cyrilzakka/clinical-trials huggingface dataset:
Endotracheal Tube (ETT) Cuff Pressure Study in the Emergency Department (ED)

Our study will measure the pressure of the endotracheal tube cuff in intubated patients in the emergency department.

Although manometers are available for the purpose of measuring ETT intra-cuff pressures, they are not currently in use at our institution's Emergency Department. This prospective cohort study will endeavor to determine the incidence of unacceptably high ETT cuff pressures in the ED, laying the foundation for follow up studies on patient outcomes and the potential need for more careful management of intra-cuff pressures in the ED.

Eligibility Criteria:
Inclusion Criteria:

* cuffed ETT in place on arrival in the ED
* cuffed ETT placed while in the ED

Exclusion Criteria:

* ETT cuff electively left deflated by practitioner
* Uncuffed ETT used
A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors

The purpose of this study is to assess the effect of multiple-dose administration of rifampin on the single dose PK of pevonedistat in adult participants with advanced solid tumors.

The study will enroll approximately 20 participants. The study will be conducted in two Parts: Part A and optional Part B. Part A will have a drug-drug interaction (DDI) assessment. In Part A, participants will be assigned to:

• Pevonedistat 50 mg/m\^2 + Rifampin

Eligible participants from Part A will continue treatment in optional Part B with pevonedistat in combination with SoC chemotherapy, docetaxel or carboplatin plus paclitaxel. The investigator will decide which SoC combination partner a participant will receive.

* Pevonedistat 25 mg/m\^2 + Docetaxel
* Pevonedistat 20 mg/m\^2 + Carboplatin + Paclitaxel

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 18 months. Participants will make a final visit to the clinic 30 days after receiving their last dose of study drug or before the start of subsequent therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Adult participants who have a histologically or cytologically confirmed metastatic or locally advanced solid tumor that is appropriate for treatment with either docetaxel or carboplatin + paclitaxel in Part B of this study, or have progressed despite standard therapy, or for whom conventional therapy is not considered effective.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
3. Expected survival of at least 3 months from the date of enrollment in the study.
4. Recovered (that is, less than or equal to (\<=) Grade 1 toxicity) from the effects of prior antineoplastic therapy.
5. Adequate organ functions (kidney, liver, cardiac, bone marrow).
6. Suitable venous access for the study-required blood sampling (including PK sampling).

Exclusion Criteria:

1. Prior treatment with radiation therapy involving greater than or equal to (\>=) 25% of the hematopoietically active bone marrow.
2. Life-threatening illness or serious (acute or chronic) medical or psychiatric illness unrelated to cancer.
3. Active, uncontrolled infection or severe infectious disease.
4. Known human immunodeficiency virus (HIV) seropositive or known hepatitis B or hepatitis C infection.
5. With significant heart or pulmonary disease.
6. Requiring chronic treatment with breast cancer resistance protein (BCRP) inhibitors.

Criteria for Continuation into Optional Part B:

To be eligible for Part B, participants must have completed Part A and be reassessed to determine if they meet the continuation criteria for Part B.
Efficacy of Photobiomodulation in the Rehabilitation of Olfactory Dysfunctions Induced by Long COVID-19

On January 30, 2020, the WHO (World Health Organization) declared the new coronavirus pandemic as the sixth public health emergency of international concern. In February 2020, the virus was designated by the Coronavirus Study Group of the International Committee on Virus Taxonomy as severe acute respiratory syndrome coronavirus 2. Many reports have described the appearance of olfactory or gustatory dysfunction simultaneously with other pre-established symptoms of COVID-19. Symptoms such as loss of taste or smell may appear 2 to 14 days after being infected with COVID-19. Worldwide, evidence regarding anosmia (loss of smell) and dysgeusia (change in taste) has been associated with COVID-19 infection. OBJECTIVES: To evaluate the effectiveness of low-intensity laser in treating changes in smell and taste after COVID-19 infection and map which changes obtained the best results. MATERIAL AND METHODS: This is an intervention study whose sample will consist of 30 individuals with loss of smell and taste for more than 6 months after COVID-19 infection, aged 18 years or older.

objective: To evaluate the effectiveness of low-intensity laser in resolving chemosensory symptoms caused by COVID-19.

This is an intervention study. The sample will consist of 30 individuals who will be allocated to the low-intensity laser treatment group.

The patients will come from research at the COVID-19 outpatient clinic at the Gafree Guinle University Hospital - UNIRIO. Patients who agree to participate in the study will be informed about the objective of the research and will sign an informed consent form.

Eligibility Criteria:
Inclusion Criteria:

* Patients who complained of loss of smell and taste more than 6 months after COVID-19 infection, aged 18 years or older, with proof of infection by PCR, will be included in the study.

Exclusion Criteria:

* Patients with comorbidities prior to COVID-19 infection that could interfere with the functions of smell and taste will be excluded from the study; patients with a history of head and neck cancer, epileptic patients; mouth breathing patients; and pregnant women.
Treatment of Social Phobia Over the Internet

Forty-eight people diagnosed with social phobia in an experimental study that randomized into two treatment groups: 1) Internet-based Cognitive Behavioural Therapy (iCBT) (n = 24) or 2) computerized attention training (n = 24). After nine weeks we change the condition of the two groups of research participants, which should therefore be given both treatments. Pre-and post measurement of functional magnetic resonance imaging (fMRI) will take place in the first round of treatment. Genotyping based on saliva samples takes place before the start of treatment, at the first fMRI measurement, for those who voluntarily leave the sample.

Study hypothesis

How is the brain activity of emotional processing and anxiety affected after completing an Internet-based CBT compared with computerized attention training? Does the treatment response of an Internet based treatment affects by variations in serotonin-transporter-linked promoter region (5-HTTLPR) and tryptophan hydroxylase-3 (TPH3) genes?

How is the genetic variations related to symptoms in social phobia (pre treatment)?


Eligibility Criteria:
Inclusion Criteria:

* Participants must meet criteria for social phobia using the International classification system Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).

Exclusion Criteria:

* Individuals with current depression and/or is suicide prone will be excluded from the study.
* With fMRI the following criteria must not be filled: previous surgery in the heart or brain, metals implanted in the body, dental braces or bridge; piercings that can´t be taken out, tattoos (shoulders, arms and back is not so good, the legs are okay if it is not too large); trouble to lie still for about an hour, pregnancy or history of neurological diseases.
Outcomes of Frozen Shoulder Treated With Small Needle-Knife Through Microcirculation and Pulse Analysis.

The aim is to investigate whether adding small needle-knife therapy to standard Western medicine enhances the treatment of frozen shoulder by evaluating its impact on microcirculation and meridian unblocking.

The aim of this research is to investigate whether the combination of small needle-knife therapy with conventional Western medicine treatment can enhance therapeutic effects compared to conventional treatment methods. In addition to clinical measurements of joint mobility and relevant scales, this study integrates instruments such as Laser Doppler Flowmetry (LDF) and pulse diagnosis devices. These non-invasive methods are employed to evaluate the microcirculation performance of patients with frozen shoulder before and after conventional Western medicine treatment or combined treatment with small needle-knife therapy. The objective is to understand the effects of small needle-knife therapy on the microcirculation and meridian unblocking in frozen shoulder patients.

Eligibility Criteria:
Inclusion Criteria:

* Limited shoulder joint mobility in various angles (forward flexion, abduction, external rotation, and internal rotation), persisting for over two months.
* Persistent pain on the affected shoulder even without rest.
* Willing and consenting to participate in this research.

Exclusion Criteria:

* Degenerative shoulder joint arthritis (osteoarthritis).
* Rheumatoid arthritis.
* Fracture of the humerus, clavicle, scapula, shoulder acromioclavicular dislocation, shoulder dislocation.
* Cervical radiculopathy.
* Thoracic outlet syndrome.
* Restricted shoulder joint mobility due to stroke, spinal cord injury, or other factors.
Evaluation of BiCROS Fitting Benefits

23 candidates for BiCROS hearing aids will be recruited and fitted with a hearing aid and a CROS device. Following a real-world trial, each participant will be tested on a range of outcome measures including speech recognition in noise, ratings of listening effort, and ratings of preference.

Unilateral Hearing Loss (UHL) can be defined as any degree of permanent hearing loss on one ear with normal hearing in the opposite ear. Unilateral hearing loss can be debilitating associated with audiological, psychosocial and educational challenges. Audiological challenges include the reduced ability to localize sounds, reduced awareness on the unaidable side and difficulties hearing in noise or at a distance.

One solution for unaidable UHL is Contralateral Routing of Signals (CROS) and Bilateral Contralateral routing of signals (BiCROS) using a so-called CROS transmitter together with a hearing aid.

The rationale for this clinical investigation is to collect clinical data with a rechargeable CROS transmitter to evaluate the benefits of a BiCROS fitting compared to the alternative treatment option, the monaural hearing aid fitting, and to no treatment in noisy listening situations.

Hearing tests, ear impressions and hearing aid fitting visits are mainly conducted at the National Centre for Audiology in London, Ontario. Those visits are available at the Sonova Innovation Centre Toronto in Mississauga, Ontario, upon request. Outcome measurements are only conducted at the National Centre for Audiology in London, Ontario.

Eligibility Criteria:
Inclusion Criteria:

* unaidable hearing loss in worse ear (\>N6)
* aidable hearing loss (N3 to N5) on the other ear
* fluent English speaker

Exclusion Criteria:

- aidable hearing loss in both ears
SCM Muscle Released in Patients with Cervicogenic Headache

Sternocleidomastoid syndrome is often characterized by referred pain in other areas. Like all muscles, the SCM can develop tight, and non-contracting bands called trigger points that can refer pain elsewhere. For the SCM, the trigger point referral areas are the eye and forehead, the back of the head (occiput), front of the neck, cheek, and side of the head. Trigger points can be treated by direct manual massage, dry needling, or platelet-poor plasma injection.

Cervicogenic headache is a specific type of headache that originates from the cervical spine and is typically chronic in nature. Diagnostic criteria for CGH have been established by the International Headache Society (IHS) and are cited extensively in the literature. Diagnosis of CGH through manual examination is a more recent practice. To our knowledge, no systematic review of manual diagnosis of CGH has been performed.

Eligibility Criteria:
Inclusion Criteria:

* History of CGH ≥ 3 months at Baseline 1, ≥5 days of CGH per month
* CGH intensity ≥3 (0-10 scale)
* Cervical spine dysfunction (cervical joint tenderness and/or restricted segmental motion)
* Clear temporal sequence linking the source of CGH to the neck: headache preceded by neck pain, stiffness, movement and/or awkward postures

Exclusion Criteria:

* Other headaches within one year of enrollment (e.g. migraine occurring on \>1 day per month in the last year, medication overuse, daily, cluster, temporomandibular joint dysfunction related headaches, sinus, posttraumatic, tumor and glaucoma related, occipital neuralgia, metabolic/toxic/substance abuse related).
* Spinal manipulative therapy, massage or exercise therapy for neck pain or headaches in the previous 3 months. Any other types of care by a licensed provider in the previous month for headaches or neck pain
* Contraindications to study treatments (e.g., inflammatory arthropathies, cervical instability, severe osteoporosis, vertigo, dizziness)
* Daily prescription or nonprescription pain medication; corticosteroid use in previous month
* Cancer in the past five years
* ear problem
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours

This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years
2. Body mass index \<35 kg/m2
3. Bladder tumour located \<3 cm in size; clinically non-muscle invasive bladder tumour
4. Clinically indicated for en-bloc resection.
5. Willingness to participate as demonstrated by giving informed consent

Exclusion Criteria:

1. Presence of endoscopic or imaging signs of detrusor muscle invasion
2. Contraindication to general anaesthesia / spinal anaesthesia
3. ASA \> 2 patients
4. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
5. Untreated active infection
6. Un-corrected coagulopathy
7. Presence of another malignancy or distant metastasis
8. Emergency surgery
9. Vulnerable population (e.g. mentally disabled, pregnant)
Simvastatin Gel With Perforated Resorbable Membranes in Treatment of Intrabony Defects in Chronic Periodontitis

Modified perforated membrane (MPM) is considered as a modality that could enable participation of periosteal cells and gingival stem cells which could improve the outcomes of guided tissue regeneration more than the use of the traditional occlusive membrane (OM). Simvastatin (SMV) modulates bone formation by increasing the expression of bone morphogenetic protein 2 and angiogenesis. Ethylenediaminetetraacitic acid (EDTA) found to be effective as low ph etchant for smear layer removal and exposing root surface collagen. The investigators compared the clinical and radiographic outcome of SMV gel combined with MPM to SMV gel combined with OM with and without an associated EDTA gel root surface etching for improving bone regeneration in intrabony defects in chronic periodontitis patients. Moreover, evaluation of SMV gingival crevicular fluid (GCF) levels availability for 30 days in cases with and without EDTA root surface etching was performed.

Forty patients with 40 intrabony defects having chronic periodontitis were randomly assigned into four equal groups to receive open flap procedure, 1.2% SMV gel and covering the defect with OM (Group I), open flap procedure, 1.2% SMV gel and covering the defect with MPM (Group II), open flap procedure, 24% EDTA root surface etching,1.2% SMV gel and then coverage of the defect by OM (Goup III), or open flap procedure, 24% EDTA root surface etching, 1.2% SMV gel and then coverage of the defect by MPM (Group IV). Plaque index, gingival index,probing pocket depth, clinical attachment level, defect base level, crestal bone level, and radiodensitometric measurements were measured at baseline and reassessed at 6 and 9 months after therapy. Additionally, GCF was collected from group I, II, III and IV at 1,7,14, 21, and 30 days in order to evaluate SMV availability and the effect of EDTA root surface etching on its availability using High-performance liquid chromatography(HPLC).

Eligibility Criteria:
Inclusion Criteria:

* Patients were all healthy and free from any systemic disease.
* No history of antibiotic therapy or periodontal treatment for at least six months preceding the study.
* Patients were willing and able to return for multiple follow up visits.
* Periodontal defects with

  1. Probing depth \> 5 mm.
  2. Clinical attachment loss \>4 mm.
  3. Standardized radiographic evidence of interproximal intrabony defect using periapical radiograph.
* Good level of oral hygiene (plaque and gingival indices score after initial phase therapy should be less than one).

Exclusion Criteria:

* Pregnancy, lactation for female patients.
* Smokers, alcoholics and those receiving any medication that could affect healing of soft tissue and bone as steroids and cyclosporines.
* History of allergic reaction to the medications used.
* Vulnerable groups and handicapped.
Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes

There is some consensus that high fat diets can contribute to the development of obesity and type 2 diabetes in humans and animals. An increase in dietary fat has been shown to produce obesity and diabetes in mice; such diet-induced diabetes can be reversed by reducing the fat in the diet. In humans, there is some evidence that low-fat diets can produce acute improvements in blood sugar control in type 2 diabetes-even in the absence of weight loss. In most human studies, however, dietary fat reduction has been accompanied by a reduction in total calorie intake. It is thus not possible to separate the effects of these 2 metabolic changes. The purpose of this study is to gather preliminary information on the effect of a very-low-fat diet on blood metabolism in persons with type 2 diabetes. The design incorporates controlled feeding procedures, and 30 men and women with type 2 diabetes will be given all foods for 4 weeks--a 2-week diet standardization period (diet composition: 35% fat, 15% protein, 50% carbohydrate), followed by a 2-week experimental diet period. The experimental diet conditions are A) continuation of the moderately-high-fat standardization diet, or B) a very-low-fat diet composed of 10% fat, 15% protein, 75% carbohydrate. Outcomes will be measured after the standardization and the experimental periods. The primary outcome variable is fasting plasma glucose; secondary outcomes are fasting insulin, carbohydrate (meal) tolerance, insulin secretion and blood lipids. In addition, we will gather descriptive data on the potential acceptability and utility of a very-low-fat diet constructed using the fat substitute, olestra (sucrose polyester). There are no results yet.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, not tightly controlled at present
* Not using medication (insulin or oral) to control blood sugar
* Overweight, but generally healthy
A Phase 3 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants with Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.

Study SSGJ-608-PsO-III-01 is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study examining the effect of 2 dose regimens of recombinant anti-IL-17A humanized monoclonal antibody versus placebo in Chinese participants with moderate-to-severe plaque psoriasis during an induction dosing period with dosing for 12 weeks and the primary endpoint measured at 12 weeks, followed by a randomized, double-blind, 40-week maintenance dosing period. During the maintenance dosing period, the study will evaluate the maintenance of response/remission, as well as relapse following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 Years to 75 Years, both male and female.
* Chronic plaque psoriasis (PSO) for at least 6 months prior to the Randomization.
* Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) score \>=3.
* According to the judgment of the investigator, the subject needs to receive systemic treatment and / or phototherapy (including subjects who have used local treatment, and / or phototherapy, and / or poor control of previous systemic treatment).
* Fertile female subjects and male subjects (and their female partners) must take effective contraceptive measures within at least 6 months from the screening period to the last medication. The subjects have no fertility, sperm donation and egg donation plans within at least 6 months from the screening period to the last medication.

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline.
* Drug-induced psoriasis.
* Ongoing use of prohibited treatments.
* Have previously received any drug that directly targets IL-17 or IL-17 receptor, or IL-12 / IL-23, or IL-23.
* Biological agents or their biological analogues were used before randomization, including but not limited to: Etanercept \< 28 days; Infliximab, adalimumab or afacet \<60 days; Golimumab \<90 days; Or other biological agents \< 5 half lives.
* Pregnant or lactating women.
Can We Improve the Comfort of Pelvic Exams?

The purpose of this study is to investigate patients self-reported comfort levels during each section of the pelvic exam.

The purpose of this randomized controlled trial is to investigate the sequence in which physicians perform the pelvic exam, describe and compare the self-reported comfort during each section of the pelvic exam and how comfort during the exam relates to quality of life, self-esteem, and sexual function in English speaking females at least 18 years of age in an outpatient setting.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking, female patients
* Are able to can read and write English
* Are utilizing outpatient services at an OBGYN outpatient office
* Are scheduled for a well-woman exam

Exclusion Criteria:

* Non-English speaking patients
* Patients who cannot read or write
* Those who are pregnant
* Have an active vaginal infection
* Patients who, otherwise, do not require a speculum exam during their appointment