cyrilzakka/clinical-trials huggingface dataset:
Impact of Neuropsychological Disorders in Multiple Sclerosis

The study involves MS patients with and without neuropsychological disorders.

The patient will benefit from:

* A routine neuropsychological assessment, including a cognitive and emotional assessment
* A clinical examination
* A three-dimensional analysis of movement


Eligibility Criteria:
Inclusion Criteria:

* Understanding and able to speak French
* Carriers of MS with relapsing remitting form (RRMS-RR) with an EDSS \<4
* No significant motor, cerebellar or somesthesia disorders of the upper limbs or visual disturbances (side to a visual EDSS \<2)
* Absence of corticosteroid intake in the last four weeks
* Benefiting from health insurance coverage
* Not showing any flare-ups or worsening of the disease in the last 6 weeks
* No botulinum toxin injection for more than 4 months

Exclusion Criteria:

* People with previous neurological pathologies, head trauma with loss of consciousness, psychiatric pathologies, serious general ailments, perceptual or dysarthric disorders preventing verbal communication or reading,
* Treatment with psychotropic drugs (except benzodiazepines and hypnotics).
* Refusal to participate after clear and fair information about the study.
* Adults under tutorship, curatorship or safeguard of justice
* With orthopedic treatment influencing walking
* Pregnant woman
Outcomes of Bariatric Surgery/UMMMC Bariatric Surgery Registry

The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular disease.

See brief Summary

Eligibility Criteria:
Inclusion Criteria:

* Must be scheduled for Bariatric Surgery @ UMMMC

Exclusion Criteria:

* Not scheduled for Bariatric Surgery @ UMMMC
Incentives for Participation Versus Outcomes

One of the most important debates in the field of disease prevention is whether financial incentives should be contingent on participation in evidence-based programs for smoking cessation or on actual outcomes, like prolonged abstinence. This study can fill a major knowledge gap in this debate, which is the lack of any population trial that compared the impacts of outcomes- and participation-based incentives in a population of smokers. This research can help policy makers and health service providers choose the incentives approach that provides the most effectiveness, cost-effectiveness and cost-savings for entire populations of smokers.

This population-based randomized clinical trial is designed to compare long-term abstinence rates in three groups of smokers: 1. Those incentivized for participation in an evidence-based treatment designed for smokers at each stage of change; 2. Those incentivized for biologically validated prolonged abstinence at 6 and 12 months who could also choose to participate in the TTM (Transtheoretical Model)-tailored intervention; and 3. An assessment only control condition.

The Specific Aims are:

1. To assess whether the treatment group incentivized for participation outperforms the control group at 12, 24 and 36 months as hypothesized;
2. To assess whether the treatment group incentivized for prolonged abstinence at 6 and 12 months outperforms the control group at each follow-up as hypothesized;
3. To assess whether the treatment group incentivized for participation outperforms the treatment group incentivized for outcomes at 36 months as hypothesized.
4. To compare the cost-effectiveness of each treatment in a population of mostly unmotivated smokers;

The Secondary Aims are:

1. To assess the long-term treatment trajectories of each treatment compared to controls with hypothesized increasing trajectory in the participation contingent incentives and decreasing trajectory in the outcome contingent incentives.
2. To identify mediators of long-term outcomes in each treatment, such as amount of treatment participation, income, severity of smoking, stage of change, self-efficacy, perceived health and intrinsic and extrinsic motivation to quit.
3. To compare cost-savings of each treatment by modeling all additional costs of smoking for employers and smokers.

Eligibility Criteria:
Inclusion Criteria:

* smoker

Exclusion Criteria:

-
Building an Evidence Base for Weight Loss Strategies Among Those With Chronic SCI-The GLB-SCI+

This study's overarching aim is to follow a systematic approach that incorporates community-based participatory research (CBPR) to develop a multi-component weight loss intervention that may yield significant effects for a chronic SCI sample. The approach is to obtain data on the 3 unique strategies (prepackaged/portion-controlled meals; enhanced self-monitoring; the GLB-SCI) to inform design of an empirically supported and consumer-validated multicomponent intervention program, that combines the best of the 3 approaches into one unique intervention, the GLB SCI+. Based on the investigators' prior experience with adapting and delivering the GLB AIM (a lifestyle intervention previously adapted for those with impaired mobility), interim findings, existing literature, and consumer feedback, they hypothesize that these 3 unique strategies may confer individualized benefits to people with SCI given their complex disability-related barriers to weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Have had a spinal cord injury for at least 1 year
* Overweight as evidenced by BMI \> 25
* Must have sufficient upper arm mobility to engage in exercise
* Must have access to the internet
* Must be able to obtain physician signed clearance to participate in a weight management intervention

Exclusion Criteria:

* Cognitive impairment which substantially impairs autonomy (e.g. mental retardation)
* Medical issues for which exercise is contraindicated such as uncontrolled hypertension or coronary heart disease,
* Pregnancy
* Not fluent in English
* Presence of grade 3 or 4 pressure ulcer
* Previously diagnosed eating disorder
A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma

The purpose of this prospective randomized study is to compare the efficacy and safety of radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very homogeneous underlying conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 and 70 years
2. Child-Pugh class A (score 5-6)
3. Single hepatocellular carcinoma
4. Maximal diameter of the tumor from 2 to 4 cm when measured on MRI or CT (The diameter on MRI was measured prior to that on CT)
5. No previous treatment
6. Platelet count \> 80,000/mm3

Exclusion Criteria:

1. HCC abutting main hepatic veins or the first branches of the main portal vein
2. HCC abutting vessels ≥ 0.5 cm
Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease

This is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.

This is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones. Subjects will be treated up to 2 times with the Enhanced Lithotripsy System and followed for 30 days after the last treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Individuals presenting with one urinary stone-apparent on a computed tomography scan within the last 14 days
* Males and females aged 18 or older
* Capable of giving informed consent, and willing to have the informed consent process videotaped
* Stone size, as estimated by pre-operative computed tomography, with all dimensions 15 mm or less.

Exclusion Criteria:

* Individuals under 18 years of age
* Individuals with radiolucent stones
* Individuals with stones in the lower pole of kidney
* Individuals not following up in the treating hospital
* Individuals with history of cystinuria
* Individuals with urine pH below 5.5
* Individuals with untreated urinary tract infection
* Individuals who are not willing to use adequate method of contraception during the study period
* Women who are pregnant, lactating or planning pregnancy during the study period
* Individuals with a coagulation abnormality or taking prescription anticoagulants.
* Individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side
* Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.)
* Individuals with a body mass index greater than 35
* Individuals with ASA score of 3 or greater general anesthesia risk level
* Known sensitivity to possible medications used before, during, or after the treatment procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics
Cardiac Dysfunction in Critically Ill Covid-19 Patients

We conducted an observation sub-study of the prospective randomized controlled trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure", in which we analysed the echocardiographic data collected both at baseline when patients where included and 3-5 days later for followup.

We conducted an observation sub-study of the prospective randomized controlled trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure" which was conducted in 2020/2021 during the COVID-19 pandemic on patients with ARDS due to COVID and requiring mechanical ventialtion. Patients underwent echocardiography at baseline, and were then randomized either to control, or treatment with inhaled nitric oxide, starting at 80ppm and then 40ppm. Followup echocardiography was performed 3-5 days later, and all echocardiographies were conducted by highly experienced sonographeres certified by the European Association of Cardiovascular Imaging. Analysis of these cardiac ultrasounds focused on the amount of patients showing signs of pulmonary hypertension, right ventricular failure and left ventricular failure. Several parameters were used to estimate these, and we also aimed to evalute the utility of more novel measures such as RV and LV GLS for this use in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18.
* Positive PCR for COVID-19.
* Admission to the ICU.
* Endotracheal intubation and mechanical ventilation.
* Severe hypoxemia, defined by PaO2/FiO2 \< 300 mmHg.
* Inclusion in the trial "High Dose Inhaled Nitric Oxide in Acute Hypoxemic Respiratory Failure"

Exclusion Criteria:

* Endotracheal intubation for \>72h before inclusion.
* Do not resuscitate order or other limitation of care.
* Known pregnancy.
* Cases where the treating physician opposes inclusion due to safety concerns or considerations that renders inclusion unfeasible.
* Not having had echocardiography performed during the trial period (exclusion criteria for this sub-study).
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy Volunteers

This study will look at the safety and tolerability of TPI 1100 in healthy volunteers and look at pharmacodynamic (PD) effect on mRNA expression of PDE 4B/D \& 7A in blood and in sputum.

Study was not initiated and terminated before start-up.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, male or female volunteers aged 18 to 55 years inclusive
* Screening/baseline FEV1 greater than 90% predicted,
* Body mass index (BMI) of 19 to 28 inclusive,
* Clinical laboratory values and/or vital signs within normal reference ranges or not considered clinically significant by the Investigator

Exclusion Criteria:

* Airways or systemic conditions that might affect respiratory function, including but not limited to clinically significant cardiac problems,
* Breast-feeding or pregnancy,
* Positive tests for smoking tobacco, alcohol, hepatitis B-surface antigen, hepatitis C antibody, and HIV at screening,
* History of serious adverse reaction to any drugs,
Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer

prospective study for response of neoadjuvant chemotherapy in metaplastic carcinoma of triple negative breast cancer

Vimentin/Pan CK staining will be performed on tissues of patient who visited Seoul National University Hospital and were diagnosed with triple negative breast cancer and decided to perform neoadjuvant chemotherapy under clinical judgement.

Histologically determined to be a metaplastic breast cancer or tested positive for vimentin/Pan CK patients decides as the metaplastic breast cancer. They evaluate the response rate of the neoadjuvant chemotherapy.

Patients with vimentin/Pan CK negative are diagnosed with non-metaplastic breast cancer and this group also confirms the response rate of neoadjuvant chemotherapy.

The group of metaplastic breast cancer will enroll 50 people, and the group of non-metaplastic breast cancer will enroll 100 people.

Eligibility Criteria:
Inclusion Criteria:

* over 20 years old
* patients with triple negative breast cancer diagnosed Seoul National University Hospital
* patients who decided to perform neoadjuvant chemotherapy under clinical judgement

Exclusion Criteria:

* not applicable
Convalescent Plasma in COVID-19 Elderly Patients

The trend of the spread of the COVID-19 pandemic demonstrates in Lombardy, starting from 28.03.2020, a slowdown in the exponential phase of infections and the probable reaching of a plateau phase.

However, a marked increase in infections was observed in the so-called "protected structures" such as nursing homes (RSA), both in health staff and in the residents of such facilities. The observed percentage of lethality, according to the more recent data provided by the National Institute of Health, is very high especially among residents.

For these reasons, the city Hospital (ASST) of Mantua , already involved in the use of hyperimmune plasma as a therapy for COVID-19, designed this study in order to evaluate RSA patients and to identify the cases eligible for this treatment.

For a detailed description of the study, see the attached protocol

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (\> 65 years old) with SARS-CoV-2 RT-PCR positivity on nasal swab or score higher than 5 with the following characteristics:

  * New onset or worsening of recently onset respiratory symptoms (\<10 days);
  * Radiological imaging (CT, X-ray, Ultrasound) of bilateral pulmonary opacities not fully explained by pleural effusion, pulmonary or lobar atelectasis, pulmonary nodules;
  * Respiratory failure (SpO2 \<95%) not fully explained by heart failure or water overload (after excluding hydrostatic causes of edema in the absence of risk factors by objective assessment, for example ultrasound);
* Patients who have signed informed consent.

Exclusion Criteria:

* New onset or worsening of respiratory symptoms that began more than 10 days ago;
* Patients with proven hypersensitivity or allergic reaction to plasma, blood products or immunoglobulins;
* Manifest desire not to be included in the research protocol.
Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children

The purpose of this study is to observe the persistence of protection, duration of protection, safety and breakthrough infection rates afforded by live attenuated varicella vaccine in children over a 5-year period.


Eligibility Criteria:
Inclusion Criteria:

* Participant are healthy children aged 1-6 years, who has inquired for medical history and physical examination, and met the requirement of the vaccine trial
* Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
* Body temperature ≤37℃

Exclusion Criteria:

* Participant with previous history of chickenpox or zoster
* Receipt of varicella vaccine
* Reported the family history of allergies, convulsions, epilepsy and mental illness
* Known allergy to any constituent of the vaccine
* Known serve illness, in a fever, acute infection and chronic disease activity
* Receipt of steroid
* Reported the history of thrombocytopenia or other coagulation disorders, which may cause
* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
* Known congenital malformation, developmental disorders and severe chronic disease (e.g. Down's syndrome, diabetes, sickle cell anemia and neurologic disorders)
* Known dermatopathy with allergy, herpes, fester, and fungal infection
* Receipt of whole blood, blood plasma or immunoglobulin in the 3 months preceding the trial vaccination
* Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination
* Participant with fever(temperature≥ 38℃) in the days
* Any condition, which, in the opinion of the investigator, would pose a health risk to the subject
Survivin as Predictive Biomarker for RA

Purpose: to examine the possibility of using the onco-protein survivin as a predictive biomarker for identifying individuals at risk of developing rheumatoid arthritis within a cohort of patients seeking treatment for joint pain/stiffness. Secondly, to study survivin as a prognostic marker for joint destruction, refractory and highly active disease in patients with established RA.

The study will analyse survivin levels in a non-selected material within a cohort of patients seeking help at their primary health care for joint pain, stiffness, swelling etc. Patients presenting with such symptoms (not explained by injury or other factors) are suspected to have an arthritic condition such as RA, and are routinely tested for presence of autoantibodies RF and ACPA. In this observational study we add measurement for survivin to the blood analyses of these patients. Information about patients expressing high levels of survivin will be reported to the referring doctor at the primary health care, and for patients not previously having been examined by a rheumatologist this will be offered.

The study will be performed at Sahlgrenska university hospital Gothenburg and Umeå university hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients seeking treatment at the primary health care for problems with their joints (pain, stiffness).

Exclusion Criteria:

* Patients diagnosed with RA
The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

The goal of this observational study is to explore the relationship between related blood indicators and diabetic peripheral neuropathy.

This is a multi-center(about five), randomized, double-blind, placebo-controlled clinical trial with over 1000 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers and electromyography. All participants provided their written informed consent to participate in this study.The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Wenzhou Medical University(KY-2022-R009).

Eligibility Criteria:
Inclusion Criteria:

* patients who had undergone nerve conduction examination by electromyography(EMG).

Exclusion Criteria:

* pregnancy and lactation; chronic liver disease, kidney disease, arrhythmias, malignant diseases, severe respiratory diseases, heart failure, and acute infections;
* patients with alcohol abuse; history of Autoimmune liver disease, liver disease or abnormal liver function at baseline;
* parathyroid diseases (including hyperthyroidism and hypothyroidism);
* pancreatitis, pancreatectomy or any transplant;
* patients with malignancy and any serious concomitant disease limit the existence of life expectancy
Total Pancreatectomies in Germany - Epidemiology, Trends,

The purpose of this study was to evaluate the real-world mortality rates of total pancreatectomy across Germany and to understand the impact of hospital caseload on surgical outcomes.

This retrospective observational study analyzed routine data from the nationwide German diagnosis-related group statistics, covering the years 2010 to 2020. The data included all inpatient episodes from acute care hospitals. The study focused on mortality rates associated with total pancreatectomy and examined how these rates varied with the complexity of the surgeries and the volume of procedures performed by different hospitals.

The mortality rates for total pancreatectomy in Germany were found to be more than three times higher than those reported by specialized pancreatic centers. Mortality rates increased significantly with the complexity of the total pancreatectomy procedures, especially those involving arterial resections. Hospitals with lower total pancreatectomy caseloads had higher mortality rates compared to high-volume centers.

Results showed that total pancreatectomies are associated with high mortality rates, particularly in hospitals with lower surgical volumes. The findings suggest that the promising outcomes from specialized centers cannot be generalized to all hospitals performing pancreatic surgeries, highlighting the need for a thorough understanding of the learning curve and specialization in pancreatic surgery to reduce mortality risks.

Eligibility Criteria:
Inclusion Criteria:

* total pancreatectomy between January 2010 and December 2020
* 18 years or older

Exclusion Criteria:

* postmortem pancreatectomy (OPS code 5-525.4)
* removal of a pancreas transplant (OPS code 5-525.3)
Korean Idiopathic Pulmonary Fibrosis Registry

This is a multicenter prospective registry of IPF patients in South Korea. The Seoul National University Bundang Hospital is the coordination center for the Korean IPF Registry built by a collaboration of the Korean Interstitial Lung Diseases (ILD) Study Group.

Korean ILD Study Group includes investigators of 30 hospitals. Demographic, pulmonary function, laboratory data, chest CT findings and hospital course of IPF patients are collected.

Eligibility Criteria:
Inclusion Criteria:

* IPF patients diagnosed by multidisciplinary discussion

Exclusion Criteria:

* Other interstitial lung diseases except for IPF
* connective tissue disease-related ILD
* exposure-related ILD
Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries

Objectives: to assess the efficiency of three methods of enamel remineralization on initial approximal caries: 1. a nano-hydroxyapatite gel, 2. gaseous ozone therapy 3. combination of a nano-hydroxyapatite gel and ozone.

Materials and Methods: Patients (n=92, age 20-30y) with initial approximal enamel lesions on premolar and molar teeth (n=546) randomly allocated to three groups subjected to a 6-months treatment: Group I: domestic nano-hydroxyapatite remineralizing gel, group II: in-office ozone therapy, group III: both remineralizing gel and ozone therapy. Caries lesions assessed on bitewing radiographs at baseline, after 1 year and after 2 years.


Eligibility Criteria:
Inclusion Criteria:

-initial approximal enamel lesions on premolar and molar teeth

Exclusion Criteria:

* distal surface of the last tooth in arch, overlapping teeth
* fillings on approximal surfaces of teeth of interest
* ongoing orthodontic therapy with braces or other appliances