cyrilzakka/clinical-trials huggingface dataset:
The Effect of an α2-Adrenoceptor Antagonist (Yohimbine) on Dynamic Autoregulation in the Human Middle Cerebral Artery and Ophthalmic Artery

Blood flow autoregulation is defined as the ability of a tissue to maintain a relatively constant flow, despite moderate alterations in perfusion pressure. Similar to the cerebral, renal, coronary and skeletal muscle circulations, the ocular vascular bed shows the property of flow autoregulation. This homeostatic mechanism allows blood supply to the eye to match metabolic demand during daily activities, such as changes in posture, or in more critical conditions.

Autoregulation has been found to be a complex phenomenon, showing heterogeneity in its site and time course of action. Since metabolic, myogenic, neurogenic and possibly endothelium-related mechanisms may be involved, several factors may vary depending on the challenging stimulus, the vessel tone, or the degree of impairment of autoregulation.

To study the dynamics of ocular autoregulation, it is necessary to introduce a step disturbance (stimulus) in ocular perfusion pressure and to record the responses of ocular blood flow continuously before and after this step disturbance. The investigators have employed a mechanical noninvasive technique to induce an ocular perfusion pressure step disturbance without drugs or changes in the concentration of vasoactive substances in the blood by using the thigh cuff technique inducing a small step decrease in ocular perfusion pressure.

With this technique the investigators could show significant differences in the time response of blood velocities in the ophthalmic and middle cerebral artery. This clearly indicates different mechanisms to be responsible for autoregulatory mechanisms distal to the vessels.

Interestingly our results indicate that in the ophthalmic artery a late vasoconstriction occurs. Many previous investigations have demonstrated that sympathetic nerve stimulation causes vasoconstriction in the ocular circulation. Accordingly, the present study tests the hypothesis that α2-adrenoceptors are involved in the dynamic regulation of blood flow in the ophthalmic and middle cerebral artery after a step decrease in perfusion pressure.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 18 and 35 years
* Non-smokers
* Normal findings in medical history and pre-study screening unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 Dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
Effects of Octanoic Acid for Treatment of Essential Voice Tremor

Essential voice tremor is a neurological condition that produces a regular, shaking quality in the voice. One form of drug treatment that produces some improvement in tremor of the hands is octanoic acid, which is a food additive that is similar to alcohol. Research suggests that octanoic acid may reduce tremor in the hands/arms with few side effects and no intoxication effects. This study will determine whether octanoic acid may be useful for reducing tremor when it affects the voice. Researchers are hypothesizing that octanoic acid will reduce the effects of tremor on the voice.

Background:

* Essential tremor of the voice produces regular shaking and hoarseness in the voice, making it difficult speech difficult to understand
* Several previous studies have found that octanoic acid and octanol, which are related to alcohol, can improve tremor in some people without producing many side effects and without producing intoxication
* Researchers are interested in determining whether octanoic acid can improve tremor that affects the voice

Objectives:

* To determine the effects of octanoic voice using voice recordings and listener ratings of voice
* To determine the effects of octanoic acid on level of voice disability experienced by people with essential voice tremor

Eligibility Criteria:
Inclusion Criteria:

* Participants have a diagnosis of essential voice tremor and show signs of tremor during the endoscopy examination (when pictures of the voice box are obtained)during screening appointment
* Participants show measurable voice tremor from recordings of the voice during screening appointment

Exclusion Criteria:

* Participants have a diagnosis or show signs of Parkinson's Disease or another non-essential tremor movement disorder
* Participants have a diagnosis or show signs of spasmodic dysphonia (a different neurological voice disorder)
* Participants have a diagnosis of a severe, non-stable medical condition, such as kidney or liver failure, severe heart disease, severe lung disease, severe metabolic disease, uncontrolled hyperthyroidism, or other life-threatening disease such as active cancer
* Participants have a diagnosis of diabetes mellitus
* Participants are unable to suspend/stop a medication that they are currently taking for tremor or voice disorder for 12 weeks to complete this study
* Participants have a dependence on alcohol or allergy to alcohol
* Participants are pregnant or lactating
* Participants have an allergy to soy
* Participants have Irritable Bowel Syndrome
Maintenance Treatment of Bipolar Depression

This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.

Depression is a serious condition that is often difficult to diagnosis and treat. Bipolar disorder-related depression is especially complex because of the presence of mania symptoms. Lamotrigine and divalproex are commonly prescribed medications for depression. However, their effectiveness in treating bipolar depression has not been thoroughly evaluated. Studies have shown that combining lamotrigine with another antidepressant may be more effective in reducing depressive symptoms than lamotrigine alone. This study will provide participants with either lamotrigine alone or in combination with divalproex and will determine which regimen is more effective in reducing symptoms of bipolar depression.

Participants will be randomly assigned to a daily regimen of either lamotrigine and divalproex or lamotrigine and placebo for 8 months. Participants will be assessed at study entry, at two unspecified times during the study, and at the end of the study. During each assessment, participants will undergo a brief interview and complete a questionnaire about their depressive symptoms, any physical manifestations of their depression, and their overall level of functioning in daily activities.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar disorder I or II
* Experiencing symptoms of depression at study entry OR have experienced symptoms of depression within 6 months prior to study entry
* Willing to use acceptable methods of contraception
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* History of liver disease
* History of substance abuse
* Previous treatment with lamotrigine or divalproex
* Lamotrigine or divalproex intolerance
Management of CSDH With or Without EMMA- a Randomized Control Trial

EMMA-Can is an open-label randomized control trial comparing the recurrence risk in patients with chronic subdural hematoma (CSDH) undergoing standard of care treatment (surgical drainage and/or medical management) with or without embolization of the middle meningeal (EMMA).

All patients in clinical need of surgical drainage or medical management for the CSDH will be randomized in our study. Patients that present in the Emergency Department (ED) or neurosurgery clinic will be assessed for standard of care treatment options based on their presenting symptoms; this may include surgical drainage or medical management. Patients will then by screened for study eligibility based on the study inclusion and exclusion criteria. After screening and consenting patients will be randomized in to the control arm or interventional arm.

Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage and/or medical management) of the CSDH.

Patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage and/or medical management) of the CSDH as per the standard of care in the institution. These patients will then undergo EMMA within 48 hours after finishing the surgical drainage. The embolic agent and use of general anaesthesia versus conscious sedation will be left to operators' preference and the institutional protocol.

All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded. The risk of recurrence at 90-days in patients who undergo standard of care treatment (surgical and/or medical management) of CSDH with or without EMMA will be observed.

Eligibility Criteria:
Inclusion Criteria:

1. Modified Rankin Scale of ≤2 at baseline
2. Patients requiring surgery or has at least 10 mm of CSDH on CT head and has one or more symptoms attributable to CSDH, including headache, cognitive impairment, ataxia, seizure, focal neurologic deficit, or decreased consciousness.
3. CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations.

Exclusion Criteria:

1. If informed consent can not be obtained from the patients or their substitute decision makers.
2. CT Angiogram showing dangerous communication between middle meningeal artery and branches of internal carotid arteries.
3. Contraindication to the embolization procedure such as severe renal dysfunction, or pregnancy
4. Life expectancy \< 6 months.
5. Known allergy to embolic agent
6. Acute subdural hematoma with homogenous hyperdensity on CT scan.
7. Secondary CSDH that may likely be due to the underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or prior craniotomy.
STI Prophylaxis and Emergence of Antimicrobial Resistance

The goal of this observational study is to understand the risk of antibiotic resistance and changes in the human microbiome (bacteria that live inside and on us), if people use antibiotics to prevent sexually transmitted infections (STI prophylaxis, doxycycline post-exposure prophylaxis, or 'doxyPEP'). The study will assess how easy and acceptable it is to find antibiotic resistance and microbiome changes in the throats and guts of men-who-have-sex-with-men (MSM) who use STI prophylaxis.

The study will recruit 108 MSM who are using and not using STI prophylaxis. Participants will visit the clinic every 6 months. At each visit, they will provide a throat swab and stool sample, and complete a questionnaire. DNA of the bacteria from the samples will be analysed to identify the bacteria and look for antibiotic resistance.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years.
* Identifies as a man (cis or trans).
* Has sex with men.
* Able to provide informed consent.

Exclusion Criteria:

* Use of an antibiotic other than doxycycline in the 3 months prior to enrolment
* Currently being treated for an STI with doxycycline
* Use of doxycycline within the prior 3 months for an indication other than STI treatment or STI prevention.
Dose Response Study of Aerobic Exercise in Older Adults

This is a randomized, 26-week study of supervised exercise assessing three doses of exercise in sedentary individuals 65 years of age and over with age-related cognitive changes. A total of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic control group, 75 minutes, 150 minutes, or 225 minutes a week of moderate intensity aerobic exercise spread over 3 to 5 days a week for 26 weeks. These exercise doses represent 50%, 100%, or 150% of the recommended exercise dose. Participants will be directly supervised during all exercise sessions for the first two months after which direct supervision will occur during at least one session a week. This is intended to provide increased flexibility while also maintaining direct contact with the participant to enhance adherence. Aerobic fitness, physical function, and cognition will be assessed at baseline and 26 weeks to examine the dose-response relationships.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 65 years or older
* Underactive or sedentary based on the Telephone Assessment of Physical Activity
* Community dwelling with a caregiver willing to accompany the participant to visits to the screening evaluation. The caregiver must visit with the subject more than five times a week.
* Nondemented: Clinical Dementia Rating (CDR) 0
* Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
* Stable doses of medications for at least 30 days prior to screening.
* Likely to participate in all scheduled evaluations and complete the exercise program over 52 weeks

Exclusion Criteria:

* Dementia
* CDR \> 0
* Current clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to Diagnostic Statistical Manual (DSM)-IV criteria or Geriatric Depression score of 5 or greater.
* Significant psychiatric symptoms (e.g., hallucinations) that could impair the completion of the study
* Current clinically-significant systemic illness likely to result in deterioration of the patient's condition or affect the patient's safety during the study
* History of clinically-evident stroke
* Clinically-significant infection within the last 30 days
* Myocardial infarction or symptoms of coronary artery disease (e.g., angina) in the last two-years.
* Uncontrolled hypertension within the last 6 months
* History of cancer within the last 5 years (except non-metastatic basal or squamous cell carcinoma)
* History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
* Insulin-dependent diabetes mellitus
* Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program
Psychological Profile of Dental Patients

The objective of this descriptive investigation was to evaluate the psychological profile of dental patients in three levels: global level, the dimensional level, and the discrete symptom level and to compare it with a control group.

Many people is afraid of dental treatment specially local anesthesia and do not refer to dental clinics until they are obliged due to dental pain. There are so many articles in the literature about dental phobia and fear of anesthetic injection. Due to these evidences, dental people are supposed to show elevated psychological dimensions such as anxiety, and somatization.

We are going to know which psychological dimensions of dental patients may be elevated when they refer to dental clinics.

Eligibility Criteria:
Inclusion Criteria:

Must:

be ≥ 18 years old and have high school degree or higher

Exclusion Criteria:

insufficient verbal capacity to comprehend the items of the questionnaire.
Hearts of Athletes

The Hearts of Athletes study is being conducted to determine the heart involvement with COVID-19 in athletes. This study aims to enroll any Adult (18 years of age or greater)

• Athlete is defined as NCAA Collegiate Athlete, Professional Athlete, Military, or Olympic Athlete will be eligible for the study.

With COVID-19

• COVID-19 diagnosed via an RT-PCR (nasal or throat swab test) prior to enrollment

Or without COVID-19

• Identified as a local Control participant (similar sport) to a participant with COVID-19, who is willing to undergo a standard cardiovascular evaluation

Participants with and without COVID-19 will use their mobile devices to provide health information, like symptoms, by answering survey questions daily for 30 days. Also, participants will allow their de-identified cardiac images to be sent to the Duke Heart Center for blinded analysis.

No physical risks are associated with this study. One possible risk, although minimal, is loss of confidentiality.


Eligibility Criteria:
Inclusion Criteria:

* Any adult athlete (defined as NCAA Collegiate Athlete, Professional Athlete, or Olympic Athlete) will be eligible for the study.
* COVID-19 diagnosed via an RT-PCR, or history of COVID-19 antibodies at least 10 days and less than 6 months prior to consent
* No longer requiring quarantine per local health recommendations, prior to cardiovascular evaluation.
* Identification as a Control participant (similar sport) to a participant without COVID-19 willing to undergo cardiovascular evaluation

Exclusion Criteria:

* Anyone with known cardiovascular disease - defined as known myocardial disease, valvular heart disease, or known coronary heart disease
* Anyone without the ability to provide informed consent
* Anyone with a known contraindication to cardiac magnetic resonance (metallic implant)
Study to Investigate the Effect of a Single Dose of AZD7624 on Inflammation Caused by an Endotoxin Challenge

Study to investigate the effect of a single dose of AZD7624 on inflammation caused by an endotoxin challenge.

This is a double-blind, randomised, placebo controlled, 2-way cross-over study to investigate the effects of a single dose of inhaled AZD7624 on white blood cells and inflammatory markers in induced sputum and blood after oral inhalation of LPS as well as the safety, tolerability and pharmacokinetics (PK) of AZD7624 following a single inhaled dose.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and/or female volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. (Healthy as determined by medical history and physical examination, laboratory parameters, and ECG performed before the first administration of the IP)
2. Female volunteers must have a negative pregnancy test at Visit 1 and on admission (Day -1 of Visit 3 and Visit 5) to the study centre, must not be lactating and must be of non childbearing potential
3. Be able to produce a minimum of 100 mg sputum (pellet weight) of good quality with total cell count (defined as total cell count \<14 x 106/g, eosinophils \<3%, sputum neutrophil % differential \<65%, \<30% squamous cell contamination and a minimum of 50% ce
4. Have normoresponsive airways with a methacholine PC20 \>16 mg/mL. Screening methacholine provocation is not required if the volunteer has been tested by the centre in the past 1 year, with documented records of this testing
5. Be able to inhale from SPIRA nebuliser

Exclusion Criteria:

1. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
2. Any infection within the previous 4 weeks. Volunteers who get an infection between Visit 1 and admission to the centre can be rescreened
3. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or reason to expect untoward reactions to LPS and/or AZD7624
4. History of chronic respiratory disease
5. Volunteers who are vegans or have medical dietary restrictions -
A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Orthopedic Surgery

The primary objective is to evaluate the analgesic efficacy and safety of IV YZJ-4729 Tartrate Injection in patients with acute postoperative pain following Orthopedic surgery


Eligibility Criteria:
Inclusion Criteria:

1. Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent
2. BMI≥18.0 kg/m2 and ≤28.0 kg/m2
3. ASA I to II
4. Experiences a pain intensity rating of moderate to severe acute pain following orthopedic surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery

Exclusion Criteria:

1. Opioid allergy
2. Nervous system diseases (e.g. epilepsy)
3. Psychiatric disorders (e.g. depression)
4. History of difficult airways
5. Random blood glucose ≥11.1 mmol/L
6. Subjects with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg or systolic blood pressure \< 90 mmHg
7. Abnormal pulse oxygen saturation (SpO2 \<92 %)
8. Abnormal liver function or renal function
9. Used agents that could affect the analgesic response
10. Used agents that could affect drug metabolism
11. Has previously participated in another YZJ-4729 clinical study
Local Changes of Skin Characteristics After an Application of a Topical Product With a Warming or Cooling Effect

The use of topical over-the-counter (OTC) products with a warming or cooling effect is widespread in the fields of sport, physiotherapy and in private households. Advertisements for such products promise pain relief when suffering from musculoskeletal disorders such as muscle tension, rheumatism or acute injuries, e.g. sprains. In literature, there are only little information about the efficacy and the physiological mechanisms of topical warming or cooling products. Therefore, the aim of this study is to investigate the local skin characteristics during and after an application of a topical product with a warming or cooling effect.

The use of topical products for local pain relief in chronic or acute musculoskeletal disorders is widely used. Despite the widespread use of these products, there is missing information on the physiological mechanisms and efficacy of topical warming and cooling ointments. Most of the existing literature is about the efficacy of topical non-steroidal anti-inflammatory drug (NSAID)-products on chronic pain in osteoarthritis. Furthermore, one study tested the cooling effect of gels with different menthol concentrations. They found that, regardless of the concentration, the skin temperature was reduced up to one hour post application in the area of application.

The aim of our study is to evaluate the change of skin characteristics after a single application of a warming or cooling topical product on healthy subjects. Outcome parameters include skin perfusion, temperature, skin redness and subjective thermal sensation. We only selected products in form of alcohol based ointments, menthol or wintergreen oil. Sprays and patches were excluded.

The application area is the unilateral lumbar back region, whereas the contralateral side serves as control area. After an acclimatization period, baseline measurements are performed, followed by standardized application of the topical product. The local skin responses are measured in 10 mins time increments up to one hour.

Eligibility Criteria:
Inclusion Criteria:

* no existing musculoskeletal disorders in the region of interest
* no surgery in the region of interest in the last year
* healthy skin conditions in the region of interest

Exclusion Criteria:

* fear of treatment
* regular intake of drugs, excluding contraceptives
* metal implants in the region between C7 and sacrum, including hip joints
* lack of epicritic and protopathic skin sensitivity
* renal insufficiency
* bronchial asthma
* pregnancy/lactation
* type 1 or 2 diabetes mellitus
* polyneuropathy