cyrilzakka/clinical-trials huggingface dataset:
The Manikin Study of Chest Compression With One Accelerometer Feedback Device

Chest compression (CC) feedback devices are used to perform CC measurements effectively and accurately on patients in hospital beds. However, these devices do not take account of the compression of the mattress, which results in overestimation of CC depth. This study is the validation study to demonstrate that a new method using one accelerometer(U-cpr) is useful to overcome this limitation and thus measure compression depth more accurately when performing cardiopulmonary resuscitation (CPR) on patients.

Data collection The participants will be divided into three groups by random drawings. Each performer in the three-groups will compress the chest of the manikin on the bed with real-time 5cm,6cm and 7cm feed-back by one accelerometer (U-cpr).We will use two beds \[Stryker ST104-747(Transport stretcher®, 760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US) ,Shinchang SB-34p (Transport stretcher® , 850 x 2080 mm,Shinchang Co.,Busan,ROK)\]. Each participants will do 6 cycles of chest compression and 1cyle will be 2minutes. Between each cycles, participants will take a rest 5minutes.

Eligibility Criteria:
Inclusion Criteria:

* Postgraduates year 1,2,3,4 and Emergency physicians in emergency department

Exclusion Criteria:

* Wrist or Low back disease
rTMS in the Prevention and Treatment of Postoperative Executive Dysfunction

Repetitive transcranial magnetic stimulation (rTMS) is a new neuroelectrophysiological technique developed in recent years. rTMS can affect local and distant cortical function, promote regional reconstruction of cortical function, and has clear curative effect on a variety of neuropsychiatric diseases. Previous study found that rTMS can improve postoperative cognitive function, and there may be a dual biological mechanism. Brain network abnormalities may be the direct cause of postoperative cognitive dysfunction, and neuroinflammation is one of the key molecular mechanisms behind postoperative cognitive dysfunction . rTMS may play a role in the regulation of brain network and inflammatory molecules, and thus play a role in the prevention and treatment of postoperative cognitive dysfunction (POCD).

This study intends to use neuroimaging methods to observe the correlation between neuroinflammation and brain network abnormalities in patients with POCD, and verify the repair effect of rTMS intervention on the pathological changes, so as to provide a theoretical basis for further optimizing the establishment of rTMS localization therapy model for POCD.

Eligibility Criteria:
Inclusion Criteria:

* Heart valve replacement.
* 45 to 75 years old.

Exclusion Criteria:

* definite cerebral infarction.
* failure and decompensation of vital organs
* physical metal implants.
* severe neuropsychiatric disorders.
* less than 9 years of education.
* alcohol abuse.
* drug dependence.
Coronary Heart Disease Incidence: Depression & Inflammation Risk

To examine the associations among depression, inflammation, and coronary heart disease using an existing data base and associated plasma samples.

BACKGROUND:

Classic risk factors for coronary heart disease (CHD) do not yet predict the majority of new cases. Of the novel risk factors recently explored, elevated depressive symptoms have been found in a number of prospective studies to predict new CHD cases, as have inflammatory markers, including high sensitivity C-Reactive Protein (CRP), interleukin-6 (IL-6), and intercellular adhesion molecule. Interestingly, depression and inflammatory markers have high covariation, and intervention studies indicate that reducing depression may reduce peripheral inflammation, while successfully treating inflammation may ameliorate depressive symptoms. It becomes critical then to know if these candidate CHD risk factors are independent or dependent of the other in the prediction of CHD incidence.

DESIGN NARRATIVE:

The study will determine if depressive symptoms and inflammatory markers are independent or dependent CHD risk factors, when controlling for the other known CAD risk factors. A population-based prospective study (the Nova Scotia Health Survey; NSHS95) was conducted almost 10 years ago, in which participants were randomly selected from the socialized medical registry, which includes all citizens. All classic CHD risk factors were obtained at baseline (age, sex, race, fasting lipids, diabetic status, family CHD history, resting blood pressure, exercise levels, body mass index, smoking status, and socioeconomic status). Depressive symptoms as assessed by the Center for Epidemiological Studies Depression scale were also obtained at baseline. Plasma blood samples were obtained and maintained in a -80 degree (Celsius) freezer. Participants gave permission for medical registry records to be linked to their survey data, so that objectively documented previous and future CAD events could be detected. The study will assay plasma samples for CRP, IL-6 and ICAM-1 and then statistically model the associations among depression, inflammation and CHD incidence.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Able to speak English
* Enrolled in the Nova Scotia Health Study (NSHS95)

Exclusion Criteria:

* Pregnant
* Active military personnel
* Lived in Nova Scotia province for less than 3 months
* Unable to provide informed consent
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

This prospective observational study will evaluate the long-term safety of MabThera/Rituxan (rituximab) in participants with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis. Data will be collected for a maximum of 4 years from participants initiated on MabThera/Rituxan therapy by their physician according to prescribing information.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), according to Chapel Hill Consensus Conference Definitions for MPA and American College of Rheumatology (ACR) Criteria for the Classification of GPA
* Disease severity requiring rituximab treatment per the investigator's assessment

Exclusion Criteria:

* Prior use of rituximab (except if received within 4 weeks of screening)
* Known hypersensitivity to rituximab, to any component of the product, or to murine proteins
* Pregnant or breastfeeding women
* Diagnosis of Churg-Strauss syndrome
Weight Loss and Abdominal Fat Responses to Different Diet Compositions

The purpose of this study is to assess the effectiveness of two different reduced calorie diets that have different combinations of carbohydrate, fat, and protein content in 2 groups of study participants: insulin sensitive participants and insulin resistant participants. The hypothesis of the study is that people with high and low levels of insulin resistance may respond differently to different diet compositions in a real-world environment using meals that are commonly available.


Eligibility Criteria:
Inclusion Criteria:

* Females between 18 and 65 years of age.
* BMI 30-40 kg/m2
* Stable weight within 10 lb (+/-) for last 2 months

Exclusion Criteria:

* Pregnant or lactating.
* Must not currently be part of a structured weight loss program
* Taking a medication for diabetes (such as insulin, metformin, glyburide, glipizide, Byetta, pioglitazone, or rosiglitazone) or a medication such as systemic glucocorticoids that are known to affect blood sugar or blood insulin.
* Beck Depression Inventory (BDI Score \>19 and/or positively endorses the suicide question on the BDI-II)
* Taking any chronic medication that has not had a stable dose for 1 month or longer.
* Diabetes mellitus defined as a fasting glucose ≥ 126 mg/dL on screening.
* Taking medications or dietary supplements that cause weight gain or weight loss (eg. antipsychotics (Seroquel, Zyprexa, and Risperdal) and/or anorectics).
* Clinically significant laboratory abnormalities at the opinion of the investigators.
* History of Bariatric Surgery
* A history of:

  * Type 2 diabetes, type 1 diabetes, or diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
  * Liver disease, such as cirrhosis, or chronic active hepatitis B or C.
  * Use of investigational drugs within 30 days of visit 1
  * A pacemaker.
  * Hospitalization for depression in the past 6 months, history of moderate to severe major depression.
  * Any other condition that in the investigators' or sponsor's opinion could interfere with the results of the trial.
Rapid Screening for Olfactory Disorders in Covid-19 Infection

Loss of smell is very frequently found in Europe during Covid-19 attack. This symptom was not initially expected as part of the classic symptomatology. This loss of smell mainly concerns patients with few or no symptoms, without criteria of severity and usually treated on an outpatient basis. As a result, given the unexpected occurrence of this symptom (with less awareness in the general and medical population) and the potential risk of contamination of Covid+ and anosmic subjects (due to their less symptomatic form), it is interesting to be able to propose large-scale screening for loss of sense of smell in order to preferentially direct subjects diagnosed as anosmic towards RT-PCR-type screening. In the medium term, the loss of smell seems to persist after the infectious phase, with delayed or persistent recovery, which can lead to negative psychological repercussions.

The objective is to propose large-scale screening of the general population for loss of sense of smell during a pandemic period, in order to facilitate diagnostic orientation of the population. The diagnosis of loss of smell will be carried out using a simple olfactory test in the form of an olfactory stick to be smelled.


Eligibility Criteria:
Inclusion Criteria:

* Subject presenting himself at the covid-19 screening centre set up by the city of Nice

Exclusion Criteria:

* Presence of a sensory deficit (auditory or visual) preventing the subject from answering the questions perfectly during the olfactory test.
* Subject receiving cancer chemotherapy
Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients

This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir administered for 12 weeks in patients with Hepatitis C (HCV) genotype1. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).


Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C virus (HCV) genotype 1 infection (confirmed at screening).
* HCVRNA greater than 10,000 IU/mL at screening.
* Participant must be willing and able to comply with the protocol requirements.
* weight was more than 40 kg.
* age is between 18-75,either sex.

Exclusion Criteria:

* Co-infection with hepatitis B virus or human immunodeficiency virus (HIV).
* Infection with HCV non-genotype 1,or Infection with mixed genotype,or Genotype cannot be confirmed.
* Medical history of major functional organ transplantation.
* Suffering from serious blood system disease(such us Thalassemia/Sickle Cell Anemia).
* Participation in a clinical study within 3 months prior to first dose
Heartbeat Sensitivity Calibration Using the ECG Accessory

This is an observational, un-blinded, non-significant risk, non-interventional study designed to collect ECG data on at least one subject out of a pool of up to three (3) healthy male subjects at one clinical site (Clinical Trials of Texas). Cyberonics will be collecting ECG recordings collected by an investigational device for comparison with conventional ECG recordings. This data will be used to validate a new device under development.

This is an observational, un-blinded, non-significant risk, non-interventional study designed to collect ECG data on at least one subject out of a pool of up to three (3) healthy male subjects at one clinical site (Clinical Trials of Texas). If acceptable data is acquired from one (1) subject the remaining subjects will not be entered into the study. Three (3) to six (6) researchers will record data, but all direct contact with the subject will be done by the study coordinator or principal investigator (PI).

The purpose of this study is to validate a Heartbeat Sensitivity calibration process utilizing the Cyberonics ECG Accessory. The non-invasive, passive collection of ECG signals from a resting healthy subject will be used to validate the use of the ECG Accessory with the Model 201 Programming Wand, Model 250 VNS Programming Software Version 9.0, Model 106 Generator, and ECG monitor (DRE True ECG-12), as well as the associated Instructions for Use. The data generated from this exercise will be used in future clinical trials utilizing this device.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients must be 18 years or older, male, and of any race.
* 2. Patient must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements.
* 3. Patient must be willing and able to complete informed consent and HIPAA authorization.

Exclusion Criteria:

* 1. Subjects with skin abnormalities or conditions that would interfere with ECG electrode patch placement or cause subject discomfort with patch placement.
* 2. Subjects report history of allergies or sensitivity to adhesive tapes or patches.
* 3. Subjects with major health condition that in the investigator's judgment would prevent the subject's successful completion of the study.
Growth of Infants Fed a New Term Infant Formula

To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk

Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent signed and dated
2. Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium
3. Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
4. Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study.
5. Infants whose parent(s)/LAR have a working freezer.
6. Healthy term, singleton infant at birth.
7. At enrollment visit, post-natal age ≤ 14 days (date of birth = day 0).
8. At enrollment, birth weight ≥ 2500g and ≤ 4500g.
9. For formula-fed group, infant of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment.

Exclusion Criteria:

1. Infants with conditions requiring infant feedings other than those specified in the protocol.
2. Infants receiving complementary foods or liquids.
3. Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results.
4. Infants who are presently receiving or have received prior to enrollment medications that could interfere with the interpretation of study results.
5. Infants or infants whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.
Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Plaque and Gingivitis.

Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1, 3, and 6, weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form.
* Male and female subjects aged 18-70 years, inclusive.
* Availability for the six-week duration of the clinical research study.
* Good general health based on the opinion of the study investigator
* Minimum of 20 permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial mean plaque index of at least 0.6 as determined by Navy Plaque index.

Exclusion Criteria:

* Presence of orthodontic appliances.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
* History of alcohol and/or drug abuse.
* Self-reported pregnancy and/or lactating subjects.
Development of an Anxiety Sensitivity-Based Intervention for Substance Use and Anxiety Comorbidity

The aim of the current study is to develop and pilot test an anxiety sensitivity-based intervention for co-occurring substance use disorders (SUDs) and anxiety. Research questions include determining whether a broadly-applicable AS-based intervention can significantly decrease both substance misuse and anxiety. Secondary aims include examining the impact of this intervention on general functioning and depressive/anxious symptoms. In phase I, an initial pilot was conducted to examine the feasibility, safety, and patient satisfaction with the protocol, and to estimate potential efficacy of the protocol. In phase II, participants will be randomized to the intervention or a control condition.

The aim of the current study is to develop and pilot test an anxiety-sensitivity based intervention for co-occurring SUDs and anxiety. In the proposed study, the investigators will develop, refine, and pilot-test an innovative cognitive-behavioral therapy (CBT) for patients who suffer from substance use disorders as well as anxiety. The goal of the research group in the proposed study is to design a protocol that can be testable on a larger sample within an externally-funded, randomized controlled trial. The investigators plan to submit a proposal for this larger grant to the National Institute on Drug Abuse, as outlined in our external funding statement.

Research questions include determining whether a broadly-applicable anxiety sensitivity based intervention can significantly decrease both substance misuse and anxiety. Secondary aims include examining the impact of this intervention on general functioning and depressive/anxious symptoms. In this translational research project, strategies that have been demonstrated to impact the psychological mechanisms thought to underlie both illnesses will be tested in a "real world" clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* score higher than 25 (established clinical cutoff) on the Anxiety Sensitivity Index (ASI; Peterson \& Plehn, 1999)
* meet the DSM diagnostic criteria for current substance abuse or psychological dependence

Exclusion Criteria:

* active psychosis, suicidality, mania, or current physiological withdrawal symptoms that necessitate medical detoxification; no substance use in the past 3 months
UCSD Get Fit, Be Fit Study

The purpose of the Get Fit, Be Fit Study is to examine the effect of incorporating pistachios in an intensive 4-month cognitive-behavioral weight loss intervention in overweight and obese men and women, to examine effects on metabolic factors, and to monitor and examine changes in dietary intake and food choices during the intervention, in a randomized controlled study.

This study investigates whether pistachios help to promote weight loss and improve metabolic and cardiovascular disease risk factors in 100 overweight or obese men and women who are participating in a 4-month behavioral weight loss intervention. Participants will be assigned to a cognitive-behavioral weight loss intervention and will be provided either general dietary advice as a component of the behavioral curriculum or prescribed an individualized pistachio-enriched reduced-energy diet plan. The pistachio-enriched diet will prescribe 42 g/day of pistachios, or approximately 13-20% (averaging 18%) of energy intake across a range of 1200-1800 kcal/day. Dietary intake will be assessed at three time points (baseline, one month, and four months) to examine changes in dietary intake and food choices that may be indicative of compensatory intake in response to regular nut consumption. Results from this study will contribute to understanding the role of pistachios in weight control, including further knowledge of the metabolic factors linked to chronic disease, and will expand knowledge of how pistachios in the diet may contribute to the prevention and management of obesity.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women who reside in the San Diego area
* Age 21 and older
* BMI ≥ 27.0 kg/m2 and ≤40 kg/m2
* No known allergy to tree nuts
* Non-diabetic
* Non-smoker
* Willing and able to participate in clinic visits, group sessions, and telephone and Internet communications at specified intervals
* Able to provide data through questionnaires and by telephone
* Willing to maintain contact with the investigators for 6 months
* Willing to allow blood collections
* Capable of performing a simple test for assessing cardiopulmonary fitness
* Willing and able to be physically active

Exclusion Criteria:

* Inability to participate in physical activity because of severe disability
* Inability to restrict consumption of nuts for four months
* History or presence of a co-morbid disease for which diet modification and increased physical activity may be contraindicated
* Self-reported pregnancy or breastfeeding or planning a pregnancy within the next year
* Currently actively involved in another diet intervention study or organized weight loss program
* Having a history or presence of a significant psychiatric disorder or any other condition that, in the investigator's judgment, would interfere with participation in the trial.
* Prior to enrollment
* Subjects will be screened for diabetes and considered ineligible with a fasting blood glucose ≥125 mg/dL.