cyrilzakka/clinical-trials huggingface dataset:
ED-TREAT (Early Detection and Treatment to Reduce Events With Agitation Tool) Compared to Usual Care

The purpose of this study is to conduct a a pilot trial that tests the acceptability, fidelity, and feasibility of ED-TREAT.

This study will be a pilot RCT that compares ED-TREAT to usual care. The scientific premise of the proposed project is that an innovative EHR-embedded clinical decision support (CDS) tool can overcome the challenges to risk assessment and suggest pre-emptive use of behavioral techniques in the emergency setting. This would help clinicians appropriately invest resources to improve the quality of care for at-risk patients regardless of ultimate medical or psychiatric diagnoses and prevent agitation from occurring.

This pilot trial will (1) test the integrity of the study protocol in preparation for a future full-scale RCT, (2) evaluate randomization protocols, (3) estimate rates of recruitment and retention, (4) assess acceptability and fidelity of the intervention, and (5) determine if the proposed effect size is reasonable.

This registered study is actually the third aim of a larger study where the tool will be developed and assessed using observational data and input from a steering committee in aims 1 and 2 prior to pilot testing.

Eligibility Criteria:
Inclusion Criteria:

1. adult (age≥18) patients presenting to the YNHH ED during the pilot trial period
2. deemed to have a mild-moderate or high risk of agitation as determined by ED-TREAT
3. do not require physical restraint orders \<30 minutes of arrival
4. with a score of "4" (quiet and awake; normal level of activity) on the Behavioral Activity Rating Scale
5. have comfort with conversational English
6. able to provide verbal consent.

Exclusion Criteria:

1. Presence of a restraint order \<30 minutes of arrival and presence of a non-violent physical restraint order where indications are not due to agitation (e.g., for protecting intubation or life-preserving equipment)
The Impact of Qigong on Quality of Life and Sleep Disturbance in Head and Neck Patients Undergoing Radiotherapy

This study aimed to observe how a six week qigong program influence patients with head and neck cancer during active radiotherapy treatment course. The quality of life, sleep dysfunction or depression and shoulder and neck function will be accessed by questionnaire, and ANS function will be objectively investigated using heart rate variability measurement.

The incidence of head and neck cancers is the 6th in Taiwan, and head and neck cancers are the 5th leading cause of cancer death, causing approximately 2000 death in 2010. Head and neck cancers patients usually require multimodality treatments, including surgery, chemotherapy and radiotherapy. These treatments can cause functional deterioration and worsened quality of life during or after the treatment, and bring tremendous effects on patient's life. When radiotherapy is indicated, it requires 6 to 7 weeks treatment, and most patients suffered from different degrees of mucositis, dermatitis, xerostomia and neck and shoulder tightness during radiotherapy. How to improve quality of life for these patients during radiotherapy is an important task.

Qigong is a mind-body exercise or therapy; it can improve quality of life, such as fatigue, sleep dysfunction and depression through regulation of breath and simple physical exercise. Some found that the qigong can decrease inflammation and show some impact on accommodation of ANS in cancer patients. Most studies focus on how qigong effect on cancer survivors, however, this study is aimed to observe how a six week qigong program influence patients with head and neck cancer during active radiotherapy treatment course. The quality of life, sleep dysfunction or depression and shoulder and neck function will be accessed by questionnaire, and ANS function will be objectively investigated using heart rate variability measurement.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of Head and neck squamous cell carcinoma, subsites including nasopharyngeal cancer, oropharyngeal cancer, oral cancer, hypopharyngeal cancer and laryngeal cancer Performance status ECOG 0-1 Physically able to participate in the qigong program

Exclusion Criteria:

- Previous radiotherapy to head and neck region Patients who refused to sign the informed consents Patients who took antihypertensive drugs, sedatives, or antiarrhythmic drugs
Efficacy of S-Adenosylmethionine in Fibromyalgia

Fundamentally, the trial aims to conduct a gold-standard test of the clinical impact of SAM-e in the treatment of depressed mood and general symptoms of fibromyalgia (FMS).

As such, salient clinical and pathological parameters will be assessed over an 8-week period in 60 patients who will be provided with either SAM-e or a placebo preparation . On the basis of previous literature, it is hypothesised that patients in the active treatment group will experience moderate but significant improvements across the clinical measures, and that these gains will be significantly greater than any reported in the placebo group. All patients will provide informed consent. All procedures will be conducted under medical supervision and the preparation itself is very safe when used in the manner proposed for the trial


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Fibromyalgia by a medical practitioner

Exclusion Criteria:

* Pregnancy, Manic and hypomanic conditions
Regional Cerebral Hemodynamics Related to Global Hemodynamics

This prospective investigation studies changes in regional cerebral hemodynamics and oxygenation as a function of cardiac output and blood pressure in intensive care patients.

Cerebral blood flow velocity (as an index of regional perfusion), dynamic cerebral autoregulation and regional cerebral oxygen saturation should be monitored if disturbances of cerebral perfusion and oxygenation have to be suspected. Noninvasive monitoring techniques are established. When detected early, disturbed perfusion and oxygenation may be treated promptly and permanent damage of brain tissue can be avoided.

In critically ill patients, hemodynamic changes occur due to the disease itself but also as a function of diagnostic and therapeutic procedures. Systemic hemodynamic changes can be monitored using PiCCO® system (pulse contour cardiac output, Pulsion Medical Systems, Munich, Germany) that combines transpulmonal thermodilution and pulse contour analysis. PiCCO® continuously monitors cardiac output (CO), as well as static parameters like global enddiastolic blood volume index (GEDVI), and dynamic parameters as difference in pulse pressure (dPP) and stroke volume variation (SVV), respectively. CC Nexfin® (BMeye, Amsterdam, The Netherlands) is a noninvasive hemodynamic monitor.

This study investigates the effects of changes in cardiac output on cerebral blood flow velocity and regional cerebral oxygen saturation in intensive care patients that underwent major abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* critically ill
* mechanically ventilated
* needing advanced hemodynamic monitoring (PiCCO)

Exclusion Criteria:

* \<18years
* \> 80years
* rhythm other than sinus
Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

The correlation of coronary microvascular function and body composition with cardiopulmonary exercise capacity will be assessed in patients with heart failure with preserved ejection fraction.

We will select the patients with chest pain or ischemic symptoms with non-obstructive coronary artery disease (\<50% stenosis) in coronary angiography and preserved ejection fraction (≥50%) in echocardiography. All patients will undergo body composition analysis and adenosine stress echocardiography with the evaluation of coronary artery blood flow by Doppler echocardiography and maximal oxygen consumption (VO2 max) by cardiopulmonary exercise test (CPET). Left ventricular end-diastolic pressure will be assessed during coronary angiography. Coronary flow reserve (CFR) is defined as the ratio of peak to baseline mean diastolic velocity of coronary blood flow. The correlation of CFR and body composition with cardiopulmonary exercise capacity will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 80
* Typical/atypical chest pain or ischemic symptoms including dyspnea
* No significant coronary artery stenosis (\>50% stenosis) in coronary angiography or computed tomography
* Left ventricular ejection fraction ≥50%

Exclusion Criteria:

* More than moderate valvular heart disease
* Congenital heart disease
* Chronic renal failure (estimated glomerular filtration rate \<30 ml/min/1.73m2) or end-stage renal failure undergoing hemodialysis or peritoneal dialysis
* Asthma, chronic obstructive pulmonary disease and primary pulmonary hypertension
* Receiving anticancer drugs
* Vasculitis associated with autoimmune diseases
* Patients with difficulty in performing exercise load evaluation (treadmill, bicycle ergometer)
* Atrial fibrillation
* Atrioventricular block with more than second degrees, symptomatic bradycardia, cryo-node failure syndrome, Wolff-Parkinson-White (WPW) patients
Saphenous Nerve Block for Partial Meniscectomy

Partial meniscectomy and meniscus repair are two of the most common orthopedic surgery procedures. As these procedures are being increasingly performed in ambulatory surgical centers, there has been a shift towards providing improved analgesia to ensure timely discharge, as well as preventing unwanted pain and side effects. As such, it has become common practice to use an intra-articular injection of local anesthetic to achieve post-operative pain control. However, these effects are short lived, requiring a multimodal approach to analgesia. To date, no optimal pain control strategy has been described for arthroscopic partial meniscectomy or meniscus repair. The purpose of this study is to examine the outcomes of subcutaneous saphenous nerve block with 0.5% ropivacaine at the medial femoral epicondyle/adductor hiatus plus portal 0.5% ropivacaine injection vs portal 0.5% ropivacaine injection alone for patients undergoing arthroscopic partial meniscectomy or meniscus repair.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Scheduled for arthroscopic meniscectomy or meniscus repair

Exclusion Criteria:

* Multiple-ligament injury
* Primary ACL reconstruction or ACL revision reconstruction
* Articular cartilage restoration surgery
* Evidence of microfracture
* History of allergy to local anesthetics
* Pre-existing saphenous neuropathy
* Unable to be prescribed opioids due to allergy or other reason
Methods of Establishing Intersegmental Plane in Segmentectomy

The aim of this study is to perform a prospective, single-center, randomized controlled study to explore whether closed insufflation technique is not inferior to dilatation and collapse technique in segmentectomy, and to provide a new option for establishing intersegmental plane in segmentectomy.

This is a single-center, prospective, randomized controlled study. A total of 200 subjects undergoing segmentectomy are scheduled to be enrolled within 1 year, and the subjects are randomly divided into closed insufflation group or dilatation and collapse group using a random number table generated by the computer, with 100 cases in each group. Intersegmental plane resolution grading, perioperative complications, operative time, intraoperative blood loss, postoperative hospitay stay, and pulmonary function 3 months and 1 year after surgery will be extracted and compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily join and sign a written informed consent;
2. The age of the subjects is 18-75 years old, regardless of gender;
3. The ECOG PS was 0 or 1;
4. Three-dimensional visualization was performed before surgery, and the surgeon judged that the tumor could be completely removed by segmentectomy, and surgical margin was expected to be greater than 2cm or the maximum diameter of the nodule;
5. Thin-slice CT suggests any of the following: ① The diameter of pulmonary nodules is 2-3cm and the consolidation-tumor ratio (CTR) is less than 0.25; ② Pulmonary nodule diameter ≤2cm and 0.25 \< CTR \< 0.5; ③ Non-peripheral pulmonary nodule diameter ≤2cm and CTR≤0.25;
6. cN0 and no distant metastasis;
7. Intraoperative freezing examination or postoperative paraffin examination suggest early lung adenocarcinoma;
8. Intraoperative freezing disease of station 12 lymph nodes showed no cancer metastasis;
9. Preoperative anesthesia risk assessment: American Society of Anesthesiologists (ASA) Level I-III;
10. Has no history of lung resection;
11. Has not received anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy and immunotherapy.

Exclusion Criteria:

1. The subject did not understand the study protocol, did not cooperate or refused to sign the informed consent;
2. The subject has a history of malignant tumor or has previously received anti-tumor therapy;
3. 3D visualization was not received before surgery;
4. The surgeon judged that segmentectomy could not ensure complete resection of the tumor;
5. has a history of lung resection, or chest trauma or surgery on the affected side of chest cavity;
6. Extensive intraoperative dense thoracic adhesion;
7. Conversion to thoracotomy;
8. Intraoperative frozen examination of intrapulmonary lymph nodes indicated cancer metastasis;
9. Pulmonary nodules are located in the right middle lung;
10. Suffered from chronic bronchitis, emphysema, asthma and other chronic lung diseases;
11. Other conditions unsuitable for inclusion in this study deemed by the researcher.
Nurse-Driven Telephone Intervention in Improving Side Effects in Cancer Patients Undergoing Chemotherapy

This clinical trial studies how well a nurse-driven telephone intervention improves side effects in patients with cancer who are undergoing chemotherapy. Receiving calls from a nurse at home while receiving chemotherapy may improve the management of side effects and overall care in cancer patients.

PRIMARY OBJECTIVES:

I. To explore the feasibility of a proactive nurse-driven telephone triage intervention for patients with cancer receiving first-line chemotherapy in the ambulatory setting.

SECONDARY OBJECTIVES:

I. To explore the symptom experience of patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting.

II. To explore the satisfaction of patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting.

III. To explore the frequency of emergency room visits and hospital admissions for symptom management by patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting.

OUTLINE:

During standard of care chemotherapy, patients receive up to 18 telephone calls from a nurse using a standardized triage call script over 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Newly diagnosed patients with a breast, sarcoma, or head and neck cancer diagnosis preparing to undergo first-line, standard of care chemotherapy (patients with head and neck cancer may be undergoing concurrent first-line chemotherapy and radiation treatment)
* All chemotherapy treatment to be completed at the study institution

Exclusion Criteria:

* Patients who have received previous chemotherapy treatment for cancer
* Patients who will be receiving chemotherapy on research protocols
* Pregnant patients, as they may be on unique treatment protocols outside standard of care or have symptom needs that are beyond the scope of this intervention
* Patients who are unable to verbalize (e.g. due to tracheostomy)
Effects of Foam Rolling Versus Stretching Exercises on Quadriceps, Hamstrings and Calf Muscle Length

This project will be Randomized control trial conducted to check the effects of foam rolling and stretching exercises on university sport's students so that we can have best treatment option for duration will be for 6 months, purposive sampling data will be done, subject following eligibility criteria from University of Lahore athlete students , were randomly allocated in two groups via lottery method, baseline assessment will be done, Group A participants were given baseline treatment along with foam rolling effects , Group B participants were given baseline treatment along with stretching exercises, pre or post intervention assessment will done via goniometer and Lower extremity functional scale (LESF)and three sessions per week will be given, data will be analyzed by using SPSS version 25.

The aim of the current study is to determine the effects of foam rolling versus stretching exercises on quadriceps, hamstrings and muscle length in university sport's students. It will be a Randomized control trial and will be conducted at University of Lahore. Purposive sampling technique will be used to collect data as per inclusion criteria the participant age between 18 to 25 years and male and female healthy participants. A history of cardiovascular or respiratory disease, any history of fractures or surgeries in the lower extremity in the past years will be excluded.

Patients will be randomly allocated into two groups; Group A will be treated with the effects of foam rolling on quadriceps, hamstrings and calf muscles. 5 min cycle ergometry, 6 min foam rolling 3 times for 30sec. Group B will be treated with the effects of stretching exercise on quadriceps, hamstrings and calf muscles. 5 min cycle ergometry, 6 min stretching exercises 3 times for 30sec for three sessions of treatment per week will be given. In both group's pre and post-test measurements of quadriceps, hamstrings and calf muscle length will be assessed through goniometer and Lower Extremity Functional Scale (LEFS) will be assessed to measure initial functions of lower limb. Evaluation will be done before session start and at the end of week. Total session will be given for at least 2 months.

Eligibility Criteria:
Inclusion Criteria:

* The age of participants between 18- 25 years.
* Both male and female young athletes will be included.
* Healthy participants involved

Exclusion Criteria:

* A history of cardiovascular or respiratory disease.
* Any history of fractures or surgeries in the lower extremity in the past year.
* Any history of third-degree sprains (e.g., anterior cruciate ligament ruptures), grade II or III muscle strain.
* Any prescribed medication
Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation

Sessile serrated adenomas are characterized by their flat shape and the presence of a yellow mucus cap overlying the lesion. These morphological features may account for their diagnostic difficulty during colonoscopy. Missed proximal sessile serrated adenomas are regarded as an important cause for interval cancers in the right colon and emphasize the importance of developing quality measures intended to enhance their detection. There is only one single-center retrospective cohort study on the impact of carbon dioxide insufflation on the detection of serrated polyps during colonoscopy. The investigators designed a randomized, controlled trial to compare the effect of carbon dioxide insufflation vs. room air insufflation on serrated polyp detection rate.


Eligibility Criteria:
Inclusion Criteria:Patients 45-75-years-old who underwent a colonoscopy -

Exclusion Criteria:polyposis syndrome, Inflammatory bowel disease, previous colorectal operation

-
The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions - a Randomized Placebo-controlled Double-blinded Intervention Trial

The goal of The BEGIN Study, a randomized controlled double-blinded intervention trial, is to learn if probiotics, with Bifidobacterium longum subspecies infantis Bifin02 (B. infantis), given to healthy newborns can affect various health outcomes and to explore impacts of the infant gastrointestinal microbiome. The main questions it aims to answer are:

* Does B. infantis probiotics impact immune function and does it lower the number of bacterial infections and use of antibiotics?
* Does B. infantis probiotics impact overall health, development, growth and wellbeing?
* Does B. infantis probiotics impact inflammatory diseases, allergies and autoimmune diseases

Researchers will compare B. infantis probiotics to a placebo (a look-alike substance that contains no probiotic) to see if B. infantis colonization impact the human immunesystem and various clinical and biochemical health markers.

Participants (parents) will

* Orally administrate the B. infantis probiotic to their newborn child daily in three weeks from 7 days of age.
* Answer baseline and follow up questionnaires in a study app
* Take five stool samples from the child and one stool sample from the mother
* Collect a 4 week of passive dust sample at home (Electrostatic Dust fall Collector)
* Donate one dried bloodspot and one blood sample from their child


Eligibility Criteria:
Inclusion Criteria:

* Infants born at term (above gestational week 37)
* Infants born in Region Midtjylland Denmark receiving a Danish CPR number.
* Parents age is above 18
* At least one parent holds a smartphone (for study app) and is able to fill out Danish questionaries
* Both legal parents are willing and able to provide written informed consent prior to participation, regarding both themselves and their future child.

Exclusion Criteria:

* Multiple pregnancy
* Child diagnosed with immune deficiency, renal, gastrointestinal, hepatic, or endocrine diseases
* Parents expecting to give other probiotics