cyrilzakka/clinical-trials huggingface dataset:
Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.

Prospective observational trial to assess immunological safety (anti-HLA antibodies, donor-derived cell-free DNA) and immunological effectiveness (anti-SARS-CoV-2 IgG) of the first booster dose of SARS-CoV-2 mRNA vaccines in kidney transplant recipients at least one year from transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients followed at Institute for Clinical and Experimental Medicine (IKEM)
* vaccinated with 2 doses of mRNA vaccine (BNT-162b2 or mRNA-1273)
* immunosuppressive regimen includes or does not include mycophenolic acid or mycophenolate mofetil
* COVID naive

Exclusion Criteria:

* age \< 18 years
* pregnant women, breastfeeding women
* unable/unwilling to give informed consent
Development, Optimization, Efficiency of the Interface System of Communication and Control of the Environment

The objective of this project is the realization of tests at home and in Hospitals or Functional Rehabilitation for the improvement of the communication with the family and medical entourage, the facility of the emotional expression, the evaluation of the pain, the control of home automation to increase their autonomy, facilitated their reintegration at home. The work is the last step of the research program started in 2009, with the optimization of the installation of the system, the improvement of physical and computer ergonomic aspects and the development of dedicated interfaces according to the type of disability and needs. of each one.

A work upstream of the definition of specifications taking into account the medical constraints was realized and the actions of improvement of the models, the algorithms, the robustness and the effectiveness of the treatment are in progress . The specific adaptation to concrete cases should lead to a system that allows 90% of the population of people with disabilities to exploit the system and significantly improve their level of communication, autonomy and in fact their daily lives.


Eligibility Criteria:
Inclusion Criteria:

* Patients (2-80 years old) with complete or near complete motor disability of both upper limbs or four limbs: Sequelae of trauma or advanced rheumatologic disease (spinal cord injury, upper limb amputation, head trauma, chronic polyarthritis), Diseases Congenital (myopathies, agenesis upper limbs), sequelae of vascular accident (medullary infarction, syringomyelia), neurodegenerative diseases (amyotrophic lateral sclerosis, multiple sclerosis, conduction block neuropathy, etc ..).
* Patients older than 55 years without disability but with a loss of dependence.
* Troubles of the communication and loss of autonomy.

Exclusion Criteria:

* Patient with severe visual contraindications (decreased visual acuity with correction of ± 6/7 dioptres, major oculomotor abnormalities).
* Patients with significant cognitive impairment to understand simple instructions related to the use of the system
Percutaneous Injection Plus Short Segment Pedicle Screw Fixation for Traumatic A2 and A3 AO-type Fractures in Adults

The aim of this study was to examine the short- to medium-term efficacy of percutaneous vertebral body reconstruction by vertebral body augmentation with Sr-HA paste plus short-segment pedicle screw fixation in fresh fractures, as well as to evaluate Sr-HA resorption/substitution. The hypotheses tested in this study were as follows: 1) whether Sr-HA is equivalent to PMMA for restoring the fractured thoracolumbar vertebral body, 2) whether leakage of Sr-HA is less than that of PMMA, and 3) whether Sr-HA is completely resorbed and replaced by cancellous bone.

Introduction Polymethacrylate (PMMA) is commonly used in vertebroplasty and balloon kyphoplasty, but its use has been associated with complications. This study tests three hypotheses: 1) whether strontium hydroxyapatite (Sr-HA) is equivalent to PMMA for restoring thoracolumbar vertebral body fractures, 2) if incidence of PMMA leakage is similar to that of Sr-HA leakage, and 3) whether Sr-HAis resorbed and substituted by new vertebral bone.

Materials and Methods Two age- and sex-matched groups received short percutaneous pedicle screw fixation plus PEEK implant (Kiva, VCF Treatment System, Benvenue Medical, Santa Clara, CA, USA) filled with either Sr-HA (Group A) or PMMA (Group B) after A2- and A3/AO-type thoracolumbar vertebral body fractures. Visual Analog Scale (VAS) score and imaging parameters, which included segmental kyphosis angle (SKA), vertebral body height ratios (VBHr), spinal canal encroachment (SCE), bone cement leakage, and Sr-HA resorption, were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* One single, severely (\>40%) compressed A2 and A3/AO-type thoracolumbar (T10-L3) fracture
* No other serious concomitant injuries

Exclusion Criteria:

* Polytrauma
* Neurologic impairment
* Spinal deformity
* Known malignancy
* Previous fracture or surgery in the same or adjacent vertebrae
Predictive Variables of the Hemodynamic Effect During the Laparoscopic Surgery in Children

This prospective observational study aimed to identify the intraoperative variables to predict the hemodynamic change according to intra-abdominal pressure in the children undergoing laparoscopic surgery.

The intraoperative variables includes Pulse pressure variation (PPV), systolic pressure variation (SPV), stoke volume variation (SVV), Pulse oximeter plethysmographic waveform amplitude (△POP),and pleth variability index (PVI).


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing laparoscopic surgery

Exclusion Criteria:

* known arrhythmia
* known lung disease
* known cardiac dysfunction (Ejection fraction less than 30%)
Blood Flow Restriction Training Combined With Abdominal draw-in Maneuver on Transverse Abdominis Strengthening

This study expects to provide a new alternative way to improve the muscle activation, strength and activation of transverse abdominis in abdominal draw-in maneuver combined with blood flow restriction.

The transverse abdominis (TrA) is the deepest muscle layer of lateral and anterior abdominal wall and also known as a significant component of core stability. Abdominal draw-in maneuver (ADIM) is the main for the strengthening of the deep muscle, however, sufficient activation of TrA by ADIM is limited. Blood flow restriction (BFR) training is a technique combined with low intensity exercise that produces similar results to high intensity training. However, there is few evidences for BFR training on core muscles.

Healthy adults (age ranged 18-34 years and BMI between 18.5\~24.99) were randomly recruited in the study. For the intervention group, an inflatable cuff (14 cm in width \* 84 cm in length) is warped around abdominal muscles below ribs which may cause to at least 60% restriction of blood flow detected by Power Doppler ultrasonography. All participants are instructed to perform ADIM both condition of BFR and BFR-free twice a week, for six weeks. Outcome measurements include Double leg lowering test (DLLT) for muscle strength, brightness mode ultrasound (USD) for muscle hypertrophy and electromyography (EMG) muscle activation. The same physical therapist will do the measurement at first week, third week and the sixth week.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* 20\~35 years old
* BMI 18.5\~24.99

Exclusion Criteria:

* Hypertension
* Have cardio-vascular disease
* Used to have abdominal operation or wound
* Have spinal surgeries or deformities
* Known neuromuscular or joint disease
* Pregnant
Effect of Vojta Therapy on Covid-19 Respiratory Disease

Vojta therapy is a physiotherapy intervention with scientific evidence in respiratory pathologies in children and proven in adults. In this pilot study with an RCT design, its effect in adult patients with respiratory pathology caused by the SARS-CoV-2 virus will be studied. The non-invasive and non-painful technique consists of applying tolerable pressure to specific areas of the patient's body. The objective is to activate, in a reflex way, the ventilatory physiology. It is compared with the conventional respiratory physiotherapy approach.


Eligibility Criteria:
Inclusion Criteria:

* respiratory disease by covid-19

Exclusion Criteria:

* patient older than 75 years
Fertility Restoration Using Autologous Mesenchymal Stem Cells

Treatment of the patients with scarring and adhesions in the uterus resulting from caesarean section or chronic inflammation in the mucosa of the uterus and fallopian tubes and preventing the occurrence of these effects in the future

The aim of the project is to develop a biomedical cell product based on autologous adipose tissue derived mesenchymal stem cells and a biodegradable carrier for highly effective treatment and prevention of scarring and adhesions in the uterus acquired as a result of cesarean section or chronic inflammatory processes in the uterine mucosa and fallopian tubes; to conduct the clinical trials of the biomedical cell product in the treatment of uterus scarring and infertility in women.

Eligibility Criteria:
Inclusion Criteria:

* chronic endometritis
* postoperative uterus scars
* uterine synechia
* fallopian tube obstruction
* absence of acute inflammation in the uterus

Exclusion Criteria:

* Patients with genetic diseases of muscle and connective tissue;
* Patients with malformations of the uterus;
* Acute and chronic infectious diseases: HIV, mycoplasma infection, hepatitis B and C, syphilis; autoimmune diseases; oncological diseases; continuous hormonal therapy with cytostatics corticosteroids; acute noncommunicable diseases;
* mental disorders;
* Drug or alcohol addiction;
* Benign tumors of uterus and appendages;
* Hypersensitivity to any component of the studied biomedical cell product.
Prenatal Exposure Effects Psychophysiology Study

The purpose of the study is to understand the biology and behavior of early mother-infant attachment, and to investigate how it may be affected by prenatal substance exposures. The investigators are interested in how drugs such as cocaine, alcohol, marijuana and cigarette smoking affect both mother and baby.

The investigators are looking for pregnant women or mothers with their newborn infants to participate in this study. Eligible women include mothers who have used any of the following drugs at any time during pregnancy (alone or in combination):

1. cocaine
2. nicotine (cigarettes)
3. marijuana
4. alcohol

The investigators are also looking for mothers who have not used any drugs during pregnancy.

Information collected in this research study is strictly confidential, and protection of sensitive information is additionally assured by an NIH Certificate of Confidentiality.

Participation in this study involves:

1. One visit at 2-4 weeks postpartum. This visit includes an interview for mother and a 30 minute brain scan (no radiation, no sedation) for baby.
2. Two visits at 3 months postpartum. Mothers will have blood pressure and heart rate measured while they look at videos about babies, listen to baby sounds, interact with their own baby. Samples of blood, urine and saliva will be taken from mother. Baby will have a developmental assessment, and saliva samples will be taken.

Payment is $300 or the equivalent in Walmart gift cards for completion of brain imaging, lab visits and 1 day of monitoring mother's blood pressure at home.

Eligibility Criteria:
Inclusion Criteria:

* During pregnancy, mother has used any of the following:

  * cocaine
  * marijuana and/or alcohol but not cocaine
  * nicotine (smoked cigarettes)
  * no drugs during pregnancy
* Mother is pregnant or no more than 4 weeks postpartum

Exclusion Criteria:

* Mother has cardiovascular disease
* Delivery before 36 weeks or later than 42 weeks gestation
* Birth weight less than 5.5 lbs
* Baby was a multiple birth
Proof of Concept Study of Latanoprost/Minoxidil (ANR-001.1) Topical Formulation

Study to Evaluate the safety and efficacy of a Latanoprost/Minoxidil formulation vs. placebo for the treatment of hypotrichosis of the eyebrows.

A Single-Blind placebo controlled trial of the efficacy and safety of the treatment of hypotrichosis of the eyebrows comparing a subset of patients receiving a combination of latanoprost/minoxidil formulation as compared to placebo measured by a validated imaging system.

Eligibility Criteria:
Inclusion Criteria: • Subjects, age 22 to 65 years, in general good health.

* Patients with diagnosed hypotrichosis of the eyebrows.
* Subjects with active hair loss within the last 12 months.
* Patients willing to refrain from initiation of any new vitamins or nutritional supplements for the duration of the study.
* Patients willing to refrain from use of any hair growth therapies (oral or topical) other than the investigational product.

Exclusion Criteria: • Subjects with an active disease or infection, or chronic dermatological condition (eczema, psoriasis, infection, etc.) of the scalp that may interfere with the assessment of scalp skin health in the treated regions.

* History of hair transplants, scalp reduction, current hair weave or tattooing in the target area, artificial hair coloring two months prior to initiation of study which makes it difficult to perform hair count assessment.
* Subjects with hair loss for greater than 5 years, as medical therapy is unlikely to have much effect at restoring hair follicles inactive for that long of a time period.
* Subjects with a history of chemotherapy, receiving cytotoxic agents, radiation, or laser/surgical therapy of the scalp within the past 12 months.
* Any known or underlying medical problem that could influence hair growth such as HIV infection, connective tissue disease, a thyroid condition, inflammatory bowel disease or other medical conditions, at the discretion of the investigator.
* Subjects with clinical diagnosis of hair loss other than hypotrichosis of the eyebrows.
* Subjects with severe cardiovascular disease, uncontrolled or untreated hypertension, arrythmia or clinically relevant hypotension.
* Subjects with known or suspected hypersensitivity or allergic reaction to any of the active or inactive components of the test articles.
* Pregnant or lactating females or planning to become pregnant for the duration of the study.
* Subjects using medications that potentially cause drug-induced hair loss (e.g., depotestosterone, haloperidol, methotrexate, methylprednisolone, prednisone, testosterone, divalproex sodium) within the last 3 months.
* Current enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation.
* Current or recent (2 months) history of severe diet or eating disorder.
Multi-detector Computer Tomography Protocol Project: Chest Imaging Technique and Case Presentation

Multi-detector computer tomography protocol project: Chest imaging technique and case presentation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with complete clinical images

Exclusion Criteria:

* Patients with incomplete clinical images
Interaction Between Gut Microbiota and TKIs in Defining the Clinical Outcomes of Patients With CML

Gut microbiome (GM) is acquiring increasing importance in human health and disease. GM influences hematopoiesis and immune cells types differentiation. Patients with cancer are characterized by dysbiosis and compromised immunity. In the case of Chronic Myeloid Leukemia (CML), treatment with Tyrosine Kinase Inhibitors (TKIs) restores immunosurveillance; in particular deep molecular response (DMR) is associated with increased levels of NK and CD8+ Tcells. There is no literature on the effects of GM on CML outcomes. This project aims to identify a microbial signature associated with a higher probability of achieving DMR.

Philadelphia positive Chronic Myeloid Leukemia (CML) is a myeloproliferative disorder originating from pluripotent hematopoietic cells. Treatment typically involves tyrosine-kinase inhibitors (TKIs), which have significantly improved long-term survival. While generally well-tolerated, TKIs can cause side effects, particularly gastrointestinal issues (diarrhea, constipation, abdominal pain, malabsorption, bleeding) and liver/pancreatic enzyme increases, which may persist and affect quality of life. Additionally, cardiovascular events, often linked to metabolic changes (e.g., glucose intolerance, diabetes, hypertension), occur more frequently during treatment. These side effects raise concerns about TKIs potentially inducing a chronic inflammatory response.

Recent research on the human microbiota highlights its importance in health. The microbiota plays a critical role in gut health, immune function, and metabolic processes, and its imbalances (dysbiosis) can contribute to a range of diseases. Factors such as diet, age, physical activity, and medication use can disrupt the microbiota. However, the relationship between gut microbiota and TKIs in CML patients remains unexplored.

The current study will evaluate by whether different CML gut microbiota genotypes influence TKI treatment responses, whether microbiota alterations cause inflammation or metabolic disorders, and whether microbiota, along with dysmetabolism and dysimmunity, contribute to variations in treatment efficacy and tolerance

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Chronic Myeloid Leukemia Patients
* Any stage of the disease

Exclusioni Criteria:

none
Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer

The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.

The program will offer twice yearly CA-125 blood tests and annual transvaginal ultrasounds to monitor women at high risk for ovarian cancer. In addition to the main purpose of providing ovarian cancer screening, the researchers would also like to build a repository of blood specimens for use in ovarian and breast cancer research and to offer genetics counseling sessions to help educate women about risk-reducing options.

Eligibility Criteria:
Inclusion Criteria:

* Must meet one of the following:

  * The family contains at least two ovarian or breast cancers in the subject or first or second degree relatives of the subject.
  * The subject is of Ashkenazi Jewish ethnicity with one first degree or two second-degree relatives with breast or ovarian cancer, or subject is of Ashkenazi ancestry and has had breast cancer.
  * The subject has a male relative with breast cancer diagnosed at any age.
  * Probability of carrying a BRCA1/2 mutation given family pedigree of breast and ovarian cancers exceeds 20% (as determined by BRCAPRO 95% posterior probability interval).

Exclusion Criteria:

* Prior ovarian cancer or peritoneal carcinomatosis
* A first or second degree relative with a BRCA1/2 mutation and has tested negative for exactly the same mutation.
* The subject has no ovaries.
* Less than 30 years of age, unless 25-30 with BRCA I or II mutation confirmed
* Currently pregnant
* Currently receiving adjuvant chemotherapy or radiation therapy for cancer (excluding tamoxifen). Patients who are being treated for local disease may enroll 3 months after completion of last treatment (excluding tamoxifen).
* Treatment (excluding tamoxifen) for prior metastatic malignancy within the past five years.
* Intraperitoneal surgery within the last 3 months.
Impact of Stress on Brain Energy Metabolism

Background: Stress plays an essential role in the pathophysiology of mental disorders. However, individual differences in the vulnerability to acute and repeated stress are not well understood.

Aim: This work aims to investigate individual differences in glucose metabolism and directional connectivity regulating the neuronal stress response.

Design: 68 healthy volunteers will undergo two simultaneous PET/MRI measurements one week apart. Participants will complete the Montreal Imaging Stress Test during each measurement and in-between. Effects of stress on cognitive performance will be assessed using the n-back working memory task. Individual cortisol levels will be acquired to identify stress (non)responders as well as (non)habituators.

Implications: This work will characterize differences between stress responders vs. non-responders and stress habituators vs. non-habituators in terms of energy metabolism and network connectivity. This individual difference in the stress response may represent an important cornerstone for future evaluation of patients with mental disorders.

Methodological details: Each participant will undergo two PET/MRI scans. Imaging will include functional PET and as well as structural and functional MRI. Stress-specific glucose metabolism will be quantified with the radioligand \[18F\]FDG. Functional connectivity will be combined with glucose metabolism to assess directional connectivity.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* right-handedness
* willingness and competence to sign the informed consent form

Exclusion Criteria:

* History of or current physical, neurological or psychiatric disorder
* History of or current substance abuse or medication, including antipsychotic, antidepressant and antianxiety agents
* Pregnancy of current breast-feeding
* Contraindications for MRI-scanning (e.g., metal implants, steel grafts, etc.), including dental implants causing signal artifacts
* For subjects participating in earlier studies using ionizing radiation, the total radiation exposure of 30 mSv over the last 10 years must not be exceeded, as specified in the Austrian legislation on radiation protection Accordingly, body weight \> 105 kg is an exclusion criterion.
* Failure to comply with the study protocol or to follow the instructions of the investigating team.