cyrilzakka/clinical-trials huggingface dataset:
The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)

Out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. The pain is often under estimated due to the frequency with which the procedure is carried out. It has been shown that the environment in which the procedure is performed (e.g with skin to skin contact and specific positioning), reduces the discomfort felt by the newborn. However, this has not yet been proven with regards to naso-gastric tube insertion.

Our clinical study (carried out in the Neonatology Unit of Mercy Regional Hospital) has shown that when positioning and other non drug related analgesic techniques are used, newborns undergoing naso-gastric tube insertion feel less pain.

Several different techniques were used, such as skin-to-skin contact with the mother and/or positioning the infant using appropriate equipment, or the "four hands" technique carried out by two health care professionals.

Neonatal unit staff were able to choose the method used depending on whether the mother was present at the time of the procedure.

In cases where the mother was absent, the "four hands technique" was favored, but in the presence of the mother skin-to-skin contact was preferable.

Eligibility Criteria:
Inclusion Criteria:

* Preterm baby born between the 32th and the 35th weeks of amenorrhea plus 6 days
* Prescription of enteral nutrition via naso-gastric tube
* Naso-gastric tube in-situ
* Informed consent of both parents

Exclusion Criteria:

For the newborn

* Under respiratory assistance
* With nasal or buccal malformation
* With abnormal heart rhythm or congenital heart disease
* With hemodynamic instability
* Transfer to type 3 neonatal unit
* With a DAN score \> 0 before treatment
* With an umbilical venous catheter in-situ
* Fed with thickened milk
* Prescription of analgesic medications

For the parents

* Minor
* Under legal protection
* Difficulties which do not permit the mother to carry out skin-to skin contact or holding support
Prevalence of Sleep-disordered Breathing in Patients With a Newly Diagnosed Non Small Cell Lung Cancer

There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.

The aim of the study is to evaluate this possibility with the help of a night record of sleep and quality of life questionnaires.

There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.

Enrollment 1200 patients This wide sample is expected to respond to the main and secondary objectives of the study

Eligibility Criteria:
Inclusion Criteria:

* patients with NSCLC undergoing diagnostic
* Performance status 0,1,2

Exclusion Criteria:

* \>75 years
* OSA known and in the last 12 months treated PS \>2
* Patients under a long-term oxygen therapy
* persons deprived of liberty by judicial decision.
* \<18 years
Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery

This study aims to evaluate the efficacy of IV Ibuprofen versus IV Acetaminophen in the reduction of pain following orthopedic low extremity procedures

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Patients undergoing orthopedic low extremity surgery were screened. Eligible subjects were then randomized into treatment group (intravenous ibuprofen) and control group (intravenous acetaminophen). In case required, patients from both group will be given Morphine (PCA) 1-2 mg every 5 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for Orthopedic Low Extremity Surgery with general anesthesia and anticipated need post operative IV analgesia with anticipated use of \>48 hours.
* Adequate IV access.
* Anticipated hospital stay\>48 hours.
* Age 18-70 years old with physical status ASA I- III.
* Patients able to fill informed consent sheet.

Exclusion Criteria:

* patients with use of analgesia, muscle relaxants, NSAIDs and sedatives less than 24 hours to study drug administration
* anemia (active, clinically significant anemia) and/or a history or evidence of asthma or heart failure
* historical or at higher risk intracerebral bleeding, history of allergy or hypersensitive to NSAID, Ibuprofen, Acetaminophen or opioid
* pregnant or nursing
* body weight less than 30 kg
* any active clinically significant bleeding or have underlying platelet dysfunction and/or receiving full dose anticoagulation therapy
* GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
* on dialysis or renal dysfunction
* impaired liver function
* inability to achieve hemostasis or inability to close surgical incision prior to operating room discharge
* operative procedure includes organ transplant, pre-and intra- operative procedure utilized for the prevention of pre- or post-operative pain (i.e, epidural or nerve blocks)
* received anoher investigational drug within the past 30 days
* known or suspected history of alcohol or drug abuse
* severe infection and/or inflammatory disease
Personalised Prediction of Disease Course in Ulcerative Colitis Using Multimodal Machine Learning - Part of the Presager Project

In patients achieving clinical remission following a flare, artificial intelligence can reliably predict a new flare within the next 12 months utilizing clinical and objective information at day 0 and week 8.

Secondary endpoints:

* An artificial intelligence model's precision in predicting a new flare within 2 and 3 years
* An artificial intelligence model's precision to rule out patients who will not experience a new flare within 1, 2 and 3 year


Eligibility Criteria:
Inclusion criteria:

* Signed informed consent
* Diagnosis of UC for at least 1 year
* Relapse due to UC.
* First endoscopic and histological evaluation of the flare Exclusion criteria
* Well-founded doubt that the flare is due to other than the patients UC
The Effect of Large Versus Small Clog Size on Emergency Response Time

In many hospitals, clogs, usually white, are provided for healthcare workers. In our hospital, health care professionals from the department of intensive care medicine may be summoned to an emergency situation on a 24/7 basis. Clogs are thought to be of importance for running. Although clogs are available in several sizes, clog size is typically left to the discretion of the individual healthcare worker. Interestingly,

The primary goal of this randomized controlled trial is to assess if wearing large size clogs as compared to small size clogs results in increased running speed.

Participants will be randomized to small versus large clog size using a using randomly permuted blocks stratified by gender. Following randomization, participants will wear the clogs of allocated size and complete a standardized running course.

The primary endpoint is the time taken to complete the course.

The enrolment of 50 subjects would provide 80% power to show a 5-second difference in the response time at an average response time of 30 seconds with a 6 second standard deviation.

The ethical committee judged the study protocol exempt from extensive review.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers aged 18 years or older.

Exclusion Criteria:

* Inability to run on clogs.
Analysis of the Potential Savings of Rivaroxaban Events Versus Vitamin K Antagonists Events

The main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data from three cohorts of patients receiving VKAs or rivaroxaban in Spain, including the time in therapeutic range (TTR) values of the same and the incidence of events in the first year following diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Diagnosis of non-valvular AF (ICD code 427.31)
* Pharmacological treatment with VKAs or rivaroxaban following diagnosis

Exclusion Criteria:

-
Evaluation of the Long-term Outcome of Dorsal Ligamentoplasty Reinforced With an Internal Brace in the Treatment of Scapholunate Instability

Prospective longitudinal multicenter observational cohort study conducted on a population of patients who underwent ligamentoplasty for scapholunate instability and agreed to be followed for a period of five years from the day of hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old who has been informed about the study and has not objected to the use of their personal data
* Patient who has undergone dorsal ligamentoplasty reinforced with an internal brace for scapholunate instability

Exclusion Criteria:

* Mental deficiency or any other reason that may interfere with understanding or strict application of the protocol
* Patient under legal protection, guardianship, or conservatorship
A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis

This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating ankylosing spondylitis, and to further evaluate the drug's safety. Approximately 130 patients from the US, Canada, Poland and Hungary will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of ankylosing spondylitis according to the Modified New York Criteria (1984).
* Inadequate response to at least 2 weeks of continuous treatment with NSAIDs, or unable to receive ≥ 2 full weeks of continuous treatment with NSAIDs because of intolerance.
* If previously treated with a biological agent, patient must not have failed due to lack of efficacy, and must have completed an appropriate washout period prior to first dose of study drug.
* Patients may continue on specified stable background therapies for ankylosing spondylitis (doses should be stable for at least 4 weeks prior to the first dose of study drug).
* Additional criteria exist.

Key Exclusion Criteria:

* Diagnosis of any other active or uncontrolled inflammatory or non-inflammatory articular disease that may interfere with disease activity assessments.
* Previously treated with intravenous immunoglobulins within 6 months prior to first dose of study drug.
* Patients requiring prohibited concomitant medications including moderate or strong CYP3A inhibitors, CYP3A inducers and Biologic Response Modifiers (BRMs) while on study.
* Trauma or other major surgeries within 8 weeks prior to first dose of study drug.
* Specific abnormal laboratory values or electrocardiogram abnormalities.
* Known positive serology for human immunodeficiency virus (HIV), hepatitis C, and/or hepatitis B.
* Additional criteria exist.
Pilot Study of Patient's Adherence to TYKERB™/TYVERB™ + Capecitabine in Metastatic Breast Cancer

This is a 6-week, single arm, pilot study to test the study procedure, educational materials, and measurement instruments for the educational intervention in HER2 overexpressing metastatic or advanced breast cancer patients

Approximately 60 subjects with HER2+ metastatic or advanced breast cancer who meet the inclusion/exclusion criteria will be enrolled into the study. All subjects will receive education intervention for 6 weeks including education on Day 0, follow-up phone calls on Day 1 and Day 7, reminder phone calls before Week 3 and 6 visit and telephone hot line number.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent;
2. Female outpatient aged 18 years or older;
3. Subjects must be about to begin their initial treatment with lapatinib + capecitabine for HER2+ metastatic or advanced breast cancer according to physician's clinical judgement as per local prescribing information
4. Subjects must be literate, be able to read, understand and write local language.

Exclusion Criteria:

1. Women who is participating in any other interventional clinical trials concurrently;
2. Women who is already taking or had taken lapatinib + capecitabine regimen prior to the enrollment;
3. Primary lesions that are not of breast origin.
Histologic Diagnoses of Incidentally Detected Lesions on MRI

Patients who received breast MRI will be evaluated for a variety of indications including : # each indication : 1) known cancer staging for local exent, 2)high risk, 3)high suspicion clinical finding, 4)questionable mammo finding, 5)silicone leak The number of incidental lesions not detected by any other method that were subsequently subjected to biopsy with the following BIRADS categories 3-# reasons for bx 4-# 5-# Of the lesions detected % of each BIRADS category were postive histologies-ductal, lobular, DCIS, etc. and negative (fibrosis, hyperplasia, etc.) Criteria for classification: morphology, dynamics, clinical significance will be evaluated and a predictive value established.

Patients who received breast MRI will be evaluated for a variety of indications including ? # each indication : 1) known cancer staging for local exent, 2)high risk, 3)high suspicion clinical finding, 4)questionable mammo finding, 5)silicone leak The number of incidental lesions not detected by any other method that were subsequently subjected to biopsy with the following BIRADS categories 3-# reasons for bx 4-# 5-# Of the lesions detected % of each BIRADS category were postive histologies-ductal, lobular, DCIS, etc. and negative (fibrosis, hyperplasia, etc.) Criteria for classification: morphology, dynamics, clinical significance will be evaluated and a predictive value established. This study is limited to retrospective chart review with the only foreseeable risk being that of disclosure of PHI. To minimize this risk, data collection forms will be identified by subject ID number. A master list of these ID numbers linked to subject medical record number will be maintained in the investigator's file and kept in a secure location accessible only to the study team for purposes of verification of data and validation of results. The medical record number will not be recorded on any other form containing subject PHI. The only foreseeable breach of confidentiality would be for the security of the investigator's files to be compromised

Eligibility Criteria:
Inclusion Criteria:

* All patients subjected to biopsy as a result of findings seen only on MRI

Exclusion Criteria:

* None
Optical Coherence Microscopy in Dermato-oncology

OCTAV is a medical device class I, CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).

At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed.

This study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.

Eligibility Criteria:
FOR PATIENT

Inclusion Criteria:

* Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision
* Consent form signed
* Major patient

Exclusion Criteria:

* Allergy or intolerance to immersion oil (used for microscopy)
* If female, pregnant or breast-feeding
* Patient unable to stand still for 60 seconds
* Skin lesions located near patient eyes (\<3 cm)

FOR CONTROL GROUP

Inclusion Criteria:

* Aged between 18 to 40 years
* Consent form signed
* Patient of the dermatology department with non-pathological forearm skin

Exclusion Criteria:

* Allergy or intolerance to immersion oil (used for microscopy)
* If female, pregnant or breast-feeding
* Patient unable to stand still for 60 seconds
Supplementation in Tennis

The aim of this observational study is to examine supplementation (e.g. caffeine or creatin) use in both male and female professional tennis players.


Eligibility Criteria:
Inclusion Criteria:

* Professional tennis player

Exclusion Criteria:

* Any metabolic disease or a possible pregnancy
Treatment of NCCL Asociated With Gingival Recession With B.O.P.T. Technique

The purpose of this clinical trial is to evaluate the gingival margin changes resulting from the treatment with biologically oriented preparation technique (B.O.P.T.) of non-carious cervical lesions (NCCL). In particular, the quantification of the cervical margin is carried out by an intraoral scanning device, both in length and width.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age, all sex;
* Presence of a non-carious lesion with loss of dental hard tissue, located in the cervical third of the tooth, and associated with R1 Cairo dental recession; as well, the tooth must be in a healthy condition.

Exclusion Criteria:

* In the tooth to be treated: presence of tartar, periodontal pocket, gingival hypertrophy and/or dental mobility grades II and III; as well as presence of necrosis, fractures and prosthetic restorations;
* Presence of diabetes, coagulopathies, hemostatic and hormonal alterations, smoking habit of more than 10 cigarettes/day;
* Patients being treated with drugs whose side effects may cause gingival hypertrophy (eg hydantoins);
* Presence of any physical and/or mental condition that prevents voluntary giving informed consent to participate in the study.
Mindfulness, Compassion and Self-compassion

Teachers in Hong Kong are susceptible to professional stress and its associated psychosomatic illnesses. To enhance teachers' well-being, mindfulness training is conducted in local schools. The present study is a randomized controlled trial to explore 1) the relationship between mindfulness, common humanity, self-compassion, compassion, and well-being of school teachers; 2) whether mindfulness and common humanity are the antecedents of self-compassion and compassion; 3) the conditions under which compassion and self-compassion are highly correlated. Participants will be randomized to either intervention (8-week .b Foundations course) or waiting-list control condition. They will complete an online survey before (baseline), after (post-intervention), and two-months (follow-up) after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or above
* Working in local schools or education institutions
* Willing to participate in mindfulness training voluntarily

Exclusion Criteria:

* Experiencing severe or unstable mental health condition currently
* Completed 8-week mindfulness training previously
* Unwilling to go by random assignment
Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China

For last decade, the innovation of mobile health platform has brought new opportunities for disease management. Previous studies have shown that health management programs based on mobile platforms for patients with diabetes can improve patients' glucose control, self-management ability and quality of life. Type 1 diabetes mellitus (T1DM) due to its characteristics needs long-term linkage care throughout the lifespan cycle of patients. Therefore, this study intends to construct a prospective and open T1DM cohort based on mobile application and platform, to deliver home-community-hospital joint management for patients, and to provide follow-up online or offline every 3 months lasting for 10 years. Mainly, the objective of this study is to observe the blood glucose control outcome of T1DM patients. Secondly, the control of comprehensive metabolic indicators such as blood pressure and blood lipid, occurrence and progression of acute and chronic complications, and psychosocial status were included as well, expecting to provide scientific evidence for continuously improving the quality of T1DM management.


Eligibility Criteria:
Inclusion Criteria:

* At least 12 years old;
* Diagnosed as type 1 diabetes according to World Health Organization (WHO) criteria in 1999;
* Be able to use smart mobile phones;
* Informed consent and voluntary participation.

Exclusion Criteria:

* Secondary diabetes;
* Complicated with malignant diseases, such as cancer, hepatic and renal failure;
* Complicated with cognitive impairment or mental illness;
* Be pregnant or lactating at the time of enrollment.
Safety Study of Dengushield in Healthy Adults

This Phase 1 study to evaluate the safety of a single dose of Dengushield (dengue monoclonal antibody) in healthy adults.

This Phase 1 study will evaluate the safety and tolerability of a single dose of Dengushield (dengue monoclonal antibody) in healthy adults in a dose-escalating study design. In addition, pharmacokinetics will also be studied.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged 18-45 years, men, or women.
2. Negative Dengue NS1 at screening indicating no current dengue infection
3. Seronegative for dengue IgG
4. Participants who are willing to comply with the requirements of the study protocol and attend scheduled visit.
5. Participants who give written informed consent.
6. Participants having laboratory parameters within normal range
7. Participants with Body Mass Index (BMI) between 18 to 30 (both inclusive)
8. Satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations that is acceptable for study entry.

Exclusion Criteria:

1. Presence of acute infection in the preceding 14 days or presence of a temperature ≥ 38.0°C, or acute symptoms of infection greater than of "mild" severity on the scheduled date of first dosing
2. History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders.
3. Evidence of any other significant active haematological disease, or having donated \> 450 mL of blood within the past three months.
4. Evidence or history of substance abuse including alcohol, or previous substance abuse within the last year.
5. Participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period.
6. Planned administration of any vaccine not foreseen by the study protocol 4 weeks before and after dosing except for influenza vaccination.
7. Receipt of immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
8. Laboratory confirmed infection with hepatitis B virus (HBsAg positive), hepatitis C virus (anti-HCV positive) or human immunodeficiency virus (HIV positive) at screening.
9. History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed).
10. Known bleeding disorders.
11. Women who are pregnant, breast-feeding, or considering becoming pregnant.
12. Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the participant.