cyrilzakka/clinical-trials huggingface dataset:
INhaled Salbutamol vs Placebo for the Treatment of Acute IgE-mediated Abdominal Pain From Allergic Food REactions

The goal of this study is to assess the efficacy of inhaled salbutamol to treat abdominal pain during food allergic reactions.

Patients experiencing abominal pain as a result of a food allergic reaction during a food challenge in the allergy clinic will be invited to participate to the study.

They will receive either 8 puffs of salbutamol (asthma inhaler) or 8 puffs of a placebo inhaler.

The abdominal pain will then be followed using a numeric scale to see if patients receiving the medication experienced a faster improvement compared to those receiving the placebo.

This trial aims to compare the efficacy of inhaled salbutamol compared to placebo to decrease the duration of abdominal pain in children and adults with IgE-mediated food allergic reactions.

The population will be children and adults aged 6 to 55 presenting with moderate to severe IgE-mediated abdominal pain in the context of an oral food challenge or an oral immunotherapy dose increase at the allergy clinic.

Eligible participants will be randomized to receive an immediate treatement with either inhaled salbutamol 800 mcg or inhaled placebo, dispensed with a spacer, at a ratio of 1:1.

Participants will be asked to rate the evolution of their abdominal pain by the minute on the NRS-11 scale until it resolves completely or that they have been discharged.

Patients still presenting moderate to severe abdominal pain 30 minutes after the administration of the investigational product will receive an open-label treatment with 800 mcg of inhaled salbutamol.

The primary outcome is the time from treatment to a decrease of the abdominal pain down to a mild intensity (defined as a pain for which the patient would not normally seek treatment).

Participants will be contacted by phone after three days to document any adverse event.

The primary endpoint will be analysed using a log-rank test.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 6 to 55 years old.
* Undergoing an oral food challenge or an oral immunotherapy up-dosing visit for the diagnosis or treatment of an IgE-mediated food allergy.
* Previous confirmation of the food allergy by either skin prick tests (SPT) or serum specific IgE;
* Able to express the intensity of their pain using the NRS-11;
* Willing to comply with all study requirements.

Exclusion Criteria:

* Previous adverse reactions to salbutamol;
* Known hypersensitivity to salbutamol or placebo or any of their components;
* Any condition that could be considered a relative contra-indication to the use of salbutamol according to the investigator (e.g. patient with a history of hyperglycemia, arrhythmia or hypokalemia);
* Patients receiving beta-blockers or a daily / long-acting beta agonists;
* Patients needing to pass an anti-doping test for high-level sport in the following 24h.
Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term

A randomised control trial to compare oral and vaginal misoprostol for induction of labour in term patients.The objective is to determine whether use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of lessthan or equal to 6 who require induction of labpour at term compared to oral misoprostol regimen.

The objective of study is to determine whether the use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of less than or equal to 6 who require induction of labour at term compared to oral misoprostol regimen.It is a randomised control trial conducted in department of obs and gynae unit 1 from june 2023.

Total 176 patients are included in this study and they will be randomised by envelope method to recieve either oral or vaginal misoprostol in a dose of 50microgram.In both groupds dose will be repeated after 6 hours if required.Maximum 2 doses will be given.patients will be monitored for uterine contractions and fetal hearts.Vaginal examination will be done at 4hours and 8 hours following misoprostol dose or earlier if patient complains of leaking and labour pains.Membranes will be ruptured once cervical dilatation is greater than 3cm.in absence of adequate uterine contractions oxytocin infusion will be started.Fetal hearts will be monitored every 30 minutes from time of induction.Progress of labour will be assessed through partogram.

Eligibility Criteria:
Inclusion Criteria:

Cephalic presentation Prelabour rupture of membranes Singleton pregnancies reaching 41 weeks G1 to G4 Bishop score of less than or equal to 6 Medical disorders(GDM,PIH) -

Exclusion Criteria:

Previous uterine scar Antepartum hemorrhage Cephalopelvic disproportion Multiple gestation Multiparity Oligohydramnios/polyhydramnios IUGR Severe systemic illness like pre eclampsia,eclampsia,cardiac,hepatic,renal disease PPROM

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Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes

Research question (s)/hypothesis:

1. . The effectiveness of the shared care management of gestational diabetes mellitus;
2. . The cost-effectiveness of the shared care management;
3. . Its sustainability

Method (s) Tianjin three-tier antenatal care network established a universal screening program for gestational diabetes mellitus (GDM) in 1998 and up to 2008, the screening program had screened 115348 pregnant women. GDM will be defined as either fasting plasma glucose (PG) ≥5.1 mmol/L or 1-hour PG≥ 10.0 mmol/L or 2-hour PG≥ 8.5 mmol/L after 75 g glucose tolerance test. A total of 920 pregnant women who have GDM and agree to participate will be randomly assign to have the shared care (diet, physical activity and insulin if indicated) or the local usual antenatal care. The sample size has ≥80% power at a 5% type I error to detect the difference in the primary endpoint, birth weight ≥4000 gram and the secondary endpoint, pregnancy-induced hypertension. Hyperglycemia and other clinical data in the two groups of women will be collected during the shared care or the usual care. Logistic regression and cost-effectiveness analysis will be used in the data analysis.

Public health significance: The introduction of the proven management of GDM in Tianjin antenatal care network will justify the universal screening for GDM and reduce the rate of macrosomic infants and reduce pregnancy-induced hypertension, and thus improve pregnancy outcomes of women with GDM.

Sustainability plan: Just as the universal GDM screening in 1998, the shared care model will be introduced into the Tianjin antenatal care network as part of the usual care routine after the proposed study. The success of the care model will also be publicized and expanded to suburban districts and rural counties of Tianjin, possibly other parts of world where universal screening for GDM is a routine practice.

ACKNOWLEDGEMENT This project is supported by a BRIDGES grant from the International Diabetes Federation. BRIDGES, an International Diabetes Federation project, is supported by an educational grant from Lilly Diabetes."

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women who are diagnosed to have GDM.

Exclusion Criteria:

* Diagnosis of overt diabetes during OGTT;
* Younger than 18 years of age;
* Non-singleton pregnancy;
* Maternal-foetal ABO blood type incompatibility;
* Maternal diseases such as chronic hypertension,thyrotoxicosis, prepregnancy diabetes and use of long-term medications that may affect glucose metabolism.
Optimizing Provider Training in Eating Disorders (OPTED)

This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders.

This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders. Clinicians who treat youth and accept Medicaid insurance within a predetermined group of participating California counties will be randomized to receive either web-based training (WBT) or live two-day training in FBT. Data will be collected on the feasibility, acceptability, appropriateness, and effectiveness of the training (web-based vs. live). Following training, a subset of clinicians may opt into group consultation for one year. Consultation groups will be kept separate by training condition. Data will also be collected from clinicians on the extent to which they perceive the treatment itself (i.e., FBT) as feasible, acceptable, and appropriate for Medicaid-insured youth. In addition to implementation outcomes, de-identified clinical data will be collected from providers about their cases up to one year following the initial training.

Eligibility Criteria:
Inclusion Criteria:

* Mental health provider licensed to practice in the state of California, or unlicensed mental health providers in California who are formally employed by their agency/clinic and have a licensed clinical supervisor who agrees to take legal responsibility for any cases treated with FBT
* Must treat patients with Medicaid insurance in a participating county

Exclusion criteria:

- Students (practicum students, interns, externs) or other learners
Management of Diverticulitis in the Emergency Department

This study aims to describe current treatment practices in the US for managing acute uncomplicated diverticulitis. In addition, we will identify clinical factors associated with the decision to discharge versus hospitalize patients with uncomplicated diverticulitis with the goal of informing clinical decision-making and providing a foundation for diagnostic algorithms to guide clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Emergency department presumptive or confirmed final diagnosis of acute diverticulitis
* Verbal or written consent provided in English (or Spanish depending on study site)

Exclusion Criteria:

* None
True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae in Women

Dietary protein intake of adequate quality is essential for human health. Traditional animal source foods play a key role in providing high quality protein but are associated with a high burden on the environment. Therefore, viable alternative protein sources are needed to be able to meet human nutritional needs for the rapidly increasing world population, while keeping food production within the planetary boundaries. T. molitor (Yellow Mealworm larvae) is a sustainably produced and commercially available edible insect, which contains a high quantity of protein with a favorable amino acid profile. Protein quality evaluation considers the amino acid composition as well as the ileal digestibility of the food's individual amino acids, to assess if human dietary requirements for essential amino acids can be met by the protein source. The present study will measure the digestibility of essential amino acids from T. molitor with a minimally invasive dual stable isotope tracer method that follows a plateau-fed test meal protocol. T. molitor will be intrinsically labelled with the stable isotope deuterium (2H), which will be given along with a reference amino acid mixture of known digestibility, labelled with the stable isotope carbon-13 (13C). Based on the results from the present study, protein quality of T. molitor as a protein source for human nutrition can be assessed, allowing a direct comparison of this novel protein source to other protein sources, such as meat and legumes.


Eligibility Criteria:
Inclusion Criteria:

* Female aged between 18-45 years
* Normal BMI (18.5 - 25 kg/m2)
* Body weight \< 60 kg
* Signed informed consent
* Able to communicate and comprehend English
* Are open-minded towards consuming insect-based meals

Exclusion Criteria:

* Anaemic (Hb \< 12 g/dL)
* Inflammation (CRP \> 5.0 mg/L)
* Pregnancy or intention to become pregnant during the study or within 30 days after the discontinuation of the study intervention
* Lactating up to 6 weeks before the study initiation
* Chronic digestive, renal and/or metabolic diseases
* Antibiotics in the last 4 weeks prior to the study and during the study
* Mineral and vitamin supplementation in the last 2 weeks prior to the study
* Chronic medication intake (except for oral contraceptives)
* Daily exercise routine of high intensity
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
* Participation in any clinical study within the last 30 days
* Food allergies, especially hypersensitivity to crustacea, dust mites, sea food, gluten, milk, or eggs
* History of serious illness or infection within 3 months of the study
* Cigarette smoking (\> 1 cigarette per day)
* Difficulties with blood or breath sampling
* Participants who cannot be expected to comply with study protocol (e.g., not available for the full 8.5 hours of the study day or unable to follow fasting period)
* Inability to understand the information sheet and the informed consent form due to cognitive or language reasons
Salvage Lymph Node Dissection in Prostate Cancer Patients With Recurrence After Radical Prostatectomy

Despite continuous technical improvements in urologic surgery, up to 40% of prostate cancer patients will develop biochemical recurrence after radical prostatectomy (RP), potentially because of micro metastasis at the time of the primary surgery.

With improved radiological modalities and nuclear medicine tracers like 68Ga-PSMA PET/CT, which allow the localization of the site of recurrence, there is increasing interest in metastasis directed therapies, such as salvage lymph node dissection.

The pelvic extended salvage lymph node dissection (sLND) is a promising option for treating prostate cancer patients with local recurrence after radical prostatectomy with curative intent. Several retrospective series has been published to determine the local value of sLND. Despite the first data seem to be feasible and promising, to date no prospective evaluation has been made. Thus sLND is still experimental according to the guidelines and is considered as an off label therapy.

This prospective single center phase I/II study was conducted to investigate the safety and early efficacy of salvage lymph node dissection in prostate cancer patients with local pelvic recurrence after radical prostatectomy (RP) with curative intention.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients with lymph node metastasis in pelvic imaging
* Status post radical prostatectomy with curative intent
* Ability for informed consent
* No sign for bone or visceral metastasis
* Male \> 18 years
* ECOG performance status 0 or 1

Exclusion Criteria:

* Male \< 18 years
* No ability for informed consent
* Sign for bone or visceral metastasis
* Deep venous thrombosis or pulmonary embolism within the last 6 months before study screening
* ECOG performance status 2 or more
A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients

to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment


Eligibility Criteria:
Inclusion Criteria:

1. Female or male subjects age 18-35 years.
2. Subjects of all Fitzpatrick skin types.
3. Subjects with moderate facial acne and prominent pores indicating sebaceous gland activity.
4. Subjects with oily facial skin.
5. Subjects who agree to use only the study product and nothing else to the face.
6. Subject must possess no scars or tattoos or other confounding dermatologic conditions on the face in the preauricular biopsy sites on the left and right face.
7. Subjects agree not to introduce any new skin care products during the study.
8. No known medical conditions that, in the investigator's opinion, may interfere with study participation.
9. Subjects have signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."
10. Subjects are dependable and able to follow directions and willing to comply with the schedule of visits.
11. Subjects in generally good physical and mental health.

Exclusion Criteria:

1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics.
2. Subjects who are not willing to use the assigned study product to their face as instructed.
3. Subjects who have used any topical prescription products on the face for 4 weeks prior to study entry.
4. Subjects who have used any OTC products on the face for 2 weeks.
5. Subjects with clinically significant unstable medical disorders.
6. Subjects who are unwilling or unable to comply with the requirements of the protocol.
7. Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
8. Subjects currently participating in any other clinical trial.
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.

Erectile dysfunction is known as any alteration that produces a modification in the erectile response, whether it is due to organic, psychogenic or relational causes. Peripheral percutaneous nerve stimulation is performed using a needle to stimulate the peripheral nerves in such a way as to stimulate most of the area of the structure, stimulating sensory and motor nerve endings in the deeper tissues.

Patients will undergo continuous stimulation at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient, observing significant changes in erectile function after transanal stimulation at intensities between 20 and 100 mA.

Eligibility Criteria:
Inclusion Criteria:

Males Ages between 18-60 years old

Primarily organic cause diagnosed by Doppler:

* Peak-systolic velocities (PSV).
* Tele-diastolic velocity (DTV).
* Resistance Index (RI) Patients with ≤ 6 months since first assessment. Initial IIEF-EF questionnaire scores: 11-25 points. (mild to moderate erectile dysfunction) Active sexual life (more than 4 attempts per month).

Exclusion Criteria:

Pelvic surgeries History of Peyronie's disease Penile surgeries, except circumcision or frenuloplasty Priapism Pelvic radiation Female
Effect of Matcha Tea Versus Green Tea on Salivary pH and Flow Rate in High Caries Risk Patients

Objectives: To evaluate the effect of green tea versus matcha tea on the salivary pH in high caries risk patients. Materials and methods: Total number of high caries risk patients were randomized into two equal groups (n=). Group 1 (intervention group) was given Matcha Tea and Group 2 (control group) was given green tea. A portable digital pH meter was used to measure the salivary pH at baseline and after consumption tea immediately, after 5 mins and after 10 mins.

Study Settings:

The study will be carried out at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University in Egypt. Ethical approval will be taken from the Research Ethics Committee of the faculty of Dentistry, Cairo University. Signed informed consent will be signed each participant.

Recruitment:

Participants will be recruited from the patients' flow at the clinics of the Conservative Dentistry Department of Faculty of Dentistry, Cairo university.

Materials:

The Commercially available green tea and matcha tea for this study will be Lipton Tea. For preparation of green tea, 2 gr of green tea will be poured into 150 mL boiling water (100°C), after 3 minutes, it will be ready for drinking. As well as for matcha tea, 3 gr of green tea will be poured into 150 mL hot water (70°C), after 3 minutes, it will be ready drinking(7) .

Methods:

On the study day, all subjects will be instructed to brush their teeth 45 minutes after eating breakfast. Between 9-11 a.m., saliva samples will be collected through spitting method, one hour after breakfast and 15 minutes after brushing(7)

. For making the subjects blind to which tea they are drinking, the prepared tea will be served in the dark glasses. After drinking the green tea and matcha tea, every subject will be asked to bend his head forward and spit his saliva into laboratory tube every 60 seconds for 2-5 minutes. Samples will be collected immediately and 5 minutes after drinking tea(7)

.

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Aim of the study:

The aim of this study is to evaluate the effect of green tea versus matcha tea on the salivary pH in high caries risk patients.

Research question:

In high caries risk patients, will matcha tea have the same effect as green tea on salivary pH?

PICOTS:

P: High caries risk patients I: Matcha tea C: Green tea O: Salivary pH T: T1: baseline T2: immediately T3: 5 mins T4: 10 mins

Eligibility Criteria:
Inclusion Criteria:

-

1. High caries risk patients

1. Satisfactory cooperative behavior
2. Age between 20-45 years old
3. Males or females
4. Subjects who signed informed consent

Exclusion Criteria:

* 1. Systemic diseases 2. Drug consumption during 3 past months 3. Salivary gland disorders 4. History of radiotherapy 5. Smoking
Rectal Dexmedetomidine Niosomes for Postoperative Analgesia in Pediatric Cancer Patients.

Applying nanotechnology in drug delivery systems improved the bioavailability and kinetic profile of drugs in biological systems

Nanotechnology which is focused on studying the properties and the applications of materials with structure size in the range of 1-100 nm has been widely used in various fields. In biomedical research fields, nanotechnology has been used to design and development of drug delivery systems (DDSs). Nanotechnology-based drug delivery systems (NDDSs) offer many potential advantages in cancer treatment, such as improving targeting of the therapeutic drugs, protecting drugs from degradation during in vivo transport, controlled drug release at specific sites or cells in response to specific signals, and thus improving the therapeutic efficacy while minimizing side effects.

Applying nanotechnology in drug delivery systems improved the bioavailability and kinetic profile of drugs in biological systems. Advances in nanotechnology aid in targeting drugs to specific molecular targets and safely delivering drugs to specific sites of action. The sustained release of nano-drug delivery systems enhances the controlled release profile of loaded drugs, thereby minimizing the dosage-regimen.

The aim of this study will be to investigate the population pharmacokinetics and pharmacodynamics of rectal dexmedetomidine Niosomes for Postoperative Analgesia in Pediatric Cancer Patients undergoing bone marrow biopsy and aspiration in comparison with the intravenous and rectal plain formulation.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I and II.
* Aged 3-7 yrs.
* Undergoing bone marrow aspiration and biopsy.

Exclusion Criteria:

* Allergy to the study drugs.
* Significant organ dysfunction.
* Cardiac dysrhythmia.
* Congenital heart disease.
* Use of psychotropic medication.
* Mental retardation.
Role of Intraoperative Ultrasound in Gastrointestinal (GI) Malignancies

Currently available investigating modalities like CT scans, MRI etc although have a high accuracy in staging of gastrointestinal(GI) tract malignancies, are not correct in all cases . The aim of this study is to assess the role of intraoperative ultrasound as a modality to increase the staging accuracy of GI tract malignancies


Eligibility Criteria:
Inclusion Criteria:

* Patients with GI tract malignancies

Exclusion Criteria:

* Patients who refuse consent