cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain

Patients with chronic masticatory muscle pain (i.e., pain greater than three months) or patients with burning mouth syndrome participate in this study. The aim of the study is to compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered with either placebo or naloxone, a drug used to treat opiate overdose. A second goal is to determine if there are sex differences in these two drug regimens. Drugs will be administered with single-use intranasal spray devices. All participants will receive two sprays (one spray per nostril). One of the two sprays will be nalbuphine (5 mg). The other spray will be naloxone in half the participants and placebo in the other half.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of temporomandibular muscle pain OR
* Clinical diagnosis of burning mouth syndrome
* Pain duration: at least 3 months
* Pain severity: 2 or greater on a 0 - 10 scale

Exclusion Criteria:

* No adverse reaction to study drugs
* Not currently using narcotic analgesic drugs
The Effect of Hallux Valgus Angle on Dynamic Knee Movement Pattern

Abstract Background/aim: Little is known about the relationship between hallux valgus and the alignment of proximal joints. Dynamic knee valgus is a movement pattern characterized by excessive knee abduction along with femoral adduction, internal rotation, and relative external tibial rotation. It is more prevalent in females and exacerbates during landing in jumping, predisposing athletes to injuries. The aim of this study is to investigate the effect of hallux valgus deformity on dynamic knee movement pattern and lower extremity injuries in athletes.

Materials and methods: This is a cross-sectional observational study. The study included 92 athletes with at least 3 years of experience in their respective sports.

Athletes without acute injuries that could affect performance tests were included. Demographic data were collected, and the hallux valgus angle was measured using a goniometer. A standard warm-up protocol was then administered. A drop jump test from a 30cm platform was conducted, and images captured during the test were analyzed in 2D using Kistler+Noraxon Measurement Device cameras.

Eligibility Criteria:
Inclusion Criteria:

* At least 3 years of experience in their respective sports.

Exclusion Criteria:

* Athletes with acute injuries
Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects

Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to genetic and / or environmental factors such as inadequate dietary pattern. The occurrence of adverse events with statins, added to recent questions about their benefits on hard outcomes, opens a gap for the importance of seeking other forms of treatment of dyslipidemia, particularly in patients for secondary prevention. The consumption of oat bran, beta-glucan source of dietary fibers with supposed action in reducing the absorption of exogenous cholesterol and the endogenous synthesis of it, and source of avenanthramides, phytochemical compounds with alleged antioxidant in lipid membranes, can be effective strategy for secondary prevention of atherosclerotic disease.

Objectives: To evaluate the effect of nutritional counseling associated with the consumption of oat bran (40g per day) in lowering cholesterol, glucose profile and anthropometric parameters of subjects in secondary prevention, evaluate the quality of the diet and the intake of processed foods and ingredients added.

Methods: A randomized block, double-blind, placebo-controlled trial lasting 90 days. Inclusion criteria: individuals aged greater than 20 years, both genders, with LDL-c equal or higher than 130mg/dL fasting lipemia. Eligible individuals were considered using oral lipid-lowering, since the dose reported in the early nutritional intervention was maintained during the study. Exclusion criteria: patients requiring reduction in daily fluid intake, supplement use in dietary fiber and gestation / lactation. Data collected: gender; age; education; drugs; body mass (BM), height, body mass index (BMI), waist circumference (WC), neck circumference (NC); blood pressure; dietary surveys, total cholesterol (TC), LDL-C, HDL-cholesterol (HDL-c), triglycerides (TG), fasting glucose (GLU), fasting insulin (INS), HOMA-IR and QUICK. The diet quality was evaluated at baseline and end of study through the Diet Quality Index Revised (IQD-R). The sample size calculation was performed from a pilot study. It came to the need for 63 subjects for each group, oat bran group (GFAV) and placebo group (GPL). The level of statistical significance was 5% (p \<0.05).

Eligibility Criteria:
Inclusion Criteria:

* LDL-c equal or higher than 130mg/dL fasting lipemia.

Exclusion Criteria:

* patients requiring reduction in daily fluid intake
* patients in use of dietary fiber supplements
* gestation
* lactation
Diabetic Foot Education

To determine the effect of foot care training given according to Interpersonal Relationship Theory on foot care behaviour and diabetic foot self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age,
* Diagnosis of Type 2 DM for at least 6 months,
* Not having received planned diabetic foot training before,
* Volunteering to participate in the study,

Exclusion Criteria:

* Neuropsychiatric drug use and disease that may affect education (Dementia- Alzheimer's and Mental Retardation etc.)
* Being visually impaired,
* Hearing impairment,
* Inability to speak Turkish,
* Presence of active diabetic foot ulcer.
COVID-19 Impact on RSV Emergency Presentations

Bronchiolitis is a very common winter disease that normally affects children less than one year of age. It is a common reason for parents and carers to bring their child to an Emergency Department (ED) and the frequent need for hospital admission means that paediatric units are at their capacity each winter.

During the COVID19 pandemic the virus that causes bronchiolitis (Respiratory Syncytial Virus; RSV) disappeared meaning this winter there have been virtually no cases of bronchiolitis in the United Kingdom. This phenomenon has been observed in many other countries around the world. Evidence from Australia suggests as restrictions such as social distancing for COVID19 are relaxed bronchiolitis returns, even in the summer. At the release of lockdown the return has been so dramatic in some areas of Australia the summer time numbers are above a typical winter. There is also evidence it may affect older children up to 2 years of age.

It is likely the Australian experience will be mirrored in the UK. The ability to track, anticipate and respond to a surge in bronchiolitis is important. There is a need to understand:

1. the onset of RSV spread at the earliest opportunity. This is important as some children are at higher risk of hospitalisation, intensive care admission or death if they contract RSV; knowing when to passively immunise these children is a public health priority.
2. whether the population at risk is a wider age range than normal and whether disease severity is greater as these will both effect service planning;

There are currently no existing studies or surveillance systems fully able to address these questions. This study will use staff in Emergency Department to report, in real time, case of bronchiolitis that they see and record essential, but non-identifying, information about them.

In 2022/23 the study evolved from a prospective surveillance study into a genomic analysis study with sites collecting positive respiratory samples for RSV genomic review.

In 2024/25 the study was amended in light of the introduction of the Bivalent Prefusion F Vaccine in Pregnancy in the United Kingdom to undertake a Vaccine Effectiveness study.

The main inclusion criteria remains the same but mothers who would have been eligible for the vaccine, and deliver an infant during the RSV season, were consented to obtain vaccination details so these could be linked to BronchSTART records.


Eligibility Criteria:
Inclusion Criteria:

i) Children under two years of age presenting to participating emergency departments with clinical features of:

* Bronchiolitis (cough, tachypnoea or chest recession, and wheeze or crackles on chest auscultation) or
* Lower Respiratory Tract infection or
* Afirst episode of acute viral wheeze.

Exclusion Criteria:

i) Children with previous episodes of wheeze responsive to bronchodilator (suggesting an underlying diagnosis of recurrent wheeze of early childhood)
Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis

Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new Pa infection.

Methods: CF children (0-18 years) with a new isolation of Pa from the airway were randomized to tobramycin inhalation solution (TOBI® 2x300 mg for 28 days) (TIS) or inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) plus oral ciprofloxacin (30mg/kg/day) for 3 months (CC). The primary outcome was eradication at end of treatment. Secondary outcome parameters were time to Pa relapse, total and Pa specific IgG, FEV1, BMI and Pa status.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CF (clinical signs consistent with CF and a sweat chloride \> 60 mEq/l by quantitative pilocarpine iontophoresis and/or two CF causing mutations identified)
* age 0 to 18 years old at time of inclusion
* 'First' or 'new Pa infection' defined as 'first Pa isolation ever' or 'isolation of Pa from the airway (sputum, throat swab or BAL) after a Pa free interval of at least 6 months and documented with at least 3 negative cultures'.

Exclusion Criteria:

* chronic Pa infection defined according to the Leeds criteria\[17\]
* pulmonary exacerbation needing IV AB treatment at time of new Pa isolate
* Pa isolation at time of CF diagnosis
* patient already on an antipseudomonal antibiotic
* interval between positive culture and start of treatment \> 4 weeks.
Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

The purpose of the study is to evaluate whether Folrex, could improve the motor recovery of the upper extremity after stroke in comparison with placebo during 4 weeks of treatment.

Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month. Each value will be compare to evaluate whether the groups of patient improve.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute stroke \< 24 hours.
* Patients with impairment up to 4 on NIHSS scale.
* Family support.
* Informed consent.

Exclusion Criteria:

* Presence of another disease not well controlled.
* Patient with dementia.
Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD)

This study is a prospective, multicenter, parallel, open-label, randomized, controlled, superiority trial. It is planned to recruit 8,250 patients with multi-vessel disease(MVD), and the patients will be followed-up for at least 12 months after being implanted with a drug-eluting stent (DES) at one of 100 different centers. All patients will be randomly divided into the treatment group and control group on a 1:1 basis, based on a complete randomization.


Eligibility Criteria:
Inclusion Criteria:

* The enrolled subjects must meet all of the following criteria:

  1. Aged 18-75 years old (inclusive).
  2. Patients with MVD who underwent DES implantation for 12 months.
  3. Patients have been treated with aspirin and can tolerant of aspirin at doses of 75-150 mg/day as maintenance therapy during the study period.
  4. Patients have signed informed consent.

Exclusion Criteria:

- Subjects who meet any one of the following criteria are excluded from the study:

1. Planned to use of ADP receptor blockers (eg, clopidogrel, ticagrelor, and ticlopidine), dipyridamole, or cilostazol.
2. Contraindication to ADP receptor blockers or aspirin.
3. Planned to use anticoagulants during the study period.
4. Planned coronary, cerebrovascular, or peripheral arterial revascularization during the study period.
5. Planned major cardiac or non-cardiac surgery during the study period.
6. Concomitant oral or intravenous therapy with CYP2C19 medium or strong inhibitors.
7. Known severe liver disease(ALT/AST is 3 times above normal).
8. Subjects with renal failure who required or anticipated dialysis during the study period.
9. Platelet count \<50×10\^9/L.
10. Patients with:

    * A history of intracranial bleed or ischemic stroke at any time.
    * A central nervous system tumor or intracranial vascular abnormality (eg, aneurysm, arteriovenous malformation) at any time.
    * Intracranial or spinal cord surgery within 5 years.
11. Pregnancy or lactation or planned to pregnant during the study period.
12. Life expectancy \< 1 year.
13. Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, active malignancy other than squamous cell or basal cell skin cancer).
14. Concern for inability of the patient to comply with study procedures and/or followup (eg, alcohol or drug abuse).
15. Participation in another clinical study and did not reach the major endpoint.
16. Involvement in the planning and/or conduct of the study.
Raman Spectroscopy and Skin Cancer

The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is:

-Can Raman Spectroscopy help figure out how far a tumor spreads?

This study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin.

Radiation therapy is an alternative to surgery for localized tumors with excellent tumor control and cosmetic outcome. Raman Spectroscopy has potential to be a useful non-invasive, non-destructive, real-time, in-vivo tool for differentiation of cancerous vs. non-cancerous tissues. With this knowledge and future studies, this will ultimately guide skin brachytherapy more accurately and avoid unnecessary radiation to cosmetically and functionally important tissues including eyelid, nose, lips or skin folds.

The purpose of this study is to determine the feasibility of Raman Spectroscopy to identify microscopic infiltration extent of skin cancer beyond grossly visible tumor, using artificial intelligence methods of supervised and un-supervised machine learning algorithms, including pattern recognition, convolutional neural networks, k-means clustering and principal component analysis.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed skin cancer (either basal cell carcinoma or squamous cell carcinoma)
* Participants must plan to receive brachytherapy treatment for the skin cancer at the study site.
* Ability to provide consent to the study.

Exclusion Criteria:

* Patient belongs to a vulnerable population (Minors (under 18 years old), Adults unable to consent, prisoners).
* Lesions on the eyelid or in close proximity to the eye
* Pregnant women, or women of childbearing age who refuse pregnancy testing.
* Patient has pacemaker.
Test Safety and Efficacy of Zotarolimus- and Everolimus-Eluting Stents (ZES/EES) Assessed by Optical Coherence Tomography

The objective of the study is to assess the superiority of the everolimus-eluting stent (Endeavor Resolute®) compared with the everolimus-eluting stent (XIENCE V®) regarding uncovered stent strut segments.

The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels.
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
* In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria:

* Lesion length \>16mm requiring a stent length \>18mm
* Target lesion located in the left main trunk.
* In-stent restenosis.
* Acute myocardial infarction
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Known allergy to the study medications: everolimus, zotarolimus, stainless steel or cobalt chrome.
* Inability to take dual antiplatelet therapy for at least 6 months.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.
A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma

This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and written informed consent;
2. Aged 18-75 years (inclusive), males and females;
3. Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy;
4. FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory;
5. At least one measurable lesion that has not been treated locally;
6. ECOG score of 0-1;
7. Expected survival ≥ 12 weeks;

Exclusion Criteria:

1. Presence of multiple factors affecting oral medications;
2. Wounds unhealed over a long period of time, or fractures not completely healed;
3. Known or suspected allergy to investigational drug or any drug related to this trial.
4. Known cases of CNS(Central Nervous System) metastasis;
5. Uncontrolled cardiac diseases or symptoms;
6. Patients with congenital or acquired immunodeficiency (such as HIV positive), or a history of organ transplants;
7. Patients previously treated with FGFR inhibitors (such as erdafitinib)
Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine

The purpose of this study is to evaluate the effects of pyridostigmine (Mestinon) on patient vocal outcomes after undergoing laryngeal botulinum neurotoxin (BoNT) injections, which is a standard treatment for spasmodic dysphonia. Pyridostigmine (Mestinon) has been used for treatment of BoNT overdose, and it is our hope that it will be beneficial in the management of post BoNT breathy phase.

The study will enroll 10 subjects and will involve 1 clinic visit with two sessions over 2 hours.

Participants' voices will then be analyzed via sentence/passage reading, sustained vowel holding, maximum phonation time, as well as subjective ratings of effort. During the second clinic visit, participants will then be administered one 60mg tablet of pyridostigmine (Mestinon) orally, and asked to return to the clinic in 2 hours, when Mestinon has reached peak plasma concentration. Upon returning, participants will repeat the vocal analysis and results will be evaluated for any change in outcome.

Patients who are pregnant, lactating, or have kidney or heart disease should not participate.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females Aged 21-100
* Scheduled for Botulinum Neurotoxin (BoNT) Treatment for Spasmodic Dysphonia (SD)

Exclusion Criteria:

* Subjects who are Pregnant or Lactating
* Subjects with Compromised Renal or Cardiac Function
* Subjects with Spasmodic Dysphonia with Superimposed Vocal Tremor
A 2-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CAT-2054 in Healthy Subjects

This is a 2-part, Phase 1, placebo-controlled, double-blind, randomized, single and multiple ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054) or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a second dose of the study drug after a high-fat meal. Additionally, at 1 dose level, CAT-2054-C or placebo will be administered as a single dose in a fasting state, and subjects will return for a second dose of the study drug after a high-fat meal. In Part B, CAT-2054 will be administered as multiple ascending doses at 4 dose levels for 14 consecutive days. In selected cohorts, CAT-2054, CAT-2054-C or CAT-2054 with atorvastatin will be dosed to assess safety in anticipation of future clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent before any study-specific procedure
* Good health as determined by medical history, physical examination, vital sign measurements, ECG, and clinical laboratory measurements
* Satisfies one of the following:

  1. Females not of childbearing potential: non-pregnant and non-lactating surgically sterile or postmenopausal 2 years or less with a follicle-stimulating hormone assessment greater than or equal to 40 IU/L
  2. Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose
* For Part B only, measured at Screening: Fasting LDL-C ≥100 mg/dL; or (Cohort B6 only) fasting LDL-C ≥130 mg/dL
* Body mass index (BMI) between 18 and 30 kg/m², inclusive, for Part A and between 18 and 40 kg/m², inclusive, for Part B, and body weight \>50 kg at Screening

Exclusion Criteria:

* Use of prescription drugs or non-prescription drugs including herbals, and dietary supplements (including multivitamins and any product containing niacin or omega-3 fatty acids above the Recommended Daily Allowance) within 2 weeks before dosing. Additionally for Part B only, use of any lipid-regulating prescription drug, non-prescription drug, herbal, or dietary supplement within 6 weeks before dosing
* Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
* Clinically significant electrocardiogram (ECG) abnormalities or laboratory results as assessed by the investigator, such as QTcF \>450
* Use of any investigational drug or participation in any investigational study within 30 days prior to screening or 5 half-lives of the study agent, whichever is longer