cyrilzakka/clinical-trials huggingface dataset:
A Real World Study on Clinical Efficacy of Bicarbonate Ringer's Solution in Biliary Atresia Children

In most babies with biliary atresia (BA) bile ducts on the inside and outside of the liver are affected eventually leading to a complete blockage of bile flow from the liver. This in turn causes scarring (fibrosis) in the liver. The surgery called the Kasai procedure and eventually, a liver transplant could treat biliary atresia. However, children with BA have poor liver function, poor renal reserve, and poor ability to regulate water and electrolytes. Therefore, A reasonable and effective perioperative fluid management is more significant. Considering the high chlorine of saline, the liver burden of Lactated Ringer's solution and Acetated Ringer's solution, the Bicarbonate Ringer's solution which composition is similar to plasma, could be the best choice for perioperative fluid management of BA children. Therefore, we hypothesize that compared with other crystalloids, Bicarbonate Ringer's solution is a better choice to maintain water, electrolyte and acid-base balance in BA children.


Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed with biliary atresia before surgery.
2. age less than 90 days.
3. American Society of Anesthesiologists score of 1\~2.

Exclusion Criteria:

1. patients with severe allergies.
2. patients with severe deformities or lesions.
3. other situations not suitable for enrollment judged by researchers.
The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients

this is a controlled clinical trial with 2 groups of patients of class II skeletal discrepancy due to mandibular retrusion one group is treated with twin block functional appliance and the other with twin block combined with low level laser therapy ,the study aims to detect the effect of low level laser on the skeletal outcomes , dentoalveolar outcomes, rate of correction and pain during treatment


Eligibility Criteria:
Inclusion Criteria:

* Age (early permanent dentition)
* Cervical maturation stage CS 3-4
* Skeletal class II due to mandibular retrusion.
* Overjet more than 4mm.

Exclusion Criteria:

* Cleft lip or palate.
* Systemic diseases.
* Previous orthodontic treatment or abnormal habits.
* Congenital craniofacial deformity.
* poor oral hygiene
The Value of CT Cholangiography in Primary Sclerosing Cholangitis

The reason for this study is to see if a new radiologic technique called computerized tomographic cholangiography (CT cholangiography) could be helpful to demonstrate the bile ducts features and measure the amount of space of bile duct canals that should be filled with bile fluid. It may be useful to find out how well these findings correlate with the previously known clinical predictors in term of the clinical outcomes that will happen in the future for patients with primary sclerosing cholangitis (PSC).

Prognostic models, which have been produced based on clinical, histological and biochemical feature, are useful in predicting survival and determining timing for liver transplantation. Preliminary feasibility studies in patients with PSC using high resolution CT with a contrast agent (CT cholangiography), has shown excellent depiction of bile ducts. CT cholangiography also has the potential to allow quantification of intraductal volume by using sophisticated computer programs. This assessment may be an important clinical feature to assess disease severity and progression.The information about cholangiographic features could be important for therapeutic decisions (e.g., in determining the usefulness of balloon dilatation or stenting for a dominant extrahepatic duct stricture), for counseling patients, and for therapeutic trials in stratifying patients and assessing efficacy of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult males or females, age 18-70 (inclusive) with suspected PSC.
* Serum carbohydrate antigen 19-9 (CA19-9) level in normal range (obtained within the previous year), or if greater than normal, the patient requires a negative cytologic or histologic evidence for cholangiocarcinoma within prior 3 months.
* Sexually active female patients of childbearing potential must be evaluated for pregnancy. A pregnancy test obtained at entry prior to the initiation of treatment must by negative. Female patient must not be breast-feeding.
* Renal function: a creatinine less than 2.0 mg/dL or a diabetic patient with a creatinine less than 1.5 mg/dL.

Exclusion Criteria:

* Evidence of cholangiocarcinoma
* Pregnancy or breast feeding
* History of allergy to iodinated contrast agents or morphine
* Renal impairment as defined as known renal disease, a creatinine higher than 2.0 mg/dL or a diabetic patient with a creatinine higher than 1.5 mg/dL.
* Any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study such as significant cardiovascular dysfunction or chronic obstructive pulmonary disease requiring specific therapy.
Effects of Metyrapone in Patients With Hypercortisolism

The aims of the present study are to evaluate in patients with mild hypercortisolism the effect of metyrapone treatment on glycometabolic control, blood pressure, thrombotic risk parameters, lipid profile, bone turnover markers, mental health and cortisol circadian rhythm.

This open prospective observational study will include patients with mild hypercortisolism of both adrenal and pituitary origin not candidate for surgery. Patients taking metyrapone since less than a week will be followed up for 24 weeks. During this period of time, patients will be re-evaluated as far as blood pressure control, glycometabolic control, thrombotic risk parameters, lipid profile, bone turnover markers and cortisol circadian rhythm is concerned.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild Cushing's Syndrome not candidate for surgery
* Current therapy with metyrapone since less than 1 week
* Cortisol levels at 08:00 after 1 mg-overnight dexamethasone suppression test (1mgDST) \>1.8 μg/dL
* Confirmed with 2 mg two days dexamethasone suppression test (2mgx2dDST)
* Presence of at least one out of the following conditions: type 2 diabetes mellitus, impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT), arterial hypertension, bone mineral density (BMD) Z-score \< -2.0 and/or fragility fracture at any skeletal site
* Stable anti-hypertensive therapies and blood pressure (BP) levels in the month before enrolment
* Stable anti-diabetic therapies and glycometabolic control during the month before enrolment
* Stable body weight during the month before enrolment

Exclusion Criteria:

* Signs and/or symptoms of overt hypercortisolism (striae rubrae, moon facies, easy bruising, buffalo hump, hypertrichosis)
* Malignant hypertension and/or BP \<200/120 mmHg
* Severe hyperglycemia (i.e. FG \>350 mg/dL)
* Urinary free cortisol (UFC) higher than 1.5 fold the upper normal range
* Presence of pheochromocytoma or primary hyperaldosteronism
* Possible adrenal metastases or radiological features suggestive for adrenal malignancy (i.e. not homogeneous pattern, necrosis, calcifications, irregular margins, local invasion and high density at computed tomography)
* Congenital adrenal hyperplasia
* Intake of drugs influencing cortisol metabolism and/or secretion
* Women in child-bearing age
* Patients with body mass index (BMI) \>35 kg/m2
Suction Drain in Axillary Lymph Node Dissection for Malignant Melanoma

Postoperative complications like seroma formation and wound site infection readily occur following completion axillary lymph node dissection (ALND) for malignant melanoma. We analyzed the impact of time-to-drain removal and drainage volume on seroma formation after ALND.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed malignant melanoma
* underwent axillary lymph node dissection (level I-III)
* daily drainage volume records over a two-week period available

Exclusion Criteria:

* daily drainage volume records over a two-week period not available
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People with Spinal Cord Injury

The HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to improve hemodynamic management and trunk control in people with sub-acute or chronic spinal cord injury (\>= 1 month post injury) between C3 and T6 inclusive, who suffer from orthostatic hypotension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Must provide and sign the Informed Consent prior to any study related procedures
* Spinal cord injury lesion level between C3 and T6 (inclusive)
* SCI ≥ 1month
* Confirmed orthostatic hypotension
* Stable medical, physical and psychological condition as considered by the investigators
* Able to understand and interact with the study team in French or English
* Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments

Exclusion Criteria:

* SCI related to a neurodegenerative disease
* Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
* The inability to withhold antiplatelet/anticoagulation agents perioperatively
* History of myocardial infarction or cerebrovascular event within the past 6 months
* Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
* Clinically significant mental illness in the judgement of the investigators
* Botulinum toxin vesical and non-vesical injections in the previous 3 months before the enrolment
* Presence of significant pressure ulcers
* Recurrent urinary tract infection refractory to antibiotics
* Presence of indwelling baclofen or insulin pump
* Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding,
* Lack of safe contraception for women of childbearing capacity,
* Intention to become pregnant during the course of the study,
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrolment of the investigator, his/her family members, employees, and other dependent persons.
Psychological Intervention on Burnout in ICU Caregivers

ICU caregivers face up to a demanding job with a high level of technical skills, a stressful environment, and a heavy work load. They run a high risk of developing burnout that can impact on their welfare, performance, and patient care. Burnout favours absenteeism and staff quitting their jobs, whereas the shortage of ICU caregivers already started. No randomised controlled intervention aimed at reducing such distresses had been run until now.

This study allowed finding a new method of psychological support applicable in the special environment of ICU. Our findings suggest that psychologists specifically assigned to treat ICU caregivers might be beneficial on their burnout.


Eligibility Criteria:
Inclusion Criteria:

* all ICU caregivers rrom the University Hospital of Geneva

Exclusion Criteria:

* refusals
Episodic Future Thinking and Future Thinking Priming for Smoking Cessation

This trial studies the main and interactive effects of episodic future thinking and future thinking priming tasks on helping participants to quit smoking. Episodic future thinking and future thinking priming tasks may decrease delay discounting rates and reduce relapse to smoking and help participants quit smoking.

PRIMARY OBJECTIVE:

I. To quantify the main and interactive effects of the episodic future thinking (EFT) and future thinking priming (FTP) tasks on delay discounting rate, latency to relapse, and multiple abstinence and self-regulation measures among smokers (n=76) who call a busy Quitline to quit smoking.

OUTLINE: Participants are randomized to 1 of 4 arms.

ARM I: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

ARM II: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete an active episodic future thinking or control future thinking priming task once per week for 12 weeks, alternating every week between tasks.

ARM III: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or active future thinking priming task once per week for 12 weeks, alternating every week between tasks.

ARM IV: Participants are provided with Forever Free relapse prevention booklets and receive a 2-week supply of nicotine patches, gum, or lozenges. Participants also receive 1 proactive coaching call within 24 hours of quit date. Beginning on the quit date, participants complete a control episodic future thinking or control future thinking priming tasks once per week for 12 weeks, alternating every week between tasks.

Eligibility Criteria:
Inclusion Criteria:

* Smoke \>= 8 cigarettes daily
* Planning to quit in the next 14 days
* No regular use of other tobacco products
* Access to the internet
* In possession of a smartphone with text messaging capabilities
* In possession of an email address accessible at least every other day

Exclusion Criteria:

* Unable or unwilling to provide consent
* Unable to provide data to the research team after the quit date
* Current use of bupropion or varenicline
* Drinking \>= 20 alcoholic drinks per week
* Use of drugs of abuse in the past 30 days
* Living in the same household as a participant already enrolled in this study
Lumbar Puncture and Syphilis Outcome

Treponema pallidum, the bacterium that causes syphilis, invades the central nervous system in about 40% of patients with syphilis. This happens early after infection. Patients with neuroinvasion are at risk of developing serious neurological complications, including vision or hearing loss, stroke and dementia. Because neuroinvasion can happen without symptoms, the only way to identify it is by performing a lumbar puncture (LP) to examine cerebrospinal fluid (CSF).The overall hypothesis to be tested in this study is that a strategy of immediate LP, followed by therapy based on CSF evaluation, results in better serological and functional outcomes in patients with syphilis who are at high risk for neuroinvasion.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females age 18 years or older
2. Current syphilis
3. Primary language is English or English is a second language but patient self-describes as fluent in English
4. Able to provide informed consent
5. If treated with benzathine penicillin G (BPG), it must have occurred less than 14 days before the entry visit (before the first visit if there is more than one entry visit)

Exclusion Criteria:

1. Provider plans neurosyphilis (NS) treatment regardless of whether the patient has an lumbar puncture (LP)
2. Receipt of antibiotic treatment that would be effective for NS (for example, IV or intramuscular (IM) beta-lactam antibiotics \[other than BPG\]) within one month before study entry; single dose of IM ceftriaxone in the last month is not exclusionary
3. Allergy to penicillin or lidocaine
4. Contraindication to LP, including untreatable coagulation disorder, use of anticoagulants that cannot be temporarily discontinued, thrombocytopenia, focal neurological examination
5. Other known cause of central nervous system (CNS) infection in the last year, including that due to bacterial, fungal, protozoal or viral agents, such as tuberculosis, Cryptococcus, toxoplasmosis or herpes zoster that could confound interpretation of CSF results
6. Unlikely to be able to comply with study requirements or complete the study, for example, planning to leave the area \< 6 months after enrollment
7. Subjects will not be allowed to re-enroll in this study with a new episode of syphilis

Individuals who are unwilling to be randomized can choose LP or no LP. Eligibility criteria for these individuals are:

1. 18 years of age or older
2. Current syphilis infection
3. Primary language is English or fluent in English
4. No contraindications to LP
5. Have not received antibiotics within one month that would treat neurosyphilis
Effect of Topical Application of Hypertonic Saline on Melanoma on Its Sizes and Number.

This study evaluates the effectiveness of applying Hypertonic Saline solution directly on the Melanomas in reducing their sizes and/or number.

Many previous studies have shown that Cancer cells are over-hydrated, and that Hyponatraemia exists in many cases of Cancer. The Cancer cell's viability depends on Angiogenesis and formation of blood vessels that carry water and nutrients to the rapidly-dividing Cancer cells. This study tests the hypothesis that reducing the water content of Melanoma could lead to increasing its tonicity and hence inhibiting its growth. This reduction of water content can be achieved using Osmotic Pressure differential via applying highly saline solution - made by Sodium Chloride crystals wet with water - directly on the Melanoma for a certain amount of time, thus leading to water withdrawal from Melanoma cells. While the surrounding healthy skin cells can sustain temporary dehydration, Melanoma cells could be negatively affected.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically-confirmed Melanoma (any location and any stage) who have poorly responded to at least one cycle of conventional and standard therapy (Chemotherapy, Radiation or Drug therapy).
* Age 5 to 80 years old
* Life expectancy of at least 1 year
* Can understand and read English
* Lives in USA.

Patient who do not meet the Inclusion Criteria but still wish to participate will be accepted as Observational participants, but their Melanoma measurements will be not be taken into account when analyzing the Study statistically.

Exclusion Criteria:

* Skin eczema and/or other skin conditions contraindicated to skin dehydration.
* Ulcers or open wounds close to Melanoma
* Any medical condition that might cause the patient to lose consciousness
* Participants who are not residents of USA.
MOTIONPODTM Validation in Free-living Conditio

In this study, the investigators propose to assess the validity in measuring physical activity (PA) of a new PA monitor system the MOTIONPODTM, that coupled a hip-worn multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope) with an automatic activity/posture recognition algorithm and an activity-specific multilinear prediction model. The MOTIONPODTM performances in predicting mean daily PA energy expenditure (PAEE) will be calculated against the reference PAEE gold standard measure, using the doubly labeled water method (DLW). The MOTIONPODTM performances in predicting PAEE and PA patterns will be compared to those of two existing activity or movement monitors: the triaxial accelerometer ActigraphGT3X+TM and a device combining cardiofrequencemetry with accelerometry, the ActiheartTM. This latter has demonstrated fair performances but at the cost of a calibration of the heart-rate/EE relationship that limits its use in large population samples. Briefly, this open study will include 120 subjects, aged 18 to 75 years of both gender and with broad range of body mass index and physical activity level. The subjects will carry a MOTIONPODTM, an ActigraphGT3X+TM, an ActiheartTM and a GPS for a total of 14 days in everyday life conditions and complete a physical activity diary. In half of the subjects, PA will be evaluated on a period of 14 days, with standard PAEE measured by DLW. The other 60 subjects will be studied twice, one month apart, to test the reproducibility of the measures.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* Age : 18 to 75 years
* Patients or healthy volunteers
* 40 obese subjects (BMI ≥ 30 kg/m2), 40 non-obese (BMI \<30 kg/m2) and active (PA level evaluated by the RPAQ questionnaire) subjects, 40 non-obese and sedentary subjects
* Absence of cardiac rate disorders

Exclusion Criteria:

* Subjects with acute disorders: cardiovascular or neoplastic, severe infection during 3 previous months
* Subjects with a pathology restricting the walking distance (confinement, distance \<200 meters)
* Subjects with implants (Pacemaker, cardiac implant or another active implant)
* Claustrophobic subjects (for subjects participating to "doubly labelled water" protocol)
* Drug use that could affect energy expenditure
Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes

Torsades de pointes (TdP) is a potentially fatal ventricular arrhythmia associated with corrected QT (QTc) interval prolongation. More than 50 commonly used drugs available on the US market may cause QTc interval prolongation and TdP. While TdP occurs more commonly in women, 33-45% of all cases of TdP have occurred in men. Older age is a risk factor for drug-induced TdP in men, possibly due to declining serum testosterone concentrations. Available evidence shows an inverse relationship between QTc intervals and serum testosterone concentrations. In addition, experimental data, including those from the investigators' laboratory, suggest that both exogenous testosterone or progesterone administration may be protective against prolongation of ventricular repolarization and TdP. Specific Aim: Establish the influence of transdermal testosterone administration and oral progesterone administration as preventive methods by which to diminish the degree of drug-induced QT interval prolongation in men 65 years of age or older. Hypothesis: Transdermal testosterone administration and oral progesterone administration both effectively attenuate drug-induced QT interval response in older men. To test this hypothesis, transdermal testosterone, oral progesterone or placebo will be administered in a 3-way crossover study to men 65 years of age or older. QTc interval response to low-dose ibutilide will be assessed. The primary endpoints will be Fridericia-corrected QT interval (QTF) response to ibutilide, in the presence and absence of testosterone, and in the presence or absence of progesterone: 1) Effect on pre-ibutilide QTF, 2) Effect on maximum post-ibutilide QTF, 3) Effect on % change in post-ibutilide QTF, and 2) Area under the QTF interval-time curves.


Eligibility Criteria:
Inclusion Criteria:

* Men ≥ 65 years of age

Exclusion Criteria:

* Prostate cancer; history of prostate cancer;
* History of breast cancer; benign prostatic hypertrophy;
* Weight \< 60 kg
* Weight \> 135 kg
* Serum k+ \< 3.6 mEq/L;
* Serum mg2+ \< 1.8 mg/dL;
* Hemoglobin \< 9.0 mg/dL;
* Hematocrit \< 26%;
* Hepatic transaminases \> 3x upper limit of normal;
* Baseline Bazett's-corrected QT interval \> 450 ms
* Heart failure due to reduced ejection fraction (left ventricular ejection fraction \< 40%)
* Family or personal history of long-QT syndrome, arrhythmias or sudden cardiac death;
* Concomitant use of any QT interval-prolonging drug.