cyrilzakka/clinical-trials huggingface dataset:
Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

The purpose of this study is to evaluate the efficacy of tracheal suctioning associate with expiratory pause maneuver in children on invasive mechanical ventilation.

After being informed about the study and potential risks, all parents or guardians giving written informed consent will be evaluate for study entry. Children in invasive mechanical ventilation who meet eligibility criteria will be submitted of two techniques of tracheal suctioning (with and without expiratory pause maneuver), randomized in a crossover trial in a 1:1 ratio, for determine the first technique to be applied.

Clinical data will be collected (sex, age, presence of previous disease, diagnosis of hospitalization), as well as the ventilatory parameters (ventilation mode, peak inspiratory pressure, positive end-expiratory pressure, tidal volume, respiratory frequency, fraction of inspired oxygen).

The protocol consists of an initial conventional tracheal suctioning with a negative pressure of 40mmHg for all the participants. After two (2) hours the first technique will be applied and an interval of another two hours for the application of the second technique. Respiratory mechanics and hemodynamic parameters will be evaluate before and after 30 minutes of each tracheal suctioning techniques.

In case of clinical alterations that may aggravate the patients condition during the protocol (oxygen saturation \< 85%, heart rate \> 190bpm and/or decrease 20% of mean arterial blood pressure), the technique will be interrupted immediately and the patient will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Children at invasive mechanical ventilation for more than 24 hours;
* Under the effect of neuromuscular blocker (level of sedation assessed using the Comfort B Scale with a score \<10 and without a cough reflex);
* Endotracheal suctioning in a period \> 2h before the application of the technique.

Exclusion Criteria:

* Patients with undrained pneumothorax or hemothorax, or presence of subcutaneous emphysema;
* Hemodynamic instability (hypotension refractory to treatment)
* Need of frequent endotracheal suctioning
Incidence, Course and Outcome of ABMR in Kidney Transplantation

Rationale: Despite improved patient and graft survival in renal transplant recipients, still 20% of the patients reaches end-stage renal disease within 5 years after transplantation. Antibody-mediated rejection (ABMR) is one of the major causes of early graft loss and perhaps even more important of late deterioration of graft function

Objective: Evaluate the occurrence of antibody mediated rejection (ABMR) and mixed ABMR and cellular/ T-cell mediated rejection (TCMR), in patients treated with the currently prevailing immunosuppressive regimens, and relate them to outcome (graft survival, function, proteinuria, histology)

Study design: Clinical cohort study.

Study population: patients of \>18 years old, about to receive a post mortal of living donor renal transplant with an immunological high risk for ABMR.

Main study parameters/endpoints: main study endpoints are the occurrence of ABMR, mixed ABMR/TCMR and renal function after 1 year of follow-up.

The main study parameter will be mapping the immune system, including B-cells, (non-)HLA antibodies, interaction between B-cells and T follicular helper cells, and complete immune profiling.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients ≥18 years old
* About to receive a post mortal or living donor renal transplant
* written informed consent (is able to read of understand in Dutch)
* Immunological high risk for rejection

  1. Luminex positive DSAs ; or
  2. Retransplantation with repeated mismatch ; or
  3. Husband to wife donation (after fathering children); or
  4. Offspring to mother donation

Exclusion Criteria:

* No immunological high risk
A Deep Learning Radiomics Model for Predicting Occult Peritoneal Metastases of Pancreatic Adenocarcinoma

Occult peritoneal metastases (OPM) in patients with pancreatic ductal adenocarcinoma (PDAC) are frequently overlooked during imaging. We aimed to develop and validate a CT-based deep learning-based radiomics (DLR) model with clinical-radiological characteristics to identify OPM in patients with PDAC before treatment.

This retrospective, bicentric study included 302 patients with PDAC (training: n = 167, OPM-positive, n=22; internal test: n = 72, OPM-positive, n=9: external test, n=63, OPM-positive, n=9) who had undergone baseline CT examinations between January 2012 and October 2022. Handcrafted radiomics (HCR) and DLR features of the tumor and HCR features of peritoneum were extracted from CT images. Mutual information and least absolute shrinkage and selection operator algorithms were used for feature selection. A combined model, which incorporated the selected clinical-radiological, HCR, and DLR features, was developed using a logistic regression classifier using data from the training cohort and validated in the test cohorts.

Eligibility Criteria:
Inclusion Criteria:

Patients with suspected pancreatic tumors who underwent contrast enhanced CT and pathological examinations at Center 1 and Center 2 were eligible for inclusion in this study.

Exclusion Criteria:

* (a) pathologically diagnosed PDAC by pathology, (b) time intervals between contrast-enhanced CT and pathology less than 2 weeks; (c) history of pancreatic surgery, (d) history of pancreatic malignancy, and (e) poor CT image quality that undermined peritoneal lesion assessment
Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases

This study is a single-center, prospective, observational clinical study to evaluate the Application of saliva EBV-DNA Detection in EBV Infection Related Diseases


Eligibility Criteria:
Inclusion Criteria:

1. According to the HLH-04 diagnostic criteria, it meets the HLH diagnostic criteria. EBV infection occurs in cells with EBV-DNA copy number significantly increased in peripheral blood or tissue, or where EBV coding small RNA(EBER) is detected in tissue or peripheral blood. Or Straus' 1988 diagnostic criteria for CAEBV.
2. Informed consent

Exclusion Criteria:

1. Patients who cannot cooperate with saliva collection
2. Patients who are unwilling to cooperate with the project research according to the project research plan.
Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors.

OBJECTIVES: I. Assess the therapeutic activity of temozolomide as first line chemotherapy in patients with recurrent oligodendroglial tumors after radiation therapy. II. Assess the objective response and duration of response of these patients given this treatment. III. Characterize the acute side effects of temozolomide in this patient population.

OUTLINE: This is an open label, multicenter study. Patients receive oral temozolomide on days 1-5. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven oligodendroglioma or oligoastrocytoma with at least 25% oligodendroglial elements Recurrent or progressive disease following radiotherapy At least 3 months since prior radiotherapy Measurable disease by MRI or CT scan Lesion must have a diameter of at least 1 cm No progressive neurological deficits from the present recurrence No new neurological deficits interfering with daily activities No tumor causing midline shift or brain stem compression due to which a rapid deterioration is to be expected in case of no response No signs of increased intracranial pressure No extracranial disease

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST/ALT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine clearance at least 60 mL/min Creatinine no greater than 1.25 times ULN Neurologic: See Disease Characteristics Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignant or nonmalignant diseases interfering with follow-up No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study and follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified Other: No other concurrent investigational drugs No other concurrent antitumor agents
Probiotic Formula and Infant Growth

This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infant
* Full-term
* Birth weight \> 2500 and \< 4500 g
* 14±3 days of age on enrollment
* Exclusively formula-fed, singleton birth
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Known or suspected cow-milk allergy
* Congenital illness or malformation that may affect infant feeding and/or growth
* Significant prenatal and/or postnatal disease
* Any readmission to hospital prior to enrollment
* Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
* Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
* Currently participating in another clinical study
* Cannot be expected to comply with treatment
Training-induced Muscle Strength and Its Role in Interface Pressure in Inelastic Compression

The present study will answer the following question: what are the effects of strength gain and muscle hypertrophy on interface pressure, static stiffness index, and working pressure amplitude in the elderly using inelastic compression?

This phase I two-armed randomized clinical trial including participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in resistance exercise programs will be conducted at the Ativas Gym, Xanxere/SC, Brazil. Participants will perform exercises during the strength-training protocol intervention, while individuals in the control group will not be offered the exercise program in the three months before data collection and during the entire period corresponding to the 12-week intervention. In addition, we will monitor their eating and physical activity habits throughout the data collection period. The study was designed in accordance with the CONSORT statement.

Eligibility Criteria:
Inclusion Criteria:

* Participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in strengthening exercise programs.

Exclusion Criteria:

* Participants who present chronic venous insufficiency (CEAP C3-6) evaluated through Doppler ultrasonography, severe congestive heart failure (functional class III and IV - NYHA), and Ankle/Brachial Index (ABI) \< 0.8. We will also exclude elderly individuals who are unable to perform the required exercises due to physical limitations and those bedridden or wheelchair-bound.
A Study of Pertuzumab in Participants With Prostate Cancer

This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50 participants may enter either cohort, for a total enrollment between 46 and 73 participants across 9 study centers.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than (\>) 18 years of age
* Histologically documented adenocarcinoma of the prostate resistant to hormone therapy, progressed at 4 to 6 weeks following anti-androgen withdrawal
* Prostate-specific antigen (PSA) values at least 20 ng/mL among those with asymptomatic or mildly symptomatic disease
* Karnofsky performance status (KPS) at least 80 percent (%)
* Castrate testosterone less than (\<) 50 ng/dL
* Life expectancy at least 12 weeks
* Left ventricular ejection fraction (LVEF) at least 50%
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* Prior chemotherapy, radionucleotide therapy, or immunotherapy for prostate cancer
* Systemic corticosteroids within 1 month prior to Screening
* Bisphosphonates within 6 months, narcotic analgesics within 2 weeks, or any investigational agent with 28 days of study drug
* Prior cumulative doxorubicin dose of \> 360 mg/m\^2 or equivalent
* Central nervous system (CNS) or pulmonary metastases
* Other malignancies, except adequately treated basal or squamous cell skin cancer
* Significant cardiovascular disease
* Active/uncontrolled concurrent illness or infection
* Major surgery or traumatic injury within 4 weeks of study drug
The Association of Ferrtin and Homocysteine Etc. With RI and MS in Polycystic Ovary Syndrome (PCOS)

The purpose of this study is to study the association of serum ferritin and homocysteine levels with insulin resistance and metabolic syndrome in women with polycystic ovary syndrome The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10% of women with reproductive age. Insulin resistance and metabolic disturbance are well-known long-term consequence of women with PCOS. Recent evidence suggests that increased body iron might be involved in the pathogenesis of insulin-resistance disorders, furthermore, hyperhomocysteinemia is associated with an increased risk of atherosclerotic and thromboembolic disorder. The investigators plan to retrospectively review the medical records of female patients who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.


Eligibility Criteria:
Inclusion Criteria:

* female patients who had been performed with fully PCOS-related survey Who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.

Exclusion Criteria:

* women who had been diagnosed with disorders of the uterus (e.g., Asherman's Syndrome, Mullerian agenesis), and chromosomal anomalies (e.g., Turner syndrome)
* women who had menopause
* women with inadequate clinical/biochemical records
* women who had had ovarian cysts or ovarian tumors
* women who took hormone, medicine for Diabetes and/or cardiovascular disease.
Endocrown Restoring First Permanent Molar in Children

Clinical and radiographic evaluation of endodontically treated first permanent molars in thirty children restored with three different restorations over 12 months

This study comprised 30 children, with age range of (10-13) years old, with endodontically treated first permanent molars. Participants were classified into three groups according to type and material of the final restoration. All selected children were assigned to either PMC group (n=10) restored with performed metal crowns (Stainless-steel Molar Crowns) , EMX group (n=10) endocrown fabricated from CAD-CAM lithium disilicate glass ceramic , COP group (n=10) endocrown fabricated from CAD-CAM reinforced composite. After cementation, all children were evaluated over one year; at one week post-operative, 6 and 12 months for the following criteria: radiographic findings, plaque index, periodontal index, parent satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ranging from 10-13 years old with closed apex.
* Normal occlusion without any para-functional habits.
* Decayed lower first molar.
* Supra-gingival margin was required after preparation.
* Absence of root fractures or cracks.

Exclusion Criteria:

* Difficulty to apply rubber dam for proper endocrown bonding.
* Lack of patient cooperation for post-operative recall and follow up.
* Bad oral hygiene
Comparative Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot.

The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars:

1. The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a movement with more amplitude and closer to the physiological movement of the ankle, and an increase in the power of the ankle, especially in the terminal support phase.
2. The technology of the three carbon blades (plantar, upper and median), including a wider plantar blade, split in the middle of the foot with a separate toe to provide efficiency over the entire length to the big toe, bringing more power to the impulse and more control, but also increased stability until the terminal support phase.
3. An anatomical foot cosmetic, to adapt and optimize the function of the blade: of light manufacture, with an adherent sole for more stability barefoot, it guarantees physiological plantar pressure during the unwinding of the foot.

The aim of this study is to demonstrate that compared to a class III ESAR foot, the PRO-FLEX PIVOT® foot improves patient mobility with a validated score.


Eligibility Criteria:
Inclusion Criteria:

Adult patient (over 18 years of age)

* Unilateral tibial amputee and fitted for at least 6 months with a class III ESAR foot.
* Regularly using (more than 8 hours/day) a class III ESAR foot
* Functional class (CNEDiMTS indication)1
* Insured person.
* Able to answer questionnaires.
* Providing informed and written consent to participate in the study.
* Having a normalized PLUS-M/FC 12 score less than 50 for vascular amputee and 55 for traumatic amputee and other causes of amputation.
* Experiencing no discomfort related to the socket indicated by a score ≥ 6 on the numerical scale from 0 to 10 (Socket Comfort Score)

Exclusion Criteria:

* Bilateral lower limb amputation
* Femoral amputation
* Wearing a temporary prosthesis
* Change of socket or suspension system planned during the study.
* Change of any functional component as torsion or choc adapter
* Significant change in the patient's routine activities expected during the study.
* Progressive associated pathology that may prevent patient follow-up.
* Associated pathology that may limit the patient's mobility (e.g. disarticulation of the knee, knee pain... )
* No osteointegration patients
* Lack of consent
* Adult subject to enhanced protection, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research.
* Person not affiliated with or a beneficiary of a health insurance plan.
* Patient unable to understand the study instructions
Requests for Voluntary Termination and Medical Termination of Pregnancy for Maternal, Psychological or Social Reasons At the Women's Center ( La Maison Des Femmes) in Saint-Denis :

In France, Article L2213-1 of the Public Health Code (law of July 4, 2001) clearly establishes that "voluntary termination of pregnancy may be performed at any time if two doctors, who are part of a multidisciplinary team, certify-after this team has provided its advisory opinion-that continuing the pregnancy seriously endangers the woman's health." Consequently, when a request for termination of pregnancy is made within the first sixteen weeks of amenorrhea, patients exercise complete autonomy in their decision-making. This process is unequivocally recognized as voluntary termination of pregnancy (VTP).

If an abortion is performed after the pregnancy has ended, the patient's request must undergo a multidisciplinary assessment. This procedure is known as medical termination of pregnancy for maternal indications.

There are generally two categories of indications for this procedure:

Organic reasons such as progressive cancer or severe heart disease. Psychosocial reasons: which include psychological and social factors.

In the case of medical terminations of pregnancy for psychological or social reasons, the National College of French Gynaecologists and Obstetricians (CNGOF) recommends that these requests be formally documented within the centers where patients receive care. However, there is considerable variability in how these practices are implemented across different locations. Furthermore, the existing literature reveals a significant lack of epidemiological and clinical data on the subject, highlighting the need for more comprehensive research in this area.

Opened in 2016, the Maison des Femmes (Women's Center) in Saint-Denis houses a family planning center and a multi-professional support service for patients who have experienced violence. It provides care for many women who have sought a termination of pregnancy but have exceeded the legal time limit for abortion.

A study conducted in 2021-2022, as part of a medical thesis, revealed a significantly high prevalence of violence experienced by women seeking a pregnancy termination for non-medical reasons at Delafontaine Hospital. The findings indicated that 65% of these patients had suffered from violence.

To strengthen our epidemiological findings, we propose a study comparing this group of women with another group who had an abortion during the same timeframe.


Eligibility Criteria:
Inclusion Criteria:

* Patients (minors or adults) who have been seen at the Women's center (Maison des Femmes) for assistance with a request of termination of pregnancy for maternal, psychological and/or social reasons, including patients under legal protection (guardianship, curatorship) at the time of the consultation.
* medical consultation between 01/01/2016 and 28/02/2022.

Exclusion Criteria:

* Refusal of participation (patient or guardian)
* Opposition to the use of data
STudy of Asthma Adherence Reminders

To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma.

This study will investigate whether adding an electronic adherence monitor to inhaled steroids, and feeding this information back to patients and families can improve adherence and outcomes in childhood asthma. The devices will also sound twice daily reminder alarms to act as direct medication prompts. This intervention will be compared to a control group in which adherence is monitored, but with no feedback or alarms.

Eligibility Criteria:
Inclusion Criteria:

* Doctor diagnosed asthma.
* On at least BTS stage 2, which means they will be on regular inhaled steroids.
* No change in regular asthma treatment in the last 1 month (on regular inhaled steroids, no change in steroid dose for

  1 month, no change in add on therapy in the last month).
* ACQ (Asthma Control Questionnaire) score more than or equal to 1.5.
* Can speak and understand English.

Exclusion Criteria:

* BTS stage 5 asthma (complex issues, too unstable).
* Recent changes to asthma treatment within the last month. (see above)
* ACQ (Asthma Control Questionnaire) score \< 1.5.
* Another chronic health condition (eg diabetes, congenital heart disease, cystic fibrosis).
* Can't speak or understand English.