cyrilzakka/clinical-trials huggingface dataset:
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants

This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room.

Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room


Eligibility Criteria:
Inclusion Criteria:

* Born between 23+0/7 to 28+6/7 weeks' gestation
* Considered suitable for full resuscitation, i.e., no parental request or antenatal decision to forego resuscitation
* Informed parental consent

Exclusion Criteria:

* Major congenital or chromosomal malformation
* Conditions that might have an adverse effect on breathing or ventilation (e.g., high risk for lung hypoplasia, congenital diaphragmatic hernia)
* Congenital heart disease requiring intervention in the neonatal period
* Hydrops requiring intervention in the neonatal period
* Neonatal resuscitation initiated before NICU team arrival
* Infants who are born outside of study center and transported to center after delivery
Ultrasound Assessment of Diaphragmatic Dysfunction in Regional Anesthesia

Awake thoracic surgery is a feasible and safe alternative to general anesthesia for pulmonary biopsy in interstitial lung disease patients, but there is still no evidence as to its superiority in terms of outcome. However, there is extensive literature about the effect of anesthetic drugs and surgery on diaphragmatic function. Furthermore, in thoracic surgery, diaphragmatic dysfunction was associated with a higher occurrence of postoperative pulmonary complications.

To assess the impact of general anesthesia on diaphragmatic function, the investigators conducted an observational prospective trial. The investigators measured both diaphragmatic excursion and Thickening Fraction at baseline and 12 hours after surgery together with pulmonary function tests and gas exchange data.

Awake thoracic surgery is a feasible and safe alternative to general anesthesia for pulmonary biopsy in interstitial lung disease patients, but there is still no evidence as to its superiority in terms of outcome.

However, there is extensive literature about the effect of anesthetic drugs and surgery on diaphragmatic function. Furthermore, in thoracic surgery, diaphragmatic dysfunction was associated with a higher occurrence of postoperative pulmonary complications.

To assess the impact of general anesthesia on diaphragmatic function, the investigators conducted an observational prospective trial. The investigators measured both diaphragmatic excursion and Thickening Fraction at baseline and 12 hours after surgery together with pulmonary function tests and gas exchange data.

The investigators divided our population into two groups: one group of patients undergoing awake thoracic surgery with epidural anesthesia, and the other group undergoing general anesthesia.

Forty-one patients were recruited and the Thickening Fraction percentage, calculated as (End Inspiratory thickness-End Expiratory thickness)/End Expiratory thickness, was evaluated by means of an ultrasound-assisted method, using a high frequency (10 MHz) linear probe.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for lung biopsy from February 2019 to September 2020

Exclusion Criteria:

* pregnancy,
* Body Mass Index \>35,
* Inability to provide informed consent,
* American Society of Anesthesiologists physical status classification score of IV
* Recommended postoperative ICU care
Simplified Antibiotic Therapy for Sepsis in Young Infants

This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families.

Primary Objective

To evaluate if out-patient (clinic-based) therapy of young infants with possible serious bacterial infection with 7 days of intramuscular procaine penicillin and gentamicin (reference therapy) is equivalent to:

* (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days;
* (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and

Hypothesis

The proportion of babies who fail therapy at (or before 7) days will be 10% in each group. A 5% or less difference in failure rates will be considered equivalent.

Study Design

This will be a randomized, three arm, open-label equivalence trial among young infants, 0-59 days of age who are diagnosed as having possible serious bacterial infection in one of the Karachi field clinics, and whose families refuse facilitated hospital referral, and the infants meet other specified inclusion criteria.

Eligible young infants will be recruited from among those referred to the clinics by trained community health workers as having clinical signs predictive of possible serious illness during regular home visits in the surveillance area, or those presenting directly to the clinics from the areas under pregnancy and newborn surveillance. A diagnosis of possible sepsis will be made by clinicians if specified clinical criteria are met.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria

  * Infants 0-59 days old who are residents of catchment population of the study hospitals or clinics
  * One or more of the following five signs: severe chest in-drawing, axillary temperature \>38.0C or \<35.50 C, movement only when stimulated, and history of feeding problems (confirmed by poor suck on feeding assessment)
  * Family refuses recommended hospitalization or hospitalization otherwise not feasible
  * Informed consent by a legal guardian.
* Exclusion Criteria:

Very severe infection/disease characterized by presence of any of the following signs (unconscious, convulsions, unable to feed, apnea, unable to cry, cyanosis, bulging fontanel, prolonged capillary refill, major congenital malformations, major bleeding, surgical conditions needing hospital referral, persistent vomiting defined as vomiting following three attempts to feed the baby within ½ hour)

* Very low birth weight: weight \<1500
* Hospitalization for illness in the last two weeks
* Previous inclusion in the study
SuperTROPO (Better Diagnostics of Myocardial Infarction With a Test for Special Forms of Troponin)

The aim of this study is to investigate whether measurement of the long forms of cTnT with the novel SuperTROPO assay would improve the diagnosis of myocardial infarction in patients in the emergency department. The main goals are:

1. To assess whether measuring long forms of cTnT with the novel SuperTROPO assay and determining the ratio of long cTnT and standard high-sensitivity cTnT could separate patients with type 1 NSTEMI patients from patients with other causes of minor (\> 14ng/L) cTnT elevation in a single admission blood sample in unselected emergency department patients with clinical indication for troponin measurement.
2. To compare the level of long cTnT and the ratio of long cTnT and standard cTnT in patients with type 1 MI and various clinical patient groups admitted to emergency department with elevated standard cTnT, e.g. patients with atrial fibrillation, heart failure or renal impairment.
3. To evaluate optimal cut-off values for long cTnT and its ratio to standard cTnT in the exclusion and diagnosis of MI in a clinical setting with elevated (\>14ng/L) cTnT.
4. To evaluate how time from symptom onset and peak symptom to blood sampling, as well as comorbidities and patients' age impact the discriminative capacity of long cTnT and cTnT ratio between patients with and without type 1 MI.
5. To investigate whether information on long cTnT and its ratio to standard cTnT can be used to cut down unnecessary coronary angiographies and hospital admissions

The long forms of cTnT are measured from the residual blood samples routinely collected from patients with suspected myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Patient has arrived at the emergency department and high-sensitivity cTnT test (P-TnT) has been ordered as part of the routine "cardiac package" of laboratory tests upon arrival
* Result of \>14 ng/L of the P-TnT test included in the "cardiac package"
* Age \> 18
* The patient or his/her legal representative has given written informed consent for participation in the study

Exclusion Criteria:

* unable to give informed consent
* legally incompetent individuals
* pregnancy
* previously participated in this study
Evaluation of the SickKids Team Obesity Management Program

In January 2010 a new interdisciplinary clinic (STOMP) was created to provide care for children and adolescents with severe 'complex' obesity. As part of the program, a subset of adolescents undergo bariatric surgery. There is a paucity of literature evaluating outcomes of children and adolescents participating in a 'clinical' setting and even fewer reports of outcomes of severely obese pediatric patients. Previously, the investigators evaluated clinical outcomes of children with craniopharyngioma and hypothalamic obesity attending an outpatient interdisciplinary program at SickKids (The Comprehensive Care Clinic for Children with Central Tumours) and found significant benefit to those attending, including reduction of weight gain (or weight loss), improved psychosocial functioning, and increased care satisfaction. STOMP is a natural extension of this program, incorporating some core elements (e.g., interdisciplinary team, frequent visits, individualized care plans for medically-complex adolescents) and building on other aspects, such as increased psychosocial intervention; involvement of a "key worker" (nurse practitioner) to support families; provision of continuity of care with other health providers in all settings, community services and schools; a more diverse patient population; and group support sessions. Evaluation of the outcomes of this clinic is needed to inform best practice for children and adolescents with severe complex obesity

The primary objective is to conduct an evaluation of the STOMP clinic as a model of care with a specific focus on: (i) patient outcomes (anthropometric, metabolic, and psychosocial); and (ii) care coordination and care satisfaction.

Patient outcomes will be compared against baseline evaluation data over time, and to a control group of patients not enrolled in the program, but who expressed interest in the program and were unable to attend.

Eligibility Criteria:
Inclusion Criteria:

* All patients enrolled in the STOMP program are eligible to participate in the study.
* Control participants must be between 12-18 years of age with a BMI \>95th percentile for age.

Exclusion Criteria:

- Control participants cannot be enrolled in the STOMP program.
The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants

The study aims to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants using patient data collected during hospitalisation at the Neonatology Centre.

Nephrocalcinosis in preterm infants develops as a result of imbalance between the factors promoting or inhibiting formation of kidney stones. It is caused by intensive treatment as well as functional and morphological kidney immaturity. There is a correlation between the prevalence of nephrocalcinosis and low gestational age.

The study aims prospectively to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants less than 32 weeks of gestation.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants of the gestational age of \<32 weeks;
* parental consent acquired.

Exclusion Criteria:

* death before 28 days of age;
* congenital defects;
* no kidney ultrasound results;
* no parental consent.
European Active Surveillance Study (EURAS)

EURAS is a multi-national, controlled, prospective, post-marketing, non-intervention cohort study of new users of drospirenone/ethinylestradiol (DRSP/EE), levonorgestrel/ethinylestradiol (LNG/EE) and other oral contraceptives (OCs) under routine conditions of medical practice in seven European countries. Baseline survey and semiannual, active follow-up are based on postal questionnaires, with validation of reported events by the women's treating physicians. A multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates. The objective of the study is the investigation of the incidence of rare serious adverse events associated with the use of new and established OCs, and specifically the incidence of thromboembolic events.

Active surveillance using valid epidemiologic study designs is desirable for any new product, because adverse effects may occur that have not yet been identified in pre-marketing studies.

The EURAS study investigates the safety of oral contraceptives with a large cohort of women attending offices of prescribing physicians. Its primary objective will be to compare incidence rates of adverse events in users of so-called new OCs and users of other OCs. The study is conducted as a phase IV commitment to the European Drug Authorities.

The combined cohort will include 50,000 to 60,000 women recruited by a selected set of physicians in six European countries. A total of more than 1,500,000 cycles are expected to be observed during the field work which will start early in 2001 and end early in 2006.

The participating women will undergo a baseline survey using a self administered questionnaire to describe the baseline risk. Every six months they will fill out a questionnaire in which they will record complaints and events during the use of the prescribed OC which will be validated. A multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates.

Based on experience obtained in previous OC studies complex sources of bias and confounding are expected. Thus, multivariate methods such as Cox regression will be used to adjust for confounding. Regarding the impact of the results on public health, the main emphasis will be on the absolute risk estimates.

Eligibility Criteria:
Inclusion Criteria:

* Women starting OC use or women switching OCs
* Women willing to participate in the active surveillance for several years

Exclusion Criteria:

* Women who have contraindications for OC use
Needs in Education for Pulmonary or Cardiopulmonary Transplanted Cystic Fibrosis Patients

Main objective : This project aims to assess the educational needs of patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis.

Specific objectives : Evaluate the specific needs dependent on seniority transplantation : 3 to 6 months, 6 months to 2 years, more than 2 years after transplantation

Secondary objectives :

* Assess the state of health
* Assess the knowledge
* Assess gestural know-how
* Assess the cognitive know-how
* Assess the behaviour adopted in reality by the patient
* Assess motivation psychosocial factors of :

  * self-efficacy and inefficiency
  * representation of obstacles, disadvantages of treatment
  * sense of control over their health
  * feeling of being supported by health professionals, by his close
  * representation of his responsibility to take care of his health, to follow his treatment, to be active about his treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis

Exclusion Criteria:

* Patient with a psychiatric disorder
* Patient in intensive care
* Palliative patient
* Patient aged under 18 years old
* Patient refusal
Effects of Oral and Topical Sea Buckthorn Oil Treatments on Skin Aging

The effect of oral supplementation of SBA24 sea buckthorn oil capsule and topical application of Omega7 sea buckthorn cream on skin ageing is studied in a single blind, parallel study.

The study is carried out on two groups of female volunteers, 30 in each group, of age 30 to 60 years, in compliance with the principles established by the World Medical Association in the Declaration of Helsinki. In group I, the subjects took SBA24 sea buckthorn oil capsule (2 x 2 capsules per day) and apply two different creams on the face, one cream on each half of the face, twice per day. In group II, the subjects apply only the two creams, one cream on each half of the face, twice per day, for 8 weeks.

The assessment is performed on the skin surface of the periocular areas.

The efficacy of the active products is assessed on the skin face at the beginning, after 4 weeks and after 8 weeks of treatment using the following instrumental measurements:

* cutaneous elasticity (CUTOMETER SEM 575 Courage \& Khazaka);
* cutaneous hydration level (CORNEOMETER CM 825 Combi 3 Courage \& Khazaka);
* cutaneous roughness by cutaneous replicas and image analysis (Quantilines, Monaderm); Determination of benefit is based on instrumental measurements and subject self-assessment questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects 30 - 60 years old with Fitzpatrick skin type I-IV \& in good general health, with facial skin manifestation related to photoaging (wrinkles, dyschromias, tissue looseness etc.)
* Subjects must have discontinued the use of topical retinoid products for 6 months prior to study entry and of systemic retinoids for 1 year prior to study entry.
* Subjects must have discontinued the use of topical alpha-hydroxy, \&/or beta-hydroxy products for 45 days prior to study entry \& all other topical facial medication to the skin immediately prior to study entry.
* Subjects must have discontinued the use of systemic antiaging or antioxidant products for at least 2 months prior to study entry.
* Subjects must be willing \& able to follow all study directions \& to commit to all follow-up visits for the duration of the study.
* Subjects must have completed the informed consent process.
* Subjects must be willing to avoid direct daily sun exposure on the face or the use of tanning beds.

Exclusion Criteria:

* Pregnant or nursing females.
* Subjects with a history of unusual skin reactions to skin care toiletry products, cosmetics, or sensitivity to any of the test article components.
* Previous facial treatments with any dermal fillers (i.e. collagen, hyaluronic acid etc)
* Concurrent therapy, systemic diseases, or skin disorders (such as eczema, psoriasis, severe acne etc.) which may interfere with the evaluation of the test articles or increase risk to the subject.
* Subjects currently involved in another clinical investigation or who have been involved within a period of 30 days prior to admission in this study.
TEFA Family Prevention: Glutenfree Diet to Preserve Beta-cell Function

To evaluate the effect of Gluten Free Diet (GFD) on beta-cell function and glucose metabolism in subjects with one or several islet autoantibodies without and with dysglycemia at baseline. Additionally, all subjects will be given treatment with Vitamin D, omega fatty acids and probiotics.

Subjects will be randomized to GFD or normal diet during 18 months. Beta cell function will be evaluated at baseline, and during follow-up by glucose tolerance tests.

The design is a randomized controlled study to determine the safety and the effect of gluten free diet during 18 months on beta-cell function and glucose metabolism. Lead-in and nonstop supplement cocktail including vitamin D, omega fatty acids and probiotics will be used to equalize differences to reduce known confounders. All study subjects will meet with a dietician to obtain a 3-day diet record and to receive instructions on a healthy normal diet or GFD.

Subjects (n=60) at 2-49.99 years of age positive for one or several islet autoantibodies will be recruited. Subjects with one islet autoantibody have done one or several oral glucose tolerance test (OGTT) prior to the baseline visit. One islet autoantibody positive subjects are only eligible if they have dysglycemia. All subjects will be randomized based on baseline intravenous glucose tolerance test (IvGTT) and OGTT into subjects without and with dysglycemia at baseline.

Beta-cell function and glucose metabolism (alternating IvGTT and OGTT) will be assessed at baseline and after 6, 12, 18 months of treatment and after 6 months of wash out on a normal healthy diet.

Adverse events and safety Adverse event will be obtained at visits and during the study, which will be monitored.

It is expected that subjects with one or several islet autoantibodies will show a loss compared to baseline of beta-cell function and glucose control. GFD is expected to reduce the loss in subjects on a healthy diet.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects from two (2) to 49,99 years of age.
2. At least one type 1 diabetes-associated autoantibody (to glutamic acid (GADA), insulin (IAA), insulinoma-associated protein 2 (IA-2A) or zinktransporter 8 (ZnT8R/W/QA) in subjects with impaired glucose metabolism OR at least two type 1 diabetes-associated autoantibodies, regardless of normal or impaired glucose metabolism.
3. Written informed consent from research subject. If a child, also from the child's parents or legal acceptable representative(s) according to local regulations.

Exclusion Criteria:

1. Ongoing treatment with immunosuppressant therapy (topical or inhaled steroids are accepted).
2. Diabetes.
3. Treatment with any oral or injected anti-diabetic medications.
4. Significantly abnormal hematology results at screening.
5. Participation in other clinical trials with a new chemical entity within the previous 3 months.
6. History of hypercalcemia.
7. Presence of associated serious disease or condition.
8. Diabetes-protective HLA-DQ6-allele.

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