cyrilzakka/clinical-trials huggingface dataset:
RE104 Safety and Efficacy Study in Postpartum Depression

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo.


Eligibility Criteria:
Inclusion Criteria:

* Is ≤15 months postpartum at Screening.
* Meet DSM-5 criteria for postpartum depression (PPD): experiencing a major depressive episode that began at any time starting at the beginning of the second trimester (≥14 weeks) of pregnancy through 4 weeks post delivery.
* Has a Hamilton Depression Scale (HAM-D) total score meeting severity threshold at Screening and Baseline.
* Is not using any psychotropic medications or psychotherapy for 30 days prior to Screening, OR are on an already stable/established regimen of SSRIs or psychotherapy for 30 days prior to Screening.
* Has ceased breastfeeding at Screening.
* Has a negative pregnancy test at Screening and Day 0 prior to study drug administration.

Exclusion Criteria:

* History or active postpartum psychosis per Investigator assessment.
* History of treatment-resistant depression within the current postpartum depressive episode.
* Has a significant risk of suicide.
* Active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder.
* Medically significant condition rendering unsuitability for the study .
* Has received electroconvulsive therapy (ECT) or transcranial magnetic stimulation within 90 days prior to Screening.
* Has used psychedelics such as psilocybin, ayahuasca, mescaline, or LSD (with the exception of cannabis) within 12 months prior to Screening.
* Has used or will need to use prohibited medications.
S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues

Surgical site infections (SSI) are a significant clinical issue that requires the use of a great amount of resources. In particular, periprosthetic joint infections (PJIs) have potentially catastrophic effects on patients' health-related quality of life, function, healthcare costs, outcomes and medical implications. National surveillance estimates may under-report the true incidence and when considering the large number of total hip (THA) and total knee arthroplasty (TKA) procedures performed each year.

Patients who have a high-level of nasal bacteria have been found to have a risk of surgical site infection that is three to six times the risk compared with noncarriers and low-level carriers. The association between a patient's nasal carriage of S. aureus, specifically MRSA, and PJI has been demonstrated in a systematic review and confirmed in recent cohort studies. While this association seems to be well accepted, no mechanistic explanation has been provided for this association.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing revision total knee or total hip arthroplasty at our institution will be eligible

Exclusion Criteria:

* Patients included in other prospective studies
Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites

This study evaluates the effectiveness of a minimally invasive treatment, consisting of partial polymer-infiltrated-ceramic-network (PICN) restorations, used in case of rehabilitation of advanced and generalized dental wear over a period of 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting advanced and generalized worn dentition
* All the posterior teeth (minus 2) present wear
* All the anterior teeth (tooth n°13 to n°23) need palatal veneers

Exclusion Criteria:

* More than one missing tooth on each mandible
* Patients with crown(s), bridge(s) or implant(s)
* Patients with non-stabilized parodontite
* Smoker
* Patients suffering from :

  1. Parkinson's Disease
  2. Severe osteoarthritis
  3. Spontaneous pain in the temporomandibular joints, shift of the mandible and an opening limit (25 mm)
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability
Pre-Anesthesia Visit: Analysis of Coverage Rate of Visit Content and Surgical Patients' Understanding of Information

The aim of this study was to systematically assess the coverage of anesthesiology residents' explanations of the content of the visit during the preoperative anesthesia visit and the patients' understanding of the content of the anesthesia approach through the physician's explanations.

Physician Component:

In order to minimize the change of the interview content due to third-party supervision, the collected data were analyzed in the form of a questionnaire about the content of the visit after the preoperative visit by anesthesiology residents, including the main content of the visit, the duration of the visit, and the presumed level of patient's understanding of the anesthesia informed consent form.

Patient section:

To investigate the degree of patients' understanding of the contents of the anesthesia visit after listening to the visit. A questionnaire was used to collect the data, which included the content of the visit that the patients could recall, their level of understanding of the content explained by the physician, their concerns, and suggestions for improvement that could be taken to promote patient understanding.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Patients who have not previously undergone surgery under general anesthesia
* Patients undergoing laparoscopic cholecystectomy or laparoscopic appendectomy

Exclusion Criteria:

* Subjects who do not wish to participate in this study
* Patients with visual or auditory impairment
* Patients who are completely unable to understand the content of the communication or have communication difficulties
Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions

Adolescence and young adulthood is a critical period for the development of social anxiety, which is often linked to other mental health challenges such as depression, mood disorders, and substance abuse. Initial evidence suggests that interacting with animals can reduce stress and anxiety, but no research has tested whether this benefit extends to adolescents at risk for social anxiety disorder. Additionally, researchers and clinicians do not understand what mechanism is responsible for anxiety reduction in animal-assisted interventions (AAIs). Therefore, the objectives of this study are to explore the specific mechanisms by which interacting with a therapy dog reduces anxiety, and to test whether such an interaction reduces anxiety in adolescents with varying levels of social anxiety.

The specific aims of this project are to (1) test the mechanisms by which AAIs reduce anxiety, and (2) determine if the anxiolytic effect of social and physical interaction is moderated by level of pre-existing social anxiety. To achieve these aims, 75 adolescents (age 13-17) will undergo a well-validated laboratory-based social evaluative stressor, the Trier Social Stress Task for Children, and be randomly assigned to one of three conditions: 1) no interaction with a dog (control condition), 2) social interaction only (no physical interaction) with a therapy dog; or 3) social interaction plus physical interaction with a therapy dog. Using a multivariate approach, three levels of outcome data will be collected: a) self-reported experience (anxiety), b) autonomic physiology (heart rate), and c) behavioral performance (error rates on mental math task). In addition, the interactions will be videotaped and behavioral coding will be used to explore the specific social behaviors between the participant and the dog that may predict anxiety reduction (such as frequency or type of social referencing or physical contact).

Eligibility Criteria:
Inclusion Criteria:

- Low, mid-range, and high levels of social anxiety

Exclusion Criteria:

* Fear of dogs
* Allergy to dogs
Efficacy and Tolerance of Naked DNA Vaccine in Patients With Chronic B Hepatitis

The purpose of this study is to determine if DNA vaccination of chronic HBV patients under treatment with NRTI can restore T-cell responsiveness and delay virologic reactivation after treatment discontinuation.

Despite the availability of effective vaccines against hepatitis B, over 370 million people worldwide remain persistently infected with HBV. Persistent infection is associated with chronic liver disease that can lead to the developement of cirrhosis and hepatocellular carcinoma in two-third of persons. Treatment of chronic hepatitis B relies on the use of analogs such as lamivudine, adefovir, entecavir or immunostimulators such as interferons. Although analogs are efficient, genotypic resistance occurs after one year of treatment and the rate of virologic relapse is high after treatment discontinuation.

HBV is a non cytopathic virus and liver damage is caused by immune response against infected hepatocytes and to a non specific inflammatory response. Immune response contributes to the virus clearance. In acute hepatitis B infection, T cell response is polyclonal, specific and vigorous, whereas in patients with chronic infection, responses remain weak, less specific and hardly detectable in peripheral blood.

T cell responses could be induced or restored by antigenic stimulation such as vaccination. In a previous phase I clinical trial, we showed that DNA vaccination with plasmid pCMVS2.S is safe and can specifically, but transiently activate T-cell responses in chronic HBV-carriers not responding to current antiviral therapies.

Analogs such as lamivudine and adefovir were shown to enhance T cell responses concomitantly with viral load decrease. In this phase I/II clinical trial, we would like to determine if DNA vaccination of chronic HBV patients under treatment with NRTI can restore T-cell responsiveness and delay virologic reactivation after treatment discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis B with or without AgHBe
* no cirrhosis and no hepatocellular carcinoma
* treatment with NRTI unchanged for at least 3 months
* undetectable HBV viral load for 12 months
* HBV viral load \< 12 IU/ml at screening
* sGPT \< 5N
* tetanus immunization or booster dose for less than 8 years
* accurate birth control or menopausal women or sterility
* sickness insurance
* signed informed consent

Exclusion Criteria:

* HLA-DR 15/16
* coinfections with HDV, HCV and/or HIV
* treatment with immunomodulators
* immunosuppressors
* long-term corticotherapy (over 4 weeks)
* active intravenous drug-users
* prolonged and excessive consumption of alcohol (men \> 40g/day ; women \> 30g/day ; for more than 5 years)
* medical history of autoimmune disease or presence of autoantibodies
* previous immunization by HBV vaccine of less than 5 years
* previous immunization by DNA vaccine against HBV
* personal or family medical history of demyelinising diseases
* uncontrolled hypophosphatemia
* renal failure, renal transplantation, haemodialysis
* pregnancy, breast-feeding
The Vertebral Vector in a Horizontal Plane. A Simple Way to See in 3D.

The diagnosis and classification of scoliosis are almost exclusively based on frontal and lateral radiographs. Current classifications of adolescent or adult idiopathic degenerative scoliosis are based only on the 2D approach. The classifications consider only the lateral deviation and the sagittal alignment and completely ignore all the changes (the axial vertebral rotation and the lateral translation etc ...) in the horizontal plane.

The demand for an accurate assessment of the vertebral rotation in scoliosis is not new. Biplane x-ray images provide insufficient quantitative or qualitative information on the anatomical landmarks needed to determine axial rotation. Several measurement methods have been published, all of which are based on the evaluation of the relative positions of various posterior vertebral elements. The Perdriolle torsiometer is currently the most accepted method in clinical practice, but its reproducibility is very limited and can not be quantified accurately.The horizontal plane deviations are more accurately evaluated by the CT scan, but the systematic use of this method is limited because of its relatively high cost and excessive radiation dose. Expert opinion is also divided on the veracity and reproducibility of CT scan for such measurements.

Given the absence of a definitive and reproducible measurement method for 3D characterization of the vertebral columnar deformities, the investigators introduced the concept and system of vertebral vectors.The vertebral vector technique is currently the only technique in the world that allows the visualization of vertebral column deformities by analyzing each vertebral body and defining characteristic mathematical and geometric parameters that uniquely characterize each vertebrae. A new digital radioimaging technique based on a low dose X-ray detection technology simultaneously creates frontal and lateral whole body radiographic images captured in a standing position, which is the basis of visualization of the vertebral vector.

To examine the two phenotypes of scoliosis, it is necessary to collect the radiological data specific to the disease. After generating the vertebral vectors and obtaining the three-dimensional coordinates, an analysis and an exact mathematical description will be performed. The projections of the curves in the three planes will also be analyzed, with particular attention to the projections in the horizontal planes. Based on the mathematical models and the axial projection of the curves, a new three-dimensional classification can be imagined for the first time not only for adolescent scoliosis, but also for adult degenerative scoliosis.

The main objective of this study is to develop new evidence-based treatments based on the unambiguous understanding of 3D features of vertebral columnar deformities.


Eligibility Criteria:
Inclusion Criteria:

Patients with adolescent idiopathic scoliosis or adult degenerative scoliosis, treated or untreated, radiographed with the EOS system

Exclusion Criteria:

None
Translation and Verification of English Lysholm Knee Scoring Scale

Through the translation and verification of the Lysholm Knee Score Scale, a Chinese version of the Lysholm Knee Score Scale supported by experimental data was obtained. And on this basis, explore the knee joint score scale that fits the Chinese situation

Lysholm Knee Scoring Scale needs to be translated and back translated into Chinese version of Lysholm Knee Scoring Scale. Through data collection and analysis, the reliability, validity and sensitivity of the Chinese version of the Lysholm Knee Score Scale were studied, and on this basis, the advantages and disadvantages of the scale were analyzed, and a new knee score scale was developed based on the domestic situation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ruptured ligaments, dislocation of the patella, meniscus injury or total knee replacement before and after surgery, and have the ability to read or communicate with others normally.

Exclusion Criteria:

* Patients with other injuries to the joints of the lower limbs, or patients who do not have the ability to read or communicate with others normally.
Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer

The purpose of this study is to treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Docetaxel may have similar efficacy and more favorable treatment related toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with advanced or recurrent endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed chemotherapy naïve endometrial cancer
* One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed
* FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT)
* At least one measurable lesion by RECIST on CT
* ECOG PS: 0-2
* Age: 20-75
* Adequate organ function BM: ANC≥1,000/mm3, Plt≥100X103/mm3 Kidney: Creatinine\<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT\< 3×UNL, T- bil\<1.5 mg/ mm3
* Informed Consent
* Contraception during study period

Exclusion Criteria:

* Previous chemotherapy
* RT, hormone therapy, or immunotherapy within 1 month
* Other malignant disease
* Uncontrolled medical disease
* Infection requiring antibiotics
* Symptomatic CHF, RF, Angina, Arrhythmia, etc.
* Neurosis or psychosis
* Pregnancy, breast-feeding
* Etc.
Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor

The study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor performance and on maternal fetal well-being.


Eligibility Criteria:
Inclusion Criteria:

* Written maternal informed consent
* Singleton pregnancy
* Gestational age ≥ 37 weeks,
* ASA I
* BMI \< 30
* fetus in cephalic presentation

Exclusion Criteria:

* Suspect or certainty of fetal malformation,
* Presence of conditions such as preeclampsia, multiparity, preterm labor
* History of adverse reaction to α-2 adrenergic agonists
* Nicotine addiction
* Chronic use of opioid
Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life outcomes when compared to a second type of food supplement (corn-soy-blend) over the course of 12 months of food supplementation.


Eligibility Criteria:
Inclusion Criteria:

* documented to have HIV infection by standard laboratory procedures
* live in the geographic catchment area of PIH services where study is taking place
* 18 years of age or older
* started antiretroviral therapy for HIV in the 24 months prior to study enrollment

Exclusion Criteria:

* if another household member is also eligible for food assistance
* if subject is pregnant at the time of enrollment
* if unable to give informed consent
Adaptation of STEPPS Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers

The overall objective of this study is to assess the feasibility, within the Penitentiary Centers of Catalonia, of adapting the STEPPS program for addressing and preventing emotional dysregulation and self-harming behaviors through an implementation study.


Eligibility Criteria:
Inclusion Criteria:

* Men or women deprived of liberty serving sentences in a penitentiary center in Catalonia.
* Presence of self-harming behaviors.
* Sufficient understanding and proficiency in Spanish to participate in the STEPPS program.
* Sufficient cognitive competence for study participation.
* Mental capacity to provide informed consent.

Exclusion Criteria:

* Inmates under security measures or classified in the first degree of treatment.
* Inmates with language difficulties.
* Presence of severe pathologies that may hinder study participation.
* Inmates with the possibility of imminent release, impending transfers to other penitentiary centers, or pending trial.
Personalized Insemination Treatment Study

This study is intended for women undergoing their first cycle of 3 intrauterine inseminations. All 3 inseminations will be personalized by using algorithms to determine the dose of study medication.

Study medication dosage for the first insemination cycle will be based on the woman's age as well as her Anti-Mullerian Hormone (AMH) levels.

Study medication dosage for the second and third insemination will depend on ovarian response (number of follicles) during previous insemination cycle and woman's age

Eligibility Criteria:
Inclusion Criteria:

* Women having consented to the study
* Women followed at fertility center
* First IUI cycle
* Women between the ages of 18 to 42 inclusively at time of consent form signature
* AMH \< 35 pmol/L (4.9 ng/mL) in participants' file in the last 24 months
* At least one permeable Fallopian tube confirmed by laparoscopy, hysterosalpingography (HSG), hysterosalpingosonography (HSSG) or one pregnancy in the last 3 years
* Insemination with either partner or donor sperm
* Male partner semen analysis considered adequate for IUI in accordance to the centre's standard practice
* Menstrual cycles from 26 to 39 days
* Presence of both ovaries

Exclusion Criteria:

* Unable to consent
* Body weight \>100 kg
* AMH ≥35 pmol/L (4.9 ng/mL) in participants' file in the last 24 months
* Severe malformation (unicornuate or bicornuate uterus) or uterine anomaly including fibroids ≥ 5 cm
* Uncontrolled thyroid or adrenal dysfunction
* Pituitary tumour
* Persistent ovarian cysts or enlargement not due to PCOS (Polycystic ovary syndrome) \> 3 cm
* Anovulatory women
* Use of contraceptives in the last 3 months prior to start of stimulation
* Diagnosis of hydrosalpinx
* Malignancies
* Breast pathology incompatible with gonadotropin stimulation
* Hypersensitivity to follitropin delta or to any ingredient in the formulation
* Addition of other infertility medication that can influence follicle stimulation and maturation such as growth hormone (GH)