cyrilzakka/clinical-trials huggingface dataset:
Specific Small RNA in Plasma for Predicting Diaphragm Dysfunction in Mechanically Ventilated Patients

Through the literature screening of MyomiRX 7, the detection of mechanical ventilation group, difficult withdrawal unit and healthy adult plasma levels of MyomiRX in the evaluation of function and skeletal muscle thickness of the diaphragm, the correlation analysis of 7 kinds of MyomiRX and diaphragmatic dysfunction. The research value of this project is to explore the predictive value of plasma MyomiRX level on diaphragmatic dysfunction in patients with mechanical ventilation, and to lay the foundation for finding the target of VIDD diagnosis and treatment

1. research content (1) screening MyomiR through literature review (2) selection of mechanical ventilation group, difficult withdrawal units and three healthy adult groups, method for the detection of plasma MyomiRX level and clinical assessment of diaphragmatic function, observation of the relationship between MyomiRX level and diaphragmatic dysfunction, prediction of plasma MyomiRX levels in patients with mechanical ventilation for diaphragmatic dysfunction in value.
2. research objectives Objective to investigate the predictive value of specific minute RNA in plasma muscle tissue on diaphragmatic dysfunction in mechanical ventilation patients Experimental grouping (1) the control group of mechanical ventilation (time of examination, preoperative, admission to ICU and before extubation); (2) difficulty in withdrawal of units (first days, third days and seventh days after the failure of the test time for the first withdrawal); (3) the healthy control group (after the test time was selected)

Eligibility Criteria:
Inclusion Criteria:

healthy control group: healthy volunteers mechanical ventilation control group: patients who underwent elective cardiothoracic surgery after scheduled and controlled mechanical ventilation for more than 12h were transferred to ICU (including coronary artery bypass grafting and valve replacement) difficult weaning: difficult to diagnose patients in ICU (weaning time from mechanical ventilation for \>48 hours and first SBT failure)

Exclusion Criteria:

1. severe respiratory depression, high paraplegia and neuromuscular lesions;
2. esophageal obstruction, esophageal perforation, severe esophageal varices bleeding, upper gastrointestinal surgery and other reasons can not be placed EAdi catheter;
3. thoracic deformity and diaphragmatic hernia;
4. serious heart, liver, kidney and other organ failure, hemodynamic instability;
5. pregnancy;
6. the end of the tumor or the family member give up the active treatment
Alt-RAMEC Expansion and Protraction by EDO in Cleft Lip and Palate Patient

Evaluate the treatment outcome of Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).

Cleft lip and palate are among the most common deformities in children.Clefts patient are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty . Patients with cleft lip and palate (CLP) commonly have maxillary arch constriction (maxillary hypoplasia) and Class III malocclusions due to deficient of maxillary growth The upper jaw of patients with cleft palate will be expanded by Maxillary Expander with Differential Opening (EDO) with alternate rapid maxillary expansion and constriction (Alt-RAMEC) , which is opened by opening the expansion device by 1 mm per day for a week, then closing the device at a rate of 1 mm per day in the second week and so on alternately for 7 consecutive weeks after the completion of the expansion, the facemask device will be used to protraction of maxilla the measurement and difference before and after treatment will be assessment by cone beam computed tomography (CBCT). .

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes.
* Cleft lip and palate patients.
* All patient age ranges from 8 to 12 years.
* All the cases showed maxillary arch constriction and deficiently
* All patients had maxillary permanent first molars.
* Primary lip adhesion and palatal closure.

Exclusion Criteria:

* Patients had received any surgical assisted expansion or maxillary protraction or fixed orthodontics before.

  2. Maxillary dentition unsuitable to bond the expander (less than two dental unit bedside first permanent molar) .

  3. Absent maxillary permanent first molars. 4. Uncooperative patients/parents
Surgeons Can Avoid Lasting Pain Through Exercise Literacy

The physical demands of surgery are in many ways similar to those of high-performance athletes. No professional athlete would consider performing without careful attention to strengthening and physical preparedness, yet surgeons routinely place rigorous demands on their bodies without any training plan specific to their work demands. A series of exercises were developed to help stretch and strengthen the key core muscles to support surgeons during operating to prevent neck pain. This study hypothesizes that Neck pain discomfort will decrease following an 8-week intervention program compared to baseline reported scores.

Participant will be asked to fill out a series 5 questionnaires at beginning of the study, end of the 8-week intervention and 1 month later to determine how the exercise program affected their general health, neck pain, and function.

1. Demographic information about their age, height, weight, sex, surgical experience, surgical frequency, level of pain, and exercise frequency and types. (21 items)
2. A questionnaire about neck pain (10 items)
3. A questionnaire about how pain interferes with their life (8 items)
4. A questionnaire about general health (10 items)
5. A questionnaire about how much the participant typically exercise. (4 items) All these questionnaires can be completed on a computer or tablet and the data will be stored on a secure site (RedCap). This should be completed in approximately 20 minutes at each assessment.

Next participants will be instructed how to perform a series of 4 exercises described in the intervention

Every week the participant will be sent a 3-item questionnaire to report their level of pain, surgical burden, and exercise compliance for the week. There are only 3 multiple choice questions which should take approximately 1 minute to complete per week.

Eligibility Criteria:
Inclusion Criteria:

* must be an actively operating surgeon either faculty, fellow, or resident.
* Must report at least 4 out of 10 with pain at worst over the previous week at intake that is attributed to operating.

Exclusion Criteria:

* Participants will be excluded if they have prior neck or upper back surgery within the last year.
* If the participant has any other medical condition that would prevent the participant from performing shoulder and neck strengthening and stretching exercises.
Innovative Central Line Securement Device in the Pediatric Population

This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a traditional securement device (dressing).

Children with central lines experience line breaks, line dislodgment's and line infections as a result of traditional securement techniques (dressings). These issues lead to the patients' increased health care utilization and possibly to restriction of movement and delayed development as the children are restricted in their home environment. The purpose of this study is to determine if a wearable central line securement device, can decrease the number of line breaks, line dislodgment and line infections as compared to traditional securement techniques. Events per month would be calculated for each arm before and after intervention and analyzed for treatment effect. The hypothesis is that the use of this wearable central line securement device can reduce line breaks, line dislodgment and line infections as compared to the traditional adhesive dressing. A secondary outcome for evaluation will be quality of life. This will be analyzed with a standardized quality of life survey and treatment effect will be reported as an ordinal odds ratio. Children are naturally active, however their activity is restricted by the parents given the delicate nature of their line. This study looks to see if quality of life can be improved a more secure wearable attachment device, as compared to traditional securement techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a central line ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study.

Exclusion Criteria:

* Those children who currently wear a central line securement device (vest)
* Children with central lines who are 19 years or older
* Those females with central lines and Tanner 2 breast or greater breast development as a wearable central line securement device (vest) will not fit properly to secure the central line and may increase the risk of the central line complications.
* If the patient does develop breast during the time of the study then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. The investgators will still collect data on that patient and they will be evaluated in the device arm consistent with the intention to treat principle.
Research Study to Investigate the Effect of NNC0174-0833 on a Birth Control Pill in Women Who Are Not Able to Become Pregnant

The study looks at how the study medicine affects the level in the blood of a birth control pill. The study also looks at how the study medicine affects the duration of emptying of the stomach. Participants will get 1 injection of study medicine once a week for 12 weeks by a study nurse at the clinic. The study medicine is injected with a thin needle in a skin fold in the stomach. In addition, participants will get 1 birth control pill per day for 8 days before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Participants will also get a dose of acetaminophen before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Acetaminophen is a mild painkiller but used here to assess the emptying of the stomach. The study will last for about 9 months, but participants will only be in the study for about 6 months. Participants will have 17 clinic visits with the study staff and some will be overnight visits. There will also be 3 phone calls with the study staff. At all visits, participants will have blood drawn along with other clinical assessments. Participants will be asked about their health, diseases and habits including mental health questionnaires. Participants must not be able to become pregnant if they want to participate in the study.


Eligibility Criteria:
Inclusion Criteria:

* Female of non-childbearing potential, aged 18-65 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 25.0 and 39.9 kg/m\^2 (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products (including acetaminophen) or related products.
* Previous participation in this trial. Participation is defined as signed informed consent.
* Previous participation in trial(s) with NNC0174-0833 unless documented that the subject was assigned to placebo treatment. Participation is defined as randomised.
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Comparison of Effectiveness In-ear and Behind-ear Vagus Nerve Stimulation

The use of vagus nerve stimulation (VSS), one of the examples of neuromodulation therapies, continues to increase in the medical field. Basically, invasive (iVSS) and transcutaneous VSS (tVSS) can be performed. tVSS is more preferred because of its advantages such as easy application, not requiring surgical procedure and having fewer side effects. VSS has long been an approved treatment modality in the treatment of epilepsy and refractory depression. tVSS can be administered from the auricular-auricular or posterior ear region. The vagus nerve (VS) belongs to the parasympathetic branch of the autonomic nervous system and has an effect on vital functions. There are also studies in the literature showing that VS stimulation reduces inflammation. In addition to this effect, the vagus nerve may also show analgesic activity through pain-related pathways. Due to its anti-inflammatory and analgesic effects, VSS has become a new treatment method in diseases in which various inflammatory processes are shown in the etiology such as inflammatory bowel diseases, musculoskeletal system diseases and central nervous system diseases.

There are no generally accepted values for taVNS (transcutaneous auricular vagus nerve stimulation) application parameters (amplitude, frequency, intensity, duration, side); therefore, there are heterogeneous applications in studies. In a meta-analysis on the safety profile of taVSS, local skin irritation (18. 2%), headache (3.6%), nasopharyngitis (1.7%), dizziness (1.4%) and nausea (1.1%) were reported and taVSS treatment was reported as an effective and safe treatment with these side effects, most of which were transient and did not require additional intervention.

During taVNS, autonomic activities increase in favour of the parasympathetic system and this results in an increase in heart rate variability (HRV). Although an increase in HRV has been demonstrated by different studies, the factors that can predict the change in HRV are not clear. In a study by Geng et al. using taVSS, it was observed that HRV indicators representing vagal nerve activity increased significantly when stimulation was performed in the morning, but evening stimulation did not yield similar results. In addition, they found that improvements in measures of autonomic balance were more pronounced in the presence of lower vagal activity; they also found that by increasing the duration of stimulation, the effect of taVNS on HRV was not regulated by duration. In other words, HRV changes had the best effect only at the beginning of stimulation.

Eligibility Criteria:
Inclusion Criteria:

* To be 18 years of age or older,
* Not having any acute or chronic health problems,
* No previous transcutaneous vagus nerve stimulation application.

Exclusion Criteria:

* Using drugs, alcohol or smoking
* Being in the post menopausal phase
* Pregnancy history
* Known history of acute or chronic illness
* Having received any medication affecting the autonomic nervous system
Determine the Prevalence and Severity of Asthma in HIV (Human Immunodeficiency Virus) Infected Patients

The purpose of this study is to determine the prevalence and severity of asthma in patients with HIV. To determine the immunological phenotype of HIV-infected patients with asthma.

Prospectively clinically phenotype and the prevalence of asthma in HIV infected patients in the Duke ID Clinic

* HIV infected asthmatic subjects meeting clinical definitions for asthma compared to HIV uninfected asthma subjects identified at the DAAAC and HIV infected non-asthmatic subjects.
* Prospective immunological phenotyping - HIV-infected asthma subjects prospectively identified and clinically phenotyped compared to HIV-uninfected asthma subjects identified at the DAAAC and HIV infected non-asthma subjects.

Regarding the sampling method of probability sample: All samples for HIV infected asthmatic patients, HIV uninfected asthmatic patients and HIV infected non-asthmatics patients will be analyzed.

Retrospectively determine overall asthma prevalence and severity among HIV-infected patients. Retrospective immunological phenotyping (circulating cytokines) of HIV-infected patients utilizing available specimens in the Duke HIV Specimen Biorepository

* HIV-infected asthmatic subjects meeting asthma definition compared to overall asthma prevalence in U.S. population
* HIV-infected asthma subjects meeting asthma definitions compared to matched HIV-infected non-asthma subjects

Eligibility Criteria:
Inclusion Criteria:

* HIV infected asthmatic and non-asthmatic adults ≥18 years
* HIV uninfected asthma adults ≥18 years
* Females of childbearing potential have to be using medically acceptable contraceptive method for the duration of the study.
* Willing and able to give informed consent and adhere to visit/protocol schedules.
* Negative pregnancy test in women of childbearing potential
* For asthma patients: known or possible diagnosis of asthma for at least one year

Exclusion Criteria:

* Antibiotic administration for upper respiratory infection within the prior 30 days
* Greater than 10 pack a year smoking history
* No prior use of steroids (systemic) within the past 3 months
* Underlying illnesses that may result in altered lung function
* Students or employees who are under direct supervision of any Project or Core PI/Director.
* Pregnant or nursing mothers.
* Poorly controlled concomitant conditions as determined by the investigator.
* Subjects who have had an elective procedure (for example, colonoscopy, cystoscopy, etc.) within less than 2 weeks of the procedure date cannot be enrolled in the HIV Asthma study
* Subjects must delay enrollment by 2 weeks into the HIV Asthma study if they have received a single dose of systemic steroids
Effects of Herbal Mouth Rinse for Chronic Periodontitis

This double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month while clinical parameters \[plaque index (PI), gingival index (GI), sulcus bleeding index (SBI), probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (GR), stain index (SI)\] were evaluated at base line, 1 month, and 3 months. CFU was also evaluating at above said time periods.

This double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month.The primary outcome of this study was CAL, while PPD was the secondary outcome measure. A single clinician (AA) who was blinded to the groups assigned to the individuals, recorded all the parameters i.e. PI, GI, SBI, PPD, CAL, GR, SI at base line (prior to the treatment), 1 and 3 months after therapy. PPD, CAL and GR were recorded at the six sites per tooth in every tooth, except third molar, with a manual UNC-15 periodontal probe (Hu-Friedy, Leinmen, Germany) to the nearest millimeter. For recording of parameters at different time periods patients were instructed to refrain from any oral hygiene procedure for 8 hours prior to the evaluation. Staining of the six maxillary anterior teeth was assessed using the Lobene index. CFUs of P. ginigvalis, T. forsythia, and T. denticola were evaluated at baseline , 1 months, 3 months.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy individuals of \> 30 years of age with previously untreated generalized chronic periodontitis (defined by Armitage in 1999),
* having minimum 15 teeth,
* minimum of six teeth with at least one interproximal site with PPD between 5-7mm,
* CAL between 5-10 mm, at least 30% of the sites with PPD and CAL ≥ 5 mm
* presence of bleeding on probing (BOP).

Exclusion Criteria:

* was any systemic disease,
* use of any medication in the previous 6 months,
* subjects wearing partial removal prosthesis or orthodontic appliance,
* allergy to ingredient used in the study, alcoholics, smokers or tobacoo users in any form, mentally retarded individual, pregnant or lactating females.
A Study of SGB-9768 in Adult Healthy Volunteers

This study is a randomized, double-blind, placebo-controlled single ascending dose study of SGB-9768 in healthy volunteers. The purpose is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered SGB-9768.

It is a phase 1, randomized, double-blind, placebo-controlled single ascending dose study of SGB-9768. The primary objective is to evaluate the safety, tolerability of SGB-9768 when administered subcutaneously as a single dose to healthy volunteers. The secondary objective is to characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered SGB-9768 in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18 to 55 years are included at the time of informed consent.
* Body mass index between 18 and 28 kg/m2 at screening, inclusive, at screening a weight of at least 45 kg for female and 50 kg for male.
* Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests be normal or slightly abnormal but not clinically significant according to investigator's judgement.
* Women of child-bearing potential who are not exclusively in same-sex relationships and males with partners of child-bearing potential must agree to use adequate contraception from signing the informed consent until 12 weeks after completion of the follow-up visit.
* Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.

Exclusion Criteria:

* A history of or current surgical or medical condition that, in the opinion of the Investigator, may put the subject at significant risk (according to Investigator's judgment) or interfere with the subject's participation in the clinical study.
* History of or evidence of tuberculosis.
* History of recurrent or chronic infections.
* Subjects with a history of meningococcal infection, or subjects who are exposed to Neisseria meningitidis.
* History of asplenia or splenectomy.
* History of abnormalities in complement or hereditary complement deficiency.
* Received an investigational agent within 30 days or 5-half-lives (whichever is longer) before the first dose of the study drug or being in other clinical study.
* History or clinical evidence of drug abuse within 12 months before screening or positive screen for drugs of abuse.
* Used prescribed or over-the-counter medication within 14 days or 5 half-lives (whichever is longer) before the first dose of the study drug unless determined not clinically relevant by the Investigator.
* Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.