cyrilzakka/clinical-trials huggingface dataset:
Mechanisms of Mindfulness for Smoking Cessation

The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.


Eligibility Criteria:
Inclusion Criteria:

* 21-65 years of age
* Smoke 10+ cigarettes/day
* \< 3 months abstinence in the past year
* Have a smartphone; and motivated to quit smoking
* Score \>18 of 20 on Action subscale of the Readiness to Change Questionnaire

Exclusion Criteria:

* Any usage of psychotropic medication: not on a stable dosage 6+ months
* Prior participation in a mindfulness course or regular meditation practice (\>20 min/week)
* Serious psychiatric, cognitive, or medical disorder
* MRI contraindications
* Structural brain damage as well as other brain abnormalities revealed by the MRI
* Claustrophobia
* Not being fluent in English
* Recreational drug use
* Pregnant women
* History of a neurological disorder
* Current participation in a smoking study
* Adults unable to consent
* Prisoners
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea

The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30 days after each vaccination dose, when administered according to the approved prescribing information (PI) in Korea in a real health care setting over a period of 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Subject or/and subjects whose parent(s)/Legally Acceptable Representative(s) \[LAR(s)\], in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Korean male or female subjects aged 9-25 years who are eligible for the series of Cervarix according to the locally approved PI.
* Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.

Exclusion Criteria:

* At the time of PMS entry, the contraindications and precautions of use indicated in the locally approved PI. PI should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved PI must be implemented immediately.
* Subjects who had previous administration of a HPV vaccine other than Cervarix will not be enrolled into the study.
* Subjects who are not eligible for vaccination with Cervarix according to the medical judgement of physician.
* Child in care.
Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pain Control After Modified Radical Mastectomy

We aim to study the effect of adding magnesium sulfate as an adjuvant to the local anesthetic used in the combined Pectoralis Nerve Block II (PECS II) and stellate ganglion block for postoperative pain control in patients undergoing modified radical mastectomy.

Post-operative pain from breast surgery can be controlled by regular pain medications such as paracetamol, non-steroidal anti-inflammatory (NSAIDs), and narcotics. Nerve blocks are commonly used as multimodal approaches for acute post-operative pain relief.

Pectoral and stellate ganglion blocks are regional anesthesia techniques that target the thoracic nerves and sympathetic nerve ganglia to provide analgesia for the upper extremity and chest regions. When combined, these blocks have shown promising results in alleviating perioperative pain for patients undergoing modified radical mastectomy.

Magnesium sulfate, a well-known adjuvant, has been studied extensively for its analgesic properties and anti-inflammatory effects.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Female gender.
* American Society of Anesthesiologists (ASA) physical status II or III.
* Patients scheduled for elective modified radical mastectomy for breast cancer.
* Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.

Exclusion Criteria:

* Bleeding tendency due to coagulopathy,
* Patients with opioid dependence or alcohol or drug abuse,
* Significant liver and renal sufficiency
* Patients with psychiatric illnesses that prevent them from proper perception and assessment of pain.
* Local infection at the site of the block.
* Known hypersensitivity or allergy to magnesium sulfate or local anesthetics.
* Patients with chronic pain syndromes or pre-existing neuropathic pain conditions.
* Pregnant or lactating individuals.
Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

The purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).


Eligibility Criteria:
Inclusion Criteria:

* PCO - ESHRE/ASRM criteria: oligomenorrhea (\<8 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone \>70ng/dl)
* Normal prolactin, TSH, 17-OH progesterone
* No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
* Age 18-40
* Reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

* Elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminases) above 2 times of upper limit of normal
* Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics.
* Use of oral contraceptives and other steroid hormones 3 months prior to the study
* Contraindications to oral contraceptives
Treatment of Social Anxiety Disorder and Selective Mutism

This study is to assess the efficacy of a brief, 11-week, manualized Taming Sneaky Fears for Social Anxiety Disorder (SAD) and/or Selective Mutism (SM) child and parent group Cognitive Behavioural Therapy (CBT) treatment protocol. Children 4 to 7 years old (n = 88) meeting criteria for SAD and/or SM, and their parents are recruited from the Psychiatry Outpatient Program and participants will be randomized to either the Taming Sneaky Fears group or a parent psycho-education and child socialization group. Trained clinicians blinded to all measures and treatment assignment will administer pre, post and 6-month follow-up outcome measures. Investigators assess within-the-child and within-the-parent/environment factors that predict treatment outcomes.

This study utilizes a repeated measures, longitudinal, randomized controlled trial design to compare the efficacy of two interventions in the treatment of children aged 4 to 7 years with SM and/or SAD. Participants are randomized into either the:

1. Taming Sneaky Fears for SAD and/or SM parent and child group CBT treatment, or
2. the Parent Psycho-education and Child Socialization comparison program.

Both programs run for 10 consecutive weeks (plus one additional introduction week). To control for the nonspecific factors associated with treatment, such as the support, attention and expectation of improvement, parents and children in both treatment protocols receive comparable levels of attention from therapists (i.e., same duration of group sessions and total number of sessions with a therapist) and comparable opportunities for socialization (e.g., for the children: invitation to discuss how the previous week went, snack time, story time; for the parents: discussion of specific topics at each session). However, parents and children in the comparison group are not taught CBT strategies.

Eligibility Criteria:
Inclusion Criteria:

* 4 to 7 year old children who meet diagnostic criteria for a primary diagnosis of Selective Mutism (SM) and/or Social Anxiety Disorder (SAD) through a clinical and semi-structured diagnostic interview .
* Presence of other anxiety disorders/symptoms is not an exclusion criterion as long as the main concern (primary diagnosis) is SAD and/or SM.

Exclusion Criteria:

* Presence of autism spectrum disorder, brain injury, or significant developmental delays (based on medical history and clinical assessment).
* Children and parents not fluent in English.
EAA/Therapy for Treating Children With ADHD

The aim of this study is 1) to investigate clinical effects of equine-assisted activities and therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD) and 2) to compare the clinical effect of EAA/T and drug therapy in children 6-13-years-of-age. This study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of EAA/T. Forty six subjects will be enrolled and various clinical tests will be administered at baseline and after EAA/T or drug therapy.

This study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of EAA/T. Forty six subjects will be aasigned 12 weeks of EAA/T or drug therapy, and various clinical tests will be administered at baseline and after EAA/T or drug therapy. Assessments included the investigator-administered ADHD-Rating Scale (ARS-I), Clinical Global Impressions - Severity scale (CGI-S), Clinical Global Impressions - Improvement scale (CGI-I), Gordon Diagnostic System (GDS), Korea-Child Behavior Checklist (K-CBCL), Self-Esteem Scale (SES), Bruininks-Oseretsky test of motor proficiency, second edition (BOT-2), and quantitative electroencephalography (QEEG) or functional magnetic resonance imaging(fMRI) study. This study has two objectives. The first objective is to investigate clinical effects of equine-assisted activities and therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD). For this one, we determine the treatment response rate as the primary outcome measure. The treatment response is defined as ≥ 30% decline than baseline in the ARS-I score or in CGI-I scores of 1 or 2 to endpoint. The second objective is to compare the clinical effect of EAA/T and drug therapy in children with ADHD.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of ADHD according to Diagnostic and Statistical Manual-IV-Text Version(DSM-IV-TR) and Korean Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Life¬time Version (K-SADS-PL)

Exclusion Criteria:

* (1) a learning disorder or an intelligence quotient (IQ) measured by the Korean Wechsler Intelligence Scale for Children-IV (K-WISC-IV) \< 70, (2) significant medical condition, schizophrenia or other psychotic disorder, bipolar disorder, a history of alcohol or drug dependence, neurologic disorders, epilepsy, and organic mental disorders; (3) a major depressive disorder that required pharmacotherapy; (4) significant suicidal ideation; (5) a Tourette's disorder or obsessive-compulsive disorder that required pharmacotherapy; (6) use of methylphenidate or atomoxetine within 90 days of baseline
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
* Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Platelet count ≥100,000/mm3.
* International normalized ratio of prothrombin time ≤1.8.
* Creatinine ≤1.9 mg/dL.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
* Subjects are willing to sign an informed consent form.

Exclusion Criteria:

* Subject has a tumor of Keratoacanthoma histology.
* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
* High probability of protocol non-compliance (in opinion of investigator)
* Women who are pregnant or breastfeeding.
Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)

The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the Calhoun Vision Light Adjustable intraocular lens (LAL) and Light Delivery Device (LDD) in treating postoperative residual refractive error by providing a stable, targeted refractive adjustment of the LAL power and lock-in treatments with the LDD.


Eligibility Criteria:
Inclusion Criteria:

* Pre-operative regular corneal astigmatism less than or equal to 1.00 diopters by keratometry.
* Adults between the ages of 40 and 80 inclusive.
* Cataract causing reduction in best spectacle-corrected visual acuity to a level of 20/32 or worse.
* Best corrected visual acuity projected (by clinical estimate based upon past ocular history and retinal exam) to be 20/25 or better after cataract removal and IOL implantation.
* Clear intraocular media other than cataract.
* Potentially good vision in the fellow eye with BCVA 20/40 or better.
* Willing and able to comply with the schedule for power adjustment/lock-in treatments and the schedule for follow-up visits.
* Fully dilated pupil diameter of more than or equal to 7.0 mm.

Exclusion Criteria:

* Zonular laxity or dehiscence.
* Pseudoexfoliation.
* Age related macular degeneration involving the presence of geographic atrophy or soft drusen.
* Retinal degenerative disorder that is expected to cause future vision loss.
* Diabetes with any evidence of retinopathy.
* Evidence of glaucomatous optic neuropathy.
* History of uveitis.
* Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris coloboma.
* Corneal pathology that is either progressive or sufficient to reduce BCVA to 20/25 or worse.
* Keratoconus or suspected of having keratoconus.
* Corneal dystrophy including basement membrane dystrophy.
* Previous corneal or intraocular surgery
* Systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, and phenothiazines.
* Complications during cataract surgery including posterior capsule rupture, zonular rupture, radial capsulorhexis tear, vitreous loss, iris trauma, corneal complications or any intraoperative abnormality that may affect the postoperative pupillary dilation, or the centration or tilt of the intraocular lens.
CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr

To enable the paradigm of mp-MRI before biopsy in all patients with suspected prostate cancer by better selecting patients who will benefit from diagnostic MRI and by improving the performance of the mp-MRI itself

Patients will undergo an advanced diffusion-weighted MRI sequence called VERDICT with the intention of better characterising prostate cancer. A panel of serum and urine biomarkers will also be analysed, which we hope will predict those patients who go on have a positive MRI.

OBJECTIVES:

* To establish a fluidic marker - prostate MRI paradigm which: (i) utilises fluidic markers to rationalise selection of patients with significant prostate cancer; and (ii) improves the diagnostic accuracy of imaging over and above standard multiparametric (mp) MRI
* Enable a pathway for rapid clinical evaluation of emerging fluidic markers and exosomes
* Assess the repeatability of VERDICT MRI
* Ascertain whether VERDICT derived quantitative parameters correlate with quantitative histological parameters
* Develop a database of fluidic marker and VERDICT characterised, mp-MRI, histologically validated patients for subsequent exploratory and longitudinal outcome analysis

Eligibility Criteria:
Inclusion Criteria:

* Men referred to University College London Hospital (UCLH) for prostate mp-MRI following biopsy elsewhere and biopsy naive men presenting to UCLH with a clinical suspicion of prostate cancer.

Exclusion Criteria:

* Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI
* Men unable to given informed consent
* Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer
* On-going hormonal treatment for prostate cancer
* Previous biopsy within 6 months of scheduled mp-MRI
Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis

In our previous study, a nomogram model was established to predict intra-abdominal infectious complications after gastrointestinal surgery. This model was based on the clinical data and the drainage fluid cytokine levels, and it received an AUC \>0.9. In this study, validation of this nomogram is planned to be conducted in this prospective cohort study.

Intra-abdominal infectious complications such as anastomotic leakage are the most feared but common complications after gastrointestinal surgery. In our previous study, a nomogram model was established to predict intra-abdominal complications after gastrointestinal surgery. This model was based on the clinical data and the drainage fluid cytokine levels, and it received an AUC \>0.9. A predicting score (i.e. APPEAL-GC score) was created based on the model. In this study, validation of this score in predicting intra-abdominal complications is planned to be conducted in this prospective cohort study.

In this study, all patients undergoing gastric or colorectal cancer surgery with a primary anastomosis will be included. The clinical data and complication data will be prospectively collected; the discarded drainage fluid will be collected and analyzed afterward. No additional intervention will be applied.

The cytokine levels in the drainage fluid will be evaluated, and together with the clinical data, an APPEAL-GC score will be created for each patient. We will investigate whether the above-mentioned score is able to predict the intraabdominal complications after surgery. The predictive value (clinical usefulness) of the score will be validated in this study.

Eligibility Criteria:
Inclusion Criteria:

* Planned surgery for gastric or colorectal cancer with primary anastomosis.
* Inform consent signed before surgery.

Exclusion Criteria:

* No drainage tube placed.
A Phase II Study of MK0457 in Patients With T315I Mutant CML and Ph+All (0457-008)

This study will evaluate MK0457 in patients with chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Efficacy and safety will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* This study will evaluate MK0457 in patients with CML (chronic myelogenous leukemia) and Ph+ALL (Philadelphia chromosome-positive acute lymphoblastic leukemia)
* Patients must have adequate organ function
* Patients must have documented T315I mutation

Exclusion Criteria:

* Patients within 3 months of allogeneic bone marrow transplant or not fully recovered from previous anti-leukemia therapy
* Patients with uncontrolled congestive heart failure
* Patients with active or uncontrolled infection or active Hepatitis B or C
* Patients with known HIV positivity or AIDS related illness
* Patients with currently active second malignancy, other than non-melanoma skin cancer.
Multivitamin Adherence Following Bariatric Surgery

Additional micronutrient supplementation is required due to the changes in the gastrointestinal anatomy and physiology following bariatric surgery along with decreased dietary intake and rapid weight loss. Good adherence to post-operative vitamins is essential to maintain healthy vitamin levels in the body following bariatric surgery. The hypothesis of this study is that patients receiving a weekly survey intervention will have better adherence to post-operative vitamins.


Eligibility Criteria:
Inclusion Criteria:

* Planning to undergo a Roux En Y Gastric Bypass or Sleeve Gastrectomy at Wake Forest Baptist Health

Exclusion Criteria:

* Admission for a psychiatric event in the past year
* History of nausea and/or significant complaint of post-operative nausea
* History of stricture and/or significant complaint of post-operative stricture
* History of ulcer and/or significant complaint of post-operative ulcer
* History of major depression or psychiatric disorder
Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.

After birth, the perineum has to be trained in order to recover its functions.

This study is designed to assess the quality of life evolution with the EMY connected device.

The secondary purposes are to evaluate patient compliance to the EMY probe, to observe the evolution of urine scores over the duration of the trial in order to consider a comparative study thereafter, and to evaluate the interest of using the EMY connected perineal probe in the context of stress urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Women with urinary leakage, at least once a week or more since more than 3 months
* Women aged 18 and over, no upper age limit
* Patient having given birth since 6 months minimum
* Patient able to do an effective voluntary contraction and avoiding abdominal synergy and apnea during contraction (attested by the health professional partner who leads the patient to the study)
* Patient who has responded favorably to a perineal reeducation with at least 2 sessions (attested by the health professional partner who leads the patient to the clinical study), rehabilitation of stress urinary incontinence or mixed incontinence with predominance of stress urinary incontinence
* Signed informed consent form
* Effective contraception throughout the study (declarative)
* The patient must have a smartphone running at least the Android 5 and iOS 8 versions
* The patient must know how to read and write French

Exclusion Criteria:

* Patient practicing any other perineal reeducation during the study period
* Patient with neurological disease or congenital malformation, urinary incontinence or prolapse treated surgically or medically or perineal hypoesthesia or local conditions that prohibit the use of an intravaginal device
* Patient with an urge urinary incontinence or mixed urinary incontinence with a predominance of urgency.
* Contraindication to the use of the medical device
* Patient with Genito-urinary cancer (in the last 5 years)
* Patient with extra-uretral "incontinence" (fistula, ectopic ureter)
* Patient with severe urinary retention
* Patient carrying a sacral neuromodulation case
* Subject in exclusion period (determined by previous or current study)
* Impossibility to give the patient clear information (patient in emergency situation, patient with difficulties for understanding, ...)
* Patient under the protection of justice
* Patient under guardianship or curatorship
* Pregnancy (positive urine test)
* Breastfeeding patient