cyrilzakka/clinical-trials huggingface dataset:
Sarcopenic Index and Related Factors in Patients With Type 2 Diabetes

Sarcopenia, characterized by a progressive loss of skeletal muscle mass and function, is particularly common in individuals with T2DM and is often associated with insulin resistance, chronic inflammation and oxidative stress. The Sarcopenia Index (SI), calculated as serum creatinine divided by serum cystatin C, is a practical tool for assessing sarcopenia and is used in many clinical settings. In this study, we aimed to investigate the relationship between sarcopenic index and variables such as age, diabetes duration, diabetes control and complication-related parameters such as NT-proBNP and Fib4 score in patients with type 2 diabetes.

This study was planned retrospectively. Between September 01, 2023 and March 31, 2024, the records of patients who presented to the Diabetes Outpatient Clinic of Goztepe Prof. Dr. Suleyman Yalcin City Hospital for Internal Medicine and whose routine biochemical tests (including NT-proBNP and cystatin C) were found in the system will be retrospectively reviewed. Both male and female patients with a definite diagnosis of type 2 diabetes were included in the study. Inclusion criteria included: age 40 years or older, age 85 years or younger, no acute infection, no steroid use, no acute changes in creatinine or cystatin C levels, no recent surgery, no limb loss. Demographic data included age, gender, duration of diabetes, medications and concomitant diseases. The Fib 4 score was calculated using the patients' routine biochemical and hematologic results. The sarcopenia index was calculated from the serum creatinine/cystatin C values. A cut-off value of 0.90 is normally used for the diagnosis of sarcopenia in people without diabetes, but there is no cut-off value for patients with diabetes. Therefore, in addition to the correlation, the SI value was divided into 3 groups and the patients in the lowest and highest groups were compared with each other.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes diagnosis
* with complete biochemical data on record

Exclusion Criteria:

* acute infection,
* steroid use,
* acute changes in creatinine or cystatin C levels,
* recent surgery,
* limb loss.
Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines

The primary purpose of this study is to prospectively determine whether capecitabine and 5-FU-induced toxicity is preventable by dose reduction prior to start of the first administration in patients heterozygous or homozygous mutant for DPYD\*2A, and to determine whether this strategy is cost-effective. Secondly, an individualized treatment algorithm for capecitabine and 5-FU therapy in DPYD\*2A mutant patients will be developed and the pharmacokinetic profile of capecitabine and 5-FU will be assessed.

Patients exhibiting a genetically determined disorder (DPYD\*2A) in the metabolic degradation of the frequently used anticancer agents capecitabine and 5-FU (fluoropyrimidines) are at high risk of development of severe and life-threatening toxicity during standard treatment with these compounds. Treatment and recovery of this fluoropyrimidine-induced severe toxicity often requires prolonged periods of hospitalization.

Screening for DPYD\*2A in patients to treat with fluoropyrimidine drugs with subsequent dose adjustments in mutant individuals prior to start of therapy will possibly reduce the number of severe toxicity events. Furthermore, by reducing the frequency and/or duration of hospitalization, substantial medical costs can be saved, making this a cost-effective strategy.

Eligibility Criteria:
Inclusion Criteria:

* Histological proof of cancer
* patient is considered for treatment with capecitabine or 5-FU
* hetero- or homozygous mutant for DPYD\*2A
* able and willing to give written informed consent
* able and willing to undergo blood sampling for pharmacokinetic analysis
* life expectancy 3 months or longer
* acceptable safety laboratory values (ANC, platelet count, ASAT, ALAT, creatinine,
* WHO performance status 0-2
* no radio- or chemotherapy within the last 3 weeks prior to study entry

Exclusion Criteria:

* patients with known alcoholism, drug addiction and/or psychotic disorders that are not suitable for adequate follow-up
* women who are pregnant or breast-feeding
Validation of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population

The aim of this study is to present the French translation of the Drooling Impact Scale (DIS-F) and to explore its validity, reliability and responsiveness to change in a group of children with Cerebral Palsy (CP)

Drooling in children with CP is likely underestimated and under treated. It is an over-handicap for these children, because it causes many complications and may lead to a decline in self-esteem and to social isolation, altering the quality of life for patients and families. The therapeutic arsenal for the management of drooling includes rehabilitation techniques, oral drug treatments, local treatments or surgical treatments whose effectiveness is variable. In order to evaluate the efficacy of these therapies, standardized and valid assessment tools must be used. The Drooling Impact Scale (DIS) developed by Dr. Sue Reid's team in Melbourne in 2008, shows good validity and sensitivity to change, especially after botulinum toxin injection. It is commonly used in English-speaking studies, but no validation in French is available yet.

The aim of this study is to present the French translation of the Drooling Impact Scale (DIS-F) and to explore its validity, reliability and responsiveness to change in a group of children with CP.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy
* Hypersialorrhea
* No change in content and frequency of speech therapy for three months following baseline
* At least 1 out of 2 parents must have a clear understanding of french language
* Oral consent

Exclusion Criteria:

* No clear understanding of french language
Conservative Management of Cutaneous Abscess

This is a single center non-blinded randomized trial of topical anesthetic cream to usual care (warm compresses and time) for superficial, non-perianal abscesses in children under 18 years of age. The primary outcome is time to spontaneous drainage. The secondary outcomes are return to emergency room/hospital/care provider and need for incision and drainage. Information on patient experience using standardized patient reported outcome measures for health-related quality of life will also be gathered. The findings of this study will provide more robust evidence of the benefit of this treatment including a potential reduction in cost and allow for more widespread dissemination.

Cutaneous abscesses are a common problem in the pediatric population, leading to a substantial number of emergency room and primary care visits each year. Historically, treatment consisted of antibiotics and surgical drainage, but as our understanding of these disease processes has progressed, treatment has moved away from invasive drainage procedures except when necessary. Now, most patients are treated with warm compresses or warm baths to the area until spontaneous resolution occurs. Recent data has demonstrated that the application of topical anesthetic cream to a cutaneous abscess underneath a non-permeable dressing can lead to improved rates of spontaneous drainage. Although this method is being used with success at our institution, its true benefit is unknown, preventing widespread dissemination of the practice. We are therefore proposing a prospective trial to evaluate the benefit of this treatment on pediatric patients. This is a single center non-blinded randomized trial of topical anesthetic cream to usual care (warm compresses and time) for superficial, non-perianal abscesses in children under 18 years of age. The primary outcome is time to spontaneous drainage. The secondary outcomes are return to emergency room/hospital/care provider and need for incision and drainage. Information on patient experience using standardized patient reported outcome measures for health-related quality of life will also be gathered. The findings of this study will provide more robust evidence of the benefit of this treatment including a potential reduction in cost and allow for more widespread dissemination.

Eligibility Criteria:
Inclusion Criteria:

* \<18 years of age
* Single, localized soft tissue abscess \<3 cm in size by clinical or imaging criteria

Exclusion Criteria:

* Signs of systemic illness/infection including but not limited to temperature \> 100.4, lethargy, or poor oral intake;
* A decision by an attending physician that incision and drainage is necessary;
* Inpatient admission; immunocompromised patients; soft tissue abscesses involving the perineum (labia, scrotum, penis, perianal), hands/feet, or face;
* Previous antibiotic use in the past seven days or previous attempt by a clinician/provider at drainage;
* Current drainage from abscess.
* Lidocaine allergy
Extension Study of Herombopag for Pediatric Patients With Chronic Immune Thrombocytopenia

The main purpose of this extended study is to enable subjects who are currently receiving the PartB experimental drug in the HR-TPO-ITP-III-PED clinical trial .To continue receiving the experimental drug after the completion of the clinical trial if they benefit from the treatment at the end of the clinical trial.Until the study physician determines that the subject has failed treatment or that the subject can no longer benefit from treatment or extends the study treatment for 6 months.In addition, the secondary purpose of this extended study was to observe the long-term efficacy and safety of tripodal in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have completed PartB of HR-TPO-ITP-III-PED clinical trial and have achieved platelet response.
2. Subjects who have signed the informed consent for the extended study.
3. Subjects with potential fertility（e.g. women who have menarche or men who have sperm loss) should agree to use effective contraception during their participation in the extended study and within 28 days after their last dose.
4. Subjects who have completed end-of-treatment visits in the original study.

Exclusion Criteria:

1. Any unstable condition or condition that may compromise the safety of the subject.
2. Patients with new myelofibrosis were examined in the original clinical trial exit group.
3. The original clinical trial cohort examined evidence of new cataract or existing cataract progression, and the study considered it unsuitable to enroll in this extension.
4. Patients with uncontrolled bleeding after standard treatment.
5. Any previous occurrence of arterial or venous thrombosis (transient ischemic attack,myocardial infarction ,deep venous thrombus, or pulmonary embolism ),or clinical symptoms and history suggest thrombus susceptibility.
6. Any other circumstances that the investigator considers likely to cause the subject to be unable to complete the study or to present a significant risk to the subject.
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 or older
* Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but \< 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and \<110 mm Hg)

Exclusion Criteria:

* Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
* History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.)
* History of myocardial infarction, stroke \[e.g. cerebrovascular accident (CVA), thrombotic stroke, transient ischemic attack (TIA)\], or onset of heart failure within the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.
Diagnosing Natriuretic Peptide Deficiency

In this pilot study, the investigators will determine the response of the natriuretic peptide (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The goal of the proposed project is to generate preliminary data that will be used to develop power calculations, inform cutoff ranges, and inform the timing of the NP response for larger subsequent studies.

Aim: To determine the range of distribution and time course of natriuretic peptide (NP) responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.

Hypothesis: Determination of the NP responses (the range and time course of changes in NP levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency of blood sampling in a definitive prospective study, as well as enable investigators to perform a sample size calculation for a definitive prospective study.

see above

Eligibility Criteria:
Inclusion criteria:

* Men and women ages 18-50 years
* BMI 18.5 to \<25 kg/m\^2

Exclusion Criteria:

* Significant use of systemically-absorbed glucocorticoids currently or for an extended period of time during the prior 6 months
* Current use of antihypertensive medications
* Current use of metformin, or any antidiabetic medications (which could affect glucose and insulin levels)
* Current use of medications known to affect dexamethasone metabolism, including phenytoin, rifampin, carbamazepine, troglitazone, and barbiturates
* Active, clinically significant infection at time of visit
* History of adrenal insufficiency or Cushing's syndrome
* Prior or current cardiovascular disease, renal disease, or liver disease
* Diabetes mellitus, pre-diabetes, impaired fasting glucose, or impaired glucose tolerance
* Atrial fibrillation
* Bleeding disorder or anemia
* Elevated Liver Functions Tests \> 2 times upper limit of normal
* Estimated glomerular filtration rate \< 60 ml/min
* HbA1c \> 5.7
* Abnormal sodium or potassium level
* Positive pregnancy test, women of child-bearing age not practicing birth control, women who are breastfeeding
Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques

Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction.

Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. This technique is considered an approach that can be of a great benefit to patients with chronic medical illnesses and those who have moderate to high risk for general anaesthesia.

In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction. The investigators evaluated the time needed for laryngeal mask airway (LMA) insertion, number of LMA insertion trials, succession of LMA insertion, adverse events related to the airway, respiratory and cardiovascular systems, haemodynamic stability and satisfaction scores of enrolled patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with Age ≥ 65 years.
* American Society of Anaesthesiologists' (ASA) score II or III.
* minimally invasive endoscopic urological procedures.

Exclusion Criteria:

* patient refusal.
* Age \< 65 years.
* family history of malignant hyperthermia.
* prolonged surgery that needed intubation.
* body mass index (BMI) \> 35 kg/m2.
Stimulating the Brain to Improve Self-Awareness

This study investigates whether Introspective Accuracy (IA) can be improved in individuals with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS).

Self-awareness is markedly impaired in severe mental illness including schizophrenia and schizoaffective disorder. This impairment spans awareness of symptoms as well as deficits in the estimation of abilities and capabilities, which we refer to as introspective accuracy (IA). Recent work has provided evidence of IA deficits in schizophrenia spectrum disorders, specifically in the abilities to retrospectively judge everyday functioning and neurocognitive impairment, as well as the ability to make correct real-time judgments of performance on neurocognitive tests.

Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric disorders. TDCS in healthy adults has been demonstrated to improve cognitive and memory performance, and in schizophrenia, tDCS has been found to improve emotion recognition ability. TDCS thus appears to be a promising therapeutic technique that may be useful for improving IA. This study will compare IA performance in individuals with schizophrenia across two conditions: active anodal tDCS and sham tDCS.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-55
* DSM-IV-TR or DSM-5 diagnosis of schizophrenia or schizoaffective disorder and clinically stable (i.e., no hospitalizations) for at least 8 weeks and on a stable medication regimen for at least 6 weeks with no dose changes for a minimum of 2 weeks

Exclusion Criteria:

* Presence or history of pervasive developmental disorder (e.g., autism) or mental retardation (defined as IQ \<70) by DSM-IV criteria
* Presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or CNS tumors)
* Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment
* Not proficient in English
* Presence of substance abuse in the past one month
* Presence of substance dependence not in remission for the past six months
* Contraindications for tDCS (e.g., pregnancy or implanted devices such as pace maker)
Internet-based Group Contingency Management to Promote Smoking Abstinence

The purpose of the study is to develop and test an Internet-based group contingency management program designed to promote smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* self-reported smoker
* ability to use the Internet
* permission to contact applicant by phone

Exclusion Criteria:

* self-report of a history of or current severe or unstable medical or psychiatric illness that would interfere with the study
* inability to avoid high levels of ambient CO (e.g., occupational exposure; lives with a another smoker who smokes in the home)
The Effectiveness of Montelukast on Atopic Dermatitis in Koreans

The purpose of this study is to assess the clinical effectiveness of Montelukast in children (2\~6 years old) with atopic dermatitis and identify the pathophysiologic background of Montelukast on the role of modulating the atopic dermatitis measured by urinary Leukotriene 4 (LTE4) and Eosinophil protein X(EDN).

Leukotriene B4 (LTB4) and the cysteinyl-leukotrienes LTC4, LTD4 and LTE4 are potent proinflammatory mediators derived from arachidonic acid through the 5- lipoxygenase pathway. They are secreted from eosinophils and other inflammatory cells such as mast cells and macrophages. The primary action of leukotrienes includes contraction of human airway muscle, chemotaxis, and increased vascular permeability, with secondary effects of inhibiting allergen-induced early and late responses. Several in vivo and in vitro studies suggest a role for cysteinyl leukotrienes in the pathogenesis of atopic dermatitis and there is a rationale for the use of pharmacological agents to antagonize their effects in the treatment of atopic dermatitis. Levels of LTE4 measured in urine (Urinary-LTE4) may be a useful measure of whole-body cysteinyl-leukotriene production in vivo, because that LTE4 is a stable urinary metabolite of LTC4 and LTD4. Urinary-LTE4 has been measured in individuals with atopic dermatitis, but in small-scale studies, and the results are conflicting.

Eligibility Criteria:
Inclusion Criteria:

* The ages of 2 to 6 years old, 54 children with moderate to severe atopic dermatitis diagnosed by the criteria of Haniffin and Rajka were included in the study.
* Volunteer children with moderate to severe atopic dermatitis were recruited from the Pediatric Allergy and respiratory Center of the SoonChunHyang University Hospital (Seoul, Korea). At the time of recruitment, written consent was obtained. The ethical committee at the SoonChunHyang University Hospital approved the trial.
* Volunteers who agreed by their parents.
* The severity of their disease was assessed by modified SCORAD index.

Exclusion Criteria:

* Too severe atopic dermatitis defined as the sum of scores is 80 and above by SCORAD index.
* A history of liver disease; allergy to montelukast or cross-reacting medication; use of phenobarbital, phenytoin or rifampicin.
* Patients on systemic steroids, immune-suppression or Korean herbal medicine during the previous 6 weeks.
Maximizing Trichiasis Surgery Success

The purpose of this study is to determine whether the rate of post-operative trachomatous trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision height of 3 mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut surgery.

In this trial the investigators will randomize 4,953 individuals with previously unoperated trichiasis on a 1:1:1 basis to bilamellar tarsal rotation trichiasis surgery with an incision height of 3 mm, bilamellar tarsal rotation trichiasis surgery with an incision height of 5 mm, or Trabut surgery. Participants will receive trichiasis surgery then will be followed at 1 day, 2 weeks, 6 weeks, and 12 months after surgery. Some participants may be asked to attend a follow-up visit at 3-6 months. The primary outcome is development of post-operative trachomatous trichiasis (PTT) within 12 months after surgery. Logistic regression analyses will be performed to compare the rates of PTT in the 3 versus 5 mm incision bilamellar tarsal rotation (BLTR) groups, in the 3 mm BLTR versus Trabut group, and in the 5 mm BLTR versus Trabut group, adjusting for demographic characteristics and pre-operative trichiasis severity.

Eligibility Criteria:
Inclusion Criteria:

* At least one eyelid with previously unoperated upper eyelid trichiasis
* Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Inability to provide independent, informed consent
* All eyes with previously unoperated trichiasis are phthisical