cyrilzakka/clinical-trials huggingface dataset:
Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors

Percutaneus radiofrequency ablation (RFA) of liver tumors causes acute pain during the periooperative setting. In order to facilitate tumor access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious.

This study aims to assess the impact of a single shot thoracic paravertebral block (TPVB) on a patient's haemodynamic stability, patient's and operator's comfort and satisfaction during the operation and analgesia in the post-operative period.

High temperatures used during the percutaneus radiofrequency ablation (PRFA) of liver tumors can cause acute pain in the perioperative setting. In order to facilitate tumor exposure and access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious. It is mandatory to provide an adequate acute postoperative pain control for our patients.

This prospective randomized, single center study was approved by the Bioethics Committee at the University of Warmia and Mazury in Olsztyn, (Poland) under the resolution No. 46/2017.

Eligibility Criteria:
Inclusion Criteria:

* patients with primary liver tumor (HCC)
* patient scheduled for an elective surgery
* tumor diameter) \<5 cm two tumors \<3cm
* Age \>18 years
* Physical State 1,2 or 3 of the American Society of Anesthesiology (ASA)

Exclusion Criteria:

* ASA IV and V
* Thrombocytopenia (\<40x10 \^ 9 / L)
* Severe cirrhosis (Child-Pugh C classification)
* History of psychiatric/cognitive disease
* Patients who do not give informed consent
* Patients with contraindications or history of hypersensitivity to local anaesthesia drugs
* History of chronic pain, chronic opioid use (\> 3 months)
Educational Intervention Among Informal Caregivers of Person With Dementia

The goal of this intervention study is to test whether the educational intervention work well or not on informal caregiver of person with dementia. The main question it aims to answer is does the educational intervention will help to reduce the caregiver burden experience by the informal caregiver.

Participants will be given an educational module and short videos that they can refer to gain more knowledge and skills in caring for the person with dementia.

Caregivers for this study will be recruited at the geriatric, neurology and, psychiatry outpatient clinic. The caregiver will be approached by the primary researcher and explained about the details of the study. The caregivers will be given the participant information sheet and if they agree to participate in the study, written informed consent will be obtained.

The researcher will then check the eligibility of the caregiver to participate. If the caregiver was eligible to participate, they will be ask to provide contact details for researcher to assign tentative date for the virtual educational session. The caregiver will be then randomly assigned to control or intervention group before the baseline data were collected. This study will use equal allocation with a ratio of one to one for each two groups. The caregiver will be randomly allocated by using permuted block randomization technique. This study will be conducted as single blind study. Only the respondents would be blinded and concealed from the group allocation.

The intervention group will be given the educational intervention which are educational module and short videos related to dementia care. After the baseline data collection, the soft copy of the educational module will be shared to the participants via WhatsApp messenger so that they can review the module before the virtual educational session. One short educational video will be then shared to all the participants through individual WhatsApp in each Wednesday of the week for 12 weeks. Each of the short video will contain subtopics of the educational module and each video will be around two to three minutes. After the video shared to the participants, they are encouraged to ask any questions related to the content of the video.

Eligibility Criteria:
Inclusion Criteria:

1. Informal caregiver of person with dementia (children, children in law, grandchildren, grandchildren in law, spouses, siblings, parents).
2. Age 18 years old and above.
3. Able to understand, read and speak Bahasa Malaysia language

Exclusion Criteria:

1. Caregiver with previous history of mental illness.
2. Caregiver with physical disabilities that cause limitation in providing care for person with dementia.
3. Paid informal caregiver (maid).
Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis

The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).

To investigate as primary objective:

* Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion;

To investigate as secondary objective:

* Superiority to LAS106521
* Improvement of treated lesions (lesion response)
* Assessment of tolerability and safety by physicians global assessment score (PGA, PGT)
* Patient's assessment of tolerability and efficacy and patient's compliance

Eligibility Criteria:
Main Inclusion Criteria:

* Have at least 4 but not more than 10 clinically confirmed AK target lesions of mild to moderate intensity within the face/forehead or bald scalp (excluding eyelids, lips, and mucosa), i.e. actinic keratosis grade I and II according to Olsen EA et al. 1991
* Woman of childbearing potential are allowed to participate in this study only if they use a highly effective method of contraception

Main Exclusion Criteria:

* Have received effective treatment of AK in the three months preceding this clinical trial
* Have known hypersensitivity to LAS41005 or LAS106521
* Have currently other malignant or benign tumors of the skin within the treatment area (e.g. malignant melanoma, basal cell carcinoma, squamous cell carcinoma)
* Patient's taking phenytoin
* Show cornu cutaneum like alterations of the skin in the face or the bald scalp (target area)
Validation of Patient Reported Outcome Measures for Use in Vulvodynia

The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with Vulvodynia


Eligibility Criteria:
Inclusion Criteria:

* Fluent in understanding, speaking and reading US-English
* Have vulvodynia with pain for at least 6 months

Exclusion Criteria:

* Clinically significant history of alcohol/drug abuse or dependence within the last 2 years
Selection of Shock Energy in Out-Of-Hospital Cardiac Arrest

Sudden cardiac death is the most frequent cause of death in industrialized countries. The most efficient interventiont in ventricular fibrillation is defibrillation in an appropriate timely manner. But since the intervention of defibrillation the optimal shock energy is unknown. As a too low energy is not able to terminate ventricular fibrillation a too high energy may cause asystole wich jeopardizes survival itself. We study the efficacy of different shock energies on the termination of ventricular fibrillatiion and survival.


Eligibility Criteria:
Inclusion Criteria:

* out of hospital sudden cardiac death
* ventricular fibrillation

Exclusion Criteria:

* non cardiac death
* asystole
Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

An equivalent parallel randomized clinical trial was approved by the local University Committee of Ethics. 260 children with necrotic primary molars were allocated into 2 equal groups (82 children per group). The participants were allocated into two groups; group "1" teeth were instrumented with OneShape rotary system (Micro Mega, Besancon, France), and group "2" teeth were instrumented with WaveOne Gold reciprocating system (Dentsply Maillefer, Ballaigues, Switzerland). Postoperative pain was assessed using a four-point pain intensity rating scale adopted from Wong-Baker FACES (WBF) pain scale . The face scale consists of four faces with a brief title describing each face representing a scale from the first face (score 1), second face (score 2), third face (score 3), and forth face (score 4) 3. Postoperative pain was assessed at 6 six time intervals (at 6, 12, 24, 48, 72 hours and one-week).


Eligibility Criteria:
Inclusion Criteria:

1. Children ages from 4 to 8 years classified as class I or II according to the American Society of Anesthesiologists (ASA).
2. No previous dental experience.
3. Non-vital primary molar (necrotic or with chronic apical periodontitis) which confirmed radiographicly with the presence or absence of periapical radiolucency.
4. Severe tooth mobility.

Exclusion Criteria:

1. Severe behaviour or emotional disabilities.
2. Analgesic intake in the preceding 12 hours.
3. Non-restorable crowns of primary molars.
4. Radiographic presence of internal root resorption or massive bone destruction.
5. Root resorption exceeded one-third of the root length.

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Efficacy of Azithromycin Plus Doxycycline Versus Doxycycline Plus Placebo in Patients With Rocky Mountain Spotted Fever

The aim of this study is to impove the pharmacological treatment of Rocky mountain spotted fever, since is a very ancient disease with an antibiotic therapy that have not changed much the mortality rates, being compared with the natural curse of the disease.

Rocky mountain spotted fever is a potentially fatal infectious disease wich is transmitted trough vectors. This particular infection is caused by Rickettsia rickettsii wich is a gramnegative intracellular bacilli. The pathophysiological mechanism and clinical manifestation is mainly due to the vascular affectation, since this pathogen has a tropism for endothelial cells. As it has been mentioned, this is an obligate intracellular pathogen, so the main choice with the antibiotic therapy is tetracyclines because of its action mechanism in the inhibition of the subunit 30S. The objective of the study is to prove new strategies of treatment to improve the pharmacological aproach by implementing Azithromycin, wich is a macrolide that inhibits de 50S subunit of the bacteria. Azithromycin has shown effectivity against other rickettsial diseases.

Eligibility Criteria:
Inclusion Criteria:

* Any gender
* Over 18 years old
* hospitalized in the internal medicine service, emergency department or intensive care unit of Hospital General de Mexicali (ISESALUD) or Hospital General Zona No. 30 (IMSS) with suspicion of RMSF that present fever and 2 or more of the next symptoms: headache, myalgia, rash, nausea, pharyngeal hyperemia, vomiting, abdominal pain, neurological disorders.
* In addition to at least one of the next epidemiologycal fators: presence of vectors in areas of residence or endemic areas visited two weeks prior to the onset of symptoms, history of visiting or residing in areas with RMSF transmission in the last two weeks, existence of confirmed cases in the locality of origin, history of vector bite or contact with dogs in the two weeks.

Exclusion Criteria:

* Other clinical suspicion rather than RMSF
* History of allergy to doxycycline, azithromycin, bean starch or bovine gelatin.
* Not signing the informed consent
* Pregnancy.
A Motivational Enhancement Approach to Skin Cancer Prevention

The specific aims of this research are:

Aim 1 - To describe the UV protection behaviors and beliefs of young adult patients in a dermatology clinic.

Aim 2 - To examine whether or not the UV protection behaviors and beliefs of young adult dermatology patients are associated with age, gender, level of education, marital status, contact with skin cancer, time outdoors, skin type, the reason for their visit, and the date of data collection.

Aim 3 - To test the efficacy of a motivational enhancement approach to UV protection counseling for young adult dermatology patients, as manifested by favorable changes in UV protection stages of change, UV protection self-efficacy, and UV protection attitudes.

Although skin cancer is the most common form of cancer in the United States, it is highly preventable by reducing exposure to ultraviolet (UV) radiation. However, recent primary prevention efforts have been inadequate in evoking behavior change, as manifested by increasing rates of ultraviolet radiation exposure, particularly among young adults. These findings indicate the need to research novel approaches to skin cancer prevention.

Motivational enhancement techniques facilitate patient-centered, directive discussions wherein practitioners provide clear structure and encourage patients to play an active role in the consultation. The use of motivational enhancement techniques for health behavior change in medical settings has thus far yielded encouraging results for other health behavior change topics, but research has not yet investigated the application of these techniques to skin cancer prevention discussions.

Eligibility Criteria:
Inclusion Criteria:

* Dermatology patient presenting for scheduled appointment
* 18-30 years old

Exclusion Criteria:

* Seeking treatment for sunburn
* Unable to read and understand English
* Having previously received medical treatment from the interventionist
Low-Level Laser Therapy and Flapless Corticopuncture Effect on Accelerating Six Maxillary Anterior Teeth Retraction

The long time needed for orthodontic treatment is considered one of the biggest obstacles that make patients refuse to undergo orthodontic treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. Therefore, the purpose of this study is to evaluate the efficiency of two new noninvasive methods (Low-Level Laser Therapy and Corticopuncture) in accelerating orthodontic tooth movement for the implant supported En-Masse retraction of the six maxillary anterior teeth.

This study will be a randomized controlled trial with a 1:1:1 allocation ratio. Sample size was calculated using Minitab version 15. 36 Participants recruited from patients attending the Department of Orthodontics and Dentofacial Orthopedics at Damascus University with class II division 1 malocclusion that indicates the extraction of first maxillary premolars will be randomly assigned into one of three groups: Low-Level Laser Therapy (LLLT) group, flapless corticopuncture group, or control group. Titanium mini-implants (1.6 mm diameter and 7 mm length) will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm height above the archwires below the mucogingival junction. After complete leveling and alignment of the maxillary dental arch, which will be defined by passive insertion of 19\*25 inch S.S. archwire, the retraction stage of the six maxillary anterior teeth will begin.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age between (18 - 24) years.
2. Class II Division 1 malocclusion that indicates extraction of two maxillary first premolars with the following parameters:

   ANB: 5 to 10 degrees. Overjet: 5 to 10 mm. Growth Pattern: normal or slightly vertical.
3. All upper teeth are existed (Except for third molars).
4. Mild to moderate crowding (3 mm or less).
5. Patient dose not undergo any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, ...).
6. Good oral hygiene (Plaque index \< 1).

Exclusion Criteria:

1. Any medical condition affecting orthodontic tooth movement.
2. Poor oral hygiene (Plaque index \> 1).
3. Patient did not undergo previous orthodontic treatment.
4. Patient lack of commitment toward follow-up appointments.
Effect of Intratracheal Dexmedetomidine Administration on Recovery From General Anesthesia in Pediatrics Undergoing Lower Abdominal Surgery:

The incidence of intratracheal tube-induced laryngeal irritation, including coughing, bucking, and cardiovascular stimulation, on emergence from general anesthesia has been reported to occur in 38% and 96% of cases. This may cause agitation and unstable hemodynamics during anesthesia recovery, and can lead to complications, such as laryngeal edema, sore throat, increased intra-abdominal pressure, and anastomotic bleeding. Accordingly, many anesthesiologists have been seeking methods through which such laryngeal irritation can be attenuated, thus allowing for a smoother extubation. Furthermore, it has contributed to the aggravation of cough reflexes.

Several strategies have been reported to facilitate smoother extubation, such as intravenous lidocaine, remifentanil, and dexmedetomidine. Dexmedetomidine is a potent, alpha-2-selective adrenoceptor agonist that causes sympatholytic, sedation and analgesia without respiratory compromise. The sedative properties of dexmedetomidine are largely due to effects on the locus ceruleus, producing a level of consciousness mimicking natural sleep Delivering dexmedetomidine intravenously to attenuate airway and circulatory reflexes during extubation has been extensively evaluated in clinical studies. Recent studies have also indicated that the intranasal application of dexmedetomidine is significantly useful and effective in the achievement of improved sedation and analgesia) and offers a safety profile similar to traditional sedatives ( ketamine and midazolam). Additionally, intratracheal local anesthetic instillation has been reported to be effective in preventing laryngeal reflexes. However, both the efficacy and safety profile of intratracheal dexmedetomidine applications are largely unknown and the technique has not been specifically investigated.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status classification I-II.
* Scheduled for lower abdominal surgeries e.g. congenital hernia repair and correction of penile hypospadias under general anesthesia (GA).

Exclusion Criteria:

* Younger than 1 year and older than 6 years of age,
* ASA score of III to IV.
* Parental refusal
* Allergy or contraindication to studied medication or anesthetic agents
* Patients with respiratory disease, heart disorders which might represent risk factors of potential complications of Dexmedetomidine such as bradycardia, hepatic or renal insufficiency.
Dyadic Yoga Intervention for the Improvement of Healthcare Utilization and Quality of Life in Patients With Head and Neck Cancer Undergoing Chemoradiation and Their Caregivers

This study evaluates if partner-based (dyadic) yoga programs may improve the quality of life of patients with head and neck cancer undergoing chemoradiation and their caregivers, and if it is a cost-effective option. Yoga programs may decrease how often patients come to the hospital during and after treatment with chemoradiation, and improve the quality of life for both patients and caregivers.

PRIMARY OBJECTIVES:

I. Examine the efficacy of the dyadic yoga (DY) intervention regarding reduced patient emergency department (ED) visits and feeding tube (FT) insertions and improved patient and caregiver quality of life (QOL) as compared to the usual care (UC) group.

II. Estimate intervention costs, direct medical costs, indirect costs (i.e., productivity loss), and evaluate the overall cost-effectiveness of the DY intervention for patients and caregivers.

III. Demonstrate that, compared to the UC group, the DY program improves patient and caregiver symptoms burden, objective physical function, and illness communication and reduces patient use of opioids during chemoradiotherapy (CRT), which will in turn mediate intervention outcomes at the follow-up assessments.

IV. Understand the patient and caregiver experience of head and neck cancer (HNC), healthcare utilization and symptom management and emerging themes as possible mediators as they relate to or suggest modifications of our proposed model using qualitative methods.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Patients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during CRT. Psychiatry, social work, interventional radiology and supportive care services are consulted as needed.

ARM II: Patients and caregivers receive standard care as in arm I. Patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions.

After completion of study, participants are followed up every 2 weeks for 3 months and then monthly for up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTS: Diagnosed with a primary HNC and going to receive at least 5 weeks (25 fractions) of CRT
* PATIENTS: Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* PATIENTS: Having a family caregiver (e.g., spouse/partner, sibling, adult child) willing to participate
* PATIENTS AND CAREGIVERS: Must be at least 18 years old
* PATIENTS AND CAREGIVERS: Able to read and speak English
* PATIENTS AND CAREGIVERS: Able to provide informed consent

Exclusion Criteria:

* PATIENTS AND CAREGIVERS: Who have regularly (self-defined) participated in a yoga program in the year prior to diagnosis
Vitamin D Replacement After Kidney Transplant

Vitamin D deficiency accelerates vascular risk progression after kidney transplant.

This trial will assess the following aims:

1. Time to plateau vitamin D concentrations after initiating vitamin D supplements
2. Safety of vitamin D replacement based on serum and urine calcium
3. Effect of vitamin D on PTH concentration in individuals with elevated parathyroid hormone
4. Effect of vitamin D on markers of insulin resistance and inflammation

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant more than 6 months ago
* 19 years or older
* 25-hydroxy vitamin D ≤35 ng/ml

Exclusion Criteria:

* Estimated Glomerular filtration rate (GFR) \<30 ml/min/1.73m²
* Previous small bowel or lung transplant
* Pancreas transplant less than 6 months ago
* Cancer or any condition that would change their weight dramatically in the near future such as malabsorption
* Willing to return for testing every two months
* Women who are pregnant or \< 6 weeks postpartum
* Calcium \> 10.5 mg/dl
* Phosphate \> 4.8 mg/dl
* Drinking more than 2 alcohol drinks a day or 14 drinks per week
* History of parathyroid surgery
* Known granulomatous disease
* Taking any seizure medication that affects vitamin D
* Taking Zemplar ® and/or Rocaltrol ®
* History of kidney stones in the past 20 years
* Not on a stable dose of bisphosphonate for the past three months
* Planning on a pancreas transplant within the next year
* In any other research study