cyrilzakka/clinical-trials huggingface dataset:
Breastfeed a Better Youngster: the BABY Study

This research will investigate different aspects of the 'signalling' between mother and infant during breastfeeding in a stressful situation following late preterm and early term delivery, when breastfeeding is often challenging. The researcher will conduct a single-blinded randomised controlled trial in Chinese mothers who deliver a late preterm infant (LPI; 34 0/7-36 6/7 weeks of gestation) and mothers who deliver a early term infant (ETI; 37 0/7-37 6/7) and plan to exclusively breast-feed.This study will investigate the role of the milk and infant gut microbiome as a potential 'signal' in this process. A relaxation intervention (meditation tape) will be used to reduce stress levels in mothers who are expressing breast-milk or breastfeeding their infant (born at 34 0/7-37 6/7 weeks completed gestation). This study will investigate whether lower levels of stress in the mother result in more successful and effective breastfeeding, leading to improved infant outcomes (better growth, longer sleep duration and reduced crying).

Participants will be recruited while they are in the maternity hospital. A baseline assessment will be conducted during the 1-week postpartum home visit, with another study visit at 8 weeks after delivery. After obtaining written informed consent, subjects will be randomly assigned to either the intervention arm or control conditions (standard management). Participants will be told that the aim of the study is to investigate factors that may make breastfeeding easier for mothers with a LPI and ETI, so they can breast-feed for longer. They will not be told about the randomisation until the end of the study, as this knowledge would most likely lead to mothers in the control group using some form of relaxation therapy. Background characteristics of mothers and their early feeding experiences will be recorded.

Participants can choose to complete the questionnaires on paper or online in their own time after the study visit. A breast milk sample will be collected pre-feed and infant anthropometry will be assessed by a trained nurse pre-feed at each home visit. Feed duration will be noted by the trained nurse. Stool samples of infants who were born vaginally will be collected by a trained nurse at baseline and at 8-weeks. At 3-month and 6-month postpartum, there will be a telephone contact to the participants for follow-up. Participants will be invited to complete the infant questionnaires again on paper or online in their own time.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous mother with singleton pregnancy who is breastfeeding her late preterm infants
* Infant is singleton born at 34 0/7-37 6/7 weeks of gestation.
* Mother and infant are generally healthy (free of serious diseases that can affect breastfeeding or nursing infant, or energy balance of the infant).
* No current involvement in other research studies that can potentially affect any of outcome measures.

Exclusion Criteria:

* Infant with serious underlying or chronic disease\*
* Mothers who smoke
* Infant receiving any medication regularly
Reliability and Validity of the IASP Clinical Criteria for Identifying Patients with Nociplastic Pain

This protocol will report on the validation of IASP clinical criteria for indentifying nociplastic pain. The study will include 2 phases. In the first phase, the vignette method will be used while the second phase will include the use of the algorithm in the evaluation of patients with chronic pain.

For the purposes of the study, in the first phase, clinical vignettes will be created, ie short hypothetical scenarios of patients with chronic musculoskeletal pain. The vignettes will feature patients with and without nocipalstic pain. Initially, two experts will evaluate and characterize which vignettes concern patients with nociplastic pain.

Next, a team of physiotherapists with knowledge of chronic pain and CS will evaluate vignettes twice according to the IASP criteria. There will be an interval of 1 month between the two measurements. One month later, the evaluation will be repeated. The investigators will design an Android application "Algo (s) rithm" to enter the questions of the algorithm. In the second phase, Algo (s)rithm app will use to evaluate patients with chronic pain (including patients with fibromyalgia) and healthy. The investigators will compare the result with PPT measurements in the same population.In the present study the inter-rater and test-retest reliability, criterion validity, construct validity will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-65 years
* with pain \> 3months, intensity of at least 3 on a 0-10 numerical pain rating scale on most days
* or patients with fibromyalgia (according to the "criteria for classification of fibromyalgia" by the American college of rheumatology (Wolfe et al 1990)).

Exclusion Criteria:

* Patients who follow a physical therapy program
* Recent surgery or trauma
* Pregnant women,
* Patients with neurological disorders or systemic diseases
Remifentanil in Children With Obstructive Sleep Apnea

This investigation tested the hypothesis that children with obstructive sleep apnea have an increased pharmacodynamic sensitivity to the miotic and respiratory depressant effects of the prototypic μ-opioid agonist remifentanil.


Eligibility Criteria:
OSA Group:

Inclusion Criteria:

* 8-14 years old
* ASA physical status 1 or 2
* undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea

Exclusion Criteria:

* Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)

Control (Non-OSA) Group:

Inclusion Criteria:

* 8-14 years old
* ASA physical status 1 or 2
* no known obstructive sleep apnea presenting for any procedure requiring general anesthtic

Exclusion Criteria:

* Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)
The Impact of Feedback Informed Treatment in Floating Support Service

Feedback Informed Treatment (FIT) is a systematic feedback method. FIT is based on two simple questionnaires and aims to assess and improve the effectiveness of therapeutic treatment. Treatment outcomes are assessed with the Outcome Rating Scale (ORS), a four-item self-report instrument measuring client functioning in the area of quality of life. Therapeutic alliance is assessed using the four-item Session Rating Scale (SRS). In FIT the feedback from the client is used to continuous adjustment and improvement of therapy. SFI will study the effect of using feedback in social work with floated support in the municipality of Copenhagen. Floating Support is a service that provides housing related support to vulnerable citizens to enable them to maintain their independence in their own home. The project is based on three different types of floating support. The aim of floating support is to improve the citizen's mental, physical and social well-being and thereby makes it more likely that the citizen can live independently at home. The study is a randomized controlled trial in which half of the caseworkers are allocated to be trained in the use of FIT, while the other half serves as a control group and will continue to work as usual. SFI is studying whether FIT can help to improve the impact of the floating support service on the citizen's mental, physical and social well-being and the citizens' likelihood of living in their own homes.

The study was designed as a cluster randomized controlled trial, where the investigators randomized 65 support workers to a treatment group (that used FIT) or a control group (that did not use FIT) at the beginning of the experiment. The investigators used block randomization within each unit to ensure that the number of support workers was evenly distributed between the treatment and control groups within each organizational unit. The investigators generated the random sequence using SAS.

When a support worker resigned during the experiment, another support worker with the same allocation took over the resigned worker's clients. If a new support worker was employed during the experiment in a unit with an even number of workers, the support worker was randomized to either the treatment group or the control group by simple randomization. If the unit had an uneven number of support workers, the new support worker was allocated to a group that ensured the unit kept the same uneven number of treatment and control workers.

The study included clients who had already begun in the support service before the experiment started and clients that started in the support service during the experiment. If a support worker only had one or two contacts with a new client, the client was not included in the study.

The study period was 16 months and ended when FIT was implemented in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Citizens who will receive floating support at the municipality of Copenhagen

Exclusion Criteria:

* Citizens who refuses to get the support. If the caseworkers do not think the citizen will need further support.
Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours

Childhood cancers are the third leading cause of death among children between the ages of 1 and 4, and the second leading cause of death among children aged 5-14 years. Biologically, it has been demonstrated that tumour aggressiveness and invasive capacity are caused by genetic modifications and cellular microenvironmental factors in a sequential and multifactorial process. The search for genetic alterations, proteins, or entire intracellular signalling pathways involved in the process of carcinogenesis and metastatisation is always evolving in order to identify new prognostic factors or potential therapeutic targets. In recent years, β-adrenergic receptors (β-ARs) have been associated with tumour progression.

This is a multicentre biological samples study which main aim is to evaluate the β3 receptor expression in the peripheral blood of patients with solid tumours compared to a healthy control group. The biological samples collected during the study are: peripheral blood sample, bone marrow aspirate and fresh or fresh paraffin biopsy tumour.


Eligibility Criteria:
Inclusion Criteria (principal study):

* Diagnoses, received after the year 2015 (Wilms' tumour, Ewing's Sarcoma, Osteosarcoma, Soft tissue sarcomas, Carcinomas, Neuroblastoma)
* Informed consent signed by parents or the patient if over 18 years of age
* Planned follow-up for 5 years
* Availability of a sufficient peripheral blood sample for analysis at onset.
* Age between 0 and 20 years

Inclusion Criteria (substudy):

* Diagnosis of Ewing's Sarcoma, Neuroblastoma, Paediatric leukaemia, Tumours of the breast, lung, colon and ovary
* Informed consent signed by parents or by the patient if 18 years of age19
* Planned follow-up for 5 years
* Availability of biological samples (peripheral blood, bone marrow blood, biopsy at onset) sufficient for the study investigations.
* Age between 0 and 20 years for paediatric patients referred to CROP Centres - Florence and Pisa
* Age between 19 and 75 years for adult patients attending the San Donato Hospital in Arezzo

Inclusion criteria (control group)

* Age between 0 and 30 years
* No evidence of acute or chronic infectious/inflammatory disease

Exclusion Criteria (for every partecipants to the principal study and substudy):

* Patients with HIV, HCV and HBV seropositivity (HBSAg) due to biohazard and bias related to patients' immunological status that could influence gene expression and tumour behaviour.
* Pregnant or lactating patients as the altered hormonal panel is a factor disturbing the expression of β3ARs
Impact of Cervical Parameters to Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients With Cervical Disc Herniation

This study is aim to disclose the effect of cervical parameters, whether they change the outcomes of epidural steroid injection treatment in patients with cervical disc herniation. The patients who had cervical disc herniation and had been performed interlaminar epidural steroid injection were included. We hypothesized that participants with abnormal cervical spine alignment parameters were less likely to benefit from treatment.

The objective of this study is to reveal the impact of cervical sagittal parameters on interlaminar epidural steroid injections in patients with cervical disc herniation. Patients who have suffered from cervical radicular pain for at least 3 months and been diagnosed with cervical radiculopathy in our pain clinic in the subsequent stage, with a clinical and physical examination, as well as radiologic assessments, were included in the study. Other inclusion criteria were intractable pain over the neck despite conservative treatment and being between the ages of 18 and 65. Patients with a history of epidural steroid injections carried out in the previous 3 months, patients with a history of cervical spine surgery, patients with systemic and/or local infections, malignancy, bleeding diathesis, acute fracture, known allergy to contrast material and/or local anesthetic substances, known history of any psychiatric disorder, and patients with a history of pregnancy were excluded from the study. Verbal and written informed consent was obtained from all patients participating in the study.

In addition to the recording of the demographic data of the patients participating in this study (age, sex, duration of symptoms, etc.), their sagittal parameters angles (C2-C7 cervical lordosis, C2-C7 sagittal vertical axis, C7 slope and spino-cranial angle) and the numeric rating scale (NRS) was employed before the procedure and in the 1st hour, 3rd week, and 3rd month after the procedure. Short Form-12 Health Survey (SF-12) was employed before the procedure and in the 3rd week and 3rd month after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have suffered from neck pain for at least 3 months and been diagnosed with cervical radiculopathy
* Intractable pain despite conservative treatment and being between the ages of 18 and 65
* Patients who will be performing with an interlaminar epidural steroid injection(ILESI)

Exclusion Criteria:

* Patients with a history of ILESI carried out in the previous 3 months,
* Patients with a history of cervical surgery,
* Patients with systemic and/or local infections,
* Malignancy,
* Bleeding diathesis,
* Acute fracture,
* Known allergy to contrast material and/or local anesthetic substances,
* Known history of any psychiatric disorder
* Patients with a history of pregnancy
Evaluation of Lab Exams Accuracy in the Intensive Care Unit

prospective, observational descriptive study assessing the accuracy of laboratory exams in the ICU.

Laboratory exams prescription for ICU patients was evaluated daily and their accuracy was determined according to locally implemented prescription protocol and to their abnormalities and the impact on further therapeutics.

Eligibility Criteria:
Inclusion Criteria:

* All adults ICU patients with a length of stay\&gt;24 hours

Exclusion Criteria:

* Patients transferred from other ICUs
* Currently unavailable laboratory tests
Efficacy of Pain Treatment on Depression in Patients With Dementia

The purpose of this study is to determine whether pain treatment can reduce symptoms of depression in patients suffering from dementia and depression. Depression is commonly diagnosed in patients with dementia. If the investigators find a reduction in depressive symptoms when pain treatment is applied, this will support the hypothesis that undiagnosed pain may present itself as depression in patients with dementia.


Eligibility Criteria:
Inclusion Criteria:

* Patients residing in long term nursing home units for at least 4 weeks prior to study
* Diagnosed with probable or possible dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), FAST score \> 4
* Diagnosed with depression ≥ 4 week duration as measured by CSDD ≥ 8
* Written, informed consent provided by the participant (if they have capacity) or assent (if they do not have capacity) and a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant

Exclusion Criteria:

* The patient is contra-indicated to study drugs of pain treatment, in another trial, or had no carer.
* Participants are ineligible if they are clinical critical (e.g. suicide risk)
* Clinician responsible for care, or study clinician considers that the patient suffers from any physical condition, which would make participation in the trial distressing or likely to increase suffering
* Advanced severe medical disease/disorder with expected survival less than 6 months or that could interfere with participation
* Psychosis or other severe mental disorder prior to dementia diagnosis
* Severe aggression (≥8) on item 3 of the NPI subscale, with aggression as the predominant symptom
* Schizophrenia, schizoaffective disorder and bipolar disorder
* Uncontrolled epilepsy
* Severe liver impairment
* Renal failure
* Severe injury or anaemia (Hb \< 8.5 mmol/l), comatose state, current enrolment in another experimental protocol
* Known allergy or adverse reaction to paracetamol or buprenorphine transdermal patch
* Advanced severe medical disease with expected survival of less than six months, severe psychiatric or neurological disorder.
* Patients with diseases that make it impossible to follow the research schedule are excluded
Efficacy of Family Constellations in the General Population

The purpose of this study is to investigate the efficacy of systemic / family constellation therapy in improving mild-moderate psychopathological symptoms and overall wellbeing in the general population. Given the limited amount of evidence on this therapeutic method, special attention will be given to monitor potential adverse outcomes to establish intervention safety. The study will use a randomized, wait-list controlled design and a 6-month follow-up time. This is the second study of this nature following a similar study from Germany.


Eligibility Criteria:
Inclusion Criteria:

* Ability to participate in the in-person intervention on the date randomly assigned to them

Exclusion Criteria:

* Participation in family / systemic constellation therapy within the 12 months prior to study launch
* Current mental disorder diagnosed by an eligible health care professional
Effects of Different Kinds of Hypotensive Drugs on Dynamic Hemodynamic Changing in Patients Under Surgeries

SVV is clinically affected by a variety of factors, such as abdominal pressure, body position, tidal volume, type and temperature of liquid treatment, etc. There are few reports on the effects of drugs on SVV.

In clinical anesthesia, surgical stimulation and stress can affect patient hemodynamic stability, used in intraoperative vascular active drug is inevitable, they shrink or dilate blood vessels, speed up or slow down the heart rate, makes the ventricular preload and corresponding changes in the SV. Now, there is a study on SVV and PPV in patients with hypertension, but there are few reports on the effect of blood pressure drugs on the changes in patients' threshold.


Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ-Ⅲ
2. body mass index (BMI) 18-26kg/m2.
3. Hypertension and non-hypertensive patients
4. diabetic no complications
5. no lung, liver, kidney and blood system diseases
6. preoperative examination is basically normal.

Exclusion Criteria:

* Any type of arrhythmia, intraoperative need for other vasoactive drug intervention.
Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

The purpose of this study is to evaluate the efficacy and safety of hydrogen-oxygen mixed gas inhalation in the treatment of insomnia.

This ia a randomized, double-blind, crossover, placebo-controlled Study. The purpose is to evaluate the efficacy and safety of hydrogen-oxygen mixed gas(H2-O2) inhalation in the treatment of insomnia, and explore the possible mechanism by detecting the changes of serum inflammatory factors (CRP, IL-6, IL-1β, TNF-α) levels, so as to seek an effective therapy for insomnia.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
2. No use of sleep medications within the preceding 2 weeks, or a stable dose of only one sedative hypnotic medicine for at least 1 month before the enrollment and remain unchanged throughout the course of the study.
3. Signed informed consent form (ICF).

Exclusion Criteria:

1. Complicated with other sleep disorders (sleep apnea syndrome, narcolepsy, restless legs syndrome, nocturia, etc.);
2. Complicated with serious heart, lung, liver or renal diseases or malignant tumor;
3. History of mental illness;
4. Drugs or substances abuse;
5. Pregnant women, breast-feeding women or those with recent birth plans;
6. Participants in other clinical trials within 1 month before the study.
Ejaculatory Abstinence in IUI Cycles

Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The aim of this study was to report the effect of ejaculatory abstinence on sperm DNA fragmentation and pregnancy rates in IUI cycles, as well as the correlation between the two.

Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The fact that IUI is less expensive, less invasive, and easier to perform than other assisted reproductive techniques makes it the first-line treatment option in infertility treatments. Several studies have been published over the past few years examining the relationship between sperm DNA fragmentation and IUI outcome. The optimal period for ejaculatory abstinence before the semen sample is a controversial issue in the literature. There are only two retrospective studies examining the relationship between the ejaculatory abstinence period and pregnancy rates after IUI.

Several studies suggested performing IUI with sperm samples obtained in a shorter abstinence period than recommended by WHO. However, there isn't enough research on this issue in the literature. Moreover, there is no specific prospective clinical research examining the relationship of ejaculatory abstinence period and sperm DNA fragmentation in IUI cycles. The aim of this study was to report the effect of ejaculatory abstinence on sperm DNA fragmentation and pregnancy rates in IUI cycles, as well as the correlation between the two

Eligibility Criteria:
Inclusion Criteria:

* Infertility for more than 12 months
* Diagnosed as unexplained infertility
* Female age between 20 and 40 years
* Regular menstrual cycles
* Mid-luteal progesterone levels of \>3 ng/ml
* Basal FSH \<12 mIU/ml, AMH \>1ng/ml
* Body mass index (BMI) 19-35 kg/m2
* No pelvic pathology documented by transvaginal ultrasound and bilateral tubal patency diagnosed by hysterosalpingography
* Normal semen parameters according to WHO criteria

Exclusion Criteria:

* Any endocrine and pelvic pathology
* PCOS (polycystic ovarian syndrome)
* Known endometriosis history
* Prior pelvic surgery
* Persistent ovarian cysts.