cyrilzakka/clinical-trials huggingface dataset:
Optical Detection of Intravenous Infiltration

The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed for monitoring the intravenous infusion site for infiltration. The hypothesis is that the changes in optical signals measured near the infusion site using the optical device can be used to monitor intravenous infusion for infiltration.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will have peripheral IV catheter with active infusions that are anticipated to be in place and functioning for 48-72 hours. The IVs and accompanying infusions are solely a part of the subject's medical care and are not started or terminated for the purposes of this Study. The rationale for choosing this time frame is that the rate of infiltration is likely to be increased the longer the IV infusion is taking place.
* Subjects are admitted to one of the institution's intensive care or intermediate care units, including Adult Emergency Department, Pediatric Emergency Department, Adult Medical Intensive Care Unit, Pediatric Intensive Care Unit, Neonatal Intensive Care Unity, Surgical-Trauma Intensive Care Unit, Cardiothoracic Surgery Intensive Care Unit, Neuroscience Intensive Care Unit, Burn Intensive Care Unit, Transplant Intensive Care Unit, Coronary Care Intensive Care Unit, Post-Anesthesia Recovery Unit, Pediatric Intermediate Care Unity, Surgical Intermediate Care Unit, and Medical Intermediate Care Unit.

Exclusion Criteria:

* Inability to consent
* Lack of a peripheral IV
Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries

Post-dural puncture headache (PDPH) or spinal (or post-spinal) headache is one of the most common side effects of spinal anesthesia, with an incidence of 6-36%. The incidence of this complication was reported to be 76-85% after accidental dural puncture in epidural anesthesia. It usually starts within several hours after spinal anesthesia, but sometimes it can be delayed for up to 2 weeks, which usually resolves within a few days

The usual symptoms of PDPH other than headache are photophobia, neck stiffness, nausea and vomiting, diplopia, tinnitus, and dizziness. The headache is usually throbbing and severe, starting from the forehead and extending to the occiput, and is aggravated by standing or sitting. This is due to meningeal traction associated with cerebrospinal fluid (CSF) pressure reduction or dilation of cerebral arteries as an indirect effect of lowering CSF pressure as a result of CSF leakage from the punctured dura. Current treatments or preventive measures for PDPH other than bed rest and hydration include theophylline, sumatriptan, caffeine, etc. In resistant or severe cases, epidural blood patch (EBP) is a well-described technique used to provide relief of pain.

The co-administration of neostigmine and atropine is a common treatment for terminating the effects of non-depolarizing muscle relaxants in the setting of general anesthesia with minimal side

Eligibility Criteria:
Inclusion Criteria:

* BMI less than 35 kg/m2
* Scheduled for infraumbilical surgeries
* American Society of Anesthesiologists (ASA) physical status: I and II

Exclusion Criteria:

1. ASA physical status more than II.
2. History of allrgic response to local anaesthetics or any of the medications used in the study
3. Patients with cognitive impairment
4. pregnancy
5. Basal body temperature of more than 38°C or less than 36°C
6. BMI more than 35 kg/m2
Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study

The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight.

Participation in this study will last up to 61 weeks, including 52 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.
* Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.
* Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
* Have obesity, \[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\]
* Have overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:

  * hypertension
  * Type 2 Diabetes Mellitus (T2DM)
  * dyslipidemia
  * obstructive sleep apnea, or
  * cardiovascular disease.
* Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and/or who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example, ustekinumab.

Exclusion Criteria:

* Have a current diagnosis of:

  * Crohn's disease
  * inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or
  * primary sclerosing cholangitis.
* Have had or will need bowel resection or intestinal or intra-abdominal surgery.
* Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.
* Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
* Have a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.
* Have a current or recent acute, active infection.
Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and immunogenicity of REGN3470-3471-3479 in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy man or woman between the ages of 18 and 60
2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent
5. Able to understand and complete study-related questionnaires

Exclusion Criteria:

1. Use of any medications started within 30 days prior to the screening visit including, prescription medications, nutritional supplements, and over-the-counter medications except for vitamin supplements, and recommended doses of acetaminophen, aspirin or ibuprofen
2. Hospitalization for any reason within 60 days prior to the screening visit
3. History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
4. History of or positive blood test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody at the screening visit
5. History of drug or alcohol abuse within 1 year prior to screening
6. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
7. Any history of receiving treatment, vaccine or mAbs against the Ebola virus
8. Pregnant or breast-feeding women
9. Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \[IUD\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

   * Contraception is not required for men with documented vasectomy.
   * Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. A baseline follicle-stimulating hormone (FSH) test will be performed for confirmation of menopausal status. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Liver and Fat Regulation in Overweight Adolescent Girls

Women with polycystic ovarian syndrome (PCOS) have increased rates of hepatic steatosis compared to weight similar women with regular menses. It is unclear if this is related to high testosterone or insulin resistance. The investigators will assess hepatic glucose release, rates of lipolysis and hepatic de novo lipogenesis in the fasted and postprandial state to determine if alterations in the processes contribute to hepatic steatosis. Participants will be overweight, sedentary girls with or without PCOS. Those with PCOS will either be medication naive, or must be taking metformin or combined oral contraceptives (COCPs) for a period of at least 6 months prior to study procedures.

Hepatic glucose release will be assessed with a stable isotope glycerol tracer, lipolysis with a glycerol tracer, and hepatic de novo lipogenesis with an acetate tracer. Data will be collected fasting and after a glucose challenge. The degree of hepatic steatosis and abdominal fat partitioning will be assessed with Magnetic Resonance Imaging (MRI), and total body composition with Dual-energy X-ray absorptiometry (DEXA).

Eligibility Criteria:
Inclusion Criteria:

* Females
* 2 years post-menarche
* BMI percentile \>90%

Exclusion Criteria:

* Type 2 diabetes
* Anemia
* Liver disease
* Medications known to effect insulin sensitivity
* Cause of oligomenorrhea or hirsutism other than PCOS,
* \>3 hours a week of moderate exercise.
Lifestyle Matters: An Occupational Approach Towards Health and Well-being in Later Life

Lifestyle Matters is an occupational approach to healthy ageing, which helps older people to get the most out of life. The intervention is based on an American model of health promotion called Lifestyle Redesign. This was found to be highly effective in enhancing the physical and mental health, occupational functioning and life satisfaction of community living older adults in Los Angeles, USA.

Weekly group meetings provide older people with the space, time and opportunity to share their experiences. Through a process of peer exchange and guidance, participants have the opportunity to reflect upon the range of activities that they engage with. They are then helped to begin to understand how these activities might impact on their health and well-being. However this approach alone cannot meet the complex needs of individual older people, and their specific and personal concerns. In recognition of this, the programme also includes monthly individual sessions with one of the group facilitators. The older person in partnership with the facilitator identifies a tailored programme to meet their individual needs, including the means by which they might work towards their personal goals. The individual programme is updated and refreshed in subsequent meetings over the months.

During 2004/5 researchers at Sheffield Hallam University in partnership with other researchers in York and Leeds, and clinical colleagues in Sheffield explored the feasibility of delivering this intervention to older people living in the UK. The project was funded through the Sheffield Health and Social Research Consortium. The summary below is an account of the process and outcomes of delivering a Lifestyle Matters programme to two groups of community living older people during 2004/5.


Eligibility Criteria:
Inclusion Criteria:

* Community living
* Aged 65 or over

Exclusion Criteria:

* Score of 18 or under on Mini-Mental State Examination (MMSE)
* high level of depression, assessed using the Geriatric depression rating scale (GDS)
Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) (EXIT)

The objective of the study is to cross-culturally adapt and validate the French version of the EXIT scale: an assessment tool on induction of labor.

Favourable agreement was obtained from the authors to adapt the Australian moose tool in a cross-cultural manner. None of the co-authors expressed a desire to collaborate on our project. The EXIT questionnaire is free of rights.

The translation of the EXIT questionnaire into French will be carried out according to the recommended steps of the cross-cultural adaptation process (21, 22, 25): translation of the source version into French by three native French translators, adaptation of the different translations by a group of experts, back translation by two native English speakers, testing with a panel of women who have been triggered for childbirth, in order to arrive at the final version which will be evaluated in a sample of the target population.

Information about the study will be given to women between Day 2 and Day 4 postpartum. Patients' non-opposition to participate in this study will be collected in the patient's medical record.

Recruitment of subjects: the study will be proposed to all eligible women who have been induced for their delivery and with an unfavourable cervix in the obstetrics department of the CHU Estaing, Clermont-Ferrand.

Completion of the questionnaire: women will complete the EXIT self-questionnaire between D2 and D4 post-delivery.

The data collection will include additional socio-demographic and clinical information for each woman participating in the study from their medical records.

The test-retest involves filling in the EXIT questionnaire twice at one to two week intervals.

The women will be contacted by phone one week after the first EXIT test, to inform them that a link will be sent by e-mail to complete the EXIT questionnaire online (on Redcap) a second time. They will be called back a second time a week later if the questionnaire is not completed online.

Eligibility Criteria:
Inclusion Criteria:

* Patients having given birth in the obstetrics department of CHU Estaing, Clermont-Ferrand
* with an induction of labor
* with an unfavorable cervix (Bishop score \<6)
* on living child(ren)
* Patients aged 18 years and over, understanding, speaking and reading French
* no object to participating in the study.

Exclusion Criteria:

* Patients induced at first with syntocinon.
* Patients who do not have an internet connection and an e-mail address.
* Patients under legal protection (guardianship, tutorship).
Effect of Laughter Yoga on Nursing Students

Nursing students experience different levels of stress due to many reasons such as lifestyle, health, academic performance, competition, choice of profession, new living environment, relationships with peer group and expectations of parents. It is important to develop different coping behaviours/strategies to manage stressful situations. Laughter yoga has proven positive effects on physical and mental health.

The aim of this randomised controlled trial was to examine the effects of laughter yoga on well-being, perceived stress and academic self-efficacy of nursing students.

Laughter yoga, which is a combination of laughter and yoga with breathing techniques, is among traditional and complementary medicine practices. Based on the view that the brain cannot distinguish between real and unreal laughter, laughter yoga aims to benefit from the mental and physical benefits of laughter. Laughter yoga has benefits such as reducing stress and depression symptoms, relaxing muscle tone, increasing blood circulation, lowering blood pressure, increasing melatonin and growth hormone release, increasing pain threshold, strengthening the immune system.

Laughter yoga will be applied to the intervention group in 6 sessions (45 minutes each session). Well-being, Perceived Stress and Academic Self-Efficacy levels of the students will be evaluated before and after the intervention.

Hypotheses of the study; H1: The well-being level of the intervention group increases after laughter yoga.

H2: The academic self-efficacy level of the intervention group increases after laughter yoga.

H3: Perceived stress level of the intervention group decreases after laughter yoga.

H4: The well-being level of the intervention group after laughter yoga is higher than the control group.

H5: The perceived stress level of the intervention group after laughter yoga is lower than the control group.

H6: The academic self-efficacy level of the intervention group after laughter yoga is higher than the control group.

Eligibility Criteria:
Inclusion Criteria:

* To be a 4th year nursing student,
* Volunteer to participate

Exclusion Criteria:

* To take part in the intern programme,
* Simultaneous participation in any methods of complementary medicine,
* Having undergone surgery within the last three months,
* Having a diagnosis of hernia (hernia)
* Having a diagnosis of epilepsy
* Uncontrolled diabetes and cardiovascular disease
Water Induced Thermogenesis in Obese Children

Drinking water is largely advocated for obesity prevention and management. Recent studies have suggested that water has a thermogenic effect, this has not been examined in children. In this study, we will measure the resting metabolic rate of 21 obese children before, and during drinking cold (4 degrees centigrade)water for up to 60 minutes.


Eligibility Criteria:
Inclusion Criteria:

* obesity
* agreement and informed consent

Exclusion Criteria:

* non-agreement
Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus

Objects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types.

Method: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.

Outcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.

Conclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.

Since December 2019, patients with unexplained pneumonia have appeared in some medical institutions in Wuhan, China. Nucleic acid testing was completed on January 10, 2020, which was confirmed to be caused by 2019-novel coronavirus. In 2020, the World Health Organization(WHO) named the virus 2019-novel coronavirus(2019-nCoV). The WHO announced that the pneumonia caused by 2019-nCoV is officially called COVID-19. Today, more than 70,000 cases have been confirmed and more than 2,000 patients have died.

At present, the epidemiological characteristics, laboratory indicators, imaging features and clinical treatment effects of COVID-19 should be reported, but the sample size is small. Large sample studies are still needed to further confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects, so as to provide a scientific basis for future clinical treatment. Therefore, it is particularly important to further review the relationship between the characteristics and prognosis of such patients.

Eligibility Criteria:
Inclusion criteria.

1. 2019-nCov (SARA-Cov-2) nucleic acid positive detected by PCR.
2. Older than 18 years old and younger than 75 years old.
3. Meet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type)

Exclusion criteria.

1. the age is less than 18 years old;
2. pregnant or lactating women;
3. severe underlying diseases, such as advanced malignant tumor, end-stage lung disease, etc.
Preimplantation Genetic Screening in Women of Advanced Maternal Age

An increased incidence of aneuploid pregnancies has been reported in women of advanced maternal age, with higher miscarriage rates. Cytogenetic studies in preimplantation embryos have shown elevated aneuploidy rate, particularly in women over 38 years. For these reasons, PGS has been applied to these patients to improve ongoing implantation rates, and most importantly, to decrease the risk of further miscarriages and affected offspring. In the past two years, several RCT have raised the question whether PGS is benefitial or not in AMA patients.

In our experience, PGS outcome in these patients offers higher ongoing implantation rates than the previously published in RCT studies, where no benefits for PGS were found. In these papers, poor technical skills, as well as unclear patients selection could explain the reported lack of PGS benefits.

Therefore, the objective of the present RCT is to analyze the outcome of IVF cycles with and without PGS in two age groups:

* Patients 38-39 years of age: 200 cyles per arm reaching embryo transfer should be performed
* Patients 40-44 years of age: 120 cycles per arm reaching embryo transfer Sample size has been calculated according to our retrospective experience with higher differences in ongoing implantation rates between cycles with and without PGS in patients of 40-44 years of age. In all patients embryo transfer will be performed on day 5. In the PGS group one cell will be biopsy in embryos with ≥5 cells on day-3 and chromosomes 13, 15, 17, 18, 21, 22, X and Y will be analyzed in two rounds. In the third round, nuclei with undoubtful or non-conclusive results will be analyzed using subtelomeric probes.


Eligibility Criteria:
Inclusion Criteria:

* Female Patients over 37 years old, attending a fertility clinic

Exclusion Criteria:

* Azoospermic partners
* Female patients with uterine malformations
* number of retreived oocytes below 5
A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).


Eligibility Criteria:
Key Inclusion Criteria:

* Heterozygous for the F508del mutation (F/MF)
* Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height

Key Exclusion Criteria:

* Clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply