cyrilzakka/clinical-trials huggingface dataset:
Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals

The purpose of this clinical study is to determine the effectiveness of low level laser light therapy when applied around the head and ears in improving unaided word recognition in ears with sensorineural hearing loss.

Sensorineural hearing loss accounts for about 90% of all hearing loss and is found in 23% of individuals older than 65 years. Sensorineural hearing loss occurs when the hair cells of the inner ear and the neural pathways to the auditory cortex are damaged. In most cases, sensorineural hearing loss cannot be improved, reversed or 'cured.' Current treatment options focus on methods that amplify external sounds and on teaching the patient various strategies to 'retrain' the brain to interpret external stimuli. Low Level Laser Therapy was first applied for the treatment of inner ear diseases by Uwe Witt, MD of Hamburg, Germany in the 1980's. Hearing impaired patients have inflammation and/or atrophy of the tissues and neural pathways connected to and supporting the cochlea's cilia hair structure, the hearing mechanism of the inner ear. Low level laser therapy is believed to stimulate the mitochondria of the adipocyte cells, which subsequently increases the production of ATP. The resultant surge in ATP production works to repair damaged tissue and regenerate cells reversing some of the damage incurred to the cochlea and thus improving aspects of hearing function.

Eligibility Criteria:
Inclusion Criteria:

* Sensorineural hearing loss.
* Mild or greater degree.
* Adult onset.
* Gradual onset.
* Hearing loss stable over past 12 months.
* Etiology of presbyacusis or noise-induced hearing loss.
* Unaided word recognition score between 28% and 86%.
* English as primary spoken language.
* Willing and able to abstain from other treatments or medications to improve hearing ability.
* Willing and able to abstain from work or other activities that involve loud noise exposure.

Exclusion Criteria:

* Central auditory processing disorder.
* Active/recurrent middle ear infection.
* Meniere's disease.
* Tympanic membrane perforation/tubes.
* Cochlear implant.
* Removal of acoustic neuroma.
* Hyperacusis/misphonia.
* Photosensitivity disorder.
* Active infection/wound in head/ear region.
* Pregnant/lactating.
* Serious mental health illness.
* Significant developmental disability/cognitive impairment.
* History of drug/alcohol abuse.
* Involvement in litigation/worker's compensation/disability benefits for hearing loss.
* Other research participation in past 90 days.
* Use of ototoxic medications known to cause temporary or permanent hearing loss.
Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations

In previous studies exploring specific sequences of MRI (susceptibility weighted imaging (SWI) and arterial spin labeling (ASL)), the investigators have shown the great sensibility of these MRI sequences to detect arteriovenous shunts, compared to angiography imaging (static or dynamic). This prospective study aims to compare multisequence MRI to brain arteriography imaging in patients undergoing brain arteriovenous malformations embolization.

Cerebral arteriovenous malformations are treated to eliminate the potential risk of haemorrhage. There are three possible treatment modalities: surgery, radiosurgery or embolisation. Complete exclusion of the arteriovenous malformation is a prerequisite for confirming that there is no residual risk of haemorrhage. After treatment, arteriography is the gold standard for confirming this exclusion. The absence of early opacification of the venous drainage is considered a sign of cure.

Several arteriographic aspects are possible after treatment by embolisation:

* Arteriography may be strictly normal (no abnormalities).
* The persistence of early venous opacification (presence of arterialised blood) indicates the persistence of a residual AVM.
* Other vascular anomalies without early venous drainage may be present: dysplastic vessels (irregular shape, "corkscrew" appearance) ; capillary blush in the embolisation bed (hyperaemia) ; other: slow flow, slow filling, or widening of afferent arteries.

Our previous studies exploring the use of specific MRI sequences, in magnetic susceptibility (SWI), arterial spin labelling (ASL) and angiography (static or dynamic) sequences, have enabled us to demonstrate the very high sensitivity of these sequences for detecting an arteriovenous shunt, whether native (when the AVM is discovered) or residual after treatment. We would like to carry out a prospective study to compare cerebral arteriography and MRI (multi-sequence) in patients treated by embolisation for cerebral arteriovenous malformation.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* with brain Arteriovenous Malformations
* embolization treatment scheduled

Exclusion Criteria:

* patient's refusal to participate in the study
* contraindication to undergo MRI examination
* patient under legal protection
Effect of a Butyrate Enema on the Systemic Concentration of Short Chain Fatty Acids

In this placebo-controlled randomized parallel study the effects of a butyrate enema on plasma short-chain fatty acids (SCFA) concentrations and fluxes from portal drained viscera, liver and the splanchnic area are investigated

Patients undergoing upper abdominal surgery are included. During surgery they receive a butyrate enema or placebo enema. Before and after rectal administration, plasma samples are taken from several veins and arteries to analyse SCFA concentrations and fluxes from portal drained viscera, liver and the splanchnic area.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing open liver resection or pancreaticoduodenectomy

Exclusion Criteria:

* known parenchymal liver disease
* presence of ileostomy or colostomy
* patients with inflammatory bowel disease
* antibiotics, prebiotics or probiotics 2 months prior to surgery
Effect of Hot Water Immersion on Heart Rate Variability and Glucose

Heat therapy has been shown to reduce risk of various diseases, including heart disease, alzheimers, and pneumonia, as well as all-cause mortality . A previous study found heating a single hand lowers postprandial blood glucose levels with a magnitude similar to certain exercise interventions such as 40 minutes of slow walking We propose that heating both feet and heating both legs up to the calves will result in similar glucose reductions in a dose response manner.Overview To determine the effect of heating both feet to the ankles and heating both legs to the calves on postprandial blood glucose


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years

Exclusion Criteria:

* previously diagnosed diabetes
Evaluation of Efficacy and Safety of Hyaluronic Acid (HA) Product for Cheek Augmentation

A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study is designed to assess efficacy with regard to aesthetic midface augmentation and safety after treatment with HA product.


Eligibility Criteria:
Inclusion Criteria:

* Provide a signed and dated informed consent to participate in the study including release of copyright of images
* Man or woman aged 18 years or older
* Be willing to abstain from any other facial plastic surgical or cosmetic procedures in close proximity to the treated area

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable HA gel
* History of bleeding disorder or treatment with anticoagulants, thrombolytics, or inhibitors of platelet aggregation, omega-3, or vitamin E within 2 weeks before treatment
* Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy, topical retinoids, systemic or topical corticosteroids within 3 months before treatment and systemic retinoids within 6 months before treatment
* Previous tissue augmenting therapy or contouring with permanent filler, fat-injection or permanent implant placed in the area to be treated
* The subject is, in the opinion of the investigator, unlikely to comply with the clinical investigational plan or is unsuitable for any other reason
Suspicion of Non IgE-mediated Cow's Milk Protein Allergy: Prevalence and Evolution

Cow's milk protein allergy (CMPA) is often evoked in infants, in particular in front of delayed symptoms such as rectal bleeding, atopic dermatitis, excessive crying, reflux, failure to thrive... But in case of non IgE-mediated CMPA, the only way to diagnose this allergy is to proceed to an elimination-reintroduction test over a period of 2 to 4 weeks, to improve symptoms first, and then provoke them. Even if the diagnosis is confirmed, we speculate that non IgE-mediated CMPA has a faster resolution than other CMPA.

The first aim of this study is to estimate the prevalence of non IgE-mediated CMPA in a cohort of infants with delayed symptoms which could be relied to a CMPA. The second goal is evaluate the age of tolerance in non IgE-mediated CMPA with oral food challenge for milk ever 2 months after 4 months of age.


Eligibility Criteria:
Inclusion Criteria:

* infants under 4 months age with delayed symptoms evoking CMPA

Exclusion Criteria:

* exclusively breastfed infants
* no improvement of symptoms despite amino acid formula
* patients with symptoms of food protein induced enterocolitis
* patients who do not have diagnostic oral food challenge within 3 months after the start of elimination diet
Comparison of the Cardiovascular Benefits of Resistance, Aerobic, and Combined Exercise

As the leading cause of death, cardiovascular disease (CVD) accounts for about one-third of U.S. mortality. Physical inactivity, one of the main CVD risk factors, causes 6% of coronary heart disease worldwide. The American Heart Association has identified cardiovascular health behaviors including smoking, obesity, diet, and aerobic exercise; however, resistance exercise was not included due to the limited evidence of its efficacy. Comparatively, the cardiovascular benefits of aerobic training have been well-documented whereas the independent and additive benefits of resistance training on cardiovascular health have not been established. Thus, this project is aimed to answer one of the most common questions about exercise and health:"What type or combination of exercise is most effective for CVD prevention?" This project will significantly contribute to developing more effective CVD prevention approaches, advancing more comprehensive physical activity guidelines, and providing important insights and novel opportunities for the future science of physical activity and health.

Participants will be randomly assigned to aerobic exercise, resistance exercise, combined aerobic and resistance exercise, or a no exercise control group for 1 year. Participants in all four groups will receive healthy diet and lifestyle education sessions and will track their daily steps, body weights, and food intake throughout the 1-year intervention. They will also complete baseline, 6-month, and 12-month physical examinations, which will include assessments of blood pressure, blood lipids, body composition, and aerobic and muscular fitness.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoker
* Systolic/diastolic blood pressure of 120-139/80-89 mmHg (without taking any anti-hypertensive medication)
* Overweight or obese: body mass index of 25-40 kg/m2; Asian 23-40 kg/m2
* Inactive: less than 150 min/week of exercise over the past 3 months
* Capable of performing the required exercise training

Exclusion Criteria:

* Unstable coronary heart disease or heart failure
* Uncontrolled arrhythmias or severe aortic stenosis
* Acute myocarditis, endocarditis, or pericarditis
* Cancer, requiring treatment in the past 5 years
* Autoimmune diseases, affecting the immune system
* Plans to be away/travel for greater than 4 weeks in the next year
* Pregnancy/anticipated pregnancy during the study
* Other medical condition that is life-threatening or can interfere with or be aggravated by the exercise training
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Lower Extremity Arteriosclerosis Occlusive Lumen

This trial was a prospective, multicenter, single-group design. To undergo endovascular treatment of lower extremity arteriosclerosis obliterans After the subjects were selected and enrolled, the surgeons used the endovascular interventional surgical instrument control system developed by Shanghai Aopeng Medical Technology Co., Ltd. and the consumables of the endovascular interventional surgical instrument control system for the interventional hand Instrumentation (guide wire, catheter, stent, balloon) for remote delivery, manipulation, and withdrawal

This study will verify the safety and effectiveness of the device in human peripheral vascular diseases, and verify 1. the degree of precision of its operation 2. the function of reducing radiation

Eligibility Criteria:
Inclusion Criteria:

* Meet all the following criteria to be included in the group.

  1. Age: 18 years old or above, regardless of gender.
  2. Suffering from arteriosclerosis obliterans of lower limbs, it has the indication of endovascular treatment.
  3. Volunteer to participate in the test and sign the informed consent form.

Exclusion Criteria:

* General criteria: If any of the following criteria is met, it cannot be included in the group.

  1. Pregnant or lactating women, or women of childbearing age with positive pregnancy test results.
  2. The target vessels were treated by arterial bypass grafting.
  3. Subjects participated in other clinical trials within 3 months before the screening period.
  4. Allergic history or contraindication of antiplatelet drugs, anticoagulants, anesthetics, contrast agents, scaffold materials and their coating drugs.
  5. Severe infection that is difficult to control.
* Vascular criteria: According to the CTA judgment of the diseased vessels, if any of the following criteria is met, they can not be included in the group.

  1. Perforation, dissection or aneurysm of the diseased vessel or the proximal vessel of the diseased vessel.
  2. The investigator believed that the vascular conditions were not suitable for the use of the test medical device.
DDEP for Lifestyle Modification in Chronic Kidney Disease

This is a randomized controlled feasibility trial conducted on patients with Chronic Kidney Disease (CKD) and their significant other

The trial will be conducted on 60 dyads, each comprising a CKD patient and a significant other, who will be randomly assigned into two groups. The intervention group will receive the Digital Dyadic Empowerment Program (DDEP) while the control group will receive routine education and care.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has a diagnosis of Chronic Kidney Disease for at least six months;
2. The patient can identify a helpful significant other and both parties are willing to participate;
3. The patient can communicate in Mandarin or Taiwanese.

Exclusion Criteria:

1. The significant other is a healthcare provider;
2. The patient or the significant other has a mental illness diagnosis;
3. The patient is currently receiving renal replacement therapies.
A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
* Subject is capable of performing reproducible spirometry maneuvers
* Subject has post-bronchodilator FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) ratio \<0.7
* Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the Global Initiative for the Treatment of Obstructive Lung Disease (GOLD) Guidelines)
* Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
* Subject demonstrates a post-ipratropium FEV1 response ≥ 12% and ≥ 200 mL of pre-ipratropium FEV1 response
* Subject has a current or past smoking history of at least 10 pack-years.

Exclusion Criteria:

* Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
* Subject has a history of reactions or hypersensitivity to inhaled anticholinergic or beta-agonist agents
* Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
* Subject has been hospitalized for COPD or pneumonia within 12 weeks.
* Subject requires long-term oxygen therapy (\>15 hours a day)
Targeting Components of Distress Tolerance

The goal of this clinical trial is to learn which aspects of distress intolerance (i.e., difficulties withstanding upsetting emotional states) are the most important for improving effective emotion regulation and associated mental health symptoms.

The main questions it aims to answer are:

How are willingness to feel upset and self-efficacy for withstanding distress associated with different emotion regulation strategies used in daily life?

Does targeting willingness to feel upset and/or self-efficacy for withstanding distress help people use more effective emotion regulation strategies in daily life when they feel upset?

Are improvements in emotion regulation strategies in daily life associated with fewer symptoms of mental health problems over time?

Participants will:

Answer questions about their moods, willingness to feel upset, self-efficacy for withstanding distress and emotion regulation strategies for three weeks using a cell phone app

Undergo a willingness, self-efficacy, combined or psychoeducational control intervention in the lab

Be prompted to use the intervention skill via the cell phone app during the second week, after the intervention

Complete weekly reports of mental health symptoms


Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Uses Android or iPhone smartphone
* Depression Anxiety and Stress Scale (DASS-21) scores of 42 and higher
* Distress Intolerance Index (DII) scores of 3 or higher

Exclusion Criteria:

* Work or School that does not allow consistent access to phone (or is unsafe)
* No internet access for completing follow-up surveys
A Dose-escalation Study in Subjects With Advanced Malignancies

This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with neoplastic disease refractory to currently available therapies or for which no effective treatment is available
* Subjects with life expectancy of 12 weeks or longer.
* Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Exclusion Criteria:

* Subjects who received any anti-cancer medications in the 21 days prior to receiving their first dose of study medication or 6 weeks for mitomycin-C or nitrosoureas.
* Subjects with history of brain metastases or spinal cord compression.
* Subjects who have undergone a bone marrow or solid organ transplant.
* Subjects who have had major surgery within 4 weeks prior to study entry or had minor surgical procedure within 7 days prior to initiating treatment.
* Subjects with clinically significant non-healing or healing wounds or subjects with lung tumor lesions with increased likelihood of bleeding
* Subjects with a history of any gastrointestinal condition
Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema

This study is designed to evaluate the safety, efficacy, and pharmacokinetics of balovaptan compared with placebo in participants with acute ischemic stroke (AIS) at risk of developing Malignant Cerebral Edema (MCE)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of LVO in the anterior circulation such that study drug administration can be initiated within 12 hours of LKW and at risk of MCE development, as defined as follows:
* Documented occlusion of terminus ICA and/or MCA on CTA or magnetic resonance angiogram and
* ASPECTS score \</=5 on NCCT and
* NIHSS \>15 for the non-dominant hemisphere and \>20 for the dominant hemisphere (or \> 20 if dominant/non-dominant hemisphere unknown)
* Present with a WUS \</=8 hours from awakening provided the above criteria are met
* Participants with a history of seizures on anti-epileptic medications may be included if they have been on stable doses of those medications for at least 12 weeks prior to LKW, they have not experienced seizures during that time frame, and their anti-epileptic medicines are continued during the study
* For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception and agree to refrain from donating eggs
* No specific contraception methods for males are required.

Exclusion Criteria:

* Participants who are \>12 hours from LKW at the start of treatment with study drug or \>8 hours from awakening with WUS
* Any MLS on brain imaging
* Evidence of intracranial hemorrhage at screening based on NCCT
* Contraindication to MRI examination
* Evidence of additional anterior cerebral artery (ACA) infarction
* Diagnosis of brain death
* Planned surgical decompression prior to randomization
* Participants with a known history of a hereditary bleeding disorder which increases bleeding risk
* Chronic kidney disease stage III or higher
* Hepatic injury
* Diagnosis of diabetes insipidus
* Participants who have received any prophylactic hyperosmolar therapy
* Participants who have received treatment with any other V1a and/or V2 receptor-blocking agent or glyburide
* A preexisting medical condition for which the participant is unlikely to survive the next 6 months
* Planned limitation or withdrawal of life-sustaining treatment during hospital admission
* Participants who are pregnant or breastfeeding, or intending to become pregnant
The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males

A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.


Eligibility Criteria:
Inclusion Criteria:

* Serum uric acid level ≥ 4.5 mg/dL (268 µmol/L)
* Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
* Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures

Exclusion Criteria:

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* History of cardiac abnormalities
* History and/or presence of drug addiction or excessive use of alcohol
Automated System for Gathering and Reporting Clinical Outcomes to Providers

The purpose of this study is to design and test the feasibility of a system to survey patients regarding the outcome of acute care visits and to report back to the healthcare providers.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 and older visiting participating primary care clinics who agree to be contacted by email to complete a survey on clinical outcomes.

Exclusion Criteria:

* None