cyrilzakka/clinical-trials huggingface dataset:
Workload and Sleep Quality of Hospital Shift Nurses

A questionnaire survey was conducted to investigate the status of workload, sleep quality and the correlation between workload and sleep quality of shift nurses in Grade 3A hospitals in Beijing

The shift nurses in the top three hospitals in Beijing were included. According to the sample size calculation method of correlation coefficient in analytical research, the correlation coefficient between workload and sleep quality was obtained by consulting literature ρ=- 29, confidence level α= 0.05, β= Then the sample size calculation software pass 11.0 was used to calculate n = 99. Considering 20% sample loss, the final sample size was n = 119. The same interviewee (head nurse / nurse) was informed of the purpose and significance of this study by using the same guiding language. The head nurses were informed one-on-one by the implementer of the project and filled in the questionnaire after informed consent; The nurse survey was conducted by the project implementer himself to the head nurse of the Department for training. The head nurse informed the nurses of the Department with unified guidelines, and after informed consent, the head nurse sent the electronic questionnaire QR code to its wechat work group for filling in. The implementer of the project will check the questionnaire in time after the respondents fill in the questionnaire, and give timely feedback if there is any doubt. This study investigated the work load and sleep quality of nurses in the top three hospitals in Beijing; The survey included general information, workload and sleep quality. General information included gender, age, working years, professional title, education level, marriage and childbearing status, etc. The workload status includes mental needs, physical needs, time needs, self performance, effort, frustration, technical autonomy, decision-making autonomy and work needs. The sleep quality status of nurses in different shifts (day shift, night shift and night shift) included sleep disorder, difficulty in maintaining sleep, early wake-up, fatigue / sleepiness in working days and idle time in working days, etc.

Eligibility Criteria:
Inclusion Criteria:

1. In service nurses who have obtained the nurse practice certificate of the people's Republic of China and have been registered;
2. At present, he has been involved in shift work for more than 3 months, and the shifts include day shift, night shift and night shift;
3. No obvious psychological or mental illness, such as depression; 4 volunteer to participate in this study.

Exclusion Criteria:

* none
Aromatherapy Massage in Migraine Attacks

The aim of the study was to determine the effect of aromatherapy massage on the pain severity and quality of life in patients diagnosed with migraine in addition to medical treatment during an acute migraine attack.

In addition to medical treatments, complementary and supportive therapies are commonly used to cope with pain during a migraine attack. In recent years, aromatherapy through massage has become more common to reduce the severity of pain, make the patient painless and improve the quality of life. Aromatherapy applications are the application of pain relief oil mixtures through massage. Lavender and peppermint essential oils are mostly used in aromatherapy applications to reduce pain. Therefore, a mixture of mint and lavender oil was used in the study.

The study was planned and conducted as a randomized controlled experiment. The sample of the randomized controlled trial consisted of 70 patients who applied to the emergency department with a migraine attack and met the study criteria. Data were collected via Patient Information Form, 24-Hour Migraine Quality of Life Scale, Visual Analogue Scale, Sphygmomanometer, and Pulse oximeter. Along with the medical treatment, patients of experimental group were massaged for 15 minutes with an aromatic oil mixture (lavender and peppermint) applied on the temple and root of the neck, and this application continued for three weeks. Control group patients, however, received only medical treatment. Descriptive statistics methods, Shapiro Wilks test, Wilcoxon Signed Ranks Test, Mann Whitney U Test, Kruskal Wallis Test, Fisher's Exact Test and Chi-Square Test were used for data evaluation.

Eligibility Criteria:
Inclusion Criteria:

diagnosed with migraine according to International Headache Society 2013 Being able to speak Turkish, being between the ages of 18 and 50, being literate, not having any communication problems, agreeing to participate in the study, having vital signs within normal limits not being diagnosed with a psychiatric disorder

Exclusion Criteria:

having a headache other than migraine being the ages under the 18 having any communication problems, having vital signs above or under normal limits being diagnosed with a psychiatric disorder
miRNAs in Periodontal Disease

It has been stated that microRNA (miRNA) play an important role in development, homeostasis and immune functions, and abnormal miRNA expression may cause faster disease progression. The aim of this study was to determine miR-203, miR-142-3p, miR-146a, miR-146b, miR-155, miR-29b gene expressions in saliva of the patients with periodontal disease before and after non-surgical periodontal therapy (NSPT) and to evaluate the effect of smoking on these miRNAs. A total of 90 individuals, 30 with periodontitis, 30 with gingivitis, and 30 periodontally healthy (control group), were included. These three groups were divided into subgroups as smoking and non-smoking individuals, with 15 people in each group. NSPT was applied to patients with periodontitis and gingivitis. Saliva samples and clinical parameters were taken from at baseline and repeated 6 weeks after NSPT.


Eligibility Criteria:
Inclusion Criteria:

Have at least 20 natural teeth, excluding third molars. Periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting \>30% of the teeth, as detected on clinical and radiographical examinations.

Gingivitis patients had without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP \> 30% in the entire mouth Periodontally healthy control group had no sign of gingival inflammation, no PD \> 3mm and no evidence of attachment or bone loss

Exclusion Criteria:

History of systemic disease. Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.

Periodontal treatment during last 6 months that could affect periodontal status.

History of radiotherapy or chemotherapy. Current pregnancy, lactation or menopause.
Effect of Cyclic Tensional Force on Osteogenic Differentiation of Human Periodontal Ligament Stem Cells

The purpose of this study is to observe cyclic tensional force on the osteogenic differentiation of human periodontal ligament stem cells.

This study is to investigate the effect of the cyclic mechanical strain on the osteogenic differentiation of mesenchymal stem cells. Mesenchymal stem cells will be cultured from the periodontal ligament tissue of the premolars extracted due to orthodontic reason.

Eligibility Criteria:
Inclusion Criteria:

* Orthodontic patients who need to have premolars extracted
Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome (CRISIS I)

CRISIS I is a prospective, multicenter, randomized controlled trial, to asses the impact of intensive blood pressure control on clinical outcome of acute ischemic stroke patients with successful recanalization after endovascular therapy.

CRISIS I aims to determine the effectiveness of more intensive BP lowering target (\<120 mmHg) compared to standard BP management target (\<140mmHg) on functional outcome in patients with successful recanalization post-MT for AIS due to anterior circulation large vessel occlusion (LVO).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of AIS with anterior circulation LVO confirmed by brain imaging
* To receive MT \<24 hours after AIS onset according to local guidelines
* Successful recanalization (TICI score ≥2b) after MT
* Sustained systolic BP ≥140 mmHg (defined as 2 successive readings \<10 mins) within 60 minutes after recanalization
* Provide written informed consent (or approved surrogate)
* Perform CTA or MRI before endovascular therapy
* Signed an approved informed consents

Exclusion Criteria:

* Significant pre-stroke disability (mRS scores 2-5)
* Definite indication/contraindication to different intensities of BP lowering treatment
* Specific contraindications to any of the BP agents to be used (eg, patients who are hypersensitive (allergic) to any of the ingredients)
* Unlikely to potentially benefit from therapy (e.g. advanced dementia) or very high likelihood of death within 24 hours post-MT, judged by responsible treating clinician
* Other medical illness that interferes with outcome assessments and follow-up (e.g.advance cancer and renal failure); Women who are lactating
* Other conditions inappropriate for inclusion judged by investigators
Intrathecal Bolus Doses of Ziconotide

The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.

The intrathecal route for administration of analgesia has been in use in clinical practice for the last 3 decades. It is recommended to trial the patient with intrathecal drug therapy prior to implanting an intrathecal drug delivery device. Trials can be performed using a single bolus injection or by a continuous intrathecal infusion administered through an external catheter. Ziconotide has been approved by EMA for the treatment of chronic severe pain in 2005. So far trials of ziconotide have largely been conducted using external catheters with the drug administered by intrathecal infusion over a number of weeks. Infusions trials have been shown to be expensive, associated with a risk of meningitis and inconvenient to both patient and physician. The option of conducting a trial of intrathecal ziconotide therapy by bolus injection remains unexplored.

This study aims to evaluate the efficacy and safety of a bolus dose of ziconotide (Prialt®) to evaluate the option of continuous administration of the drug via implanted pump in the event of a successful trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient, at least 18 years of age
* suffering from severe chronic (≥ 6 months) pain, who has failed on conventional pharmacological treatment
* only patients with peripheral neuropathic pain or central neuropathic pain, due to trauma or surgery, will be included
* Average usual VASPI last week ≥ 40 mm
* Patient capable of judgment, i.e. able to understand information regarding the drug, the mode of administration and evaluation of efficacy and side effects Signed informed consent

Exclusion Criteria:

* Limited life expectancy (investigator's judgement)
* Intrathecal chemotherapy
* Known or suspected intracranial hypertension
* Known liver or kidney disease, defined as ASAT, ALAT, Total Bilirubin, ALP or S- Creatinine \> 1.2 x ULN
* Advanced cardio-pulmonary disease (investigator's judgment)
* Ongoing infection, whether systemically or locally in the lumbar area
* Coagulopathy (including medication with warfarin, clopidogrel and heparin)
* Allergy to ziconotide or any of the excipients in the ziconotide vial
* History of psychiatric disorders which in the investigator's opinion would put the patient at risk
* Pregnant or lactating woman.
* Menstruating women must use an effective contraceptive method (contraceptive pill or intrauterine spiral) during the trial period
Development and Evaluation of Functional Probiotic Powder in Human Trials

Purpose: To optimize the preparation process of probiotic powder and assess its impact on healthy athletes, providing a scientific basis for functional foods.

Procedures:

Probiotic Powder Preparation: Using vacuum freeze-drying to improve bacterial survival rates.

Human Trials: Recruiting healthy athletes aged 20-30, divided into placebo and probiotic powder groups for an 8-week trial.

Testing and Analysis: Conducting running exhaustion tests and blood biochemical analysis to evaluate the effects of probiotic powder.

Importance: Understanding the effects of probiotics on athletes helps develop better health products.


Eligibility Criteria:
Inclusion Criteria:

* Age Range: Individuals aged 20 to 30 years old.
* Health Status: Healthy, without chronic illnesses or disabilities.
* Athletic Background: Well-trained athletes with a history of regular physical activity.
* Lifestyle: No history of smoking or excessive alcohol consumption.
* Compliance and Consent: Capable of understanding and adhering to study protocols and willing to provide informed consent.

Exclusion Criteria:

* Chronic Illnesses: Individuals with unmanaged chronic diseases
* Substance Use: Current smokers or individuals with a history of substance abuse.
* Allergies and Supplements: History of food allergies or long-term use of nutritional supplements and medications.
* Probiotic and Antibiotic Use: Use of probiotics, fermented products, or antibiotics during the study period.
* Other Conditions: Pregnant or breastfeeding women, individuals with severe mental health conditions, or those participating in other clinical studies.
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of JS401

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single-dose of JS401 in healthy volunteers with normal or mildly elevated triglycerides.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects aged 18\~60 (inclusive) at the time of signing the ICF, with no less than 1/3 of either gender;
2. Fasting TG≥1.1mmol/L (100 mg/dL) and ≤ 5.0mmol/L (450mg/dL) at screening; (3) Fasting LDL-C at screening\> 1.8 mmol/L (70 mg/dL).

Exclusion Criteria:

1. Have a medical history or clinical evidence that the subject has obvious concomitant diseases (including but not limited to: cardiovascular, respiratory, digestive, urinary, neurological, blood, immunological, endocrine and metabolic, infection, etc.), or any clinically significant abnormalities found in physical examination, laboratory examination, and ECG examination, which are judged by the investigator to not meet the standards of clinical health or are not suitable for participating in clinical trials;
2. Acute or chronic infection requiring hospitalization or undergoing systemic parenteral therapy (antiviral/bacterial/fungal/parasitic, etc.) within 60 days prior to randomization;
3. Positive for syphilis antibodies, or positive for human immunodeficiency virus (HIV) antibodies, or positive for hepatitis C virus (HCV) antibodies, or positive for hepatitis B virus surface antigen (HBsAg) at screening;
4. History of substance abuse within 12 months prior to screening, or positive urine drug screening at screening;
5. History of alcohol dependence within 6 months prior to screening, or positive breath test for alcohol at screening
Immediate Pressor Response to Oral Salt

The goal of this study is to establish a diagnostic accuracy of an immediate pressor response to oral salt (IPROS) to identify salt sensitivity of blood pressure (SSBP)

Participants are given dietary salt and their BP is measured every 10 minutes for 2 hours. IPROS is diagnosed with significant mean arterial pressure increase

For SSBP, participants are put on high salt diet for a week and monitored and low salt week. The Mean arterial pressure difference between high salt and low salt is used to diagnose SSBP

Eligibility Criteria:
Inclusion Criteria:

* Participants will be included if they are males or females, aged 18-65 years.

Exclusion Criteria:

* Kidney disease, Cardiovascular disease
A Study of HS-10383 in Chinese Adult Subjects With Refractory or Unexplained Chronic Cough (RUCC)

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-designed phase 2 clinical trial to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of HS-10383 in Chinese adult subjects with refractory or unexplained chronic cough (RUCC).

The primary objectives of this study are to evaluate the efficacy of HS-10383 in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of HS-10383. The primary hypothesis is that at least one dose of HS-10383 is superior to placebo in reducing coughs per hour (over 24 hours) at Week 4.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects should have a full understanding of the study contents, process, and possible adverse reactions, and voluntarily sign the informed consent form;
2. Subjects aged 18-70 years (including the critical value) with RUCC ≥1 year (diagnosis of RUCC according to the Expert Consensus on Diagnosis and Treatment of Refractory Chronic Cough in China \[Released in 2021\]);
3. Subjects whose serum pregnancy test is negative in both screening and baseline visits;

Exclusion Criteria:

1. Subjects who are diagnosed with chronic obstructive pulmonary disease, bronchiectasis, idiopathic pulmonary fibrosis and other serious lung diseases;
2. Any physiological or mental disease or condition that may increase study risks or interfere with the conduct of the study or affect the ability to complete this study in the opinion of the investigator, such as medical history of depression;
3. Subjects who cannot meet the requirements for piror treatment or who cannot adhere to the concomitant treatment as specified in Section 6.7-Prior/concomitant medications and non-drug treatment.
4. Subjects with positive hepatitis A IgM antibody, hepatitis C antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody at screening visit; subjects with positive hepatitis B surface antigen (HBsAg) at screening (except for quantitative detection result of HBV-DNA is below the lower limit of the detection reference range).
5. Any former smoker with more than 20 packs/year; or have quited smoking for less than 6 months; or subjects who are still smoking (including e-cigarettes);
6. Subjects who have a history of serious drug, food or environmental allergies, or who are known to be allergic to the ingredients of investigational product;
7. History of drug dependence,drug or alcohol abuse in the past year;
8. Female subjects who are pregnant or breastfeeding;
9. Subjects who have previously received anything that may affect drug absorption, including but not limited to: gastrectomy, gastroplasty, any type of weight-loss surgery, vagotomy or enterotomy;
10. Subjects who have been vaccinated within 30 days before screening visit, or have a vaccination plan during the whole study period.
Coordinated Endoscopic Colorectal Cancer Screening

The investigators aim to use a randomized design to test the effects of 1) tailored physician recommendations, relative to non-specific recommendations, and 2) coordinated physician office management systems on patient adherence to colorectal cancer screening recommendations.

The investigators aim to use a randomized design to test the effects of 1) tailored physician recommendations, relative to non-specific recommendations, and 2) coordinated physician office management systems on patient adherence to colorectal cancer screening recommendations.

To accomplish these aims, the investigators propose 1) to use existing physician practice-based computerized patient registration systems to define populations of 50 to 79 year-old pri-mary care patients, 2) to use mailed questionnaires to determine colorectal cancer risk factor status and prior colorectal cancer screening history, 3) to use responses from mailed questionnaires to identify persons not adhering to colorectal cancer screening guidelines, 4) to use computer driven algorithms to help physicians prepare and deliver individually tailored and written colorectal cancer screening recommendations, and 5) to develop, implement, and evaluate a centralized service for delivering high quality screening flexible sigmoidoscopy.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* history of colorectal cancer or polyps
* flexible sigmoidoscopy within five years of enrollment
* barium enema within five years of enrollment
* colonoscopy within five years of enrollment
Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis

Aim: To investigate whether cholecalciferol (4800 U/daily) or placebo for 16 weeks reduces proteins levels associated with vascular calcification (osteoprotegerin, osteopontin, osteocalcin) in patients treated with peritoneal dialysis and 25(OH) vitamin D deficiency.

Patients with chronic kidney disease on peritoneal dialysis have very low 25-(OH) vitamin D levels. Vitamin D deficiency may be involved in generalized atherosclerosis, vascular calcification and cardiovascular mortality. Among others, Osteoprotegerin (OPG) has been implicated in the pathogenesis leading up vessel calcification in this patients. Furthermore, very low levels of 25-(OH) vitamin D in peritoneal dialysis patients are associated with increased levels of OPG and high values of vascular calcification scores in x-rays.

It is unknown whether cholecalciferol supplementation in patients on peritoneal dialysis with low levels of 25-(OH) vitamin D could change the proteins associated with vascular calcification.

The objective is to conduct a randomized, double-blind, placebo-controlled study focusing on the impact of Cholecalciferol substitution in 25-OH vitamin D deficient peritoneal dialysis patients on circulating OPG and other osteogenic biomarkers levels during 16 weeks of intervention.

Moreover, the impact of cholecalciferol on serum calcium and phosphorus levels, Kidney Disease Quality of Life Short Form, and ultrasound characteristics of carotid arterial will be performed during the first four weeks after inclusion, and after 28 weeks postintervention.

Peritoneal dialysis patients found to have 25-(OH) vitamin D levels \<20 ng/ml will be included and will be randomized to receive either oral cholecalciferol therapy or placebo. Cholecalciferol will be administered at a daily dose of 4800 IU over a time period of 16 weeks.

All in all, 58 subjects will be included in this study.

Eligibility Criteria:
Inclusion Criteria:

* Peritoneal dialysis treatment for at least 3 months.
* Concentrations of 25-oh vitamin D \<20 ng / mL
* Corrected calcium \<10.5 mg / dL
* Serum phosphorus \<7.0 mg / dL
* Intact parathyroid hormone \> 50 pg / mL and \<1500 pg/mL

Exclusion Criteria:

* Active participation in another protocol.
* Vitamin D deficiency due to a hereditary disease or liver disease.
* Use of cholecalciferol ≥ 2000 IU per day within 6 months prior
* New prescription of calcitriol or paricalcitol at any dose within three months prior to the intervention (The subjects may be taking calcitriol or paricalcitol only if these drugs are taken at least three months before and no substantial changes in dosage have been made).
* Use of bisphosphonates.
* Treatment with anticonvulsants or other drugs that affect the metabolism of vitamin D.
* Pregnancy and lactation.
* Active cancer or other active inflammatory disease.
* HIV or AIDS