cyrilzakka/clinical-trials huggingface dataset:
Pulse Oximeter Screening in Congenital Heart Disease

Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey

The early detection of life-threatening, critical congenital heart defects in newborn babies still presents an important clinical challenge. Most defects are amenable to intervention but timely diagnosis (ie, before presentation with cardiovascular collapse or death) is crucial. In high-income countries, examination and, increasingly, antenatal ultrasound have formed the basis of screening, but test accuracy of these procedures is variable and many babies with critical congenital heart defects are discharged before diagnosis. Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey

Eligibility Criteria:
Inclusion Criteria:

* Babies within the first 24-72 hours followed up in well baby nurseries
* Babies prior to discharge, if discharged before 24 hours of age,
* Babies ≤5 days and still followed up in well baby nurseries
* Babies born ≥35 gestational weeks

Exclusion Criteria:

* Babies within the first 12 hours of life
* Babies \>5 days of life
* Babies with a gestational age of \>35 weeks
* Babies with major congenital anomaly except congenial heart disease
* Babies who had a prenatal diagnosis of congenital heart disease
Identifying Mental Health Distress in EM Physicians

This project seeks to develop and test provider-centered strategies that improve the detection and facilitate the treatment of physiologic and mental health symptoms in emergency medicine physicians. This will be done by investigating the feasibility and acceptability of wearable device and EMA feedback with personalized linkage to an evidence-based mental health platform at the University of Pennsylvania Health System.

This proposal aims to conduct a 3-month pilot randomized control trial (n=60) testing feasibility, acceptability, and the exploratory effectiveness of digital data feedback (wearables and EMA) with tailored, symptom-specific linkage to mental health and resilience resources versus control on mental health symptoms (depression, anxiety, PTSD) and burnout in EM clinicians. The study will recruit and enroll 60 emergency medicine physicians, residents, and advanced practice providers via email and inperson outreach. Once enrolled, both arms be asked to take a baseline survey which will measure their level of well-being, burnout, depression, and anxiety.

Study participants will be randomized following consent and completion of baseline surveys. Participants will be randomly assigned to usual care or intervention. We will use 2:1 randomization. We will randomize in block sizes of 3 and 6.

Intervention: The intervention arm will then be given a wearable device and will be asked to wear it for 3 months. The device will collect biometric data on stress levels, sleep patterns, and other physiological measures of well-being. The intervention group will receive biweekly EMA short surveys, personalized bi-weekly reports from their EMA data, biometric feedback from wearable devices (sleep, heart rate variability, physical activity), and linkage to tailored and symptom-specific Cobalt resources on health and resilience. After 3 months, we will survey providers to complete a post-survey followed by a survey at 6-months following a 3-month washout period.

Control: The control arm will be asked to complete a baseline survey as well as one assessment at the end of the three-month study period. They will receive usual care, or clinician-initiated use of Penn Cobalt. They will then complete additional surveys at 3-months and 6-months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Emergency Medicine (EM) physician or advanced practice provider
* Daily access to smart phone
* Ability to use a wrist-worn wearable device
* Has or is willing to create a Gmail / Google account
* Provides at least 20 hours per week of clinical care.

Exclusion Criteria:

* Under 18
* Not a Penn EM physician or advanced practice provider
* Does not have daily access to a smart phone
* Unwilling or unable to wear a wearable device
* Does not have or is unwilling to create a Gmail / Google account
* Does not provide at least 20 hours per week of clinical care
Effect of Wii Fit Training in Comparison to Vestibular Rehabilitation Training on Balance in Patients With Benign Paroxysmal Postional Vertigo

THIS STUDY IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THE STUDY IS TO DETERMINE THE EFFECT OF WIIFIT TRAINING IN COMPARISON TO VESTIBULAR REHAB TRAINING ON BALANCE IN PATIENTS WITH BENIGN PAROXYSMAL POSITIONAL VERTIGO

Effects of wiifit training will be assessed for balance and vertigo which includes the parameters of balance training.

Benign Paroxysmal Positional Vertigo patients aged 30-60 years The participants will be assessed through Vestibular Rehabilitation questionnaire (VRBQ), Dizziness handicap inventory (DHI), Functional reach test, Clinical test for sensory integration in balance and vertigo symptom scale.

Informed consent will be taken after which the participants will be recruited into two groups, where one group will receive wiifit training and other group will receive vestibular rehabilitation training.

Base-line and post-treatment measurement will be taken for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with benign paroxysmal positional vertigo.
* Aged 30-60 years.
* Ability to stand and walk independently.
* Male and Female
* Positive Dix Hallpike Test
* DHI Scale: 36-42 (moderate Handicap)

Exclusion Criteria:

* patients with history of vestibular surgery or cochlear implantation.
* Patients with history of seizures or epilepsy.
* patients with a pacemaker or implantable cardioverter-defibrillator(ICD).
* Patients with history of severe head injury or concussion within the past year.
* No other vestibular disorders or conditions that may affect balance.
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin

The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin analogues will improve post prandial glycaemic control in patients with type 1 diabetes

This trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of IAsp, BIAsp 50, BIAsp 70 and Fast-acting Human Insulin after a standard test meal in subjects with type 1 diabetes. The profiles will be derived over a 12-hour period after subcutaneous injection in the abdominal region with a single dose of IAsp, BIAsp 50, BIAsp 70 or Fast-acting Human Insulin at a test meal. The trial consists of a screening period of 4-21 days and 4 treatment visits.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities.
* Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.
* Insulin treatment of any regime for more than one year at time of inclusion.
* Total insulin demand ≥ 0,4 U/IU/kg/24 hrs
* HbA1c between 7% and 12% (both values included).
* Age ≥ 18 years.
* BMI between 18 and 35 kg /m2 (including both values).

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products.
* Recurrent major hypoglycaemic episodes.
* Heart: Unstable Angina Pectoris, AMI \< 12 months or heart insufficiency classified according to NYHA III-IV
* Blood Pressure: Severe uncontrolled hypertension with BP \> 180/110 mmHg, sitting
* Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase \> 2 x upper reference limit of the local laboratory.
* Kidneys: Impaired renal function corresponding to serum-creatinin \> 150 μmol/l according to the local laboratory.
* Any disease judged by the investigator to affect the trial.
* Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.
Improving Medication Prescribing-Related Outcomes for Vulnerable Elderly in Transitions

Medication safety is a crucial health issue for every older Canadian since many of the medications causing serious harm are those which also have life-saving or important symptom-relieving benefits. Very few specialists can accurately advise seniors which medications provide more benefit than harm for them personally, and make changes safely as this requires a very large breadth and depth of knowledge about the patient, the conditions they have and their therapies. Now that telemedicine is compatible with smart phones, this extends the ability of scarce specialists to 'see' any patient in Canada in a way that is more convenient for the patient and may be less expensive than current care. This project will find out whether a unique Clinical Pharmacology specialist team in Hamilton, Ontario can improve medication safety (stop medications no longer needed, reduce doses where appropriate, change to safer medications) for a high risk group of older hospitalized Canadians taking many medications. The hospital where this pilot study will take place was the first to install the world's leading electronic health record and set it up to facilitate and support high quality research. Patients who volunteer will be assigned to their usual care, or to the intervention which is the Clinical Pharmacology specialist team approach starting in hospital and following up with the patient at home using telemedicine and detailed communication with them, their caregiver, family physician, community pharmacist and other specialists. The investigators will study whether the intervention is effective and cost-effective at reducing harmful medication burden, reducing the need to return to hospital, or improving the patient's ratings of their care coordination. The results will determine whether a subsequent large trial is worthwhile.


Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 65 years.
* Admitted to Medicine or Surgery services for more than 2 days.
* High cost users (defined as):
* Have at least one other hospitalization within the previous year.
* Taking 5 or more chronic medications including at least one TRIIM-Med.
* Provide informed consent.

Exclusion Criteria:

* Patients with "do not approach status".
* Patient or Caregiver not fluent in English.
* Patients who do not provide informed consent.
* Patients admitted for \< 2 days.
* Patients \< 65 years of age.
* Not a high cost user (as defined above).
TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss

The PI3K, protein kinase B (AKT), and mTOR signaling network promotes cell growth, survival, metabolism, and motility, but becomes a critical oncogenic driver under aberrant conditions that control the tumor microenvironment and angiogenesis. The PI3K-AKT-mTOR axis is the most frequently deregulated signaling pathway in primary osteosarcoma and other bone tumors. PI3Ka has high rates of 25-50% activating mutations associated with tumor formation in osteosarcoma. Other causes of pathway hyperactivation include loss of function of the tumor suppressor PTEN, gain-of-function mutations in AKT and PDK1, or upregulation of receptor tyrosine kinases. TQB3525 is an orally bioavailable, potent, dual catalytic site inhibitor of PI3Ka and PI3Kd. Tumor growth inhibition has been demonstrated in multiple xenograft osteosarcoma models with PI3K-mutant, PTEN-null cell lines. The investigators try to investigate TQB3525 in primary osteosarcoma and other bone tumors for its safety, tolerability, dose-limiting toxicities (DLT), MTD and antitumor efficacy.


Eligibility Criteria:
Inclusion Criteria:

* progression upon first-line chemotherapy;
* with target lesions according to RECIST 1.1;
* geno-profiling with PI3KA mutations or PTEN loss;
* ECOG PS status 0 or 1 with a life expectancy \>3 months;
* adequate renal, hepatic, and hematopoietic function;

Exclusion Criteria:

* been previously exposed to other TKIs;
* had central nervous system metastasis;
* had other kinds of malignant tumors at the same time;
* had cardiac insufficiency or arrhythmia;
* had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++, and so on;
* had pleural or peritoneal effusion that needed to be handled by surgical treatment;
* had other infections or wounds;
* pregnant or breastfeeding.
Physical Activity and Immigrant Health

There is today a growing need for culturally adapted initiatives among immigrants to prevent and treat T2D. Others have failed to increase the level of physical activity in this sedate group. The investigators believe this is due to missing assistance and lack of influence from the Pakistani milieu. To improve this, a culturally adapted physical activity will be established in this project in close cooperation with the Pakistanis themselves.

Through this program it is the investigators' goal to increase their physical activity level and prevent lifestyle diseases among Pakistanis in Oslo with a high risk of developing these diseases.


Eligibility Criteria:
Inclusion Criteria:

* Pakistani background
* 25-55 year old
* Physically inactive

Exclusion Criteria:

* Diabetes
* heart condition
* medication that could affect the results
Balloon Catheters in Cases of Abnormal Placentation

Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted into the uterine myometrium. The most significant complication is intense bleeding, mainly during labor. The most important risk factors are previous cesarean delivery, placenta previa, and advanced maternal age. Cesarean hysterectomy is the recommended management. During the recent years, inserting intravascular balloon catheter for occlusion and/or arterial embolization, was introduced as an adjuvant therapy in order to minimize blood loss during cesarean hysterectomy or in conduct with conservative management with the intent of avoiding hysterectomy in selective cases. Contradicting reports exist regarding the effectiveness and safety of the catheters in cases of placenta accreta. The objective of this study is to estimate the efficacy of the balloon catheters among women diagnosed with a placenta accreta.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women age 18-45
* antepartum diagnosis of placenta accreta

Exclusion Criteria:

- women who refuse to participate
Surgeons' Satisfaction With Two Types of Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)

The development of surgical site infections (SSI) in clean-contaminated surgery is regarded as being preventable. Known to be effective in the prevention of surgical site infection are the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic prophylaxis where indicated, and certainly the preparation of the skin at the incision site. During the last decades the use of alcoholic chlorhexidine has replaced povidone iodine for preoperative skin preparation. In order to improve the way alcoholic chlorhexidine is applied, pharmaceutical industry has developed new applicators.

This randomized study was conducted to know the surgeons' satisfaction within the use of two tinted applicators: Chloraprep® and Nex Clorex 2%


Eligibility Criteria:
Inclusion Criteria:

* Volunteer surgeons from colon, cardiac, knee and hip surgical departments. Once surgeon has enrolled the study, patients will be selected if they have hospital admission with scheduled surgery and have signed informed consent

Exclusion Criteria:

* Urgent surgeries
* Outpatient surgery
* Surgical complex cures
* Mixed interventions: exploratory or sequential
* Unscheduled surgeries
* Rejection of participation
* Chlorhexidine or isopropyl alcohol hypersensibility patients
* If any patients changed its mind after signing the informed consent will be removed from the study.
Novel Treatment for Syndromic Ichthyoses

This is an open label-pilot study to assess the efficacy and safety of a novel cholesterol-lovastatin topical solution in children with rare syndromic ichthyoses. Often times, these children have difficulty in finding easily applied treatments to make their psoriasiform and ichthyotic plaques more manageable. We propose the use of a cholesterol-lovastatin topical solution as a treatment option with the hypothesis that it will lead to regression of involved areas and decreased erythema and warty-like appearance of the plaques. We plan to enroll children with syndromic ichthyoses over the age of 1 year for a 12 month study with a total of 5 visits and 5 phone calls.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent form signed by the subject or subject's legal representative; also, if the subject is under the age of majority but capable of providing assent, signed assent from the subject.
* Diagnosis of a syndromic ichthyoses (verified by Dr Amy S. Paller).
* Children and adults 12 months of age and above

Exclusion Criteria:

* Use of any investigational drug within the 30 days before enrollment.
* Current malignancy.
* Pregnancy or breastfeeding during the study. (All female subjects of childbearing potential will be assessed for pregnancy at all visits.)
Pharmacokinetic Study Of EPZICOM Tablet

This study was designed to explore the drug levels in the blood in Japanese HIV-infected patients taking EPZICOM tablet at least for 2 weeks prior to administration of the study drug. Pharmacokinetics after administration of EPZICOM tablet will be investigated in a total of 8 subjects.


Eligibility Criteria:
Inclusion criteria:

* A Japanese HIV-infected patient who continues to use one EPZICOM tablet in the morning (00:00 to 12:00) at least for 2 weeks prior to administration of the study drug.
* A patient who agrees to abstain from alcohol from 48 hours prior to administration of the study drug until completion of blood sampling for pharmacokinetic analysis.

Exclusion criteria:

* A patient developing AIDS (Patients who developed AIDS in the past but have no symptoms or findings that may serve as indicators at screening may be eligible for the study.)
* A patient with a history of hypersensitivity to the study drug and the ingredients (lamivudine, abacavir sulfate) of the study drug
Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr

This study is a prospective, multicenter and randomized clinical trial (DEBULK trial) to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) in cervical cancer stage IIICr.

Bulky or multiple lymph nodes metastasis in cervical cancer shows poor prognosis and can also diminish the effect of radiotherapy or concurrent chemoradiation therapy (CCRT). However, it is difficult to increase the dose of radiation and chemotherapy considering their side effects. Therefore, the objective of this study is to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) compared to CCRT only, in cervical cancer stage IIICr. This study is a phase III, multicenter and randomized clinical trial (DEBULK trial).

* Concurrent chemoradiation therapy (CCRT)
* Surgical debulking of bulky or multiple lymph node followed by CCRT

Eligibility Criteria:
1) Inclusion Criteria

(1) Women aged ≥ 20 years and ≤ 70 years (2) Patients newly diagnosed with squamous cell carcinoma (SCC), adenocarcinoma, or adenosquamous carcinoma (3) Patients with a short-axis diameter of the pelvic LN or para-aortic LN under the renal vein of ≥ 1.5 cm or ≥ 2 LNs with a short-axis diameter ≥ 1 cm in CT or MRI (PET-CT can be used as an auxiliary tool) (4) Patients with CCRT planned as a treatment for cervical cancer (5) Patients whose competency is Eastern Cooperative Oncology Group performance score 0-1 (6) Patients who have signed the approved informed consent form for study participants (7) Patients in whom surgical debulking for LN metastasis was possible, as confirmed by radiological examination.

2) Exclusion Criteria

(1) Patients who have been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years (2) Patients who are pregnant or plans to conceive during the clinical study period (3) Patients with any active infectious disease or incurable severe inflammation (4) Patients who cannot undergo surgery due to internal or surgical disease (5) Patients who cannot receive chemotherapy due to internal or surgical disease (6) Patients with a history of pelvic RT (7) Patients with a history of subtotal hysterectomy (8) Patients with remote metastasis other than a pelvic or para-aortic LN (e.g., lung, subclavian, and inguinal LNs)
Combined and Simultaneous Approach for the Treatment of High-risk Gastric Varices Using B-RTO and EVO

The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with balloon occluded-retrograde transvenous obliteration (B-RTO) for the treatment of high-risk gastric varices

Although less frequent than esophageal varices, gastric varices constitute a severe and potentially life threatening complication of portal hypertension. Various methods have been described to treat gastric varices, including endoscopic and interventional radiology techniques. Endoscopic variceal obliteration (EVO) is currently considered as standard of care for the treatment of gastric varices in most centers. However, this technique is associated with significant rebleeding rates and incomplete obliteration is observed in about 50% of patients. Alternatively, few centers also use an interventional radiology technique, called balloon-occluded retrograde transvenous obliteration (B-RTO) to treat gastric varices, which has been shown to be associated with less recurrence of gastric varices and high rates of eradication of about 90%. Both techniques have their inherent weaknesses, such as frequent incomplete eradication of varices and thromboembolic events for EVO, while data suggest that B-RTO may aggravate esophageal varices.

The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with (modified) B-RTO. Stopping the outflow of gastric varices by endovascular balloon occlusion may allow better endoscopic visualization, blood stagnation and thus eradication of varices, while preventing thromboembolic events. Furthermore, during study follow-up, the eradication rates and recurrence of varices, short-term and long term complications, effects of the procedure on portal pressures/hemodynamics and liver function will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Informed Consent as documented by signature (Appendix "Fiche d'information aux patients et formulaire de consentement éclairé")
2. Patients with endoscopically proven high-risk (diameter \>2 cm, mosaic gastropathy, red spots or signs of previous bleeding) and GOV2, IGV1 and IGV2 type of gastric varices (according to Sarin classification)
3. Portal hypertension secondary to cirrhosis
4. Age \>18

Exclusion Criteria:

1. Acute gastric or esophageal varice bleeding
2. GOV1 varices according to Sarin classification
3. Hemodynamic instability
4. Uncompensated cirrhosis
5. Contraindication to general anesthesia
6. Contraindication to CT-scan/angiography (impaired kidney function, allergy to iodine based contrast)
7. Allergy to cyanoacrylate, drugs or material used during procedures
8. Absence of gastro-renal shunt
9. Pregnancy
10. Participation to another study involving ionizing radiation (dose superior to 5mSV) without direct benefice for patient during the 12 last months