cyrilzakka/clinical-trials huggingface dataset:
Pre-oxygenation With High-flow Nasal Cannula in Caesarian Section Under General Anesthesia

The investigators and other groups have demonstrated that high-flow nasal oxygen used during preoxygenation for emergency surgery is at least equally effective as preoxygenation compared to standard tight fitting mask. The investigators also have data from a recent study that indicates that high-flow nasal oxygen might decrease the risk of clinically relevant desaturation below 93% of arterial oxygen saturation.

The studies investigating the concept of high-flow nasal oxygen has up to this date excluded pregnant women. Pregnant woman is a patient group with known difficulties to maintain adequate saturation levels during apnoea. Due to smaller functional residual capacity their oxygen stores after preoxygenation are smaller compared to patients with a normal body mass index. The pregnant woman also have a higher oxygen demand and metabolism due to the growing placenta and the fetus. Pregnant women are therefore a patient group where a method that could prolong time until desaturation would be even more valuable and potentially could save lives.

Based on the above, the investigators now aim to conduct a clinical pilot study, where pregnant women undergoing caesarian section under general anesthesia are pre and perioxygenated with high-flow nasal oxygen. Data from that group will be compared with patients preoxygenated in a traditional manner with tight facemask. This study is done to evaluate an established technique on a patient category that in theory could gain a lot from it.


Eligibility Criteria:
Inclusion Criteria:

1. Adult, \>18 years old
2. Caesarian section under general anesthesia.
3. Pregnant in week 30 or later
4. Capable of understanding the study information and signing the written consent.

Exclusion Criteria:

1. BMI \>45
2. Dependency on non-invasive ventilation to maintain oxygen saturation
Efficacy of Snap on Symptomatic Arrhythmia

Participants in the Snap arm were instructed to undertake once-day recording and transmission of a 30-second single-lead iECG trace to a secure server, plus additional submissions if symptomatic over a 3-month period. Snap traces were analyzed by an automated analysis software and cardiologists. Clinical review and appropriate care was arranged for those clinically significant arrhythmia. Patients in the RC group were followed up as normal methods including ECG, Holter.

Individuals with symptomatic arrhythmia without known arrhythmia were recruited.

Participants were required to have access to the internet via WiFi and to be able to operate the Snap system after simple instruction. Written consent was obtained, and eligible participants were randomized (1:1) to an intervention (Snap) group or RC group.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic arrhythmia

Exclusion Criteria:

* can not use the Snap instrument and Sign informed consent
Age-related Cognitive Change of Femur

Age-related change of femur is not well-known. The investigators investigated the longitudinal changes of femur.

Recently, bisphosphonate-related atypical fracture of femur (AFF) is paid attention in clinicians. Almost all AFFs were occurred in thicker cortical thickness. But age-related change of femur is not well-known.

The main objective of this study is to reveal the age-related change of femur.

Eligibility Criteria:
Inclusion Criteria:

* Osteoporosis or osteopenia patients who presented to our hospital

Exclusion Criteria:

* Patients without osteoporosis or osteopenia
Breast MRI as a Preoperative Tool for DCIS

Breast MRI is a fairly new technology, but it has been well studied. It is now used routinely in many patients with breast cancer. It has been shown to be useful in detecting areas of cancer that cannot be seen using other types of scans or tests.

The purpose of this study is to see how often MRI can find other areas of cancer in women with one area of breast cancer, and to determine how having the MRI test affects their treatment. The purpose is also to study any areas of abnormality seen on your MRI with special methods that allow the images of your breast tissue and the microscopic analysis of your breast tissue to be compared very carefully. The study also aims to follow women who enter the study over a 10-year period to determine how often the breast cancer comes back.


Eligibility Criteria:
Inclusion Criteria:

* Age less than 60 at time of consent
* Clinical stage is consistent with Stage 0 or Stage I T1mic at presentation
* Core biopsy proven DCIS or DCIS with microinvasion (invasion ≤0.1 cm), prior to enrollment
* Breast surgery to be performed at MSKCC
* Informed consent obtained
* Female

Exclusion Criteria:

* Age 60 or over at time of consent
* Patients who are pregnant or nursing
* Patients with contraindications to breast conservation
* Excisional biopsy of DCIS or DCIS with microinvasion, prior to enrollment
* Patients with any contraindications to MRI including pacemaker, tissue expander, other metallic surgical implants, weight over 350 lb., previous gadolinium reaction, metal fragments in eye
A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome

This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with fragile X syndrome. Patients will be randomized to receive one of 2 dose levels of RO4917523 or placebo orally daily for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents, 5 to 13 years of age
* Diagnosis of fragile X syndrome based on prior DNA testing confirming Fragile X Mental Retardation 1 (FMR1) full mutation and qualifying scores on the ABC and CGI-S

Exclusion Criteria:

* Previous treatment with another mGlu5 receptor antagonist within the prior 3 months
* Participation in a clinical trial involving an investigational drug (unapproved) or non-drug treatment within the prior 6 weeks or 5 times the half-life (whichever is longer) before the start of this study
* Any uncontrolled, unstable clinically significant psychiatric condition other than fragile X syndrome
* History of suicidal behavior
* Other protocol defined inclusion/exclusion criteria may apply
Hallux Mobilization in Patients With Parkinson's Disease

Parkinson's disease is a degenerative disorder of the central nervous system. The motor symptoms of Parkinson's disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain; the cause of this cell death is unknown. Early in the course of the disease, the most obvious symptoms are movement-related; these include shaking, rigidity, slowness of movement and difficulty with walking and gait. A multidisciplinary intensive rehabilitation treatment (MIRT) is able to improve different parameters in PD that are poorly responsive to dopaminergic therapy. In this study, we aim to understand whether the passive mobilization of the metatarsophalangeal joint of the hallux determines an increase in the joint range in this district, allowing to improve, at least, the gait.

Parkinson's disease is a degenerative disorder of the central nervous system. The motor symptoms of Parkinson's disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain; the cause of this cell death is unknown. Early in the course of the disease, the most obvious symptoms are movement-related; these include shaking, rigidity, slowness of movement and difficulty with walking and gait. The main families of drugs useful for treating motor symptoms are levodopa dopamine agonists and Monoamine oxidases-B inhibitors.A multidisciplinary intensive rehabilitation treatment (MIRT) is able to improve different parameters in PD that are poorly responsive to the pharmacological therapy. In this study, we aim to understand whether the passive mobilization of the metatarsophalangeal joint of the hallux determines an increase in the joint range in this district, allowing to improve, at least, the gait in patients with PD. In this course, we will evaluate whether passive mobilization of this joint, lead to positive effects on the freezing of gait and on the festination.

Eligibility Criteria:
Inclusion Criteria:

PD patients stage 3 H\&Y with FOG

Exclusion Criteria:

we excluded patients with atypical parkinsonism, with other concomitant neurological conditions (with cerebrovascular etc.), with joint disorders, muscle disorders or with other orthopedic conditions.
Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol

This study involves the prospective collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not having) endometriosis at the time of scheduled surgery. The investigators plan to enroll approximately 500 women to validate and optimize the use of genomic classifiers alone or in combination with serum markers (such as cytokines) as a non-surgical marker of disease.


Eligibility Criteria:
Exclusion Criteria:

* • Currently pregnant

  * Current or past diagnosis of any malignancy (with the exception of non-melanoma skin cancer)
  * Known to be HIV-positive
  * Unable to give informed consent
  * Unwillingness to have samples banked in Repository for future use
  * Clinical evidence of active cervical infection
  * Lupron (or other GRH agonist) therapy within the last 2 months (or Depo-Lupron within the last 4 months)
  * Current use of estrogen or progestin (oral, transdermal, intrauterine or ring).

    o Current use is defined as use in the index menstrual cycle (since the onset of the last menstrual period).
  * Use of depo estrogen or progestin in last 3 months
  * Current use of aromatase inhibitor

Inclusion Criteria:

* Women aged 18-44 scheduled to undergo gynecologic surgery (laparoscopy/laparotomy).

Indication for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
fMRI in Posttraumatic Stress Disorder (PTSD) During Working Memory Updating

Neuropsychological studies investigating trauma-exposed and posttraumatic stress disorder (PTSD) subjects have generally underlined the significantly poorer performance of tasks that require attention, concentration, and verbal memory, and difficulty in regulating memories surrounding the traumatic event. A previous study (El Hage et al. Cognitive Neuropsychiatry, 2006) revealed that the trauma-exposed subjects scored higher on anxiety/depression scales, and lower on processing speed tests. Moreover, the study showed significant impairment in working memory partially mediated by speed processing, but not by anxiety or depression. These results suggest that processing speed makes a major contribution to trauma-related working memory decline, and needs to be investigated in further studies.The aim of the present study is to explore correlation between hippocampus volume, frontal dysfunction and cognitive slowing in trauma-exposed subjects, while examining brain activation during performance of working memory tasks using functional magnetic resonance.

Working memory performance will be assessed using the "3-back test", and processing speed evaluated with "words comparison test". The study will be conducted on 2 years. The study should include 18 right-handed females victims of sexual abuse and suffering from PTSD, and 18 controls right-handed females without any history of abuse ad not suffering from PTSD. Brain activation will be measured during performance of working memory tasks (3-back test) and processing speed test using functional magnetic resonance.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed women
* Victim of sexual abuse
* Suffering from PTSD

Exclusion Criteria:

* Epilepsy
* Claustrophobia
* MRI contre-indication
* Addictive disorders
* Sightless
* Detection of a brain injury at the MRI
TIP Repair of Distal Penile Hypospadias Using Rapidly Absorbable Braided Vs Slowly Absorbable Monofilament Sutures

Objective:

To study the effect of tubularizing the urethral plate in DPH in children using 2 different absorbable suture materials, rapidly absorbable, braided 6/0 Vicryl and slowly absorbable monofilament 6/0 Polydioxanone, on complication rates.

Patients and methods:

A prospective, randomized controlled study conducted at the Urology Department, Cairo University Specialized Pediatric Hospital, Abou El Reesh, between September 2021 and September 2022. A total of 69 boys aged between 8 and 120 months with DPH were randomly divided into 2 groups: group(A) Vicryl included 39 boys and group(B) PDS included 30 boys. All boys were uncircumcised with no chordee and were primary repairs. TIP was the surgical technique used by a single pediatric urologist. Follow up was performed in outpatient clinic at 7 days, 1, 3, 6 and 12 months postoperatively. The complications and reoperation rates for both groups were compared.


Eligibility Criteria:
Inclusion Criteria:

* Any child(aged from 6m to 12 years old) with distal penile hypospadias (DPH) ( uncircumcised, without chordae, with good penile size and urethral plate(candidates for T.I.P repair)

Exclusion Criteria:

* reccurent cases,
* circumcised cases
* other types of hypospadias rather than DPH,
* presence of chordae,
* poor urethral plate
Study on Hypoallergenic Hair Dye

Permanent hair dyes are commonly used in over the counter direct to consumer products and within hair salons. Allergy, also known as contact dermatitis, to hair dye is a well known phenomenon. Herein, we seek to decrease the risks of allergy to hair dyes by testing a novel version of p-phenylenediamine (PPD) with less allergy potential.

For patients with PPD sensitizations, it is important to find alternatives for dark hair dyes. P-toluenediamine (PTD) and potentially also 2-methoxyethyl p-phenylenediamine (ME-PPD) show cross-reactivity with PPD and therefore we want to prove that our new compounds PPD-6 and PPD-7 show no or significantly reduced cross-reactions with PPD and do not induce relevant allergic reactions in patients with proven PPD sensitizations.

Our specific aims for this study are the following:

A1) To show that PPD 6 and PPD 7 have reduced or optimally no reaction in standard patch tests in patients with proven allergy to PPD A2) To compare the sensitization pattern to other possible commercially available alternatives for hair dye, such as ME-PPD and PTD A3) To evaluate and rule out any possible non-specific irritant reaction of PPD-6 and PPD-7 in these patch tests (i.e. confirm in-vitro safety profile in-vivo)

Eligibility Criteria:
Inclusion Criteria:

- Proven Diagnosis of PPD and/or PTD sensitization (patch tests and clinically relevant eczematous reactions to hair dye)

Exclusion Criteria:

* Use of oral immunosuppressive, anti-inflammatory and chemotherapy medications, particularly corticosteroids for at least 1 month before testing.
* Immunocompromised patient (e.g. Cancer, Diabetes mellitus, medication, Immunodeficiency, radiation therapy)
* History of acute hepatitis, chronic liver disease or end stage liver disease.
* History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
* Use of illicit drugs within the past 6 months prior to study start and/or opioid use disorder.
* Pregnancy as established by questionnaire
Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability

The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.


Eligibility Criteria:
Inclusion criteria:

* Integral skin test in the region;
* To use products of the same category;

Exclusion criteria:

* Lactation or gestation;
* Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs;
* Cutaneous disease (local or spread) in the evaluation area;
* Pathology which may cause immunity depression, such as HIV, diabetes;
* Endocrine pathology
* Solar exposure 15 days before evaluation;
* Treatment until four months before the selection.
* Allergic or atopic history to cosmetics products

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery

The objective was to compare the frequency and intensity of symptoms of fear in patients of preoperative cardiac surgery who received empathic behaviour from nurse or those who received no specific type of empathic behaviour. This is a randomized clinical trial. The sample consisted of 44 patients in preoperative of cardiac surgery, who were divided in two groups: empathic behaviour by nurses and without specific empathic behaviour. Fear was assessed at two time points: before and after the intervention. The instrument used was developed and validated, comprising 15 defining characteristics of the nursing diagnosis fear. The hypothesis is that the group who received empathic behaviour from nurse will reduce the anxiety.

Primary outcome is fear. Fear was assessed by a nurse using of an instrument developed and validated previous, based on 15 defining characteristics described by North American Nursing Diagnosis Association for the nursing diagnosis fear: apprehension, increased tension, exciting, nervousness, verbalization of fear (expressed concern), increased pulse, nausea, vomiting, fatigue, abnormal respiratory rate, increased perspiration, dry mouth, fear of death (reported), crying and impaired bowel motility.

Patients were evaluated for the presence and absence of these fear symptoms through scores: 0 (no symptom) and 1 (presence of symptom). For analysis of the results was carried out the sum of the scores of each symptom, ranging from 0 to 15, with the higher the score, the greater was the fear symptoms presented by the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patient who agreed to participate in the study by signing the consent form at least 24 hours prior to surgery

Exclusion Criteria:

* Patients in preoperative cardiac transplantation
* Patients who did not have at least two defining characteristics of the nursing diagnosis fear
* Patients using anxiolytics
* Smokers and / or patients who drank any amount of alcohol daily
Comparing Fluoride Varnish and Sealant to Prevent White Spots in Orthodontic Patients

The purpose of the study is o compare the efficacy of CPP-ACP MI Varnish and ProSeal sealant in preventing white spot lesion (WSL) formation in orthodontic patients.

This prospective randomized clinical trial included 40 orthodontic patients between the ages of 12-17 who were randomly allocated to two groups. Group 1 (Sealant Group) received sealant on the maxillary anterior canines, lateral incisors, and central incisors, with reapplication of the sealant every 3 months. Group 2 (Varnish Group) had MI Varnish applied every 4-6 weeks, without sealant placed on the maxillary anterior teeth. White spot lesion formation was evaluated with standardized digital photographs at two timepoints, T1 (initial appointment before bonding), and T2 (12 months later, with brackets removed). The brackets were removed in order to facilitate an adequate photographic exam. Photographs were analyzed side-by-side at the conclusion of the study with the Enamel Decalcification Index (EDI). The location of WSLs were recorded by tooth type and by region. Oral hygiene was evaluated at T1 and T2.

Eligibility Criteria:
Inclusion Criteria:

* no significant medical history
* no underlying medical problems such as Sjogren's Syndrome or conditions requiring more than 2 medications (to prevent bias of possible dry mouth)
* less than 17 years old at the start of orthodontic treatment,
* fully erupted permanent maxillary canines and incisors, starting fixed orthodontic treatment
* ability to come to appointments every 4-6 weeks.

Exclusion Criteria:

* professional fluoride application in the last 3 months
* allergy to milk
* untreated cavitated lesions
* heavy initial fluorosis
* dry mouth
* pregnancy
* any illness/condition that the investigators felt would affect the study outcome.
ThRombectomy In Mild Ischemic Stroke With a Visible Intracranial veSsel Occlusion

The purpose of TRIMIS is to study how a medical procedure by the name of endovascular therapy compares to medical treatment alone in patients with mild stroke and a blood vessel occlusion in the brain


Eligibility Criteria:
Inclusion Criteria:

1. Acute ischemic stroke in an adult patient (18 years of age or older).
2. Onset (Last Seen Normal) time to treatment time \<24 hours or unknown Last Seen Normal in whom Endovascular Therapy could be considered per local radiographic guidelines.
3. Mild stroke defined as an NIH Stroke Scale ≤ 5 at the time of treatment decision.

   a. Patients with NIH Stroke Scale=0 can be included in the study if they have relevant abnormalities on neurological exam.
4. An acute intracranial vessel occlusion (Intracranial Internal Carotid Artery terminus (T or L clot), Middle Cerebral Artery (M1, M2, M3/beyond), Anterior Cerebral Artery (A1, A2, A3), V4, Basilar, Posterior Cerebral Artery) defined by non-invasive acute imaging (Computed Tomography, angiography (Computed Tomography Angiography) or Magnetic Resonance angiography (MRA)) that is neurologically relevant to the presenting symptoms and signs.

Exclusion Criteria:

1. Stroke symptoms due to another non-ischemic acute neurological condition such as seizure with Post-ictal Todd's paralysis or focal neurological signs due to severe hypo- or hyperglycemia.
2. Hyperdensity on Non-contrast Computed Tomography consistent with intracranial hemorrhage. Any clinical suspicion of any intracranial hemorrhage even in the absence of visible blood on baseline brain imaging.
3. Large acute stroke \>1/3 Middle Cerebral Artery territory or Alberta Stroke Programme Early CT score (ASPECTS\<6 or established frank hypodensity relevant to the presenting acute stroke already visible on baseline CT scan.
4. Findings on acute CT or MRI to suggest that the
5. Patient has a severe or fatal or disabling illness that will impact decision regarding acute reperfusion therapies.
6. Pregnancy.
7. Clinical history, past imaging and clinical judgment suggest that the intracranial occlusion is chronic.
8. Stroke occurred as an inpatient.
9. Inclusion into any randomized control trials.
Measurements of Skin Physiological Parameters as Mean of Metabolic Assessment

To investigate the relationship between hungry-satiation situation including meal time and metabolism, skin temerature changing, simpathetic \& para-simpathetic response To investigate the relashionship between hungry-satiation situation including meal time and heart rate


Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years old
2. BMI: 22-30 Kg / m2

Exclusion Criteria:

1. Any unbalanced chronic disease
2. Any infection disease