cyrilzakka/clinical-trials huggingface dataset:
Study on Communication Comprehension in the Schizophrenic Spectrum

The purpose of the present study is to evaluate the effect of emotional prosody on the perception of emotional discourse in the schizophrenic spectrum. The investigators hypothesize that participant may use emotional prosody as an emotional cue to understand the emotional content of discourse.

The integration of ortholinguistic and paralinguistic functions in language, particularly of the emotional prosody, is necessary to interact adaptively with others. People in the schizophrenic spectrum have social difficulties. Is emotional prosody comprehension altered in these people? According to Edwards et al. (2002), there is methodological issues concerning the tasks used to answer this question. Investigators built an emotional judgment task more adapted to study the perception of emotional prosody in the schizophrenic spectrum than the classical paradigm designed to evaluate participants with cerebral injury. The investigators have elaborated a material that consists of 140 short sentences (7±2 words) with a simple syntactic structure. The verbal content expressed positive, neutral or negative emotions. These sentences were announced by four professional actors (two female) with an emotional prosody content congruent or inconsistent with the verbal content. Participants will have to evaluate the emotional intensity of the recordings on a five points Likert scale, from strongly negative to strongly positive. Psychotic experiences of all participants will be evaluated too.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of schizophrenia and being in a stable phase of the disease
* Having between 18 to 60 years old
* Speak french or using french at school
* Accepting not to use psychoactive substances during the preceding 48h
* Being affiliated to the French social security
* Providing their written informed consent

Non-inclusion Criteria:

* Having not audio deficits, nor visual uncorrected deficits
* Having not suffering from depressive symptoms during the last 6 months

Exclusion Criteria:

- Having no neurological, nor psychiatric disease except schizophrenia for the patients groups.
Toronto Gestational Glucose Tolerance Cohort

In this prospective observational cohort study, women representing the full spectrum of gestational glucose tolerance status are undergoing longitudinal cardiometabolic characterization at regular intervals in the years after the index pregnancy.

In this prospective observational cohort study, women reflecting the full spectrum of glucose tolerance in pregnancy (from gestational diabetes mellitus (GDM) to lesser degrees of gestational glucose intolerance to those with completely normal glucose tolerance) are being recruited in late 2nd trimester. This cohort of women thus carries a broad range of risk for the future development of type 2 diabetes (T2DM) and cardiovascular disease. At regular intervals in the years after the index pregnancy, this cohort of women is undergoing serial cardiometabolic characterization, including assessment of glucose tolerance, beta-cell function and insulin sensitivity. The longitudinal changes over time in this cohort should provide insight into the early pathophysiology and natural history of T2DM and cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women

Exclusion Criteria:

* Pre-existing diabetes before the index pregnancy
A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement

The subject will treat 68 patients with symptomatic sacral canal cysts as the research object, and adopt a randomized controlled research method, respectively, using two methods of reinforcement and reconstruction of the nerve root sleeve, sacroplasty and nerve root sleeve plasty, and observed the operation of the patient Complications, preoperative and postoperative short-term and long-term VAS pain scores, JOA neural function scores, and changes in cyst size on imaging examinations, to evaluate the safety of nerve root sleeve reconstruction and sacroplasty in reducing the safety of postoperative cyst recurrence Sex and effectiveness, so as to further improve the surgical treatment of sacral canal cysts, improve the curative effect, and formulate the operation specifications for the treatment of sacral canal cyst

In this subject, a cohort observation method was used to observe 52 patients with two types of surgical removal of hematoma in the basal ganglia under the guidance of frontal ultrasound through keyhole neuroendoscopy and microsurgery for hematoma removal under the guidance of frontal ultrasound. They were divided into endoscopic surgery group and microsurgery. In the endoscopic surgery group, 26 cases were treated with keyhole neuroendoscopy under the guidance of frontal ultrasound for hematoma removal in the basal ganglia area, and 26 cases in the microsurgery group were treated by craniotomy microsurgery hematoma removal surgery. Observe the removal rate of surgical hematoma in the two groups And the safety of the operation and the GCS score, GOS score and MRI examination of nerve fiber damage and postoperative complications at 1 week, 1 month, and 3 months after the operation. Observe and analyze the improvement of the hematoma clearance rate in the endoscopic surgery group. And whether it has an advantage in terms of efficacy

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic nerve root cysts diagnosed by MRI
2. Intact cyst capsule, no defect of sacral canal lamina
3. No other diseases of nervous system, pelvic floor and important organs
4. Agree inclusion

Exclusion Criteria:

a ) Non-radiculent cysts or asymptomatic cysts b) Cysts cause severe bone erosion to lamina resorption c) Combined with other diseases of nervous system, pelvic floor and important organs d) Disagree to join e) Cannot complete follow-up -
Continuous Clopidogrel Dose Adjustment in Acute Coronary Syndrome Patients With High On-treatment Platelet Reactivity

The purpose of this study is to determine whether continuous clopidogrel dose adjustment targeted after platelet function testing improves outcomes during 12 months of follow-up in acute coronary syndrome patients treated with coronary artery stenting and with determined high platelet reactivity on clopidogrel.

Dual antiplatelet therapy (DAPT) with aspirin and P2Y12 receptor antagonists during 12 months presents cornerstone treatment in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). Clopidogrel is the most widely used P2Y12 inhibitor despite it's limitations that include highly variable P2Y12-receptor inhibition which causes wide interindividual platelet reactivity variability. Since high on-treatment platelet reactivity (HTPR) on clopidogrel is strongly associated with adverse events, antiplatelet therapy tailoring has been vastly investigated to determine whether individualized approach could improve outcomes. In the time of progressive personalized approach to therapy, effective strategies are needed to minimize the risk of ischemic adverse events without increasing the risk for bleeding.

Aim of this study is to investigate whether continuous clopidogrel dose adjustment according to platelet function testing (PFT) using Multiplate® function analyzer (Roche Diagnostics, Mannheim, Germany) could decrease the rate of adverse events in ACS patients treated with PCI and with HTPR during early and late period of DAPT treatment.

Cut off values for HTPR and enhanced platelet response were set according to the consensus statement at \>46 U and \<19 U, respectively. PFT and therapy tailoring was performed at day 1, 2, 3, 7, 30 and month 2, 3, 6, 9 and 12.

Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndrome patients treated with successful PCI
* age 18-80 years
* determined high on-treatment platelet reactivity

Exclusion Criteria:

* continuous postinterventional glycoprotein (GP) IIbIIIa receptor inhibitor infusion
* thrombocytopenia (\<150x109/L)
* significant renal insufficiency (creatinine\>200 µmol/L)
* anemia (Htc\<30%)
* hemorrhagic diathesis
* history of intracranial bleeding or ischemic cerebrovascular insult 6 months before
* major operation 6 weeks before
* concomitant chronic anticoagulation therapy
* age \<18 years and \>80 years
A Study to Evaluate the Safety of Withholding Anticoagulation in Patients With Subsegmental PE Who Have a Negative Serial Bilateral Lower Extremity Ultrasound

Blood clots in lung arteries (pulmonary embolism) are usually detected using a radiological test called computed tomography (CT scan). As technology advances, the CT scans are able to detect smaller and smaller blood clots. Over time, the frequency of blood clots in the pulmonary arteries has increased significantly (CT scan are now detecting very small blood clots that the investigators could not see before). As a result, more and more people are on blood thinners to treat these small blood clots but their true clinical significance is unknown.

The management of blood thinners is costly and also utilizes scarce healthcare resources. These blood thinners need to be monitored with frequent blood work. Furthermore, every year, approximately 3 percent of patients on blood thinners will have a major bleeding event requiring medical attention.

The investigators don't think that treating these small blood clots in the pulmonary arteries detected on CT scan is worth the risk of bleeding from the blood thinners.

The main goal of this study is to find out if it is safe to not treat very small blood clots in the pulmonary arteries.

The investigators plan to follow 300 patients with small blood clots in their lungs for 90 days. These patients will not be treated with blood thinners but will be followed closely with other non-invasive tests to avoid progression or recurrence of blood clots.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater or equal to 18 years old.
2. Patients with newly diagnosed isolated SSPE\* (any number).

   * Isolated SSPE is defined as CTPA demonstrating an intraluminal filling defect in a subsegmental artery with no filling defects visualized at more proximal pulmonary artery levels.

Exclusion Criteria:

1. Proximal lower extremity (popliteal vein or above) or upper extremity (subclavian vein or above) DVT.
2. Need for long term oral anticoagulant therapy for reasons other than VTE.
3. SSPE diagnosed in a hospitalized patient (\> 48 hours after hospital admission).
4. Requiring oxygen therapy to maintain an O2 saturation over 92%
5. Previous history of DVT (proximal or distal) of upper or lower extremities, PE, or unusual site thrombosis (e.g. splanchnic or cerebral vein thrombosis).
6. Geographically inaccessible for follow-up
7. Active Malignancy (defined as other than basal-cell or squamous cell carcinoma of the skin; cancer within the past 6 months; any treatment for cancer in the past 6 months; or recurrent or metastatic cancer)
8. Pregnancy
9. Have received more than 48 hours of therapeutic anticoagulation.

   * Prophylactic dose allowed if required for separate indication and acceptable by the investigator.
10. Unable/refuse to sign informed consent
11. Asymptomatic SSPE (e.g. SSPE is an incidental finding on a CT scan conducted for reasons other than suspected PE)
Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)

The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Diagnosis of pancreatic cancer
* Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy, total pancreatectomy) for treatment at Moffitt Cancer Center
* Discharged on an oral diet
* Able to speak and read English or Spanish
* Able to provide informed consent

Exclusion Criteria:

* Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)
Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

Outcomes for minimally invasive and open pancreatoduodenectomy for distal cholangiocarcinoma have not been compared. This is an international multicenter propensity score matched cohort study including patients after MIPD or OPD for dCCA. Primary outcomes included overall survival (OS) and disease-free interval (DFI).

This study is an international multicenter propensity score matched cohort study using the database of the International Study Group on non-pancreatic periAmpullary CAncer, the ISGACA consortium (www.isgaca.com), including all patients who underwent a pancreatoduodenectomy for non-pancreatic periampullary cancer. Data will be retrospectively collected. To minimize differences between groups, all the participating centers perform both OPD and MIPD and all centers meet the Miami guideline minimum volume of at least 20 MIPD per year. This study is approved by all the locals Ethical Committees (approval number from the promoting center, Comitato etico di Brescia, NP 5318 - 01.06.2022) and it will be performed according to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE guideline and checklist), and the Declaration of Helsinki.

Eligibility Criteria:
Inclusion criteria:

* Adult patients
* Elective upfront curative MIPD or OPD between January 1, 2010 and December 31, 2021
* Pathological confirmed dCCA

Exclusion criteria:

* Neoadjuvant chemotherapy
* Palliative surgical procedures
* Intraoperative detection of unresectable disease (i.e., metastasis or locally advanced disease)
* Post-operative pathological diagnosis was other than dCCA (e.g., neuroendocrine tumor, polyposis adenoma)
* R2 positive resection margin
* Pregnancy
* Missing primary endpoints
An Observational Study of Perioperative Immunotherapy in MSI-H Gastrointestinal Tumors

Gastrointestinal cancer like Gastric cancer and colorectal cancer are high-incidence tumors worldwide. Surgery is the only curable way. Perioperative treatment can improve the survival of patients. Microsatellite instability-high（MSI-H）are a special subtype of gastrointestinal tumors, accounting for about 15-22%. According to current research, patients with this type of gastrointestinal tumors cannot benefit from traditional perioperative chemotherapy, which directly affects the long-term survival of patients. Because patients with MSI-H have a unique tumor immune microenvironment, thus they are more likely to benefit from immunotherapy. Current studies have confirmed that the use of immunotherapy during palliative care can prolong the survival of patients with MSI-H. In the neoadjuvant treatment stage, according to the previous clinical practice of our center, the use of immunotherapy can make some patients achieve complete postoperative pathological remission. However, in the perioperative treatment stage, the value of immunotherapy is still lack of powerful clinical evidence.

Based on this, our group intends to start an observational study to prospectively enroll patients with MSI-H gastrointestinal tumor using immunotherapy during the perioperative period.The primary endpoint is safety while survival outcomes as secondary endpoints. In order to evaluate the safety and effectiveness of immunotherapy during the perioperative treatment stage in MSI-H gastrointestinal cancer


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old,diagnosed as gastric or colorectal cancer by pathology;
2. Diagnosed as a mismatch repair deficient by immunohistochemistry,or diagnosed as microsatellite instability-high by polymerase chain reaction(PCR) or next-generation sequencing(NGS);
3. Suitable for tumor radical resection;
4. Join this trial voluntarily,and could sign an informed consent form;
5. With good compliance.

Exclusion Criteria:

1. Do not use immunotherapy containing PD-1/PD-L1 antibody during the perioperative period;
2. Simultaneous diagnosis of dual primary tumors, and the second tumor cannot be resected radically, or the second tumor is not dMMR/MSI-H;
3. Complicate with uncontrollable immune system diseases;
4. Patients who need to use glucocorticoids and other immunosuppressive agents for a long time;
5. Patients who received live vaccines or live attenuated vaccines within 30 days before the medication, except for inactivated vaccines;
6. Those who cannot provide detailed medical records or cannot cooperate with follow-up.
Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy

Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment

Inherited genetic changes, including rare pathogenic mutations (RPMs) in several major genes and single nucleotide polymorphisms (SNPs)-based genetic risk scores (GRS) have been consistently associated with prostate cancer (PCa) risk. Furthermore, results from retrospective analyses of two clinical trials (PCPT and REDUCE) and biopsy cohorts revealed Caucasian men with higher GRS are 1) more likely to have positive biopsy and 2) have higher number of positive biopsy cores. These findings suggest inherited risk assessment may have clinical utility in identifying men who have a higher likelihood of positive results from diagnostic prostate biopsy. The objective of this observational trial is to confirm the clinical utility of both RPMs and GRS in a prospective study of multi-racial patients. Results from this trial will provide a critical piece of evidence for guideline committees to consider the adoption of inherited risk assessment in decision making for prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing prostate biopsy for detection of prostate cancer
* Aged 40 to 69 years
* Four ethnicity groups (Caucasian, African Americans, East Asians, Latinos)
* PSA between 2.5-10 ng/mL

Exclusion Criteria:

* Previous diagnosis of prostate cancer.
* Ethnicity outside the inclusion criterion (including mixed ethnicity).
* Any prior PSA test result outside the range of inclusion criterion.
Single Incision Versus Conventional Laparoscopic Appendectomy

The aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy.

Appendicitis is the most common abdominal emergency. The treatment is surgical and single incision laparoscopic surgery (SILS) involves performing laparoscopic surgery through a single transumbilical point, in an attempt to improve the results of laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected acute appendicitis

Exclusion Criteria:

* Perforated appendicitis
Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients

This is a phase Ib, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, efficacy and pharmacokinetics of ASC10 tablets in mild or moderate COVID-19 subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥18 years at screening;
2. Those females who do not have plans for pregnancy within six months and are willing to take effective contraceptive measures from the first dose of the study drug to 3 months after the last dose;
3. If male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug;
4. Has a documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤5 days prior to randomization.

Exclusion Criteria:

1. Females who are pregnant, planning to become pregnant, or breastfeeding;
2. Has at least one characteristic or underlying medical condition associated with an increased risk of developing severe or critical illness from COVID-19;
3. Has hypersensitivity or other contraindication to any of the components of the study interventions;
4. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates

This study investigates the effects of enterally supplied glutamine on gastric emptying, intestinal transit, age of total enteral nutrition and age at the end of hospitalisation. Forty neonates, aged at least 2 days and free of acute illness participate in a prospective, randomised, double-blind study. All are fed with parenteral and enteral nutrition enriched with glutamine (0.7 g/kg/per day, group 1) or isonitrogenous control (group 2). Gastric emptying is analysed by sequential measure of intragastric residue by diluted polyethylene glycol (PEG) 4000. Intestinal transit is analysed by Rouge Carmin test.


Eligibility Criteria:
Inclusion Criteria:

* Premature neonates aged 30-33 weeks of gestational age
* Aged at least 2 days and no more than 10 days
* Free of acute illness
* Written informed consent is obtained from the parent prior to enrolment.

Exclusion Criteria:

* Premature infants with respiratory (fraction of inspired oxygen \[FiO2\] \> 30%), or cardiovascular, liver, intestinal or acute diseases
* Premature infants with congenital syndrome
Topical Amethocaine Gel for Intramuscular Injection in Term Neonates

This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K.

Study Hypothesis: We believe that topical amethocaine gel will be superior to placebo in decreasing the pain from intramuscular injection in term neonates.

This randomized controlled trial will assess the efficacy of topical amethocaine gel (Ametop) compared with placebo (Eucerin plus) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K. Neonatal pain response between groups will be assessed using the Neonatal Facial Action Coding System (NFCS) which is currently the gold standard for infant pain assessment, latency to first cry and cry duration. Parents' (father) perception of infant's pain will be assessed using a visual analogue scale (VAS) when possible.

Neonates will be randomized to receive either amethocaine gel or identical appearing placebo administered locally at the injection site (the upper part of the neonate's thigh) using a pre-prepared syringe 30 minutes prior to the administration of vitamin K. The gel or placebo will be covered using a Saran wrap. Each neonate will be videotaped during the procedure. Parents (father) will be present during the procedure (observing) so that they (he) can assess their neonate's pain response using VAS.

Eligibility Criteria:
Inclusion Criteria:

1. Term neonates \> 37 weeks and
2. Birth weight \> 2500 grams (appropriate for gestational age - AGA) -

Exclusion Criteria:

1. Neonates with major congenital anomalies
2. Neonates with known neurological abnormalities (antenatally diagnosed)
3. Neonates who require admission to the neonatal intensive care unit at birth