cyrilzakka/clinical-trials huggingface dataset:
The Effect of Child Choice With Accompanying Parent on Postoperative Delirium During Induction of Anesthesia

Induction of anesthesia can be distressing both for children and their parents. Nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative drugs.

The aim of this study will be to evaluate whether the children's or parental preference with attending parent affects on the postoperative delirium of the children or not. The delirium of the children will be assessed by the Pediatric Anesthesia Occurrence Delirium Scale (PAED)

Anesthetic induction can be one of the most stressful experiences for the child during the perioperative period, with almost 50% of the children showing significant anxiety. . To minimize the effect of anxiety, several methods have been adopted, such as the introduction of day-case surgery, parental presence at the induction of anesthesia, distractions and the use of pharmacological agents like midazolam to reduce anxiety. Although the effect of parental presence on the anxiety of children and parents was studied in various studies. Whether the children's choice of parental selection affects anxiety and postoperative delirium not studied yet. In this study, we will evaluate the anxiety of children by using mYPAS and postoperative delirium by using PAED.

Eligibility Criteria:
Inclusion Criteria:

1. 5-12 years aged children
2. ASA physical Status I-II
3. Who underwent day-case surgeries in the Ear Nose and Throat Clinic

Exclusion Criteria:

1. Mentally challenged
2. Deaf Child
3. Cerebral Palsy
4. Premedicated Child
5. Language Problem
6. Unco-operative
7. Previous surgery or anesthesia history
Exhaled Breath Condensate Biomarkers and Cough in IPF

Analysis of exhaled breath condensate biomarkers and cough severity in patients with idiopathic pulmonary fibrosis.

This study will aim to investigate the levels of the reactive oxygen species (ROS) 8-isoprostane in idiopathic pulmonary fibrosis patients' exhaled breath condensate (EBC). EBC samples will be collected using RTube, prior to analysis for levels of 8-isoprostane. An acceptability assessment will be performed for this non-invasive method of EBC collection through a non-validated questionnaire.

A regression analysis will then be performed for 8-isoprostane levels against the severity of the patient's cough, assessed through the use of the visual analogue scale for cough (VAS), the King's brief interstitial lung disease questionnaire (KBILD), the Medical Research Council (MRC) dyspnoea scale and the Leicester cough questionnaire. Alongside this an exploratory comparison of cough scores and 8 isoprostane concentration between patients with and without honeycombing and traction bronchiectasis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female above the age of 40
* IPF diagnosed by a multi-disciplinary team meeting following review of clinical history, thoracic high resolution computed tomography (HRCT) and/or surgical lung according to international guidelines

Exclusion Criteria:

* A recognised significant co-existing respiratory disease, defined as a respiratory condition that exhibits a clinically relevant effect on respiratory symptoms and disease progression as determined by the principal investigator following multi-disciplinary discussion. For example, patients with bronchiectasis will only be included if the bronchiectasis is deemed to be traction bronchiectasis as a result of idiopathic pulmonary fibrosis
* Airflow obstruction defined as a forced expiratory volume at one second over forced vital capacity (FEV1/FVC) \<60% predicted or a residual volume greater than 120% predicted
* Significant medical ,surgical or psychiatric disease that in the opinion of the patient's attending physician would exhibit a clinically relevant effect on the patient's health related quality of life
* The patient is unable to provide written informed consent
Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement

Aim of the study was to compare the efficacy of internal versus external photobiomodulation (PBM) in the management of patients with TMJ internal derangements (TMJ-ID).


Eligibility Criteria:
Inclusion Criteria:

* Painful click at temporomandibular joint (TMJ) area.
* Pain at the lateral pterygoid muscle.
* Presence of full or nearly full complement of natural teeth with acceptable occlusion

Exclusion Criteria:

* Patients who have radiographic evidence of degenerative conditions of TMJ.
* Patients under current dental or physical therapy that could affect TMD.
* History of recent trauma.
* The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
* Pregnant and lactating females.
* Presence of open bite.
Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide

To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in participants who are normal weight (body mass index \[BMI\] \< 25 kg/m2, overweight or class I obese (BMI 25-34.9 kg/m2), or class II-III obese (BMI ≥ 35 kg/m2). The hypothesis is that participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than participants who weigh less. Restated, the area under the drug-concentration time profile, also known as the AUC, in participants will decrease as participant weight increases.

This single site study will be conducted at the UT Southwestern Simmons Cancer Center. This study is designed to measure drug concentrations in the blood of 18 female breast cancer patients who require doxorubicin (30 minute infusion) and cylcophosphamide (30 minute infusion) as part of standard medical care. Up to a total of 40 adult female participants will be consented for the study at the cancer center. Eighteen of these participants are needed to complete the study. The others will likely be screen failures. The participants will have no more than 100 ml of blood drawn via a peripheral intravenous catheter just prior to the doxorubicin infusion, and then at 0.5, 1, 1.5, 2, 3, 4, 5, 12-24, and 24-72 h after the beginning of the doxorubicin infusion. The 5 hour blood draw is optional. The intravenous catheter will be removed when the participant is discharged from the cancer center on day 1. The participant will be asked to return to the cancer center at 12-24 and 24-72 hours to have the final 2 blood draws conducted.

The participants must be treated with Doxurubicin and Cyclophosphamide in order to participate in this pharmacokinetic analysis study.

Eligibility Criteria:
Inclusion Criteria:

* Females, age 18 years of age or older, of all racial and ethnic origins that are scheduled to receive the first cycle of a single intravenous dose of doxorubicin (30 minute infusion) and cylcophosphamide (30 minute infusion) as part of standard medical care for breast cancer. English and/or Spanish speaking participants are eligible to participate.

Exclusion Criteria:

* Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of doxorubicin and cyclophosphamide on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of doxorubicin or cyclophosphamide, so that the pregnancy and post-partum state would be a confounding variable.
* Participants unwilling to comply with study procedures.
* CrCl \< 10 ml/min
* Participants requiring peritoneal or hemodialysis
* Serum bilirubin \> 1.19 mg/dL
* Receipt of the following drugs that: a) Alter doxorubicin concentrations: carbamazepine, cyclosporine, fosphenytoin, paclitaxel, phenytoin, sorafenib, valspodar, verapamil; b) Alter cyclophosphamide concentrations: cyclosporine, nevirapine, ondansetron; c) All other drugs will be reviewed during screening of the patient
Portal Hypetension and Bariatric Surgery (BARIAPORTAL)

The worldwide obesity epidemic has led to an increase in the proportion of patients with chronic liver disease due to non-alcoholic fatty liver disease (NAFLD) and in the prevalence of obesity in patients with cirrhosis of all etiologies. The reported prevalence of obesity in patients with cirrhosis is of 30% which appears similar to that of the general population.

Bariatric surgery is currently considered as the most effective and durable means for the management of morbid obesity as it is associated with the remission and/or improvement of many obesity associated comorbidities as well as improved quality and expectancy of life.

However, the surgical risk is increased compared to individuals without cirrhosis, and determining the risk/benefit ratio of bariatric surgery in the setting of cirrhosis is a complex task further hampered by the lack of randomized controlled trials.

The Nationwide Inpatient Sample study reported a slightly increased rate of mortality of bariatric surgery in the setting of compensated cirrhosis compared to individuals without cirrhosis (0.9% vs 0.3%). Interestingly, this risk was as high as 16.3% in individuals with decompensated cirrhosis (16.3%). However, this study has been published more than 10 years ago and the mortality of bariatric surgery has decreased significantly and is around 0.1%. Furthermore, the introduction of transient elastography in clinical practice has allowed the early identification of patients with chronic liver disease (CLD) at risk of developing clinically significant portal hypertension (CSPH).

A few series including a limited number of patients have been published indicating that CSPH should not be considered as a formal contraindication for bariatric surgery.

This study is meant to assess the outcomes of bariatric surgery in patients with morbid obesity and compensated advanced chronic liver disease (cACLD) (currently synonymous of the term "compensated cirrhosis'') associated with clinically significant portal hypertension (CSPH) in a large multicentric, multinational series.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with morbid obesity (BMI \> 40 or 35 with at least one comorbidity) undergoing bariatric surgery and CSPH (defined as HVPG \> 10 mmHg and/or cross-sectional imaging showing collateral circulation, and/or varices at esophagogastroduodenoscopy.
* Information available to determine postoperative mortality (at least first postoperative month of any duration in case of primary hospitalization longer than 1 month)

Exclusion Criteria:

* Absence of preoperative evidence of CSPH in spite of evidence liver cirrhosis.
* Absence of information to determine at least postoperative mortality.
Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood

The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with mixed dyslipidemia (trigylcerides, \> or = to 150 mg/dL to \< 400 mg/dL; HDL-C \< 40 mg/dL for males, \< 50 mg/dL for females; LDL-C, \> or = to 130 mg/dL).
* Subjects must agree to use adequate birth control methods and to adhere to the American Heart Association (AHA) Diet.

Exclusion Criteria:

* Subjects with unstable or uncontrolled medical conditions considered inappropriate in a clinical trial.
* Subjects with an unstable dose of medications or receiving Coumadin, oral, intravenous or intramuscular cyclosporine, statins, or certain other medications.
* Women who are pregnant or plan on becoming pregnant, or women who are lactating.
Retrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair

Vaginal laxity" syndrome is an increasingly frequent reason for gynecological consultations. Patients complain above all of a sensation of excessive vaginal looseness. This syndrome can be isolated or associated with genital prolapse. Women with vaginal laxity may experience sexual dysfunction manifested by hypersensitivity during penetration and vaginal gas, resulting in decreased libido. Among urogynecology patients, vaginal laxity has been reported in up to 24% of cases, with a mean discomfort of 5.7 (on a scale of 0 to 10). Vaginal laxity is more common in younger women who have given birth vaginally. Gynecologic examination usually finds widening of the urogenital hiatus during the Valsalva maneuver, suggesting that vaginal laxity may be a manifestation of hyperdistensibility or disinsertion of the levator ani muscles. Campbell et al. noted that vaginal laxity was reported by 38% of 22621 women attending a urogynecology clinic and was associated with vaginal parity, prolapse symptoms, stress, and urinary urgency incontinence, reduced sensation on the ePAQ-PF questionnaire. In an IUGA survey of member physicians, 83% of respondents felt that vaginal laxity was underreported by patients.

The most common clinical definition of vaginal laxity is a urinary meatus to vulvar fork distance (GH measure of the POP-Q classification) \> or = 4cm.

The first-line treatment for vaginal laxity is perineal rehabilitation. If this fails, surgical perineal repair, combining posterior perineorrhaphy and myorrhaphy of the pubo-rectal bundles of the levator ani muscles, can be performed with the aim of narrowing the introital vaginal caliber and improving the symptoms of laxity. This procedure is poorly evaluated in the literature.

The purpose of this study is to evaluate the functional and sexological results of surgical perineal repair.


Eligibility Criteria:
Inclusion Criteria:

* women who underwent surgical perineal repair (CCAM codes JMMA002 and/or HKCA005) between July 2012 and September 2020 at Nîmes University Hospital.
* Adult patient (≥18 years old)
* Enrolled in a social security plan
* Patient does not object to the study

Exclusion Criteria:

* Prolapse surgery without perineal repair
* Perineal repair without levator myorrhaphy
* Patient who objected to the use of their data.
* Pregnancy since the operation
* Persons under court protection,
* Person participating in another research study with an ongoing exclusion period,
* Severely impaired physical and/or psychological health that, in the opinion of the investigator, may affect the participant's compliance with the study
Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease

This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine to treat chorea in participants with Huntington disease.


Eligibility Criteria:
Inclusion Criteria:

1. Have a clinical diagnosis of Huntington Disease (HD) with chorea
2. Be able to walk, with or without the assistance of a person or device
3. Participants of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently while participating in the study until 30 days (females) or 90 days (males) after the last dose of the study drug
4. Be able to read and understand English

Exclusion Criteria:

1. Have a history of previously established therapy with a VMAT2 inhibitor, in the judgement of the investigator
2. Have difficulty swallowing
3. Are currently pregnant or breastfeeding
4. Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular block, uncontrolled bradyarrhythmia, or heart failure
5. Have an unstable or serious medical or psychiatric illness
6. Have a significant risk of suicidal behavior
7. Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening
8. If taking antidepressant therapy, be on a stable regimen
9. Have received gene therapy at any time
10. Have received an investigational drug in a clinical study within 30 days of the baseline visit or plan to use such investigational drug (other than valbenazine) during the study
11. Have had a blood loss ≥550 milliliters (mL) or donated blood within 30 days before the baseline visit
12. Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome
Comparison of Boric Acid vs. Terconazole in Treatment of RVVC

Vulvovaginal candidiasis (VVC) caused by Candida species, predominantly C. Albicans is considered one of the most common infections of the lower female genital tract affecting 75% of women at least once in their lifetime. Recurrent VVC (RVVC) is arbitrarily defined as four or more episodes every year. RVVC is a debilitating, long-term condition that can severely affect the quality of life of women. Several factors have been associated with RVVC such as prolonged use of antibiotics, inadequately treated infection, uncontrolled diabetes, immune mechanisms (e.g. HIV), oral contraceptive use as well as the resistance of non-albicans Candida species (e.g. C glabrata, C krusei) to conventional antifungal agents as azoles.

Fluconazole administered orally is the most commonly used antifungal drug in the case of RVVC. However, in the last decade, fluconazole-resistant C Albicans has been reported in women with RVVC. Terconazole is a broad-spectrum, triazole antifungal treatment agent for both C Albicans and non-albicans. Its use (80 mg vaginal suppository daily for 6 days) was as effective as two doses of oral fluconazole (150 mg) in the treatment of patients with severe VVC and RVVC.

Boric acid or boracic \[B(OH)3\] is a weak acid with proven antifungal action. In RVVC especially in azole-resistant strains and in non-Candida Albicans, 600 mg of the boric acid vaginal suppository is recommended once daily for 2 weeks. This regimen has a mycologic cure rate varied from 40% to 100%. However, there are no published studies comparing the intravaginal use of boric acid with terconazole for RVVC. Accordingly, a prospective randomized study in patients with RVVC will be conducted to address this important issue.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RVVC will be defined as four or more episodes of VVC that occurred during the previous 12-month period.
* Has symptoms and signs of VVC e.g. itching, burning, discharge, and erythema.
* Documented VVC on high vaginal swabs (HVSs) by the demonstration of blastospores and pseudohyphae in a wet vaginal smear treated with 10% potassium hydroxide, and a positive fungal culture.
* Age: 18-50 years old and premenopausal.
* Agree to abstain from sexual intercourse during the treatment period.
* Agree to abstain from using any other vaginal product during the study period.

Exclusion Criteria:

* Postmenopausal.
* Pregnancy.
* Sexually transmitted infection (Chlamydia, gonorrhea, trichomonas).
* Any antifungal or antibiotic use 14 days prior to treatment.
* Gynecological conditions requiring treatment e.g. Bartholin's cyst, abscess, PID.
* Patients receiving corticosteroids or immunosuppressive therapy.
* Patients expected to menstruate within seven days of the start of treatment.
Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants

This study evaluates resuscitation with an intact umbilical cord compared to resuscitation with the umbilical cord cut. Half of the newborn babies in need of resuscitation will be handled while having an intact umbilical cord and half will have their umbilical cord cut.

The routine procedure when a newborn baby is in need of resuscitation is to cut the umbilical cord and move the baby to a designated area for resuscitation, which can include stimulation, clearing the airways, administration of oxygen and/or positive pressure ventilation by bag and mask och T-piece resuscitator.

It has been suggested, and pilot studies has shown preliminary results, that keeping the umbilical cord intact while performing resuscitation may improve the babies outcome, by continued exchange of oxygen and carbon dioxide be the placenta and facilitating the neonatal pulmonary and circulatory transition.

Because of the limiting length of the umbilical cord, resuscitation with an intact cord must be performed in close proximity to the mother.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy week ≥35 + 0
* Singletons
* Expected vaginal delivery
* The woman / couple can adequately assimilate information about the study
* Signed informed consent of both prospective parents

Exclusion Criteria:

* Congenital malformation that complicates resuscitation (such as severe malformation of mouth, pharynx, respiratory system) or which causes the child not to be resuscitated due to internal structural malformations (such as more severe heart failure, diaphragm fractures, etc.)
* The child is born via acute caesarean section after inclusion and opening of study envelope
* placenta abruption / or damage to umbilical cord during childbirth (when circulation through an intact umbilical cord cannot be achieved after birth)
PD-L1 Specific 68Ga-THP-PD-L1-3 Probe for PET Imaging in Solid Tumors

The objective of the study is to constrcut a noninvasive approach 68Ga-THP-PD-L1-3 PET/CT to detect the PD-L1 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from anti-PD-L1 treatment.

Analysis plan: 1. recruit 10 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution and tumor uptake information via whole-body PET/CT imaging; 2. recruit 20-30 participants to analyze in vivo safety and tumor targeting information; and 3. recruit all participants for a final summary.

Eligibility Criteria:
Inclusion Criteria:

1. Aged \>18 years old; ECOG 0 or 1;
2. Patients with solid tumorsin or suspected tumor lesions;
3. life expectancy \>=12 weeks.

Exclusion Criteria:

1. Significant hepatic or renal dysfunction;
2. Is pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refusal to join the clinical study;
5. Suffering from claustrophobia or other mental diseases;
6. Any other situation that researchers think it is not suitable to participate in the experiment
The Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines

To Confirm the non-inferiority of CUNOX® to BOTOX® in the glabellar line improvement of moderate to severe glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 65
* Subjects attaining ≥ grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum forced frown
* Subjects who voluntarily sign the informed consent

Exclusion Criteria:

* Subjects with allergy or hypersensitivity to the investigational drugs or their components
* Subjects who are participating in other clinical trials or have participated in clinical trials 30 days before screening
* Subjects who are not eligible for this study at the discretion of the investigator