cyrilzakka/clinical-trials huggingface dataset:
Manicaland PrEP Uptake Through Interactive Counselling Trial

Primary Objective:

The purpose of this trial is to evaluate the impact of an interactive tablet based counselling session correcting risk perception and addressing ambiguity around availability, usability and effectiveness of PrEP on PrEP uptake within 6 months in adolescent girls and young women (AGYW) aged 18-24 years.

Hypothesis:

Correcting misperceptions of risks of HIV infection and off-setting ambiguity effects about the availability, usability and efficacy of PrEP, through localized, interactive, tablet-based counselling, will increase uptake of PrEP in HIV-negative AGYW.

Study outcomes:

The primary outcomes for the study will be risk perception measured in a follow-up survey at 6 months and proportion of women taking up PrEP within 6 months measured with biomarkers of plasma antiretroviral (ARV) drug presence.

With 6 clusters per arm, mean cluster size of 48 individuals, with co-efficient of variation in outcomes between 0.15 to 0.55, the trial will have 80% power to detect difference of 5 - 9 percentage points when baseline PrEP uptake is assumed to be 1%.

Primary analysis:

A two-stage intention-to-treat (ITT) analysis of cluster level summaries will be used. The parameter of interest is the adjusted risk difference in primary and secondary outcomes.

In the first stage, Logistic regression will be used to adjust for confounding variables at the individual level. The model will be fitted using data from both trial arms. The regression model will include terms for the covariates of interest and pair but not trial arm. Adjustment variables will include age group (\<20, 20-24), highest level of education completed, marital status and baseline measures of outcomes. In the second stage, a formal statistical comparison for differences in observed versus expected uptake by arm will be conducted using a two-sided paired significance test with α=0.05.

Secondary analysis:

In secondary analysis, the complier average causal effect (CACE) will be estimated using an instrumental variables approach. The parameter of interest is the adjusted risk difference in primary and secondary outcomes.

Heterogeneity by age and baseline levels of risk and time preferences will also be estimated.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Age 18-24 years

Exclusion Criteria:

* Participants testing HIV-positive at baseline
* Self-reporting taking PrEP at baseline
Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying

The primary objective of this trial is to show that an hypoallergenic infant starter formula containing starch and the probiotic L. reuteri decreases the severity of regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have taken it for 4 weeks, in comparison with a standard infant starter formula.

The primary objective of this trial is to show that the test formula (HA formula + starch + L. reuteri) decreases the severity (frequency + volume) of regurgitation/spitting-up in infants and ultrasound gastric emptying time, compared to a classical infant starter formula.

Eligibility Criteria:
Inclusion Criteria:

* Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
* Age of infant between 5 days and 5 months
* NGA
* Infant exclusively formula-fed at enrollment
* Presenting regurgitation/spitting-up according to the parents' perception
* Vandenplas score of at least 2 and maximum 5
* Having obtained the subject's legal representative's written informed consent

Exclusion Criteria:

* Previous antireflux treatment
* Previous consumption of AR infant formula or external thickener
* Previous consumption of a formula with L. reuteri
* Cow's milk allergy symptoms according to medical decision
* Congenital illness or malformation that may affect growth
* Significant pre-natal and/or post-natal disease
* Newborn whose parents / caregivers cannot be expected to comply with study procedures
* Newborn currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
Pathological Comparisons of Surgical Open Lung Biopsies and Cryobiopsies in Non-IPF ILD

Pathological comparisons of surgical open lung biopsies and cryobiopsies in non-IPF ILD. Patients with non-IPF ILD eligible for an open lung biopsy will undergo cryobiopsy in the same time. Between observers agreement will be assessed for each pairs of samples.


Eligibility Criteria:
Inclusion Criteria:

* Non IPF ILD eligible for surgical lung biopsy reviewed during multidisciplinary approach

Exclusion Criteria:

* Ineligible for lung biopsy: pulmonary hypertension, coagulation deficiency, FEV\<11, giant emphysematous bullae, hemodynamic instability severe hypoxia, general anesthetic ineligibility
Closed Sinus Augmentation With a Calcium Phosphosilicate Putty

The goal of this clinical study is to learn if cone beam computed tomography (CBCT) or 3-dimensional x-ray can help to let the investigator know if dental implant placement can be done after performing closed sinus surgery.

The study will look at the structure of your gum where the implant will be placed after performing the surgery using 3-D x-ray and compare that to how the structure of your gum looks 6 months later.

The 3-D imaging will happen after standard of care surgery to prepare your gum for an implant and then 6 months later to verify that the site is ready for the implant.

While you are taking part in this study, participants will be asked to attend approximately two visits with the researchers or study staff. For research purposes, one visit is the surgical appointment and a postoperative visit at six months, these will likely be scheduled at standard of care visits.

If the participant elects a dental implant for tooth replacement, your sinus grafting will be performed, and the dental implant will be placed on the same appointment.

Study Procedures - as a participant in this research, you will undergo the following procedures:

1. Immediately upon completion of your sinus grafting and dental implant placement a three-dimensional x-ray will be taken in the Graduate Periodontics clinic.
2. At six months following your dental implant placement an additional three-dimensional x-ray will be taken in the Graduate Periodontics clinic.

Eligibility Criteria:
Inclusion Criteria:

1. Ability of participant to understand and the willingness to sign a written informed consent document.
2. English speaking.
3. Individuals who are normal healthy or have a diabetes diagnosis with a current HbA1c (glycated glucose)\< 7.0.
4. Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement
5. At minimum 5mm of native bone below the maxillary sinus inferior border

Exclusion Criteria:

1. Maxillary sinus disease
2. Diabetes diagnosis with a current HbA1c \> 7.1 or greater due to diabetes effect on bone metabolism
3. Pregnant or attempting to become pregnant
4. Having a disease that affects bone metabolism
5. Use of medications known to affect bone metabolism
6. Tobacco, cannabis or vaping use
7. Alcoholism or other recreational drugs
Caries Prevalence, Experience and Risk Related Factors Among Early Middle-aged Patients Attending Cairo University

Dental caries, a widespread oral health issue, results from a complex interplay of factors including behavior, hygiene, diet, and socio-demographic aspects. While preventive measures are available, it remains prevalent globally, affecting numerous teeth per individual. Improved oral hygiene practices and increased awareness have led to a reduction in caries prevalence. However, rising sugar consumption exceeds dietary guidelines, contributing to the problem. Despite limited epidemiological studies in Egypt, addressing individual-level factors is crucial. Surveillance of oral health in the early middle age group is standard, allowing decision-makers to assess the impact of caries and oral health care provision. Stratifying data by age, geography, and gender aids in understanding prevalence and planning effective prevention strategies. Overall, promoting awareness of dietary habits and preventive practices is vital for improving oral health outcome So, The purpose of this study is to assess the prevalence of dental caries among early middle age patients attending dental hospital in Faculty of Dentistry, Cairo university and to analyze the related risk factors utilizing WHO Oral Health Questionnaire for Adults.


Eligibility Criteria:
Inclusion Criteria:

1. Patients whose age between 35 to 44 years old.
2. Patient consulting in the outpatient clinic
3. Provide informed consent
4. Co-operative patients approving to participate in the trial.
5. Males \& Females
6. Egyptian

Exclusion Criteria:

1. Patients under or over this age group
2. Lack of compliance
3. Disabilities
Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer

In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is well tolerated with minimal myelosuppression, so that it is likely that fully efficacious doses of all three drugs can be administered

Upon determination of eligibility, all patients will be receive:

Trastuzumab + Vinorelbine + Docetaxel

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic breast cancer confirmed by biopsy
* Overexpression of the Her-2 oncogene
* Age \> 18 years
* Measurable disease
* Able to perform activities of daily living with minimal assistance
* No previous chemotherapy for metastatic disease
* One or more previous hormonal therapies for metastatic disease.
* Adequate bone marrow, liver and kidney function
* Patients with \< grade 1 peripheral neuropathy are eligible.
* Must give written informed consent prior to entering this study.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Abnormal heart function
* Previous treatment with trastuzumab
* Brain metastases untreated
* Pre-existing symptomatic peripheral neuropathy
* Serious underlying medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Validation of a Smartphone-based Recorder for Detection of Cardiac Arrhythmias

The investigators will evaluate the diagnostic yield of the new AliveCor device versus a 12 lead ECG when used simultaneously to detect cardiac arrhythmia

The investigators are planning to record 250 pre-defined abnormal ECGs (50 each of atrial fibrillation, atrial flutter, pre-excitation, ventricular tachycardia, , supraventricular tachycardia) and 150 control ECGs (100 sinus rhythm, 50 sinus tachycardia) using both the AliveCor Smartphone device and a 12-lead ECG. All 400 ECGs will then be read by 3 blinded reporters - a Consultant Electrophysiologist, a Consultant General Cardiologist and a General Practitioner. The output of the AliveCor automatic detection algorithm will also be recorded as a fourth reporter. The screening characteristics of all 4 reporters using the AliveCor device vs the definitive 12 lead ECG will be analysed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \>18 years
* 12 lead ECG finding of arrhythmia, manifest pre-excitation, pacing rhythm (in the EP lab), sinus rhythm or sinus tachycardia

Exclusion Criteria:

* Age \<18 years
* Patients unable to or unwilling to use the device
* Patients with cardiac pacemaker, ICDs, or other implanted electronic devices
Impact of c242T Polymorphism of p22phox in Diabetic type1 Nephropathy

The physiopathology of diabetic nephropathy (DN) is unclear. To investigate risk factor, the investigators choose to look about some oxidative stress genes. Today a one-gene explanation is not really possible. So the theory of some genetic predisposition to DN is more likely.

The aim of the study is to look about the association of the C282T polymorphism of P22phox, a sub unit of the nicotinamide adenine dinucleotide phosphate-oxidase (NADPH oxidase) in the occurrence of DN. To follow the oxidative stress pathway of the DN, the investigators also investigate three other polymorphisms: -429 T/C, -374 T/A polymorphism of advanced glycation end-products receptor (AGER) and the p.Arg261Gln polymorphism of the 12 lipoxygenase (ALOX 12). Discordant data suggest a link between the first 2 polymorphisms and DN. The last polymorphism is correlated to albuminuria in diabetic patients.

To avoid confounding factors, we choose type 1 diabetic patients. We plan, with the data of literature a number need to be significative with a power of 80% and an Alpha risk at 5%, the inclusion of 160 patients for our primary analyze of p 22 phox. Those patients are included consequentially from the diabetic consultation of the university hospital of Grenoble, if they have a history of more than 20 years of diabetes. Those patients have been separated according to the existence of DN, and their polymorphism. Then we estimate with the Fisher test the prevalence of DN in risky patient, and the prevalence of the risky phenotype in the nephropathic patients. Then we investigate with the same statistical test the -429 T/C,he -374 T/A AGER and p.Arg261Gln 12 ALOX polymorphisms.

Eligibility Criteria:
Inclusion Criteria:

* caucasian
* diabetic type 1
* older than 18 years old
* written consent

Exclusion Criteria:

* other etiology of diabetic nephropathy
* pregnancy
* other type of diabetes
Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation

The purpose of the study is to compare the the efficacy and tolerance of 2 cough assistance techniques requiring no equipment other than the volumetric fan. The two methods are air-stacking and hyperinflation .

The study is a Cross-over, monocentric and open label study

Primary outcome : Peak Expiratory Flow (PEF)

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years, neuromuscular disease,
* restrictive syndrome and/or cough peak flow \< 270.l/mn and/or maximal expiratory pressure \< 40 cm HO2,
* patient under non invasive ventilation
* steady state for at least one month
* written consent form given

Exclusion Criteria:

* bronchial congestion
* hemodynamic instability
* previous pneumothorax or emphysema bubbles
* Major bulbar dysfunction
* plan of legal protection
* pregnant or breastfeeding women
* no affiliation to a social security scheme
Early Versus Delayed Cholecystectomy

This study examines complications, mortality rates, cost-effectiveness and safety of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC). Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy.

There is only few knowledge about the comparison of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC) for the treatment of acute cholecystitis considering the surgeon's work experience. This study examines complications, mortality rates, cost-effectiveness and safety of DLC versus ELC. This prospective randomized clinical trial was performed between November 2015-2016 in our General Surgery Clinic. Patients suffering acute cholecystitis in their first 72 hours of pain were enrolled in one of the two study groups: Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy. All operations and medical treatments were done by surgeons having work experience \<2 years.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering acute cholecystitis in their first 72 hours of pain

Exclusion Criteria:

* clinical duration longer than 72 hours, complicated acute cholecystitis (bilirubin \>2gr/dl, elevated transaminases (\>100 u/l), and cholestatic enzymes (gamma glutamyl transferase \>50 u/l), ultrasonographically confirmed dilated intrahepatic or extrahepatic bile ducts, and elevated amylase levels three times more than normal range
Oral Glibenclamide in Preterm Infants with Hyperglycaemia (GALOP)

The purpose of this study is to confirm hypothesis that Glibenclamide can be administered orally and is an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.

Transient hyperglycemia of premature newborns results from an overall decrease in insulin sensitivity, which is responsible at the beta cell level for abnormalities of intragranular cleavage of proinsulin into insulin, leading to reduced active insulin secretion. Intravenous administration of exogenous insulin can be used to combat insulin resistance and lower blood glucose, but it is difficult to manage in premature newborns and is associated with a substantial risk of hypoglycemia. Glibenclamide, which stimulates endogenous insulin secretion and can be administered orally, might be an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.

Eligibility Criteria:
Inclusion Criteria:

* Newborn less than 34 week of amenorrhea corrected age
* Birth weight \< 1500 g
* Birth term \< 32 week of amenorrhea
* Hyperglycemia ≥ 10 mmol/l in 2 measurements, 3 hours apart after potential reduction of glucose intakes following each department's protocol
* Secure venous access point (umbilical venous catheter or epicutaneo-cava catheter)
* Enteral feeding considered before inclusion or already established
* Consent obtained from persons holding parental authority
* Beneficiary of social security

Exclusion Criteria

* Contraindication to enteral feeding (at the discretion of the clinician responsible for the child)
* Contraindication to glibenclamide according to current SPC
* Foetal growth restriction (FGR) birth weight \< 3rd percentile (AUDIPOG definition)
* Severe birth defect, including cardiac malformation associated with a risk of myocardial ischemia
* Severe sepsis requiring mechanical ventilation or haemodynamic support
* Severe renal dysfunction (serum creatinine \> 120 µmol/l)
* Severe hepatocellular failure (V factor less than the standard laboratory range for the age) and/or severe cholestasis (\> 50 µmol/L)
* Hyperglycemia associated with an error in administering glucose infusion
* Profound hypophosphoremia (\< 1 mmol/l)
* Hypersensitivity to glibenclamide or other sulphonylureas or sulphonamides, or one of the excipients
* Patient with continuous insulin IV administration
* Patient treated with miconazole
Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study

Peanut allergy is increasingly common, especially in countries such as UK and Australia. There is currently no accepted routine clinical therapy to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. Although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects during protocol, resulting in a significant rate of drop-outs.

Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may therefore provide a safer way of inducing desensitisation in patients who are allergic to roasted peanut, by first inducing tolerance to boiled peanut.

Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted peanut, in peanut-allergic individuals.


Eligibility Criteria:
Inclusion Criteria:

* IgE-mediated peanut allergy, confirmed at double-blind placebo-controlled food challenge
* Tolerant to at least 1/4 boiled peanut (boiled for 4 hours) at open food challenge.
* Informed consent of parent/legal guardian and patient assent

Exclusion Criteria:

* Allergic to 1/4 boiled peanut at PCFC
* Tolerates ≥1.4 g roasted peanut protein at entry PCFC
* Unstable asthma
* Unwilling or unable to fulfil study requirements
* Undergoing other forms of immunotherapy (e.g. SCIT or SLIT to aeroallergens)
* Previous admission to ICU for management of allergic reaction to peanut
* Clinically significant chronic illness (other than asthma, rhinitis or eczema).
* Undergoing subcutaneous or sublingual immunotherapy and within the first year of therapy, for respiratory allergy.
* Subjects receiving anti-IgE therapy, oral immunosupressants, beta-blocker or ACE inhibitor therapy.
A Trial of Yoga in Pediatric Inflammatory Bowel Disease

IBD adds additional stressors as a chronic disease that has unpredictable and sometimes embarrassing symptoms to the normal challenges that teenagers face. Stress and how stressful events are perceived, may contribute to worsening of disease. Complementary and alternative medicine (CAM), are used often by pediatric IBD patients and maybe beneficial in decreasing stress and improving quality of life. Yoga could be a well suited paring with standard medical therapy to decrease and provide a better sense of control and improve quality of life.

Approximately 25% of Inflammatory bowel disease (IBD) is diagnosed in the pediatric age group, with the peak age of onset in the adolescent years. IBD adds additional stressors of a chronic disease with unpredictable and potentially embarrassing symptoms to the expected challenges of psychological and social adjustment that teenagers face. Various techniques, such as psychotherapy programs and IBD overnight camp experiences, have been studied to decrease psychological distress and improve quality of life. Stress, and particularly how stressful events are perceived, may play a role in triggering IBD flares. Complementary and alternative medicine (CAM), especially mind-body techniques are used often by pediatric IBD patients and may be beneficial in decreasing stress and improving quality of life (QOL). Yoga may be well suited as an adjunct to conventional IBD therapy to decrease stress, provide a greater sense of bodily control and improve QOL.

The primary goal of this project is to determine if a structured Yoga program, in addition to standard medical therapy, improves HRQOL in pediatric patients diagnosed with inflammatory bowel disease (IBD). Investigators will also examine if the yoga program improves self efficacy, which is a person's belief about their ability to influence events that affect their lives. Disease response and remission rates will be followed as well, in order to stratify HRQOL outcomes in the yoga group.

Patients will each serve as their own control and complete questionnaires at enrollment and at the start and end of the 12 week group yoga class sessions. They will also complete the questionnaires three months after finishing the class sessions. .The program will consist of a live group class session over 12 weeks. Baseline and follow-up questionnaires will be used to determine there are changes in QOL, self-efficacy, and disease response.

Eligibility Criteria:
Inclusion Criteria:

* Both males and females patients with IBD
* Ages 10-17 years
* Not currently practicing specific mind-body techniques (yoga, pranayama - deep breathing, biofeedback, hypnosis, guide imagery)
* Diagnosis of IBD

Exclusion Criteria:

* Other chronic systemic disease ex. Rheumatoid arthritis, Cystic fibrosis, Celiac or chronic neurologic conditions