cyrilzakka/clinical-trials huggingface dataset:
Does Local Cooling of Testis in Patients With Epididymitis Relieve Pain and Reduce Quantity of Analgetics Intake?

The investigators propose to examine the effect of local cooling of testis in participants with acute epididymitis or orchiepididymitis on participants reported pain level and analgetics consumption.

Epididymitis or orchiepididymitis is an acute disease causing pain and discomfort.

our hypothesis is that local cooling of the affected testis or epididymis may relieve the pain and reduce the analgetics consumption In order to examine this hypothesis we will recruit adult patients with epididymitis or orchiepididymitis and will randomize these patients to two arms.

One arm will receive every 8 hours a brick cooled for at least 2 hours in -20(celsius) for local use on the affected hemiscrotum, while the second arm will receive a brick in room temperature.

Pain level will be estimated one hour following the application of the brick using visual analogue pain score. Patient will receive analgetics according to a predefined escalating protocol.

Pain level and analgetics consumption will be compared between the two arms.

Eligibility Criteria:
Inclusion Criteria:

* Male patients 18-99 years
* Acute epididymitis or acute orchiepididymitis

Exclusion Criteria:

* Patient unable to informed consent
* Suspicion of testicular malignancy
Transforming Diabetes Care: Pharmacist-Led Education and Its Impact on Patient Knowledge, Self-Management, and Health Outcomes

This interventional study is to evaluate the impact of pharmacist-led education on diabetic patients' knowledge, self-management, and overall health outcomes. Participants in this study will attend pharmacist-led educational sessions designed to improve their understanding of diabetes and self-care practices. Researchers will assess changes in patients' knowledge, self-management behaviors, and clinical health markers before and after the intervention. The study will compare pre- and post-intervention results to determine the effectiveness of pharmacist-led education in transforming diabetes care.

The purpose of this study is to investigate whether pharmacist-led education can enhance the knowledge, self-management behaviors, and health outcomes of diabetic patients. Effective diabetes management requires a comprehensive understanding of the disease, adherence to lifestyle modifications, and consistent monitoring of health indicators. Poor knowledge and suboptimal self-care can lead to inadequate glycemic control, complications, and reduced quality of life. This study will evaluate the impact of pharmacist-led educational interventions on patients' motivation, diabetes-related knowledge, and self-care behaviors, as well as their effects on clinical outcomes, including improved HbA1c levels, reduced hypo- and hyperglycemic episodes, and enhanced patient satisfaction. By addressing these critical aspects, the study aims to highlight the transformative role of pharmacist-led education in advancing diabetes care and fostering sustainable, patient-centered healthcare practices.

Eligibility Criteria:
Inclusion Criteria:

* We will include all confirmed diabetic patients who visit the SIH endocrinology OPD Clinic during the study duration.

  * Both male and female patients visiting the Endocrinology Unit of the hospital will be eligible.
  * Patients with HbA1c levels greater than 8% will be included.
  * Both follow-up and newly diagnosed patients will be considered.
  * Patients who sign the informed consent form will be enrolled in the study.

Exclusion Criteria:

* We will exclude patients with gestational diabetes mellitus (GDM).

  * Patients with central obesity will not be included in the study.
  * Type 1 diabetes mellitus (DM) patients under the age of 20 will be excluded.
  * Patients with inadequate medical history will be excluded from participation.
  * Patients with HbA1c levels less than 8% will not be included.
  * Patients who do not provide informed consent or express a lack of interest in the study will be excluded.
PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

The overall design of the study is to perform both a PET and MRI scan on objectively identified borderline personality disorder patients, to treat them with olanzapine for 8 weeks, and to then re-scan the patients with PET.

The primary objective of this proposed study will be to compare the baseline PET scan to the endpoint scan in 15 BPD patients who have been treated with olanzapine. The comparison of the scans will be done through a statistical image analysis, using a pixel-by-pixel group mean subtraction strategy with appropriate correction for multiple comparisons. In an exploratory fashion we will compare frontal and temporal regions of interest to address hypotheses of which areas of the brain might show changes with olanzapine treatment.

A secondary objective is to use a normal database to compare the baseline PET scan of the 15 patients in a medication free state to normal subjects. The advantage of this strategy is the ability to closely match subjects by gender and age. As noted earlier, Dr. Pardo has data on 35 control subjects studied on the same scanner we plan to use for this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-45 years
2. Diagnosis: borderline personality disorder by DSM-IV criteria
3. Gender: Female
4. May have history of substance use and other Axis II disorders

Exclusion Criteria:

1. Axis I diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder during the subject's lifetime. No current major depression or PTSD.
2. Treatment with psychotropic medication in the previous month.
3. Medical disorder that would influence outcome of the study - e.g. epilepsy, thyroid disease, HIV, etc.
4. Medical disorder that would not allow use of olanzapine
5. Active substance abuse or dependence
6. Previous adverse reaction to olanzapine
7. Females whom are pregnant or nursing
Effect of Music on Patients in Intensive Care Units

The purpose of this study is to investigate the effects of patient-preferred music, relaxation music, and standard care environment on patients in intensive care units.

This study is a prospective randomized clinical trial. The purpose of this 4-stage study is to explore the effects of patient-preferred music, relaxation music, and standard care environment on patients in intensive care units.

Stage 1: Recommendation of relaxation music by music therapists who serves as expert panel

Stage 2: Analysis of recommended relaxation music by music therapists

Stage 3: Content validation of relaxation music by healthy adults

Stage 4: Comparison of patients' physiological, psychological, and biological responses to patient-preferred music, relaxation music, and standard care environment

Eligibility Criteria:
Inclusion Criteria:

Communicative (non-intubated, non-sedated)

* At least three days of admission (excluding day of admission)
* 18 years or older
* Mean arterial blood pressure equal or greater than 65 throughout study
* Mean SpO2 equal or greater than 90 throughout study
* Glasgow coma scale equal or greater than 14
* Bilirubin level less than 5
* Ammonia level less than 1
* Hematocrit level greater than 15
* BUN equal or less than 100

Non-communicative (intubated, sedated)

* At least three days of admission (excluding day of admission)
* 18 years or older
* Mean arterial blood pressure equal or greater than 65 throughout study
* Mean SpO2 equal or greater than 90 throughout study
* Glasgow coma scale equal or greater than 10
* Bilirubin level less than 5
* Ammonia level less than 1
* Hematocrit level greater than 15
* BUN equal or less than 100

Exclusion Criteria:

Communicative (non-intubated, non-sedated)

* Patients admitted for or less than 3 days
* Patients with hearing impairments
* Patients with neurological impairments that might impair their ability to process information
* Patients on glucocorticoid medications
* Patients with mental health diagnoses and currently experiencing active psychosis such as hallucinations and/or delusions
* Patient's condition altered dramatically over the 3 days of research

Non-communicative (intubated, sedated)

* Patients admitted for or less than 3 days
* Patients with hearing impairments
* Patients with neurological impairments that might impair their ability to process information
* Patients on glucocorticoid medications
* Patients with mental health diagnoses and currently experiencing active psychosis such as hallucinations and/or delusions
* Patient's condition altered dramatically over the 3 days of research
Medications for Obstructive Sleep Apnea In Children With Down Syndrome

This is a randomized, double blind, cross-over study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with DS and OSA documented by polysomnography (PSG). Participants will receive high dose ato-oxy for four weeks as well as low dose ato-oxy for four weeks in random order. During the high dose ato-oxy period, participants will take 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine nightly for one week. Atomoxetine dose will then be increased to 1.2 mg/kg/day (max 80 mg). During the low dose ato-oxy period, participants will take 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. Dosing of the study treatment will occur approximately 30 minutes prior to bedtime. Participants who withdraw from the study will not be replaced.

Study participants will undergo eligibility screening that will include an initial screening to determine whether non- PSG enrollment criteria are met, followed by a 1 night in-lab PSG and health-related quality of life assessment for participants who qualify based on non-PSG criteria. For participants who are eligible and enroll in the study, the screening PSG night will serve as the baseline measure for apnea hypopnea index (AHI) and other PSG endpoints. On the final night of dosing for both high dose ato-oxy and low-dose ato-oxy, participants will return for inpatient PSG and health-related quality of life assessment. The primary efficacy endpoint is the change in obstructive AHI from baseline (high dose ato-oxy vs. low dose ato-oxy).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit. Enrollment will be stratified to ensure equal representation of children age 6-12 and age 13-17. No more than 14 subjects will be randomized for each age group.
2. Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism)

Exclusion Criteria:

1. Hypoxemia independent of respiratory events on polysomnography (≥5 minutes with oxygen saturation \<90%)
2. Presence of central sleep apnea on polysomnography (central AHI ≥ 5)
3. Currently using and adherent to PAP therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent report)
4. MAO inhibitor use
5. Urinary retention
6. Prematurity \< 37 weeks estimated gestational age
7. Seizure disorder
8. Untreated or inadequately treated hypothyroidism
9. Significant traumatic brain injury
10. Congenital heart disease and not cleared to participate by the patient's cardiologist
11. History of current, untreated depression
12. History of liver disease
13. 3+ or greater tonsillar hypertrophy.
Phase I Study of Continuous Administration of Salvianolic Acid A Tablet

Salvianolic acid A has a variety of pharmacological effects, such as: anti-oxidation, scavenging oxygen free radicals, anti-fibrosis, anti-myocardial ischemia, anti-coagulation, anti-thrombosis, anti-tumor, etc. Professor Du Guanhua, at Institue of Materia Medica, Chinese Academy of Medical Sciences, first discovered that salvianolic acid A can alleviate diabetic complications and improve patients' quality of life. With the support of major national science and technology projects, the preclinical research work of salvianolic acid A was completed, and the application was approved by the State Food and Drug Administration (Clinical Approval No.: 2016L06293).The purpose of this study is to assess the safety,tolerability, and pharmacokinetics (PK) of an extended dosing regimen ofsalvianolic acid A: open label, continuous subcutaneous infusion for 7 days were tested as ascending doses of salvianolic acid A from 90mg up to 180 mg.

This was a Phase I repeated incremental doses study in healthy volunteers. A total of 24 subjects was planned to be enrolled. This was performed according to a double blind, randomized, placebo controlled design and included two sequential dose groups of repeat doses. Each group enrolled 12 subjects on salvianolic acid A or placebo (ratio 9 experimental: 3 placebo) and received salvianolic acid A or placebo twice daily (90mg) or daily (180mg) for 7 days, and follow-up to 3 or 4 days.

Eligibility Criteria:
Inclusion Criteria:

* 1) Gender: male or female, healthy volunteers; 2) Age: 18\~45 years old; 3) Weight: Male subjects need to weigh ≥ 50kg, female subjects should have ≥ 45kg, body mass index \[BMI = weight (kg) / height 2 (m2)\] in the range of 19 \~ 25 kg / m2; 4) Subjects must give informed consent to the trial prior to the trial and voluntarily sign a written informed consent form; 5) The subject is able to communicate well with the investigator and is able to complete the trial in accordance with the protocol.

Exclusion Criteria:

* (1) Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus and syphilis positive; (2) alcoholics; (3) subjects who took any drug or long-term use of drugs within 2 weeks before screening (4) Blood donors within 3 months prior to the trial; (5) participated in any drug clinical trial within 3 months prior to screening; (6) had a clear history of allergic disease; (7) had central nervous system, cardiovascular Systematic, kidney, liver, digestive tract, lung disease, metabolic and skeletal muscle system with a clear history or other significant disease; (8) pregnant, lactating women; (9) other factors not suitable for participation in the study.
CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

It has previously been shown that nitroglycerine induces cluster headache attacks in episodic cluster headache patients (ECH patients) in bouts but not in remission phase. Furthermore, plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown to be significantly higher during, but not before and after, an attack.

The attack appears around 20-40 min after nitroglycerine infusion with vasodilatation. During this latency period preceding the attack, no increase in CGRP plasma concentrations is seen. CGRP induces migraine attacks in 65% of migraine patients, and CGRP antagonists as well as monoclonal antibodies against CGRP are effective in migraine treatment.

Based on the above the investigators hypothesize the following:

1. Provoking ECH patients in bout with CGRP triggers cluster headache attacks
2. Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks
3. Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks more often than in ECH patients.


Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of IHS criteria for cluster headache either chronic or episodic
* Patients in bouts 1-32 attacks per week
* Patients in remission minimum of 1 month remission time
* fertile women must use safe contraception

Exclusion Criteria:

* All other primary types of headache
* headache 8 hours or less before study day begins
* pregnant or lactating women
* any history or clinical sigs of hyper/hypotension, heart disease, mental disorder, substance abuse, or other illness deemed relevant by the medical doctor assessing the patient
Optical Measurements of the Skin Surface to Infer Distinctions in Myofascial Tissue Stiffness

This study involves imaging the skin movements of surface tissue on the back. A clinician will perform assessment and intervention procedures manually, using manual and light movements of stretch and compression.

This study includes a demographic questionnaire, self-report on level of pain, application of ink to the skin, manual clinical assessments, and a massage intervention. The study will take place entirely in Olsson Hall. All information collected will be recorded using a randomized identification number.

1. Upon arrival for the study, a participant will be asked to read, review, and sign this informed consent agreement.
2. Next, the participant will be asked verbally to complete a demographic questionnaire.
3. The study team will verbally ask the participant to rate the current level of pain.
4. The participant will have been asked to bring clothes (e.g., sports bra, halter top, or swimming suit, etc.) to expose the upper back/neck region, and will change into those in an isolated room and within the overall laboratory space. A gown will be provided for additional privacy.
5. Two researchers will be in the room during the session, with the gender of the researchers taken into account per participant. For example, for a male participant, the investigators plan to have a male researcher present during the session along with the female physical therapist. For a female participant, the investigators plan to have both the female physical therapist and a female researcher present.
6. The study team will apply non-toxic, washable ink to the participant's back in two 10 by 10 cm areas near the shoulder blades on either side of the body.
7. The participant will lie flat on a massage table.
8. A camera system will record the movements of the fingers of the physical therapist, along with the movements of the skin. The investigators will videotape the upper part of the participant's back. A participant's face will never be videotaped, nor will audio be recorded.
9. The physical therapist will conduct standard assessment procedures for about 2 minutes per side of the body, where the skin tissue will be compressed and slightly stretched
10. A soft tissue intervention, or massage, lasting about 15 minutes will take place in the participant's upper back/neck region.
11. Another assessment like that prior will be performed.
12. The participant will again be verbally asked about the current level of pain.

Eligibility Criteria:
Inclusion Criteria:

* Healthy or diagnosed with benign, non-vascular headache and associated cervical musculoskeletal dysfunction (e.g. tender spots, trigger points, stiffness.
* Adult male and female.

Exclusion Criteria:

* Migraine headaches.
* Known cardiovascular, pulmonary, or metabolic disease.
* Any co-morbidities that could contribute to back or neck pain (e.g., head trauma, cancer, seizures, tumors, radiculopathies, rheumatoid arthritis, systemic auto-immune or inflammatory conditions).
Examination of Cognitive Function in Obesity and Following Weight Loss

Bariatric surgery is the most effective, long-term treatment for morbid obesity, and consistent with previous findings, individuals who lose significant weight after surgery also have improved cognition or "brain function". The mechanisms behind these cognitive improvements are currently unknown, but are the focus of much research effort. The goal of this pilot study is to thoroughly describe these changes in surgical versus medical weight loss patients over time in a repeated measures fashion.

Recent studies have demonstrated that obesity is associated with decreased cognitive function and, interestingly, weight loss is associated with improved cognitive function. Bariatric surgery is the most effective, long-term treatment for morbid obesity, and consistent with these previous findings, individuals who lose significant weight after surgery appear to have improved cognition. Previous results have only reported the appearance of cognitive improvements starting at three months postoperatively, thus, the main focus of this study is to discover whether cognitive function improvements are seen as early as one month after bariatric surgery. An acceleration in the onset of cognitive function changes could provide insight towards the ambiguous underlying neural mechanisms. The benefits of bariatric surgery extend beyond reversible cognitive deficits. Many of the medical comorbid conditions that these patients have before surgery (e.g. high blood pressure, high cholesterol, diabetes) typically resolve prior to any significant weight loss. The mechanisms for these weight-independent improvements are also undetermined. A secondary focus of this study is to determine whether or not cognitive function following bariatric surgery also improves prior to significant weight loss. To test whether cognitive function changes following bariatric surgery, two cohorts of surgical patients will be recruited as well as another group of patients undergoing medical weight loss treatment. The goal of this pilot study is to reproduce and expand upon previous findings that demonstrate cognitive improvements following bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Within the age rage of 18-70 years
* Able to give informed consent

Exclusion Criteria:

* Neurological disorder or previous injury (e.g. stoke, dementia, seizures, traumatic brain injury)
* History of any moderate to severe head injury (i.e. \>5 minutes of loss of consciousness)
* History of severe psychiatric illness requiring current pharmacologic therapy(e.g. schizophrenia, bipolar disorder, personality disorders)
* History of illicit drug or alcohol abuse
* Known diagnosis of learning or developmental disability
* Impaired sensory function
* Any prior suicide attempt
* Revisional bariatric surgery
* Current or former tobacco user / smoker
* Currently pregnant
Hypertension Management Using Remote Patient Monitoring

A longer-term follow-up of patients with remote patient monitoring ordered from the initial six pilot primary care clinics (from the prior study periods: Study 1 and Study 2) will be performed and compared to a cohort of patients without RPM orders, matched on clinical and demographic characteristics, from the same six pilot primary care clinics, to serve as contemporary controls.


Eligibility Criteria:
Inclusion Criteria Cases Patients from any of 6 primary care sites that participated in remote monitoring pilots who had remote patient monitoring (RPM) ordered by a primary care clinician between November 18, 2018 and August 14, 2021

-

Exclusion Criteria:

* Patients whose RPM ordered by non-primary care clinics

Matching cohort Inclusion

* Patients from the six pilot clinics AND
* Meet the matching criteria Exclusion
* Patients with any RPM order between between November 18, 2018 and August 14, 2021
Study of the Predictive Marker FLT in Patients Suffering From AML

Positron emission tomography uses various radioactive tracers to measure the metabolic activity in a none-invasive way, and specially to follow the activity of the disease during the treatments.

Among those new tracers, fluorothymidine (18F-FLT) arouses a lot of interest. This new tool would allow to image and follow time wise acute myeloid leukemia (AML). The investigators want, with the (18F-FLT), to characterise the aggressivity of the tumors and the prognostic before and after chemotherapy treatment.

The aim of this study is to be able to identify earlier the responders, because if they are detected sooner, these patients will benefit from more aggressive treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years or above at the time of inclusion;
2. Patients newly diagnosed with acute myeloid leukemia;
3. No contraindication or intolerance to any of the components of the standard chemotherapy by induction (7+3);
4. Patients able to give written informed consent.

Exclusion Criteria:

1. Patients unable to tolerate decubitus position for at least 45 minutes;
2. Any previous neoplasia or other neoplasia simultaneously;
3. Previously treated buy radiotherapy, with bone marrow in the field of radiation;
4. Other chemotherapy treatment than the standard chemotherapy by induction (7+3), before the second FLT-TEP was done.