cyrilzakka/clinical-trials huggingface dataset:
Impact of Intermittent Kangaroo Mother Care Versus Conventional Care Method on Vital Sign and Arterial Oxygen Saturation in Preterm Hospitalized in Neonatal Intensive Care Unit

- To study the vital sign ,oxygen arterial saturation of preterm babies provided skin to skin contact versus conventional care from birth to discharge

The mother and baby will be supported by a nurse and researcher. Hence, the study group mothers will be trained properly, and the required information and explanations along with displaying the video description about the KMC method will be provided for them, and the KMC will apply to their newborns.

Thus, the naked newborn, only wearing diaper and cap, was placed in a straight state between the mother's breasts and supported by a cloth bag. The caring is performed for 3 consecutive days, three times a day and each time for 2-h.

The procedure will be conducted for all samples by the head nurse and with the researcher's presence and monitoring in the morning shift, and the mothers should be supported and encouraged during the caring process. The changes in pulse ,respiration, temperature, and arterial oxygen saturation rate of the study group is controlled and recorded during the care process, at 60 min after starting the procedure and at the end of caring process before returning the newborn to the incubator. The mentioned items in the control group (conventional incubator care) should also measure and recorded simultaneously with the study group. The pulse oximetry in NICU used to measure the arterial oxygen saturation rate, and a mercury thermometer was used to measure the temperature with an auxiliary approach for 3 min. To maintain the reliability of the instrument during the research, the same pulse oximetry device and monitoring system will be applied to newborns in the same situation. The pulse oximetry probe will be taped to the toe of the left foot of all newborns

Eligibility Criteria:
Inclusion Criteria:

Birth weight between 1200 to 1800 gram Gestational age 28 weeks to 36+6 weeks Clinically stable Off oxygen support Hemodynamically stable baby No surgery performed on baby No cardiac ,nervous system problems

-

Exclusion Criteria:

Extreme preterm\<28 weeks Hemodynamically unstable Underlying cardiac problems Surgical problems Those who do not give consent Unwell or hospitalized mother who is bed bound problems Gestational age 37 weeks or \>37 weeks

-
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects

The purpose of the study was to determine if treating a limited volume of normal tissue surrounding the tumor or tumor bed using conformal radiation therapy would achieve similar rates of disease control compared to standard radiation therapy. The study was also conducted to examine the effect of irradiation on neurological, endocrine and cognitive function.

Radiation therapy is commonly used to treat a variety of brain tumors in children including ependymoma, craniopharyngioma and low- and high-grade glioma. The ability of the therapy to control brain tumors in children is known to depend on the tumor type, extent of resection and other clinical factors. Children who received radiation therapy on this study were evaluated for treatment failure at 12 months. In addition to the primary objective, the study was designed to explore the association between radiation dose and volume and a variety of neurological, endocrine and cognitive deficits up to 5 years after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age at time of irradiation is greater than or equal to 8 months and less than or equal to 25 years
* Histologically diagnosed craniopharyngioma, ependymoma, low-grade astrocytoma or high-grade glioma and radiographically diagnosed selected patients with craniopharyngioma and low-grade glioma.
* Adequate performance status, participant has an ECOG (Performance Status Score) of 0-2(0=Normal Activity; 1=Symptoms but Ambulatory; 2=Bedridden \<50% of time)
* Histologic type that requires only focal irradiation.
* No prior fractionated external beam irradiation
* Informed consent signed by patient, parent, or guardian.
FoodSEqual Food Study

Diet is an important modifiable risk factor for many chronic diseases, but there is a paucity of dietary data from disadvantaged communities. The last Low Income Diet and Nutrition Survey (LIDNS) was conducted more than a decade ago and disadvantaged communities are known to be under-represented in other national surveys.

The aim of the study is to investigate diet and health and factors contributing to dietary choice in a sample of socio-culturally diverse disadvantaged communities using a combination of dietary intake assessment methods, including nutritional biomarkers

The FoodSEqual project is part of a five-year national consortium project led by the University of Reading and involves academics from Plymouth, Sussex, Kent and Cranfield Universities. It is funded by the UK Research and Innovation (UKRI) Strategic Priorities Fund (SPF). The vision of the FoodSEqual project is to provide citizens of socio-culturally diverse disadvantaged communities with choice and agency over the food they consume by co-developing new products, new supply chains and new policy frameworks that deliver affordable, attractive, healthy, and sustainable diet. The FoodSEqual Health project is a follow-on project to investigate associations between diet, health, and food affordability in the context of the FoodSEqual project.

Diet is an important modifiable risk factor for many chronic diseases, but there is a paucity of dietary data from disadvantaged communities. The last Low Income Diet and Nutrition Survey (LIDNS) was conducted more than a decade ago and disadvantaged communities are known to be under-represented in other national surveys.

The aim of the study is to investigate diet and factors contributing to dietary choice in a sample of socio-culturally diverse disadvantaged communities using a combination of dietary intake assessment methods, including nutritional biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over

Exclusion Criteria:

* unable to provide consent
A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medications in Children With ADHD

This study will assess the efficacy of the text messaging (SMS-based) disease management intervention for children with Attention Deficit/Hyperactivity Disorder (ADHD) using the timeliness of stimulant prescription renewals over a 9-month period.

Parents of participants in the study will receive customized text messages once a day, Sunday through Friday, for a duration of 9 months. The text messages will include reminders to adhere to the individualized medication regimen, reminders to call their child's clinician for a prescription refill followed by reminders to pick up medication from the pharmacy, and educational reminders about ADHD and its treatment.


Eligibility Criteria:
Inclusion Criteria:

* Children 6-12 years of age of both sexes and their parent
* A diagnosis of ICD-10 or DSM 5 diagnosis of Attention Deficit/Hyperactivity Disorder including the following ICD codes (F90 Attention-deficit hyperactivity disorders; F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type; F90.1 Attention- deficit hyperactivity disorder, predominantly hyperactive type; F90.2 Attention-deficit hyperactivity disorder, combined type;F90.8 Attention-deficit hyperactivity disorder, other type; F90.9 Attention-deficit hyperactivity disorder, unspecified type) and/or the following DSM 5 diagnoses (314.01, F90.2 Attention-deficit/hyperactivity disorder, combined presentation; 314.01, F90.1 Attention-deficit/hyperactivity disorder, predominantly hyperactive/impulsive presentation;314.00, F90.0 Attention- deficit/hyperactivity disorder, predominantly inattentive presentation)
* Starting or currently on stimulant medication including (Amphetamine/Dextroamphetamine (Adderall);Dextroamphetamine (Dexedrine, ProCentra, Zenzedi, Adderall XR); Dexmethylphenidate (Focalin, Focalin XR); Methylphenidate (Ritalin, Ritalin SR, Metadate ER, Methylin ER, Concerta, Daytrana, Metadate CD, Quillivant XR, Ritalin LA); Amphetamine sulfate (Evekeo); Lisdexamfetamine (Vyvanse))
* Proficient in English
* Has a cellular phone with text messaging capabilities and is interested in and willing to receive free of charge text messages

Exclusion Criteria:

* Investigator and his/her immediate family
* Unwilling/unable to comply with study procedures
Home Bicycle Exercise and Aerobic Capacity

The subjects with MetS or type 2 diabetes were enrolled for this exercise-training program. All participators underwent an indoor bicycle exercise for twelve weeks. In addition to demographic data and biochemical tests were determined after an overnight fasting. Extension of muscle strength was detected in the dominant lower extremity.

This prospective open-labeled study was conducted in Taichung Veterans General Hospital. The adult participants with metabolic syndrome and/or type 2 diabetes were enrolled. MetS. The procedures were fully explained to all subjects before the cardiopulmonary exercise test. ll enrolled subjects received a scheduled twelve-week program for exercise-training program. A commercially available bicycle with an indoor bicycle trainer are used as the home exercise training modality. All medications were not allowed to be changed during the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult with metabolic syndrome or type 2 diabetes

Exclusion Criteria:

* hyperglycemic crisis or HbA1c \> 12%;
* serum creatinine levels greater than 200 mmol/L;
* acute or chronic infectious diseases;
* limitations in the ability to undertake regular exercise
Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB)

A non-intervention cohort study on the use of Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB). Primary endpoint was the reduction of urinary incontinence.

The investigators wanted to cunduct an analysis of children with urinary incontinence who received intradetrusor injection of BoNT-A in the period 01.01.2016 to 31.12.2020 at their centre. All patients were refractory to standard urotherapy, anticholinergics, mirabegron and combination of treatments. Patients with neurogenic bladder were excluded.

Primary endpoints were the effect on the frequency of urinary incontinence episodes. Secondary endpoints included urodynamic parameters and uroflow characteristics in relation to side effects and response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* OAB
* Intradetrusor BoNT-A

Exclusion Criteria:

* Neurogenic OAB
NIS for Patients Using Symbicort Turbuhaler for Maintenance and Reliever Therapy in a Single Inhaler

The aim of this non-interventional study is to ensure that patients in routine clinical practice follow given treatment instructions and to evaluate the number of reliever inhalations as well as the number of patient/days with more than 8/12 total inhalations at any day. If the number of reliever inhalations and thus the received inhaled glucocorticosteroid dose is not excessive, the safety conclusions from the clinical studies can be extrapolated to real life for better acceptance of SMART (Symbicort Maintenance and Reliever Therapy).


Eligibility Criteria:
Inclusion Criteria:

* Persistent asthma
* Prior Symbicort Turbuhaler maintenance and reliever therapy in a single inhaler
Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease

The purpose of this study is to determine whether a brief course of SSKI (saturated solution of potassium iodide) administered preoperatively provides any benefit in the surgical management of patients undergoing thyroidectomy as definitive management of their Graves Disease.

Historically Potassium Iodide was given to patients for 1 week prior to thyroidectomy. This common practice was used to decrease thyroid function and prevent thyroid storm during the thyroidectomy. However, in modern practice, nearly all patients presenting for surgical management have been made euthyroid through the use of medications such as propylthiouracil. Despite this potassium iodine continues to be administered with the presumption that it decreases the friability of the gland making surgery easier, with less blood loss.

The outcomes to be measured in this surgery are operative time, operative complications and blood loss.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a clinical diagnosis of Graves Disease
* Patients who have selected surgical resection as treatment of their Graves Disease
* Prior use of anti thyroid medication so that patient is clinically and biochemically euthyroid

Exclusion Criteria:

* Patients deemed unfit for surgery by operating surgeon or anesthesist
* Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of normal
Comparison of Otezla to SFA-002 to Placebo in Plaque Psoriasis Patients

The goal of this clinical trial\] is to learn if SFA002 can treat mild, moderate and severe plaque psoriasis as good or better than Otezla, compared to placebo in adult and pediatric patients.

The main questions it aims to answer are:

How much does oral SFA002 treatment improve plaque psoriasis measured at different timepoints, 12 weeks, 24 weeks and 52 weeks of treatment.

How much does Oral Otezla (Apremilast) improve plaque psoriasis measured at different timepoints, 12 weeks, 24 weeks and 52 weeks of treatment.

These treatments will be compared to placebo, a look-alike substance that contains no drug.

Participants will be randomly placed into 3 groups to receive either SFA002, or oral apremilast or placebo for the duration of the trial. Patients that do not respond to apremilast or placebo treatment in 12 weeks will be offered the opportunity to take SFA002 for the remainder of the study.

There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.


Eligibility Criteria:
Inclusion Criteria:-

1. Candidates for systemic therapy with mild to moderate chronic plaque psoriasis (PsO) (with or without psoriatic arthritis) at Screening and Baseline for at least 6 months prior to Baseline defined as:
2. Body Surface Area (BSA) \>= 10% and \<= 15%; and Psoriasis Area and Severity Index (PASI) \>= 12; and Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4) -

Exclusion Criteria:

1. Participant has any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
2. History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
3. History of active ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
4. Prior exposure to SFA002 or apremilast. -
Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata

This is an interventional pilot study assessing the tolerability of needle-free delivery administration of ILTA with the Med-Jet as an alternative to conventional syringe and needle in patients with patchy pediatric alopecia areata. There will be a total of four (4) or five (5) visits necessary for study participation. The investigators hypothesize that the Med-Jet will have acceptable pain tolerability, efficacy, safety, and a positive impact on patient quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with alopecia areata by either:

  * A board-certified dermatologist, OR
  * Dermatology Nurse Practitioner, OR
  * Skin punch biopsy
* Patient has at least 2 alopecic patches each measuring at least 2 cm2 and are...

  * Located on contralateral body sites OR
  * Within the same body site but separated by ≥ 1 cm
* Patient is a candidate for intralesional triamcinolone.
* Patient able to give informed assent under IRB approval procedures when appropriate.
* At least one parent or guardian is able to provide informed consent.

Exclusion Criteria:

* Patient has alopecia totalis, alopecia universalis, or alopecia areata with ophiasis pattern.
* Known allergy or hypersensitivity to triamcinolone acetonide
* Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
* Patient is unable/unwilling to provide informed assent when applicable.
* Known medical diagnosis or use of a medication that alters pain response at time of injection.
* Active infection at site designated for injection.
* If currently being treated for alopecia areata, the current treatment regimen has been started within less than 4 weeks of screening.
The Determinants of Fertility Preservation in TRANSgender Patients.

The study is monocentric, retrospective, non-interventional and does not involve human subjects.

The main objective is to compare the profiles of transgender patients who undergo fertility preservation with those who do not.

The secondary objectives are to define the rate of recourse to fertility preservation, determine the proportion of patients wishing to become parents.

Statistical analysis will be carried out with a view to highlighting significant determinants in transgender patients by comparing those who undergo fertility preservation with those who do not.

The data will have been collected during routine consultations as part of the transition process for transgender patients. This is taking place in the reproductive medicine department of the regional university hospital centre in Nancy.

This study aims to assess the determinants of fertility preservation (FP) among transgender patients at the University Regional Hospital Center (CHRU) of Nancy. The secondary objective was to establish a database to gain a deeper understanding of the challenges related to fertility preservation in the context of a transition project and thus provide more tailored support to transgender patients.

The primary endpoint is the significativity of profiles elements of transgender patients who undergo fertility preservation with those who do not.

It may help the understanding of the determinants of fertility preservation in transgender patients.

We expect to include between 200 and 300 patients. The data will be transcribed onto the anonymised data collection Excel sheet. Statistical analysis of qualitative and quantitative data will be carried out with a view to highlighting significant determinants in transgender patients by comparing those who undergo fertility preservation with those who do not.

The study is monocentric, retrospective, non-interventional and does not involve human subjects. In fact, this research is based on existing data, extracted from patient files in the médifirst software. The data will have been collected during routine consultations as part of the transition process for transgender patients. This is taking place in the reproductive medicine department of the regional university hospital centre in Nancy.

Eligibility Criteria:
Inclusion Criteria:

* Transgender patients who consulted the Assisted Reproductive Technology centre of the Nancy Regional University Hospital, between 1st January 2020 and 30th June 2023. The consultations occurred for the start of transition care, for follow-up or for a parenting project for transgender patients.

Exclusion Criteria:

* minors
* patients under guardianship or under tutelage
Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

In this non-interventional one year study, data about overall and particularly gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are collected by basic questionnaires, which are handed out by pharmacists to patients who acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter) Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study. After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to get information about safety, usage and compliance under everyday's conditions, because in Germany low-dose aspirin is an OTC product with Rx indication.


Eligibility Criteria:
Inclusion Criteria:

* Patients who buy Aspirin protect 100 mg in a pharmacy and are willing to participate in the study.

Exclusion Criteria:
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.

This study is enrolling participants by invitation only. This is an open-label, international, longer-term extension study for eligible subjects who have participated in one of the Aimmune AR101 clinical studies.

Eligibility Criteria:
Key Inclusion Criteria:

* Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol
* Written informed consent and/or assent from subjects/guardians as appropriate
* Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

* Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study
* Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless allowed in the parent study, and except during the follow-up observation period in this study
* Discontinued early from the parent study
Cardiovascular Morbidity During Treatment of Overactive Bladder With B3 Agonists

Overactive bladder syndrome complicates life for many women. 60-70% of women report improvement with treatment but the antikolinergic treatment is often limited by the adverse events, for example dry mouth, obstipation and urinary retention. Mirabegron is a b3-adrenoreceptor agonist which induces detrusor relaxation. Earlier studies has demonstrated similar efficacy comparing Mirabegron with antimuscarinics but a significant reduction of adverse events. The aim of the present study is to survey cardiovascular adverse events with Mirabegron treatment in a general population suffering from overactive bladder syndrome.

Overactive bladder syndrome complicates life for many women. For 30 years the dominant treatment of overactive bladder syndrome has been antimuscarinics as first-line pharmacotherapy. 60-70% of women report improvement with treatment but the therapy is limited by the adverse events, for example dry mouth, obstipation and urin retention. In Sweden, prescription of antimuscarinics has increased by 69% during the period of 2000-2007 which implies an increasing desire to seek treatment.

Mirabegron is a b3-adrenoreceptor agonist which induces detrusor relaxation. Earlier studies have demonstrated similar efficacy when comparing Mirabegron with antimuscarinics but a significant reduction of adverse events. Clinical phase I-III trials have registered an increased pulse rate and effects on blood pressure in some patients. The aim of the present study is to survey cardiovascular adverse events with treatment with Mirabegron in the general population suffering from overactive bladder syndrome.

Eligibility Criteria:
Inclusion Criteria

* Overactive bladder syndrome, eligible for Mirabegron treatment

Exclusion Criteria:

* As specified by regulatory authorities for drug prescription