cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of Epilepsy Localization and Prognosis Based on PET and Resting-state fMRI

1. By following up the prognosis of surgical patients, the application value of Cortex ID quantitative analysis in the localization of epilepsy foci was studied.
2. By studying the correlation between autonomic nerve function and epilepsy neural network in epilepsy patients, and analyzing the differences between different epilepsy patients, it can provide more information for judging the prognosis of epilepsy patients.

This study included diagnostic trials and case-control studies, which were observational studies with no intervention. First, the demographic and clinical information of epilepsy patients in the Neurology Department of Xijing Hospital were collected, including gender, age, age of onset, course of epilepsy, seizure performance before treatment, seizure frequency before treatment, type and dose of antiepileptic drugs, past history, Family history, etc., as well as imaging, EEG, quality of life, and neuropsychological assessment, etc. were collected; secondly, functional magnetic resonance imaging (fMRI) and 24-hour Holter monitoring were performed on patients who met the inclusion criteria. Positron Emission Computed Tomography (PET) images of patients who have undergone or plan to undergo surgery are analyzed; finally, appropriate statistical methods are used for analysis.

Eligibility Criteria:
Inclusion Criteria:

Meet the diagnostic criteria for epilepsy,

* No contraindications for fMRI examination.
* The patient had no other heart and lung diseases except epilepsy.
* Patients and their families were aware of this study and signed informed consent.

Exclusion Criteria:

* Patients with severe infection, cerebrovascular disease, malignant tumor and other systemic diseases that can affect the nervous system, and those with serious dysfunction of the heart, liver, kidney and other organs.
* Non-epileptic seizures such as syncope and hysteria.
* Pregnant or lactating women. Incomplete clinical data
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of ulcerative colitis (UC) at least 3 months' duration prior to screening
* Moderately to severely active UC as assessed by the modified Mayo score
* Documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications: oral 5-aminosalicylic acids, corticosteroids, immunomodulators, anti-tumor necrosis factor (TNF) agents, integrin inhibitors\[SA1\]
* Documentation of prior treatment with corticosteroids for ≥ 4 weeks
* Males and females must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, or pseudomembranous colitis
* Current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
* History or evidence of any extensive colonic resection, or subtotal or total colectomy
* Women who are pregnant or breastfeeding
* Prior exposure to BMS-986165 or a tyrosine kinase 2 (TYK2) inhibitor

Other protocol-defined inclusion/exclusion criteria apply.
Health Behavior Change in Chronic Disease Management

The purpose of this pilot trial is to provide preliminary evidence of the effectiveness of a brief behavioral intervention using telemedicine home monitoring to help individuals with multiple sclerosis adhere to medications that slow disease progression.

There is increasing recognition that coordinated approaches to disease management improve medication adherence. Intervention in chronic illness may be viewed as a multidisciplinary and collaborative process based upon behavioral principles, including the idea that illness management skills are learned and behavior is self-directed, motivation and self-efficacy can affect self care, monitoring and responding to changes in physical and mental health improves adaptation to illness, and the health care system can support or hinder self care. Preliminary findings suggest that telemedicine home monitoring providing cues to medication administration, brief evaluation of potential barriers (e.g., fatigue, cognition, side effects), identification of areas for future education (e.g., additional injection training), and an opportunity for feedback to providers (e.g., side effects) are well tolerated and may improve self monitoring of chronic medical conditions.

The proposed study is a six-month, two group parallel-design, controlled trial to evaluate feasibility and obtain effect size estimates for a behavioral intervention to improve adherence to MS disease modifying therapy (DMT) using telemedicine home monitoring. Monitoring will include brief weekly text-based prompting to complete a series of approximately 10-15 questions regarding factors that are expected to affect adherence to DMT. Areas of assessment will include the development of side effects (e.g., flu-like symptoms), disease specific symptoms (e.g., fatigue), adherence expectation, and DMT self-efficacy. MS clinic staff will examine responses to weekly home monitoring assessment. They will provide telephone follow-up for medical advice, support, specific educational materials, and referral for services if necessary. Potential services will also be informed by Research Project 1, and will follow the general principle that they will be selected from a standardized list (e.g., additional injection training, energy management strategies for fatigue), but tailored to individual patient need based upon information obtained by home monitoring.

Primary outcome measures to assess feasibility will be the percentage of eligible participants who complete the study protocol, and comparisons between home monitoring recipients and controls regarding the overall benefits of participation. Outcomes will be assessed via monthly telephone calls.

Eligibility Criteria:
Inclusion Criteria:

- Must have Multiple Sclerosis and be on a disease modifying therapy

Exclusion Criteria:

- Inability to participate in self-care
Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination

The study aims at clarification of venous collapsibility measures with real venous flow measurements during dynamic maneuver testing fluid responsiveness in septic shock patients.

Sedated and mechanically ventilated patients in septic shock will be enrolled in the study. A fine catheter with ultrasound doppler probe will be introduced into the central venous catheter already in place in superior vena cava. Doppler signal will be evaluated by console prototype (NILUS Medical) and continuous analysis of blood flow velocity respiratory variation will be performed. These values will be compared to standard hemodynamic monitoring parameters (central venous and arterial pressures) and to parameters acquired by transoesophageal (TOE) and transthoracic echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* patients in severe sepsis or septic shock
* intubation and mechanical ventilation
* sedated patient without spontaneous respiratory efforts
* central venous catheter in place inserted via right internal jugular vein
* signed informed consent by family members

Exclusion Criteria:

* superior vena cava vascular anomaly
* irradiation of neck or mediastinum in medical history
* thrombosis of superior vena cava in medical history
* atrial fibrillation or other irregular rhythm
* permanent or external pacemaker
* aggressive mechanical ventilation (PEEP above 10 cm H2O, Pmax above 30 cm H2O)
* TOE contraindication (oesophageal varices, stricture, tumour, upper gastrointestinal bleeding)
* Pericardial effusion, constrictive pericarditis
* Moderate or severe valvular lesion
* Severe systolic dysfunction of the left (EF less than 30%) or right ventricle (FAC less than 25%)
* Intraabdominal pressure above 20 mmHg
* Open chest
* Obvious severe hypovolemia ( LVEDA\<5.5cm2/m2BSA)
Basket Study (CT-100-002) to Evaluate the Effects of a DiNaMo™ Component Training

CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a multimodal treatment in supplementary or standalone prescription or nonprescription software-based digital therapeutics (PDT/DTx), being developed by Click Therapeutics, Inc. (Click).

The Study App (CT-100-002) contains a class of Digital Neuro-activation and Modulation (DiNaMo™) mechanisms of action that are part of the Click Neurobehavioral Intervention (CNI) Platform™. DiNaMo™ provide interactive, software based therapeutic components that may be included in a multimodal treatment for developing future digital therapeutics.

Chronic pain is a transdiagnostic condition which manifests in patients with diverse underlying pathologies such as rheumatoid arthritis, diabetic neuropathy, fibromyalgia, and irritable bowel syndrome. This basket study aims to evaluate the efficacy, safety, and tolerability of CT-100-002 on measures of pain, pain-related functioning, and mood across multiple indications. The study results will further future clinical development of digital therapeutics comprising DiNaMo™ mechanisms of action.

Eligibility Criteria:
Inclusion Criteria:

* Meets indication-specific eligibility criteria as reported by the study participant with adequate clinical documentation
* Self-reported average pain intensity during the last 7 days of ≥ 3 of 10 on the Numeric rating Scale (NRS scale) associated with the primary indication
* Fluent in written and spoken English (confirmed by ability to read and comprehend the informed consent form.)
* Willing and able to comply with study protocol and assessments, evidenced by completion of the Screening Survey.
* Lives in the United States.
* Has an active email address and is willing and able to receive email messages.
* Is the sole user of an iPhone with iPhone operating systems (iOS) 14 or later capabilities or a smartphone with an Android operating system (OS) 10 or later capabilities with cellular and/or internet access for the duration of the study period.

Exclusion Criteria:

* Has a comorbid acute pain condition, such as from current injuries
* Participation in a clinical trial (including psychotherapy, mindfulness, cognitive training, or drug treatment) within the last 2 months
* Initiation or change in primary disease-specific medication for 30 days prior to entering the study
* Self-reported substance use disorder within the past 1 year
* Daily use of opioids of 30 MME (Morphine Milligram Equivalents) or more
* Substance use disorder within the past 1 year.
* Initiation or change in central nervous system-active medication (e.g., antidepressants) during the last 2 months.
* Participation in a clinical trial within the last 2 months.
* Planning to introduce new therapies or change therapies during the study duration
* Visual, dexterity or cognitive deficit so severe that precludes the use of an app per investigator judgment.
* Severe psychiatric disorder involving a history of psychosis
* Other significant medical condition that may confound the interpretation of findings
Extra Vascular Lung Water and Pulmonary Permeability in Critically Ill Patients With SARS-CoV-2 (COVID-19)

Acute respiratory distress syndrome (ARDS) is a syndromic definition of an acute lung injury with alteration of biomechanics (lower respiratory system compliance) mostly associated with increased lesional edema. Increase in Pulmonary Vascular Permeability Index (PVPI) accompanied with accumulation of excess Extravascular Lung Water (EVLW) is the hallmark of ARDS. In routine clinical practice, the investigators measure the EVLW and PVPI in ARDS patients, as suggested by expert's recommendations, using a transpulmonary thermodilution (TPTD) technique.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly recognized illness that has spread rapidly throughout Wuhan (Hubei province) to other provinces in China and around the world. Most critically ill patients with SARS-CoV-2 will present the criteria for the definition of ARDS. However, many of these patients have a particular form of ARDS with severe hypoxemia often associated with near normal respiratory system compliance. This combination is almost never seen in severe ARDS. Thus other mechanisms (including probably vascular mechanisms), that are still poorly described, have to be involved in SARS-CoV-2.

EVLW and PVPI have never been assessed in SARS-CoV-2 mechanically ventilated patients. The aim of this study is to evaluate these two parameters in order to best characterize and understand the mechanisms related to SARS-CoV-2.

Based on observation of several cases in intensive care units (ICU), the investigators hypothesize that there are following different SARS-CoV-2 patterns:

1. Nearly normal compliance, low lung recruitability, normal EVLW and low PVPI.
2. Low compliance due to increased edema, high lung recruitability, high EVLW and high PVPI.


Eligibility Criteria:
Inclusion criteria:

* COVID-19 critically ill patients
* Invasive mechanical ventilation

Exclusion criteria:

* Age under 18
* Pregnancy
* Legally protected adults
* Contra-indication of using PiCCO device: jugular venous thrombosis, or severe chronic femoral/iliac artery occlusive disease
The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration

Percutaneous nephrolithotomy (PCNL) is a safe and effective procedure that is considered the standard treatment for large and complex renal stones. Although it has lower complication and morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube can cause distress for patients.

Managing this pain with opioids can lead to sedation, nausea, vomiting, and constipation, which defeat the purpose of this minimally invasive procedure.

Skin infiltration with bupivacaine around the nephrostomy tube is not effective. Infiltration of renal capsule has shown to facilitate painless insertion of nephrostomy tube, suggesting the role of renal capsule in pain management.

Peritubal infiltration of bupivacaine from renal capsule to the skin along the nephrostomy tract may alleviate postoperative pain. A unilateral Low thoracic paravertebral (PVB) block offers the option of providing extendable perioperative pain relief without the above side effects or the physiologic derangement associated with local anesthetics in the central neuraxial space.

The aim of this study is to determine whether ultrasound guided low thoracic paravertebral block effective post-operative analgesia as compared to peritubal infiltration analgesia in patients undergoing percutaneous nephrolithotomy.

Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary endpoints are visual analogue pain scores, opioid related side effects.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients undergoing percutaneous nephrolithotomy

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
Oxidative Stress Gene Polymorphism and Ovarian Reserve Functione

the relationship between FOXO3A-bim pathway gene polymorphisms and ovarian reserve function of paitients with ovarian endometrioma

Ovarian reserve refers to the left ovarian cortex follicle growth, development, the quantity and quality of potential ability of oocytes, reflects the fertility in women. Ovarian endometrioms have an effect on ovarian reserve function. Oxidative stress is one of the important reasons. The effect has individual differences and the mechanisms are not clear.FOXO3A-bim pathway gene polymorphisms have been reported to related to individual variation of ovarian reserve function of paitients with POF. Our working hypothesis is that FOXO3A-bim pathway gene polymorphisms are also related to ovarian reserve function of paitients with ovarian endometrioma. In recent 10 years, we have set up a database including more than 2000 cases of ovarian endometrioma. In this project, we are going to investigate the oxidative stress factors, the level of sexual hormone, ultrasound information and the relationship between FOXO3A-bim pathway gene polymorphism.All these multi-diciplinary research will lead to novel understanding of individual variation of ovarian reserve function.

Eligibility Criteria:
Inclusion Criteria:

20 to 35 years old, non-menstrual period, not in pregnancy or puerperal period, diagnosed with ovarian cyst according to preoperative clinical symptoms, physical examination, ultrasound, CA125 and other non-surgical diagnosis methods, and all the participants having surgical indications, and ultimately conformed through histopathological diagnosis

Exclusion Criteria:

Participants receiving hormone therapy within the past six months, HIV or hepatitis B/C positive, autoimmune diseases, endocrine diseases and systemic diseases (such as diabetes, hormone therapy diseases, severe liver and kidney dysfunction), severe mental illness and malignant tumors.
ClotTriever Outcomes (CLOUT) Registry

Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.


Eligibility Criteria:
Inclusion Criteria:

* Proximal lower extremity DVT involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination.
* Willing and able to provide informed consent.

Exclusion Criteria:

* Prior venous stent in the target venous segment
* IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
* IVC filter in place at the time of the planned index procedure
* Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
* Life expectancy less than 1 year
* Chronic non-ambulatory status
* Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period
* Unavailability of a lower extremity venous access site
Current Outpatient Cardiac Rehabilitation in Austria

Aim of this study is to give evidence to outpatient cardiac rehabilitation in Austria. The database created in this context is supposed to pave the way as instrument to document and comprehend quality of outpatient cardiac rehabilitation in Austria as a key for quality management. Analyses of the created database should be made on a regular basis.


Eligibility Criteria:
Inclusion Criteria:

Any patient who meets inclusion criteria for outpatient cardiac rehabilitation in Austria -

Exclusion Criteria:

* Medical conditions which prevent patients from complying with the exercise program
* Acute infections
* Hypertrophic cardiomyopathy
* Pulmonary artery embolism or phlebothrombosis within the previous 6 months
* Unstable angina pectoris
* Heart failure (NYHA IV)
* Hemodynamically unstable arrhythmia
Efficiency of Continuous Glucose Monitoring in Critically Ill Patients

The purpose of this study is to determine whether, real-time continuous glucose monitoring in critically ill patients with intensive insulin therapy would increase the percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl.

Hyperglycemia is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. The current gold-standard in intensive care units to achieve normoglycemia in critically ill patients is intensive insulin therapy according to a well established algorithm along with frequent blood glucose measurements. However, applying this gold-standard method, normoglycemia, defined as blood glucose levels below 110 mg/dl, can be achieved in approximately 50 percent of time only. We hypothesized, that real-time continuous glucose monitoring would increase the percentage of time of blood glucose levels below 110 mg/dl in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Admitted critically ill patients expected to stay \>48h on the ICU after initiation of intensive insulin therapy.
* Age \> 18 years.

Exclusion Criteria:

* Admitted patients expected to stay \<48h
* Age ≤ 18 years
Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (Asfotase Alfa)

This observational study will evaluate the treatment effect of Strensiq (asfotase alfa) on Patient Reported Outcomes (PROs) in participants diagnosed with pediatric-onset hypophosphatasia (HPP) registered in the patient support program managed by OneSource™.

Participants consenting to participate in this study will be asked to complete study questionnaires by phone interviews upon consenting (Baseline), and up to 12 months following treatment initiation with asfotase alfa. Demographic and clinical characteristics of participants in the study will be characterized.

This is an observational study and no intervention will be administered. Participants will be treated in accordance with standard of care.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Clinical diagnosis of pediatric-onset HPP
* Naïve to asfotase alfa
* Expected to begin treatment with asfotase alfa for HPP
* Registered in OneSource
* Willing and able to provide voluntary, verbal informed consent to participate in this study

Exclusion Criteria:

* Pregnant or breastfeeding
* Unable to speak and understand English
* Unable or unwilling to complete the study surveys via telephone interview at the protocol-required time points
To Motivate Elderly to Move

This study examines the short- and long-term-effects of different repeated frames in which an exercise program is offered on behavior (i.e., frequency of exercise) and motivation (i.e., autonomous/controlled) in older people (65+). The frames are manipulated experimentally as either prevention focused (e.g., to prevent worse health), promotion focused (e.g., to gain better health) or neutral (control condition).


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age

Exclusion Criteria:

* severe mental/physical problems