cyrilzakka/clinical-trials huggingface dataset:
Federal Learning Algorithm for an Intelligent Insulin Decision System for Dynamic Glucose Control in Type 2 Diabetic Patients

Constructing an intelligent insulin decision-making system for dynamic glucose control in type 2 diabetes mellitus via a multicentre federated learning algorithm, comparing the performance of the federated learning model, the local model and the initial model, and evaluating their feasibility and safety.

Constructing an intelligent insulin decision-making system for dynamic glucose control in type 2 diabetes mellitus via a multicentre federated learning algorithm, comparing the performance of the federated learning model, the local model and the initial model, and evaluating their feasibility and safety.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes inpatients receiving insulin therapy

Exclusion Criteria:

* use of insulin pumps or glucocorticoids during hospitalisation
* less than two days of insulin therapy
Cystic Fibrosis Related Diabetes Screening.

Cystic fibrosis-related diabetes is a late cystic fibrosis (CF) associated comorbidity whose prevalence is increasing sharply lifelong. Guidelines for glucose metabolism (GM) monitoring relies on oral glucose tolerance test . However, this test is neither sensitive nor specific.

The aim of this study is to compare sensitivity and specificity of different methods for GM monitoring in children and adolescents with CF.

Continuous GM system (CGMS) will be used as the reference method. Results will be compared to those of oral glucose tolerance test (OGTT), intravenous glucose tolerance test (IGTT), homeostasis model assessment index of insulin resistance (HOMA-%IR) , homeostasis model assessment index of beta-cell function (HOMA-%B) and HbA1C dosage (glycated haemoglobin A1C). Patients will be classified into three groups according to CGMS: normal glucose tolerance, impaired glucose tolerance and diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with confirmed diagnosis of Cystic Fibrosis with a sweat chloride \> 60 mmol/L.
* Subjects will be aged between 10 and 18 years with at least one class 1 or 2 Cystic fibrosis transmembrane conductance regulator (CFTR) mutation.
* Subjects will be pancreatic insufficient.
* Subjects must have a forced expiratory volume 1 (FEV1)\> 40 % of predicted normal for age, sex and height at the screening visit.
* Stable CF disease as judged by the investigator

Exclusion Criteria:

* Subjects with glucose intolerance abnormalities
* Subjects with pulmonary exacerbation within 4 weeks before screening
* History of lung or hepatic transplantation or awaiting transplantation
Sarcopenia and Related Factors in Coronavirus Disease 2019 (COVID-19) Following Intensive Care

The primary aim of this study is to evaluate the patients who had pneumonia or severe acute respiratory distress syndrome (ARDS) due to COVID-19 in terms of sarcopenia and related factors following Intensive Care Unit (ICU).

The patients who had COVID-19 infection in the ICU and the patients who admitted to the 'Physical Medicine and Rehabilitation' clinic for other reasons during the pandemic period will be compared in terms of sarcopenia.

Patients with acute respiratory distress syndrome (ARDS) could develop muscle weakness associated with impairment of physical function defined as intensive care unit acquired weakness. Significant muscle loss occurs in the first week of the Intensive Care Unit (ICU) hospitalizations due to acute respiratory failure. Patients lose 18 percent of their body weight when discharged from the ICU. The presence of sepsis is known as the hypercatabolic process for the muscles. Hypophosphatemia and hypomagnesemia can cause respiratory muscle weakness. Fever and inflammation, use of muscle relaxant or sedatives may also cause muscle loss in intensive care during this period.

COVID-19 is an acute infection with a high risk of enormous cytokine storm exacerbating the clinical condition in acute respiratory distress syndrome and is thought to further increase the risk of muscle weakness.

The patients will be evaluated for hand grip strength, calf circumference measurement, 'Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls' (SARCF), SarQoL, timed up and go test, sit to stand test, and Short form-36.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ARDS or severe pneumonia due to COVID-19 hospitalized in intensive care unit
* \> 18 years old
* Age and gender matched patients admitted to the 'Physical Medicine and Rehabilitation' clinic for control group

Exclusion Criteria:

* Other diseases that may cause sarcopenia (cancer, non-respiratory organ failure and heart, liver or kidney failure)
* Neurological diseases that may cause sarcopenia (stroke, spinal cord injury, muscle diseases)
Aquatic Exercise for Cognition and Mobility in Older Adults

The purpose of this study is to assess the effects of an aquatic exercise program on cognition and physical function of older adults.


Eligibility Criteria:
Inclusion Criteria:

* Able to ambulate 100 ft independently with or without assistive device
* Score greater than or equal to 3 on the Mini-Cog Test
* Stable medical condition within one month prior to the study
* Stable exercise program within one month prior to the study
* Available during study testing and group class times
* COVID-19 vaccination
* Permission from medical provider to participate in the study

Exclusion Criteria:

* History of dementia or Alzheimer's
* Contraindication to exercise or pool immersion (e.g., unstable cardiovascular conditions, fever, diarrhea, aqua-phobia)
Treatment for Non-Suicidal Self-Injury in Young Adults

The purpose of this study is to investigate an intervention specifically for non-suicidal self-injury (NSSI) in young adults. The goal of this 9-session outpatient intervention is to reduce the frequency and severity of NSSI. During Phase I, 12 patients will be treated in an open pilot trial. During Phase II, 60 patients will be treated in a randomized controlled pilot study in order to determine the feasibility and acceptability of the intervention and to investigate change in NSSI frequency and severity over time.

Non-suicidal self-injury (NSSI), deliberate harm to the body without suicidal intent, is highly prevalent in young adults, with 1 in 10 college students engaging in over 100 episodes in their lifetimes. Consequences of NSSI are severe, including physical injury ranging in medical severity, distress from shame associated with the behavior, social isolation, psychological symptoms, and increased risk and lethality of NSSI over time. Despite the prevalence and significant consequences of NSSI, no empirically supported treatments specific to NSSI exist. The purpose of this study is to develop, implement, and evaluate an intervention specifically for NSSI in young adults, the Treatment for Self-Injurious Behaviors (T-SIB). This time-limited intervention will integrate theoretically-based strategies whose utility has been identified through empirical research with the goal of reducing frequency and severity of NSSI. The research plan consists of 2 phases. During Phase 1, 12 patients will be treated in an open pilot trial. During Phase 2, 60 patients will be treated in a randomized controlled pilot study to determine the feasibility and acceptability of T-SIB, investigate change in NSSI frequency and severity between T-SIB and treatment as usual (TAU) through a 3-month follow up period, and evaluate the research design of the randomized controlled pilot study to inform both the utility and design of a larger randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-29
* NSSI within the past month OR history of NSSI and urge to self-injure within the past month

Exclusion Criteria:

* Psychotic symptoms
* Severe suicidal ideation
Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation

The purpose of this study is to compare microwave ablation using the Acculis Microwave Tissue Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien cool-tip radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (HCC).

The investigators hypothesize that microwave ablation can achieve a better complete ablation rate as compared to radiofrerquency ablation.

A randomized comparative study is performed by randomly assigned participants to microwave ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed by the complete tumor ablation rate at 1 month, recurrence rate and survival time of participants. Safety of the procedures is also compared between the 2 treatment arms.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Unresectable hepatocellular carcinoma (HCC) and tumor amendable for local ablation
* Resectable HCC but patient opts for local ablation
* Maximum diameter of tumor ≤6cm
* Maximum number of tumor nodules ≤3
* Absence of radiology evidence of major vascular or bile duct invasion
* Child's A or B liver function
* Karnofsky performance status ≥70%

Exclusion Criteria:

* Informed consent not available
* Pregnant female patients
* Tumors unfavourable for local ablation (e.g. tumor close to porta hepatis)
* HCC with history of rupture
* Concomitant hepatectomy
* Patients with chronic renal failure
C2-C4 Compartment Block Versus Block of Costagliola, in TEAC

C2-C4 compartment block compared to the Costaiola block, in the control of persistent postoperative pain (somatic and neuropathic) in patients undergoing carotid thromboendarterectomy

A comparative analysis will assess the somatic pain (scores ≥4 on the NRS scale) and neurapathic pain (by the Lindblom roller and Von Frei hair tests) between group A (block group of the C2-C4 compartment ) and the control group B (block group according to Costagliola), during the 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing to carotid thromboendarterectomy

Exclusion Criteria:

* ASA status: 4
* pregnancy
* BMI \> 39,99
* neurological impairment
* neck anatomical abnormalities
* status of sepsis
* coagulopathy
* neck cancer
* neck infections
Efficacy and Safety of DLBS3233 in Prediabetic Patients

This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of DLBS3233.

It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as measured by the improvement of prandial (particularly the first phase) insulin secretion as well as insulin resistance in prediabetic subjects which may prevent the conversion of prediabetes into type 2 diabetes mellitus.

There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 for 12 weeks of therapy.

Subjects will be provided with an education on lifestyle modification given by the assigned nutritionist. All subjects will be advised to follow such a lifestyle modification throughout the study period.

All subjects will be under direct supervision of a medical doctor during the study period.

All clinical and laboratory examinations to evaluate the investigational drug's efficacy, will be performed at baseline, Week 8th and Week 12th (end) of study treatment. Blood glucose level (both FPG and 2h-PG) will be performed at baseline and at interval of 4 weeks over the 12 weeks of study treatment. Safety examinations will be performed at baseline and at the end of study. Occurrence of adverse event will be observed during the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with age of 18-60 years
* Prediabetic patients (2h-PPPG level of 140-199 mg/dL)
* Serum ALT ≤ 2.5 times upper limit of normal
* Serum creatinine \< 1.5 times upper limit of normal
* Able to take oral medication

Exclusion Criteria:

* Female of childbearing potential
* History of diabetes mellitus
* History of symptomatic coronary arterial disease, stroke, and cardiovascular events
* Current treatment with systemic corticosteroids or herbal (alternative) medicines
* Any other disease state or uncontrolled illness, which judged by the investigator, could interfere with trial participation or trial evaluation
* Participation in any other clinical studies within 30 days prior to screening
Genetic Influences Between Cognitive Function and BMI

In this study the investigators will interrogate an existing data set to examine whether genetic variants contribute to an inverse association between weight status and cognitive function. Investigators hypothesize that body mass index (BMI) will be inversely related to a number of variables measuring cognitive function, and that that this inverse relation will be at least partially attributable to genetic variants which influence both BMI and cognition.

Investigators will use existing data collected as part of the Texas Twin Project (TTP). TTP collected neuropsychological task data on cognition (executive functioning and general cognitive abilities) from a computerized test battery, as well as BMI data, on a sample of 869 twins. Investigators will use information from the known extent of genetic and environmental sharing between members of MZ (monozygotic; identical) and DZ (dizygotic; fraternal) twin pairs to quantify the genetic correlation between measures of cognition and BMI using biometric genetic modeling under the assumptions of the classical twin model. The specific aims are:

* To examine the association between BMI and executive functioning (EF) in a sample of 869 twin children, ages 7 to 15 years old, who participated in the Texas Twin Project (TTP)
* To gauge the specificity of EF-BMI relations relative to academic achievement and general cognitive abilities.
* To examine the relative contribution of genetic and environment influences to the inverse association between BMI and EF

Eligibility Criteria:
Inclusion Criteria:

All participants in the TTP database with executive functioning and BMI data, without a parent-reported medical disorder affecting growth

Exclusion Criteria:

Parent-reported medical disorder affecting growth More than one sibling in the dataset (if triplets are present, only two randomly selecting siblings will be included).
Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa

Male and female patients aged ≥ 30 years with advanced stage idiopathic Parkinson's disease, not well controlled on existing levodopa will take part in a research study at approximately 82 sites in Europe, Israel, South Africa, Australia and new Zealand.

The purpose of the study is to evaluate the effectiveness, safety and tolerability of the rotigotine patch (SPM 962) at an individual patient's optimal dose for a period of 4 months

Each patient who qualifies and chooses to participate in the study will receive either rotigotine, pramipexole, or placebo at gradually increasing doses over a period of up to 7 weeks, and then maintain their optimal dose for 4 months.

The study clinic visits will include a medical history and physical exam, ECG, blood and urine sample collection, completion of various questionnaires, and completion of a diary to record the severity of their Parkinson's symptoms.

Patients who complete the study may enroll in an extension trial and receive active study drug.


Eligibility Criteria:
Inclusion Criteria:

* Advanced stage idiopathic Parkinson's disease

Exclusion Criteria:

* Well controlled on levodopa
Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of childbearing age. PCOS can be individualized into several phenotypes, taking into account in particular the presence of hyperandrogenism, insulin resistance and BMI. Hyperandrogenism and insulin resistance appear to be important factors in the development of cardiovascular cardiovascular disease. In addition, patients frequently use anti-androgenic and/or contraceptive treatments contraceptives, such as combined hormonal contraception (CHC), the use of which is associated with an increased cardiovascular and thrombo and venous thrombosis (VTE). A meta-analysis published in 2020 by Gariani et al.

based on three large studies, estimated the risk of VTE in women with PCOS after adjustment for obesity and hormone therapy. This risk was significantly higher compared with women without PCOS (pooled OR 1.89, CI95% 1.60-2.24). No study has looked specifically investigated the risk of VTE according to different PCOS phenotypes. Such data would be very useful in clinical practice, as it would enable monitoring, contraceptive treatment and anti-androgenic anti-androgen treatment according to the PCOS phenotype, while limiting risks. Assessing the differences PCOS phenotypes is limited by the large sample size required. required. VTE is a rare event in women of childbearing age, and the number of PCOS phenotypes is high.

PCOS phenotypes. Intermediate markers of VTE risk are used in these situations. These markers are thrombin generation tests (notably ETP) and their sensitivity to activated protein C (nAPCsr) and thrombomodulin (nTMsr), as well as sex-hormone binding globulin (SHBG).


Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 35 years of age at the time of inclusion;
* Able to give non-opposition
* Strong suspicion of PCOS according to 2023 recommendations
* Have stopped hormonal contraception for at least 3 months or insulin-sensitizing treatment for at least 3 months.
* Fasting for at least 12 hours.
* Be affiliated to a health insurance scheme.
* French-speaking

Exclusion Criteria:

* Already included in a type 1 interventional research protocol (RIPH1).
* Be under guardianship or curatorship
* Deprived of liberty
* Under court protection
* Pregnant (positive urine or blood pregnancy test), or within 3 months of post-partum or post abortum, or breastfeeding (or within 3 months of weaning)
* Using hormonal contraception or insulin-sensitizing therapy (a wash-out of at least 3 months before inclusion).
* Have a personal history of VTE or known thrombophilia.
* Current anticoagulant or antiaggregant treatment or treatment stopped less than one month before inclusion.
* Have a severe personal medical history in the previous 6 weeks (fracture, infection, hospitalization, surgery, cardiovascular event, cancer).
Using TMS to Understand Neural Processes of Social Motivation

The purpose of this study is to use transcranial magnetic stimulation (TMS) to better understand the neural circuits associated with social motivation.

Participant includes four study visits each that range from 1.5 - 3.0 hours in duration over approximately a one month period. The first study visit involves answering survey questions, a clinical interview, and computer tasks. The second study visit involves a magnetic resonance imaging (MRI) scan, computer tasks, and a brief TMS protocol. The second and third study visits involve a full session of TMS followed by an MRI scan and computer tasks.

Adults in the Auburn/Apelika area who avoid social situations, experience symptoms of depression or social anxiety, and are between 25 years old and 50 years old are eligible to participate.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Major Depressive Disorder OR a diagnosis of Social Anxiety Disorder (assessed/confirmed at screening visit).
* Scoring above clinical threshold on a measure of social avoidant behavior (assessed/confirmed at screening visit).

Exclusion Criteria:

* Unstable medication regimen (i.e., changes in medication or dosage in past 3 months).
* Current or lifetime diagnosis of Bipolar Disorder.
* A diagnosis of substance use disorder within past 12 months.
* A diagnosis of psychotic-spectrum disorder such as Schizophrenia.
* Pregnancy or probable pregnancy.
* Medical illness or medical treatment that would preclude or inhibit study participation.
* Neurological disorder or prior neurosurgical procedure.
* History of seizures or head trauma.
* Metal implants or objects within body (e.g., pacemaker).
Non-invasive Measures of Distal Lung Disease in Asthmatics

This is a Phase 4, single center study conducted in mild-to moderate asthmatics.

The study consists of 3 phases. There are 7 study visits.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Currently using SABA prn or a low-to-moderate persistent asthma

Exclusion Criteria:

* Tobacco use within 1 year or \>= 5 pack years
Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal Strategies to Reduce Methicillin-resistant Staphylococcus Aureus (MRSA) in Intensive Care Units (ICUs)

The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care units. The three strategies to be evaluated are:

* screening on admission followed by isolation of MRSA+ patients
* screening on admission followed by isolation and decolonization of MRSA+ patients
* universal decolonization on admission with no screening. The decolonization regimen involves bathing with chlorhexidine plus intra-nasal application of mupirocin. The main outcome will be MRSA+ clinical cultures.

The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital Corporation of America.

Baseline data involving 12 months of data for participating hospitals (July 2008 - June 2009) was collected prior to randomization to account for size and ICU baseline prevalence of MRSA in randomization scheme. Randomization occurred at the hospital level.

Eligibility survey was conducted to determine exclusion criteria.

As of May 2010, enrollment has been closed. 45 hospitals were randomized, but two were found to meet exclusion criteria and were excluded. As-randomized (or as-assigned) analysis included 43 hospitals, representing 74 ICUs. Individual (patient-level) subject enrollment during intervention is 74,256.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria will include all HCA hospitals that reside in US states where physicians do NOT routinely prescribe decolonization for MRSA + ICU patients.

Exclusion Criteria:

* Exclusion criteria will include hospitals where ICU physicians often prescribe decolonization for MRSA+ ICU patients.
* Dedicated burn ICUs will also be excluded due to the inability to perform routine bathing.
* Finally, since the intent is to assess the intervention in adult ICUs, pediatric hospitals will be excluded although patients \<13 years old that are admitted to participating adult ICUs will be included in the unit-based intervention.