cyrilzakka/clinical-trials huggingface dataset:
Endorphin at Labor Pain and Acupressure

This study was performed to determine the impact of different acupressure procedures, performed on women's hands during labor, on endorphin levels and labor pain perception.

The sample consisted of 140 pregnant women. The study was conducted with three experimental groups and one control group, each including 35 pregnant women. Conventional acupressure and warm and cold acupressure procedures were performed on the Large Intestinal 4 energy meridian zone acupressure point of the experimental group. No procedures were performed on the women in the control group. Data were collected using a "Personal Information Form", "Labor Intervention Follow-up Form", "Visual Analog Scale" and "Verbal Category Scale".

The comparison between the experimental and control groups indicated that the conventional acupressure procedure was effective in reducing labor pain and that the warm acupressure procedure increased endorphin levels.


Eligibility Criteria:
Inclusion Criteria:

* Being a primipara
* Having intact membranes
* No skin diseases (such as urticaria...),
* No use of narcotic drugs
* Having a term pregnancy
* Having a single fetus at vertex position
* Planning to have vaginal delivery
* Having contractions and ongoing regular augmentation
* Having recent augmentation starting periods
* Being in the latent phase (0-3 cm dilatation)
* Having no history of high-risk pregnancy
* Not using analgesic drugs to reduce pain during delivery
* Having no systemic and neurologic diseases
* Having no contraction anomaly (hypotonic or hypertonic contractions)

Exclusion Criteria:

Having any of the above criteria.

-
Treatment With Elexacaftor/Tezacaftor/Ivacaftor, in Patients With Cystic Fibrosis and Caloric Intake

The aim of the study is to describe the evolution of caloric intake in patients with cystic fibrosis with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization, between the start of treatment and at 12 months.

Cystic fibrosis is a genetic pathology linked to a dysfunction of the CFTR protein.

Undernutrition is common in the natural course of cystic fibrosis, it is linked to exocrine pancreatic insufficiency but also to the increase in energy expenditure due to respiratory damage.

At a time when these CFTR modulators are greatly modifying the prognosis and management of cystic fibrosis, it is important to describe how caloric and nutritional intake evolve under treatment with Elexacaftor/Tezacaftor/Ivacaftor in order to be able, in the long term, to adapt nutritional recommendations under treatment with CFTR modulators.

The aim of the study is to describe the evolution of caloric intake in patients with cystic fibrosis with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization, between the start of treatment and at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient with cystic fibrosis
* Patient with an indication to start treatment with Elexacaftor/Tezacaftor/Ivacaftor according to the Marketing Authorization.
* Patient who has not received treatment with CFTR modulators in the 6 months preceding inclusion.
* No opposition expressed by the patient (if ≥ 18 years) or by at least one of the holders of parental authority and the child (if \< 18 years).
* Be affiliated to a social security scheme or be a beneficiary of such a scheme.

Exclusion Criteria:

-
Dexmedetomidine and Remifentanil in NORA

Endoscopic retrograde cholangiopancreatography (ERCP) procedure is frequently encountered in non-operating room anesthesia applications (NORA). It is a procedure that requires deep sedation and analgesia in terms of gastroenterologist and patient comfort. Dexmedetomidine, which is increasingly used in NORA applications, comes to the fore because it does not cause respiratory depression, reduces the stress response, and provides hemodynamic stability. This study aims to compare the effects of dexmedetomidine-propofol (DP) and remifentanil-propofol (RP) combinations on hemodynamic stability, rapid recovery, and patient comfort in patients who underwent ERCP.


Eligibility Criteria:
Inclusion Criteria:

-ASA 1-3

Exclusion Criteria:

* Neurological disease,
* Psychiatric disease,
* Coronary artery disease,
* Long-term sedative drug use,
* Pregnant patients,
* Known allergy to planned drugs
An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment

This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/=18 years of age
* Moderate to severe rheumatoid arthritis defined as DAS 28\>3.2
* Body weight \</=150 kg
* Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any time prior to study start
* Inadequate clinical response to a stable dose of a non-biologic DMARD

Exclusion Criteria:

* Major surgery within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* Rheumatic autoimmune disease other than rheumatoid arthritis (RA)
* Functional class IV as defined by the ACR classification
* History or current inflammatory joint disease other than RA
* Previous treatment with any cell depleting therapy
* Previous treatment with methotrexate
* Previous treatment with tocilizumab
* Previous treatment with any biologic drug that is used in the treatment of RA
Protein Supplementation and HIIT: Impact on Cardiorespiratory Fitness

The aim of this study is to investigate the effects of an 8-week high-intensity interval training (HIIT) or HIIT plus resistance training program combined with post-exercise protein supplementation on cardiorespiratory fitness and cardiometabolic risk indices in previously untrained individuals.


Eligibility Criteria:
Inclusion Criteria:

• Sedentary Lifestyle over at least 6 months prior to the study

Exclusion Criteria:

* Pregnancy, Lactation
* Psychological disorders, epilepsy, sever neurological disorders
* Participation in other exercise- or nutrition studies within the last 6 months
* coronary heart disease, heart failure
* malignant disease
* severe rheumatic or neurological disease
* severe/unstable hypertension (resting RR: \>180/\>110 mmHg)
* severely restricted lung function (FEV1 \<60%)
* unstable Diabetes mellitus
* severe orthopedic disease/restriction
* acute / chronic infectious diseases
* Electronic implants (defibrillator, pacemaker)
* Persons in mental hospitals by order of authorities or jurisdiction
Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS

A double-blind, parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) compared to current Standard of Care (SOC) for EHS.

Following triage and primary assessment in the emergency medical facility, subjects will be randomized to 1 of 2 treatment arms, SOC plus Ryanodex or SOC only. Subjects will be dosed and followed for up to 6 hours post-randomization. Current SOC is limited to body cooling and supportive measures.

Eligibility Criteria:
Inclusion Criteria: Core body temperature of greater than or equal to 40.0 degrees C (104 degrees F); recent history of exertional activity; GCS score less than 13; tachycardia -

Exclusion Criteria: clinical severe infection; hyperthermia secondary to another condition; endotracheal intubation;; sedative drugs administered prior to or at time of study entry; likelihood of head trauma within 6 months pre-study; positive pregnancy test; history of myocardial infection within 30 days; history of seizure disorder or epilepsy; concomitant or prior use of calcium channel blockers.

-
Effect of Sleep Disorder on the Development of Lung Tumors

The goal of this observational study is to observe the lung tumor development in lung tumor patients with long-term sleep disorder. The main questions it aims to answer are:

* will long-term sleep disorder promote the malignancy of lung tumor
* if so, how exactly will the microenvironment of lung tumor change Participants will receive PSQI scale and MRI functional brain imaging before surgery, blood and tumor tissue will be collected during the surgery.

Researchers will set non-sleep disorder group as control group to see if lung tumor microenvironment change when long-term sleep disorder exists in lung tumor patiens.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* elective sublobectomy for primary lung tumor
* ASA grade I-II
* Informed consent of the patient or family

Exclusion Criteria:

* Combination of serious heart, liver, kidney, central nervous system, blood system, immune system diseases or serious mental illness
* Combination of other cancers
* untreated active lung infection
* patients with preoperative neoadjuvant radiotherapy
Validation of Coronary Calcium Subtraction to Improve Diagnostic Accuracy of Coronary CT Angiography

Coronary calcium hampers accurate evaluation of the coronary arteries with coronary computed tomography angiography (CCTA). A novel approach to potentially overcome this limitation is coronary calcium subtraction.

The primary hypothesis of the study is:

- Coronary calcium subtraction CCTA will improve diagnostic accuracy as compared to conventional CCTA on a per-patient basis

CCTA is a very important clinical method for the clinical evaluation of patients with chest pain of potential cardiac ischemic origin. However Coronary calcification and/or previously implanted coronary stents may limit the diagnostic accuracy of CCTA. A novel approach - coronary calcium subtraction - has been developed to potentially overcome this limitation.

* Study Objective: To assess diagnostic accuracy using coronary calcium subtraction coronary CT angiography (CCTA) as compared to conventional CCTA.
* Material and Methods: A total of 200 patients with suspected or known coronary artery disease (CAD) who have been referred for invasive coronary angiography (ICA) will prior to ICA undergo additional research CCTA with the newly developed coronary calcium subtraction protocol. Based on the coronary calcium scan (CS), coronary calcium score will be calculated according to the Agatston score. Conventional contrast enhanced CCTA studies will be analyzed for image quality and the presence and extent of coronary stenosis. Using a dedicated algorithm, subtraction will be performed on all datasets to obtain CCTA subtraction images. Subtracted images will be analyzed similar to the conventional CCTA images. ICA will serve as the gold standard. Image quality will be compared between conventional and subtracted CCTA. In addition, diagnostic accuracy in the evaluation of coronary stenosis as determined on ICA will be compared. Finally, factors influencing the performance of coronary calcium subtraction will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 55 Years
* Scheduled for invasive coronary angiography
* Logistically possible to perform CCTA before invasive evaluation

Exclusion Criteria:

* Known Iodine-contrast allergy
* Estimated GFR below 50 ml/min
* Atrial fibrillation or other persistence cardiac arrythmia
* Contraindication to betablockers (bronchospasm, LVEF less than 40%)
* Implanted PM or ICD
* Previous mechanical heart valve surgery
* Inability to maintain breath-hold for at least 5 sec
* Patient-related condition resulting the inability of the patient to understand the informed consent form of the study
High Sensitive Troponin T (hsTnT) and Copeptin as Prognostic Parameters in Patients With Elective Total Endoprosthesis

Summary: The purpose of the study is to prove if the biomarker high sensitive troponin T (hsTnT) and the biomarker of endogenous stress copeptin can serve as surrogate parameter of prognosis in patients with elective knee and hip total endoprosthesis.

Consecutively, high sensitive troponin T and copeptin will be measured in all patients with elective knee and hip endoprosthesis in the orthopedic department of the University of Heidelberg. The blood is taken during the routine blood testes if possible, on admission and the days 1-4 following the operation. Usual baseline characteristics are taken as well as usual blood results (hb, cholesterol and so on). Primary endpoint is the detection of perioperative myocardial infarction and pulmonary embolism.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with elective knee and hip endoprosthesis

Exclusion Criteria:

* Not willing or not able to take part in the observational trial
* No written inform consent
The Use of Transcranial Direct Current Stimulation (tDCS) to Study Implicit Motor Learning on Patients With Brain Injury

The purpose of this study is to study motor learning and recovery of patients with brain damage caused by traumatic brain injury or stroke with transcranial direct current stimulation (tDCS). It is hypothesized that anodal tDCS on the lesion side and/or cathodal tDCS on the healthy side of motor cortex could improve the recovery of motor function such as learning.

We aim to apply transcranial direct current stimulation (tDCS) to study the recovery process of motor learning on the patients with brain damage caused by traumatic brain injury or stroke. Both anodal and cathodal tDCS will be used to test whether the increase of motor cortical activity by anodal tDCS over lesional side or the decrease of brain activity by cathodal tDCS on healthy side will improve the learning skill (SRTT: serial reaction time task). The result could help to understand the mechanism of motor and cognitive recovery after brain damage, and further rationalize the application of non-invasive brain stimulation such as tDCS for patient rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* TBI or stroke patients
* with partially preserved fine motor function

Exclusion Criteria:

* with metal clips in head or device (e.g. pacemaker)
* with active CNS drugs
Robotic Single Port Donor Nephrectomy

Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms.

Our center has performed over 200 single-port donor nephrectomies with standard laparoscopy and has reported patient benefits associated with a single port approach. The single port robotic platform offers the potential to ameliorate the significant technical and ergonomic challenges that currently limit more widespread application of single port donor surgery. After being informed of the potential risks and off-label use of the da Vinci Single-Site approach in our study, patients will undergo a robotic-assisted single-site donor nephrectomy performed by a two-surgeon team utilizing existing da Vinci instrumentation and Single-Site platforms. Renal mobilization and vascular dissection will be performed with manual laparoscopy performed for vascular division utilizing stapling devices.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be approved by the Living Donor Center.
* Patient must have compatible blood type with the recipient.
* Patient must have body mass index less than 35.
* Patient must have appropriate anatomy for left kidney donation.

Exclusion Criteria:

* Any patient receiving anticoagulant drugs such as Coumadin or warfin
* Any patient suffering from an active urinary tract infections
* Any patients suffering from cancer.
* Any patients suffering from diabetes.
* Any patients suffering from kidney disease.
* Any patients suffering from heart disease.
* Any patients suffering from liver disease.
* Any patients suffering from HIV or hepatitis
* Any patients suffering from previous major abdominal surgery.
* Any patients suffering from more than two left renal arteries.
Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23

The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine.

This study adopted a randomized, double-blind, equivalency design with different batches of experimental vaccine. 990 individuals aged 18-59 were included and divided into three groups at a ratio of 1:1:1, with 330 individuals in each group receiving three batches of experimental vaccines, respectively. All subjects were vaccinated with 1 dose of 0.5ml, intramuscularly injected into the lateral deltoid muscle of the upper arm.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 18-59;
* Voluntarily participate and sign an informed consent form;
* Subjects are able to comply with the requirements of the clinical study protocol and complete the prescribed follow-up;
* Has not received pneumococcal vaccine or any other preventive products recently (has not received attenuated live vaccine within 14 days, has not received inactivated vaccine within 7 days);
* Underarm temperature ≤ 37.0 ℃;
* Female participants of childbearing age agree to take effective contraceptive measures within 3 months from the start of the study until the full vaccination period.

Exclusion Criteria:

* Subjects with a history or family history of progressive neurological disorders such as epilepsy, encephalopathy, and mental illness;
* Has a history of severe allergies to any drugs or vaccines in the past;
* Has a allergy history to any component of the experimental vaccine (the main components of the vaccine include type 23 pneumococcal polysaccharides, sodium chloride, sodium dihydrogen phosphate, and sodium dihydrogen phosphate);
* Suffering from severe cardiovascular diseases (heart disease, pulmonary heart disease, pulmonary edema, drug-resistant hypertension (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg)); drug-resistant diabetes;
* Subjects with a history of thrombocytopenia or other coagulation disorders that may cause contraindications for subcutaneous injection;
* Subjects with known immunological dysfunction or low levels, or HIV infection;
* Any situation leading to splenomegaly, splenectomy, or functional splenomegaly;
* Malignant tumors, active or treated tumors that have not been clearly cured, or are likely to recur during the study period;
* Anti tuberculosis prevention or treatment is under way;
* Subjects who are participating in or planning to participate in clinical trials of other drugs or vaccine clinical trials throughout the entire observation period;
* Women of childbearing age are in pregnancy (positive urine pregnancy test) or lactation period;
* Any situation that the researcher believes may affect the evaluation of the study.
Human Epidermal Growth Factor Receptor 2 (HER2) Advanced Gastric Epidemiology Study in Korea

This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric and gastroesophageal junction cancer as assessed by local laboratories in a real-life setting. No investigational products will be provided or evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Formalin-fixed, paraffin-embedded tumor tissue samples with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with locally advanced, recurrent, and/or metastatic disease
* Sufficient invasive tumor tissue for HER2 evaluation, including surgical excision specimens or at least 6 to 8 available biopsies

Exclusion Criteria:

* None specified
Decreasing Unused Opioids in the Home Post Supracondylar Fracture Repair

Over the past two decades, the misuse of prescription opioids has significantly increased. A recent systematic review reported as much as 67% to 92% of opioids dispensed on discharge post-surgery go unused. This culture of overprescribing is consistently observed across surgical specialties. Less frequently observed is the potential for opioid use and misuse in children and adolescents post-surgery. The research to date in this area has been poorly performed with heterogenous data collection, analysis and reporting, as well as large loss of patients to follow-up.

The investigators' previous prospective observational deception study identified three areas of concern:

1. There is a culture of postoperative opioid over-prescribing at discharge as demonstrated by heterogenous opioid dosing and duration of treatments across practitioners for single procedures
2. This overprescribing is in excess of patients' home-requirements and results in significant quantities of leftover opioids
3. There is a culture of inappropriate storage and lack of safe disposal of prescribed opioids in the community

This study focuses on addressing and minimizing pediatric surgical over-prescribing. It aims to reduce the amount of opioids prescribed by focusing prescribers and families on regular use of simple non-opioid analgesics, as well as decreasing the amount of opioids prescribed and dispensed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with supracondylar fractures undergoing surgical wire placement or pinning that return to fracture clinic at three weeks for removal of pins/wires.
* Patients discharged on the weekday.
* Families filling a prescription for opioids at Shoppers Drug Mart at SickKids Hospital.
* Parent has strong command of the English language (i.e., no interpreter required).

Exclusion Criteria:

* Patients with a history of chronic pain.
* Patient used opioid medication within the previous 6 months.
* Patients who are discharged on the weekend (as participant emails will need to be entered into redcap the day of recruitment, for data collection to commence the next morning).
Effects of Aerobic Exercise on Occupational Burnout

The aim of the present study is to investigate the impact of regular aerobic exercise on psychopathology, cortisol secretion, BDNF, sleep, cognitive performance, and psychological functioning in people suffering from professional burnout. Pre- and postassessments after 12 weeks of training will be performed.


Eligibility Criteria:
Inclusion Criteria:

* burnout
* male participants
* non-smokers

Exclusion Criteria:

* psychiatric disorders
* smokers
* physical diseases