cyrilzakka/clinical-trials huggingface dataset:
Auricular Acupuncture for Treatment of Preoperative Anxiety

In this prospective nonrandomized study the investigators are going to investigate whether auricular acupuncture with indwelling fixed needles is feasible for treatment of preoperative anxiety.

Patients, scheduled for ambulatory gynecologic surgery, will be asked, if they wish to receive auricular acupuncture (AA) against preoperative anxiety. The patients who will not wish AA, will be asked to take part in questioning (State-Trait-Anxiety-Inventory (STAI) questionnaire) and will form the control group. The preoperative anxiety using STAI, as well as the duration and quality of sleep on the night before surgery, the incidence of side effects, blood pressure and heart rate will be the outcome measures in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with an American Society of Anaesthesiologists physical status of I to II scheduled for elective ambulatory gynaecological surgery under standardized general anaesthesia
2. Surgery time does not exceed 60 minutes
3. Patients without previous opioid and psychotropic medication
4. Patients aged between 19 and 55 years, able to fill in the STAI questionnaire
5. Patients who have given written informed consent

Exclusion Criteria:

1. Current psychiatric disease
2. Local skin infection at the sites of acupuncture
3. Aged \< 19 or \> 55 years
4. Failure to follow the standardized schema of general anaesthesia
5. Surgery time more than 60 minutes
6. Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
7. Patients who consumed opioid medication at least 6 months before surgery
8. Patients who are unable to understand the consent form or to fill in the STAI questionnaire
A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome

The investigators plan a prospective randomized controlled study that compares the treatment decisions made by patients who receive decision aids, as compared to patients treated with usual care and the American Society for Surgery of the Hand brochures. The investigators expect to enroll 126 patients.

Decision aids are tools that help patients participate in making decisions by providing detailed, specific, and personalized information regarding the benefits and risks of various potential treatment options for a diagnosis. Decision aids can reduce the level of uncertainty and mental anguish associated with choosing a particular course of action, i.e. 'decisional conflict'. The most common manifestations of decisional conflict include verbalized uncertainty about choices or undesired consequences of alternatives, vacillation between choices, and delayed decision making.

Besides the advantages of decision aids in the process of decision-making, the literature is not conclusive about the effect of decision aids on patient satisfaction. Of the 86 randomized controlled trials identified by authors Stacey et al., eleven studies measured satisfaction. Of these, four studies reported that people exposed to decision aids had higher satisfaction with their choice compared to usual care, and the remaining seven reported no statistically significant difference.

Studies that have directly investigated the effect of decision aids in orthopaedic practice are limited and further study is necessary to determine the best way to implement decision aids in a clinical orthopedic practice. 7-12 Randomized trials evaluating the impact of decision aids on patient knowledge, decisional conflict, satisfaction, and outcomes may have substantial impact in hand surgery where most treatments are elective and address quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Diagnosis of moderate or severe:

  2.) Carpal Tunnel Syndrome (CTS) 5.) Trigger Finger (TF)

Exclusion Criteria:

* Patients with previous interventions for CTS or TF
* Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
Ability of Modulated Imaging and Laser Speckle Imaging to Determine Burn Wound Severity and Healing Potential

According to the National Burn Repository 2007, the most common type of burn injury is a partial thickness burns. The current standard of care for partial thickness burns is two weeks of topical therapy and wound care. Burns that do not heal within two weeks undergo surgical excision and skin grafting.

Researcher can use the combination of Modulated Imaging and Laser Speckle Imaging can be used as an adjuvant to standard clinical evaluation to gauge burn wound and severity of infection. Researcher can image the burn wounds of and compare with current standard of care, clinical exam, and can use the outcomes information in terms of time to healing and treatment

Modulating Imaging is a noninvasive optical modality measure the metabolic functions of the burn wound.

Laser Speckle Imaging is a noninvasive optical modality can measure blood flow of burn wound.

Eligibility Criteria:
Inclusion Criteria:

1. Male / female all age
2. Subjects is an inpatient or out patient with burn wound

Exclusion Criteria:

1. Subjects cannot lied flat and still for the duration of the imaging
2. Subjects pregnant.
Screening Herbs for Drug Interactions

The purpose of this study is to detect potential herb-drug interactions in volunteers.

The use of herbal medicines in the treatment of various medical and psychiatric conditions has accelerated in the last decade. It has also become evident that herbal medications are being used concomitantly with conventional prescription and over-the-counter medications. However, the systematic evaluation of the potential of these agents to interact with conventional medications has been generally neglected. Compounding this problem is the fact that even single entity herbal products can contain a multitude of naturally occurring chemicals which serve as candidates for potential herb-drug interactions by inhibiting or inducing specific hepatic isozymes. Numerous reports document the importance of pharmacokinetic interactions involving inhibition or induction of the cytochrome P450 (CYP) enzyme system. In this study, the ten most commonly used herbal products in the US will be systematically evaluated for inhibition of CYP 3A4 and 2136, and induction of CYP 3A4. Collectively, these enzyme systems are involved in the metabolism of approximately 80% of all marketed medications.

Participants in this study will receive a single dose of the prescription drug alprazolam and the over-the-counter cough suppressant, dextromethorphan on two occasions. A combination of probe drugs will be given to normal volunteers both in the absence and presence of herbal medications. The plasma and urine concentration of these agents and their respective metabolites will be determined in order to evaluate individual herbal products degree and specificity of enzyme inhibitory or inductive effects.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy volunteers who are taking no medications.
* Must be non-smokers.
Detection of Ureteral Stent Encrustation

Ureteral stents are the most commonly used postoperative implantable materials in urology. The indwelling ureteral stents often lead to the formation of encrustation, with an incidence of 10%, which will lead to complications such as obstruction, lower urinary tract symptom (LUTS）, and difficulty in extubation. At present, there is no accurate and sensitive diagnostic criteria for ureteral stents encrustation. Previously, we developed the artificial intelligence-based ureteral stents encrustation identification software - GREE-AI Medical Software (GAIMS) with the collaboration of GREE ELECTRIC APPLIANCES,INCORPORATED.OF ZHUHAI(a city of Guangdong, China). In order to further evaluate the diagnostic sensitivity and accuracy of the software in practical clinical applications, and to verify its predictive ability for ureteral stents encrustation, the following single-center, prospective, double-blind, diagnostic cohort study is planned.

This study will use the gold standard as a reference to evaluate the sensitivity and specificity of GAIMS for detecting ureteral stents encrustation. At the same time, it will be compared with non-enhanced contrast Computed Tomography examinations interpreted by clinical radiologists to evaluate the pros and cons of GAIMS in detecting ureteral stents encrustation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who plan to undergo ureteral stent placement due to urinary calculi or urinary system obstruction;
2. Aged over 12 years old;
3. The estimated time of ureteral stent placement is more than 2 weeks but less than 1 year;
4. Voluntarily participate in this clinical study, abide by the requirements of this clinical study and sign the informed consent.

Exclusion Criteria:

1. Transplanted kidney, severe urinary system deformity, hydronephrosis caused by the compression of tumors of the urinary system and surrounding organs (such as cervical cancer);
2. There are serious diseases in heart, lung, liver and other major organs;
3. Pregnancy;
4. The subject cannot complete the study or comply with the requirements of the study (due to administrative reasons or other reasons).
A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

The purpose of this study is to evaluate the efficacy and safety profiles of E6005 ointment in patients with atopic dermatitis compared to vehicle. The pharmacokinetic profile after topical application of E6005 is also assessed.


Eligibility Criteria:
Inclusion Criteria

* Adults of both genders aged 20 to 64 years at the time when the written informed consent is obtained.
* Outpatients diagnosed with atopic dermatitis.

Exclusion Criteria

* Patients with a present illness of Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo contagious, psoriasis, connective tissue disorder, collagen disorder or Netherton's syndrome, etc., which could have an effect on the pathological evaluation of the atopic dermatitis.
* Patients with active infection that requires oral or intravenous administration of antibiotics, antifungal or antivirus agent/s at baseline.
* Patients with advanced disease or abnormal laboratory tests that would possibly affect the safety of the subject or the implementation of this study.
Diamorphine or Alfentanil for Subcutaneous Use in Hospice In-patients?

OBJECTIVES:

How does Alfentanil compare with the standard drug Diamorphine for subcutaneous analgesia in the palliative care setting?

STUDY DESIGN:

An open-label pilot comparison between alfentanil and diamorphine for palliative care patients who require subcutaneous opioids.

STUDY DESIGN

Study 1 - Open Label Pilot Day - 1 Hospice in-patients who are thought by a clinician to need subcutaneous strong opioids will be asked if they wish to take part in the study.

They will be given a patient information leaflet and a 'cooling off period' (a minimum of 1 day) to think about it. If the clinician feels that strong parenteral opioids are needed diamorphine will be commenced immediately (as standard practice).

Day 0 If the patient agrees to take part in the trial they will be asked to complete a consent form and this will be stored with the patient's notes.

The following assessments will be performed:

1. McGill Pain Questionnaire Short Form(MPQ-SF)
2. Brief Pain Inventory Short Form (BPI-SF)These measures were recommended by an EAPC Expert Working Group for pain syndrome characterization
3. Memorial Delirium Assessment Scale (MDAS). This has been validated in an advanced cancer population and used recently with hospice in-patients.
4. Nausea Visual Analogue Scale (VAS)
5. Nausea Duration over last 24 hours
6. Number of vomits in previous 24 hours

Randomisation Once baseline measures are completed the participant will be randomised using the next available of a series of numbered, opaque, sealed envelopes. These will be prepared remotely. Blocking will be used to prevent an imbalance in terms of the number allocated to each group. Block size will be appropriate to the size of the study and not be divulged to the investigators responsible for consent and revealing the allocation. This will reduce the risk of investigators anticipating the allocation for particular patients. A study log will be kept on site where participant details will be completed before the envelope is opened.

Subsequent Days

On each subsequent day the following assessments will be performed:

1. BPI-SF
2. MDAS
3. Nausea VAS
4. Number of vomits in previous 24 hours

   In addition the following measurements will be taken:
5. Stool chart for previous 24 hours
6. Breakthrough medication (number of doses and dosage) used
7. Laxatives taken
8. Other changes to medication

Patients will cease participation after assessment on day 7.

Eligibility Criteria:
Inclusion Criteria:

1. To be thought by a hospice doctor to require parenteral strong opioids.
2. To have an estimated prognosis of less than 1 year.

Exclusion Criteria:

1. Inability to read English sufficiently to be able to complete assessment questionnaires.
2. Confusion sufficient so that patient is unable to complete questionnaires.
3. Weakness or fatigue sufficient so that patient is unable to complete questionnaires.
4. Radiotherapy to source of pain in last 4 weeks.
5. Change in corticosteroid dose in last week.
Kaletra: Therapy With Double Protease Inhibitors

Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants

This study is intended to observe and collect data on the usage, dosing, tolerability, and effectiveness of lopinavir/ritonavir (Kaletra) when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free double protease regimen. Enrollment in the study was independent of the decision to prescribe Kaletra.

Eligibility Criteria:
Inclusion Criteria:

* Participants with Human Immunodeficiency Virus infection
* Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor

Exclusion Criteria:

* Hypersensitivity against lopinavir, ritonavir or other ingredients
* Severe liver insufficiency
* No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
A Multicenter, Observational Study to Evaluate Clinical Manifestation, Diagnosis and Treatment of Primary Hemifacial Spasm in Chinese Patients

To determine the clinical manifestation, diagnosis and treatment options of primary hemifacial spasm in Chinese outpatient subjects

About 1000 outpatient subjects will be recruited. The inclusion criteria include clinically diagnosed primary hemifacial spasm, male or female 18 to 80 years old and informed consent has been obtained. The exclusion criteria include secondary hemifacial spasm, other involuntary facial movement disorder, history of surgery of microvascular decompression of the facial nerve and so on. The outcome measures include the percentage of the treatment methods of HFS in outpatient subjects, aggrevated and relieved factors of HFS symptom, concomitant symptoms of HFS and adverse events of botulinum toxin treatment in HFS patients.

Eligibility Criteria:
Inclusion Criteria:

1.Clinically diagnosed primary hemifacial spasm

1. Tonic and clonic contractions of muscles innervated by the unilateral facial nerve.
2. No other neurological disorder. 2.Male or female 18 to 80 years old 3.Informed consent has been obtained

Exclusion Criteria:

1. Secondary hemifacial spasm: brainstem tumor, surgery, facial neuritis and so on.
2. Other involuntary facial movement disorder: facial synkinesia after facial palsy, tics, myokymia and focal motor seizures.
3. History of surgery of microvascular decompression of the facial nerve.
4. Participation in another clinical study currently.
5. Not able to understand and answer questionnaire.
6. Investigator's opinion that the subject has a concurrent condition(s) that may confound the study results.
Neuropathology in Adults Intensive Care Unit Patients With COVID 19

This is a single center observational autopsy study, conducted during the first wave of the coronavirus disease (COVID-19) pandemic in France. The main objective is to evaluate brain damages in patients who died from COVID-19 to inform the cause of death. Investigations include macroscopic and histology examinations, and virology analyses.

Setting: academic center designed as a referral center for patients with COVID-19 Design: single center observational autopsy study Participants: intensive care unit (ICU) adults who died from confirmed COVID-19 during the first wave of the pandemic in France.

Oversight: As per legal health authority requirement only patients with suspected or confirmed severe acute respiratory syndrome (SARS)- related to coronavirus 2 infection were admitted to the ICU. The department of pathology and forensic medicine is allowed by legal authority to perform autopsy of non-survivors from COVID-19 to inform the cause of death as per ministerial decree of July 12 2017 and March 28, 2020. In this context, of autopsy for medical purpose and public interest there is no requirement for institutional review board submission. However, consent from patients legal representative or closest relatives is required for autopsy.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* admitted to the ICU
* confirmed COVID-19
* died during ICU stay

Exclusion Criteria:

* refusal from patient's legal representative or closest relative
Corneal and Conjunctival Sensitivity and Staining Study

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens. Observations will be made to monitor physiology.

Eligibility Criteria:
Inclusion Criteria:

An eligible participant is one who:

* Is between 17-45 years old and has full legal capacity to volunteer.
* Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)
* Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.
* Has normal binocular vision (no strabismus, no amblyopia).
* Has clear corneas and no active ocular disease.
* Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS.
* Has astigmatism less than or equal to -1.00DC.
* Agrees to wear the study lenses on a daily wear basis.
* Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study.

Exclusion Criteria:

A person is ineligible if he/she:

* Has undergone corneal refractive surgery.
* Is aphakic.
* Has any active ocular disease.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that may affect ocular health.
* Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study.
* Is pregnant or lactating.
* Is participating in any other clinical or research study.
* Has a known clinically significant sensitivity to the contact lens care solutions used in the study.
* Has ocular or systemic allergies that could adversely affect contact lens wear.
* Currently wears lenses on a continuous or extended wear basis.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
* Has pinguecula/pterygium that, in the investigator's judgment, makes contact lens wear inadvisable.
* Is a rigid lens wearer.
* Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.
A Phase 2a Study of BIIB074 in the Treatment of Erythromelalgia

The primary objective of the study is to investigate the efficacy of repeat oral dosing of BIIB074 on paroxysmal pain in participants with Primary Inherited Erythromelalgia (EM). The secondary objective of the study is to investigate the efficacy of repeat oral dosing of BIIB074 on varying additional aspects of pain in participants with EM; and to investigate the safety and tolerability of repeat oral dosing of BIIB074 in participants with EM.

This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* A diagnosis of primary inherited EM with family history of EM made at least 3 months from initial diagnosis.
* Failed at least one prior treatment for EM (defined as an inadequate response or intolerance to treatment).
* Approved concomitant medications must have been stable for at least 4 weeks prior to day 1.

Key Exclusion Criteria:

* Positive screening Hepatitis B surface antigen or positive Hepatitis C antibody result.
* Received nerve blocks and/or steroid injections for neuropathic pain within 4 weeks prior to Day 1.
* Males whose partner is pregnant.
* Failed at least one prior treatment for EM (defined as an inadequate response or intolerance to treatment).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Stable Angina Management and Treatment

The Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE) is an observational study on an all-comer stable angina population hospitalised in a highly specialized cardiovascular centre with cardiac surgery facilities. The aim of the study is to assess the clinical characteristics, treatment modalities, early and long-term outcomes in this population.

The Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE) is a single-center, observational study recruiting consecutive patients with stable angina, who were diagnosed and treated in the 3rd Chair and Department of Cardiology in the Silesian Centre for Heart Diseases in Zabrze, Poland. The Silesian Centre for Heart Diseases is a highly specialised cardiology centre with cardiac surgery facilities

The main objective of the PRESAGE Registry is to clarify the overall clinical characteristics of patients with stable angina, their demographics and clinical profile, current management, early and long-term outcomes, with regard to the administered treatment.

The diagnosis of stable angina was based on clinical characterization, coronary angiography, and the current guidelines of the European Society of Cardiology. Patients with vasospastic and/or microvascular angina were also included to the registry. Performance of coronary angiography is the criterion of the enrolment in the registry.

Patients with acute coronary syndromes are excluded from the analysis.

Data collection is patient-based (not event-based).

Complete patient demographics: medical history, complete hospitalization data (diagnostic and therapeutic) and in-hospital results are collected in an electronic form by the attending physician. The patients are under constant follow-up for all-cause mortality and major cardiac adverse events.

Eligibility Criteria:
Inclusion Criteria:

* symptom based diagnosis of stable angina

Exclusion Criteria:

* acute coronary syndrome on admission
* ≤ 18 years old