cyrilzakka/clinical-trials huggingface dataset:
The Bone-Myoregulation Reflex and Development of Sarcopenia in Osteoporosis

Bone and skeletal muscle are in a single unit that interacts with each other structurally and functionally. The aim of this study is to determine the contribution of bone myoregulation reflex as a neuronal crosstalk mechanism on the development of sarcopenia in postmenopausal and senile osteoporosis

Bone and skeletal muscle are in a single unit that interacts with each other structurally and functionally. While myokines synthesized and released in skeletal muscle modulate the bone formation and destruction process, osteokines synthesized and released by bone cells have positive or negative effects on muscle (4,5,6,7,8,9). In addition to humoral crosstalk mechanisms between muscle and bone, there is also a neuronal crosstalk mechanism defined as bone myoregulation reflex. The aim of this study is to determine the contribution of bone myoregulation reflex as a neuronal crosstalk mechanism on the development of sarcopenia in postmenopausal and senile osteoporosis (10,11,12,13,14). Osteoporotic cases would be determined by standard DXA measurements.

The vibration will be applied with the PowerPlate® Pro5 whole-body vibration (London UK) device. The vibration amplitude will be 2 mm. The vibration frequency will be 30, 33, and 36 Hz. Each vibration frequency will be applied for 45 seconds. A 5-second rest period will be applied between vibrations of 45 seconds.

Surface EMG recordings will be taken from the right soleus muscle using the bipolar technique. A pair of self-adhesive Ag/AgCl (Redline®) electrodes will be adhered to the skin according to the SENIAM protocol(2). Recordings will be taken in the 1-500 Hz frequency band. Surface electromyography (EMG) recordings will be taken with a PowerLab ® (ADInstruments, Oxford, UK) data recorder with a sample rate of 20 KHz. EMG recordings will be analyzed offline with LabChart7 Pro® version 7.3.8 (ADInstruments, Oxford, UK). The acceleration measurement data will be recorded with the PowerLab (ADInstrument London) data acquisition simultaneously with the EMG recording. Acceleration recording will be made with a sample rate of 20 KHz.

Eligibility Criteria:
Inclusion Criteria:

* For healthy young adults control Healthy volunteers aged 20-45 years
* For postmenopausal osteoporosis Hip DXA T-score (neck or total hip) \< -2.5
* For the Senile osteoporosis Over 65 years Male Hip DXA T-score (neck or total hip) \< -2.5 Female

Exclusion Criteria:

* Osteopenic cases
* Possible sarcopenia (according to EWGSOP2 criteria)
* Vertigo
* Kidney stone
* Panic attack story
* Secondary osteoporosis
* Those with polyneuropathy, central nervous system disease clinic/history
* Myopathies (steroid, vitamin D deficiency, primary muscle diseases, etc.)
* Cases with lesions on the soleus skin
* History of fracture in lower extremity, joint prosthesis
* Lower extremity active/acute thrombophlebitis
The Effect of Transtheoretical Model-Based Motivational Interviewing on Postpartum Contraception

The goal of this clinical trial is to evaluate the effect of transtheoretical model-based antenatal and postnatal motivational interviewing on contraceptive self-efficacy, contraceptive attitude, and postpartum contraception use. This study was planned as a single-centre, parallel-group, randomized controlled trial design. The study group consisted of 72 women at 28-32 weeks of gestation (intervention group n=36, control group n=36). Block randomization stratified by parity will be used to assign participants to groups. The intervention group will receive antenatal and postnatal motivational interviewing in addition to routine care, while the control group will receive routine care only. Outcomes will be evaluated at 12 weeks postpartum. Data will be collected using a personal information form, Contraceptive Self-Efficacy Scale, Contraceptive Attitude Questionnaire, Contraceptive Use Form and Stages of Behavior Change Short Form.

Short gestational intervals are known to be directly associated with adverse pregnancy outcomes, such as gestational diabetes, maternal obesity, anemia, maternal mortality, severe maternal morbidity, preterm delivery, low birth weight, and infant mortality. The most important step in establishing optimum pregnancy intervals can be achieved by meeting the contraceptive needs of postpartum women. Motivational interviewing incorporates components of contraception counseling best practices, such as building trust, optimizing the decision-making process, improving self-efficacy, and protecting the autonomy of the individual, which allows it to be actively used in the counseling process. Therefore, this study aimed to investigate the effects of transtheoretical model-based motivational interviewing on postpartum contraception. In this study, the intervention group will receive two motivational counseling sessions in the antenatal period and one motivational interviewing session in the postnatal period in addition to routine care, while the control group will receive only routine care. The data will be coded as A and B in SPSS (Statistical Package for the Social Sciences) and analyzed by an independent statistical expert.

Eligibility Criteria:
Inclusion Criteria:

* 28 to 32 weeks of gestation
* At least literate in Turkish
* Agree to participate in the study
* Willing to participate in the postpartum follow-up
* Having access to a smartphone

Exclusion Criteria:

* Women who do not have a sexual partner
* Women who give consent for female sterilization immediately after delivery
Drug Use Study of Febuxostat After Recent Changes in the Prescribing Information

The prescribing information provides information on medicines. This study will check the number of patients starting febuxostat and the number of febuxostat users with cardiovascular disease after changes to the prescribing information.

This is a descriptive, cross-sectional, non-interventional study of participants with gout. The study will evaluate the impact of the 2019 labeling changes (boxed warning and modified indication), based upon results of the cardiovascular safety of febuxostat and allopurinol in participants with gout and cardiovascular morbidities (CARES) trial, on febuxostat utilization.

The study will evaluate data from approximately 24046 participants. The data will be collected from optum clinformatics dataMart (CDM) including the medicare advantage administrative US claims database and the IQVIA pharmetrics plus claims database.

All participants will be enrolled in a single observational cohort. This trial will be conducted in the United States. The overall duration of this study is approximately 14 months.

Eligibility Criteria:
Inclusion Criteria:

1. Index fill date on or after 01 June 2016.
2. Having at least one diagnosis for gout (identified with diagnosis codes, International Classification of Diseases, clinical modification, ninth revision \[ICD-9-CM\]: 274.x or International Classification of Diseases, tenth revision \[ICD-10\]: M10.x) at any time in the participant's record.
3. Continuously enrolled for at least 12 months prior to index fill date.
Meta-Analysis of Drug Therapy in Patients With Severe Alcoholic Hepatitis

In the specific setting of the evaluation of corticosteroids, pentoxifylline of their combination in severe alcoholic hepatitis, only meta-analysis combining individual data is able to provide detailed information from each individual with severe alcoholic hepatitis assessed by a DF ≥ 32. The need for such an approach is confirmed by the fact that in both univariate and multivariate analyses, truth survival is lower for conclusions from meta-analysis of the literature than for conclusions derived from non-meta-analyses.

The present study is a meta-analysis of individual data from RCTs restricted to patients with a DF ≥ 32. The primary endpoint will be to compare 28-day survival of patients receiving either corticosteroids, or pentoxifylline or their combination to those of patients not receiving them adjusted on the independent prognostic factors at baseline.

The secondary endpoints will be: a) assessment of response to the assigned treatment using the Lille model; b) analysis of 6-month survival according to allocated therapy.


Eligibility Criteria:
Inclusion Criteria:

* patients included in 10 randomized controlled trials testing either corticosteroids alone, or pentoxifylline alone or their combination have been published.

Exclusion Criteria:

-
A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235)

The primary objective of this study is to obtain safety information on the use of sitagliptin phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists, internists, and general practitioners.


Eligibility Criteria:
Inclusion Criteria:

* Must be taking sitagliptin phosphate/metformin HCl (JANUMET®) for the treatment of type 2 diabetes mellitus
* Treating physician must agree to provide information regarding the participant's treatment
Second Generation LMA Versus Endotracheal Tube in Obese Patients

This prospective, randomized, comparative study is intended to enroll a total of 148 patients with a BMI 30-49.9 kg/m2 undergoing surgery at Parkland Hospital. The efficacy and performance of a second-generation LMA will be compared to endotracheal intubation. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Obese (BMI \> or equal to 30 kg/m2
* Scheduled for a non-emergent surgery that requires general anesthesia (e.g., orthopedic, breast, urological, colorectal, ENT, vascular, general surgery)
* Willing and able to consent in English or Spanish
* No current history of advanced pulmonary or cardiac disease

Exclusion Criteria:

* Age less than 18 or older than 80
* BMI ≥50 or \< 30 kg/m2
* Patient does not speak English or Spanish
* Expected surgical duration longer than 4 hours
* Planned postoperative ICU admission
* Patient refusal
* Monitored anesthesia care (MAC) or regional anesthesia planned
* Pregnant or nursing women
* "Stat" (emergent) cases
* Known or suspected difficult airway
* Full stomach/significant aspiration risk (gastroparesis, emergency surgery, untreated moderate to severe gastroesophageal reflux disease, hiatal hernia)
* No history of gastric surgery
* Surgery in position other than supine (e.g., Trendelenburg)
* Laparoscopic surgery
Brain Health Project for Korean American Dementia Caregivers

The caregivers of persons with dementia face significant emotional, physical, and financial challenges, particularly among under-resourced communities like Korean Americans, who encounter unique obstacles, including language barriers and limited culturally tailored resources. In this pilot study, the investigators propose the Brain Health Project, which focuses on increasing knowledge of Alzheimer's disease and related dementia and enhancing caregiving skills among Korean American dementia caregivers.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and older
* self-identified as Korean American
* able to read and/or speak English or Korean
* care for a person with undiagnosed or diagnosed dementia for the last 6 months
* have access to a mobile phone to receive text messages

Exclusion Criteria:

* planning a trip out of the United States during the next four months
Phase 1 meCS6 + LT(R192G) Vaccine Study

The study will enroll approximately 60 volunteers. The vaccine is given as a drink in flavored soda water. Volunteers will either receive a 3-dose vaccination with doses spaced two weeks apart or a 4-dose vaccination with doses spaced 2 days apart depending upon their availability for follow-up.

Once assigned to a vaccination schedule, volunteers will be randomly assigned to receive the meCS6 vaccine with or without the mLT adjuvant for all vaccine doses. Neither the study investigators nor the volunteers will know which group they are assigned.

Volunteers will be asked to be available for clinic visits and telephone follow-ups during the study period and provide blood and stool specimens for testing.

The Phase 1 section of this study is a randomized double blind trial in which a total of 60 subjects (minimum of 52 allowable) will receive on of two oral vaccine doses according to the following chart:

Group Subset N CS6(Encapsulated) LT(R192G) I A 15 0.95mg 2 micrograms II B 15 0.95mg -- III A 15 0.95mg 2 micrograms IV B 15 0.95mg --

\*minimum of 13 volunteers/group

Volunteers in Group I will receive three immunizations (study days 0, 14, and 28) during the vaccine series. Volunteers in Group II will receive four immunizations (study days 0, 2, 4, and 6) during the vaccine series. The two groups will be vaccinated separately for logistical purposes. Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Vaccine safety will be actively evaluated during vaccination and for 4 weeks following the final vaccine dose.

Eligibility Criteria:
Inclusion Criteria:

* Available for required follow-up period
* Women must have a negative pregnancy test
* Women must not to try to become pregnant while on study and for 2 months after study is completed

Exclusion Criteria:

* History of travellers' diarrhea
* Occupation that involves handling of E. coli or cholera bacteria, or E. coli vaccine
* Regular use of anti-diarrheal, anti-constipation, or antacid therapy
* Abnormal bowel habits
* Pregnant or nursing women
* History of chronic gastrointestinal illness or major gastrointestinal surgery
* Allergies to vaccines
* Positive HIV, Hepatitis B or Hepatitis C tests
* Regular use of oral steroid medication
* Clinically significant abnormalities on physical examination
A Game-based Neurodevelopmental Assessment for Young Children

The aim of this study is to evaluate a novel tablet game-based neurodevelopmental assessment tool for young children aged 3 to 8 years old.

The study's main aims are: (1) to determine whether the novel tablet-game based assessment tool can accurately differentiate children's neurodevelopmental status based on their performance on the game and (2) assess the validity of the game-based neurodevelopment assessment tool.

The study aims to recruit 590 children who are 'typically' developing and/or have a diagnosed neurodevelopmental disorder including Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Specific Learning Disorder, or a Communication Disorder.

All participants will complete the tablet game-based assessment which aims to assess a range of neuropsychological functions including attention, memory, language, motor, executive functions and social-emotional skills. Parents/carers of participants will also complete a demographic questionnaire and the Adaptive Behaviour System - Third Edition (ABAS-3), which is a questionnaire that assesses a child's development. Some participants will be re-tested on the tablet game-based assessment approximately 2 weeks after the first tablet game-based assessment to ensure the game's validity.


Eligibility Criteria:
Inclusion Criteria:

* 3 to 8 year old 'typically' developing children with no known neurodevelopmental disorder.

OR

* 3 to 8 year old children with a diagnosed neurodevelopmental disorder, including Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Specific Learning Disorder, or a Communication Disorder.

All parents/caregivers and children must have a minimum level of English fluency required to complete the parent questionnaire and the game-based assessment.

Exclusion Criteria:

* Children with medical comorbidities, a chronic illness or any additional diagnoses that would impact their ability to complete the game-based assessment.
Tissue Samples and Bodily Fluid Specimens Banking

The purpose of this study is to collect a portion of blood/tissue specimens that will be generated during the participants office visit or surgery. The investigators are asking whether a small portion of the specimen/s could be set aside and banked for future research purposes. Data originating from participants will be gathered and analyzed in research studies that will help understanding various medical conditions such as polycystic ovary syndrome (PCOS), congenital uterine malformations, endocrine malfunctions, endometriosis, and infertility.

PURPOSE: Women present to the Reproductive Endocrinology clinic with different concerns. These may involve conditions such as pelvic pain, endometriosis, Mullerian anomalies, polycystic ovary syndrome, abnormal uterine bleeding, menopausal symptoms, or infertility. Understanding the meaning of different biologic markers in their blood serum or tissues could help advancing the medical knowledge in the different conditions.

RATIONALE: To understand the meaning of different biologic markers in the patients' blood serum or tissue samples.

POPULATION: Patients identified among all women presenting to the reproductive endocrinology clinic.

Patients may undergo endometrial biopsy or surgery to evaluate their condition. In these instances, the investigators will ask the patients whether a small portion of their specimen/s could be collected and banked for future research purposes.

DESIGN: Prospective blood/tissue collection.

PROCEDURES: A small portion of the patient's blood or tissue specimen collected at the time of a medically indicated blood draw or surgical procedure will be collected and banked for future research purposes. Sample collection will be performed on existing specimens, once the specimens have been obtained for medical indications. No additional procedures will be performed on the patients for research purposes only.

OUTCOME MEASURES: Creation of a blood serum/tissue specimens bank for future clinical research studies.

Eligibility Criteria:
Inclusion Criteria:

* females of childbearing potential experiencing reproductive endocrinology related problems.

Exclusion Criteria:

* male or female not of childbearing potential
A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy

This is a phase 2 study whose purpose is see how useful investigational drug, avelumab, is in patients with locally advanced or metastatic penile cancer who are unfit for or progressed on platinum-based chemotherapy.

The usefulness of avelumab in this study population will be determined by anti-tumor activity assessed by objective response rate.

Avelumab is a monoclonal antibody that binds to a protein called programmed death-ligand 1 (PD-L1) and blocks its communication with another protein called programmed death protein 1 (PD-1). The communication of these proteins are thought to be important in the growth of tumors. Blocking these proteins from communicating may stop or shrink tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the penis
* Measurable disease per Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
* Unresectable/metastatic disease that is unfit for platinum-based chemotherapy OR disease that has progressed on or after treatment with platinum-based chemotherapy
* ≥18 years of age
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Exclusion Criteria:

* Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* Major surgery ≤4 weeks or major radiation therapy ≤2 weeks prior to enrollment
* Known symptomatic central nervous system (CNS) metastases requiring steroids
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
* Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy
Self-Hypnosis for the Enhanced Recovery After Surgery in Patients with Gynecologic Cancer

This trial studies how well self-hypnosis works in enhancing recovery after surgery in patients with gynecologic cancer. A guided relaxation method called self-hypnosis may help affect how patients feel pain and symptoms after surgery.

PRIMARY OBJECTIVE:

I. To evaluate whether participation in pre-operative self-hypnosis (SH) is feasible and will improve patients' perception of post-surgical pain, after undergoing open gynecologic surgery (laparotomy) on an enhanced recovery pathway.

SECONDARY OBJECTIVES:

I. To evaluate whether participation in pre-operative SH is associated with changes in use of opioid medication, including time to first postoperative opioid and total dose of opioids taken (converted to morphine equivalents) and avoidance of opioids.

II. To explore whether participation in pre-operative SH is associated with changes in length of stay.

III. To explore whether there are differences between the two study arms in other common symptoms of women undergoing gynecologic surgery, functional recovery after surgery and quality of life (QOL).

IV. To explore whether expectations regarding symptom management or hypnotic susceptibility are related to or influence the perception of symptoms after surgery.

V. To measure satisfaction with the intervention (patients on arm 2). VI. To perform sub analyses to explore whether other common clinical or demographic factors are potential covariates.

EXPLORATORY OBJECTIVE:

I. To compare two different instruments measuring patient reported outcomes in hospital postoperative recovery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive usual care including receipt of multi-modal analgesia and the injection of a local analgesic at the time of surgery on the enhanced recovery after surgery (ERAS) pathway.

ARM II: Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
* Planned participation in the Gynecologic Enhanced Recovery Pathway
* Patient must be able to read, understand, and speak English
* Consents to being part of a randomized study
* Patient has physical and mental capabilities to take part in study

Exclusion Criteria:

* Sensitivity to amide-type local anesthetics
* Patients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 days
* Emergency surgery of any type that does not allow for proper time for protocol review by the patient
* Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
* Patients undergoing known/anticipated anterior abdominal wall hernia repairs
* Patients undergoing pelvic exenteration
* Patients with known major psychiatric disease
* Patients with hearing impairment such that they are unable to hear the intervention
Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion

The purpose of this study is to determine whether continued administration of Drotrecogin Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion period - results in a more rapid resolution of hypotension in severe septic patients.


Eligibility Criteria:
Inclusion Criteria:

* Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
* Continue requirement of Vasopressor support after 96 hour commercial infusion

Exclusion Criteria:

* Patients require extensive surgical procedures within next 3 days
* Patients with platelet count below 30,000/mm3
* Patients receiving therapeutic heparin of 15,000 units/day and more
* Patients not expected to survive 24 days
* Patients contraindicated as to the country specific registration