cyrilzakka/clinical-trials huggingface dataset:
VR-based Avatar Therapy for Treatment of Auditory Hallucinations

The primary aim of this study is to evaluate the safety and efficacy of AVATAR therapy, developed to address residual auditory hallucinations persisting despite medication in schizophrenia spectrum disorder. The intervention aims to reduce the intensity and frequency of these symptoms, as well as alleviate associated depressive and anxiety symptoms, using a virtual reality (VR)-assisted intervention developed for this purpose by the Danish company HEKA VR. The study will be a pre-post non-invasive, waiting list-controlled study, enrolling 30 patients from three clinical sites (Hungary, Spain, Poland).

The study centers around administering therapy based on VR over a 12-week period, comprising a total of 7 sessions. These sessions are conducted individually and last 50 minutes each. The psychotherapist leading the sessions adheres to a strict protocol defined by the method's developers.

During the intervention, VR technology is used to simulate the source of distressing auditory hallucinations. The therapist facilitates coping with these experiences externalized in this way through simulated conversations, supporting the development of more adaptive responses.

Patients undergo a comprehensive cross-sectional evaluation of their condition before and after the intervention, including assessments of symptom severity, quality of life, and their experience with the method. The intervention is conducted with constant monitoring for possible adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia spectrum disorder according to DSM-5,
* Age 18 or older,
* The fluent use of the spoken language at the site (Hungarian/Spanish/Polish),
* Informed consent provided by the patient or their caregiver after being informed about the research procedure
* Stable medication dosage for at least 4 weeks prior to recruitment,
* Regular psychiatric follow-up,
* Experience of auditory hallucinations for at least three months (PANSS hallucination score of at least 3 points),
* Meeting the remission criteria described by Andreasen, except for the score related to auditory hallucinations

Exclusion Criteria:

* Inability to identify a single dominant voice that is the subject of the intervention,
* Lack of cooperation,
* Intellectual disability based on medical history,
* Regular substance abuse
* Central nervous system injury or neurological disease that affects cognitive performance,
* Suicidal risk
* Aversion to virtual reality,
* Severe visual impairment
Tranexamic Acid in Breast Esthetic Surgery.

The investigators prepared a novel tranexamic acid (TXA) study designed to estimate the quantity of blood loss in patients undergoing breast esthetic surgery. This study aims to quantify blood loss during abdominoplasty with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in breast esthetic surgery patients.

Tranexamic acid (TXA) treatment is increasingly emphasized in plastic surgery because TXA inhibits fibrinolysis. Increased clot stability offers the possibility of preventing blood loss (prevention) and mitigating ongoing hemorrhage. TXA therapy has been principally studied in populations; the results of studies in plastic surgery still need to be improved.

Tranexamic acid is an antifibrinolytic agent that acts as a competitive inhibitor at the lysine binding sites of plasminogen and inhibits the ability of protease plasmin to cleave the fibrin clot. In large randomized controlled trials, it has been reported to be effective in decreasing perioperative blood loss in various circumstances, primarily involving trauma patients.

The investigators designed a randomized placebo-controlled trial comparing TXA dosing before incision for breast esthetic surgery. The purpose is to quantify blood loss during plastic surgery with and without TXA.

Eligibility Criteria:
Inclusion Criteria:

* women scheduled for breast esthetic surgery
* ASA 1 or 2
* age \>18 and \<75 years

Exclusion Criteria:

* BMI \<20 or \>35 kg/m2
* ASA 3 or \> 3
* medical history of thromboembolism
* history of hematological disease
* treatment with aspirin 14 days before the procedure
* treatment with anticoagulants 5 days before the procedure
* epilepsy
* allergy to tranexamic acid
* coagulation disorders
Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI)

Thrombotic event is one of the most serious complications of coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice

The aim of this multicenter prospective, randomized, controlled study is to observed policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after Percutaneous Coronary Stent Implantation (PCI) and occurrence of platelet aggregation and short-term prognosis to find new ways to the prevention of platelet aggregation .

Thrombotic event is one of the most serious complications in coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary heart disease and had received coronary stenting
* high on-treatment platelet reactivity defined as an ADP-induced platelet aggregation (by LTA)\> 65% at 24 hr after clopidogrel loading (300 \~ 600mg)or 5 days after maintenance dose treatment (75mg / d)
* Informed Consent

Exclusion Criteria:

* receiving GP IIb / IIIa receptor antagonist treatment within 24h before enrollment
* using cilostazol within 7d before enrollment
* aspirin, clopidogrel or policosanol allergies
* NYHA grade III \~ IV
* planned elective coronary revascularization for multivessel coronary artery disease
* long term warfarin treatment after persistent atrial fibrillation, valve surgery or other circumstance
* Severe liver or kidney dysfunction
* Active ulcer or a history of recent gastrointestinal bleeding
* History of coagulation disorder, or recent history of active bleeding
* history of intracranial hemorrhage within 6 months
* Pregnancy
* LDL less than 70mg/dL
* Severe systemic diseases with life expectancy less than 1 year
* planned surgery within next 6 months
Morphofunctional Lung Analysis by Positron Emission Tomography

Patients affected by acute lung injury-acute respiratory distress syndrome (ALI-ARDS) undergo a positron emission tomography (PET) scan in order to analyse lung function.


Eligibility Criteria:
Inclusion Criteria:

* Ali-ards
* Age \> 18yrs

Exclusion Criteria:

* COPD
An Implementation and Biobehavioral Study of Temporomandibular Joint and Muscle Disorder (TMJMD)

With the great economic costs and traditionally poor outcomes among chronic temporomandibular joint and muscle disorder (TMJMD) patients, it has become important to treat patients in the acute state, in order to prevent these more chronic disability problems. This has been the goal of two past funded grant projects. Results of the initial project isolated risk factors that successfully predicted the development of chronicity with a 91% accuracy rate. A statistical algorithm was developed which was used in the second project to screen out "high-risk" patients. These patients were then randomly assigned an early intervention or non-intervention group. One-year follow-up evaluations documented the treatment efficacy and cost effectiveness of early intervention. These results have major implications for effective early intervention and significant health care cost savings for this prevalent pain and disability problem. For the present proposed project, we plan to implement this treatment program in order to evaluate its effectiveness in more community-based dental practices. This is in response to NIH's request for the implementation of evidence-based treatment approaches, developed in controlled clinical settings, to the "real world" of diverse practices in the community. Acute TMJMD patients will be recruited from two community-based clinics. Based upon our "risk" screening algorithm, high-risk patients will be randomly assigned to one of two groups (n=225/group): an early biobehavioral intervention or an attention-control group. It is hypothesized that the attention control "high-risk" patients will display more chronic TMJMD problems, relative to the "high-risk" early intervention patients, at one- and two-year follow-ups. A number of biopsychosocial measures will be evaluated, including chewing performance, the RDC/TMD, self-reported pain and stress, etc. Such a multi-level, multi-systems approach has not been applied to better understand the biopsychosocial underpinnings of TMJMD. Results from this component of the project will greatly aid in stimulating future research leading to the better understanding of TMJMD, as well as better tailoring of prescribed treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* Subject Must be an Adult Aged 18 or Older.
* Subject's First Acute Jaw Pain/Discomfort Episode Must Have First Developed Within the Last 6 Months

Exclusion Criteria:

* Younger than 18 years of age
* TMD pain/discomfort of greater than 6 months' duration
Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy

Objective: To compare the occurrence and intensity of pelvic pain as well as patient satisfaction and quality of life after total laparoscopic and laparoscopic supracervical hysterectomy.

Design: Prospective randomised trial.

Null hypothesis 1: There is no significant difference in occurrence and intensity of pelvic pain following TLH compared with following LSH.

Null hypothesis 2: There is no significant difference in patient satisfaction and quality of life following TLH compared with following LSH.

Sample: 62 consecutive premenopausal women referred to the department for hysterectomy on the basis of a benign condition. The expected mean pain reduction (m) in the LSH group: 3.32, sd (s): 2.71.24 A difference in mean pain reduction (d) equal to 1 sd is considered a clinically important improvement (standardised difference d/s=1). Number of women required (power 90 % and a level of significance 0.05): 62 patients.

Methods: The study participants are randomised to total laparoscopic hysterectomy (n = 31), or laparoscopic supracervical hysterectomy (n = 31).

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women who are referred to the department
* benign condition requiring hysterectomy
* Dysmenorrohea/cyclic pelvic pain
* Informed consent

Exclusion Criteria:

* Women who are unable to communicate in Norwegian language.
* Women with a previous history of cervical dysplasia, with cellular changes suggestive of dysplasia in preoperative cervical smear.
* Women with atypical hyperplasia or malignancy in preoperative endometrial biopsy.
* Women with a substantially enlarged uterus requiring abdominal hysterectomy or not suitable for TLH (\> 12 week amenorrhea).
* Women with a concomitant condition requiring uni- or bilateral oophorectomy.
* Postmenopausal women.
* Women with no dysmenorrohea/cyclic pelvic pain (\<1 on a 10-point visual analogue scale).
* Women with deep infiltrating endometriosis.
US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma

The aim of this study is to investigate the incidence of intermetatarsal bursitis and Morton's neuroma in patients with metatarsalgia (i.e. pain in the forefoot) and control subjects by diagnostic imaging with ultrasound and MRI.

In a group of patients with intermetatarsal pain found by an orthopedic surgeon, the investigators want to assess the incidences of intermetatarsal bursitis and Morton's neuroma, using diagnostic imaging; ultrasound and MRI.

The hypothesis is, that intermetatarsal bursitis is an overlooked diagnosis in patients with metatarsalgia. As a result of sparse literature and lack of knowledge about this condition with symptoms mimicking Morton's neuroma, a part of patients diagnosed with Morton's neuroma, suffers from intermetatarsal bursitis instead.

Additionally, the investigators want to evaluate the clinical sign opening toes.

Based on clinical photos of the feet, the investigators want to document the presence of opening toes and investigate if there is a correlation with either intermetatarsal bursitis and/or Morton's neuroma.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Pain in an intermetatarsal space (patient group)

Exclusion Criteria:

* Age \<18 years
* Open wounds or ongoing infection in the forefoot at the time of examination
* Persons with contraindications to participate in MRI scan
* Persons with a history of significant trauma in the forefoot, e.g. any fracture or previous surgeries in the forefoot
* Persons who have previously received treatment for Morton's neuroma in the same foot, e.g. injection (within 6 months) or operation (anytime)
* Persons with severely impaired renal function (GFR \<30 ml/min)
* Persons with a systemic inflammatory condition like rheumatoid arthritis, due to clinically silent intermetatarsal bursitis in this group (control group)
Evaluation of the Prenatal Trip Assistance Pilot Project

The prenatal trip assistance project is a study comparing two methods of delivering transportation assistance to pregnant women living in communities with high rates of infant mortality. Franklin County, Ohio, home of the state's capital of Columbus, has one of the highest rates of infant mortality in the U.S. at 8.2 per 1,000 live births.There have been many advances in "smart" applications in transportation over the past 10 years. However, despite the fact that the vast majority of impoverished women have a mobile phone, the transportation providers currently used by the Medicaid managed care plans are low tech with no mobile alerts or two-way communication with the woman. The purpose of the proposed study is to examine the preliminary efficacy of providing expanded and "smart" transportation services to increase communications, reliability, and customer satisfaction and reduce adverse pregnancy outcomes among women whose children are at high risk of infant mortality. The investigators aim to enroll and randomize 500 eligible pregnant women to either on-demand services or usual transportation services as provided by their Medicaid managed care organization. The primary outcome for the proposed trial will be overall satisfaction with transportation services as assessed by the final study questionnaire (i.e., two months after delivery or miscarriage) and secondary outcome measures will include: adequacy of prenatal care, preterm birth and infant mortality.


Eligibility Criteria:
Inclusion Criteria:

* Willing to consent to communication by phone, text, and email
* Access to a telephone (mobile or landline), tablet or computer
* Pregnant \& \<32 weeks of gestation
* Last menstrual period on or before 2/9/2020 or due by November 15, 2020
* At least 18 years old
* Enrolled in one of two Medicaid managed care organizations
* Residence in Franklin County, Ohio
* Ambulatory
* English speaking

Exclusion Criteria:

* No plans to move out of Franklin County prior to delivery
* Able to read, understand, and communicate in English
* Woman has not been previously enrolled in this study
* Race/ethnicity stratum is not full
* Willing to meet staff to be interviewed
Dose-dependent Effects of Oxytocin on the Amygdala and Reward System

The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala and reward system responses vary as a function of treatment dose in women in comparison to men.

The objective of the present study is to determine whether intranasal oxytocin (IN-OXT) effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD fMRI) in the amygdala and striatal regions (putamen, nucleus accumbens, caudate, pallidum) vary as a function of dose. In particular, the investigators plan to compare effects of three different IN-OXT doses (6, 12, and 24 international units, IU) on established neural and behavioural correlates of emotion processing in women. Results will be discussed in comparison to a previous study of OXT kinetics in men.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers
* Right-handed
* Non-smoker

Exclusion Criteria:

* Current psychiatric or physical illness
* Hormonal contraception
* Psychoactive medication
* MRI contraindication (e.g. metal in body, claustrophobia)
* Pregnancy
Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics

The purpose of this study is to determine the effect of Semielevated Side-Lying (ESL) and Semielevated Supine Position (ESU) positions used in bottle-feeding of very preterm infants upon their physiological characteristics and feeding performances.

Semielevated supine position (ESU) is a position frequently used in neonatal intensive care units. In this position, infant is laid and fed on its back and the head is elevated to an angle of 45-60° in order to reduce the respiratory load of lungs. The ESL position, head of the infant is elevated to an angle of 45-60° and the infant is fed in the side-lying position. Since this position mimics the breast-feeding position, very preterm infants are supported to utilize the advantages of breast-feeding. A randomization was provided in the sample group consisting of totally 80 infants and while 38 infants were included in the ESL (experimental) group, 42 infants were included in the ESU (control) group.In the power analysis repeated at the end of the study, the power of the study was determined as 87% at a reliability of 95%.

Eligibility Criteria:
Inclusion Criteria:

* To be born between 26-31+6 gestational weeks according to mother's last menstruation date,
* To be between 32-39+6 postmenstrual weeks during the study,
* Have a body weight above 1500 g,
* Have a full enteral feeding,
* To be in a transition from orogastric catheter feeding to oral feeding for less than 24 hours,
* Have an oral feeding in this process for at least once,
* Tolerate at least 80% of amount of food given lastly during oral feeding,
* Voluntarily signing of the written informed consent form by parents

Exclusion Criteria:

* Infants suffering from craniofacial abnormalities like cleft palate,
* cleft lip and facial muscle paralysis; gastrointestinal, neurological and genetic disorders (necrotising enterocolitis, intracranial haemorrhage, periventricular leukomalacia, hydrocephalia, down syndrome, omphalocele, gastroschisis, short bowel syndrome etc.)
* moderate and severe bronchopulmonary dysplasia (BPD) (Jobe \& Bancalari, 2001)
* patent ductus arteriosus requiring surgical therapy were excluded from the study
Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays

The purpose of this study is to evaluate the effects of early intervention support sessions via video conferencing as an adjuvant option to motor development on infants at risk of neurodevelopmental delays or disorders.

The parents will be informed about the procedure and will be given a written informed consent in order to participate in the study. Then, the families will be randomized into one of two groups: standard treatment or telematic support. Both treatments in a 2-month period.

Eligibility Criteria:
Inclusion Criteria:

* Minor infants with a chronological or corrected age of 3 to 12 months and their parents attending physical therapy early intervention protocol at the Neuropediatrics and Neurodevelopment Unit of San Cecilio University Hospital in Granada.
* At risk of neurodevelopmental delays or disorders.
* Whose family has a cell phone with WhatsApp Application installed and internet to be able to carry out the telematic tests.

Exclusion Criteria:

* Independent walking children.
* Minor infants with diagnosis of neuromotor injury, visual and auditory sensory disorders or congenital anomalies.
* Infants with orthoses and/or prostheses.
* Children with health complications that enable the child's participation in the study.
* Not spanish-speaking parents.
Study of the Impact of Virtual Patient Designs on the Reasoning Pattern and Therapeutic Decision Making

There is a lack of evidence of the impact of the information provided in the introduction screen on the students diagnostic and therapeutic decisions. The reasoning pattern may also be altered if positive findings are provided to the student without an active request for it.

The results will be of importance when virtual patients are used for assessing students.

The problem-solving approach is found in virtual patient designs concerned with teaching clinical reasoning and diagnosis. Generally the student has to collect a range of information, usually from menus of possible history questions, physical examination, and lab tests, and make diagnostic and therapeutic decisions based on their findings. The information is not cued - the student have to decide what is relevant. An introduction screen is shown to the student when the virtual patient is initiated. Case author have used it differently - some entered a complete chief complaint and part of anamnesis findings while other have not disclosed anything about the patient. There is a lack of evidence of the impact of the information provided in the introduction screen on the students diagnostic and therapeutic decisions. The reasoning pattern may also be altered if positive findings are provided to the student without an active request for it.

The results will be of importance when virtual patients are used for assessing students.

Eligibility Criteria:
Inclusion Criteria:

* All the students enrolled in the comprehensive dentistry course at the time of the study (2007)
Diagnosis of Metastatic Tumors on 68Ga-FAPI-RGD PET-CT and Radioligand Therapy With 177Lu-FAPI-RGD

FAP and RGD are overexpressed in many tumor tissues. This study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177Lu-FAPI-RGD--a new dual-targeted 177Lu therapeutic drug for the first time in the world.

Fibroblast activation protein (FAP) and RGD are serine peptidase on the surface of tumor associated fibroblasts. It has special biological characteristics and stable genome. They are usually not expressed or expressed at a low level in the resting tissues of normal adults, but it is highly expressed in diseases related to tissue repair and matrix reconstruction,Receptor imaging with a single target also has some limitations in clinical application. For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. The dual-target molecular imaging based on FAP expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors and used to 177Lu PRRT. We'll try to assess the safety and therapeutic response to 177Lu-FAPI-RGD in patients with metastatic tumors in human.

Eligibility Criteria:
Inclusion Criteria:

* confirmed treated or untreated metastatic tumors patients;
* 68Ga-FAPI PET/CT and 18F-FDG PET/CT within two weeks;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance