cyrilzakka/clinical-trials huggingface dataset:
Exercise Training in Children With Corrective Cardiac Surgeries

To determine the effects of preoperative exercise therapy on postoperative cardiopulmonary outcomes and quality of life in children with corrective cardiac surgeries.Within literature there is limited evidence on preoperative exercise therapy in the pediatric population, positive results of the study can introduce a new tradition of preoperative exercise therapy and significantly reduce post-operative complications. Secondary complications would also be addressed in the study, a positive result can reduce the total costs by reducing hospital stays and improving the quality of life of child.

Cardiac surgeries are often associated with some post-operative cardiopulmonary complications most often cardiac arrhythmias, pulmonary atelectasis, and hospital induced pneumonia and reduced inspiratory capacities which can be reduced by exercise therapy this study is therefore significant not only for the determination of the effects of preoperative exercise therapy, it will also provide a path toward pre-habilitation followed by effective postoperative cardiac rehabilitation which is mostly lacking in many setups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with congenital heart disease
* Undergoing elective corrective cardiac surgery
* Vitally stable

Exclusion Criteria:

* Having acquired heart disease or undergoing emergency cardiac surgeries
* Patients undergoing valvular repairing surgeries
* Functional status is limited due to conditions other than CHD or having any contraindications
* Inability to adhere to study protocols
* Participants who refused or withdrew from the study
A Study of PTR-01 in Recessive Dystrophic Epidermolysis Bullosa

Protocol PTR-01-002 is a 3-part Phase 2, open-label study of PTR-01. While new patients will be enrolled, priority will be given to patients that satisfactorily completed study PTR-01-001.

Protocol PTR-01-002 is a 3-part Phase 2, open-label study of PTR-01. While new patients will be enrolled, priority will be given to patients that satisfactorily completed study PTR-01-001.

In Part 1, patients will receive a dose of 3.0 mg/kg every week for a total of 4 doses. This will be followed by Part 2 in which patients will receive a dose of 3.0 mg/kg every other week for a total of 7 doses. In Part 3, patients will be followed for 12 weeks. No investigational therapy will be administered during this time. At the end of each dosing period, an efficacy assessment will be performed. Safety will be assessed continuously throughout the study.

Following the end of Part 3, patients may be eligible for a potential long-term extension to further refine the dosing regimen, depending upon study drug availability.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following criteria to be eligible for study participation in the three month run in period of the study:

1. Willing to provide informed consent form, or if 12 to \<18 years of age, legal guardian has provided informed consent form and the minor has signed an assent form acknowledging that they understand and agree to study procedures.
2. Has a diagnosis of RDEB based on genetic analysis and consistent with a recessive inheritance pattern.
3. Has deficient C7 staining at the dermal-epidermal junction (DEJ) by IF.
4. Agrees to use contraception as follows:

   For women of childbearing potential (WOCBP) agrees to use highly effective contraceptive (including abstinence) methods from Screening, through the study, and for at least 10 weeks after the last dose of study drug. Non-childbearing potential is defined as a female who meets either of the following criteria: age ≥50 years and no menses for at least 1 year or documented hysterectomy, bilateral tubal ligation, or bilateral oophorectomy.

   For males, agrees to use a condom with any WOCBP sexual partner from Day 1 of study treatment, through the study, and at least 10 weeks after the last dose of study drug.
5. Be willing and able to comply with this protocol.

Exclusion Criteria:

Patients with any of the following will be excluded from participation in the study:

1. Has known systemic hypersensitivity to any of the inactive ingredients in PTR-01.
2. Has previously had an anaphylactic reaction to PTR-01.
3. Is pregnant or nursing.
4. Has received in the last six months any investigational gene therapy product or in the last three months any non-gene therapy investigational products.
5. Is anticipated to receive new regimens of antibiotics or other anti-infectives during the trial.
6. Has any other medical or personal condition that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's
Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

The aim of this trial is to evaluate the effectiveness of osteopathic manipulative therapy in reducing the asymmetries of skull in infants with nonsynostotic plagiocephaly.

Nonsynostotic plagiocephaly (NSP) is defined as the deformation of the head resulting from external forces that mould the skull during the first months of life.

Four months seems to be a critical age for the development of NSP, but many positional head shape deformities may improve with time.

Early assessment and diagnosis is important not only for the shape of the skull, but also for possible clinical significant differences in gross motor development.

In paediatric conditions the effect of osteopathic manipulative treatment is documented in systematic reviews; in NSP the only study, which is a pilot, reveals an average reduction of 50% asymmetry on 12 infants who have undergone a course of four osteopathic treatments.

Eligibility Criteria:
Inclusion Criteria:

* Infants with NSP, ODDI score of 104% or more.
* To be at term corrected age if born prematurely.

Exclusion Criteria:

* Synostotic Plagiocephaly
* Infant who underwent an osteopathic manipulative treatment before the enrolment
* Dysmorphisms
* Syndromes
* Congenital Muscular Torcicolis
* Cerebral Palsy
Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

The investigators wish to standardise and optimise perioperative care for consecutive patients undergoing laparoscopic sleeve gastrectomy for weight loss. The investigators will compare patients under a standardised perioperative care program to patients who undergo routine perioperative in our hospital and determine whether patients who had optimised perioperative care went home earlier and had fewer complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparascopic sleeve gastrectomy for weight loss by surgeons who have agreed to participate in the study
* Surgery occurs at Manukau Surgery Centre

Exclusion Criteria:

* Surgery not occuring in Manukau Superclinic
Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning

Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing two sessions of HBO at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide poisoning.


Eligibility Criteria:
Inclusion Criteria:

* patients older than 15 years of age
* admitted for domestic CO poisoning within 12 hours after the end of CO exposure
* initial coma, regardless of consciousness at hospital admission
* carboxyhemoglobin level at presentation greater than 10% or 5%, in smokers and non-smokers, respectively

Exclusion Criteria:

* poisoning by more than one compound (e.g., CO plus a drug or CO plus other toxic gases such as those found in fire smoke)
* suicide attempt
* pregnancy
* contraindications to HBO (circulatory collapse or pneumothorax)
* technical obstacles to HBO
* non domestic CO poisoning
* difficulty in determining whether the patient experienced initial loss of consciousness or initial coma
* consent refusal
Lupus Flares and Histological Renal Activity at the End of the Treatment (LuFla)

At this moment, the duration of the treatment in Proliferative Lupus Nephritis has not been determined.

Almost 30 percent of patients in total remission during or after a treatment, will relapse in the first 5 years.

The factors associated to Renal relapses are not completly known. The investigators think that an histological control study performed to patient with complete remission for a year at the end of a 3 years treatment could help us to know which patients are going to relapse.


Eligibility Criteria:
Inclusion Criteria :

* Patients between 18 and 70 years old with Proliferative Lupus Nephritis
* 3 years treatment with a 6 month induction therapy and 2 years and a half of treatment maintenence

Exclusion Criteria :

* Membranous Nephropaty
* Mesangial Nephropathy
* Less than 3 years treatment
* Less than 1 year of complete remission
Neurological Effects of Chemotherapy and Radiation Therapy in Patients With Colon Cancer

RATIONALE: Learning about the long-term effects of chemotherapy and radiation therapy on brain function may help doctors plan cancer treatments.

PURPOSE: This clinical trial is looking at the neurological effects of chemotherapy and radiation therapy in patients with colon cancer.

OBJECTIVES:

Primary

* Identify the nature and long-term ramifications of CNS injury as a result of cancer treatment in patients with colon cancer.

Secondary

* Analyze differences in cognitive measures and MRI data in these patients.
* Correlate MRI measures with cognitive performance in these patients.

OUTLINE: Patients undergo cognitive performance assessment and MRI.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer
* Received chemotherapy and radiotherapy for colon cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Development and Validation of an Orthopedic Visit Prompt List

Investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.

Visiting a doctor with a musculoskeletal problem can be quite a daunting experience for patients. A visit question prompt list may help to empower patients and increase their role in active decision-making. Previous studies have shown that patient activation is correlated with a disability, pain intensity, and satisfaction with treatment. Perceived empathy is strongly associated with satisfaction among people with arm problems. A list that prompts patients to ask about things that matter to them, might improve their connection with the surgeon and their perceived empathy. The investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18+)
* Orthopedic visit

Exclusion Criteria:

* Patients who are illiterate.
* Patients who do not speak English.
Kisspeptin Levels in Early Pregnancy

Kisspeptins are a family of neuropeptides that are critical for the puberty initiation and female fertility. The investigators aimed to investigate in this study kisspeptin levels in early pregnancy, ectopic pregnancy, and early pregnancy loss.

Clinicians can easily do a differential diagnosis of early pregnancy, miscarriage, and ectopic pregnancy when the human chorionic gonadotropin (hCG) values higher than 2000 mIU/mL with transvaginal ultrasound. However, in cases where the hCG value is below the critical threshold of 1500 to 2000 mIU/mL (often called the discrimination level) and ultrasound is not likely to be diagnostic, the pregnancy is of unknown location. Plasma or serum kisspeptin is mainly derived from the placenta during pregnancy and plasma kisspeptin levels significantly increase across pregnancy. Plasma kisspeptin levels could be used as a potential biomarker for the discrimination of miscarriage and ectopic pregnancy.

All statistics will be carried out with the use of SPSS (ver. 21, IBM). A P value of \<.05 is considered to be statistically significant. Pearson chi-square test will be used to evaluate between-group differences by pregnancy outcome for categoric data. Kisspeptin differences will be calculated between groups with one way ANOVA.

Eligibility Criteria:
Inclusion Criteria:

Women aged between 18-37 years presented with between 5-6 weeks of gestation by last menstrual period.

Exclusion Criteria:

* Women older than 37 years or younger than 18 years
* Women with a molar pregnancy, multiple gestations, gestational age past 6 weeks at the time of blood draw, or if pregnancies were assisted conceptions
Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect

The aim of this randomized trial is to determine efficacy of dexmedetomidine in improving quality of recovery in pediatric patients undergoing interventional catheter closure of ASD while maintaining the hemodynamic parameters. Additionally he stress reducing effects of dexmedetomidine will be investigated in this population .

The main questions it aims to answer are:

Does Dexmedetomidine maintain stable hemodynamics in pediatric patients undergoing transcatheter ASD Closure while improving their quality of recovery?

Does dexmedetomidine prolong duration of recovery and time to extubation in pediatric patients ?

Does dexmedetomidine exert stress reducing properties in this population?

Participants will:

Either be administered Dexmedetomidine in a loading/maintenance regimen or a placebo, with hemodynamics being monitored at the baseline, intraoperatively and postoperatively, with recovery time and quality of recovery especially emergence delirium being monitored. Stress hormone levels will be sampled at baseline and postoperatively.

Atrial Septal Defect (ASD) is one of the most common congenital anomalies in pediatric and even in adult population, it is associated with a left-to-right shunt resulting in right ventricular (RV) volume overload and increase in pulmonary blood flow eventually culmination in right ventricular heart failure (RVHF) and pulmonary hypertension.

Percutaneous closure of ASD was devised nearly a half century ago, and now constitutes a viable alternative to the standard approach of surgical closure. Anesthesia for pediatric patients undergoing percutaneous closure involves a spectrum from sedation to general anesthesia using a variety of drugs according to institutional protocol.

Stress response represents the sum of metabolic nd hormonal perturbations initiated by the hypothalamo-pituitary-adrenal axis in response to the surgical stimulus.

Dexmedetomidine is an α2-adrenoreceptor agonist possessing stress ameliorating effects exerted on the central sympathetic outflow. It can be used either alone in sedation or as supplementation to general anesthesia. It possesses a remarkable hemodynamic stability profile and due to its prolonged duration of action, it plays a significant role in reducing emergence delirium.

This study aims at evaluating utility of dexmedetomidine as a supplementary agent to general anesthesia on hemodynamic stability / cardiac output, reduction of pediatric emergence delirium and stress hormone levels in pediatric patients undergoing transcatheter closure of ASD.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric Patients 3-12 years of age admitted for device closure of ASD secundum

Exclusion Criteria:

* ASA IV, V
* Neurological problems (cerebral palsy, mental retardation, etc.,)
* Children with chromosomal abnormalities or other multiple congenital anomalies or other complex cardiac anomalies
* Hepatic or renal insufficiency
* History of allergy to the drugs used
* Previous Cardiac Surgery
Cardiac Murmurs in Children: Predictive Value of Cardiac Markers

Heart murmurs are commonly discovered in young children during clinical encounters in general practice. Heart murmurs might signal a structural cardiac disease that need to be treated, such as atrial septal defect. Thus, children with heart murmurs are routinely referred to comprehensive cardiac examination at a paediatric hospital department featuring echocardiography ('gold standard'). However, the great majority of such murmurs are innocent or physiological; ie., they do not represent a cardiac disorder. The prevalence of such innocent murmurs during routine random auscultation is estimated at 30 %.

It would be advantageous if patients with a heart disease to a greater extent could be identified at the general practitioners' office:

* Healthy children would not be exposed to comprehensive cardiac examination
* The burden on the family would subside.
* Scarce medical resources in highly specialized departments would be better allocated, to the benefit of patients with real heart disease.

The primary aim of this study is to establish the predictive value of cardiac markers in children with heart murmurs. Secondary aims are a) To do a pilot study of pediatric cardiac ultrasound examination in general practice; b) To establish age-adjusted reference range for cardiac markers in children, and c) To explore aspects of cardiovascular physiology in children.

The investigators will include a total of 500 children aged 4 weeks to 10 years who is consecutively referred to the Dept. of Paediatrics, Akershus University Hospital, for assessment of heart murmurs. All participants will be subjected to clinical examination, symptom assessment, pulse oximetry, blood sampling (for troponin T, proBNP and other biomarkers), ECG recording, and echocardiography. A randomized subgroup of children will also undergo echocardiography performed by a general practitioner who has not received formal training in pediatric cardiology. The value of possible predictors will be assessed through the construction of Receiver Operating Characteristics (ROC) curves, and calculation of negative predictive value.


Eligibility Criteria:
Inclusion Criteria:

* Spontaneously discovered heart murmur at general practitioner's office

Exclusion Criteria:

* Known cardiac disease
* Other chronic or acute disorder
* Medications
A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations

DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations

Eligible participants will be those diagnosed with unresectable, locally advanced or metastatic histologically documented non-squamous NSCLC with HER2 exons 19 or 20 mutations and who are treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease.

The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) as compared with Standard of Care treatment (Investigator's choice of cisplatin or carboplatin + pembrolizumab + pemetrexed). This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse or simply to live longer, compared to patients receiving standard of care treatment. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Participants at least 18 years of age
* Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease
* Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA
* Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Measurable disease assessed by Investigator based on RECIST 1.1
* Protocol-defined adequate organ function including cardiac, renal, hepatic function
* ECOG 0-1
* Having tumour tissue available for central testing

Exclusion Criteria:

* Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy)
* Any untreated brain metastases, including asymptomatic or clinically inactive brain metastases
* Active autoimmune or inflammatory disorders
* Medical history of myocardial infarction within 6 months prior to randomization
* History of non-infectious pneumonitis/ILD, current or suspected ILD
* Lung-specific intercurrent clinical significant severe illness
* Contraindication to platinum-based doublet chemotherapy or pembrolizumab
abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies

This is a multicenter, prospective, observational study designed to determine the clinical sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on Abionic's abioSCOPE device using K3-EDTA anticoagulated plasma samples from atopic and non-atopic pediatric and adult patients. Patients' sensitization determined with the abioSCOPE will be compared to the clinical assessment of allergy.


Eligibility Criteria:
Inclusion Criteria:

Atopic and non-atopic individuals are needed for this study. For enrollment in the atopic arm, patients must meet all of the inclusion criteria listed below to be eligible for participation:

1. Provide signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and less than 18 years of age.
2. Male or female, ≥ 6 years of age.
3. Consulting for signs and/or symptoms of IgE-mediated allergies to perennial allergens.

For enrollment in the non-atopic arm, patients must meet all of the inclusion criteria list below to be eligible for participation:

1. Provide signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and less than 18 years of age.
2. Male or female, ≥ 6 years of age.
3. Apparently healthy individuals who exhibit no signs/symptoms of IgE-mediated allergies including rhinitis, conjunctivitis, asthma, eczema, urticaria or food allergy symptoms upon exposure to animal danders, dust mites, cockroaches, pollens or food allergens (non-atopic).

Exclusion Criteria:

Patients must not meet any exclusion criteria below to be eligible for participation:

1. Patient participating in another study that may influence test results.
2. Subjects taking any of the following medications: antihistamines in the week preceding the consultation, systemic steroids (inhaled or nasal steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection local interferon α for the treatment of HPV is allowed), anti-IgE therapy (approved or investigational) or treated with systemic chemotherapy.
3. On-going allergen immunotherapy or prior allergen immunotherapy within the prior 3 years.
4. Patient with a history of cancer, autoimmune, or immune deficiency disease.
5. Patient suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood test.
6. Known severe allergic reaction to any of the IVD CAPSULE Allergic Asthma panel allergen components