cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Art-therapy on Alexithymia in Patients Suffering From Anorexia Nervosa and From Bulimia

Alexithymia is often found in patients suffering from anorexia nervosa or from bulimia. Art-therapy is widely used in this indication without there is a study in the literature assessing it. ALEXART is an observational prospective multicenter cohort pilot study, assessing the effect at 3 months of art therapy on alexithymia, in patients presenting anorexia nervosa or bulimia.

Alexithymia, defined by difficulties to identify and describe feelings as well as a poverty of imaginary life, is found in patients with anorexia nervosa (AN) or bulimia (BN) in numerous studies. Some publications show that it is a factor of resistance in several forms of psychotherapies and of poor prognosis for these patients who already present a high rate of chronification and mortality because of the complications of the undernutrition and the suicide risk. Art therapy is very wide-spread in the care of AN and of BN, but little studied. About alexithymia, if there is no psychotherapy having made the proof of its efficiency currently, some studies suggest the interest of art-therapy on alexithymic features, but none, to our knowledge, estimated the effect.

The investigator suggest to describe the evolution at 3 months of art therapy on alexithymia, using the Toronto Alexithymia Scale in 20 items (TAS-20), in patients with AN or BN. The investigators shall also describe the evolution at 3 months with the TAS-20 as well as the relationship between variations of alexithymia and BMI in patients presenting AN at 1 and 3 months globally and in each of the centers. The investigators will also evaluate the effect of depression and anxiety at 1 and 3 months of art therapy on alexithymia.The investigators shall realize an observational prospective multicenter cohort study design. Each patient will receive standard care: multidisciplinary and corresponding to the HAS recommendations and semimonthly or weeklies sessions of art therapy, using all types of art. Thus, each patient will be her own control before art therapy.

Eligibility Criteria:
Inclusion Criteria:

* to be a woman, aged 16 or more, having DSM-5 diagnosis of anorexia nervosa or bulimia nervosa, inpatient in "Psychiatry, Psychotherapy and Art Therapy" ward at CHU de Toulouse or at " clinique Castelviel " in Toulouse.

Exclusion Criteria:

* acute psychotic symptoms
* pregnant women
* breast-feeding women
* people under justice protection.
Opioid-free Total Hip Arthroplasty

The primary objective of investigators' proposed study is to demonstrate that the following two cohorts undergoing total hip arthroplasty will have equivalent visual analog scale (VAS) scores up to 3 months post-operatively: one that is administered a modified multimodal analgesic pathway without opioids and the other administered the current standard multimodal analgesic pathway used at Johns Hopkins Bayview Hospital (which includes opioids). The secondary objective is to demonstrate that these cohorts will also have equivalent functional outcomes as determined by both objective measures (such as hip range of motion) and patient-reported outcome measures, such as the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the University of California at Los Angeles (UCLA) activity score.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages with end-stage primary hip osteoarthritis.

Exclusion Criteria:

* Patients with creatinine clearance between 30 and 60 mL/min
* Use of any opioid analgesics in the 6 months preceding surgery
* Revision total hip arthroplasty
* Patients with liver insufficiency
* Patients on chronic anticoagulation
* Workers compensation patients
* Patients who cannot receive Acetaminophen, Ketorolac, Celecoxib, or Gabapentin for any reason (e.g. allergies)
Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause

Introduction: The genitourinary menopause syndrome (MMS) affects 50% of postmenopausal women and, due to a decrease in hormone levels, triggers functional changes in the vagina and vagina, and impairment of quality of life and sexual function. Objective: To test the hypothesis that the 405 nm light emitting diode in the treatment of vulvovaginal atrophy is safe and effective, by reducing the symptomatology of the disease and histological alteration of the tissue. Methods: This is a pilot study in 10 volunteers with SGM, followed by a randomized, blinded trial in a sample of 58 individuals that will be performed at the Pelvic Floor Care Center (CAAP). Menopausal women up to 65 years of age and with clinical signs and symptoms of vulvovaginal atrophy syndrome (vaginal dryness and irritation, pruritus, pain or discomfort in intercourse, bleeding after sexual intercourse) and who voluntarily participate in the study will be included. Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, use of pacemaker, pregnant women, those who have performed Oophorectomy or presented ovarian cancer, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases. Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them. In the clinical trial, the study group will perform kinesiotherapy and LED.

The control group will perform kinesiotherapy and the LED will be turned off. Data collection will be performed initially and after the sessions through self-administered questionnaires containing socio-demographic and clinical information, Medical Outcomes Study 36, Short-Form Health Survey (SF-36), Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7). At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction. Expected results: The 405nm LED in the vaginal canal is expected to be safe and effective for SGM.


Eligibility Criteria:
Inclusion Criteria:

* menopausal women up to 65 years of age
* presence of clinical signs and symptoms of Menopause Genitourinary Syndrome :dryness and irritation of the vagina, pruritus, pain or discomfort in sexual intercourse, bleeding after sexual intercourse
* voluntarily participate in the research.

Exclusion Criteria:

* patients undergoing hormone replacement for less than 6 months
* diagnosis of vaginal infection
* difficulty in understanding the proposed instruments
* patients with chronic neurological degenerative diseases.
Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.

The research aims of this study are:

1. To further explore differences in a modified selection of patient-reported outcome measures (PROMs) and (as a new addition in APPROACH-IS II) explore differences in patient-reported experience measures (PREMs), by enrolling adults with congenital heart diseases in low, middle, and high income countries and including new potential explanatory variables ("Part 1").
2. To explore the profile and healthcare needs of a subgroup of older adults with congenital heart disease, with a particular focus on investigating the frailty phenotype ("Part 2").

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with congenital heart disease, defined as: "a gross structural abnormality of the heart and/or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and complex heart defects)"
* Aged 18 years of age or older at the moment of study inclusion
* Diagnosed with congenital heart disease before the age of 10 years
* Follow-up at an ACHD center or included in a national/regional registry
* Physical, cognitive, and language abilities to complete self-report questionnaires

Exclusion Criteria:

- Prior heart transplantation
A Study Evaluating the Safety and Tolerability of QRL-201 in ALS

The primary objective of this study is to determine the safety and tolerability of multiple doses of QRL-201 in people living with ALS

This first-in-human, Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of QRL-201 administered intrathecal (IT) to participants with Amyotrophic Lateral Sclerosis. Two dose escalation cohorts of 8 participants each, followed by an additional 48 participants, receiving the study drug in a 6:2 ratio of QRL-201 to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 18 to 80 years diagnosed with ALS
* ALS symptom onset within 24 months of Screening
* Slow vital capacity \>50%
* Clinical or electrodiagnostic evidence of lower motor neuron involvement
* Not pregnant and not nursing
* Willing and able to practice effective contraception
* Able to tolerate lumbar puncture
* If on approved therapies for the treatment of ALS during the course of the study, must be on a stable dose (at the Sponsor's discretion)

Exclusion Criteria:

* Pathogenic variant, likely pathogenic variant, or variant of uncertain significance in the superoxide dismutase 1 (SOD1) and/or fused in sarcoma (FUS) genes
* Currently enrolled in any other clinical study involving either an investigational product (IP) or off-label use of a drug or device
* Prior exposure to stem cell or gene therapy products
* Any contraindication to intrathecal drug administration
* Abnormal laboratory values deemed clinically significant by the Investigator
* Significant infection or known inflammatory process
* Any sign and/or history of neurological conditions and other neuromuscular disorders that could affect the electrophysiological recordings.
* An EEG that shows signs of abnormal electrical activity (e.g., epilepsy)
Internet-based Self-help for Tinnitus: The Role of Support

Internet-based cognitive behavioural self-help (iCBT) has become increasingly popular to provide psychotherapy. For several psychological and psychosomatic disorders, treatment efficacy was shown. Previously, iCBT has also been applied to patients suffering from tinnitus and results show significant and long-term stable improvements in tinnitus distress. However, the role of therapeutic support in iCBT has not been thoroughly investigated. Previous results suggest that iCBT without therapeutic support is less effective and leads to higher dropout rates than therapist-guided iCBT. The aim of the randomized controlled trial is thus to investigate the role of therapeutic support in an iCBT for tinnitus sufferers.


Eligibility Criteria:
Inclusion Criteria:

* tinnitus duration of more than 6 months
* severe or most severe tinnitus distress
* age of at least 18 years
* fluent in German

Exclusion Criteria:

* psychosis, severe psychological disorder, risk for suicide
* prior participation in associated study
* medical disorder as reason for tinnitus, i.e. morbus ménière
The Application of Multimodal Artificial Intelligence Systems in Prostate Cancer Diagnosis and Prognosis Analysis

The application of multimodal data fusion in prostate cancer will bring new opportunities to improve diagnostic accuracy and treatment outcomes. By integrating imaging, genomics, pathology, and clinical data, we expect to realize precision medicine for prostate cancer and significantly improve the survival prognosis of patients.

Prostate cancer stands as one of the most prevalent malignancies among men across the globe. Global cancer statistics reveal that the number of new prostate cancer diagnoses rises annually.

In recent years, the advent of multimodal data fusion technology has paved the way for innovative diagnostic and prognostic approaches in prostate cancer. For instance, the synergy of MRI imaging with clinical indicators such as PSA levels and Gleason scores not only refines the staging of prostate cancer but also sheds light on a patient's likely response to treatment and survival outlook.

The exponential growth of artificial intelligence, particularly the broad adoption of deep learning and machine learning algorithms, has emerged as a formidable asset in the realm of multimodal data analysis. By developing an AI-driven multimodal data fusion system, vast medical datasets can be efficiently processed, laying the groundwork for a more nuanced auxiliary diagnostic and therapeutic decision-making framework.

Eligibility Criteria:
Inclusion Criteria:

1. Male, 18-80 years of age;
2. Patients with normal prostate, prostatic hyperplasia, or prostate cancer who have undergone a prostate or pelvic magnetic resonance (MR) examination;
3. First visit on January 1, 2014 or later.

Exclusion Criteria:

1. Patients with a diagnosis of any other malignancy within the previous 5 years;
2. Patients who have undergone transurethral resection or enucleation of the prostate prior to undergoing imaging;
3. Patients who are not suitable for participation in this clinical trial in the judgment of the investigator;

Patients who meet any of the above criteria may not be enrolled as subjects.
Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers

To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound

This is a randomized, split-face, subject-blinded, comparative study to assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound.

This study is designed to enroll and randomize approximately 15 subjects in a 1:1 ratio of treatment to Restylane Contour or Juvederm Voluma. All subjects are to have midface volume loss and contour deficiency.

Eligible subjects are randomized to receive treatment were injected by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator and subject.

At the 4-week visit, after all study procedures for the visit are completed, treated subjects have the option of receiving a touch-up treatment to achieve optimal aesthetic improvement. At the 6-month, 9-month, and 12-month visits, similar study procedures are performed.

Eligibility Criteria:
Inclusion Criteria:

* Subject with midface volume loss and contour deficiency
* Ability of giving consent for participation in the study
* Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments

Exclusion Criteria:

* History of allergy or hypersensitivity to lidocaine and/or injectable hyaluronic acid
* Previous permanent or semi-permanent implant in proposed treatment area
* Previous biodegradable tissue augmentation therapy in the proposed treatment area within 12 months prior to the baseline visit
* History of other facial treatment/procedure at the study area (midface) in the previous 6 months that would potentially interfere with study injections (e.g., facial surgery, oral surgery, resurfacing, mesotherapy, lipolytic injections, botulinum toxin injections)
Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

The study will investigate the effects of Metformin and Topiramate prescribed at 4 weeks post-surgery on overall weight loss at 6 months post-surgery. The investigators will study patients who, based on current diagnoses and medication regimens, could be expected to benefit the most by taking a medication to facilitate additional post-surgery weight loss. Patients scheduled to undergo laparoscopic sleeve gastrectomy (LSG) at Hartford Hospital's Bariatric and Metabolic Surgery Program will be screened, consented and enrolled in the study. Prior to surgery patients will be randomized to either pharmacotherapy or no pharmacotherapy following LSG. For those randomized to receive pharmacotherapy, medications will be initiated at 4 weeks, as this is the estimated time post-LSG at which patients advance from a liquid diet to soft foods allowing medications to be better tolerated. Once randomly assigned to the medication group, patients will receive Metformin or Topiramate based upon physician judgment and medical history. Dosages will not be adjusted during the course of the study. The primary outcome will be % total body weight loss (%TWL) at 6 months following surgery, as the majority of the weight loss after LSG occurs during the first 6 months. Data collected through up to 12 months will be analyzed. The %TWL for both arms of the study will also be assessed at 8 weeks, 16 weeks, and 9 months and one-year post-LSG. Resolution of comorbidities will be noted.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for sleeve gastrectomy as primary bariatric treatment

Exclusion Criteria:

* Qualified for Roux en Y gastric bypass
* On FDA approved weight loss medications prior to bariatric surgery
* Required to continue Topiramate, Zonisamide, and Buproprion for other chronic diseases after bariatric surgery
* On Metformin, Dulaglutide, Exenatide, Exenatide Extended Release, Liraglutide, Empaglifozin, Canaglifozin, Dapaglifozin, Buproprion, Zonisamide, and Topiramate, prior to surgery.
* Have had lap band or other prior bariatric surgery
* Glomular filtration rate \< 45
* Over 70 years old
* Not fluent in English
Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India

This project aims is to monitor the effectiveness of HPV vaccination in real-word conditions, at least 7 years after initiation of HPV vaccination in Sikkim. This study would give an opportunity to provide rapid feedback to the Indian public health authorities about the impact of the HPV vaccine.

The investigators would like to estimate the prevalence of HPV infections based on cervical samples collected from the Sikkimese women aged 18 to 22 years at baseline (i.e. when the study participants are expected to have no benefit of vaccination) and seven years after the launch of the HPV vaccination programme, by which time the initial vaccinated cohorts will be aged 18 to 22 years and many of them will be sexually active. If the vaccination programme continues with the current high coverage rate, the cohort of women in the second age group are expected to be protected due to herd immunity, irrespective of whether any individual woman receives the vaccine or not. Overall effectiveness to protect women aged 18-22 years against targeted and non-targeted HPV infections will be monitored through repeated cervical sample -based surveys.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 22 years, resident of Sikkim and married.
* Pregnancy will not be considered as exclusion criteria.
* Sample collection should be avoided during active menstruation.

Exclusion Criteria:

* Women who do not provide written consent
* Women who are not able to cooperate in collection of cervical cell sample or respond to questions due to any acute or severe mental and physical illnesses.
* Women who had undergone hysterectomy.
* Vaccinated in research project
The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery

The purpose of this study is to determine whether ERAS is safe and can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery.

The key factors that keep a patient in hospital after uncomplicated major colorectal surgery include the need for parenteral analgesia(persistent pain), intravenous fluids (persistent gut dysfunction), and bed rest (persistent lack of mobility). These factors often overlap and interact to delay return of function. Obviously, postoperative complications will also prolong the time until recovery and ultimately length of stay. A clinical pathway, called Enhanced Recovery After Surgery(ERAS), to accelerate recovery after colonic resection based on a multimodal programme with optimal pain relief, stress reduction with regional anaesthesia, early enteral nutrition and early mobilisation has demonstrated improvements in physical performance, pulmonary function, body composition and a marked reduction of length of stay.

Comparison(s): A total of 500 cases colorectal surgery were randomized to receive ERAS protocol or the traditional protocol, such as mechanical bowl preparation, intravenous fluids until bowl movement recovery and bed rest.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal surgery patients
* Age 20～80
* Without comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction

Exclusion Criteria:

* Emergency
* Combined other organ resection
* Age \> 80
* Comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction
Comparison of Two Different Insole Types in Painful Flexible Flatfoot

The purpose of this study is to compare computer aided design/computer aided manufacturing (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and also to decide whether they are necessary in treatment of painful flexible flatfoot.


Eligibility Criteria:
Inclusion Criteria:

* minimum subtalar pronation of 5 degrees while standing (tibiocalcaneal angle, measured with goniometer),
* minimum of + 6 points on the foot posture index,

Exclusion Criteria:

* treatment of the foot for at least six months,
* leg length discrepancy of more than 1 cm,
* history of lower extremity surgery, and no disease that could affect lower extremity biomechanics.
Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism

This protocol is primarily looking to see if the IL-4Ra R576 polymorphism is associated with increased clinical, immunological and microbial markers of disease activity in patients with Atopic dermatitis.

For this study, participants ages 6-65 years, who have atopic dermatitis and don't have any of the exclusion criteria will be invited to participate in the study. There will be a 1 time visit where questionnaires, blood draw, skin swab and skin biopsies will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants ≥6 to 65 yrs of age
2. Meet AD Standard Diagnostic Criteria

Exclusion Criteria:

1. Enrollment in another clinical trial
2. Hypersensitivity to an agent used for the skin decolonization protocol
3. Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, JAK inhibitors, azathioprine, methotrexate)
4. Phototherapy for AD within 4 weeks
5. Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks
6. Use of topical steroids, topical calcineurin inhibitors or crisaborale within 7 days
7. Bleach baths within 7 days of the first Visit
8. Use of oral or topical antibiotics within 21 days of the beginning of the study
9. Asthmatics receiving more than 500 μg per day of inhaled corticosteroids
10. History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy
11. Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,,
12. Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease.
13. Febrile illness at time of visits
14. Suspected immune deficiency or family history of primary immunodeficiency