cyrilzakka/clinical-trials huggingface dataset:
Management of Coccydynia: A Prospective, Observational Study of Coccygectomy

The purpose of the study is to analyze the outcomes of patients with coccygodynia (pain in and around the coccyx region) treated with coccygectomy (a procedure during which the coccyx is removed) and to report on the rate of complications of the procedure. The study will also aim to find pre-operative clinical predictors of good outcomes after coccygectomy. The investigators hypothesize that coccygectomy will not improve scores on the Short Form-36 (SF-36), Oswestry Disability Scale (ODI), tolerable sitting time, or Visual Analog Pain Scale (VAS). Also, the investigators hypothesize that there are no independent variables associated with improved outcomes.

Coccygodynia can be a functionally limiting and painful disease with conservative treatment providing mixed results. When proper surgical indications are met, results seem to be promising. However, there is a lack of data in the literature to support surgical treatment. The case series reports currently in the literature are small and retrospective with ill-defined selection criteria. To date there has been no study prospectively following patients undergoing coccygectomy. This type of study could accurately obtain data prospectively. This information will help better guide the clinician through treatment of this disease.

All patients will be seen and enrolled through an outpatient spine specialty clinic of the senior author. Patients that meet the inclusion criteria will be offered enrollment in the study by a third party (clinical research assistant). Patients enrolled will then complete pre-treatment SF-36, Oswestry Disability Scale and a pain visual analog scale. Patients will be followed at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years after treatment. Patients will complete the questionnaire containing the VAS and tolerable sitting time at all visits with SF-36 and Oswestry disability scale completed at one year post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pain in the region of the coccyx
* Pain for greater than 2 months
* Tenderness to palpation over coccyx
* Radiographic abnormalities of the coccyx

  1. Hypermobility of greater than 25 degrees, posterior subluxation of a mobile segment, or a coccygeal spicule on sitting radiographs
  2. post-traumatic coccygodynia
* Failure of conservative treatment methods: 4 weeks of NSAIDS, seat cushion, and rest
* Partial coccygectomy

Exclusion Criteria:

* Coexisting low back pain
* Total previous coccyx surgery or previous lumbar fashion
* Under 18 years of age
Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere, France

This study evaluates the relation between sens of coherence and primary dysmenorrhea. Aself-questionnaire is completed by a sample of girls aged between 14 and 19, schooled in Finistère (France).

Primary dysmenorrhea affects more than 60% of adolescent girls. Menstrual pain increases absenteeism and lowers self-esteem and academic performance. Moreover, dysmenorrheal women suffer more depression and anxiety.

Sense of coherence (SOC) is composed of three items:

* comprehensibility: what the person understands about his illness
* manageability: what the person does to cope
* meaningfulness: what the disease means to the person. A high SOC score is related to good mental and physical health. The aim of this study will be to determine if there is a relationship between primary dysmenorrhea and the sense of coherence.

A self-questionnaire composed of the SOC-13 and a scale evaluating dysmenorrhea will be proposed in the voluntary high schools of Finistère (France) to the girls of the classes chosen at random.

Eligibility Criteria:
Inclusion Criteria:

* student in high schools
* aged 14 and 19 years
* with menstrual cycle

Exclusion Criteria:

* Illiteracy
* student and parents opposition
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure

Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates.

When the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve.

The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes.

The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication).

The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.

To determine the acute and long-term outcomes of Redo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of Bioprosthetic Valve Failure (BVF) affecting Transcatheter Aortic Heart Valves (THVs)

To determine the factors which predict the acute and long-term outcomes of Redo TAVI

To determine the proportion of patients presenting with BVF affecting THVs who are deemed unsuitable for Redo TAVI by the Heart Team

To determine the acute and long-term outcomes of surgical explantation and surgical aortic valve replacement (SAVR) for the treatment of BVF affecting THVs

To determine the survival of patients presenting with BVF affecting THVs who are managed conservatively - including optimal medical therapy (OMT) +/- balloon aortic valvuloplasty (BAV)

Eligibility Criteria:
Inclusion Criteria:

1. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention

Exclusion Criteria:

1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation
2. Active endocarditis
3. Untreated acute valve thrombosis
4. Life-expectancy less than 1 year
5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable.
A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants

This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh and arm.

The study will be conducted in healthy people to investigate the effect of different injection sites on the amount of insulin lispro in the bloodstream.

Side effects and tolerability will be documented. The study will last for about 10 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
* Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
* Are nonsmokers, have not smoked for at least 6 months prior to entering the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Had blood loss of more than 450 milliliters (mL) within the last 3 months
A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain

To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients.

Patients are randomized to receive SNX-111 or placebo (AS PER AMENDMENT 1/22/98: with randomization weighted 2:1 in favor of SNX-111) via external pump and an intrathecal catheter (thin tube inserted into the spinal canal). (AS PER AMENDMENT 1/22/98: the dose is increased every 24 hours, in the absence of onset of analgesia or adverse events. After 2-5 days, patients who respond to their medication continue treatment at home for 5-8 days. Patients who do not respond will be switched to the other regimen (i.e., placebo to SNX-111, or SNX-111 to placebo). After 10 days, responding patients are unblinded and asked to enroll in the long-term, open-label extension protocol. Patients remain on a fixed dose at the therapeutic level found in the previous study. The dose may be increased or decreased at the discretion of the investigator. Patients may continue therapy on a long-term basis until the drug is approved.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Rescue analgesia.

Patients must have:

* Chronic pain related to AIDS or cancer.
* Unsatisfactory response to prior opioid therapy.
* Life expectancy \> 3 months (or 1 month if an infusion pump is in place).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Signs of sepsis or inadequately treated infection.

Patients with the following prior conditions are excluded:

History of heart disease, heart failure, or asthma.
Clinicoepidimiological Study and Clinical Outcome in Patients With Urinary Bladder Cancer

To pinpoint the clinical ,epidimiological factors and clinical outcomes in urinary bladder cancer patients attending to our department during 5 years period between 2015-2019.

Bladder cancer is the ninth most common cancer throughout the world. The incidence of bladder cancer is three to four times greater in men than in women. However, women are diagnosed with more advanced disease at presentation and have less favorable outcomes after treatment. Statistical data show that between 2002 and 2012, worldwide, the number of bladder cancers increased from 375.000 to about 430.000 , while the mortality increased from 145.000 patients in 2002 up to 165.000 patients in 2012. In the United States, bladder cancer is the fourth most common cancer in males with an age-adjusted incidence rate of 37.3/100,000 person years (PY) using the US standard population.

In developed countries, over 90% of the bladder cancer cases diagnosed are transitional cell carcinoma (TCC), with squamous cell carcinoma (SCC), adenocarcinomas, and rare types of bladder cancer comprising the remaining 10% of bladder cancer cases.

Exposures to tobacco smoke, occupational toxins, and environmental sources of heavy metals such as arsenic are the major reported risk factors for TCC.

Unlike TCC, the main risk factors for SCC are not environmental exposures, but exposure to infectious agents. Age, smoking, tumor stage and the treatment modalities such as surgery and adjuvant chemotherapy were proved to affect the overall survival in patients with urinary bladder cancer. Our study may give an important evidence about clinical, epidemiological factors and clinical outcomes in urinary bladder cancer patients at Assuit University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* age 18 :70
* Histologically proved urinary bladder carcinoma

Exclusion Criteria:

* Age less than 18 or more than 70
* Patient not documented having bladder carcinoma with biopsy \[cysyoscopic or operative\]
* Patient with synchronous or metachronous double primary
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis

The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the absence of cinacalcet, in subjects with chronic kidney disease receiving hemodialysis


Eligibility Criteria:
Inclusion Criteria:

* Adults with chronic kidney disease receiving hemodialysis.
* Lab tests required at screening include Parathyroid Hormone (PTH), calcium, and phosphorus.
* A screening coronary artery calcification score of at least 30.

Exclusion Criteria:

* Subjects on non-calcium or aluminum containing phosphate binders (example: sevelamer HCl, lanthanum) 30 days prior to screening.
* Subjects on cinacalcet 30 days prior to screening.
* Current or previous use of some osteoporosis medications.
* Started or required change in cholesterol lowering medications within 30 days before screening.
* Abnormal rhythm of the heart.
* Parathyroidectomy done within 3 months prior to screening.
* Anticipated parathyroidectomy or kidney transplant.
* Current intolerance to oral medications, or inability to swallow.
* Unstable medical condition.
* Currently enrolled, or fewer than 30 days have passed since subject used another investigational device or drug.
* Pregnancy or breast feeding.
[S,S]-Reboxetine Add-On Trial

The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with \[S,S\]-Reboxetine against pregabalin monotherapy in patients with PHN


Eligibility Criteria:
Inclusion Criteria:

* Patients must have pain present for more than 3 months after the healing of shingles skin rash
* Patients at screening must have a score \>/=40 mm on the pain visual analogue scale

Exclusion Criteria:

* Patients with significant renal and hepatic impairment
* Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
* Patients with clinically abnormal electrocardiogram
SUNLIGHT Study: Online Support Groups for MS to Address COVID-19

Stress and anxiety can have an adverse impact on health, and the experience of many around the 2020 outbreak of COVID-19 is affecting health and well-being. Individuals with chronic disease such as multiple sclerosis may be particularly vulnerable in some ways, but also particularly resilient in others. This study evaluates the effects of belonging to online support groups that meet weekly for 12 weeks to address the stress and anxiety felt by individuals with Multiple Sclerosis (MS). This study will also measure and explore the effects of online support groups.

Anxiety is a pervasive and debilitating symptom for individuals with MS, who are at much greater risk for anxiety than the general population. The lifetime prevalence of anxiety in MS is estimated at 48.9%, compared to 37.9% in the general population. The negative consequences of anxiety for individuals with MS include impairment of work function and workplace attrition, increased healthcare usage and healthcare costs, increased physical disability (i.e., higher Expanded Disability Status Scale (EDSS) score), and reduced overall quality of life. And while anxiety has been shown to be acutely elevated both before and in the first years after diagnosis, individuals with longstanding MS also exhibit anxiety at higher rates than the general population. Of note, women are at heightened risk for both anxiety and MS, and lower socioeconomic status (SES) is associated with increased prevalence of anxiety in MS. In the SUNLIGHT study, participants join a structured meeting in which they receive content specifically focused on anxiety, its detrimental impact on individuals with MS, and an emphasis on techniques to reduce anxiety. Over the 12-week period of the intervention, participants learn techniques for stress reduction that can be self-administered, such that the benefits of participation outlive the active period of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* MS Diagnosis
* 18 years or older

Exclusion Criteria:

* None
Explorative Proteomics in Pediatric Neuroborreliosis

This study aims to use proteomic analysis to diagnose Lyme Neuroborreliosis (LNB) in children. Pediatric patients with suspected LNB will be enrolled, and their blood samples will be collected for proteomic analyses. Mass spectrometry will be used to compare protein profiles of LNB-positive and LNB-negative patients. The data will be analyzed by bioinformaticians. The expected impact is to establish a non-invasive, reliable method for early LNB diagnosis to improve patient outcomes.

Objective:

The primary objective of this study is to investigate the utility of proteomic analysis in diagnosing lyme neuroborreliosis (LNB) in children. By identifying specific protein markers associated with LNB (proteomics), the investigators aim to enhance early detection and improve patient outcomes.

Methods:

Participant Recruitment:

The investigators will enroll pediatric patients (aged 1 month to 17 years) presenting with suspected LNB.

Informed consent will be obtained from parents or legal guardians.

Sample Collection:

Peripheral blood samples will be collected from each participant in EDTA tubes. Samples will be processed to carry out proteomic analyses.

Proteomic Analysis:

Mass spectrometry will be employed to compare protein profiles between LNB-positive and LNB-negative patients.

Data Analysis and Presentations:

Protein profiles will be analysed by trained bioinformaticians and mainly presented in volcano plots and heat maps.

Outcome Measures:

Unique proteomic profiles of children with LNB.

Expected Impact:

This study aims to establish a non-invasive and reliable method for diagnosing LNB in children. Early identification will facilitate timely treatment and prevent complications associated with LNB.

Eligibility Criteria:
Inclusion Criteria:

* Presenting at a pediatric ward with facial nerve palsy and/or suspicion of lyme neuroborreliosis
* Parental informed consent

Exclusion Criteria:

* Parents or legal guardians unable to understand given information or comply with study criteria
* Patient unable to cooperate to study procedures (blood sample)
* Unclear etiology after lumbar puncture
M-CPP and Fenfluramine in Cocaine Addicts - 3

The purpose of this study is to evaluate predictive value of M-CPP and fenfluramine challenges for outcome.


Eligibility Criteria:
Please contact site for information.
Body Composition Monitor in Hemodialysis Patients

Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical management for maintaining normovolemia is needed.

The investigators hypothesized that intervention of volume status with the body composition monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis patients.

The investigators will assess BCM in enrolled hemodialysis patients by 4 weeks for 16 weeks During the former 8-week intervention period, The investigators will adjust patients' volume status according to the results of BCM.

During the latter 8-week observational period, The investigators will evaluate the changes of patients' hemodynamic parameters and biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* 6-month or more stable hemodialysis patients
* 18 years or more
* less than 5% of changes of dry weight for last 3 months

Exclusion Criteria:

* pregnancy
* active malignancy
* cardiac pacemaker or defibrillator
* history of extremity amputation
* active infectious disease within 3 months
* admission history for complication related to hemodialysis within 3 months
Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children

Dose-finding study to compare intranasal midazolam doses of 0.2, 0.3, 0.4 and 0.5 mg/kg in children undergoing laceration repair to achieve the following aims:

Specific Aim #1: To determine the most effective dose of intranasal midazolam for producing adequate sedation state associated with each dose.

Specific Aim #2: To determine the time to recovery and describe the adverse events associated with each dose.

Intranasal midazolam is a common and effective sedative whose use in children presenting to emergency departments has been described. However, the doses of intranasal midazolam used have varied greatly, with no identified optimal dose. Doses most commonly described in literature reviews, research studies, and clinical guidelines range from 0.2 to 0.5 mg/kg. There is only one study, retrospective, that compares doses and suggests that clinical efficacy is improved with higher doses, without any clear difference in safety. There is a need for a rigorously-conducted trial to determine the dose of intranasal midazolam that optimizes the adequacy of sedation state without leading to adverse events or compromising emergency department-centric outcomes such as time to onset of sedation and time to recovery. To fill this important and persistent gap in knowledge, the investigator will conduct a dose-finding study using an adaptive trial design to compare intranasal midazolam doses of 0.2, 0.3, 0.4, and 0.5 mg/kg in children undergoing laceration repairs, one of the most common types of minor trauma treated in emergency departments.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6 months to 7 years old (i.e. before their 8th birthday)
* Simple laceration
* Attending physician has decided intranasal midazolam indicated to facilitate repair

Exclusion Criteria:

* Repair using tissue adhesive (e.g. Dermabond) or staples
* Known or confirmed developmental delay
* Baseline motor neurological abnormality (e.g. motor deficit, cerebral palsy)
* Autism spectrum disorder
* Illness associated with chronic pain
* Known allergy to midazolam or any other benzodiazepine
* Eyelid laceration
* Tongue or intraoral lacerations
* Nasal obstruction that cannot be easily cleared
* Does not speak English or Spanish
* Foster children, wards of the state