cyrilzakka/clinical-trials huggingface dataset:
Exploratory Study of Effective Core Formula of Chinese Medicine to Treat Primary Insomnia

The objective of this study is to screen the effective core formulation in insomnia treatment with Chinese medicine with a double-blind, randomized, placebo-controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 65 years,
* meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) of insomnia,
* Spiegel scale score is ≥ 18,
* The informed consent must be obtained from patient

Exclusion Criteria:

* total sleep time ≤ 2 hours,
* secondary insomnia,
* Self-rating Anxiety Scale (SAS) score ≥ 18,
* Beck Depression Inventory (BDI) score ≥ 6,
* having hypertension, diabetes, stroke, and coronary heart disease,
* have drug abuse history,
* pregnancy or preparing to pregnancy,
* used immunotherapy or hormone therapy in past 1 years,
* participating in another clinical trial.
Neutrophil Lymphocyte Ratio as a Predictor of Outcome in Critically Traumatic Patients

Neutrophil lymphocyte ratio NLR is an important index that evaluate the inflammatory status . It is a cost effective and readily available , and simply calculated , so that why investigators try to use it as a predictor of short term survival in the critically ill patients

NLR will be used as predictor for short term survival and patients stay in ICU in 2 groups of patients . Investigators will use it in a group of Medical Critically ill patients as respiratory failure , neuromuscular disorders , renal impairment . the other group is the critically ill surgical patients , as patients with multiple trauma , post major surgery

Eligibility Criteria:
Inclusion Criteria:

* Critically ill trauma patients

Exclusion Criteria:

* auto immune disease endocrine disease renal dysfunction hepatic dysfunction malignancy smoking
To Relieve Pain and Anxiety - an Intervention Study in Ambulance Services

This is an intervention study focusing on both medical and nursing questions. The study is a joint project between the Ambulance services at four cities in West Sweden and Knowledge and research centre, PreHospen at University of Borås. The aim is to prove the importance of a caring relation between a patient and a caregiver in cases when a caregiver treats a patient with benzodiazepines (Midazolam). The overall aim is to show that knowledge and skills in both caring science and medicine can be applied at the same time in order to relieve pain and anxiety in acute myocardial disease.

The nursing intervention involves a professional development course for caregivers. The course is expected to deepen the caregivers' knowledge about the encounter with patients as well as cardiovascular treatment.

Following questions are formulated:

A. What are the effects regarding relieving pain and anxiety in acute myocardial disease? B. What are the effects regarding circulatory influence? C. What are the effects regarding patients' experiences of the ambulance services? D. What are the effects regarding number of care days in relation to acute myocardial disease? E. What are the effects of patients' disease complications?


Eligibility Criteria:
Inclusion Criteria:

1. Patients in Ambulance service with chest pain and suspicion about acute coronary syndrome.
2. At least 4 on a Coloured Analogue Scale.

Exclusion Criteria:

1. Blood pressure less than 100 mmHg
2. Children under 18 years
3. Under the influence of alcohol
4. Under the influence of drugs
5. Treatment with benzodiazepines
6. Disorientated
7. Communication problems
8. Trauma
Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches

The aim of the study is to compare the accuracy of peripheral blood oxygen saturation measurements using smartwatches from three manufacturers compared to a standard medical pulse oximeter.

The aim is to create a study that compares multiple smartwatch models simultaneously with a standard medical pulse oximeter using a single measurement methodology. According to the available literature, no such study exists. The methodology of the study and the subsequent statistical evaluation are based on the guidelines of the standard ČSN EN ISO 80601-2-61, which specifies requirements for the basic safety and necessary functionality of pulse oximetry devices. The comparison will be performed non-invasively in healthy volunteers during gradual desaturation in the range of 70-100 % SpO2 (normobaric hypoxia). The data obtained could help to increase the awareness of the possibilities of SpO2 monitoring using smartwatches in medical conditions that are manifested by a decrease in SpO2 level over a longer time period, where measurement with a conventional oximeter is impractical.

Eligibility Criteria:
Inclusion Criteria:

* Passing the initial examination, which will determine the following data: wrist circumference, heart rate, blood pressure and blood oxygen saturation

Exclusion Criteria:

* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* injury to the upper limbs or hands that could affect the peripheral perfusion
* diabetes
* hypotension or hypertension
A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR).

Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.


Eligibility Criteria:
Main Inclusion Criteria:

1. Voluntarily sign the informed consent form.
2. Seasonal allergic rhinitis has been prevalent for at least 2 years.
3. Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
4. Positive SPT or serum-specific IgE test results.
5. Symptom severity scores for the season met the enrollment criteria.

Main Exclusion Criteria:

1. Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
2. Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
3. Subjects with poorly controlled recent asthma conditions.
4. Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
5. Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.
6. Have a serious underlying medical condition that, in the opinion of the investigator, may pose a risk to subject safety by participation in a clinical trial.
PACAP-38 Infusion in Patients With Cluster Headache

A randomized, double-blinded, two-way crossover study investigating the headache inducing capabilities of PACAP-38 in patients with cluster headache. Forty-five patients (15 episodic patients in cluster, 15, episodic patients in remission and 15 chronic cluster headache patients) are expected to participate. Each patients will on two separate study days in a randomized way receive an infusion of PACAP-38 and VIP over 20 minutes followed by an observation period of 70 minutes. Blood samples for investigation of VIP, PACAP38; CGRP, NSE, Histamine and Tryptase will be drawn at fixed time-points during experiment.


Eligibility Criteria:
Inclusion Criteria:

* Episodic or chronic cluster headache according to international classification of headache disorders
* Age 18-65 years
* Weight 50-100 kg
* If women of childbearing potential, then must use safe contraceptives

Exclusion Criteria:

* Episodic tension-type headache \> 15 days per month
* Other primary headache disorders, except tension-type headache \< 5 days per month
* Episodic cluster headache patients outside cluster must be completely headache free a minimum of 8 hours prior to experiment
* Episodic cluster headache patients in cluster and chronic cluster headache patients must be completely headache free a minimum of 4 hours prior to experiment
* Current or recent use (30 days) of injected or oral corticosteroids
* Pregnant or lactating women
* A history or clinical signs of hypertension (BP \> 150mmHg systolic / 100mmHg diastolic)
* A history or clinical signs of hypotension (BP \<90 mmHg systolic / 50mmHg diastolic)
* A history of cardiovascular or cerebrovascular disease
* A history of psychiatric disease or substance abuse
* A medical history or clinical signs of disease that according to investigator would preclude participation in the study
Caretaker Hemodynamic Parameters Validation

Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings, continuous beat-by-beat left ventricular ejection times (LVET) against matching LVETs obtained from central catheters, cardiac output (CO) and stroke volume (SV) measures against thermo-dilution and Fick measurements, and standard HRV parameters based on Caretaker-provided inter-beat intervals (IBI) against the same HRV parameters obtained from ECG-based IBIs.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age, who are able and willing to participate and have given written assent

Exclusion Criteria:

* Unable to give written assent

  * \<18 years of age
  * No or poor finger pulse, as determined through visual inspection for ischemic hands
Effects of Intravenous Anesthesia and Balanced Anesthesia on Flash Visual Evoked Potentials

Intraoperative flash visual evoked potentials (FVEPs) could monitor visual function during neurosurgery. There are fewer reports comparing the effects of sevoflurane-propofol balanced anesthesia and propofol-based total intravenous anesthesia under comparable bispectral index (BIS) levels on the amplitude and latency of flash visual evoked potentials (FVEPs) for sellar or parasellar tumors resection neurosurgeries.

The overall incidence rate of sellar tumors is 10-20% of brain tumors. Most of the initial symptoms of this tumor are visual or visual impairment. One of the primary complications of these operations is visual impairment, which directly relates to the quality of patients' life. Flash visual evoked potentials (FVEPs) is an important means of intraoperative visual function evaluation under general anesthesia. Intraoperative visual function damage can be avoided or reduced by observing the changing of FVEPs waves to guide the choice of surgical path.

However, since the diversity of anesthetic drugs and methods, there is still a great uncertainty impact on FVEPs, which will interfere with the interpretation and judgment of surgeons and neuroelectrophysiological physicians respect to the changes of FVEPs amplitude and latency, and further affect the operation decision-making. Therefore, it is urgent to establish a perfect anesthesia method for intraoperative monitoring of FVEPs. Although total intravenous anesthesia has been widely accepted for FVEPs monitoring, there are still some limitations, such as the possibility of intraoperative body movement and cough due to the restriction of muscle relaxant use under electrophysiological monitoring, as well as the depression on FVEPs of high maintained dosage under total intravenous anesthesia. The purpose of this study was to investigate the feasibility of FVEPs monitoring during endoscopic sellar tumor resection under combined intravenous anesthesia compared with total intravenous anesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years;
2. ASA I-III;
3. Elective sellar or parasellar tumors resection;
4. Informed written consent

Exclusion Criteria:

1. Preoperative visual acuity\<0.3;
2. BMI\>30kg/cm2;
3. Uncontrolled hypertension, diabetes or cardiac diseases;
4. Preoperative cognitive disorders;
5. Sedatives, alcohol or analgesic addiction history;
6. Allergy to drugs of this study or contact allergy to Silicone products
Treatment of Asymptomatic Bacteriuria in Pregnancy

This is a prospective randomized controlled day comparing the efficacy of three-day antimicrobial treatment of asymptomatic bacteriuria (ASB) in pregnancy to the standard seven-day treatment. Half the patients will receive 3-day treatment and the other half will receive 7 days of antibiotics.

The current standard of practice is to treat pregnant patients with ASB with a 7-day course of oral antimicrobial agents. If bacteriuria persists women are retreated with the same of different agent for a second course of 7 to 14 days and they may be subsequently placed on prophylaxis.

In nonpregnant women, an uncomplicated lower urinary tract infection may be treated with a short course regimen from 1 to 3 days. This approach has similar rates of persistent bacteriuria or symptoms following treatment when compared to women treated with a more conventional approach. If the infection recurs or persists, the patient may then be treated with the more traditional 7 to 14 day course. The advantages of single-dose regimens are cost and patient compliance, but a major disadvantage is the failure to eradicate uropathogens from the vaginal reservoir, which results in more frequent early recurrences.

The three-day regimen is advocated to maintain the advantages of lower costs and patient compliance but improving cure rates. Multiple studies have shown the advantage of even a short course of antibiotics as opposed to no treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ≥ 18 years of age seeking prenatal care at the Academic Obstetrics and Gynecology Center at St. Joseph Mercy Hospital, Ann Arbor, Michigan
* Randomization will occur if the patient every has a urine culture demonstrating ≥10,000 cfu/ml of a pathogenic urinary tract organism

Exclusion Criteria:

* Symptomatic bacteriuria (cystitis or pyelonephritis) at the time of urine collection
* Previously treated bacteriuria in current pregnancy
* Past medical history of known congenital or acquired urinary tract anomaly or abnormality (i.e. pelvic kidney, single kidney, renal transplant)
* Any antibiotic use within the week prior to urine sampling
* Urine culture revealing growth of the following organisms: Lactobacillus, coagulase-negative staphylococcus
Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).

The main objective of this study is to evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections.

Prospective, prospective, multicentre, double-blind, randomised, multi-centre study of three parallel groups of patients:

* Group 1 (n=15): standard of care + C1 inhibitor
* Group 2 (n=15): standard care + icatibant + C1 inhibitor
* Group 3 (n=15): standard support + placebo

The study has two parts:

* A 4-day (96-hour) therapeutic part during which the patient will be evaluated nine times (H0, H4, H12, H24, H36, H48, H60, H72 and H96).
* A follow-up part of 6 days with at least two assessments (D7 and D10).

The maximum duration of patient participation in the study will be 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age, having read and signed the consent form for participation in the study after the reflection period (≤ 15 minutes)
* Patient screened for COVID+ by RT-PCR on nasopharyngeal swab
* Patient with at least three of the following respiratory signs:

  * Temperature \>38° C
  * Non-productive dry cough
  * Presence of crackling rales on auscultation
  * Respiratory discomfort felt by the patient
  * Heart rate \> 90/min
  * Respiratory rate \>20/min
  * O2 saturation ≤ 93%
* Patient whose clinical condition, in the opinion of the investigator, requires hospital monitoring.
* Patient who would have been monitored and treated outside of study participation, including prevention of thromboembolic risk with LMWH.

Exclusion Criteria:

* Patient with pre-existing respiratory disease (cancer, COPD, asthma, emphysema) or smoking history of \> 25 years)
* Patient with a known allergy to one of the study products
* Patient treated with anti TNF, IL1 or IL6
* Patient requiring immediate intubation
* Patient on a low sodium diet
* Patient under protective custody, guardianship or trusteeship
* Patient not affiliated to the French social security system
* Patient participating in another therapeutic protocol
* Pregnant or likely to become pregnant (woman of childbearing age without effective contraception and without HCG dosage)
* Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient
Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents

This study will determine the differential cumulative mean number of isoniazid (INH) pills completed over 9 to 12 months for adolescents assigned to one of the following two groups: 1) peer adherence coaching, parent training, and self-esteem/life skills counseling; or 2) self-esteem/life skills counseling alone. The study will also estimate the costs and cost effectiveness of peer adherence coaching versus control procedures; this will be done from a provider and societal perspective.

BACKGROUND:

Tuberculosis (TB) was responsible for almost one billion deaths in the 20th century. It is epidemic in the developing world and immigrants introduce TB to developed nations. TB control requires treatment for latent TB infection (LTBI) and active disease, as well as adherence to medical regimens. This study will determine the effectiveness of a public health model of LTBI control among high-risk adolescents. The integration of behavioral science, medical services, parent instruction, and assistance from schools and clinics (coordinated by the county health department) is based on recommendations from the Centers for Disease Control and Prevention (CDC). The effectiveness of this system is dependent, in part, on patient adherence.

DESIGN NARRATIVE:

The primary outcome of this study is adherence to an INH treatment regimen. For a given participant, adherence is assessed every 30 days, with the final outcome determined 12 months after treatment start date. Adherence is assessed using participant recall, urine testing for INH metabolites, pill counts, and medication event monitoring system (MEMS) caps.

The key secondary outcomes are parent knowledge and practice of intervention support procedures, parent knowledge of TB, self-esteem effects and life skills acquisition, cost and cost effectiveness of the intervention, and knowledge and practice of LTBI care by providers at participating community clinics.

Eligibility Criteria:
Inclusion Criteria:

* PPD positive
* San Diego County residents (without plans to relocate out of the county in the 12 months after study entry)
* Able to respond to the interview questions in English or Spanish
* Eligible for INH treatment

Exclusion Criteria:

* Receiving treatment in Mexico (due to differing medications and length of treatment)
Increasing Detection of Sub-Clinical Atrial Fibrillation in Defibrillator Patients With the Use of a VDD-ICD Lead

This study aims to compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.

Recipients of implantable defibrillators (ICD) are at high risk of developing both AF and stroke, given the presence of multiple cardiovascular risk factors. Oral anticoagulation can prevent most strokes in patients with AF; provided that AF is recognized before a stroke occurs. Up to about 40% of incident AF may be sub-clinical, producing minimal or no symptoms, or being too short to allow detection.

DX AF is a prospective, randomized-controlled, open-label trial. Patients who are identified on clinical grounds for a single-chamber ICD will be randomized to a VDD ICD (experimental group) or single chamber ICD (control group).

The study will compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic or non-ischemic cardiomyopathy,
* LVEF\<50%, scheduled for primary or secondary prevention ICD
* Treating physicians feel that the use of single chamber ICD is appropriate
* No ECG-documented history of AF or flutter
* Age \> 50 years

Exclusion Criteria:

* Known AF or flutter
* Current use of class I or III anti-arrhythmic medications
* Participants unwilling to attend study follow-up visits, considered unreliable for compliance or with an anticipated life expectancy less than 3 years
Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord Injury

Severe trauma induces massive metabolic changes that are characterized by hypermetabolism with increased energy expenditure and catabolism. Early enteral and, if necessary, parenteral feeding is a major focus of modern intensive care medicine.

After acute spinal cord injury, denervation of skeletal muscle leads to a massive loss of muscle mass in the area below the level of injury. This dramatic muscle atrophy again leads to a decrease in energy expenditure. Whereas other survivors of severe trauma typically regain muscle mass during rehabilitation, spinal cord injury patients typically continue to lose muscle mass over time, which also leads to changes in body composition. The time course of these changes is not known. Continuing nutrition without adaption to the reduced energy expenditure leads to weight gain and adiposity, exposing many chronic spinal cord injury patients to the known unfavorable metabolic consequences. Knowledge of the time course of these changes would help to provide adequate caloric intake to the patients and improve our ability for nutrition counseling.

The investigators plan a prospective clinical trial in 25 acute spinal cord injury patients to determine the changes in energy expenditure and body composition. Major inclusion criteria are acute traumatic spinal cord injury, age 18-70, neurological level above L1, AIS (American Spinal Injury Association Impairment Scale) A, B or C.

Measurements of energy expenditure, body composition and nutritional markers in venous blood are scheduled 2, 6, 10 and 14 weeks after spinal cord injury and at the end of rehabilitation (at the latest after 26 weeks).


Eligibility Criteria:
Inclusion Criteria:

* patients admitted for acute treatment and rehabilitation after traumatic spinal cord injury
* no longer then two weeks after onset of spinal cord injury
* age 18 - 70 years
* body mass index 18-30
* neurological level C4 to Th12
* American Spinal Injury Association Impairment Scale (AIS) A, B or C

Exclusion Criteria:

* complications during acute treatment, which make study participation impossible or would endanger the recovery of the patient
* pre-existing diabetes mellitus type 1 and 2
* pre-existing hypercholesterolemia
* untreated hypothyroidism or hyperthyroidism
* invasive mechanical ventilation
* cardiac pacemaker