cyrilzakka/clinical-trials huggingface dataset:
Steady State Vestibular Evoked Myogenic Potentials

Objective: At present, vestibular evoked myogenic potentials are analyzed only in the time domain. A technique to evaluate this potential in the frequency domain could provide more information, but has only been applied within the last year. Design and Study Sample: In this study we recorded vestibular evoked myogenic potential in the time domain, in 156 ears of 78 normal-hearing young adults, at frequencies of 250, 500, 1000 and 2000 Hz, with intensity of 90 dB nHL. Next, the steady state vestibular evoked myogenic potential was recorded at the same carrying frequencies, modulated at 20, 37, 40, 43, 70, 77 and 80 Hz. Results: The responses found by modulated frequency, regardless of carrier, recorded a higher presence of peaks and mean amplitudes between 20 and 70 Hz, especially at 40 Hz. Conclusions: The results show that the observation technique in the frequency domain is feasible and shows a strong association with the time domain for recording vestibular evoked myogenic potentials, at carrying frequencies of 250, 500, 1000 or 2000 Hz.


Eligibility Criteria:
Inclusion criteria: age between 18 and 35 years and auditory threshold less than or equal to 20 dBHL, between 0.5 and 8 kHz, with inter-ear frequency difference less than or equal to 10 dB.

Exclusion criteria were: exposure to occupational or leisure noise; otological surgery; more than three ear infections within the last year; use of ototoxic medication; buzzing in the ear, vertigo, dizziness or other cochlear-vestibular symptoms ; presence of systemic alterations that could contribute to cochlear-vestibular pathologies, such as diabetes, hypertension, dyslipidemias and/or hormonal alterations.
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease

This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of Chronic Kidney Disease (CKD) after conversion from an Erythropoiesis Stimulating Agent (ESA).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of anemia of chronic kidney disease (CKD)
* Diagnosis of non-dialysis-dependent (NDD) CKD with an estimated glomerular filtration rate of greater than (\>) 10 and less than (\<) 60 milliliters/minute/1.73 meters\^2 (mL/min/1.73 m\^2) or diagnosis of dialysis dependent (DD) CKD
* Mean hemoglobin (Hb) between 9.0 and 12.0 grams/deciliters (g/dL) (inclusive)
* Transferrin Saturation ≥ 20%

Exclusion Criteria:

* Anemia due to a cause other than CKD
* Active bleeding or recent clinically significant blood loss
* History of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
* Red Blood Cells transfusion within 4 weeks
* Serum albumin level less than 2.5 g/dL
* Uncontrolled hypertension
* Active malignancy or treatment for malignancy within the past 2 years prior to Screening
* Evidence of iron overload or diagnosis of hemochromatosis
* Known hypersensitivity to vadadustat or any excipients in vadadustat tablet
Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA)

The goal of this pilot trial is to test how feasible is to conduct a large clinical trial that evaluate both implementation and effectiveness outcomes of a community-based interventions for older adults with depression in low-resource urban settings from Lima, Peru.

The main questions:

Is the way we are planning the study, including those who are taking part and what they will do, good for a large study?

Is the interventional package we are developing good the way it is, and can it be done the way we planned it?

Participants who join will be split into two groups: one group will get the interventional program, and the other group will get standard care. In the interventional group, community health workers will meet with participants eight times to do activities and talk about how they feel. The standard group will have two visits where they will learn things about mental health.

The results of the study will help the researchers understand whether they can test the program in larger study. Additionally, see whether those participants in the interventional group feel better than those who are in the standard group.

Sample size: This is a pilot trial. No sample size calculations are needed because the objective is NOT to evaluate the effect of the intervention, but rather the feasibility of conducting a large-scale clinical trial. It is expected to enroll 64 participants (32 control group vs 32 intervention group). This number is based on previous formative study and training of community health workers.

Researchers will collect basic information to assess feasibility for a larger trial, including:

* Number of potential participants screened per month;
* Number of participants enroled per month;
* Average time from enrolment to randomisation.
* Average time to reach enrolment goal
* Proportion of eligible participants who enrol
* Proportion of people who maintain the study in both groups.
* Reasons for abandoning the study.
* Visit durations

Eligibility Criteria:
Inclusion Criteria:

* Having depressive symptoms (score equal to or greater than 6 on the Patient Health Questionnaire - PHQ 9).
* Capacity to give consent.
* Current residence in Villa El Salvador, Lima, Peru.

Exclusion Criteria:

* Previous diagnosis of bipolar disorder
* History of substance abuse
* History of dissociative disorder, psychosis or dementia, or moderate memory and/or cognition problems.
Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms

The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence

This is a multi-center study under a common protocol. Approximately 20-30 patients will be enrolled across 5 sites in the U.S. The study population is females at least 21 years of age who have attempted but have not been satisfied with conservative therapy for their fecal incontinence symptoms. The study follow-up is two years.

Eligibility Criteria:
Inclusion Criteria:

* Females at least 21 years of age who have evidence of pelvic floor weakness
* Females who attempted but not been satisfied with conservative therapies such as dietary changes, dietary bulking agents, biofeedback, etc.
* Subjects, who have an external anal injury, must have some voluntary sphincter control

Exclusion Criteria:

* Subjects who are unwilling or unable to sign an Informed Consent form
* Subjects who are currently pregnant or considering future child-bearing
* Subjects who are contraindicated for surgery
* Subjects who are allergic to polypropylene mesh
* Subjects who are enrolled in a concurrent clinical trial
* Subjects with previous implantation of mesh or trauma to the pelvic area
* Subjects who engage in anal receptive intercourse
* Subjects with a significant evacuation disorder such as chronic constipation
* Subjects with Crohn's Disease, ulcerative colitis or chronic diarrhea as the primary cause for fecal incontinence
* Subjects who had a hysterectomy within 6 months prior to enrollment
* Subjects with vaginal prolapse that passes the hymen
* Subjects with complete rectal prolapse
* Subjects with a history of pelvic radiation that compromises the anal canal
* Subjects who have psychiatric disturbance or debilitation as a possible cause for fecal incontinence
* Subjects with a neurological disorder such as amyotrophic lateral sclerosis, multiple sclerosis, or brain tumor as a possible cause for fecal incontinence symptoms
* Subjects with an active pelvic infection or a recto-vaginal fistula
* Subjects who have not had a negative screening exam for colon cancer within 10 years of enrollment
* Subjects who have other inappropriate conditions as determined by the physician
Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET

MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification \[increase number of gene copies\]). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments.

If testing has not already been performed, the study will provide for the testing.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-small cell lung cancer
* Metastatic or locally advanced disease
* Prior platinum chemotherapy or immunotherapy
* Test result showing genetic change in MET tumor gene
* At least one tumor that can be measured on a radiographic scan

Exclusion Criteria:

* Prior treatment with inhibitor of MET or HGF
* Prior positive test for EGFR mutation or ALK gene rearrangement
* Uncontrolled tumor in the brain
Screening and Nutrition for Patients With Diabetes: A Pilot Study

The goal of this project is to provide diabetes self-management education and support (DSMES) and simultaneously address food insecurity for a high-risk, ethnically diverse adult population who participate in a food pantry. This project will utilize a Community-Based Participatory Research model (CBPR). Community representatives will engage in project implementation by participating in designing the messaging for cultural impact and advising in study operations. This intervention targets food pantry clients self-reporting a T2DM diagnosis or who screen positive for T2DM through on-site HbA1c testing. Once enrolled, participants will complete self-paced web-based/mobile DSMES modules, available in English and Spanish, that include the ADCES7 (Association of Diabetes Care and Education Specialists) Self-Care BehaviorsTM. Support through text messaging, monthly group sessions, and peer mentorship will be facilitated by nursing students, registered dietitian nutritionists (RDNs), and diabetes care and education specialists (DCES) for 12 weeks. Participants will receive nutritious food from the pantry consistent with dietary guidelines for diabetes.

Eligible patients who agree to participate in the study will be screened for diabetes via HbA1c fingerstick measurement. Participants will receive diabetes self-management education, food items recommended by registered dietitians, peer support, monthly in-person group support sessions held at the foot pantry, and text messaging with continued education. Data will be collected at intake. Follow up data will be collected 90 days after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Existing and/or new diagnosis of T2DM
* Food pantry participants
* English and/or Spanish speaking
* Willing/able to provide informed consent
* Must have a mobile device able to receive text messages

Exclusion Criteria:

* Under the Age of 18
* No T2DM or do not meet HbA1c \> 6.5 criteria
* Not a food pantry participant
* Unwilling/unable to provide informed consent
* Spoken language is other than English/Spanish
* Individuals who do not have access to a mobile device or are unable to receive text messages
Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

This study is designed to compare the surgical efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique. Specifically, the purpose of this study is to collect time data to enhance the existing economic model.

The study is designed as a prospective, multi-center, controlled, non-randomized, clinical investigation to compare the efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female and between the ages of 18 and 80 years old, inclusive.
* Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
* Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy
* Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation, and co-operate with investigational procedures.
* Subject, who, in the opinion of the Clinical Investigator, are suitable for implantation using TruMatch™ instrumentation. For example, no femoral nails/bone plates that extend into the knee, ie. within 8cm of joint line; no metal device that could cause CT scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture are consistent with TruMatch™ instrumentation.

Exclusion Criteria:

* The Subject is a woman who is pregnant or lactating.
* The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
* The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
* The Subject has previously had a prosthetic knee replacement device (any type) of the affected knee.
* The Subject requires simultaneous bilateral total knee replacements.
* The Subject had a contralateral TKA and that knee was previously entered in the study.
* Subject in whom the surgeon intends to implant a knee prosthesis that is not in the PFC Sigma primary knee system.
* Subject who has inflammatory arthritis.
* Subject who has a Body Mass Index (BMI) of ≥ 40. (Please see Table 2-1: Definition of Terms, for BMI definition and calculation formulas).
NBI With Magnification for Dysplasia Detection in Ulcerative Colitis

The purpose of the study is to determine whether a new colonoscopic viewing technique called narrow band imaging (NBI) helps doctors detect more patients with at leat one pre-cancerous area (dysplasia associated lession or mass, MALMs) than conventional colonoscopy using white light alone.

Colorectal cancer is the second commonest cause of cancer death. Patients with colitis have a substantially increased risk of death from colorectal cancer which increases with lenght of time the patient has had colitis. This can be as high as a 30% chance of colorectal cancer after 30 years of colitis. Colonoscopic surveillance of colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed.

Precancerous lesions in colitis are difficult to see and endoscopist have used spraying dye on the lining of the bowel (chromoendoscopy) successfully to improve detection of abnormal areas: however this is time consuming and requires extra time and equipment and despite the benefits seen in multiple studies is not widely used in routine clinical practice in the UK.

Narrow band imaging (NBI) is a technique that relies on light filters to improve contrast for the smallest blood vessels in the bowel lining which shows up precancerous areas as they have a richer vascular network. It is sometimes described as "digital chromoendoscopy" as the images produced are similar to chromoendoscopy, but it is much simpler and quicker to use. With magnification it allows assessment of the fine mucosal surface pattern (pit pattern) of lesion which allows and assessment of their likelihood of being precancerous. Autofluorescence endoscopy uses short wavelength light and light filters to produce a false colour image of the bowel lining where polyps stand out. These techniques have been used with some success in the oesophagus and stomach but little work is available for the colon.

We aim to see if NBI with magnification is better that standard colonoscopy for detecting precancerous areas. This is likely as it produces images similar to chromoendoscopy which is already shown to help. If a potentially precancerous area is found we will use other types of endoscopy, particularly NBI autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non pre-cancerous areas

Eligibility Criteria:
Inclusion Criteria:

* petients with colitis who meet surveillance criteria
* patients over 18 years of age

Exclusion Criteria:

* pregnant patients
* unable or unwilling to give informed consent
* patients with severe active colitis who would be unsafe to endoscope
Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride

This study is to evaluate the efficacy and safety that the occurrence of incontinence is significantly decrease using the propiverine hydrochloride for 200 female patients with mixed (stress and urge) urinary incontinence in one week during a twelve-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients with mixed urinary incontinence (MUI)
2. Patients having symptoms of urinary incontinence for at least 3 months
3. Patients having at least one episode of urge urinary incontinence per week and 4 episodes of stress urinary incontinence per week in a bladder diary.
4. 20 years old or older
5. Patients who meet all the following criteria in ICIQ-SF (1) "2-3 times or more in one week" was selected at Q1. (2) "Small or more" was selected at Q2. (3) "leak at the time of cough or sneeze" or "leak at the time of exercise" was selected at Q4.
6. Less than 100mL of residual urine volume
7. Written informed consent.

Exclusion Criteria:

1. Patients with organ disease such as bladder stones, bladder tumors and urethral stricture in the lower urinary tract
2. Patients with bacterial infections (i.e. bacterial cystitis) or nonbacterial infections (i.e. interstitial cystitis)
3. Patients with advanced lower urinary tract obstruction or urinary retention
4. Patients without urinary sensation
5. Patients with overflow incontinence
6. Patients with history or complications of pelvic organ prolapse
7. Patients with pyloric, duodenal or intestinal obstruction
8. Patients with gastric or intestinal atony
9. Patients with angle-closure glaucoma
10. Patients with myasthenia gravis
11. Patients with severe heart disease
12. Patients with severe constipation
13. Patients with dementia who are not able to complete the questionnaires
14. Patients with history of allergic reaction to Propiverine Hydrochloride or other similar medicine
15. Patients with history of surgery that affect urination such as Trans-Obturator Tape（TOT）or Tension-free Vaginal Tape（TVT）
16. Women who are pregnant, lactating, potentially pregnant or willing to get pregnant
17. Patients with previous surgery of the abdomen and pelvis or radiation within 6 months
18. Patients who started pelvic floor muscle exercise within 3 months
19. Patients who took Propiverine Hydrochloride or other similar medicine within 2 weeks before entry
20. Judged as being unsuitable for the trial by physician.
Preventing and Arresting Dental Root Surface Caries in Community-dwelling Older Adults

This study is a randomized clinical trial lasting for 30 months. A total of 300 subjects will be recruited from social centres for elders located in different districts in Hong Kong. Baseline clinical examination will be conducted by a single calibrated examiner in the social centres using an intra-oral LED light, mouth mirrors and probes. Subjects will be randomly allocated into the three study groups and receive interventions accordingly. Follow-up examinations at 6-month intervals will be carried out to assess the clinical outcomes, i.e. whether new root caries has developed and whether the active root caries found at baseline have become arrested (remineralized and hardened) or not. Photographs of the arrested lesions will be taken to assess their colour. Results of this study will provide the much needed evidence to guide the dental professionals in Hong Kong and worldwide in deciding on the most appropriate intervention for the prevention and treatment of this common dental disease of the older adults.

The primary and secondary outcome of this study was new root caries and arrested root caries. A root surface with new caries experience was recorded when a root surface which was sound at baseline was found to have a carious lesion or a filling at a follow-up examination. Arrested root caries was recorded when the active root caries found at baseline changed into inactive root caries at follow-up. The status of each root surface was recorded using the codes recommended by the International Caries Detection and Assessment System (ICDAS Ⅱ) Coordinating Committee in 2009. Color of the arrested root caries lesion was classified into one of four types according to PANTONE® color plates placed next to the lesion (Fig 1), namely yellow (7401U), light brown (1245U), dark brown (4635U), and black (Black U).

A mean root caries increment of around 0.8 root surface per year of control group was reported in a previous clinical trial conducted in Hong Kong. Thus, in this study, a 30-month increment of 2 new decayed root surfaces was anticipated. The ratio of the mean to the standard deviation of the root caries increment was expected to be around 1:1.5. In order to show that a 50% difference in mean caries increment between the highest and the lowest values in the three groups was statistically significant at a 5% significance level and at an 80% power, 80 subjects in each group was required. Allowing for a drop-out rate of 25% over 30 months, a total of 300 subjects (100 in each group) were needed.

Eligibility Criteria:
Inclusion criteria:

* have at least 5 teeth with exposed root surfaces and not indicated for extraction, and
* living in the community and have self-care ability for normal daily activities.

Exclusion Criteria:

* have life-threatening or serious health problems,
* have cognitive problems in communication or in receiving oral hygiene instructions
* have salivary gland diseases or received radiotherapy in the head and neck region.
Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly

The objective of the current study is to determine the acute effect of a glucose drink and a sacharose drink compared to a placebo on cognitive performance in elderly with light memory complaints. The investigators expect that the sugar containing drinks will improve memory and attentional functions. Furthermore, blood glucose response will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* 70 years and older
* Memory complaints

Exclusion Criteria:

* Type I or II diabetes
* Parkinson disease
* MMSE \< 25 (to exclude cognitively impaired subjects
* CES-D \> 16 (to exclude depressive subjects)
* Pharmacological antidepressives or medication for dementia
* Liver disease
Regional and Seasonal Variations in the Incidence and Causative Organisms for Post-traumatic Wound Infections and Osteomyelitis After Open Fractures

To determine if there is a relationship between people with open fractures and the season and location of where the injury occurred and the infections they develop


Eligibility Criteria:
Inclusion Criteria:

Open Fracture treated surgically between distal radius and distal tibia

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Exclusion Criteria:

* GSW Unable to follow for one year