cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcomes in Elderly Patients With Preoperative Cognitive Dysfunction

Preexisting cognitive impairment, such as mild cognitive impairment, is common in many elderly patients who undergoing major surgeries. Accumulating evidence has demonstrated that preexisting cognitive impairment is associated with increased mortality, increased incidence of postoperative complications, decreased quality of life, and worse outcomes. However, few studies have evaluated the relationship between preexisting cognitive impairment and cognitive trajectories and clinical outcomes.

Preexisting cognitive impairment is common in many elderly patients who undergoing major surgeries. The number of surgical procedures in the elderly will increase dramatically as a result of the increased elderly population in the future. It has been suggested that preexisting cognitive impairment is associated with increased incidence of postoperative complications, decreased quality of life, and increased mortality. Preoperative risk assessment is becoming increasingly important because preoperative risk stratification allows the clinical team to forecast postoperative outcomes. Currently, the most common strategy to identify high-risk patients before surgery is assessment of single end-organ function. This tactic is most widely recognized by the American Heart Association's guideline for cardiac evaluation, but is also well described for pulmonary, hepatic, and renal organ systems. Little is known about the effects of pre-existing cognitive (or brain) function (perhaps the most vital human organ) on postoperative outcomes. Therefore, the present study evaluated whether patients with pre-operative cognitive impairment would have a more precipitous drop in cognitive function and worse outcome in geriatric surgical patients.

Eligibility Criteria:
Inclusion Criteria:

- Inclusion criteria were persons 65 years and older undergoing an elective operation on the general, noncardiac thoracic, urologic, and vascular surgical services.

Exclusion Criteria:

- Patients with vision or hearing impairment who could not visualize pictures or hear instructions associated with the delirium assessments and patients who could not provide informed consent.
Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels

Recently, it has been seen that investigations from saliva samples could be an alternative to those from blood samples. Saliva collection is a simple, non-invasive, cost-effective, and relatively easy method, making it potentially suitable as a new diagnostic tool in pediatric patients. In the current literature, elevated levels of saliva CRP, TNF-α, IL-6, and IFN-γ have been reported in inflammatory conditions. However, while there are animal studies suggesting the use of saliva PCT levels for focal diseases such as gingival inflammation and periodontitis and as a potential tool for non-invasive detection of sepsis, there is no human study regarding its use in systemic infections.

The aim of this study is to evaluate the correlation between serum PCT levels and saliva PCT levels in children suspected of SBE and to determine the diagnostic value of saliva PCT.


Eligibility Criteria:
Inclusion Criteria:

* Being under one year of age
* Having serum Procalcitonin (PCT) requested due to suspicion of systemic infection

Exclusion Criteria:

* Being over one year of age
* Having a chronic illness that could cause elevation in inflammatory biomarkers
* Taking any medication (such as antibiotics, immunomodulatory, or immunosuppressive drugs, etc.) that could affect inflammatory biomarkers
* Diagnosis of gingivostomatitis
Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506

To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A

Phase 1 to evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A. Which is designed as ramdomized, oral, single dose, two-way crossover.

Eligibility Criteria:
Inclusion Criteria:

* Over 19 ages healthy men
* Over 50.0kg, 18.0kg/m2 ≤ BMI ≤ 30.0kg/m2
* Men who don't have congenital disease and other cronic disease need to be cared. etc.

Exclusion Criteria:

* Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN)
* Men who have drunken or eatten something including caffeine within 24 hours before. etc.
Feasibility of Partners in Care Program for Caregivers of Patients With Acute Myeloid Leukemia

This trial studies the feasibility of delivering the Partners in Care Program to caregivers of patients with acute myeloid leukemia. Psychological counseling interventions, such as the Partners in Care Program, may help to improve caregivers' psychosocial functioning, marital adjustment in the context of the cancer, communication, and support skills to the patient.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP A: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.

GROUP B: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.

After completion of study, participants are followed up at 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AML within the recent 2 months
* Caregivers and patients need to write, read, and speak English as one of their languages of choice; and currently sharing a residence at least 50% of the time together
* Patient must have no other concurrent cancer diagnosis except for basal or squamous cell
* Caregiver must be able to sustain up to 60 minutes of interaction with patient educator
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Participants will be excluded if either the patient or the caregiver cannot write, read, and speak English as one of their languages of choice; are not currently sharing a residence at least 50% of the time together
* The patient cannot have another concurrent cancer diagnosis except for basal or squamous cell
* Caregiver cannot sustain up to 60 minutes of interaction with the patient educator
* Caregiver does not have access to a computer with 2-way video capability (i.e. ZOOM) or a cell phone
Autogenous Demineralized Dentin Block Graft Versus Autogenous Bone Block Graft for Alveolar Ridge Preservation

The aim of this trial is to compare the effect of autogenous demineralized dentin block graft (ADDBG) versus autogenous bone block graft (ABBG) harvested from maxillary tuberosity on alveolar ridge preservation after extraction of non-restorable single rooted teeth

Many studies have reported an approximately 50% reduction in alveolar bone both the horizontal and vertical directions over 12 months with more than two-thirds of the reduction occurring in the first three months after extraction. Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. A broadly recognized approach is the maintenance of bone walls through bone substitute (graft) delivery into the socket, where guided bone regeneration may be a requisite. Autogenous bone graft has osteogenic and osteoinductive effect. however, when attempts were made to use autologous bone chips in socket preservation, they failed to promote healing or stimulate hard tissue formation in the socket. On the other hand, autogenous bone block graft from the tuberosity has shown a feasible, user-friendly, low-cost solution for minimizing soft and hard tissue collapse and dimensional loss following single-rooted tooth extraction.

Moreover, root dentin block is composed of Type I collagen matrix with several osteoinductive non-collagenous proteins such as bone morphogenetic proteins (BMP) and dentin matrix proteins. Geometrically, alveolar bone morphology was maintained by dentin block graft as well as it has micropores (dentinal tubules) of 3-5 μm diameter and macropores of 0.2-0.3 mm diameter for enhancing osteoinductive and osteoconductive functions.

Both demineralized dentin block and autogenous bone block grafts has been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear

Eligibility Criteria:
Inclusion Criteria:

* Non-restorable tooth indicated for extraction
* Single-rooted teeth
* Motivated patients, agree to sign informed consent and complete the follow-up period

Exclusion Criteria:

* Pregnant females
* active infection at extraction site
* Smokers
* systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)
Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse

This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE).

Women with symptomatic prolapse (grade II-IV) who seek for a conservative treatment, with no history of previous POP-surgery will be randomised to either the laser-arm or the PFE-arm.

There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.

The primary objective is to evaluate the effects of VEL treatment for reduction of prolapse symptoms and as a secondary outcome objective measurements. These endpoints are in line with the recommendations by Durnea et al., as being the most relevant and patient centered outcomes.

The second goals are to register adverse events and to determine for how long the effects of laser are sustained, with a maximum of two years. To do so, the investigators will measure long term satisfaction with, and the longevity of the effect (measured by the need for repeat or alternative therapy) of laser therapy.

Duration of follow-up per patient: max 27 months


Eligibility Criteria:
Inclusion Criteria:

* The presence of POP symptoms
* Diagnosis of cystocele or rectocele of grade II to IV according to the POP-Q system, leading the prolapse (i.e. C ≤ Ba/Bp)
* Voluntary informed consent

Exclusion Criteria:

* Symptoms or anatomical evidence for intussusception / rectal prolapse
* Leading descent of the middle compartment (C \> Ba/Bp)
* Grade IV prolapse
* Previous POP surgery
* Pregnancy or \<12 months postpartum
* Vaginal bleeding, injuries or infection in the treated area
In Vitro Effects of Procyanidine on Semen Parameter and DFI

Proanthocyanidins are a class of polyphenols found in a variety of plants that have antioxidant activity in vitro, which is stronger than vitamin C or vitamin E.

Several studies have been performed evaluating the administration of antioxidant therapy in the form of oral antioxidant supplementation or in vitro addition of antioxidant to culture media during assisted reproductive techniques (ART).

However, the impact of in vitro addition of proanthocyanidins to semen has not been studied yet. The research question evaluated in the current study was whether semen samples of infertile men supplemented or not with procyanidine immediately after their production, differ in semen parameters, sperm DFI.


Eligibility Criteria:
Inclusion Criteria:

* Infertility defined as:

  * At least twelve (12) months of non-achieving pregnancy despite unprotected sexual intercourse or six (6) months, if the female is \> 35 years of age AND
  * At least two (2) semen analyses with at least one abnormal parameter (sperm concentration, motility and morphology), according to WHO 2010 criteria.
* Not on any type of infertility treatment for the last three (3) months
* Sperm concentration \> 8 x 106/ml and semen volume at least 2.5 ml for technical reasons.
* Normal hormonal profile (TSH, FSH, LH, total testosterone, prolactin)
* Seminal white blood cells \< 1 x 106/ml
* No abnormalities in scrotal ultrasound

Exclusion Criteria:

* Underlying genetic cause of infertility
* History of undescended testis (cryptorchidism)
* History of orchidectomy
* History of testicular cancer
* History of severe cardiac, hepatic or renal disease.
* History of endocrine disease (primary or secondary hypogonadism, hyperprolactinemia, thyroid disease, pituitary or adrenal disease)
* History of epididymo-orchitis, prostatitis, genital trauma, testicular torsion, inguinal or genital surgery
* History of systemic disease or treatment during the last three (3) months
* Positive sperm culture for Chlamydia or Ureaplasma urealyticum
* Female infertility factors
* Body mass index (BMI) \> 30 kg/m2
* Participation in another interventional study and a likelihood of being unavailable for follow-up.
Efficacy of K-Y Jelly in Prevention of Postoperative Sore Throat After Nasal Surgery

Postoperative sore throat (POST) is a fairly common side effect of general anesthesia which is caused by the mucosal injury and nerve compression associated with tracheal intubation or laryngeal mask airway device insertion. In this randomized study, the authors evaluate the effect of K-Y jelly-soaked nasopharyngeal packs on POST and postoperative nausea and vomiting in patients subjected to nasal surgery.

Postoperative sore throat (POST) is a fairly common side effect of general anesthesia which is caused by the mucosal injury and nerve compression associated with tracheal intubation or laryngeal mask airway device insertion. In this randomized study, the authors evaluate the effect of K-Y jelly-soaked nasopharyngeal packs on POST and postoperative nausea and vomiting in patients subjected to nasal surgery.

The present double-blinded randomized controlled study was conducted at Al-Azhar University Hospitals, Cairo, Egypt. The study protocol was approved by the local ethical committee of Al-Azhar Faculty of Medicine and all patients provided informed consent before enrollment in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to nasal surgery under general anesthesia.

Exclusion Criteria:

* Acute of chronic nasopharyngeal conditions,
* Gastroesophageal reflux, regurgitation,
* History of postoperative sore throat,
* nasal surgery for malignant disease,
* concurrent or recent use of systemic or topical agents used for sore throat or
* Mallampati grade more than 2.
Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer

This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination.

The iBreastExam is a handheld device that performs a painless electronic palpation (examination by touch) of the breast. The device is designed to detect breast abnormalities that may require breast imaging and additional clinical examination by a nurse or doctor. The iBreastExam device creates a color map of the breast, with red spots indicating areas that may be abnormal.


Eligibility Criteria:
Inclusion Criteria:

* Female patient
* Over 18 years of age, able to consent
* RLC patients presenting to RLC or BAIC for mammogram and CBE
* Asymptomatic and symptomatic patients will be included

Exclusion Criteria:

* Male patients
* Patients under 18 years of age, unable to consent
* Pregnant patients
* Lactating patients
* Non-intact skin
Developing Optimal Focal Muscle Vibration for Improving Spasticity

The overall aim of the proposed study is to determine optimal parameter of focal muscle vibration for improving spasticity and identify neurophysiological mechanism in healthy subjects.

In investigation I-1, subjects will undergo focal muscle vibration with 40, 80, 120 Hz frequency at the medial gastrocnemius muscles (mGCM). As a surrogate maker of spasticity, H-reflex and compound motor action potential (CMAP) of the tibial nerve at mGCM will be recorded pre, during, and post vibration.

In investigation I-2, subjects will undergo focal muscle vibration with 0.1, 0.3, 0.5 mm amplitude at mGCM. H-reflex and CMAP of the tibial nerve at mGCM will be recorded pre, during, and post vibration.

In investigation II, subjects will undergo focal muscle vibration with predetermined parameters by the investigation I at mGCM. H-reflex and CMAP of the tibial nerve and motor evoked potential at mGCM will be recorded pre, during, and post vibration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

* Unstable medical conditions
* History of epilepsy
* History of drug abuse
Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy

The objective of this is to compare surgical outcomes of anterior colporrhaphy using nonabsorbable sutures with anterior colporrhaphy using absorbable sutures.

This trial is a prospective, randomized trial conducted with the aim to determine superiority of anterior colporrhaphy using nonabsorbable sutures over absorbable sutures with regard to the primary outcome. Participants will undergo reconstructive surgery for prolapse, including anterior colporrhaphy using the assigned suture materials under general or spinal anesthesia. The anterior colporrhaphy will be performed in a traditional manner with midline plication of the fibromuscular layer using either 2-0 nonabsorbable (polyester or polypropylene; Ethicon, Somerville, NJ) or absorbable (polyglactin 910 or polydioxanone; Ethicon) sutures. Concomitant procedures will be performed as intended prior to surgery. Women with a uterus in situ will undergo hysterectomy and all women will receive an apical suspension procedure, including uterosacral ligament suspension, sacrospinous ligament fixation, and iliococcygeal suspension, according to the preference of surgeon. Posterior colporrhaphy and incontinence surgery will also be performed, if indicated (i.e. women with Bp ≥-1 or documented urodynamic stress incontinence).

Enrollment, treatment and data collection will be standardized by all sites. The study will be a single-blind study, as it is impossible to blind the study surgeon for the surgical procedure to which the subject in assigned. However, all outcomes assessors and the subjects will be blinded to the treatment assignment. Postoperative follow-up will take place after 5 weeks, 6 months and 12 months. Patients will undergo a standard gynecological examination including POPQ and fill in questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Anterior vaginal descent beyond the hymen (i.e. POPQ Ba\>0)
* Vaginal bulge symptoms (i.e. an affirmative response to the question 3 from the PFDI-20)
* Reconstructive surgery is planned

Exclusion Criteria:

* Recurrent anterior vaginal wall prolapse
* Reconstructive surgery using mesh or obliterative surgery for prolapse is planned
* Known pelvic malignancy
* Systemic glucocorticoid or immunosuppressant treatment
* Subject wishes to retain her uterus
* Subject is unable and unwilling to participate in
Low Intensity Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy

Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. A few small studies have recently shown that low-intensity shockwave therapy may improve sexual performance in men with ED. However, the optimal dosage and length of treatment is yet to be determined. The investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ED following prostatectomy surgery.

Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. At present, this debilitating consequence of surgery is managed in a step-wise approach including oral medication, injections and in severe cases, insertion of a penile prosthesis. A few small studies have shown that low-intensity shockwave therapy may improve sexual performance in men with ED. However, the optimal dosage and length of treatment is yet to be determined. The investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ED following prostatectomy surgery. Low-intensity shockwave therapy would be a non-invasive treatment to preserve and improve patient's sexual function.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 - 65
* Diagnosed with low/intermediate-risk prostate cancer:
* PSA \< 20 ng/ml
* Gleason score \< 8
* PCa stage =\< T2b
* Baseline IIEF-ED 17-30 without erectogenic aids
* No pre-operative urinary incontinence (no usage of urinary pads)
* Sexually active
* Able to understand and complete patient questionnaires
* Consent to participate

Exclusion Criteria:

* Anatomical abnormalities in the genitalia or pelvic region
* Post-RP complications that could impact safety or effectiveness of ESWT (eg. hematoma, fistula, unresolved anastomotic leak)
* Incomplete tumor removal (positive surgical margin)
* Tumor upstaging beyond T2b
* Nerve sparing score \> 5
* Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
* Untreated hypogonadism (serum total testosterone \< 300 mg/dL)
* Anti-coagulant medication, except acetylsalicyclic acid up to 100mg daily
* Any other condition that would prevent the patient from completing the study, as judged by the principle investigator
Effect of Polymorphisms in the IL-1 Gene Complex on the Development of Chronic Hepatitis and Hepatocellular Carcinoma

The purpose of this study is to determine the effect of polymorphisms in the IL-1 gene complex on the development of chronic hepatitis and hepatocellular carcinoma.

We analyzed single-nucleotide polymorphisms in the genes for interleukin-1a, interleukin-1b, interleukin-1-receptor antagonist, interleukin-1-receptor type I, and interleukin-1-receptor type II in 400 normal control and patients (chronic hepatitis and hepatocellular carcinoma). Genotypes were tested for an association with development of chronic hepatitis and hepatocellular carcinoma by multivariable analysis. A second cohort of 1200 normal control and patients (chronic hepatitis and hepatocellular carcinoma) was independently analyzed for the genotype associations identified in the first cohort.

Eligibility Criteria:
Inclusion Criteria:

* Normal controls
* Cases of chronic hepatitis and hepatocellular carcinoma

Exclusion Criteria:

* Pregnant women
Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children

Anemia continues to be a major public health problem in many regions of the world and it is still not clear which strategy is more effective in children population in terms of adherence and efficacy. The objective was to evaluate the efficacy and acceptance of several strategies that have been recently recommended to treat anemia on anemic children (6 to 43 mo):Iron supplement, iron+folic acid supplement, a multiple micronutrients supplement a micronutrient fortified complementary food in the form of porridge powder or zinc+iron+ascorbic acid fortified water.


Eligibility Criteria:
Inclusion Criteria:

* Hemoglobin less than 11.7g/dL and above 7.0g/dL

Exclusion Criteria:

* Breastfeeding
* Chronic gastroenteritis
* Any other severe illness