cyrilzakka/clinical-trials huggingface dataset:
Subcutaneous Wound Infiltration of Ketamine or Bupivacaine Pain Perception After Cesarean Section

Aim: To assess the analgesic efficacy of subcutaneous infiltration of ketamine, either alone or as an adjuvant to bupivacaine, following CS and to compare their effects on postoperative pain scores and opioid consumption.

Methods: Included patients were allocated to four treatment groups using computer-generated randomization number chart as follows; Group 1 (Ketamine, n=30) received subcutaneous infiltration of ketamine, Group 2 (Bupivacaine, n=30) received subcutaneous infiltration of bupivacaine 0.5%, Group 3 (Ketamine+Bupivacaine, n=30) received subcutaneous infiltration of ketamine+bupivacaine 0.5% and Group 4 (Placebo, n=30) received subcutaneous infiltration of placebo (0.9% saline solution). Patients, anesthetist, surgeon, and other medical and nursing staff were blinded to the contents of the medications. VAS scores at resting and on coughing and analgesic consumptions were compared.

the Group 1 (Ketamine, n=30) received subcutaneous infiltration of ketamine 1 mg/kg (Ketalar®, 10 mL inj., 50 mg ketamine hydrochloride/ml, Pfizer Drug Company, USA). The Group 2 (Bupivacaine, n=30) received subcutaneous infiltration of 20 mL (100 mg) of bupivacaine 0.5% (Marcaine®, 20 mL inj. 5 mg bupivacaine hydrochloride/ml, AstraZeneca Drug Company, Turkey). The Group 3 (Ketamine+Bupivacaine, n=30) received subcutaneous infiltration of ketamine 1 mg/kg (Ketalar®) plus subcutaneous infiltration of 20 mL (100 mg) of bupivacaine 0.5% (Marcaine®). The Group 4 (Placebo, n=30) received subcutaneous infiltration of 30 mL placebo (0.9% saline solution). All medications were diluted with sterile 0.9% saline solution to 30 ml solutions in the similar volume and shape syringes and were infiltrated subcutaneously along the skin wound edges and close to the fascia prior to skin closure. There were four separate syringes which were prepared by an anesthesiology technician for four different treatment groups labeled G1, G2, G3 and G4 containing the ketamine, bupivacaine, ketamine plus bupivacaine and normal saline solution. Patients, anesthetist, surgeon, and other medical and nursing staff were blinded to the contents of the medications.

Eligibility Criteria:
Inclusion Criteria:

* singleton term pregnancy,
* between 38-41th weeks of gestation,
* absence of any medical or obstetrical problems.

Exclusion Criteria:

* multiple pregnancies,
* intrauterine fetal deaths,
* active stage of labor,
* obstetric emergencies such as antepartum hemorrhage, eclampsia and acute fetal distress,
* special request for general anesthesia,
* history of allergic reaction or sensitivity to any of the drugs used in the study,
* reflected anxiety and depression during the cesarean operation,
* any systemic diseases (chronic hypertension, thyroid diseases, renal or hepatic insufficiency, psychiatric disorders,
* chronic pain syndrome, epilepsy or intracranial hypertension)
* medications that would affect the perception of pain,
* current or past history of narcotic use or a history of narcotic abuse,
* inability to understand how to score a 10-cm visual analogue scale (VAS) for pain.
Evaluation of Inflammatory Cytokines During COVID-19

The aim of this study is to evaluate pro-inflammatory cytokines as well as microvesicles during the course of SARS-CoV2 infection in the context of clinical parameters.

In this prospective trial, 100 patients with an acute SARS-CoV2 infection are enrolled. After confirmation of COVID-19, blood samples are taken for evaluation of various inflammatory cyokines and microvesicles at day 1, 5, 9 and 13 during hospitalisation and are interpreted in the context of clinical parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Confirmation of acute SARS-CoV2 infection
* Ability to provide informed consent
Comparison of AuraGain With I-gel for Pediatric Patients

Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status: 1-3
* age: from 6 months to 6 year
* body weight: 5-20kg
* patients undergoing upper/lower extremity surgery at supine position

Exclusion Criteria:

* patients who do not want to participate in this study
* patients with known difficult airway including congenital facial anomaly or history of difficult airway management
* patients with aspiration risk (gastrointestinal stenosis or stricture)
* patients with symptom of upper respiratory infection on the day of surgery
* patients scheduled for day surgery
* patients judged as not eligible by researchers for other reasons
Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia

The purpose of this study is to assess the safety and the immediate effect of the VascuActive device on patients with peripheral vascular disease and limb ischemia.


Eligibility Criteria:
Inclusion Criteria:

* Leg Ischemia, Fontaine grade IIa and IIb, i.e.: pain free walking distance in the range of 50 - 100 meters.
* Absent pulses in the two foot arteries (Anterior Tibial a., Posterior Tibial a.)
* ABI \< 0.7 by Doppler, in at least one of the two foot arteries

Exclusion Criteria:

* Absent femoral pulses
* Venous insufficiency by Duplex
* Pregnancy
* Infectious disease
* Malignant disease
* Severe cardiac disease, e.g., CHF grade 3 or higher
* Acute MI within last 3 months
* CABG within last 3 months
* Other severe systemic disease
Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients

The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:

How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Females, \>18 years old;
2. Diagnosed with advanced breast cancer when using metronomic chemotherapy;
3. At least one clinical evaluation, including physical examination and imaging, according to the instructions of the supervising physician during the use of metronomic chemotherapy. Examinations include ultrasound, computed tomography, and magnetic resonance imaging;
4. Metronomic chemotherapy can be used alone, and patients who use it in combination with other drugs can also be included;
5. The clinical pathological information that needs to be collected is complete.

Exclusion Criteria:

1. Taking the drug for less than 2 weeks;
2. losing follow-up after taking the therapy;
3. The patient's breast cancer was still in the early stage when taking the therapy.
The Impact of Breath Exercises by Telemedicine in Patients Aged 8-18 Years With a Diagnosis of Asthma

The goal of this randomized, placebo controlled study is to evaluate the effect of respiratory exercises on asthma attack frequency, symptom and medication scores and quality of life of children with a diagnosis of asthma.

Participants will be asked to perform respiratory exercises described at once in hospital at home regularly. Control group will comprised children with asthma without respiratory exercises.

At the beginning of the study anthropometric measurements, basal respiratory function assessment, drugs, demographic information, allergen sensitivity, asthma control levels and quality of life scales will be documented. Patients will be randomly divided into two groups; one group following respiratory exercises and relaxation exercises and the other following only relaxation exercises. Both groups will be called regularly to remind the exercises.

The spirometric tests and asthma control forms will be reevaluated at the 3rd and 6th month at hospital.

Peak flow meters will be given to patients to document PEF values during study.

Eligibility Criteria:
Inclusion Criteria:

clinical diagnosis of allergic asthma allergic asthma severity step 1 or step 2 -

Exclusion Criteria:

asthmatic children more severe than step 2 other comorbid disorders involving respiratory system or neuromusculatory disorders

-
Treatment of Social Anxiety in Youth

This research is designed to determine the effectiveness of attention bias modification for socially anxious children and adolescents. Over the course of 3 years, 50 youth will be enrolled in the trial.

The primary objective of this study is to develop an Attention Training (AT) protocol for adolescents with social anxiety disorder (SAD). Attentional biases to threat have been shown to be associated with the development and maintenance of anxiety disorders, in both adults and youth. Given these relations, AT paradigms have been developed to modify these attentional biases. Such paradigms have been shown to be promising in the treatment of adult anxiety. However, to date, only two small studies have examined the use of AT with children, and no ATT protocol has been developed specifically for use with children or adolescents. This is important, given the complications and possible ineffectiveness of applying adult-designed therapies to youth. Given this gap in the literature, the primary aims of the current study are intended to develop a treatment program to address attentional biases and anxiety in adolescents with SAD, to collect preliminary data regarding the program's short-term efficacy and feasibility, and to explore attention biases as a mediator and moderator of initial treatment outcomes. It is hypothesized that the AT protocol developed in the current project, compared to a placebo control comparator condition, will result in reductions in social anxiety among a sample of adolescents with SAD. Further, the AT protocol is expected to reduce attentional biases to threat among those adolescents who possess such biases prior to treatment (not all adolescents are expected to show this bias yet AT has been shown to be potentially effective with these youth; the presence/absence of attention bias will be explored as a moderator of change). The proposed study will be a pivotal step towards assessing the feasibility of an adolescent-focused AT procedure for the treatment of SAD. Results will contribute to an emerging body of research exploring the ameliorating effects of experimental paradigms that target information processing biases in anxious youth. Given emerging evidence regarding the use of AT in adult populations, findings from this study may have implications for improving the current prevention and treatment options available for anxious adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Social Anxiety Disorder;
* English Speaking

Exclusion Criteria:

* Suicide Intent,
* Psychosis,
* Autism Spectrum Disorder
Impact of Multidisciplinary Program on Falls in Elderly Inpatients

Falls among elderly inpatients are common, multifactorial and associated with a significant increase of complications and morbidity. According to a recent Cochrane review, the effectiveness of fall prevention program has been assessed in community-dwelling and in long stay wards but not in rehabilitation wards (RW) and geriatric acute wards (GAW). IPR study aims to measure the impact of a multidisciplinary prevention program on falls in elderly inpatients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged over 65 years
* Admitted during the study
* Participation agreement

Exclusion Criteria:

* Patients with a MMSE\<10 and incapable to participate to a reeducation program
* Patient with an evolutionary and\\or badly checked psychiatric pathology
* Bedridden patient
Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study

The aim of this study is to investigate the pregnancy, delivery, neonatal, and epilepsy outcomes in individuals with epilepsy undergoing pregnancy at the Maternal and Infant Health Programs at the University Health Network - Sinai Health and followed for epilepsy at the Toronto Western Hospital Epilepsy Clinic. In particular, we are interested in the association between following recommended epilepsy management guidelines for pregnant individuals with epilepsy and those aforementioned outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. WWE seen at the Toronto Western Hospital Epilepsy Clinic since June 1st 2022.
2. Pregnant at any point between June 1st 2022 and June 1st 2024 (period of enrolment).
3. Diagnosed with epilepsy as per the International League Against Epilepsy (ILAE) 2014 definition of epilepsy.

Exclusion Criteria:

* None
A Need-based Nutritional Intervention in Nursing Home Residents

To examine the effectiveness of a "need-based nutritional intervention" strategy in improving the nutritional and physical functional status of nursing home elderly.

Ninety-two nursing home residents aged 65 years or older and BMI \<25 were randomly assigned to the intervention or control groups. Subjects in the treatment group received a soy-protein-based nutritional supplement, if his/her BMI was \<24kg/m2 and nutritional score was \<24 according to the Mini Nutritional Assessment. The supplementation would be suspended if both conditions were not met. At baseline and every 4 weeks up to 24 weeks, thereafter, all subjects were measured for anthropometric parameters. At baseline, 12 weeks and 24 weeks subjects were measured for blood biochemical indicators, handgrip strength and Barthel's index.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 65 years of age
2. BMI ≤ 25 (kg/m2)
3. ≥1 month of residency
4. Able to self-feed or receive oral-feeding
5. Non-bed-ridden
6. Cognitively able to answer the questionnaire

Exclusion Criteria:

1.Hospitalized or having acute infection/diseases
Perfexion Brain Metastasis

Brain metastases occur in 20% to 40% of all patients with cancer , with an incidence 10 times higher than that of primary malignant brain tumors. Patients with brain metastases have a poor prognosis with a median survival of 1-2 months with corticosteroids and 5-7 months with whole brain radiotherapy (WBRT). Local control achieved with WBRT in patients with otherwise controlled systemic disease remains at issue. A single high dose of radiation delivered with high precision to the target lesion (Stereotactic radiosurgery (SRS)), is considered standard care in salvage of recurrent lesions after WBRT. SRS can destroy tumour with very little damage to surrounding tissue. Research suggests that delivering radiotherapy in a number of smaller doses is more beneficial than receiving all of the radiotherapy in a single dose. Brain metastases are well suited for SRS as they are often small, radiographically well-circumscribed, pseudospherical tumors that are noninfiltrative.

With increasing volume of tumor, the dose of radiosurgery that can be safely delivered to recurrent oligo-metastases in the brain must be reduced. However, reducing the dose of radiosurgery also compromises local control. There is mounting evidence of a local control benefit to a hypofractionated approach in radiation delivery for brain metastases compared with single fraction radiosurgery. Here we propose a novel therapeutic strategy that builds on this concept whereby time between each delivered fraction will enable us to measure and adapt to response, with the objective of reducing irradiated volumes and improving outcomes. In general, the treatment of malignant tumors benefits from fractionation of the dose due to a number of radiobiological properties (redistribution, reoxygenation, repair) that distinguish, and select against, malignant lesions in the fractionation process. Hypofractionated stereotactic radiotherapy (HSRT) is a method of delivering a highly conformal dose distribution in a few treatment sessions using a relocatable stereotactic frame. HSRT may be an attractive alternative to SRS because it may 1) improve patient comfort by removing the invasive nature of SRS frames, 2) confer a radiobiologic advantage over single fraction treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1-5 recurrent brain metastases after WBRT, and
* At least 1 lesions \>2cm in maximum diameter
* ECOG 0-2
* Life expectancy \>3months
* Age ≥ 18 years old

Exclusion Criteria:

* Edentulous patients
* Prior surgery or injury to hard palate
* Severe claustrophobia
* Contraindication to MRI
* Contraindication to IV contrast (Gadolinium) administration
* Other medical conditions that would preclude study investigations
* Prior radiosurgery to recurrent lesions
* Radiation cannot be delivered at the assigned dose level in a manner that respects OAR constraints (3.2.2.4.2.3.4) (e.g. lesions within brainstem or abutting optic structures)
* Any lesion \>5cm in diameter, or total volume of tumor \> 60cc
* Pregnant Women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis

The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have 1 of the following 9 CFTR mutations on at least 1 allele: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D
* On ivacaftor therapy
* FEV1 value ≥40% and ≤100% of predicted mean for age, sex, and height

Key Exclusion Criteria:

* History of clinically significant cirrhosis with or without portal hypertension
* History of solid organ or hematological transplantation
* Lung infection with organisms associated with a more rapid decline in pulmonary status

Other protocol defined Inclusion/Exclusion criteria may apply
The Real World of Acute Cholecystitis

Meta-analysis of randomized controlled trials and population based studies in acute cholecystitis are in favor for early laparoscopic surgery versus a delayed operation several weeks later. The main problems in these studies are the exclusion criteria used, thus not reflecting the real world setting of acute cholecystitis. The purpose of this study is to demonstrate that a delayed laparoscopic cholecystectomy in a real world scenario has no worse outcome in comparison with an early operation (within 72 hours after onset of symptoms).

Background:

Randomized controlled trials (RCTs) and population based studies are in favor of an early operation in acute cholecystitis (1, 2). Thus, one of the largest RCT so far, demonstrated significant more complications in a group of delayed cholecystectomy. The main problems in these studies are the exclusion criteria used, ie severe cases are not considered.

Objective:

In a cohort study all cholecystectomy patients are analysed to demonstrate that delayed laparoscopic cholecystectomy (DLC) in a real world setting has a less complication rate than early cholecystectomy (ELC).

Setting:

Academic Teaching Hospital with 400 beds, seven departments (anesthesiology and intensive care medicine, orthopaedics and trauma surgery, visceral and thoracic surgery, gastroenterology, cardiology, gynecology and obstetrics, psychiatry. The visceral and thoracic department has a main focus on minimally invasive techniques.

Participants:

All cholecystectomy patients during 1/2006 and 9/2015

Variables:

Clavien Dindo Complication score, American Society of Anaesthesiologist (ASA) Score, conversion rate, onset of symptoms, histology, hospital stay

Data sources:

Chart analyses

Eligibility Criteria:
Inclusion Criteria:

* All patients with cholecystectomies

Exclusion Criteria:

* No exclusion criteria
A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis

The purpose of this study is to determine whether VIB4920 (formerly MEDI4920) is safe and well tolerated in participants with adult-onset rheumatoid arthritis (RA).

Study with completed results acquired from Horizon in 2024. Originally Viela Bio was the sponsor.

Eligibility Criteria:
Inclusion Criteria:

* adult-onset rheumatoid arthritis
* swollen and tender joints

Exclusion Criteria:

* venous thromboembolism or arterial thrombosis
* pregnant or breastfeeding
* positive hepatitis B, hepatitis C, and human immunodeficiency virus infection
* active or untreated latent tuberculosis
A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to establish a safe and tolerable dose of BMS-986393 in combinations with alnuctamab, mezigdomide, and iberdomide in participants with relapsed and/or refractory multiple myeloma (RRMM).


Eligibility Criteria:
Inclusion Criteria:

* History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1 and Part 2) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2)
* Measurable multiple myeloma (MM)
* Eastern Cooperative Oncology Group performance status of 0-1

Exclusion Criteria:

* Condition that confounds the ability to interpret data from the study
* Known active or history of central nervous system (CNS) involvement of MM

Note: Other protocol-defined inclusion/exclusion criteria apply
Physiotherapy With Positive Expiratory Pressure (PEP) Bottle in Patients With Bronchiectasis

The aim of this study is to determine whether respiratory physiotherapy using the Positive Expiratory Pressure (PEP) bottle has an effect on respiratory function, measured through spirometry, in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Subject over 18 years of age
* Confirmed diagnosis of bronchiectasis based on high-resolution chest CT, showing bronchial dilation according to one or more of the following radiological criteria in accordance with the 2019 BTS guidelines.
* Ratio between the internal lumen of the bronchus and the adjacent pulmonary artery \>1
* Absence of normal bronchial tapering
* Visibility of the airways within 1 cm from the pleura
* Subject with chronic bronchial hypersecretion (daily secretion ≥ 15ml)
* Patients capable of performing physiotherapy using the PEP bottle
* Patients capable of performing global spirometry

Exclusion Criteria:

* Subject already undergoing regular respiratory physiotherapy
* Subject without significant bronchial hypersecretion
* Concomitant diagnosis of Cystic Fibrosis, Primary Ciliary Dyskinesia, NTM-PD, TB, Sarcoidosis, Active Neoplasia
* Diagnosis of Asthma according to the 2023 GINA guidelines, defined as documented excessive variability in pulmonary function (positive bronchodilation or bronchoprovocation test with methacholine, or diurnal variability of PEF) + documented limitation of expiratory airflow.
* Diagnosis of COPD according to the 2023 GOLD guidelines, defined as FEV/FVC post-bronchodilation \<0.7 on forced spirometry in the presence of suggestive symptoms (dyspnea, chronic cough, sputum production) and/or exposure to risk factors for the disease (e.g., cigarette smoking).
* Contraindications to PEP-Bottle Physiotherapy (Pneumothorax; Hemoptysis; Myocardial infarction in the 4 weeks prior to informed consent signature)
* Exacerbation of disease in the previous 4 weeks
* Use of inhalation therapy in the 4 weeks prior to informed consent signature
* Active smoker
* Subject undergoing non-invasive ventilation or with a tracheostomy
* Inability to provide informed consent
A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.

The study is designed to see if stress heart imaging can be used as a screening exam in patients with diabetes and risk factors of developing of coronary artery disease and experiencing future cardiac events.


Eligibility Criteria:
Inclusion Criteria:

* History of diabetes for at least 5 years, with a least 2 risk factors (i.e. hypertension, elevated cholesterol levels, history of or current smoker, obese, family history of heart disease) \& atypical chest pain.

Exclusion Criteria:

* Typical chest pain being treated with medication, unable to exercise, previous confirmed heart disease