cyrilzakka/clinical-trials huggingface dataset:
Observational Study on the Application of High-Flow Therapy After Percutaneous Transfemoral Aortic Valve Replacement

Percutaneous catheter-assisted valve replacement in aortic position (TAVI) for patients with high perioperative risk has become a standard method in recent years. In addition to the detection of bleeding and cardiac rhythm complications, follow-up care is mainly focused on the monitoring of respiratory parameters after an operation under intubation anesthesia or deep analgosedation. In addition to normal oxygen therapy, non-invasive ventilation and, in case of weaning failure, renewed tracheal intubation in the first 24 h after TAVI have been considered. High flow oxygen therapy (HFOT) now provides a good opportunity to treat patients with a warmed and humidified air-oxygen mixture and to independently control the oxygen content in the inhaled air and the flow in the pharyngeal area.

The aim of the Study is to investigate the Change in oxygenation after high-flow oxygen therapy as a measure of weaning success in postinterventional patients after TAVI.


Eligibility Criteria:
Inclusion Criteria:

* High-flow oxygen therapy after TAVI

Exclusion Criteria:

* patients without consent
* age \< 18 years
An Investigation Into the Efficacy of Herpecin L at Reducing the Frequency and Severity of Cold Sores

Focus Consumer Healthcare has developed Herpecin L. Herpecin L combines many different ingredients hypothesized to promote quick healing and symptom reduction from cold sores.


Eligibility Criteria:
Inclusion Criteria:

* Male Female between 18-60 years of age.
* Must be in good health with no significant chronic conditions and a BMI under 35.
* Must experience regular cold sores or fever blisters
* Must agree to avoid daily lip balm or another product designed to alleviate their cold sore (e.g., Abreva or other over-the-counter cold sore products).

Exclusion Criteria:

* Suffers from pre-existing conditions that would prevent them from adhering to the protocol including chronic conditions such as oncological or psychiatric disorders.
* Anyone with known severe allergic reactions.
* Unwilling to follow the study protocol.
* Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.
Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT

The purpose of this study is to see if the investigators can prevent or reduce the severity of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin moisturizers are recommended to patients who receive Cetuximab treatment. In addition to these topical agents they will be given a pill to take once a day. This pill has already been shown to help fight rashes from Cetuximab.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older with underlying diagnosis of metastatic colorectal cancer or head and neck squamous cell carcinoma including newly diagnosed patient
* Patients must provide written informed consent to participate in the study
* Anticipated initiation of cetuximab treatment with or without additional chemotherapy.
* Able to self-administer topical interventions or provide for another person to apply the topical interventions

Exclusion Criteria:

* Females of childbearing potential who are pregnant or nursing
* Patients with allergy, hypersensitivity or other contraindication to dapsone, sulfa antibiotics, or excipients of the dapsone gel product
* Patients with pre-existing dermatologic condition affecting the face and chest that would impair assessment of papulopustular rash including dense and/or long facial hair (per investigator discretion)
* Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 ± 2 days through day 28 ± 2 days)
* Previous or concurrent radiation therapy to head, neck, and chest (i.e. application sites only)
* Previous therapy with cetuximab within 6 months of consent
Effectiveness of Adding Morphine to Intraosseous Vancomycin for Pain Control in Total Knee Arthroplasty

Study investigators propose to investigate if a bony injection of pain medication during a knee replacement will help pain levels following primary knee replacement surgery. To investigate this, 86 patients will be enrolled. Half of the patients will receive a bony injection of antibiotics with morphine (pain medication) while the other half will receive a bony injection of antibiotics with placebo (no pain medication). Following surgery, patient pain levels and pain medication consumption will be measured.

The injection is intraosseous meaning in the bone. The needle pierces the bone and the medication is injected into the bone. The site of injection is on the anterior (front) of the upper portion of the tibia. The medications are Vancomycin (antibiotic) and Morphine (pain medication) which are mixed in separate syringes and then injected. Intraosseous vancomycin is standard of care while intraosseous vancomycin with morphine is also standard of care, depending on operating surgeon.


Eligibility Criteria:
Inclusion Criteria:

1. 18-100 years old
2. Primary total knee arthroplasty
3. Participants must be able to consent for themselves
4. Capable and comfortable with text messaging

Exclusion Criteria:

1. Non-primary total knee arthroplasty
2. Intraoperative or postoperative deviation from standard of care
3. Post-traumatic surgical indication
4. Post-infectious surgical indication
5. Chronic narcotic use or history of narcotic addiction
6. Allergy to vancomycin
7. Allergy to morphine
8. Inability to receive spinal anesthesia
9. Inability to receive intraoperative adductor canal block
10. Inability to provide informed consent for the study
11. Inability to speak English fluently
EXPLORER PET/CT in Healthy Volunteers

The objective of this pilot study is to collect preliminary data using total body scans on a new, first of its kind, FDA 510k-cleared positron emission tomography/computed tomography (PET/CT) scanner, called EXPLORER.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18 years of age or older
* Willing and able to fast for at least 6 hours before and for the duration of the scan
* Willing and able to lay motionless in a supine position for 60 and 20 minutes at separate timepoints.
* Willing and able to give informed consent

Exclusion Criteria:

* No Primary Care Physician
* Body weight \>240 kg
* Allergy to iodine contrast (only for subjects enrolled in Arm 3)
* Creatinine levels \> 1.5 mg/dL or estimated glomerular filtration rate (eGFR) \< 60 ml/minute (only for subjects enrolled in Arm 3)
* Recent (1 month) contrast enhanced CT
* Any known concomitant acute infection (including upper respiratory infection, genitourinary infections, etc.
* History of metastatic or newly (last 5 years) diagnosed locally invasive cancer.
* Chemotherapy in the last 5 years
* Radiation therapy in the last 3 years
* Major surgery within the last 6 months.
* Pregnancy or breast-feeding
* Diabetes
* Fasting blood glucose level \> 160 mg/dL before administration of FDG
* Prisoners
* The standard MRI contraindications apply, including but not limited to:

Having a pacemaker or other implanted electronic device. Metal foreign bodies, aneurysm clips, heart valve prosthesis, vascular stents, cochlear implants, embolization coils, gunshot wounds with retained bullet fragments, penile implant, IUCD.

Claustrophobia
Clinical Trial to Evaluate the Efficacy and Safety of DP-R212

The purpose of this study is to determine superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Both man and woman who is over 19 years old
* Hypertension patient with hypercholesterolemia

Exclusion Criteria:

* sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg
* A history of cardiovascular disease
* rhabdomyolysis, myopathy
* Hypertension or hypercholesterolemia due to secondary causes
* Uncontrolled diabetes
* Evidence of hepatic or renal disease
The Impact of Non-pulsatile Blood Flow on CO2-Reactivity

The investigators hypothezised that CO2-reactivity of cerebral vessels is affected by systemic non-pulsatile blood flow. Patients undergoing elective cardiac surgery with CPB were enrolled in this prospective case control study. Blood flow velocity in the middle cerebral artery as well as regional cerebral oxygenation was determined during step changes of PaCO2 between 30, 40, and 50 mmHg. Measurements were conducted intraoperatively during non-pulsatile as well as postoperatively after admission to the ICU under pulsatile blood flow.


Eligibility Criteria:
Inclusion Criteria:

* undergoing elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Carotid artery stenosis (\> 50%)
* Neurological pathologies
* COPD with CO2 retention
* Women of childbearing age
Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy

The purpose of this study is to determine whether the hospitalized patients with increased waist circumference exhibit cardiorespiratory alterations after chest physical therapy.

The physiotherapist assessment will consist of anthropometry (body mass index, abdominal circumference, adipometer); chest inspection and palpation, vital signs (blood pressure, heart rate, respiratory frequence, oxymetry), dyspnea index and capillar blood glucose; and later with pulmonary tests (thoracoabdominal perimetry, respiratory muscle strength and pulmonary volume and capacity). This will be a quasi-experimental study. Patients will be divided into four groups according to waist circumference (increased or not, with respect to cardiovascular risk) and respiratory disorders (obstructive and restrictive). After this assessment, chest physical therapy will begin according to the protocol for obstructive and restrictive respiratory disorders. The treatment will have an average duration of 30 minutes. At the end of treatment (single session) the patient will be assessed again after five and thirty minutes.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (\> 18 years old), clinical stability characterized by axillary body temperature below 38 ° C, hemoglobin higher than 7 g / dL, oxygen saturation by pulse oximetry greater than or equal to 88%, mean arterial pressure (MAP) greater than 70 or less than 120 mm Hg, heart rate between 50 bpm to 140 bpm ; ability to understand, carry out the commands appropriately for evaluative tests, with the Glasgow Coma Scale score greater than 8, locomotor integrity of the lower limbs, spontaneous breathing, lack of hospital physiotherapy during hospitalization, prescription for respiratory therapy; bronchodilator, if applicable four hours before intervention.

Exclusion Criteria:

* inadequate perform to the maneuvers of the evaluation (e.g. spirometry), hemodynamic instability, thoracic dermal injury, disabling orthopedic complications that compromise the techniques of assessment and intervention, lymphedema of the trunk; sudden weight gain with edema in limbs, ascites, nephrotic syndrome, congestive heart failure, liver cirrhosis, erysipelas, deep vein thrombosis, heart bypass, heart transplantation, arrhythmias, atrioventricular block, severe dyspnea (Borg\> 5), spinal cord injury, hemoptysis, osteoporosis, recent surgeries, coagulopathy, bronchopleural fistula, subcutaneous emphysema, presence of diabetes mellitus associated with cardiac autonomic dysfunction, bronchoconstriction.
Phase III Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects of either sex and any race 18 years or older with open-angle glaucoma or ocular hypertension. Patients with logMAR visual acuity not worse than 0.6 in either eye or any clinically relevant ophthalmic/systemic condition will be excluded.

Exclusion Criteria:

* See Inclusion Criteria
Topical Phytoterpenes for Plantar Fasciitis

Randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary, clove, pepper, in a formulation with skin permeation enhancers including limonene for the treatment of plantar fasciitis in adult men and women. Forty-two patients will be randomized to receive twice daily topical application of the treatment formulation or plain tea tree oil as a control. Analog pain scores will be assessed at the start of treatment and at two weeks. Analysis will be by student's T-test.

Randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary, clove, pepper, in a formulation with skin permeation enhancers including limonene for the treatment of plantar fasciitis in adult men and women. Forty-two patients will be randomized to receive twice daily topical application of the treatment formulation or plain tea tree oil as a control. Analog pain scores will be assessed at the start of treatment and at two weeks. Analysis will be by student's T-test. Primary outcome measure will be the difference in pain score between baseline score and pain score at 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Plantar fasciitis diagnosed by a medical practitioner and at least 3 months in duration

Exclusion Criteria:

* Age under 18 years, any history of diabetes, history of foot surgery
Probiotics at the Treatment of Antibiotic Associated Diarrhea

The purpose of this study is to know the efficacy of the treatment with probiotics, Lactobacillus casei and Bifidobacterium breve, on clinical evidences and occurence of relapses on antibiotic-associated diarrhea.

The Antibiotic-Associated Diarrhea (AAD)is defined as that developed after the started antibiotic therapy ou until six to eight weeks after the end of the treatment. The occurence of AAD is about 5% to 25% of the patients using antibiotics and cause watery diarrhea, fever and vomit, mainly on pseudomembranous colitis. Several studies had demonstrated the use of probiotics as therapeutic or preventive form of AAD with or without the presence of C. difficile. About the tolerance of the probiotics,there weren´t observed deleterious effects on health with the consumption of 106 - 107 UFC of Lactobacillus spp and Bifidobacterium spp during a period of one year. The realization of this study can demonstrate the efficacy of Lactobacillus casei e Bifidobacterium breve at the treatment of AAD.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with diarrhea using antibiotic during, at least, 24 hours or had used antibiotic 07 days prior to study entry.

Exclusion Criteria:

* Patients with chronic diarrhea, viral diarrhea, critical patients, during or after radio or chemiotherapy treatment,
* HIV infections,
* Ulcerative colitis,
* Crohn´s disease,
* Hydroelectrolytic disturbance,
* Small intestine syndrome,
* Colostomized, jejunostomized
* Lactose intolerance,
* Rapid enteral diet infusion (\>120mh/h),
* Hyperosmolar enteral diet.
Postoperative Analgesia Intervention With Non-opioid Alternatives (PAIN-Alt) Trial - Breast Surgery

North America is experiencing a crisis of opioid use and abuse, partially caused by excessive prescribing by doctors. People often receive their first opioid prescription for pain treatment after outpatient breast surgery (i.e., surgery to remove all or parts of the breast(s), where patients leave the hospital the same day). Many patients misuse these drugs and become addicted. Additionally, many of the opioid pills prescribed to patients are left unused and may be misused by family members, friends, or other community members. To prevent this problem, surgeons can avoid prescribing opioids by prioritizing opioid-free analgesia (i.e., pain treatment using only non-opioid interventions). Prescribing only non-opioid pain medications after surgery is very common in many countries outside of North America; however, few studies have assessed whether opioid-free analgesia is as effective as opioid analgesia after breast surgery. Therefore, the main question driving this study is: For patients who undergo outpatient breast surgery, is pain treatment without opioids as good as pain treatment with opioids?

The proposed trial will compare two groups of patients: one group will receive opioids to treat pain after surgery, while the other group will receive only non-opioid medications. The impact of these different medication strategies will be measured on pain intensity, pain interference with daily activities, medication side effects, and other outcomes. An expert team of scientists, surgeons, pain specialists, nurses, and patients has been assembled to maximize the success of this study. The results will provide important information to guide surgeons' decisions to prescribe (or not to prescribe) opioids. If opioid-free analgesia is found to be effective, doctors may be able to substantially reduce opioid prescribing after breast surgery and prevent more people from misusing opioids.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing mastectomy (i.e., total, modified radical, radical, or skin/nipple sparing) or lumpectomy (i.e., excisional biopsy, partial or segmental mastectomy, oncoplastic breast-conserving surgery) for malignant (cancer) and non-malignant diseases (i.e., ductal carcinoma in situ)
* Planned discharge on the day of the operation.

Exclusion Criteria:

* Immediate breast reconstruction, i.e., implant, tissue-expander, or autologous/flap-based (often leads to higher levels of pain and analgesia requirements)
* Contraindications to the drugs used in the trial in accordance with Health Canada Monographs (i.e., opioid use disorder, pregnancy, breastfeeding, heart failure, allergy/hypersensitivity, peptic ulcer, bleeding disorders, renal or liver impairment)
* Taking opioids preoperatively
* Cognitive impairment precluding patient-reported outcome assessment
* Need for postoperative hospitalization decided before randomization (i.e., same-day discharge cancelled for medical \[e.g., intra-operative complications\] or non-medical reasons \[e.g., lack of support at home\]).
The Effect of Web-Based Breast Self-Examination Education

Breast cancer is the most common type of cancer among women. Reasons such as diagnosing breast cancer at an early stage increases the chances of treatment and survival, and the fact that the masses are largely noticed by the individual themselves, point to the importance of breast self-examination (BSE) . BSE skill is among the nursing skills. When the literature was examined, it was seen that the web-based education method was frequently used for cognitive skills during nursing education, but its use was limited for psychomotor skills training. It was determined that in BSE training, in addition to traditional education, methods such as concept maps and peer-supported education were used, but web-based education methods were not used. It is thought that the study will contribute to the literature in these aspects.

Due to the recent pandemic, nursing education, like other universities, was conducted web-based. Skills training in nursing, which is an applied education, has also been tried to be provided on a web-based basis. It is stated that the positive attitude towards e-learning increases the quality of education and student success. Additionally, with e-learning, the learner assumes individual learning responsibility. On the other hand, lack of motivation, attention, communication and interaction are the disadvantages of e-learning . Breast cancer is the most common type of cancer among women. Reasons such as diagnosing breast cancer at an early stage increases the chances of treatment and survival, and the fact that the masses are largely noticed by the individual themselves, point to the importance of breast self-examination (BSE). BSE skill is among the nursing skills. When the literature was examined, it was seen that the web-based education method was frequently used for cognitive skills during nursing education, but its use was limited for psychomotor skills training. It was determined that in BSE training, in addition to traditional education, methods such as concept maps and peer-supported education were used, but web-based education methods were not used. It is thought that the study will contribute to the literature in these aspects.

Hypotheses of the study;

H1: The BSE knowledge test score of the intervention group after the intervention is higher than the control group.

H2: BSE skill score of the intervention group is higher than the control group. H3: After the intervention, the intervention group's attitude towards web-based education is higher than the control group.

H4: After the intervention, the self-directed learning skills of the intervention group are higher than the control group.

H5: The initiative group's attitude towards web-based education increases after the initiative.

H6: Self-directed learning skills of the initiative group increase after the initiative.

Eligibility Criteria:
Inclusion Criteria:

- Being enrolled in the Surgical Nursing course (breast self-examination education is given for the first time within the scope of this course)

Exclusion Criteria:

- Having received breast self-examination education before
Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery

The purpose of this study is to determine whether preload of carbohydrate or water before elective hip replacement improve insulin sensitivity and or beta cell function in human.


Eligibility Criteria:
Inclusion Criteria:

* Elective hip replacement

Exclusion Criteria:

* Known diabetes mellitus
* Kidney failure (creatinine clearance \<40 ml/min
* Liver failure (aspartate and alanine aminotransferases x 2 above reference)
* Hb \<110 g/l
* Ongoing severe bacterial or viral infection
* Malignancies
* Psychiatric disease