cyrilzakka/clinical-trials huggingface dataset:
An Online Intervention Promoting HPV Vaccination Among Chinese MSM

Hong Kong Chinese speaking men who have sex with men completed a baseline survey, and then received an online intervention promoting uptake of Human Papillomavirus (HPV) vaccination. All participants are followed up by telephone 12 months after the completion of baseline survey.

The primary objective of this study is to investigate prevalence of uptake of Human Papillomavirus (HPV) vaccination after exposure to health promotion among men who have sex with men in Hong Kong within a 12-month project period.

Inclusion criteria are Hong Kong Chinese speaking males aged 18-45 years old and self-reported having had oral or anal intercourse with at least one man in the last six months. Those who have ever received HPV vaccination are excluded.

Participants are recruited through outreaching in gay venues, online advertisement and referral made by peers and non-governmental organization. With verbal informed consent, participants completed a baseline survey through telephone. They are then exposed to online interventions including: 1) watching an online video, 2) receiving a discount coupon to receive HPV vaccination at collaborative private clinics, 3) visiting the project webpage, and 4) receiving follow-up reminders 1, 2, 4, 6, and 8 months after the baseline survey.

All participants are followed up by telephone 12 months after the baseline survey to access the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese speaking males aged 18-45 years old and self-reported having had oral or anal intercourse with at least one man in the last six months

Exclusion Criteria:

* Have received any HPV vaccination
Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain

A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the treatment of breakthrough pain in adult patients with moderate to severe non-malignant chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will last up to 15 days. Eligible patients who complete the open-label arm will be allowed to enroll in the double-blind study arm.

ZARS Pharma is developing a Matrix Transdermal Fentanyl/CHADD (Controlled Heat-Assisted Drug Delivery) Drug Delivery System to be used for the treatment of chronic and breakthrough pain. The Matrix Transdermal Fentanyl/CHADD Drug Delivery System has been designed to provide long-term delivery of fentanyl for the treatment of chronic pain as well as intermittent increases in fentanyl concentrations for the treatment of breakthrough pain. Breakthrough pain is defined as a transitory exacerbation of pain that occurs on a background of otherwise stable pain in a patient receiving chronic opioid therapy.

Matrix Transdermal Fentanyl/CHADD Drug Delivery System has 2 components: a matrix transdermal fentanyl patch (the ZR-02-01 patch in doses of 25, 50, 75 and 100 mcg/hr) with corresponding thin film dressing (ie, overlay) and the CHADD (Controlled Heat-Assisted Drug Delivery).

The matrix transdermal fentanyl patch provides a continuous delivery of fentanyl over 72 hours, in a manner similar to Duragesic®. During a breakthrough pain episode, a CHADD unit is placed over (adhered to) the matrix transdermal fentanyl patch. The CHADD is a thin patch-like chemical heating device that generates a controlled level of heat for approximately 15-20 minutes. The application of heat delivers increased amounts of fentanyl when applied over the ZR-02-01 matrix transdermal fentanyl patch.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 through 70 years of age.
* Patient has moderate to severe non-malignant chronic pain.
* Patient is opioid-tolerant, requires treatment with chronic opioids and is currently taking a dose of 50 mcg/hr transdermal fentanyl for the treatment of chronic pain. Patient must have been taking this dose for at least 2 weeks.
* Patient must be experiencing 1 to 4 episodes of target breakthrough pain (breakthrough pain that is related to the patient's chronic pain condition) a day while taking a dose of 50 mcg/hr transdermal fentanyl.

Exclusion Criteria:

* Patient has active cancer.
* Patient has a history of substance abuse or has a substance abuse disorder.
* Patient is pregnant or breastfeeding.
Analysis of Risk Factors and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease

This hospital-based retrospective study reviewed patients who underwent surgery for CHD between 2017 and 2020 and analyzed the clinical features and outcomes associated with airway anomalies.


Eligibility Criteria:
Inclusion Criteria:

* all pediatric patients (age \<18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020.

Exclusion Criteria:

* with much missing clinical data
Bruxism and Parafunctional Oral Habits in Children and Adolescents With Cerebral Palsy

The aim of the study is to evaluate and analyze the rates and relationships between bruxism, other parafunctional oral activities, and oral-motor activities in children and adolescents with spastic CP.

This cross-sectional study was conducted on children and adolescents with CP receiving care services in three different private rehabilitation centers between January 2020 and March 2021. All the parents or primary caregivers included in the study were mothers of children with CP. Initially, information about bruxism and parafunctional oral habits and the study's aims were given to the mothers. All the mothers provided written informed consent for voluntary participation.

63 children and adolescents with spastic CP were analyzed, comprising 35 girls and 28 boys.

All the children were observed in clinical environments for classification according to the Gross Motor Function Classification System (GMFCS) and levels of activity and communication.

Data were collected from an evaluation form, clinical examination of the individuals, and interviews with the mothers.

In the first section of the evaluation, the medical records of the children with CP were reviewed for demographics, and clinical data, including age, gender, CP type, medication, and history of epilepsy. The GMFCS was used to determine the level of impairment in gross motor functions of the children.

In the second section of the evaluation, bruxism and other parafunctional oral activities were evaluated in detail through a face-to-face interview with each child's mother.

Other parafunctional oral habits were both questioned and observed in the clinical environment. The presence of sucking habits (thumb sucking, lip-biting, nail-biting, and cheek biting) and the use of a pacifier for more than 24 months was noted and recorded as present or absent.

The tongue-thrust reflex evaluation scale was applied for tongue thrust. Swallowing problems were evaluated with the water swallowing test, drooling with the saliva control problem severity, and frequency scale.

The habit of chronic breathing through the mouth was evaluated through information gained from the mother and from observation of whether nasal or buccal breaths were taken during routine treatment and evaluation in the clinical environment. For the evaluation of chewing problems, information about feeding was obtained from the mother and recorded as difficulty in chewing solid food, otherwise as absent.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with a diagnosis of spastic CP.
* Children and adolescents ages between 3-18 years old.

Exclusion Criteria:

* Children and adolescents with a diagnosis of dyskinetic, ataxic, and/or mixed type CP
* were aged \<3 years or ≥19 years,
* had severe sight or hearing impairment, or had received any orthodontic treatment
Delayed CNI-based Immunosuppression With Advagraf After MELD-based Liver Transplantation

Prolonged-release low-dose Advagraf should better protect from CNI-side effects compared to standard immunosuppressive regiments while the rate of rejection is not increased and thus graft function is well maintained. We hypothesize that especially in high-MELD (MELD-score \>20) recipients who have a decreased immune competence the prolonged-release low-dose Advagraf concept would better protect from side effects of immunosuppression (i.e. infection). Nevertheless, we assume that also patients with a MELD-score ≤20 will benefit from this concept in regard to lower infection rates and less side effects of immunosuppression.

The MELD-score (model of end stage liver disease) was designed to estimate the prognosis after TIPS (transjugular intrahepatic porto-systemic shunt). Nowadays it is the key-score for patients awaiting a liver graft and consists of serum-creatinine, serum-bilirubine and the INR-ratio with values between 6-40. The MELD-based liver allocation follows the sickest patient first strategy which significantly decreased outcome after liver transplantation (LTx) in Germany. There is evidence that the immune competence of very sick patients is decreased. Monocytic HLA-DR status is a marker for the function of the immune system. A reduced monocytic HLA-DR expression is indicative for a suppressed immune system.

Blood levels of Advagraf are slowly increased during the first week until the aimed tacrolimus trough levels are reached. Since therapeutic tacrolimus trough levels are reached not before the end of the first week after transplantation this is a concept for prolonged-release immunosuppression.

We assume, that high-MELD patients (MELD \>20) undergoing LTx are immunosuppressed per se. Thus prolonged-release low-dose immunosuppression with Advagraf would decrease both- infection rate (CMV-reactivation, wound infection urinary tract infections, pneumonia, etc.) and side effects of immunosuppression. The immune capacity of patients will be determined by the measurement of monocytic HLA-DR status. To ensure that graft function is not impaired due to rejection episodes, liver function will be determined with the LiMAx-test, a routine procedure in our institution. After 13-C-Methacetin is given to the patient, it is metabolized to paracetamol and 13CO2 by the enzyme CYP1A2 which is localized in hepatocytes. The 13CO2/12CO2 ratio in the exhaled air correlates with liver function.

Eligibility Criteria:
Inclusion Criteria:

* age \>18, \<65
* first liver transplantation
* Immunosuppression with Advagraf, MMF, corticosteroid
* surgery and postoperative treatment at the department for general-, visceral- and transplantation surgery

Exclusion Criteria:

* missing informed consent
* re-transplantation
* acute infection: CMV (pp65 positive), pneumonia, urinary tract infection, wound infection, reactivation of Hepatitis B/C
Effect of Oral Health Educational Program on Oral Health Quality of Life of Group of Type1 Diabetes Children

The study is a before and after study made to assess the oral health related quality of life after oral health educational program on children with type1 diabetes mellitus.

The main questions it aims to answer are:

* oral health related quality of life
* caries experience

Participants will answer oral health quality of life questionnaire and will be checked for DMF and def indices and then given an oral health education program and followed up after 3 months.

The oral health educational program will be conducted in Arabic in the form of flyers given to the children and their parents plus modeling on brushing habits on a cast and tooth brush.The educational program will emphasize on three main messages (brushing twice daily, healthy diet compatible with their disease and regular dentist visits).

Data in the flyer contained dietary tips as well as oral hygiene habits, design was made by the primary investigator.

The child oral health related quality of life will be measured by the validated Arabic child perception questionnaire (CPQ8-10)

Dental history, def and DMF indices will be measured by dental chart that will be modified to include a section for current medications.

To avoid selection bias all participants matching inclusion criteria in examination day will be included and all outcomes will be reported to avoid reporting and detection bias.

Study size: To the best of our knowledge there are no other studies found in literature to estimate a sample size so this study is going to be a pilot study with sample size of 50 child.

Statistical method: Categorical data will be represented as frequency (n) and percentage (%) and will be analyzed using chi square test. Numerical data will be investigated for normality by checking the data distribution, calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro-Wilk tests. If the data was normally distributed, it will be shown as mean and standard deviation values and an independent t-test will be used for analysis. If the assumption of normality was violated; the data will be presented as median and range values and will be analyzed using Mann-Whitney U test. The significance level will be set at p ≤0.05 for all tests. Statistical analysis will be performed with IBM® SPSS® Statistics Version 26 for Windows.

Eligibility Criteria:
Inclusion Criteria:

* Children of both sexes
* Age from 8 to 10 years old
* Diagnosed with type 1 diabetes mellitus

Exclusion Criteria:

* Children with other systemic diseases
* Parents who refuse participation
The Relationship Between Q Angle and Quadriceps Muscle Activation on Dynamic Balance in Women

The quadriceps angle (Q angle) is significant for the lower extremity alignment. Anatomical alignment of Q angle is related to Quadriceps muscle strength. Women have consistently been found to have larger Q angles than men and are more often affected due to patellofemoral problems. Quadriceps muscle activation and lower extremity alignment affect musculoskeletal health in women.The aim of this study wa s to determine the relationship between Q angle and quadriceps muscle activation on dynamic balance in women.

Objective: To determine the relationship between Q angle and quadriceps muscle activation on dynamic balance in women. Design: Correlational Study. Setting: University. Participants: Forth women will be included in the study. Interventions: Q angle in standing and supine positions, quadriceps muscle activation, static and dynamic balance and functionality were measured. Main Outcome Measurements: Q angle will measured with a tape measure; muscle activation will measured with Surface Electromyography (EMG) static balance will measured with Flamingo Balance Test (FBT); dynamic balance will measured with ProKin 252 Techno Body device; and, functionality will measured with Short Form Musculoskeletal Assessment (SFMA). Before the evaluation of EMG amplitude on dynamic balance position, the Q angle will measured in supine and standing positions. The EMG signals collected by measuring the muscle activation of the Vastus Medialis and Vastus Lateralis during dynamic balance position on the ProKin device will recorded.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were being women, being aged 19-25, and not having musculoskeletal or neurological problems.

Exclusion Criteria:

* Exclusion criteria were having an operation in the past year, taking medicine related to lower limb problems, persistent pain and discomfort of the lower extremity.
A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

Evaluation of myeloma disease burden is currently suboptimal. This limits treatment planning and evaluation of residual disease following treatment. 89Zr-DFO-daratumumab is a novel immunoPET tracer, designed to detect CD38 on myeloma cells and allow visualization of myeloma in a PET scanner. A phase I study of 89Zr-DFO-daratumumab demonstrated safety and successful visualization of myeloma with 89Zr-DFO-daratumumab. This will be a phase II study of 89Zr-DFO-daratumumab to evaluate potential clinical applications of this novel imaging agent.

This will be a phase II clinical trial to assess the potential clinical value of 89Zr-DFO-daratumumab immunoPET. 60 patients with multiple myeloma (MM) and a plan for daratumumab containing combination therapy will be enrolled. Prior to therapy, current standard of care (SoC), as well as a research 89Zr-DFO-daratumumab PET/CT, tests will be performed. Patients will then undergo standard of care therapy for myeloma as defined by a medical oncologist and SoC response assessments as defined by the International Myeloma Working Group (IMWG). Upon suspected complete response (CR) or completion of 12 cycles of therapy, a repeat research 89Zr-DFO-daratumumab PET/CT will be repeated and standard of care minimal residual disease (MRD) assessment will be performed. This design will determine how 89Zr-DFO-daratumumab immunoPET compares with current methods of measuring and localizing disease prior to therapy, if immunoPET can predict response to therapy, and how immunoPET compares with current methods of detecting MRD after therapy.

The therapy in this trial is standard of care. The research component is the addition of a novel immunoPET imaging test before and after standard of care therapy, to determine if the novel imaging test adds value over current measures of myeloma disease burden.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 21 years of age
2. Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma
3. At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment
4. ECOG performance status 0 to 2
5. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
2. Life expectancy \< 12 months
3. Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
4. History of anaphylactic reaction to humanized or human antibodies.
Does Letrozole Improve the Outcomes and/or Reduce the Cost of IVF-ET Cycles?

This research is being done to determine whether the success rate of in vitro fertilization treatment can be improved, while lowering the cost incurred from infertility medications using a pill called letrozole.

Specific Aim:

1. To determine whether addition of letrozole to gonadotropins would reduce the amount of gonadotropins used in an IVF-ET cycle, thereby reducing the cost.
2. To determine whether letrozole improves IVF-ET success compared to standard ovarian stimulation protocols.

Null Hypothesis: Use of Letrozole for ovulation induction in IVF is not less expensive than the standard therapy by a clinically relevant amount.

Alternative Hypothesis: Use of Letrozole for ovulation induction in IVF is better than the standard therapy by a clinically relevant amount.

Protocol:

Infertile women \<40 years of age with age-appropriate ovarian reserve (as determined by day2/3 E2, FSH, and AMH) will be randomized between two protocols: one with letrozole and one with standard ovulation induction.

In both groups, serum FSH will be measured each time a sample is obtained for estradiol. Sera will be frozen for further batch assay.

Number of embryos to be transferred will be decided following the ASRM guidelines. The day of embryo transfer (D-3 vs D-5) will be based on the number and quality of embryos as per established clinical criteria.

Power Considerations

A review of 1473 cycles of patients less than 40 years old over the last 6 years (2002 - 2008) revealed average cost per cycle to be $3,152 +/- 1685(SD).

For the purpose of this power analysis we consider a 20% decrease in medication cost to be clinically significant. Thus a decrease from $ 3152.83 to $ 2522.26 will be considered clinically significant (20% decrease). For an alpha of 0.05 and a power of 80% for a two tailed test 113 patients will need to complete each arm.

Allowing for 10% drop-out we will attempt to randomize 125 patients to each arm of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Normal Ovarian Function
2. Normal uterus

Exclusion Criteria:

1. Age 40 and above
2. Diminished ovarian reserve (based on markers and/or previous poor response)
3. Previous oophorectomy
Littlears Auditory Questionnaire: Validation Study in CI Children

The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years. The questionnaire has been validated on children with normal hearing whose native language is German. A comparison was made between North American English speaking children with normal hearing and found that it was consistent with the German data. This study is to validate the questionnaire in children with cochlear implants.


Eligibility Criteria:
Inclusion Criteria:

General:

* Less than or 24 months of age prior to implantation
* Cochlear implant candidate deemed by the clinic
* To be implanted with a MED-EL cochlear implant PULSARCI100 or SONATATI100
* English as the primary language at home
* Realistic expectations of guardians
* Willing and available to comply with all scheduled procedures as defined in the protocol

Medical:

* Good general health status, as judged by Primary Investigator
* No contraindications for surgery, in general, or cochlear implant surgery in particular

Exclusion Criteria:

General:

* Prior experience with any cochlear implant system
* Older than 24 months at time of implantation

Medical:

* Severed or non-functional auditory nerve in the ear(s) to be implanted
* Cognitive and/or neurological dysfunction
Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo

The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).


Eligibility Criteria:
Inclusion Criteria:

* Either has medically-confirmed diagnosis of chronic constipation (per Rome III), or meets the diagnosis as confirmed using the Rome III constipation module questionnaire during the Screening period.
* Is male or female, 18 or older years of age
* Should be on stable dose of fiber supplement or a concomitant medication for the indication of lowering blood pressure

Exclusion Criteria:

* Has any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation
* Is unable to eat or drink, take oral medications, or to hold down oral medications due to vomiting