cyrilzakka/clinical-trials huggingface dataset:
AM-101 in the Treatment of Acute Tinnitus 3

The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months or within the last \>3 to 6 months.

This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratympanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (Stratum A), or between \>3 and 6 months (Stratum B) from onset).

Eligibility Criteria:
Inclusion Criteria:

1. Persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months (Stratum A) or between \>3 months and 6 months (Stratum B) prior to randomization, as documented by medical report or by documented medical history. Upon implementation of protocol amendment 6, subjects with tinnitus following traumatic cochlear injury will only be eligible if they are affected only unilaterally.
2. Age ≥ 18 years and ≤ 75 years;
3. Negative pregnancy test (woman of childbearing potential);
4. Willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
5. Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Fluctuating tinnitus;
2. Intermittent tinnitus;
3. Tinnitus resulting from traumatic head or neck injury;
4. Presence of chronic tinnitus;
5. Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
6. History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
7. Ongoing acute or chronic otitis media or otitis externa;
8. Other treatment of tinnitus for the study duration;
9. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction;
10. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
11. Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months;
12. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization.

Other protocol-defined exclusion criteria may apply.
Effectiveness of a Home-Based Cognitive Rehabilitation Program in Patients With MCI

In this study, a more specific and systematic Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application is developed and the purpose of the program is to check whether cognitive function is improved when the program is applied to patients with MCI.

The subjects of recruitment were the elderly with mild cognitive impairment living in the local community. Assessments were conducted 7 days before and after the intervention. Subjects received Korean-Montreal Cognitive Assessment(MoCA), semantic verbal emory test (SVLT), number memorization test; Digit Span Test (DST), category word fluency test (CWFT), phonemic word fluency test (PWFT), Korean-mini mental state test (K-MMSE), and geriatric depression scale (GDS) before and 8 weeks after the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women over the age of 55
2. Those who have visual and auditory abilities without difficulties in conducting this research
3. Those with K-MMSE (Korean-Mini Mental State Examination) score of 24 or higher and 16≤K-MoCA score\<23
4. In the case of patients taking dementia treatment, those who have the same treatment regimen and dose for 3 months or more from the screening date
5. A person who can understand and respond to the questionnaire questions.
6. A person who voluntarily decided to participate in this study and gave written consent to the informed consent form

Exclusion Criteria:

1. Those with a history of alcohol or drug abuse,
2. Those with a past history of uniaxial psychiatric disorders, including intellectual disability, schizophrenia, alcoholism, and bipolar disorder
3. A person who is unable to communicate
4. Those who show all neurological symptoms that cause cognitive decline, such as Parkinson's disease, cerebral hemorrhage, brain tumor, and hydrocephalus
5. Those with a record of being unconscious for more than 1 hour due to head trauma or mild repetitive head trauma
6. Those with symptoms of depression that may affect cognitive function
Investigating the Possible Link Between Habitual Diet, Physical Activity, Sleeping Patterns, Obesity Status and Age With Gut Bacterial Composition, Gut Barrier Function, Metabolic Endotoxemia, Systemic Inflammation and Glycaemic Control.

In the UK, 25% of the adults are affected by metabolic syndrome (NHS, 2016). Metabolic syndrome is a cluster of different conditions including: hyperglycaemia, insulin resistance hypertriglyceridemia, dyslipidaemia and hypertension. Such individuals also have increased risk of developing type 2 diabetes and cardiovascular disease. The factors contributing to the development of metabolic syndrome are potentially numerous and understudied in humans, with much of what we think we know coming from animal research. Recent animal studies have pointed towards gut health playing a role in metabolic health. More specifically it has been suggested that changes in the composition of the gut microbiota may drive insulin resistance and type 2 diabetes through a mechanism that is linked to increased gut permeability and the development of metabolic endotoxemia and inflammation. Yet, this link has not been confirmed in humans. This research will look at the relationship between diet, physical activity, sleeping patterns, obesity status and age etc. and measures of gut bacterial composition, gut barrier function and metabolic health. Findings will provide us with new insights on the effect of different physiological and behavioural/ lifestyle variables on gut health and metabolic function.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-70 years
* BMI 18.5-50 kg/m2
* Not taking antibiotics and antimicrobial drugs for at least three months
* Both physically active and sedentary individuals will be eligible to take part in the study
* Weight stable (±5kg) for at least 6 months

Excusion Criteria:

* No cardiometabolic (e.g. heart disease, high blood pressure) or inflammatory illness
* Smokers (including the use of vaporisers and e-cigarettes)
* Taking anti-inflammatory drugs (excluding aspirin)
Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia

Community-based exercise programs have demonstrated potential for implementation in older adults; however, it remains imperative to ascertain whether this strategy will yield comparable benefit in stroke patients with dysphagia.Participants were randomly assigned to either the intervention group or the control group. Patients in the intervention group received swallowing function training in community public spaces for 5 days every week for four-week period (60 minutes per day). Patients in the control group received no intervention. Penetration-Aspiration Scale and Standardized Swallowing Assessment (SSA), depressive symptoms (Geriatric Depression Scale-15), and meal duration were assessed before and after all the treatment.

Stroke is complicated by oropharyngeal dysphagia in 29 to 81% of patients. Up to 40% of these individuals continue to experience swallowing difficulty even after a year later, which is associated with an increased risk of consequences such as aspiration pneumonia, dehydration, and malnutrition.

Community-based exercise programs have demonstrated potential for implementation in older adults; however, it remains imperative to ascertain whether this strategy will yield comparable benefit in stroke patients with dysphagia.Participants were randomly assigned to either the intervention group or the control group. Patients in the intervention group received swallowing function training in community public spaces for 5 days every week for four-week period (60 minutes per day). Patients in the control group received no intervention. Penetration-Aspiration Scale and Standardized Swallowing Assessment (SSA), depressive symptoms (Geriatric Depression Scale-15), and meal duration were assessed before and after all the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age over 65 years old.
* No hospitalization within the past six months.
* With clear consciousness and able to cooperate with questionnaires and training.
* The elderly people who voluntarily participate and agree to adhere until the end of the study.
* early dysphagia.

Exclusion Criteria:

* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Physical disability.
* Simultaneously receiving other therapies that might influence this study.
* Individuals with a gastrostomy.
* Abnormalities of the oral, pharyngeal, or esophageal structures.
Blue Light Therapy of C. Acnes

This proposal aims to investigate a novel light-based treatment to reduce morbidity in shoulder surgical patients. This has potential to improve outcomes and reduce health care utilization associated with infectious complications of shoulder arthroplasty. Participants will be healthy male volunteers at least 18 years of age. They will be on study for approximately 2 days.

Participants will have two study visits (consent plus treatment and swabs for culture). These visits will be conducted at the main UW Hospital, UW Health at the American Center, or UW Health at 1 S. Park. All visits will be conducted in reserved conference rooms at each location.

Once a subject is determined to be eligible and has consented to the study, they will be randomized into one of three treatment groups. Study team has blank envelopes that contain one of the three treatment groups enclosed. After a subject consents to the study, the study team will randomly draw an envelope to assign a treatment arm.

Arm 1. One group will receive 5% topical benzoyl peroxide gel plus 2% chlorhexidine gluconate with 70% isopropyl alcohol

Arm 2. One group will receive blue light therapy plus 2% chlorhexidine gluconate with 70% isopropyl alcohol

Arm 3. One group will receive both of the above treatments

All participants will have their contralateral shoulder serve as the control (2% chlorhexidine gluconate with 70% isopropyl alcohol only). All treatment will be provided by the study team. Participants will also be asked to complete a research intake form.

If C. acnes does grow for a tissue culture, Investigators plan to bank a colony of the bacterium for potential use in a future study. There will be no added risk to research subjects as no additional cultures will be taken and samples will be completely anonymized. The banked samples will simply be a colony of growth from the culture media for storage for possible future use. Samples will be banked for 5 years from the date of study completion after which time the samples will be destroyed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* 18 years or older

Exclusion Criteria:

* Allergy to benzoyl peroxide or chlorhexidine
* \<18 years of age
* Previous history of shoulder infections
* Antibiotics taken within one month of research visit
* Immunocompromised state
* Active cancer
* Diabetic
* Skin lesions or abrasions over the deltopectoral interval
* Topical corticosteroid treatment to either shoulder or or systemic corticosteroid treatment within 2 weeks of research visit
* Topical benzoyl peroxide treatment to either shoulder within 2 weeks of research visit
* Blue light therapy treatment to either shoulder within 2 weeks of research visit
* Prior incision over the deltopectoral interval of either shoulder
* Contraindication to blue light treatment
The Turkish Version of the Simple Physical Activity Questionnaire (SIMPAQ)

The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to assess physical activity level particularly people with mental illnesses. The purpose of this study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its psychometric properties.

The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to assess physical activity level particularly people with mental illnesses. The purpose of this study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its psychometric properties. Eighty individuals with mental illnesses (major depression, bipolar disorder, anxiety disorder, schizophrenia, alcohol and substance addiction) will include. For cross-cultural adaptation and validation procedure, developers' manual in the official site will be followed (http://www.simpaq.org/). Within a 5-to-7-day period after the first assessment, the participants completed the Turkish version of the SIMPAQ to evaluate test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The correlations with the Turkish version of the International Physical Activity-Short Form (IPAQ-SF) and Brief Psychiatric Rating Scale (BPRS) and Turkish version of the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Scale-Adult Version (DSM XC) will determine to check the validity.

Eligibility Criteria:
Inclusion Criteria:

Aged between 18 and 60 years Being a volunteer to participate Being an outpatient or inpatient at the place of the study Being diagnosed with major depression, bipolar disorder, anxiety disorder, schizophrenia, alcohol and substance addiction according to DSM-5 or ICD.

Exclusion Criteria:

Having cognitive impairment Having disabilities in understanding, speaking and reading Turkish Having vision and / or hearing problems
Pharmacology of Insulin Injected With Jet-Injection

The purpose of this study is to compare the pharmacological profile of insulin administered with jet-injection with that of insulin injected with a conventional insulin pen.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years
* Body-mass index 18-28 kg/m2
* Blood pressure \<160/90 mmHg
* Stable glycaemic control with HbA1c 6.5-9.0% (for patients with type 1 diabetes mellitus)
* Duration of diabetes \>1 year (for patients with type 1 diabetes mellitus)

Exclusion Criteria:

* Inability to provide informed consent
* Chronic use of medication other than oral contraceptives or thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months)
* Chronic use of medication other than insulin or low-dose angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment (for patients with type 1 diabetes mellitus)
* Type 2 diabetes in first-degree relatives (for healthy subjects)
* History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty)
* Pregnancy
* Macroalbuminuria, i.e. urinary albumin excretion \>200 microg/min in collected urine sample or urinary albumin-to-creatinine ratio \>300 mg/g in spot urine sample (for patients with type 1 diabetes mellitus)
* Symptomatic diabetic neuropathy (for patients with type 1 diabetes mellitus)
* Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion) (for patients with type 1 diabetes mellitus)
Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail

The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519 Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.

Open label, single-site

Eligibility Criteria:
Inclusion Criteria:

* Male and females 18 - 74 years of age inclusive
* Fungal toenail infection of one or both of the large (great) toenails
* The nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed)
* Willingness not to have professional pedicures or application of any nail polish product or nail cosmetics to the toenails after the screening visit

Exclusion Criteria:

* History of any significant chronic fungal disease other than onychomycosis or immunocompromised condition
* Any abnormalities of the nail or previous surgery of the toenail that could prevent a normal appearing nail if clearing of infection is achieved
* Significant confounding conditions as assessed by the study doctor
* Participation in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* No administration of systemic antifungal medications within 6 months prior to screening visit
* No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
* Tinea pedis (athlete's foot) that would require systemic treatment

Other protocol-defined inclusion/exclusion criteria may apply
A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR™) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal.

A multi-center, early feasibility study of using the Mechanical Tissue Resuscitation™ (MTR™) therapy system for removal of excess fluid in subjects who have had a portion of their skull removed to expose the dura/brain and require drainage for fluid removal.

Mechanical Tissue Resuscitation (MTR™) is intended for short-term (up to 7 days) use to externally drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy) for which a portion of the skull has been removed resulting in exposure of the dura/brain and require drainage of fluid.

This is a single arm early feasibility study. The study will comprise of patients who will receive MTR™ therapy to remove fluid from the surgical site in patients that have undergone a craniotomy/craniectomy.

The patient population will include male and female patients ages 22-65 who have undergone a surgical procedure to remove a portion of the skull to expose the dura/brain (craniotomy or craniectomy) in which the dura is intact or has been closed (repaired), and who, as an integral part of their care would require placement of a Jackson Pratt drain.

Patients will be treated with MTR™ for up to seven (7) days, with a follow up evaluation approximately one month post treatment.

Patients who have suffered a traumatic brain injury (TBI) and require such a surgical procedure are not to be included in the patient population for this early feasibility study.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is willing and able to provide written informed consent.
2. The patient's age is ≥ 22 and ≤ 65 years.
3. The patient has a clinical need for a craniotomy/craniectomy and for which, as an integral part of their care, a Jackson Pratt (JP) drain would be placed at the surgical site.
4. The surgical case is classified as 'clean'.

Exclusion Criteria:

1. Patient has suffered a traumatic brain injury.
2. Patient is pregnant or lactating.
3. Patient's BMI = (Weight (lb) x 703)/(〖Height〗\^2 (inches)) \> 45; BMI may also be calculated at http://nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm
4. Patient is participating in another clinical investigation .
5. Patient's anticipated survival is \< 48 hours.
6. Patient is incarcerated at time of hospital admission.
7. Patient has a coincidental infection.
8. Patient has thrombocytopenia (platelet count \< 150,000/µL).
9. Patient has an International Normalized Ratio (INR) \> 1.5.
10. Patient is an active opioid abuser.
11. Patient is an active alcohol abuser.
12. There is active bleeding at the site of surgery.
Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers

This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to compare the safety and pharmacokinetics of YH22162 in healthy male volunteers.

Hypothesis: Study drug and comparator drug are showing equal pharmacokinetics.

In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.

In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria:

* History of and clinically significant disease
* Administration of other investigational products within 3 months prior to the first dosing
* Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing

An intravenous bolus of fentanyl often induces a cough reflex. This study investigates whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.

Fentanyl is widely used for analgesia and anesthesia because of its rapid onset, its intense analgesic effect, and is associated with lessened cardiovascular depression and low histamine release. Although the cough reflex is usually transient and self-limiting, it should be avoided in situations such as elevated intracranial, intraocular, or intra-abdominal pressure, and unstable hemodynamics.

The cause of FIC is unclear. One hypothesis is that vocal cord spasms might induce coughing because of fentanyl-induced muscle rigidity and histamine release. Muscle relaxants are commonly used to treat this condition. This study hypothesizes that priming muscle relaxants could prevent or suppress FIC. This study investigates whether the muscle relaxant rocuronium attenuates FIC effectively.

Eligibility Criteria:
Inclusion Criteria:

* 260 ASA I-II patients,
* aged between 18 and 80 years, and undergoing various elective surgeries at Taichung Armed Forces General Hospital.

Exclusion Criteria:

* a history of asthma,
* chronic cough,
* smoking,
* upper respiratory tract infection in the previous 2 weeks, and
* medication containing angiotensin-converting enzyme inhibitors or anesthetic premedication.