cyrilzakka/clinical-trials huggingface dataset:
Preventing Alcohol Withdrawal Syndrome With Oral Baclofen

Adult medical/surgical inpatient hospital care is more difficult and more expensive when complicated by alcohol dependency (AD), especially for patients who develop alcohol withdrawal syndrome (AWS). AWS can be mild, moderate or severe. The Severity of Ethanol Withdrawal Scale (SEWS) is tool used to assess severity and is the current standard of care for both monitoring and treating AWS at Denver Health. Moderate/severe AWS (i.e., SEWS ≥ 7) has important clinical implications and requires pharmacological treatment. At present, there are no safe and effective options for preventing AWS in at-risk inpatients. Baclofen is a GABA-B receptor agonist that has been used in the alleviation of spasticity in patients with multiple sclerosis since the 1970s. Baclofen has shown promise in the management of alcohol dependency in preclinical and clinical studies. We propose to examine baclofen in the prevention/amelioration of AWS in adult medical inpatients. The investigators hypothesize that Baclofen, as compared to placebo, will significantly reduce the number of adult inpatients with AD who will develop moderate/severe AWS (SEWS ≥ 7) when assessed at 72 hours after enrollment. Further the investigators hypothesize that Baclofen, as compared to placebo, will significantly reduce the need for symptom-triggered benzodiazepine administration during the 72 hours of hospitalization. These hypotheses will be tested in adult inpatients who are determined to be at risk for alcohol withdrawal and are subsequently placed on the SEWS monitoring and treatment protocol. These patients will be randomized to baclofen 10mg three times daily vs placebo.

See Brief Summary. Patients will recieve standard of Care treatment and monitoring for ETOH withdrawl per our insitution wide SEWS protocol. They will then be randomized to recieve baclofen 10mg tid vs placebo tid for the course of their hospital stay or 7 days, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 21-100 admitted to medical floors at Denver Health
* Patients placed on SEWS protocol by admitting physicians (at risk for AWS).

Exclusion Criteria:

* Unable to provide informed consent
* Unable to take oral medications
* admitted for AWS or with SEWS score \>7 at baseline
* no alcohol intake for ≥ 48 hours
* baclofen use at baseline
* baclofen sensitivity
* hospital discharge anticipated in within 48 hours
* pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential
* other active drug dependence (except tobacco)
* taking a medication known to interact with baclofen.
Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects

This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male and female volunteers aged 18-55 years.
* 19kg/m2 ≤ BMI \<24kg/m2.

Key Exclusion Criteria:

* A positive HBsAg, HCV Ab and/or HIV Ab.
* Pancreatic injury or pancreatitis.
* History of organ transplantation, including bone marrow transplantation.
Mirena in Idiopathic Menorrhagia

This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.


Eligibility Criteria:
Inclusion Criteria:

* Woman diagnosed with idiopathic Menorrhagia according to assessment of the investigator and according to international guidelines. These woman should also accept to be on contraception during the time period that they have Mirena in situ.
* Age limit 30-45
* BMI= 18-34
* Signed informed consent

Exclusion Criteria:

* Medical conditions featured in the Mirena data sheet (See Appendix 1) that contraindicate its use, listed below:
* Known or suspected pregnancy; current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product.
* Nulliparity
* Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study.
* History of diabetes mellitus,cardiovascular disease and thyroid abnormalities
* Anticoagulation therapy
* Cancer history including breast cancer.
Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

The purpose of this study is to compare the safety and efficacy of manual super small incision cataract surgery (MSSICS) and Phacoemulsification.


Eligibility Criteria:
Inclusion Criteria:

* Age related cataract patients
* Cataract density grade II-III according to the Emery-Little system classification system

Exclusion Criteria:

* Legal guardian(s) is/are not present for permission
* Other eye diseases impairing visual acuity (ie. glaucoma)
* patients with severe systemic diseases not good for ocular surgery
The Effect of Multiple Injections of (PRF) on The Rate of Canine Retraction

this clinical trial aims to prove that multiple injections will produce a steady rate of acceleration of orthodontic tooth movement.

Platelet-rich fibrin injection is a second-generation platelet concentrate, prepared from centrifuged blood which is a rich source of platelets, stem cells, and growth factors seven times greater than that released by platelet-rich plasma. It is a simplified procedure with no biochemical manipulation of blood, free from anticoagulants which are known to inhibit wound healing or any gelling agent, and easily usable with a low rate of mistakes during the preparation procedure.

A variety of growth factors are released by PRF such as platelet-derived growth factor (PDGF), transforming growth factor β (TGF-β), and vascular endothelial growth factor (VEGF), which play a crucial role in angiogenesis, collagen synthesis, and bone regeneration.

Treatment with extraction especially in adult patients may take a longer time due to reported increase in bone density and lower bone regenerative rate. Also, the retraction process to close extraction spaces most of the time is accompanied by bone loss and root resorption as reported in the previous studies. i-PRF can accelerate tooth movement, in addition, prevent tooth retraction undesirable side effects.

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* Full set of permanent dentition (excluding third molars).
* Good oral hygiene
* protrusion cases that require extraction of premolars (Bimaxillary protrusion or class II div 1)

Exclusion Criteria:

* History of previous orthodontic treatment.
* Systemic disease or drugs affecting tooth movement.
* Smokers
* Poor oral health that precludes orthodontic treatment (presence of caries, active white spots, or periodontal diseases)
* Severe crowding cases with ectopic erupted canines
Effects of TaVNS on Fibromyalgia Pain

Transauricular vagus nerve stimulation (taVNS) is a newer delivery system, using a non-invasive stimulation device placed at the ear's concha. TaVNS is a portable, safe, and low-cost intervention, and according to some studies, taVNS may influence nociception and pain perception, which can lead to potential applications for various painful illnesses, including fibromyalgia (FM). This trial aims to investigate the clinical effects of taVNS on pain control in FM subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Older than 18 years old.
2. Diagnosis of FM pain according to the American College of Rheumatology (ACR) 2010 criteria (existing pain for more than six months with an average of at least 3 on a 0-10 VAS scale).
3. must have the ability to feel sensation by Von-Frey fiber on the forearm.
4. Able to provide informed consent to participate in the study.

Exclusion Criteria:

1. Subjects who have unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, or chronic obstructive pulmonary disease) or who have functional deficits, as self-reported.
2. history of substance abuse within the past six months as self-reported (if the subject reports a history of substance abuse, we will confirm using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria).
3. Presence of implanted cranial electronic medical devices (e.g., cochlear implants).
4. pregnancy (as the safety of taVNS in the pregnant population (and children) has not been assessed (though the risk is non-significant), we will exclude pregnant women (and children). Women of child-bearing potential will be required to take a urine pregnancy test during the screening process and every two weeks of stimulation).
Supporting Treatment Adherence Needs in Diabetes

There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to reduce depressive symptoms, improve family functioning, and improve medication compliance. The intervention is delivered in two phases (1 - reduction of depressive symptoms and family conflict, 2 - adherence promotion) as efforts to improve adherence will have a greater likelihood of success if individual and family functioning variables are addressed first. To test the effectiveness of this intervention in reducing depressive symptoms and improving adherence, we will conduct a randomized controlled trial comparing this new intervention to usual care in a sample of fifty-two adolescents with type 1 diabetes and their primary caregivers. Given the absence of this type of intervention and the significance of the problem, this study is timely and important, as it has the potential to positively impact diabetes-specific health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 13-17
* Diagnosis of type 1 diabetes according to criteria from the ADA for at least 1 year
* Daily insulin dosing of at least 0.5 units per kilogram per day
* Clinical elevation on the CDI (i.e., score at or above 13)
* Assent to participation in study

Exclusion Criteria:

* Other chronic, physical disease or condition except for celiac or thyroid disease
* Diagnosis of major mental disorder (e.g., bipolar disorder, thought disorder, anorexia nervosa)
* Diagnosis of developmental disorder (e.g., mental retardation, autism, Asperger's)
* Current enrollment in psychotherapy specifically targeting depression
Randomized Study of Silq Urinary Catheter

To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce biofilm formation in subjects that require a long-term indwelling Foley catheter when compared to other commercially available urinary catheters.

A prospective, randomized, multi-center, post-market study in subjects that require a long-term indwelling Foley catheter.

A randomly assigned catheter will be inserted using standard techniques. Non-surgical subjects will rate the level of pain associated with the insertion procedure using the visual analog scale (VAS). A urine sample will be collected immediately after catheter insertion, in order to generate a baseline urinalysis and urine culture.

Follow-up visits will be performed on Day 28, or upon catheter removal, whichever occurs first. The catheter will be removed on Day 28 or earlier if clinically indicated. The removed catheter will be processed and sent to the core laboratory for analysis. Urine will be collected immediately prior to catheter removal in order to conduct urinalysis and urine culture. Subject will rate level of pain associated with the removal procedure using the VAS. The subject will also fill out a questionnaire about their experience with the catheterization immediately after catheter removal. Subjects will then be exited from the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female age ≥ 18 years old;
2. Requiring indwelling 16Fr Foley catheter for at least 7 days;
3. Able and willing to comply with study procedure; and,
4. Able and willing to give informed consent.

Exclusion Criteria:

1. Allergy or sensitivity to any catheter materials used in this study;
2. Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheter;
3. Planned Prophylactic use of antibiotics for CAUTI or any other infection beyond day 1 of the study (catheter implantation);
4. Symptomatic UTI being treated with antibiotics (as determined by the study PI, including at least one of the following: fever, chills, headache, burning sensation, burning of urethra or genital area, blood in urine, foul smelling urine and ≥ 10,000 cfu/mL);
5. Any other infection being treated with antibiotics at the time of catheter implantation;
6. Subjects requiring bladder irrigation during the study (an active voiding trial in surgical subjects prior to catheter removal is allowed);
7. Currently enrolled in another interventional clinical trial;
8. Any other condition that, in the opinion of the investigator, precludes study participation or poses a significant hazard in case of study participation; and
9. Females who are pregnant or breastfeeding or who plan to become pregnant during the study.
DK Nano-Culotte Stenting For Coronary Bifurcation Lesion

True coronary bifurcation lesions are still great of interest due to their complex anatomy, uncertainty of optimal stenting strategy and increased adverse cardiovascular outcomes. Provisional stenting is recommended in patients with non-complex coronary lesions while 2-stent strategies should be considered in complex coronary bifurcation lesions. However, optimal 2-stent strategy is still controversial. Double kissing (DK) crush stenting is the prominent technique in true bifurcation lesion, especially in patients with left main coronary artery disease. DK mini-culotte stenting, increasing use in clinical practice, has become popular over DK crush stenting. It was demonstrated in a bench test that stent malapposition was lower in the DK mini-culotte stenting compared to the DK crush technique. Thus, DK mini-culotte stenting may be preferred over DK crush stenting in complex true coronary bifurcation lesion. On the other hand, it was demonstrated in previous studies, less than minimal protrusion (generally called as nano protrusion) had better clinical outcomes. Kawasaki et al was first demonstrated the minimal (nano) protrusion of culotte stenting technique. Then, Toth et al revealed a novel modified culotte stenting technique named single string culotte. There was no major adverse cardiac events (MACE) in patients underwent single string stenting technique with a median follow-up period of 6±4 months. Unsurprisingly there was no MACE occurred in patients who underwent Szabo 2-stent technique. In the light of foregoing data, the least possible amount of protrusion is known to have the best results. In addition to this, double kissing balloon dilatation with culotte stenting technique seems to have better results than other stenting techniques. In our study, we aimed to evaluate the angiographic and clinical results of a novel DK Nano-Culotte stenting in coronary bifurcation lesion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with de novo true bifurcation lesion (Medina classification 1,1,1 or 0,1,1 or 1,0,1)
* The main vessel diameter is least 2.5 mm and the side branch diameter is at least 2.25 mm

Exclusion Criteria:

* Patients presenting with ST segment elevation myocardial infarction, cardiogenic shock and Killip class III-IV heart failure
* Patients with a history of coronary artery bypass grafting surgery
* Patients with a chronic total occlusion in the bifurcation area
* Lesions with severe calcification that needs additional intervention such as atherectomy
* Patients who are not suitable to use long term dual antiplatelet therapy and patients not participating in clinical follow-up
* Patients with hematological disorders, malignancy, end stage renal (GFR\<30 ml/min) and hepatic failure
* Patients with active bleeding
* Pregnant women
* Patients with life-expectancy \< 1 year
* Patients treated with small open cell stent platforms
resVida and Fat Oxidation

There is now a general consensus that the combination of excessive energy intake and a low capacity to oxidize fat will lead to muscular fat accumulation and insulin resistance. It is known for many years that physical exercise is the most powerful treatment to combat insulin resistance, but it is also known that it is difficult to get people to exercise. A major breakthrough has come from the nutrition field, with the finding that resveratrol, a natural polyphenolic compound, could serve as an "exercise mimetic" by protecting mice from many detrimental effects of diet-induced obesity. Therefore the researchers would like to investigate if resVida can increase skeletal muscle mitochondrial function and fat oxidative capacity in obese subjects. The researchers hypothesize that an increased mitochondrial function together with an increased intrinsic activity will lead to a better control of fatty acid handling in muscle, upon a high-fat challenge.


Eligibility Criteria:
Inclusion Criteria:

* male sex
* age 45-65 years
* body fat percentage \> 25%, BMI 30-35 kg/m2
* sedentary
* stable dietary habits
* willingness to abstain from ingestion of resveratrol-containing foods
* healthy

Exclusion Criteria:

* female sex
* unstable body weight (weight gain or loss \> 3 kg in the last three months)
* total body fat percentage \< 25%
* fasting plasma glucose \> 6.1 mmol/l
* hemoglobin \< 7.8 mmol/l
* engagement in programmed exercise \> 2 hours total per week
* impaired kidney and/ or liver function
* first- or second-degree family member with type 2 diabetes mellitus
* any medical condition requiring treatment and/ or medication use
* intake of dietary supplements except vitamins and minerals
* unwilling to restrict high-resveratrol containing foods
* current alcohol consumption \> 20 grams/day
* participation in another biomedical study within 1 month before the screening visit
* a contraindication to MRI scanning. These contraindications include patients with the following devices:
* central nervous system aneurysm clips
* implanted neural stimulator
* implanted cardiac pacemaker or defibrillator
* cochlear implant
* insulin pump
* or metal containing corpora aliena in the eye or brains
Testicular Growth During Puberty in Boys With and Without a Left-sided Varicocele

Prospective observational study.

A varicocele is defined as a dilatation of the veins in the plexus pampiniformis in the testicles. Varicoceles are a diagnostic dilemma and a therapeutic challenge. Most of the boys with a varicocele don't show any symptoms, but approximately 15-20% experience some sort of infertility later during their life. There still isn't any consensus on when treating the patient is the right choice. Reliable scientific research about parameters able to predict the later stages of the boy with a varicocele is therefore needed. The purpose of this study is to how testicular growth could predict the outcome of boys with a varicocele.

During this study, testicular growth in boys with and without a left-sided varicocele will be examined in different schools using ultrasound to measure the testicular volumes, the PRF and the TAI to be able to collect sufficient data with the purpose to be able to predict whether testicular growth is a significant predictor on the progression of a varicocele.


Eligibility Criteria:
Inclusion Criteria:

1. Boys aged 11-16 years without any evidence of a current or past pathology influencing testicular growth

Exclusion Criteria:

1. Boys with a current or past inguinoscrotal pathology (varicocele, testicular microlithiasis, cryptorchidism, retractile testis, orchidectomy, testicular torsion, orchitis or epididymitis, hypospadias, inguinal hernia, oeprated varicocele, hydrocele and epididymal cysts)
2. Boys with evidence of disorders influencing testicular growth (e.g. growth disorders)
3. Boys with missing or incomplete data on Tanner stages for genital development
4. Boys with a psychiatric disorder
Clinical Evaluation of Dimethyl Sulfoxide Wet Bonding Technique

Dimethyl sulfoxide (DMSO) wet bonding has shown promising results in several in vitro studies. However, there are a lack of clinical trials which prove the advantages of this technique. The aim of the study is to clinically assess the effect of DMSO wet bonding on composite restoration in non carious cervical lesions.


Eligibility Criteria:
Inclusion Criteria:

* Two similar non carious cervical lesions (NCCLs) on the facial/labial surfaces of premolars.
* NCCLs of score 1-3 on the Smith and Knight tooth wear index.
* Favorable occlusion and teeth are in normal contact.

Exclusion Criteria:

* NCCLs on the lingual surface.
* Medically compromised individuals.
* Periodontally compromised teeth.
* Bruxism and visible wear facets in the posterior dentition.
* Fractured or visibly cracked premolars and canines.
* Known allergies to resin-based restorative materials.
* Presently undergoing orthodontic treatment.
* Abutment teeth for fixed or removable prostheses.
RNA and Heat Shock Protein Biomarkers in Radiation-induced Fibrosis in Breast Cancer

The purpose of this study is to seeking a molecular signature of pathological radiation induced fibrosis based on the response of skin fibroblasts after irradiation, comparing two groups of patients distinguished by their individual radiosensitivity. The signature will integrate recent insights in terms of alternative splicing of mRNAs and level of expression of non-coding RNAs, particularly long non-coding RNAs, snRNAs, snoRNAs and microRNAs. In each group each expression patterns of candidate HSP proteins potentially predictive of pathological radiation induced fibrosis (HSP27, HSP70, αβ crystalline) in the serum and on cell culture will be characterized.


Eligibility Criteria:
Inclusion Criteria:

* women
* age ≥ 18 and \<70 years old
* non metastatic disease
* ECOG performance status 0 or 1
* chest size ≤ 110 cm et bra size \<D
* absence of reconstructive breast surgery
* patient able to undergo blood samples (haematological conditions allowing blood sample)
* non-evolving carcinological disease
* absence of systemic inflammatory disease (other than scleroderma) or diabetes
* no inflammatory ou infectious flare on biopsy site at the time of inclusion
* invasive or in situ breast carcinoma
* ability to provide an informed written consent form
* affiliation to a social security system

Then stratification into two groups :

group 1 : radio-sensitive patients

* Post-operative radiotherapy completed at least 6 months ago AND
* radiation induced dermal and/or soft tissue toxicity (dermatitis, fibrosis, atrophy) rated \> 2 (CTCAE v4.0 scale)

group 2 : radio-tolerant (control) patients

* Post-operative radiotherapy completed more than 4 years ago AND
* radiation induced dermal and/or soft tissue toxicity (dermatitis, fibrosis, atrophy) rated ≤1 (CTCAE v4.0 scale) .

Exclusion Criteria:

* age \<18 or \> 70 years old
* evolutive cancer / metastatic disease
* chest size \> 110 cm et bra size ≥ D
* previous reconstructive breast surgery
* ECOG performance status \> 1
* systemic inflammatory disease or diabetes
* inflammatory ou infectious flare on biopsy site at the time of inclusion, very significant ulceration in the treated breast
* anemic patients
* use of oral anticoagulants
* pregnant or likely to be in 6 months
* patients deprived of liberty or under supervision
* non-affiliation to a social security system