cyrilzakka/clinical-trials huggingface dataset:
The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock

Background： The mean arterial pressure（ MAP） is a key pressure index to improve tissue perfusion. At present, there are no surprising results of large-scale clinical studies on sublingual microcirculation. The changes of sublingual microcirculation were more severe in septic shock non-survivors than survivors. Purpose： This study is mean to increase the MAP in septic shock patients whether with chronic hypertension or not, so as to observe the change of the microcirculation and prognosis. Method： This is a single-center, randomized, prospective cohort study. Eligible patients will be allocated into chronic hypertension or denying chronic hypertension group. These patients will be treat with vasopressors to maintain MAP at 90±5 mmHg and 70±5 mmHg. Outcome： The 28-day all-cause mortality, the 90-day all-cause mortality, the 28-day without organ dysfunction days, the Changes of sublingual microcirculation, SOFA， APACHE-Ⅱ score Will be recorded.


Eligibility Criteria:
Adult patients (≥18 years) admitted to The Critical Medicine Departments Three of Fujian Provincial Hospital will be considered eligible，who are presence of infection or suspected infection，requiring mechanical ventilation. At the same time, without the vasopressors the MAP would be less than 65mmHg, and the blood lactic acid level is higher than 2mmol/l.
Effect of Kinesiotaping Application in Preterm Infants Undergoing Noninvasive Ventilation

Kinesiotaping (KT) applied to the thorax is believed to enhance breathing by supporting the respiratory muscles. Infants born premature usually have respiratory problems because of depletion of surfactant and respiratory muscle weakness. Therefore, we are going to use KT for premature infants in NICU who are undergoing non-invasive ventilation. Forty-two participants divided into two groups. The first group will be applied KT to chest wall, abdomen and diaphragm, and the other group will not receive any KT application during non-invasive ventilation. KT application will be going on as long as the infant underwent non-invasive ventilation. We are going to measure blood gas parameters (pH, pCO2, pO2, base excess), respiration rate, peak heart rate, percentage of Fio2, FiO2/pO2 rate, PEEP and PIP values before non-invasive ventilation, 2 hours after non-invasive ventilation, within 72 hours and shortly before weaning from non-invasive ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient infants in NICU, born in Baskent University Ankara Hospital, undergoing non-invasive ventilation and age between 24-36.6 weeks.

Exclusion Criteria:

* Infants with multiple kongenital anomaly, hypoxic ischemic encephalopathy, tracheoesophageal fistula, diaphragmatic hernia.
First Evaluation of COMET-Y

The goal of this pilot study is to evaluate COMET-Y in 22 adolescents (11-18 years) with various mental health problems and low self-esteem. The main questions is: Does COMET-Y, parallel to care as usual (CAU), improve self-esteem?

Before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. Some of the outcomes are measured through diary methods. Youth and therapists will be assessed to evaluate feasibility and acceptability of the COMET-Y training.

Low self-esteem plays an important role in various mental health problems, and targeted treatment of self-esteem could potentially enhance the efficacy of existing treatments. Research in adults shows that self-esteem training improves self-esteem and mental health problems, but in adolescents this is still unknown. COMET-Y is a personalized self-esteem training, specifically developed for adolescents.

In this pilot study, 22 adolescents (11-18 years) with various mental health problems and low self-esteem will be included. Participants receive COMET-Y parallel to care as usual (CAU). Before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. Some of the outcomes are measured through diary methods. Feasibility and acceptability of the COMET-Y training will be evaluated with youth and therapists.

Eligibility Criteria:
Inclusion Criteria:

* sufficient mastery of Dutch to complete the measurements
* age between 11 - 18 years
* having self-esteem below average (based on a score =\<15 on the Rosenberg Self-esteem Scale; RSES)
* currently receiving care for a mental disorder, for example (but not limited to) anxiety disorder, depression, eating disorder, attention-deficit/hyperactivity disorder, oppositional defiant disorder, or autism spectrum disorder.
* willingness to participate in weekly sessions

Exclusion Criteria:

• As intensive treatment can restrain the feasibility of attending the 7 weekly sessions of COMET-Y and engage in homework assignments, participants who need acute care are excluded (e.g. crisis, acute suicidality, or psychotic episode).
Catatonia in Nodding Syndrome and Lorazepam Treatment

Nodding Syndrome is an enigmatic neuropsychiatric syndrome affecting children and adolescents mostly in Eastern Africa. The symptoms of Nodding Syndrome and catatonia seem to overlap. The researchers' objectives in this study were to investigate the presence and types of catatonic symptoms in children with Nodding Syndrome and observe their response to one or two doses of lorazepam, the first-line treatment for catatonia.

In this pilot study, the investigators examined a convenient sample of children and adolescents with Nodding Syndrome (NS) for catatonic symptoms using standardized criteria. The investigators also tested whether oral lorazepam (LZP) administered to those who qualified to have pediatric catatonia would alleviate symptoms. This was a cross-sectional descriptive study of catatonia in NS patients in Northern Uganda and an exploratory study of using one or two doses of lorazepam as a catatonia test.

All the children with confirmed NS that had 2 or more of symptoms of catatonia were recruited to undergo the catatonia test using oral Lorazepam EG® (n.v. Eurogenerics s.a. Brussels, Belgium) using the 1 mg formulation tablets. It was proposed to perform a catatonia test using Lorazepam (LZP) as first choice medication, as this is the medication that has been used most commonly in pediatric catatonia.

The amount of drug given was based on the weight of the child. The lower dose (0.5 mg) was used as starting dose for patients with \<30 kg body weight, while the higher dose (1 mg) as the starting dose for patients with \>30 kg body weight.

A positive response to a catatonia test consisted of a reduction in catatonic symptoms, 30 or 60 minutes later, by at least 50% .Positive responses were documented by video footage before and after administration of LZP.

If no response to the initial dose of LZP, was observed after one hour, a second administration of the same medication at double the dose was given. Catatonia was again assessed at 30 and 60 minutes thereafter. If no response was observed, the test was considered negative.

Eligibility Criteria:
Inclusion Criteria:

1. Children and adolescents with Nodding Syndrome as defined by the consensus definition agreed upon in the international Nodding Syndrome research meeting held in Kampala, Uganda July 2012.
2. Presence of two or more catatonic items on the Kampala Catatonia Panel.
3. Written informed consent from caregiver.

Exclusion Criteria:

1. Children and adolescents with Nodding Syndrome who had a history of having used a benzodiazepine drug in the past 48 hours prior to intervention.
2. Children and adolescents with Nodding Syndrome who had a concurrent acute illness (e.g febrile illness, pneumonia) at time of assessment.
Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans (DETTECH)

NIRS technology is therefore a technique that exploits the different absorption properties of oxygenated and deoxygenated hemoglobin to evaluate the degree of tissue oxygenation. This hemodynamic response is measured in a completely non-invasive and silent manner, by the simple emission of light passing through different layers of biological tissue.

In the literature, some studies concerning the use of the NIRS method for the study of urodynamics exist. They seem to show a correlation between the data of the urodynamic assessment and the data obtained with the NIRS method. Certain trends seem to be repeated with, for example, an increase in oxyhemoglobin at the beginning of the filling phase and the beginning of the urination phase.

The aim of the study is to analyze the NIRS signal and find correlation with urodynamic data.

The main objective is to detect a urodynamic variation of the detrusor muscle during a contraction.

Eligibility Criteria:
Inclusion Criteria:

* Person whose urodynamic evaluation for diagnosis purposes is necessary
* Male or female ≥ 18 years
* Person affiliated with a social security scheme
* ECBU / BU negative

Exclusion Criteria:

* Minors
* Pregnant or parturient or lactating women
* Refusal of consent
* Contraindications usually provided for the realization of a Urodynamic exam
* Sensory disturbances making the participant insensitive to pain
* Motor or mental disorders that prevent the participant from expressing pain
* Behavioral problems that make the participant excessively agitated or aggressive
* Irritation and / or erythema, or open sore in the area covered by the NIRS
* Half-sitting position impossible
* Tattoo or stretch mark in the lower abdomen or pubic area
* External cutaneous or internal scar in the area covered by the NIRS
* Allergy to a component of the textile part of the device: polyamide, cotton, polyester, elastane, silver, other synthetic materials
* Simultaneous participation in another search
T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients

This is an international, multicenter, randomized study of intravenous T138067 versus intravenous doxorubicin in hepatocellular carcinoma (liver cancer). Patients can not have been treated before with chemotherapy and surgery is not recommended for their cancer. A total of 750 subjects will be enrolled in this study.


Eligibility Criteria:
Key inclusion criteria include:

* pathologic diagnosis of unresectable HCC
* chemotherapy-naïve for HCC
* Child-Pugh Class A or B liver disease
* measurable disease (i.e., at least one lesion that is at least 20 mm in one dimension) on computerized tomography (CT) scan or magnetic resonance imaging (MRI) or at least one lesion that is at least 10 mm on spiral CT scan
* Karnofsky Performance Status of ≥ 70%
* life expectancy of ≥ 12 weeks
* adequate hematologic function (i.e., absolute neutrophil count \[ANC\] of ≥ 1500 cells/mm3, platelet count of ≥ 80,000 cells/mm3, hemoglobin of ≥ 8.5 g/dL)
* total bilirubin of ≤ 1.5 upper limit of normal (ULN)
* aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 ULN
* serum creatinine of ≤ 2 x ULN

Key exclusion criteria include:

* severe, concurrent disease that would make the subject inappropriate for enrollment
* Subjects who have received prior intravenous or intra-arterial chemotherapy, chemoembolization, intratumoral ethanol injection, cryosurgery, radiofrequency ablation, or embolization for their HCC. (note: prior surgical resection, immunotherapy, hormonal therapy, radiotherapy, and/or orthotopic liver transplantation are allowed)
* history of other cancer within the past 5 years other than adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
* New York Heart Association (NYHA) class III or IV heart disease or a left ventricular ejection fraction of \<50% or acute anginal symptoms
* females who are pregnant or breast-feeding
* received any investigational agent within 4 weeks of enrollment
* history of central nervous system metastases or carcinomatous meningitis
* clinically apparent ascites
* major surgery within 4 weeks of study enrollment
Doppler and Biological Second Trimester Placental Insufficiency Screening

To assess the role of uterine artery and maternal serum leptin and lipids and their combination in screening for pre-eclampsia and small-for-gestational-age (SGA) fetuses at 20-24 weeks of gestation

Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are known as major factors in perinatal morbidity and mortality. Routine antenatal care is focused on the detection of women at increased risk to apply this population a program of careful monitoring and appropriate intervention.

Uterine artery Doppler during anomaly scan at 20 to 24 weeks in selected women at increased risk, has proved to be accurate to detect those who will develop PE or IUGR during the second half of pregnancy. Studies have reported detection rate of 50-70% for a 5% false positive rate in women developing early pre-eclampsia.

A variety of proteins and hormones have been studied as potential markers for pre-eclampsia. Among these protein serum placental leptin has demonstrated higher levels in pregnant women who will subsequently develop pre-eclampsia. However, screening performance of leptin detection in early pregnancy has never been assessed.

Our study is aimed to evaluate the performance of serum leptin measurement in association with uterine artery Doppler as a screening too for placental insufficiency.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hypertension under medication
* Diabetes
* Thrombophilia
* Previous history of pre-eclampsia
* Previous history of unexplained stillbirth
* Previous history of placental abruption
* Previous history of SGA (\< 10th centile)
* History of pre-eclampsia or chronic hypertension before 45 years in the mother or a sister
* Obesity (BMI\>30)
* Nulliparous after 40 years
* Assisted conception with donor

Exclusion Criteria:

* Multiple pregnancy
* Complicated pregnancy with a high probability of required fetal extraction before term
* Pregnancy requiring termination
* Unability to understand the study
Supine Percutaneous Nephrolithotomy

there is an increased incidence of renal stones, especially in the pediatric age group. the percutaneous approach in the pediatric age took a long time till it again accepted among surgeons worldwide. the prone position is the preferred approach to perform percutaneous nephrolithotomy in the pediatric age group. this study aims to compare supine versus prone position percutaneous nephrolithotomy in the pediatric age group.

The incidence of renal stones in the pediatric age group increased from 18.4 to 57.0% per100,000 children in the period from 1999 to 2008. The acceptance of PCNL in pediatrics was slow at first due to concerns of the small kidney size compared to relatively large instruments percutaneous nephrolithotomy in pediatric patients was conventionally performed in the prone position for historical reasons, being more familiar to surgeons and it was considered safer to avoid colonic injury.

Supine PCNL has several valuable advantages to pediatric patients in particular better irrigation shorter operative time with a comparable outcome with the prone position.

our study aims to assess the efficacy and the safety of percutaneous nephrolithotomy in the supine position in comparison to the prone position in the pediatric age group.

Eligibility Criteria:
Inclusion Criteria:

* patients aged from two to sixteen years old with single or multiple renal stones indicated for percutaneous nephrolithotomy

Exclusion Criteria:

* patients with renal anomalies, bleeding tendency, elevated kidney function tests for age, previous renal surgical intervention on the same site of intervention.
* patients with skeletal abnormalities and spine deformities were also excluded
* patients with a single kidney were also excluded
Physiological, Behavioral and Subjective Effects of Drugs (GHB)

The purpose of this study is to learn more about the effects of gamma-hydroxybutyric acid (GHB) by comparing its physiological, behavioral and subjective effects with those of several other drugs.

The purpose of this study is to learn more about the effects of gamma-hydroxybutyric acid by comparing its physiological, behavioral and subjective effects with those of several other drugs.

This trial will be conducted as a double-blind, double-dummy, placebo-controlled, counter-balanced (Latin-square design) crossover study in volunteers with histories of sedative abuse. Volunteers will be recruited through advertising and word-of-mouth.

Volunteers will reside on our residential research unit for the duration of the study and participate in a maximum of 16 experimental sessions. Sessions will be conducted five days a week (Monday through Friday). The primary subjective and behavioral measures will be taken before drug administration and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours after drug administration.

Eligibility Criteria:
INCLUSION CRITERIA

* are ages 18-50 years
* have histories of sedative (e.g., GHB, alcohol, benzodiazepine or barbiturate) abuse
* are within 20% of their ideal body weight
* are healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, and routine medical blood and urinalysis laboratory tests
* are not currently pregnant or breast-feeding, if female
* have signed and dated an informed consent form prior to beginning the study
* are willing and able to participate

EXCLUSION CRITERIA

* have a history or current serious medical or psychiatric conditions, including (but not limited to): heart condition, lung disease, diabetes, seizure disorders, significant gastrointestinal disturbances, narrow angle glaucoma, ulcers, sleep apnea, schizophrenia, personality disorder, bipolar disorder, paranoia, multiple personality disorder
* have hypersensitivity/allergy or other contraindications to sedatives or stimulants
* are physically dependent on alcohol or other drugs, excluding nicotine and caffeine
* are females who are pregnant or are breast feeding
* are females who become pregnant during the study as evaluated using periodic pregnancy tests
Longitudinal Observational Study for mIddle Term Follow-up Patients Admitted for Acute Dyspnea in TunIsia

The purpose of the SIDI study is to follow, few months after discharge from the hospital, the patients admitted to the 3 emergency departments in Tunisia for acute dyspnea and to determine the proportion and the factors favoring rehospitalization and death.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for unexpected respiratory difficulty
* Patient admitted to the emergency department
* One of the following 3 criteria have to be present at admission to the ER:
* O2 \< or = 95%
* Respiratory rate RR \> or = 20
* Suffocation sensation

Exclusion Criteria:

* Patients \<18 years old and\> 85 years' old
* Pregnancy
* History of allergic asthma at early age
* Diagnosis retained of pulmonary embolism
* Patients with heart failure (HF) with left ventricular ejection fraction LVEF \<40% are known beforehand or discovered at admission to ER
* known Allergy for Polyamide; Polyester; Elastane; Silicone; Silver; Synthetic material Cardiorespiratory disorders which may be aggravated by the slight compression of the thorax Open wound on the skin, at the level of the trunk
Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers

This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male adults aged between 20 and 45
* Satisfying baseline nerve conduction criteria in below at screening visit CMAP M-wave amplitude of EDB ≥ 4.0mV CMAP M-wave amplitude of AH ≥ 5.0mV CMAP M-wave amplitude of ADQ ≥ 5.0mV

Exclusion Criteria:

* Have history of childhood botulism
* Have a pacemaker or any other heart device
* Have peripheral neuropathy or accessary peroneal nerve
* Have history of lower limb myotomy or denervation surgery
Low Dose Estriol With Lactobacilli Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women

Recurrent urinary tract infections (UTI) are a problem for postmenopausal women. The aim of this trial is to evaluate the effectiveness of lactobacilli in combination with low dose estriol for preventing recurrent urinary tract infections in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman
* History of urinary tract infection
* Agree to abstain from self-medication with antibiotics for UTI symptoms
* Agree to abstain from the use of any other intra-vaginal product
* Capable of providing informed consent

Exclusion Criteria:

* Ovarian cancer, cervical cancer, breast cancer
* Estrogen treatment within last 2 years
* Vaginal bleeding
* Antibiotic therapy fewer than three days prior to randomization visit
* Known congenital urologic or gynecologic abnormalities
* Indwelling urinary catheter
* Thromboembolic disease
* Uncompensated liver disease
* Immunosuppressive drug within 60 days
A Newly Modified Technique for Levator Muscle Tucking in Blepharoptosis Surgery: An Egyptian Tertiary Center Study

Mild to moderate blepharoptosis with good levator function is usually corrected by levator muscle resection or advancement with their modifications with high success rate. Levator plication technique has been strongly suggested in patients with mild to moderate ptosis, advocated by its simple and rapid recovery. Its drawback is a high recurrence rate.

We suggest a modified tucking technique that improves the force of eyelid elevation with preserved normal anatomy of Muller's muscle and conjunctiva with less disturbance to the Levator muscle aponeurosis. It is a short procedure, less complications with good aesthetic results and high patient's satisfaction.

A prospective single-centre study enrolling 180 patients with blepharoptosis at Ain Shams University Hospitals from March 2017 to February 2019. Patients of unilateral or bilateral mild to moderate ptosis with good levator function (more than 8 mm) were included. Those with severe, traumatic, recurrent, mechanical ptosis, Marcus-Gunn jaw winking syndrome, third nerve palsy, absent Bell's phenomenon, or abnormal ocular motility were excluded. The follow-up was at one week, one month, three months, six months, and one year visits. Functional outcome was assessed by analysis of the upper eyelid margin position in relation to the superior limbus and classified as very good (2 mm), good (2-4 mm), poor (5 mm) and preoperative to postoperative difference in marginal reflex distance (MRD). The aesthetic outcome was assessed in the form of symmetry of eyelid height, lid contour, lid crease presence, and degree of patient's postoperative satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Mild _moderate blepharoptosis

Exclusion Criteria:

* severe, traumatic, recurrent, or mechanical ptosis, third nerve palsy, Marcus-Gunn jaw winking syndrome, abnormal ocular motility, and absent Bell's phenomenon