cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia

This is a 16-week non-blinded, parallel, controlled trial to determine the feasibility and potential efficacy of an olive oil dietary intervention to alleviate facial pain caused by trigeminal neuralgia type 1 (TGN).

Trigeminal neuralgia (TGN) pain is debilitating and unpredictable. Alleviation of intensity or frequency to any degree will improve the quality of life of the individuals affected. Current medical treatments for TGN are often not effective. In some cases, the pain is a result of myelin degeneration. If diet can provide the basic building blocks for myelin regrowth, then the investigators may be able to reduce facial pain by supporting the myelin nerve sheath.

Animal studies have shown that a dietary intervention with olive oil favorably impacts myelin but no human study has been conducted to date. The investigators propose undertaking a feasibility study to determine if a comparable intervention may work in a similar way in humans. If olive oil impacts myelin repair, then pain will be decreased by this dietary intervention and quality of life will be improved. However, it is not known if individuals with TNG will be able to consume a diet relatively high in olive oil. Feasibility will include testing the logistics of distributing the olive oil intervention to the study subjects, incorporation of olive oil into the participants' daily diets, and online/distance monitoring of compliance and reporting of pain intensity, pain frequency, and quality of life. This feasibility study will lay the groundwork for potential future studies examining the efficacy of olive oil on alleviating facial pain caused by TNG and may provide data for a power analysis for a future interventional trial.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Trigeminal Neuralgia
2. Able to provide written informed consent in English
3. Self-identifying females 18-99 years of age
4. Willing to consume 60 mL (4 tablespoons) of olive oil and accommodating dietary changes, and thereby achieve weight maintenance.
5. Willing to provide information about dietary intake at baseline, at the study midpoint, and at the end of the study to assess dietary changes.
6. Willing to complete online questionnaires associated with the study.
7. Willing and able to provide a valid social security for study payment purposes.
8. Have access to the internet to complete online questionnaires
9. Willing to maintain confidentiality of the Penn Facial Pain Scale

Exclusion Criteria:

1. Do not meet the above criteria.
2. Currently participating in another interventional clinical trial.
Ultrasound-guided Intervention and Hand Tenosynovitis in Patients With Diabetes Mellitus

Evaluates the efficacy of ultrasound guided versus clinically guided steroid injection in the management of tenosynovitis in DM patients.

The current study will based on follow up study, conducted among patients presenting at outpatient rheumatology clinics of Al-Azhar University Hospitals, Egypt. with Diabetes mellitus duration at least 3 years and tenosynovitis of hand tendons with Richie tenderness grade 3.

All patients will randomized in two groups: Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance. Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.

The affected tendons will scanned and scored for inflammation using ultrasound in all patients before the triamcinolone injection and then to be reassessed one month after the injection to determine the change in the tendons in both groups.

Eligibility Criteria:
Inclusion Criteria:

* • Diabetes mellitus.

  * Disease duration 3 years or more.
  * Tenosynovitis of hand tendons with Richie tenderness grade 3.

Exclusion Criteria:

* • Patients with recent hand trauma.

  * Patients with inflammatory hand arthritis.
  * Previous tendon surgery.
  * Previous tendon injection.
  * Patients with contraindication for injection as related infection, uncontrolled DM or bleeding tendency.
Selection of Potential Predictors of Worsening Heart Failure

Multicentre study with the objective to correlate heart failure hospitalizations and deaths with Home Monitoring data in ICD/CRT-D recipients, in order to identify the combination of Home Monitoring data with the greatest sensitivity and specificity in predicting Heart Failure events.

All data are prospectively collected.

Home Monitoring remotely provides continuous trends of potential HF-related variables with a sampling interval of 24 hours. Although the predictive value of individual variables may be limited, a proper combination of more variables and their 24-hour sampling may allow developing a HM diagnostic algorithm to accurately predict HF worsening within given time windows.

The objective of this Study is to select the predictive variables which are most likely to be effectively included in a future algorithm.

This is a multicentre, exploratory Study with the objective to prospectively collect follow-up and Home Monitoring data from a population of subjects with indication for ICD and/or CRT-D implantation, to document HF hospitalizations and deaths and to correlate these events with HM data to identify the combination of HM data with the greatest sensitivity and specificity in predicting HF events.

Fifty first hospitalizations for worsening HF (adjudicated by an independent board) are necessary to reach the study objective (Event driven study), which were initially assumed to be generated by 650 patients fulfilling inclusion and exclusion criteria. Sample size estimation has been reviewed after an interim analysis.

Eligibility Criteria:
Inclusion Criteria:

* Left Ventricular Ejection Fraction (LVEF) ≤ 35%
* NYHA Class II or III Heart Failure
* Men and women 18 years of age or older
* Understand the nature of the procedure
* Give written informed consent

Exclusion Criteria:

* No indication or contraindication for ICD or CRT-D therapy
* Permanent AF
* NYHA Class IV Heart Failure
* Subjects with irreversible brain damage from preexisting cerebral disease;
* Subjects with acutely decompensated heart failure
* Expected heart transplantation within next six months or planned cardiac surgery within next 3 months
* Have a life expectancy of less than six months
* Presence of any disease, other than the subject's cardiac disease associated with a reduced likelihood of survival for the duration of the trial, (e.g. cancer)
* Unstable geographical residence (unable to anticipate to be resident in the area of the referring participating centre during the study period) and/or GSM-free residence
* Subjects who were not been implanted with ICD or CRT-D devices compatible with HM transmissions
* Age \<18 years
* Pregnancy
Effect of Calcium-fortified Cereal Bars on Dietary Calcium Intake in Women

The purpose of this study is to determine whether eating Kellogg's Nutri-Grain cereal bars will increase calcium intake in healthy adult women.

The average intake of calcium in women in the United States from the diet (about 800 mg/day) is below the Recommended Dietary Allowance (1000 mg/day for ages 18 to 50 years, 1200 mg/day for age above 50 years), which increases their risk of developing osteoporosis. Consumption of two calcium-fortified cereal bars per day may be a feasible way to increase the dietary intake of calcium. This study will use Kellogg's Nutri-Grain® cereal bars, which provide 200 mg of calcium per bar, or a total of 400 mg/day.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Able to speak, read, and understand English
* Able to consume Kellogg's Nutri-Grain® cereal bars

Exclusion Criteria:

* Consumption of calcium supplements or calcium-containing medications
* Regular consumption of 2 Kellogg's Nutri-Grain® cereal bars per month
* Currently pregnant or planning to become pregnant during the course of the study
* Liver disease
* Kidney disease
* Gastrointestinal disease (celiac disease, ulcerative colitis, or Crohn's disease)
* Have a history of bariatric surgery
* Had a major cardiovascular event (stroke or myocardial infarction)
* Undergoing treatment of cancer with the exception of non-melanoma cancer
* Following a weight control diet, a disease specific diet, or a vegan diet
* Have a diagnosed eating disorder
* Allergic to any of the ingredients in the study bar
The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children

Voice disorders are the most common communication disorder across the lifespan and vocal fold nodules are the most frequent pathology affecting voice in children. The goal of the present study is to determine the safety, feasibility, and efficacy of a short-course of inhaled corticosteroids in addition to standard voice therapy for treating vocal fold nodules.

Voice disorders are the most common communication disorder across the lifespan, affecting more than 5 million school-aged children annually in the United States. Vocal fold nodules are the most frequent pathology affecting voice in children, with 21% of children negatively influenced at any given point in time, resulting in negative quality of life consequences and inferior academic performance. The traditional first-line approach to treatment of vocal fold nodules is voice therapy by Speech-Language Pathology, although corticosteroids are often implemented in conjunction with voice therapy to reduce focal inflammation at the lesion site. Operating room procedures are the traditional method to administer corticosteroids to the lesion site, although recent advances in office-based laryngeal steroid injections have become a widely popular alternative to reduce lesion size. Unfortunately, although in-office injections are more favorable to operating room procedures, due to their less invasive nature, in-office procedures are still an invasive alternative in the pediatric population. Specifically, they involve equipment that may be intimidating to the child and require the child to remain very still for prolonged periods of time, which may not be feasible with some children. Furthermore, focal vocal fold injections still involve potential adverse effects such as vocal fold hematoma. To mediate these concerns, a short course of inhaled corticosteroids may be a safe and non-invasive alternative to reducing inflammation and lesion size within the larynx. The goal of the present study is to determine the safety and feasibility of a short-course of inhaled corticosteroids in addition to standard voice therapy for treating vocal fold nodules. The study also aims to examine the effects of inhaled corticosteroids on quality of life outcomes and acoustic and aerodynamic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with vocal fold nodules;
* Considered behaviorally and cognitively appropriate by PI for voice therapy;
* English comprehension and production sufficient to participate in the protocol and in voice therapy;
* Not currently on inhaled corticosteroids;
* No previous voice therapy;
* Willing to participate in voice therapy at Children's Hospital of Pittsburgh

Exclusion Criteria:

* Other medical conditions or medications that would mask or amplify voice outcomes, including developmental or other neuromuscular conditions, major illness or disorders, chronic or acute with the exception of laryngopharyngeal reflux disease or allergies and their treatments.
Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction

The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (UUI), with or without bladder outlet obstruction (BOO).


Eligibility Criteria:
Inclusion Criteria:

* Male 40 years of age
* Clinical signs and symptoms of frequency and urgency, with or without UUI, with or without BOO, for at least three months
* Mean urinary frequency of 8 micturitions/24h verified by the Screening micturition diary

Exclusion Criteria:

* Post-void residual urine volume (PVR) of \> 200 ml as measured by an ultrasound
* Maximum urinary flow rate (Qmax) of \< 5 ml/second as measured by a flowmeter; a voided volume of 75 ml is required in order to accurately record the Qmax
* Prescribed and administered an antimuscarinic or antispasmodic within 1 month
* Prescribed and administered an a-1-adrenergic antagonist within 2 weeks
Tongue Mobility in Patients with Ankyloglossia Following Frenectomy

This study aimed to evaluate the improvement in tongue mobility in patients with ankyloglossia (tongue-tie) following frenectomy. Ankyloglossia restricts tongue movement, potentially causing issues with speech, swallowing, and dental malocclusion.


Eligibility Criteria:
Inclusion Criteria:

* (1) at least four years of age, (2) report a limitation in tongue mobility at least at the moderate class (class II) according to Kotlow criteria and did not response to tongue lengthening exercise.

Exclusion Criteria:

* Patients who have limited mouth openings that interfere with tongue mobility measurements and patients who have bad compliances due to mental problems or uncooperative children were excluded.
Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of Four Nerve Blocks With Bupivacaine in Total Knee Arthroplasty

The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block in total knee arthroplasty. The aim of this study is to determine whether this is a systemic or local effect.


Eligibility Criteria:
Inclusion Criteria:

* Pre-surgical total knee arthroplasty patients

Exclusion Criteria:

* Skin infection near block site
* Allergy to local anesthetics
* Peripheral neuropathy
* Proven opioid dependency
* Coagulopathy
* Dementia
A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.

The efficacy analysis was performed in the Intent to Treat (ITT) set which included all participants who were randomized. The safety analysis was performed in the safety set which included all participants who received at least one dose of study drug. No participants were excluded from the efficacy analysis. Three participants in the FUMADERM® group discontinued after randomization prior to receiving any study drug and were thus not included in the safety set.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration since diagnosis may be reported by the participant
* Participant has stable moderate to severe plaque psoriasis (body surface area \[BSA\] \>10, Psoriasis Area and Severity Index \[PASI\] \>10, and Dermatology Quality of Life Index \[DLQI\] \>10) with or without psoriatic arthritis at Baseline
* Must be naïve to and candidate for systemic therapy, as assessed by the investigator
* Participant has an inadequate response, intolerance or contraindication to topical psoriasis treatment

Exclusion Criteria:

* Participants with non-plaque forms of psoriasis
* Participant has previously received systemic therapy for psoriasis, whether biologic or non-biologic or photochemotherapy
* Active systemic infection during the last 2 weeks (exception: common cold) prior to screening.
* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
* Participant has any condition or contraindication to Fumaderm that would preclude the patient's participation in the present study
A Short, Animated Storytelling Video to Increase Knowledge About Sodium Intake as a Cardiovascular Risk Factor

This study will evaluate the effect of a short, animated storytelling intervention video on sodium intake as a major risk factor for cardiovascular disease on immediate and medium-term retention of knowledge about the risks of cardiovascular diesaes due to increased sodium intake. We will also measure voluntary engagement with the content of the short, animated storytelling intervention video on positive psychological capital.

In this 4-armed, parallel, randomized controlled trial, 10,000 adult, US participants will be randomly assigned to (1) a short, animated storytelling intervention video on sodium as a cardiovascular disease risk factor followed by surveys assessing the facts om sodium and cardiovascular disease conveyed in the video (2) the surveys only, (3) an attention placebo control video followed by the before mentioned surveys, and (4) an arm that is exposed to neither the video nor the surveys. Two weeks later, participants in all four arms will complete all of the surveys.

The primary outcome is knowledge about the cardiovascular disease risk associated with increased sodium intake (immediate and medium-term). The major scondary outcome is the extent of voluntary engagement with the short, animated storytelling video content.


Eligibility Criteria:
Inclusion Criteria:

* Registration with the Prolific Academic platform

Exclusion Criteria:

* none
A PK-PD Study of PSN821 in Type 2 Diabetes Patients (T2DM)

The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of PSN821 in patients with type 2 diabetes.

Subjects will be assessed for beta-cell function using a hyperglycaemic clamp before the start of treatment and at the end of a 12 week treatment period as the primary endpoint. HbA1c, fasting plasma glucose and body weight are secondary endpoints.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes according to the American Diabetes Association criteria, diagnosed at least 12 months prior to screening.
* Male or female, between 18 and 75 years of age, inclusive.
* Body Mass Index of 25 - 45 kg/m2, inclusive.
* Diabetes managed on a stable regimen of diet, exercise and metformin monotherapy (without dosage adjustments within 4 weeks prior to screening).
* Haemoglobin A1c (HbA1c) of 7.5 10% at screening.
* Fasting plasma glucose (FPG) of between 7 - 13.3 mmol/L at screening and Day -1.
* Males who are, and whose partners are able to comply with contraceptive advice.
* Females of non child-bearing potential.
* Willing to sign the written Informed Consent Form (ICF) to participate in the study and to abide by the study restrictions.

Exclusion Criteria:

* Patients with Type 1 diabetes or maturity onset diabetes of the young or secondary forms of diabetes, such as due to pancreatitis.
* Marked diabetic complications.
* Illness or medication that impacts on the scientific integrity of the study.
A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer

The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth), can reduce tumor sizes in patients with bladder cancer


Eligibility Criteria:
Inclusion Criteria:

* Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra).
* Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by curative surgery and/or curative radiotherapy
* Must have had a maximum of 2 prior chemotherapeutic regimens, one for unremovable and/or metastasized disease, and the other in the adjuvant or neo-adjuvant setting.
* Ambulatory and capable of all selfcare more than 50% of waking hours

Exclusion Criteria:

* Prior treatment with investigational or standard anti-cancer agents, including radiotherapy, within 4 weeks prior to first dose of study medication; 6 weeks if prior systemic mitomycin, nitrosourea, or suramin.
* Inadequate bone marrow reserve
* Inadequate liver function in the presence of liver metastases
* Impaired renal function
Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).

This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 35.0 kg/m2.
* Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
* Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.

Exclusion Criteria:

* Psychiatric hospitalization during the current major depressive episode.
* History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
* Participants who, in the Investigator's judgment, are at significant risk for suicide.
* Pregnant or planning to become pregnant.
Efficacy of the Wavefront Optimized (WFO) Profile in Non-anterior Astigmatisms

The purpose of the study was to assess the efficacy of the Allegretto Wave excimer laser and the wavefront optimized ablation profile in correcting primarily non-anterior astigmatism faults, following laser in-situ keratomileusis (LASIK) and photorefractive keratectomy (PRK).

Different optical components of the eye contribute to the total astigmatism error.In specific, the anterior corneal surface is responsible for the anterior component of astigmatism fault (anterior astigmatism), while the posterior corneal surface and the lens are responsible for the posterior one (posterior astigmatism).

Regarding our study, 74 refractive surgery candidates were recruited. Only one eye from each candidate was randomly enrolled in the study. Of them, 40 eyes underwent LASIK treatment (LG group), while 34 eyes underwent PRK treatment (PG group). The Allegretto Wave excimer laser (software version: 2.020 / WaveLight AG, Erlangen, Germany) was used for the ablation in all groups. Preoperatively, the ocular residual astigmatism (ORA) was calculated for each eye, according to which each astigmatism fault was characterized as primarily anterior or non-anterior.ORA is the vectorial value of astigmatism arising from non-anterior sources. Its amount on total astigmatism (R) is determined by the magnitude ratio ORA/R. Ratios below 1 indicate primarily anterior astigmatism, while ratios above 1 indicate primarily non-anterior astigmatism. 20 LG eyes and 16 PG eyes presented primarily anterior astigmatism (LG-A and PG-A subgroups, respectively), while 20 LG eyes and 18 PG eyes demonstrated primarily non-anterior astigmatism (LG-NA and PG-NA subgroups, respectively). Postoperatively, vector analysis of astigmatism correction was conducted; The following indexes were calculated: a) Correction index (CI), b) Difference vector (DV) and c) Index of Success (IOS).

Eligibility Criteria:
Inclusion Criteria:

* astigmatism fault

Exclusion Criteria:

* previous incisional eye surgery
* evidence of any type of corneal pathology
* evidence of any type of optic neuropathy
* history of optic neuropathy
* diabetes mellitus