cyrilzakka/clinical-trials huggingface dataset:
A Study to Analyze the Impact of Treatment With Paliperidone Palmitate on Clinical Outcomes and Hospital Resource Utilization in Adult Participants With Schizophrenia in Portugal

The purpose of this study is to investigate the mean number of schizophrenia-related hospital admissions, in adult participants with schizophrenia, occurred during 12 months before and 12 months after initiation of Paliperidone Palmitate 1-month formulation treatment.


Eligibility Criteria:
Inclusion Criteria:

* Must have a confirmed diagnosis schizophrenia according to the International Classification of Diseases (ICD) 9th Edition codes, or the correspondent ICD-10 codes if applicable
* Must have been treated with oral antipsychotics (OAPs) and who switched to paliperidone palmitate 1-month formulation (PP1M) due to poor adherence, or lack of efficacy (no significant symptom reduction, as judged by the treating physician, at maximum recommended dose of an antipsychotic for 6 weeks), or participants' choice, or unknown reason when the switch has not been clearly justified
* Had been treated with OAPs for at least 12 months prior to switching to PP1M. During the treatment with OAPs, dose adjustments were allowed. Participants should have been treated with PP1M for at least 4 consecutive months after the switch
* Must have available information concerning the annual schizophrenia-related hospitalizations before and after initiation of PP1M treatment during the observation period, and with the indication of PP1M initiation in their medical charts
* Must be being treated at an ambulatory setting at study entry

Exclusion Criteria:

* Participants with schizophrenia resistant to treatment (TR). TR is defined for the purpose of this study by at least two failed adequate trials with different antipsychotics (at maximal antipsychotic efficacious label dose for 4 to 6 consecutive weeks)
* Participants that used clozapine as treatment for schizophrenia in any given period prior to or during the observation period, independently of other concomitant psychotropic medication
* Participants who have participated in a clinical trial during the observation period
* Participants that switched to PP1M before the 31st of July 2014, that is in the first 6 months after it was available for reimbursement in Portugal
Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter

Diagnoses and follow up of muscles diseases lack imaging. Severity assessment of masticatory dysfunction and follow up of treatment effectiveness is currently based only on clinical features. Supersonic ShearWave Imaging® is a new, non-invasive, non-irradiating and dynamic imaging technique that uses ultrasound and allows shear wave elastic modulus in a muscle in order to study its viscoelastic properties.

In this study, the investigators study the correlation between changes of shear wave elastography modulus and surface electromyogram features of the masseters between rest and maximal voluntary contraction.


Eligibility Criteria:
Inclusion Criteria:

* People with social security.
* People aged 20 to 40 years, of both sexes.
* People that gave and signed consent to participate in the study.

Exclusion Criteria:

* Any concomitant muscle disease (myopathy, myositis...)
* Botulinum toxin injections in the masseter in the last 3 months preceding the study.
* Any treatment that induces muscular effect (baclofen, benzodiazepine)
* Bruxism or any masticatory apparatus disease
* Any surgery of the masticatory apparatus
A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)

This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. There is no formal hypothesis, however, it is expected that the coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase the systemic exposure of BMS-626529.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female
* Nonsmoking subjects
* Ages 18 to 50 years
* Inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive
* Women of childbearing potential
* Must agree to follow instructions for methods of contraception for the duration of the study plus 34 days post-treatment completion

Exclusion Criteria:

* Any history of acute or chronic medical and surgical illness.
* Personal of family history of hemophilia A or B
* Other protocol defined exclusion criteria could apply
Minerals Status in Relation to Overweight and Obese Adolescent

Evaluation of the concentration of serum Mn, Se, iron, Cu \& Zn levels in obese and overweight adolescents, Correlate the body composition parameters with these minerals' concentration, Study the association between the metabolic risk factors and the disturbance in minerals levels in these patients.

Obesity in the population tends to be a notable public health threat on the global scale . individuals with higher body mass index (BMI) are considered to have a lower life expectancy . Among the obesity-related indicators, visceral adipose tissue (VAT) is acknowledged an emerging and sensitive predictor for the risk of metabolic syndrome and cardiovascular disease . Therefore, adverse VAT accumulation can influence metabolic health in the population, and its related risk factors should be further investigated.

Micronutrients in obese people are explored because of an excess energy consumption, and therefore, an inadequate intake of trace elements and minerals. This imbalance among energy consumption and the intake is known as hidden hunger. Obesity can lead to nutritional metabolic disorders, in which the general state of trace elements and minerals are altered.

Only a few studies on child and adolescents obesity concerned Trace Elements (TE). TE is involved in the pathogenesis of obesity and obesity related diseases. We tried to assess trace elements status \[ Manganese (Mn), selenium (Se) copper (Cu),zinc (Zn)\] in obese children and their relationships with VAT and metabolic risk factors of obesity.

Manganese (Mn) is an essential trace element . It plays an important role in fat metabolism.

Selenium (Se) is an essential micronutrient that acts as an antioxidant and possesses multiple metabolic properties.

Copper (Cu) is a trace element that is vital. Cu has been reported to play a role in fat metabolism.

Zinc (Zn) plays an important role. Its deficiency impairs growth, metabolism and immunity.

Iron (Fe) is an essential trace element to sustain all forms of life. Existing research indicates iron deficiency is one of the comorbidities associated with obesity .

Eligibility Criteria:
Inclusion Criteria:

1. Patients in adolescent age (12-18 years old)
2. Patients with BMI over 25.

Exclusion Criteria:

1. Patients younger than 12 years old or older than 18 years old.
2. Patients with history of chronic use of mineral and /or vitamin supplements .
3. Patients with syndromal obesity , endocrine disorder and history of any chronic diseases ,
4. Patients under special diets or chronic use of medication .
Neuropathic Pain in Patients With Degenerative Lumbar Stenosis

Pre- and postoperative pain in patients with degenerative stenosis requires great attention, as it can mislead the doctor about treatment tactics. Neuropathic pain in the legs before and after the surgical procedure, as well as the residual or recurrent pain syndrome existing against this background, overshadow the patient's recovery and cast doubt on the fullness of the performed decompression. Neural compression in the spinal canal and back pain may be the cause of the patient's antalgic posture and sagittal imbalance as seen on X-Ray, to need for corrective interventions surgical procedure.

Thus, it is necessary to clarify the role and the influence of the pain and its type on the perioperative period in patients with degenerative lumbar spinal stenosis.

The current study is prospective observational study to evaluate the role of pain syndrome including neuropathic pain in surgical outcomes in patients with degenerative lumbar spinal stenosis.

This study will be conducted at Priorov Central Institute for Trauma and Orthopedics, Moscow, Russia.

The study is expected to enroll at least 120 adult patients with degenerative lumbar stenosis. The neuropathy will be assessed preoperatively, and then the patient will undergo decompressive lumbar surgery without fusion.

The neuropathic pain will be evaluated according to DN4 preoperatively, each patient will be assigned to one of two groups depending on the total value of DN4 - with the presence of neuropathy (DN4\>= 4) and without neuropathy (DN4 \<4).

Postoperative evaluation will include 2 visits during one year to evaluate clinical and radiological outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-85 years;
2. Radicular leg pain with or without neurogenic claudication with or without back pain;
3. Planned decompressive surgery for degenerative lumbar stenosis with or without degenerative spondylolisthesis;
4. Symptoms persisting for at least 3 months prior to surgery;
5. Given written Informed Consent;
6. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements

Exclusion Criteria:

1. Prior lumbar fusion at any level;
2. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
3. Back or non-radicular pain of unknown etiology;
4. History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);
5. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;
6. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
Molecular Pathology of Colorectal Cancer: Investigating the Role of Novel Molecular Profiles, microRNA's, and Their Targets in Colorectal Cancer Progression

Molecular pathology of Colorectal Cancer: Investigating the role of novel molecular profiles, microRNA's and their targets in Colorectal Cancer progression

Single centre observational cohort study Prospectively recruited patients biomarker evaluation and identification of novel biomarkers

Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer

Exclusion Criteria:

* hereditary CRC; tumours with extensive necrosis
A Novel IUD Insertion Technique

A previous trial performed by our research team, in order to reduce the pain associated with intrauterine device insertion, compared the novel technique of IUD insertion under the guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain score and time taken for insertion, when compared with the traditional method. In this study our researchers aim to abolish the distracting effect of the technician and the TAS probe (which might have interfered with previous results).


Eligibility Criteria:
Inclusion Criteria:

* Females desiring contraception with the use of IUD
* Females with history of previous vaginal delivery

Exclusion Criteria:

* Are pregnant or think they may be pregnant
* Septic pregnancy or abortion
* Have unexplained abnormal vaginal bleeding
* Have untreated cervical cancer
* Have malignant gestational trophoblastic disease
* Have uterine cancer
* Have uterine abnormalities
* Have or may have had a pelvic infection within the past three months
* Have or may have any sexually transmitted disease
* Have pelvic tuberculosis
* Are postpartum between 48 hours and 4 weeks
* Have benign gestational trophoblastic disease
Effect of Dapagliflozin on IAH in T1DM

Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect hypoglycaemia, a condition referred to as impaired awareness of hypoglycaemia (IAH) that causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IAH is usually the end-result of a process of habituation to recurrent hypoglycaemia that is potentially reversible. Treatment with sodium glucose cotransporter (SGLT)-2 inhibitors (SGLT-2i) in addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1 diabetes. This study will test the hypothesis that treatment with the SGLT-2 inhibitor, dapagliflozin, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with type 1 diabetes and IAH. In a randomized doubleblind placebo-controlled cross-over trial, patients will be treated for 8 weeks with dapagliflozin (or placebo), after which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic hypoglycemic glucose clamp study.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes, disease duration \>1 year
* Age \>18 years, \<75 years
* BMI 19-40 kg/m\^2
* Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
* Impaired awareness of hypoglycemia as assessed by a score of 3 or more on the modified Dutch translation of the Clarke questionnaire
* Glycated haemoglobin (HbA1c) ≥42 mmol/mol (6%) and ≤75 mmol/mol (9.0%)
* Ability to provide informed consent

Exclusion Criteria:

* Treatment with SGLT-2 inhibitors
* Known intolerance to SGLT-2 inhibitors
* Treatment with loop diuretics or other anti-hypertensive agents
* Treatment with glucose-modifying (other than insulin) or immune-modifying agents (e.g. prednisolon)
* Treatment with pioglitazone
* Use of statins
* A history of cardiovascular disease (e.g. myocardial infarction, stroke, heart failure) or hypotension
* A history of galactose-intolerance, lactase deficiency, glucose-galactose malabsorption
* History of diabetic ketoacidosis requiring medical intervention within 1 month before screening
* Admission to the hospital for hyperglycemia or hypoglycemia within 1 month before screening
* Frequent episodes of severe hypoglycemia within 1 month before screening
* Laser coagulation for proliferative retinopathy (past 6 months)
* Proliferative retinopathy
* Diabetic nephropathy as reflected by an albumin-creatinin ratio ˃ 30 mmol/mg or an estimated glomerular filtration rate (by MDRD) ˂60ml/min/1.73m2
* History of pancreatitis (acute or chronic) or pancreatic cancer
* Use of premixed insulin or of long-acting insulin alone
* Total daily insulin dose requirements \<20 units unless on pump treatment
* Pregnancy or unwillingness to undertake measures for birth control
Understanding the Transition from Normal Melanocytes to Nevus to Melanoma

The primary objective of this study is to identify the molecular identity profiles of all cellular states that characterize the progression from benign nevi to malignant melanoma in CAYA patients with L/GCMN. The secondary objectives are:

* To longitudinally characterize the cell-free DNA (cfDNA) from CAYA patients.
* To improve the early diagnosis and treatments for intermediate conditions such as L/GCMN through evidence-based interpretation of personal risk from endogenous or exogenous sources.
* To test pre-clinical strategies to best model and improve patient response.

NevustoMel is an international multicentric retrospective cohort study with molecular and experimental design. It will involve the genomic characterization of cell-free DNA and affected tissues from patients. Methylomics and single-cell multi-omics will be used to identify co-existing molecular (transcriptional and epigenomic) states at single-cell level and will be generated from affected tissues. These results will be exploited using machine learning-assisted integration of multi-modal transcriptomics, epigenomics and spatial information. Integrated analyses of single-nucleus RNA sequencing from a selection of frozen tissues and spatial transcriptomics on formalin-fixed paraffin-embedded samples will allow the comparison of the findings to ground-state Human Developmental Cell Atlas data. Distinctions will be validated either with in situ hybridization (such as RNA sequencing) or immunostaining on test cohort tissues. These results will be complemented with in vitro functional analyses, high throughput sequencing and bioinformatic analyses.

Eligibility Criteria:
Inclusion criteria:

* Congenital nevus with estimated size of 20 cm
* Be over 18 years of age

Exclusion criteria:

* No available biological material
* Not having signed the informed consent
Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block in Multiple Rib Fractures

The aim of this study is to compare the incentive spirometry volume and analgesic efficacy of ultrasound guided continuous Retrolaminar block and continuous Erector spinae plain block in patients with multiple rib fractures.

Thoracic epidural analgesia (TEA) and thoracic paravertebral block (TPVB) are strongly recommended techniques for managing thoracic neuropathic pain However, they can be technically challenging to perform and are associated with up to 15% failure rate in Thoracic epidural analgesia (TEA)and potential risk of pneumothorax in thoracic paravertebral block (TPVB).Newer approaches have been the focus of many studies in recent years; these approaches include retrolaminar block and erector spinae plane block.

Retrolaminar block (RLB) is a new thoracic truncal block for controlling somatic pain in both the thoracic and abdominal walls.

The Erector Spinae plane block (ESPB) has been used successfully to manage severe neuropathic pain arising from ribs .The basis to use ESPB is its likely site of action which is the dorsal and ventral rami of the thoracic spinal nerves.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years old.
* Both sexes.
* Patients with unilateral multiple traumatic rib fractures (≥ 3 ribs).

Exclusion Criteria:

* 1st ken refusal.
* Patients with any contraindication for regional block as:

  * Bleeding disorders.
  * Infection at the injection site.
  * Patients with hemodynamic instability.
* Patients with known hypersensitivity to the study drugs
* Unconscious patients
* Patients with significant trauma outside the chest wall e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries
* Patients with significant lung contusions, pneumothorax, flail chest
* Chronic opioid users.
* Uncooperative patients and patients with psychiatric illness
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis

This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active ankylosing spondylitis.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed informed consent.
* AS diagnosis consistent with the Modified New York Criteria for AS (1984);
* Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4 and a Patient's Assessment of Total Back Pain score \>= 4 based on a 0 - 10 Numeric Rating Scale (NRS) at the Screening and Baseline Visits.
* Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
* If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
* BMI ≥18 kg/m2

Exclusion Criteria:

* Pregnant women or refuse to receive contraception during the study.
* Lab abnormality within 4 weeks of randomization as follows: WBC count \<3.0×10\^9/L；neutrophil count\<1.5×10\^9/L;hemoglobin level\<90.0 g/L ; platelet count \<100×10\^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
* History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
* Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 6 months of randomization.
Diagnostic Accuracy of Magnetic Resonance Cholangiopancreatography in Patients With Obstructive Jaundice

Evaluate the diagnostic accuracy of Magnetic Resonance Cholangiopancreatography (MRCP) compared with Ultrasound and Computed Tomography (CT) in patients with obstructive jaundice taking findings of ERCP/ PTC and histopathology as gold standard.

MRCP as a diagnostic role to determine the presence and severity of biliary and pancreatic ductal dilatation. It can also detect the length of the stricture as well as the exact cause and location of the obstructing lesion in comparison to other modalities.

Eligibility Criteria:
Inclusion Criteria:

Adult male and female patients clinically diagnosed obstructive jaundice are included in the study with positive laboratory tests.

Exclusion Criteria:

Patients with non-obstructive (prehepatic/hepatic) cause of jaundice. Patients having contraindications to perform MRI (Patients with any electrically, magnetically or mechanically activated implants, pacemaker, cochlear implants or any metallic orthopedic implants and claustrophobic patients).
Psychological Evaluation After SCS Implantation

Spinal cord stimulation (SCS) is a therapeutic option for patients with chronic low back pain (CLBP) syndrome, when pharmacological, psychological, physical and occupational therapies or surgery fail to reduce symptoms. CLBP is a common disease with several negative consequences on the quality of life, work and activity ability and increased costs to the health-care system. We have therefore designed this observational study to assess global cognitive functioning in three different groups of patients: patients with chronic pain undergoing intervention (experimental group), patients with chronic pain following traditional therapies (comparison group) and healthy participants matched for age and schooling (healthy subjects).

A neuropsychological assessment battery designed to assess global cognitive functioning, behavioral symptomatology, metacognition, quality of life, interoception, pain perception, self-efficacy, and coping styles will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* presence of chronic pain treated with spinal cord stimulation (Experimental Group)
* presence of chronic pain receiving standard therapies (Comparison Group)
* healthy participants matched for age and schooling (Control Group).

Exclusion Criteria:

* consent denied