whether the most used pharmacy was urban.

Finally, the investigators intend to analyze which medications (grouped using the ATC-system with 4 digits, e.g. C07A) that has the highest proportion of prescriptions that were either issued by a non-main prescriber or redeemed at a non-main pharmacy, which roughly translates into the most 'infidel' medications. To insure relevance we intend to use a cut-off-value of the medication being prescribed at least 50.000 times, which equals about 85 % of the data according to preceding analyses.

The data for this study will be obtained from the Odense University Pharmacoepidemiological Database (OPED). In brief, it is a research database with full coverage of all reimbursed prescriptions in the Region of Southern Denmark (1.2 million inhabitants). The data included in each prescription record includes the prescription holder, the prescriber, the pharmacy, the date of dispensing and a full account of the dispensed product, including substance, brand name, route of administration, ATC-code and Defined Daily Dose (DDD).

Some drugs are exempt from re-imbursement and thus not covered by the database, including benzodiazepines, oral contraceptives, laxatives and certain antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Having filed more than 9 prescriptions during 2009.

Exclusion Criteria:

* None
Fast Ultra Low Dose CT Interpretation

An ultra-low-dose CT(ULDCT) image viewer prototype was developed in an iterative fashion that aims to reduce average interpretation times of ULDCT images. Ultimately, by reducing reading time of ULDCTs, we aim to enable general replacement of X-ray by ULDCT imaging, which is theorized to have large population-level health outcome impact in terms of early detection of lung cancer, coronary calcification, and aortic aneurysm, among others.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic radiologists, diagnostic radiology fellows, and diagnostic radiology residents employed by LUMC who read CTs and x-rays as part of clinical workflow.
* Diagnostic radiologists, diagnostic radiology fellows, and diagnostic radiology residents who have been employed by LUMC who have read CT's and x-rays as part of clinical workflow.
* Diagnostic radiologists, diagnostic radiology fellows, and diagnostic radiology residents who are visiting LUMC and who read CT's and x-rays as part of clinical workflow.
* Willing and able to provide informed consent.
* Interested and able to participate in at least two study arms, even if those have not yet been scheduled.
* Proficient in Dutch and/or English.

Exclusion Criteria:

* Prior exposure to elements of the advanced reading environment, i.e., prior to the first research arm.
* Not willing and able to provide informed consent. Contacts and Locations
CYT003-QbG10 for Treatment of Allergic Asthma Bronchial

The purpose of the study is to test whether treatment with CYT003-QbG10 can improve asthma symptoms in patients with allergic bronchial asthma. The active treatment will be compared against placebo.


Eligibility Criteria:
Inclusion Criteria:

* Persistent allergic asthma bronchial requiring long-term treatment with inhaled corticosteroids
* Further criteria as defined in the study protocol

Exclusion Criteria:

* Use of oral corticosteroids within past 3 months
* Hospitalization for asthma exacerbation within past 6 months
* Uncontrolled asthma
* Contraindication to any study test or procedure
* Further criteria as defined in the study protocol