cyrilzakka/clinical-trials huggingface dataset:
A Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction

This study assesses whether the addition of chemodenervation to an established regimen of pelvic floor physical therapy for painful high tone pelvic floor dysfunction improves patients' objective and subjective outcomes. Study subjects will select one of three treatment approaches: injection of 50 units Botulinum toxin A with local sedation as an office procedure, injection of 100u BoNTA-cosmetic in either the office or while anesthetized, or injection of 150 units Botulinum toxin A while anesthetized.

High-tone pelvic floor dysfunction is often a painful condition that can be associated with a number of female pelvic syndromes including childhood elimination disorders, idiopathic urinary retention, vaginismus, dyspareunia, pelvic pain, constipation, sport injuries, postoperative and bladder pain syndrome/interstitial cystitis. Following appropriate patient education about pelvic floor function, mainstays of therapy for high-tone pelvic floor dysfunction pelvic pain include pharmacotherapeutic agents and pelvic floor physical therapy. The investigators hypothesize that chemodenervation with Botulinum toxin A will offer a safe, efficacious intervention for women with high tone pelvic floor dysfunction that cannot be adequately treated with pelvic floor physical therapy alone.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* \>6 month history of pelvic pain or dyspareunia with high tone pelvic floor dysfunction on exam (pain with palpation of superficial transverse perineii, bulbocavernosus insertion to perineal/central tendon and/or levator ani complex/iliococcygeus)
* Women with male sexual partners
* History of undergoing pelvic floor physical therapy with internal manipulation including trigger point release as directed, with inability to meet goals of therapy despite appropriate pelvic floor physical therapy approach
* Able to read, write, and comprehend English sufficiently to offer informed consent

Exclusion Criteria:

* Presence of intact hymen, preventing internal manipulation during pelvic floor physical therapy
* Pregnancy at the time of injection
* Breast feeding at the time of injection
* History of Myasthenia Gravis, Amyotrophic Lateral Sclerosis, Lambert-Eaton syndrome, allergy to Botulinum toxin A, or other contraindication to Botulinum toxin A injection
* History of documented skin disorder of the vulva other than vaginal atrophy or lichen planus
* Prior pelvic radiation
* Stage II-IV pelvic organ prolapse
* Has had a pelvic floor Botulinum toxin A injection within the last 12 weeks
* Unable to provide informed consent
Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome

Developing a molecular genetic test that can identify prognostic factors which can predict response to treatment, and to contribute to the establishment of future therapeutic strategies base on prognostic factors by undergoing peripheral blood and bone marrow examination of Myelodysplastic Syndrome (MDS) patients at diagnosis and relapse.


Eligibility Criteria:
Inclusion Criteria:

* MDS diagnosed by bone marrow aspiration and biopsy at Severance Hospital.

  * Male and Female over 16 years of age. ③ Written consent of the patient to participate in the cohort ④ Deaths during the study period are waiver of consent

Exclusion Criteria:

① Refusal or trouble understanding the written consent
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with other anticancer agents including taxanes (docetaxel, paclitaxel), or sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).


Eligibility Criteria:
Inclusion Criteria:

* Participant must be at least 18 years of age
* Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy
* Have evidence of homozygous loss of MTAP or MTAP deletion
* Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns
* Measurable disease
* ECOG performance status \<= 1
* Adequate organ function
* Able to swallow and retain orally administered study treatment
* Recovery from acute effects of prior therapy
* Able to comply with contraceptive/barrier requirements

Exclusion Criteria:

* Known symptomatic brain metastases
* Known primary CNS malignancy
* Current active liver or biliary disease
* Impairment of gastrointestinal (GI) function
* Active uncontrolled infection
* Clinically significant cardiac abnormalities
* Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan
* Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry
* Radiation therapy within 2 weeks prior to study entry
* Prior irradiation to \>25% of the bone marrow
* Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
* Currently receiving another investigational study drug.
* Known or suspected hypersensitivity to IDE397/excipients or components
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia

This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and PD as measured by reduction in serum uric acid levels.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 70
* Subjects with hyperuricemia who are otherwise healthy

Exclusion Criteria:

* Pregnant or nursing
* Known history of gout
* Clinically significant infection at Screening
* Known sensitivity to tranilast or febuxostat
O6-benzylguanine Followed by Surgery in Treating Patients With Solid Tumors That Can Be Removed During Surgery

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of O6-benzylguanine followed by surgery in treating patients who have solid tumors that can be removed during surgery.

OBJECTIVES: I. Determine the minimal O6-benzylguanine (O6-BG) dose required to deplete tumor activity to less than 10 fmol/mg protein at a specified time after administration in patients with surgically resectable solid tumors. II. Correlate tumor tissue AGT depletion with AGT depletion in peripheral blood mononuclear cells (PBMC) obtained at a specified time after O6-BG administration in these patients.

OUTLINE: This is a dose escalation study. Patients receive a single dose of O6-benzylguanine (O6-BG) IV over 1 hour at one of two dose levels. Patients undergo surgery 16-20 hours after administration of O6-BG. Up to 13 patients receive the lower dose level of O6-BG. If more than 3 patients have detectable AGT levels, additional patients receive the higher dose. The optimal biologic dose (OBD) is defined as the lowest dose level at which at least 11 of 13 patients have AGT activity less than 10 fmol/mg protein after O6-BG dosing. Patients are followed at 1 and 3 weeks post surgery.

PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study over approximately 10 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed surgically resectable solid tumor

PATIENT CHARACTERISTICS: Age: Not specified Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Medically cleared for surgery No active medical or psychiatric disease that would prevent compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
Insulin Resistance and Substrate Metabolism After Acute Erythropoietin (EPO) Administration

Recently EPO receptors have been found in human muscle tissue, but what is still not known is the physiological role of these receptors. In this study the researchers want to investigate if there is any effect of a acute administration of EPO on insulin resistance and/or substrate metabolism in muscle tissue.

Recently EPO receptors have been found in human muscle tissue, but what is still not known is what the physiological role of these receptors are. It has previously been shown that Growth Hormone mediate insulin resistance. The GH receptor and EPO receptor belong to the same family of cytokine receptors, and thereby share many of the same signalling pathways. In this study we want to investigate if there is a similar effect on insulin resistance and/or substrate metabolism after acute administration of EPO in human muscle tissue. Different signalling pathways are investigated på western blotting, and insulin sensitivity are measured be a hyperinsulinemic euglycemic clamp, and substrate metabolism is measured by the forearm model.

Eligibility Criteria:
Inclusion Criteria:

* Healthy persons
* Between 18 and 30 years
* Normal weight (BMI: 18-25)

Exclusion Criteria:

* Severe heart disease (NYHA 3)
* Uncontrolled hypertension
* Previous cerebrovascular disease
* Proliferative retinopathy
* Diabetes
* Musculo-skeletal diseases
Refractive Change Induced by 2.8-mm Corneal Incision

The investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral.

Patients will be randomized to nasal or temporal incision, or assigned to superior incision, depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and after phacoemulsification.

Outcome measures will be induced corneal refractive change (Fourier power vector analysis), ISV change, and visual acuity, at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Visual impairment for daily tasks caused by cataract
* Age older than 50 years
* Steep axis of corneal astigmatism at 90° ± 20° or 180° ± 20°
* Ability to cooperate in the protocol procedures

Exclusion Criteria:

* Age below 50
* Inability to cooperate with measurements
Determining the Specificity of High Definition Electrical Brain Stimulation Using Simultaneous Magnetoencephalography

Non-invasive human brain stimulation using weak transcranial direct-current stimulation (tDCS) has been thousands of times in research studies over the past fifteen years as a therapy to help improve the effectiveness of repeated training sessions (e.g., hand exercises in the context of daily physiotherapy), due to its safety, tolerability, convenience and cost-effectiveness. tDCS works by temporarily enhancing brain activity during performance of a specific task, helping with learning and training.

The investigators will use magnetoencephalography (MEG) brain imaging to view the real-time effects of high definition (HD) tDCS on several brain areas involved in vision, hearing, movement, and memory. The investigators hypothesize that changing the task (auditory, visual or memory task) but keeping the position of the electrodes over the motor cortex will result in modulation of brain activity in only the central target motor area, and not on non-target temporal, occipital or pre-frontal areas.


Eligibility Criteria:
Inclusion Criteria:

* Normal hearing and vision

Exclusion Criteria:

* Current pregnancy
* Presence of metallic implants in the head
* Use of any medications
* Any history of mental health or neurological conditions
* Inability to perform any of the tasks for any reason
Impact of Monsplasty in Women Undergoing Abdominoplasty

Evaluate The aesthetic and function satisfaction outcomes of different monsplasty surgery with or after abdominoplasty

The high incidence of female obesity has resulted in common complaints of a large mons pubis and labia majora (outer labial lips) related to unsightly fat deposits. The mons and labia majora enlarge, protrude, descend, and hang. Even with dramatic weight loss, these areas remain descended and bulky, with excess fat and skin. The affected majora can cause difficulty with sexual intercourse and maintenance of hygiene, and result in discomfort when wearing pants and swimsuits. These unnatural .fat deposits can also severely affect self-esteem

The surgical treatment of the enlarged mons pubis and labia majora has been poorly understood and therefore often neglected. Traditionally, the mons has been treated by fat reduction, whether by liposuction or open excision, along with a pubic skin lift. However, skin elevation is usually unsatisfactory, because the mons will descend again upon standing. Many of these unsuccessful lifts present after a simultaneous abdominoplasty.

In many ways, the treatment of the mons pubis correlates with the treatment of the hidden penis in the obese or formerly obese male.1-3 Excess suprapubic skin and mons fat removal-along with tacking of the fibrofatty tissue of the pubic skin flap to the rectus fascia-are mandatory to achieve a lasting, successful mons pubis lift.4 Labia majora reduction. Depends on the surgically appropriate removal of fat and/or skin

Eligibility Criteria:
Inclusion Criteria:

* Any adult married woman from 20 to 45 years old candidate for abdominoplasty with stable weight in last 6 months

Exclusion Criteria:

* patients less than 20 years old and more than 45 years old
* patients with medical conditions affecting wound healing
* patients with skin infection in lower abdomen and pubic area
BEOVU Versus Eylea in the Treatment of Age-related Macular Neovascular Degeneration

Age-Related macular neovascularization degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management.

Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. Procedure included randomized intravitreal injection of Brolucizumab (BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea; Regeneron, Tarrytown,NY)

Eligibility Criteria:
Inclusion Criteria:

* • Age-Related macular neovascularization degeneration

Exclusion Criteria:

* other causes of macular neovascularization degeneration
* other macular diseases
A Survey on the Under-treatment of hypercholeSterolemia (EPHESUS Trial)

In this study, within the secondary prevention group patients ( diabetes mellitus, coronary artery disease, peripheral artery disease, who have had events atherosclerotic cerebrovascular ) , statin use requirement , patients compliance and reaching target LDL-cholesterol levels (according to European guidelines ) will be evaluated.

In the majority of patients treated with lipid lowering agents are not under control in accordance with the lipids manual. In this study, within the secondary prevention group patients ( diabetes mellitus, coronary artery disease, peripheral artery disease, who have had events atherosclerotic cerebrovascular ) , statin use requirement , patients compliance and reaching target LDL-cholesterol levels (according to European guidelines ) will be evaluated.

The investigators' aim is to determine the role of education and knowledge in reaching target LDL cholesterol levels in these patients. İn addition , the investigators want to emphasize in high-risk patients who are receiving or not receiving cholesterol-lowering treatment what is their target values , (LDL \< 100 mg / dL and high -risk patients with LDL \< 70 mg / dL in very high-risk patients ) and to determine what is the rate of patients and to the importance of reaching their target cholesterol levels. İn addition ,to evaluate the patients habits of the using statin dose .After screening , physician treatment decisions and reasons will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease (acute coronary syndromes, post- myocardial infarction patients, who have a history of percutaneous coronary intervention , history of coronary artery by-pass graft )
* Patients with carotid artery lesions or peripheral artery disease ,
* Type 2 diabetes mellitus patients

Exclusion Criteria:

* acute coronary syndrome in last 1 month
* pregnancy or the first 6 months postpartum
* ICU patients or emergency patients...etc.(other than polyclinic)
Working Memory Training in COPD Patients: the Cogtrain-Trial

General cognitive impairment is highly prevalent in chronic obstructive pulmonary disease (COPD) patients. Domain-specific cognitive impairments include deficits in domains such as cognitive flexibility, verbal memory, working memory, planning, and psychomotor speed; which in general are associated with poor health behaviours, such as infrequent exercising and poor diet. Additional cognitive training may reverse these effects. Recent evidence suggests that working memory training is linked to self-control and, indirectly, to improved lifestyle behaviour including increased physical activity. The investigators hypothesise that enhancing cognitive performance through administering specific working memory training not only improves cognitive function but that it facilitates better adherence to a more active lifestyle and a healthier diet in COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of COPD based on the Global Initiative for Chronic obstructive Lung Disease (GOLD) guidelines
* Patients also need to provide written informed consent
* Be motivated as evaluated by the self-determination questionnaire

Exclusion Criteria:

* Disease and or disability limiting the ability to undergo a neuropsychological testing battery and/or to follow a working memory training (e.g., blindness)
* Neurological disorders (e.g., Alzheimer's Disease or cerebrovascular disease)
* Insufficient mastery of the Dutch language
* Individuals who during the study period are or will be participating in a PR programme
Reducing Musculoskeletal Stresses and Work-related Injuries Among Allied Health Professionals in Surgical Care

1. What are the risk factors that contribute to musculoskeletal injuries and fatigue on allied health professionals in surgical care (e.g. scrub nurses, surgical assistants, and circulating nurses)?
2. Can the investigators design wearable devices that the investigators can later evaluate?


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Employed at Mayo Clinic Rochester as Surgical Assistant, Circulating Nurse, and Scrub Nurse (Surgical Technicians)

Exclusion Criteria, Aims 1 and 2:

* None
Impact of Virtual Reality Hypnosis Before an Invasive Medical Procedure for Patients With Chronic Pain

Management of chronic pain involves an array of tools, such as radiofrequency thermocoagulation (Rf-Tc). Like many other invasive procedures, Rf-Tc can generate an increase in pain perception and anxiety levels. Virtual reality hypnosis (VRH) is a promising tool in managing anxiety and pain. Nevertheless, its effectiveness has not been investigated in patients with chronic pain goig througha Rf-Tc procedure. The goal of this study is to evaluate the effectiveness of VRH on self-assessed anxiety in patients with chronic pain having to undergo an act of Tf-Rc. Patients were randomly assigned into two groups: VRH or Control (usual care). Assessment were carried-out at 4 periods of time: T0 (the week before the Rf-Tc); T1 (pre-intervention the day of the Rf-Tc); T2 (post-intervention the day of the Rf-Tc); and T3 (post-Rf-Tc). Medical and socio-demographic data, immersive tendencies pain, anxiety, and satisfaction were assessed at each time points.


Eligibility Criteria:
Inclusion Criteria:

* suffering from chronic pain
* \>18 years old
* French speaking
* no claustrophobia
* no head or face wounds
* sufficient auditory and visual acuity for an effective use of the VRH technique
Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy

This study compared the gain of periodontal attachment after concomitant one-stage removal of bacterial biofilms and subgingival calculus with a two-stage procedure removing subgingival calculus 6 weeks after the initial removal of soft subgingival bacterial biofilms.

The concomitant removal of subgingival calculus and soft bacterial biofilms in a one-stage procedure might impair periodontal healing in deep infrabony pockets due to the mechanical disruption of demineralized bone sections at the bottom of periodontal lesions. This randomized controlled clinical trial therefore aims at comparing the resulting attachment gain 6 months after one-stage antiinfective periodontal therapy comprising the concomitant subgingival removal of soft bacterial biofilms and calculus with a two-stage approach removing subgingival calculus only 6 weeks after the initial removal of soft subgingival bacterial biofilms.

Eligibility Criteria:
Inclusion Criteria:

* presence of periodontal disease
* minimum of 1 tooth with an infrabony periodontal lesion and pocket depth ≥ 6mm
* minimum of 15 natural teeth

Exclusion Criteria:

* systemic disease interfering with periodontal healing (e.g. diabetes)
* antibiotic therapy ≤ 12 month prior to study participation
* necessity for preventive antibiotic therapy during dental interventions
* inability to comply with the study protocol
The Effect of Game-Based Virtual Reality Application on the Development of Postoperative Care Skills of Nursing Students for Hysterectomy

This study aimed to determine the effect of game-based virtual reality application on nursing students' self-confidence in postoperative care knowledge, skills, satisfaction and learning following hysterectomy surgery.

Method: A total of 179 third-year students studying in the third year of Ege University Faculty of Nursing in the fall semester of 2023-2024 were included in this study, who had the theoretical knowledge about Gynecology and Obstetrics Nursing within the scope of the Diseases and Nursing Care II course, were in the practice of Gynecology and Obstetrics Nursing, and voluntarily agreed to participate in the study. The students were divided into two groups, 42 control and 42 intervention groups, using simple random sampling method. Prior written consent was obtained from both the ethics committee and the institution for conducting the study. Data collection instruments included a Demographic Data Collection Form, a Form for Determining Student Opinions Regarding Game-Based Virtual Reality Application, a Postoperative Care Knowledge Test for Hysterectomy Surgery, a Satisfaction with Education Methods Questionnaire, and the Student Satisfaction and Confidence in Learning Scale.

Eligibility Criteria:
Inclusion Criteria:

* Being in the 3rd year internship of Women's Health and Diseases Nursing Course,
* Having internet access,
* Being able to use a computer,
* Volunteering to participate in the research.

Exclusion Criteria:

* Being a graduate of Health Vocational High School,
* Working as a nurse,
* Taking the Women's Health and Diseases Nursing Course 3rd year internship for the second time