cyrilzakka/clinical-trials huggingface dataset:
Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder

OBJECTIVE: The objective of this study is to compare the effect and safety of conventional dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive disorder (OCD).

OVERVIEW OF STUDY DESIGN: Prospective, Randomized, Active-controlled, Double-blind, Multi-center, Clinical Trials STUDY POPULATION: Patients with OCD EFFICACY EVALUATIONS: Y-BOCS (D-YBOCS), HAM-D, HAM-A, CGI-S \& -I, GAF, OCI-R SAFETY EVALUATION: Adverse Events / Serious Adverse Events, UKU


Eligibility Criteria:
Inclusion Criteria:

1. Man or woman, aged 18 to 65 years, outpatient
2. Primary OCD patients diagnosed with DSM-IV-TR, having OCD symptoms for more than six months
3. Severity: Y-BOCS score of \>= 20 at screening and baseline
4. No history or evidences of clinically significant physical problem, or abnormal laboratory findings at screening
5. Drug free period of at least 2 weeks before study drug administration (in case of fluoxetine, at least 5 weeks). However, allowed medications in this study could be taken even before study drug administration.

Exclusion Criteria:

1. primary active DSM-IV axis I diagnosis other than OCD
2. History of substance, including alcohol, dependence and psychotic symptoms
3. Current depression A. Risk of suicidal attempt B. 20-item Hamilton Depression Rating Scale (HAM-D)(exclude 21th item, obsession) of \>17 at screening or baseline
4. Drug allergy A. Known or suspected hypersensitivity to escitalopram or citalopram B. History of severe drug allergic reactions or hypersensitivity
5. History of no response to escitalopram or citalopram treatment
6. History of electroconvulsive therapy or received an injectable antipsychotic formulation within 6 months before screening
7. Women who are pregnant, planning to become pregnant, or breast-feeding
8. Ongoing cognitive behavior therapy (CBT) of OCD
9. Hoarding or collecting type
10. Unable to perform study protocol as clinically assessed by the investigator (ex, severe personality disorder)
Potato Consumption and Risk of Hypertension

Government has popularized potatoes as a major staple food in China. Potato, a potassium-rich food with high glycemic responses after consumption, exhibits unclear effects on hypertension. In this study, the investigators aimed to examine the association between potato consumption and hypertension risk among Chinese people.

Potato is considered as a superior crop due to its significant nutritive value and great production yield. China is the largest potato producer with a quarter of world production, followed by India, Russia, and USA. The potato production as well as consumption has enhanced in developing countries while continuously declined in developed countries during the last decade. The investigators therefore explored the prospective associations of consumption of total potatoes, sweet potatoes, stir-fried potatoes, and non stir-fried potatoes with the risk of hypertension in general people of the China Health and Nutrition Survey (CHNS) cohort study from 1989 to 2011. A total of 11,763 participants (≥20 years old) who were free of hypertension at baseline were enrolled from CHNS Cohort study. Cox proportional hazards regression models were used to estimate the associations after adjusting for potential confounders. This study provides new evidence on the association of various potato consumption with the incidence of hypertension in China. As urbanization accelerates across the whole domain of China, the tendency of transition to Western-style diets and lifestyles appears continuously and steeply growing. More and more potatoes will be consumed as processed potato products including potatoes chips and French fries, which may be a potential risk factor of hypertension occurrence.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 20-93 with complete data on diet and follow-up time
* Adults with no chronic disease history

Exclusion Criteria:

* Adults aged \< 20 years
* Identified to be pregnant
* Previously diagnosed with hypertension, cancers, infarction, apoplexy, and diabetes
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source

This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.


Eligibility Criteria:
Inclusion Criteria:

* Subject signed informed consent
* Age \>/= 18 years
* Biopsy confirmed adenocarcinoma pancreatic cancer
* Patient capable of undergoing anesthesia
* Patient is a surgical candidate
* Patient selected to undergo pancreatic cancer resection
* Patient will have known or suspected close/positive surgical margin
* Confirmed diagnosis of resectable pancreatic adenocarcinoma
* Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle

Exclusion Criteria:

* Pregnant or breast feeding
* Patient has metastatic disease
* Patient has had prior radiation therapy to the region for separate cancer
* Patient has had prior chemotherapy
* Any other invasive cancer in the past 5 years, except basal cell skin
* Recurrent or previously resected tumors
* Alcoholism/Drug abuse
Effectiveness of Dynamic Neuromuscular Stabilization Breathing Exercises With Schroth in Adolescent Idiopathic Scoliosis

In our study, the degree of scoliosis curvature in volunteers will be determined using full-body standing X-rays. Additionally, the rotation degree of the spinal curvature in volunteers will be assessed with a scoliosis meter (a type of ruler) through the forward bending test while standing. To measure the impact of scoliosis on the quality of life, the SRS-22 questionnaire, consisting of 22 questions, will be used. The level of pain experienced by volunteers as a result of scoliosis will be evaluated using the visual analog scale (VAS), where pain intensity is marked on a 10 centimeter line. Lastly, the volunteers; breathing patterns will be assessed by measuring chest circumference with a tape measure.

In this randomized controlled trial, we aim to assess various physical and quality of life parameters in volunteers with scoliosis. The degree of spinal curvature will be measured using full body standing X-rays, providing a detailed assessment of the scoliosis angle. Additionally, the rotation degree of the spinal curvature will be evaluated with a scoliosis meter during the forward bending test, which is commonly used to gauge the rotational component of scoliosis.

Quality of life will be assessed using the Scoliosis Research Society-22 (SRS-22) questionnaire, a validated tool consisting of 22 questions designed to evaluate function, pain, self image, mental health, and satisfaction in individuals with scoliosis. To quantify pain levels experienced due to scoliosis, the Visual Analog Scale (VAS) will be used, in which participants mark their pain intensity on a 10 centimeter line, ranging from "no pain" to "worst pain imaginable." This provides an accurate, subjective measure of pain severity.

Breathing patterns will also be evaluated by measuring the volunteers' chest circumference at full inspiration and expiration using a standard tape measure, allowing us to assess any potential restrictions in lung expansion related to the spinal curvature. Through this comprehensive evaluation, we hope to gain a clearer understanding of how scoliosis affects both the physical and psychological well being of individuals and identify potential areas for therapeutic intervention.

Eligibility Criteria:
Inclusion Criteria:

* Radiologically measured Cobb angle value between 10 degrees and 50 degrees
* Age between 10 and 18
* Being diagnosed with Adolescent Idiopathic Scoliosis by a physician
* Being between 0 and 5 in the radiologically determined Risser sign
* Being between 12-25 kg/m2 according to body mass index measurement

Exclusion Criteria:

* Having had any surgery related to scoliosis
* Having been diagnosed with any psychiatric disease
* Having been diagnosed with an oncological disease
* Having a neurological disease, vestibular or visual problem
* Having any pathology that will affect motor performance
* Using medication that affects the central nervous system
* Having been diagnosed with a rheumatological disease
* Having been diagnosed with any cardiovascular disease
Benefit of CoQ-10 in Patients on Statins

This study will investigate whether a supplement called co-enzyme Q10 can help ease or eliminate some of the side effects that result from taking statin medications. These side effects include muscle pain, fatigue or muscle cramping.

Specific Aim 1: to demonstrate that supplementation with coQ10 in patients treated with statins ameliorates symptoms of muscle pain and fatigue and improves energy metabolism and muscle function.

This objective will be achieved in a randomized, placebo-controlled double blind trial by assessing the degree of muscle symptoms and interference of pain with daily activities, aerobic capacity, and muscle function before and after supplementation with either coQ10 or placebo in groups of statin-treated subjects.

Specific Aim 2: to examine changes at a molecular/cellular level that are associated with improved pain and muscle function in statin-treated subjects supplemented with coQ10.

This aim will be addressed by analyzing muscle biopsies taken from statin-treated patients before and after supplementation with coQ10 or placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women 21 years and older taking statin medications for hyperlipidemia under the current National Cholesterol Education Program guidelines (NCEP III) and complaining of myopathic symptoms.

Exclusion Criteria:

1. diagnosis of cancer;
2. acute illness of any sort;
3. hemoglobin less than 12,
4. creatinine greater than 1.5 mg/dl;
5. liver dysfunction as evidenced by elevations in transaminases 3-fold higher than upper limit of normal;
6. use of certain medications or nutritional supplements within the past month;
7. untreated hypertension (diastolic BP\> 100 mm HG);
8. diagnosis of diabetes mellitus (fasting blood glucose \> 126 mg/dl);
9. untreated hypothyroidism;
10. overt congestive heart failure (by physical exam);
11. active inflammatory diseases such as rheumatoid arthritis, lupus, etc.,
12. bleeding disorders;
13. history of adverse reactions besides myopathy associated with the use of statins;
14. any previous adverse reaction to coQ10 or to multivitamin supplements containing coQ10;
15. plasma CPK levels \> 3 times the upper normal limit; OR
16. congenital myopathies and/or neuromuscular degenerative diseases.
Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery

This study compares the effect of three different dose levels of tranexamic acid（TXA）in reducing blood loss and transfusion requirements in cardiac valve surgery.

The effect of TXA to reduce perioperative blood loss and blood transfusion has been well established in many trials, but the optimal dosage of TXA in cardiac surgery has always been a problem of debate. This is a single-center randomized controlled trial to study different dose regimens of TXA in cardiac surgery. We use three different dose levels of TXA in cardiac valve surgery with CPB, and see if there are any differences in perioperative blood loss and transfusion requirements. Serious adverse events and seizure attacks are also recorded until three months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 18 to 60 years old scheduled for cardiac valve surgery (replacement or plasty) requiring CPB

Exclusion Criteria:

* known allergy to TXA, combined CABG operation or other cardiac procedures other than valve surgery, previous cardiac surgery, EF\<45% or cardiothoracic ratio\>0.65, serious coagulation disorder, serious hepatic insufficiency, receiving antiplatelet therapy at any time within 7 days of surgery, receiving low molecular weight heparin at any time within 24 hours of surgery, and pregnancy.
Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy

The purpose of this study is to evaluate the effect of lipo-prostaglandin E1 （lipo-PGE1) on renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent magnetic resonance imaging (BOLD-MRI).patients with stable chronic kidney disease (CKD) were included. All patients were divided into two groups: diabetic nephropathy（DN) and CKD without diabetes. In addition to the conventional treatments, all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days. Kidney BOLD-MRI were performed before and after lipo-PGE1 administration to acquire bilateral renal cortical R2\*(CR2\*) and medullary R2\* (MR2\*) values. Meanwhile, the clinical indexes at baseline and under lipo-PGE1 including 24 hours urinary protein and serum creatinine were collected. the investigators want to prove Lipo-PGE1 can improve kidney medullary oxygenation in patients with DN.

R2\* maps were calculated using the in-house software in Matlab (version 7.0, The MathWorks, Inc., Cambridge, MA, USA) on a pixel-by-pixel basis by fitting㏑(signal intensity) versus echo time. The R2\* map was windowed from 0 to 60 s-1.

Regions of interest (ROIs) with unfixed size (7 to 53 pixels) were defined at the upper, middle and lower poles of both kidneys in the medulla and cortex in the renal hilum plane based on the anatomical images. Three ROIs were placed in the medulla and cortex, respectively, carefully avoiding vessels, renal sinus and susceptibility artifacts, yielding a total of 6 ROIs in both kidneys. The values in each ROI were averaged for the bilateral cortex and medulla. To prevent significant bias from measurement variability, each sample was measured independently by three professional radiologists with more than 5 years of experience who were blinded to the clinical results. Thereafter, assuming the tests were coincident, the results were the averaged.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic kidney disease

Exclusion Criteria:

* Intolerance to lipo-PGE1, contraindication for MRI, concurrent urinary tract infection, acute kidney injury, acute cardiovascular and cerebrovascular complications and diabetic emergencies, with the use of corticosteroid and diureses.
Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic

The question of the immune response of the population, particularly of professional populations in contact with vulnerable populations (such as those with chronic conditions such as cancer), is an important issue. Knowing the evolution of this response over time in this population can help answer outstanding questions. The PRO-SERO-COV study is a seroprevalence study of caregivers working in the hospital sector with a follow-up at 3 months and 12 months. The objective is to evaluate and monitor at 3 and 12 months the serological immune status to an infection by the SARS-CoV-2 virus in active volunteer professionals working at the Institut Bergonié with different types of exposure: healthcare professionals and professionals in other services.


Eligibility Criteria:
Inclusion Criteria:

1. Adult 18 years-old and older.
2. Person in employment (on fixed-term or permanent contracts) since (at least) March 17th, 2020, the date of national implementation of containment measures in response to the COVID-19 pandemic.
3. Signed informed consent.
4. Person affiliated to a French social security regimen in accordance with Article 1121-11 of the French Public Health Code).

Exclusion Criteria:

1. Report of known active SARS-CoV-2 infection within 10 days prior to the date of signing the consent. Known active SARS-CoV-2 infection is defined as a positive result on a diagnostic RT-PCR test.
2. Presence of known symptoms suggestive of COVID-19 within 10 days prior to the date of signing consent: fever, fatigue, dry cough, shortness of breath, loss of taste and/or smell, headache, body aches, aches and pains, conjunctivitis or colds, digestive disorders (vomiting, diarrhea).
3. A person who is unable to follow and comply with research procedures due to geographical, social or psychological reasons.
4. Pregnant or breastfeeding woman.
5. Person deprived of their liberty, incapable or incapable of giving their consent.
Correlation of Orbital Cerebrospinal Fluid Pressure and Retinal Venous Outflow in Primary Open-angle Glaucoma

A spontaneous venous pulsation over the optic disc is an ophthalmological sign that can potentially be found in up to 98% of healthy individuals. In fact, the lack of this spontaneous retinal venous pulse has been consistently implicated as an indicator of a more advanced form of certain ocular diseases, specifically open-angle glaucoma. However, the mechanisms behind these change in the retinal venous system are not clear. Some evidence suggests that extraocular features such as intracranial pressure (ICP) may play a role in regulating the intraocular venous outflow. The reasons for this hypothetical downstream resistance to venous outflow are not fully understood, with advances in this field being limited by our technological-imposed difficulties in assessing the structures behind the globe.

However, it has been established that the volume of cerebrospinal fluid surrounding the optic nerve correlates with the ICP at the orbital level. Recent studies have suggested that non-invasive ultrasound-based recordings have correlated this surrogate for orbital ICP with the intraocular pressure (IOP) in glaucoma patients with an otherwise normal IOP range (normal tension glaucoma - NTG).

The investigators will therefore conduct a test to determine if this cerebrospinal volume surrounding the optic nerve correlates with the frequency of observation of an otherwise signal of venous dysfunction (i.e. the lack of a visible pulse in the retinal central vein) Additionally, the investigators will assess if this correlation is different between healthy individuals, hypertensive primary-open angle glaucoma or NTG patients.

1. Spontaneous venous pulsation will be recorded after a one minute fundoscopy observation.
2. B-mode ultrasound of the orbit will be performed and the optic nerve sheath diameter measured 3mm behind the globe
3. Visual field examination will be performed.
4. Structural examination of the optic disc (confocal microscopy) will be performed.

Eligibility Criteria:
Inclusion Criteria:

* individuals over 18 years old
* willing to sign an informed consent and able to comply with the requirements of the study
* having no other ocular diseases besides glaucoma

Exclusion Criteria:

* history of ocular trauma
* intraocular surgery (except for cataract surgery)
* eye disease (except glaucoma)
* systemic diseases with ocular involvement like diabetes or graves ophthalmopathy
P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.

This is a double-blind, placebo controlled study in subjects with moderate to severe acne. Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe acne
* Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face
* Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

Exclusion Criteria:

* Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant
* Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne
Supreme Versus Proseal Laryngeal Mask Airways in Infants

In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.

Both the Supreme™ and ProSeal™ laryngeal mask airways (LMAs) are widely used for paediatric anaesthesia; however, LMA use in infants is limited, as many anaesthesiologists prefer to use tracheal intubation in infants.

In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.

Infants of ASA physical status I who were scheduled for elective, minor, lower abdominal surgery were divided into two groups: the Supreme LMA group and the ProSeal LMA group. Heart rate (HR), oxygen saturation and end tidal carbon dioxide values were recorded both before and after LMA insertion, as well as both before and after extubation. After extubation, complications and adverse effects were noted.

Demographics and surgical data were similar between the two groups. LMA insertion times for the ProSeal group were shorter, the leakage pressure for the ProSeal group was statistically higher. The ProSeal LMA is superior to the Supreme LMA for use in infants, due to its ease of insertion, high oropharyngeal leakage pressure and fewer induced changes in hemodynamics.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective, minor (\<1 hour duration), lower abdominal surgery, including unilateral herniorrhaphy and unilateral orchidopexy

Exclusion Criteria:

* premature birth, potentially difficult airway, clinically significant upper respiratory tract infection and risk of aspiration, such as gastro-oesophageal reflux disease