cyrilzakka/clinical-trials huggingface dataset:
Cytoreduction Followed by Normothermic Versus Hyperthermic Intraperitoneal Intraoperative Chemoperfusion (HIPEC): a Study in Peritoneal Carcinomatosis

Peritoneal carcinomatosis from appendix or colon (large bowel) cancer is treated in suitable patients with surgery followed by instillation of heated chemotherapy inside the abdominal cavity. This procedure is termed 'Hyperthermic intraoperative Peritoneal Chemoperfusion' or HIPEC. Many center perform HIPEC with high dose oxaliplatin, a standard chemotherapy drug active against colon cancer, administered during 30 minutes at 41°C. The hypothesis of this study is, that chemoperfusion at normal (37.5°C) temperature but longer duration (90 minutes) may be safer and at least as efficient. Patients will be treated with one of three possible HIPEC regimens using oxaliplatin: high dose, 30 min, 41°C; high dose, 30 min, 37.5°C; or low dose, 90 min, 37.5°C. The outcome parameters are pharmacokinetic and pharmacodynamic: using specialized techniques, tissue penetration of chemotherapy and cancer cell kill effects will be compared in order to establish the safest and most active HIPEC regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients with peritoneal carcinomatosis from colorectal origin (including appendiceal mucinous neoplasms and the pseudomyxoma syndromes) amenable for cytoreduction and HIPEC.

Exclusion Criteria:

* No written informed consent
* Irresectable and/or metastatic disease found during surgery
* Known allergy to oxaliplatin
Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies: Follow-up Study

The purpose of this study is to compare the therapeutic outcomes and safety of the study patients who received radiofrequency ablation (RFA) using separable clustered electrodes with those of a matched historical control group who had received RFA using multiple internally-cooled electrodes.

Although RFA is widely used as a curative treatment option for a variety of liver malignancies, it is generally limited for treating tumors larger than 2 cm in diameter with a sufficient tumor-free margin. Thus, various strategies are employed to create a sufficient ablation zone such as internally cooled-electrodes, expandable electrodes and adaptation of switching mono/bipolar controllers. Despite that these attempts have created larger ablative zones in clinical and preclinical studies, the efficacy should be validated in terms of clinical outcome.

In this study, investigators evaluated the therapeutic outcomes and safety of RFA using separable clustered electrodes for treatment-naive hepatocellular carcinomas (HCCs) in comparison with RFA using multiple internally-cooled electrodes. The study group is a subgroup of our prospective study cohort (NCT02683538) and a control group is a matched historical group received RFA in our institution using multiple internally-cooled electrodes.

Eligibility Criteria:
Inclusion criteria

* HCC diagnosed on biopsy OR typical imaging features of HCC on CT or MRI according to AASLD guidelines
* 1-3 HCCs equal to or smaller than 5cm in the liver
* no direct contact with or invasion into the hepatic hilar structures or inferior vena cava
* treatment-naive HCC

Exclusion criteria

* patients with uncontrolled coagulopathy
* patients with Child-Pugh classification C
* patients with tumor invasion into the portal vein or hepatic vein
* extrahepatic spread
Clinical Management of Anxiety and Access to Health Care

Dental and health anxiety are common and potentially distressing problems, for both patients and health care providers. Anxiety has been identified as a barrier to regular dental visits and as an important target for enhancement of oral health-related quality of life. possible groups, (1) high dental anxiety and (2) low dental anxiety. The study aimed to develop and evaluate a computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT) that could be easily implemented in dental healthcare settings.

A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental procedures, and cognitive restructuring was developed. A randomized controlled trial was conducted (N=151) to test its efficacy. Consenting adult dental patients who met inclusion (e.g., high dental anxiety) and exclusion criteria were randomized to one of two groups, (1) immediate treatment (IT) (n=74) or (2) a waitlist control (WL) (n=77).

Analyses of covariance (ANCOVAs) based on intention to treat analyses were used to compare the two groups on dental anxiety, fear, avoidance, and overall severity of dental phobia. Baseline scores on these outcomes were entered into the analyses as covariates.

Eligibility Criteria:
Inclusion Criteria:

* high dental anxiety
* fluent in spoken and written English

Exclusion Criteria:

* unable to provide written, informed consent
Efficacy Study of the Effect of Budesonide on Emphysema

To assess the effect of up to 4 years treatment with budesonide on progression of emphysema in patients with Chronic Obstructive Lung Disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Chronic Obstructive Pulmonary Disease diagnosis
* smoker

Exclusion Criteria:

* No exacerbation within the last 30 days
* no long term use of oral corticosteroids
Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy

The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation.

Eligible pregnant women in the first or second trimester who carry a diagnosis of iron deficiency anemia as defined by the American College of Obstetrics and Gynecology will be approached, consented, and randomized to receive either daily oral ferrous sulfate (325mg) supplementation or every other day oral ferrous sulfate (650mg). Participants will undergo a phone survey 2-4 weeks after starting the study to assess for side effects. Participants will continue routine care and surveillance of iron deficiency in pregnancy until the end of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Hemoglobin less than 11 g/dl in the first trimester or less than 10.5 g/dl in the second trimester
* Microcytic anemia
* Singleton gestation in the first or second trimester

Exclusion Criteria:

* Malabsorptive disorder or history of restrictive or malabsorptive gastric surgery
* Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic, sickle cell, etc.)
* History of cardiopulmonary disease
* Severe anemia requiring parental infusion or transfusion of blood products
3D Ultrasound - Based Hysteroscopy Versus Virtual Hysteroscopy

To prove that the 3 dimensional sonohysterography is, at least, as effective as the diagnostic hysteroscopy in examining the uterine cavity.


Eligibility Criteria:
Inclusion Criteria:

- Diagnostic hysteroscopy prescribed either for a case of infertility or in case of doubt of endometrial / uterine pathology suspected by ultrasound or hysterography.

Exclusion Criteria:

* Current Pregnancy.
* Genital infection
Influence of Pharmacist and Student Pharmacists on Medication Adherence in Community Pharmacy Setting in Underserved Population

The overall objective is to examine the influence of various services provided by the community pharmacy on patients' diabetes and diabetes-related health outcomes.

Diabetes affects approximately 30.3 million people in the U.S. and is the 7th leading cause of death (ADA 2019). Uncontrolled diabetes leads to various complications including cardiovascular disease, kidney disease, diabetic retinopathy, peripheral neuropathy, and lower extremity amputation. Estimated healthcare expenditure for individuals with diabetes is approximately $327 billion per year (ADA 2017). In San Bernardino County, the prevalence of diabetes was higher (12.4%) than the national rate (9.4%). More specifically, the federally qualified health center in which the Loma Linda University (LLU) community pharmacy serves has a diabetes prevalence rate of about 16% (HRSA 2017). To decrease risk of diabetes complications, HbA1c is recommended to be \<7% in most patients; however, about 35% of the investigator's patient population have poorly controlled diabetes which is defined as HbA1c \>9% (ADA 2019). Given high prevalence rates of uncontrolled diabetes in this high-risk population, it is pivotal that individuals are provided with appropriate diabetes self-management strategies, regular monitoring, and preventative care by their primary care provider to adequately control the disease. Numerous studies illustrate that clinical pharmacists improve health outcomes for chronic disease managements with medication therapy management (MTM) services in underserved patients. Additionally, team-based or coordinated care with the community pharmacist and the patient's health care providers has also demonstrated to assist with improvements in clinic outcomes of chronic diseases. Recently, combination of blister packaging and MTM services have been shown to improve medication adherence and clinical endpoints. Given the high prevalence of diabetes in this community, there is a critical need to achieve improvement in clinical diabetes outcomes possibly via monthly blister packaging and MTM services including point-of-care testing (POCT).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age, any gender
* Hemoglobin A1c \>8.5%
* Taking total of ≥5 medications and taking ≥2 anti-diabetes medications

Exclusion Criteria:

* Unable to give informed consent
* Individuals included in Inland Empire Health Plan's Complex Care Program
Coronary Artery Plaque Burden in Stable Angina and Non-obstructive Coronary Artery Disease

Non-obstructive coronary artery disease (CAD), particularly common in women, has been associated with impaired quality of life and risk of recurrent hospitalizations. Several studies have also demonstrated increased risk of incident acute coronary events and mortality.

The main objective of the project is to assess the association between coronary artery plaque features by coronary CT angiography and long term prognosis in a large unselected population undergoing CT coronary angiography due to stable angina and suspected myocardial ischemia from the Norwegian Registry for Invasive Cardiology (NORIC) diagnosed with non-obstructive CAD by coronary CT angiography.

Patients with stable angina and non-obstructive coronary artery disease by CT coronary angiography will be selected from the Norwegian Registry of Invasive Cardiology (NORIC). This is a national quality control registry run and controlled by the Norwegian Institute of Public Health (www.fhi.no). All CT coronary angiograms will be reanalyzed using advanced post-processing analysis software to assess coronary artery plaque burden, distribution and composition. Through linking with the Norwegian Cardiovascular Disease Registry and the Cause of Death Registry (www.fhi.no) we will be able to assess the association between long-term prognosis (5 years) and coronary artery plaque features.

Eligibility Criteria:
Inclusion Criteria:

* Stable angina
* Non-obstructive coronary artery disease by CT coronary angiography defined as \<50% stenosis (lumen diameter reduction)

Exclusion Criteria:

* Obstructive coronary artery disease
* Unstable angina
* Previous myocardial infarction, heart surgery or percutaneous coronary interventions
Local Anesthesia for Pediatric Cochlear Implant

Propofol with remifentanil provides good operative conditions for pediatric cochlear implant (CI); however, large doses of remifentanil usually result in postoperative hyperalgesia and increase postoperative pain. Local anesthesia (LA) is commonly used as an adjunct to general anesthesia in children; however, otologists are usually reluctant in the use of LA as it can cause abolishment of the electrical stapedial reflex threshold (ESRT).

Seventy children (1-6 years) undergoing CI were recruited. Children were divided into two groups. The LA group received subcutaneous infiltration of 0.5 ml/kg lidocaine 1% in adrenaline 1:200,000 and the CT group received 0.5 ml/kg of Na CI 0.9% in adrenaline 1:200,000. The primary outcome was number of patients requiring rescue analgesia (tramadol) during the first 24-h postoperative. Secondary outcomes were haemodynamic variables, the ESRT, intraoperative anesthetic requirements, time to LMA removal, time to total recovery, pain scores, time to first rescue analgesia and incidence of vomiting.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II physical status,
* age between 1 and 6 year,

Exclusion Criteria:

* known allergy to local anesthetics,
* predicted operative difficulty (i.e. syndromic hearing loss, congenital cochlear abnormalities or cochlear ossification.
The Effects of Open Versus Closed Kinetic Chain Exercises on Ankle Joint Function

The goal of this Randomized clinical trial is to find the effects of open versus closed kinetic chain exercises on ankle joint function in athletes with chronic ankle instability. The main question it aims to answer is:

• To compare the effects of open versus closed kinetic chain exercises on pain, instability and balance in athletes with chronic ankle instability.

Participants were given consent form and after subjects read and signed the informed consent and completed the self-reported questionnaires designed to identify subjects with CHRONIC ANKLE INSTABILITY, subjects completed baseline measurements that included Foot and Ankle Ability Measure (FAAM)-Sport Subscale, Reach distance, and SEBT. Participant were divided into two groups (Group A and Group B) through lottery method. Group A received open kinetic exercises 3times a week for 3-4 weeks. Group B received close kinetic exercises 3 times a week for 3-4 weeks.

Chronic instability is a common condition in sports and there are many treatment methods and rehabilitation protocols available which are used according to extent of injury. The purpose of this study is to find out the effects of close kinetic chain exercises and open kinetic chain exercises and to find out which technique is more efficient for treating ankle instability, pain, and imbalance in athletes with chronic ankle instability. This study will help physical therapists and medical team to enhance the rehabilitation process.

The study was randomized clinical trial conducted at Pakistan Sports board Lahore in which convenient random sampling technique was used. This study included total 26 participants and for this purpose Open Epi tool would be used as a sample size calculation. Participants falling in this category were recruited into the study after inclusion and exclusion criteria. The Cumberland ankle instability tool was used as a tool for pre and post assessment of athletes. In this study we divided population into two groups. Group A received open chain kinetic exercises and Group B was treated with Closed chain kinetic exercises. Data was analyzed through SPSS 25 version.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 18-30years
* Tennis, Football, Cricketers, volley ball and Hockey players
* Athletes with balance problems
* Chronic ankle injuries

Exclusion Criteria:

* Acute injuries
* Non-athletes (minimum once a week sports participation)
* Athletes with pain related to calf muscles and achillies tendon
Impact of an Infusion Therapy Nursing Expert Service on Length of Stay and Clinical Results of Venous Access Devices

The purpose of this study is to determine whether an infusion therapy nursing expert service is effective in decreasing hospital length of stay, improving the clinical results of venous access devices and increasing patient satisfaction with venous access.


Eligibility Criteria:
Inclusion Criteria:

* Require an estimated long prescription of intravenous treatment. These treatments may be of fluid therapy, pharmacological, nutritional or hemotherapy.

  * Estimation of 7 days or more of continuous intravenous therapy.
  * Estimation of an intermittent intravenous therapy of less than a week, but on a monthly basis or less and a total estimated duration superior to 3 months.
* Be patient at Araba University Hospital

Exclusion Criteria:

* To have a central venous catheter indwelled
* MRSA (Methicillin Resistant Staphylococcus Aureus)
* Younger than 18 years old
Message Communicating Latest Data on COVID-19 Transmission in Patient's Area

This experiment is part of a megastudy with a total of ten experimental conditions and a holdout control condition to which patients will be randomly assigned. The focal comparison in this experiment is between a message encouraging vaccination by communicating to patients that they live in an area with significant COVID transmission and a control message telling patients that an updated COVID booster vaccine is waiting for them.


Eligibility Criteria:
Exclusion Criteria:

1. The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message
2. The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message.
Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Thoracic Cancer Surgeries

To evaluate the effectiveness of ultrasound guided Erector Spinae Plane Block (ESPB) in controlling post thoracotomy ipsilateral shoulder pain.

The aim of thoracotomy surgery is to explore the thoracic cavity and manage different pathologies including pulmonary, diaphragmatic, mediastinal, esophageal and vascular pathologies. It can be performed posterolaterally, anterolaterally or even anteriorly.

Post-thoracotomy Ipsilateral Shoulder Pain could undermine pain management in the post-thoracotomy patient.

Erector spinae plane block is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016. It is an inter-fascial plane block, but it may be classified as a paraspinal block due to its mechanism of action and injection site. It has been reported for a variety of indications, as in thoracic neuropathic pain and in postoperative analgesia after major open abdominal surgery. Erector spinae plane block has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2.

Ultrasound imaging made the practice of regional anesthesia easier in visualization and identification of usual and unusual position of nerves, blood vessels, needle during its passage through the tissues, as well as deposition and spread of local anesthetics in the desired plane and around the desired nerve.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status class I and II.
2. Age ≥ 18 and ≤ 60 Years.
3. Patients undergoing thoracic surgery e.g.: metastatectomy, lobectomy, pneumonectomy or pleuro-pneumonectomy.

Exclusion Criteria:

1. Patient refusal.
2. Local infection at the puncture site.
3. Coagulopathy with the international normalized ratio (INR) ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities and deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency \& therapeutic anticoagulants drugs).
4. Unstable cardiovascular disease.
5. History of psychiatric and cognitive disorders.
6. Patients allergic to medication used.
Bispectral Index (BIS) on Ventilated Patients in the Prehospital Setting

To evaluate the effectiveness of use of the bispectral index for monitoring of depth of sedation in ventilated patients during their prehospital management by a physician- staffed EMS. Hypothesis: there is a correlation between BIS and sedation scores.

The protocol compares BIS values to the RAMSAY score, which is the validated sedation scoring system in the prehospital setting.Ventilated patients receiving sedatives drugs can be included during primary prehospital interventions or interhospital transfers. During primary prehospital interventions, the protocol starts before endotracheal intubation. Depth of sedation is assessed every 5 minutes by the physician of EMS team. Blinded BIS monitoring is performed at the same time and recorded by the nurse at the end of out-of-hospital management. Data are analysed secondarily by the principal investigator.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18
* Ventilated patient

Exclusion criteria:

* None
Comparative Analysis of Heart Rate Variability in Patients with Cervical Pain, Lumbar Pain, and Healthy Controls

This is a cross-sectional study designed to evaluate potential differences in heart rate variability (HRV) indices based on the affected body region (cervical vs lumbar) in individuals with chronic pain. The study will compare HRV parameters between three groups: individuals with chronic neck pain (CNP), individuals with chronic low back pain (CLBP), and a control group without pain. HRV will be assessed using a Firstbeat Bodyguard® device over a 10-minute period, and the data will be analyzed with Kubios® HRV software. The study aims to determine whether autonomic nervous system modulation differs depending on the location of chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* - Adults aged between 18 and 65 years.

For the chronic low back pain group:

* Diagnosis of chronic neck or low back pain lasting at least three months.
* A minimum pain intensity of 3/10 on the Numerical Pain Rating Scale (NPRS).

For the healthy group:

* Absence of any chronic or acute pathology.
* No regular medication that could alter autonomic nervous system function.
* No episodes of low back pain in the past six months.

Exclusion Criteria:

* Presence of uncontrolled neurological or cardiac disorders.
* Use of medications that could influence autonomic function or pain perception (e.g., opioids, antidepressants, benzodiazepines, anti-inflammatory drugs, beta-blockers) within two weeks prior to the study.
* Body Mass Index (BMI) equal to or greater than 30 kg/m².