cyrilzakka/clinical-trials huggingface dataset:
The Level of sST2 in Pediatric Heart Failure

Introduction: Suppression of tumorigenicity 2 (ST2) is a receptor member belongs to the Interleukin-1 (IL-1) family. The ligand and soluble versions are its two isoforms. The interleukin-33-ST2 ligand complexs development provides protection against heart fibrosis and hypertrophy. Investigations on heart failure in adults has demonstrated that it does not change by age, body mass index (BMI), creatinine, hemoglobin, and albumin levels, in contrast to NT pro brain natriuretric peptit. In adult heart failure patients, it has been demonstrated to be an independent predictor of mortality and cardiovascular events. The most recent guideline recommends using it as class 2b in the diagnosis of adult heart failure. Studies on ST2 in children are rare. The purpose of this study is to assess the prognostic value of ST2 for cardiovascular events in young individuals suffering from heart failure.

Method: The study included pediatric patients (0-18 years old) with congenital heart disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment. Height, weight, gender, saturation, heart failure classification (Ross or New York heart Assosiation), medications taken, the electrocardiogram, echocardiography, Pro BNP, and sST2 values of the patients, as well as any hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery during follow-up Data on arrhythmia and death were gathered during a 1-year follow-up. The SPSS software application was used to carry out the statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* The patients were those with congenital cardiac disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment.

Exclusion Criteria:

* . Excluded from the trial were individuals who had undergone cardiac surgery within past one month, had chronic renal failure, septic shock, myocardial dysfunction related to cardiopulmonary resuscitation, or for whom consent could not be received.
Rapid Non-Invasive Brain Stimulation for OCD (oTMS)

The purpose of this study is to understand how cortical stimulation affects Obsessive-Compulsive Disorder (OCD) symptoms.

Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to understand how cortical stimulation affects Obsessive-Compulsive Disorder

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Primary diagnosis of OCD
* Sufficient severity of OCD symptoms
* Capacity to provide informed consent

Exclusion Criteria:

* Psychiatric or medical conditions or medications that make participation unsafe
* Pregnant or nursing females
* Previous exposure to TMS or ECT
* History of any implanted device or psychosurgery
* Presence of metallic device or dental braces
Risk Factors and the Role of Albumin-to-globulin Ratio in Idiopathic Granulomatous Mastitis

Albumin-to-globulin ratio (AGR) is an inflammation-based index that has been shown to have a role in many cancers and inflammatory diseases. Idiopathic granulomatous mastitis (IGM) is a rare inflammatory disease of the breast with a high recurrence rate. As a relatively new biomarker for inflammatory diseases, AGR's role in IGM recurrence has never been investigated in the literature. This study primarily investigates the possible risk factors for IGM recurrence and whether AGR can be used as a predictive factor.

Patients diagnosed with IGM on pathology reports between January 2016 and March 2021 were enrolled in the study and their medical records were analyzed retrospectively. The patients were divided into two groups: recurrence and non-recurrence. Clinical, demographic characteristics, and laboratory parameters were compared. The best cut-off value for significant factors in predicting recurrence was determined by receiver operating characteristic (ROC) analysis. Univariate and multivariate logistic regression analysis was used to determine the risk factors that are effective in IGM recurrence.

Eligibility Criteria:
Inclusion Criteria:

* The patients with a pathologically confirmed diagnosis of granulomatous mastitis
* Patients over the age of 18
* Female patients

Exclusion Criteria:

* Male patients
* Secondary granulomatous mastitis etiologies (tuberculous mastitis and Wegener's granulomatosis)
* Patients who do not have enough follow-up information
* Patients with missing data
Culturally Adapted Family Intervention For Psychosis

Aim:

To assess the feasibility of culturally adapted Family Intervention for Psychosis.

Design:

Randomized Control Trial

Setting:

psychiatric department of different hospitals

Participants:

A total of 36 caregivers of Psychosis patients will be randomized to psychological Intervention and treatment as usual arm.

Intervention:

Culturally Adapted Family Intervention for Psychosis

Outcome measure:

Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care Well-Being \& Support(CWS)

The purpose of the study is to test the feasibility of culturally adaptive family intervention for Psychosis

Primary Objective :

* To test whether Pakistani families caring for someone with psychosis will engage with a model of family intervention which has been culturally adapted to meet their needs.
* To evaluate the acceptability of the intervention to the families who receive it and to gather feedback regarding any changes that might improve the intervention.
* To gain an impression of whether the intervention has the potential to address unmet psychological and social needs of the families and how this affects their levels of stress

the investigators will conduct a feasibility pilot study to test whether Pakistani families offered the intervention will want to receive it. The Participants will be recruited from psychiatric department of different hospitals. They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirty six participants will be recruited in the pilot study and divided equally into two arms. This will ensure that, even after loss to follow-up, we will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf).Randomization will be carried out by the on offsite statistician. This will provide a reliable geographically remote service. For intervention group ten sessions of family intervention will be provided by trained research clinician during the period of three months. Relatives of Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested families will be offered family intervention

Eligibility Criteria:
Inclusion Criteria:

1. Living with or with at least 10 hours per week face to face contact with an individual with psychosis who has a caring role. Plus the individual with psychosis themselves.
2. Individuals aged between 18-65.
3. Resident of Karachi.
4. Participant is able to give informed written consent.

Exclusion Criteria:

1. Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).
2. Unstable residential arrangements such that the likelihood of being available for the duration of the trial is low.

   .
Sinopsys Lacrimal Stent Indicated for Sinus Irrigation

The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.

For purposes of this clinical study, the Sinopsys Lacrimal Stent is intended to provide a means of administering saline sinus irrigation via a transcaruncular-ethmoid sinus access in patients with moderate to severe chronic rhinosinusitis with ethmoid involvement. The purpose of the administration of saline irrigation is to reduce the intensity of symptoms of chronic rhinosinusitis in this patient population.

Eligibility Criteria:
Inclusion Criteria:

1. The Investigator has determined that the potential study subject has moderate to severe chronic rhinosinusitis with ethmoid involvement and has followed at least twelve (12) weeks of appropriate medical therapy prior to enrollment
2. Age ≥ 22 years
3. The potential study subject meets the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) criteria for chronic rhinosinusitis 12 weeks or longer of two or more of the following signs and symptoms:

   * Mucopurulent drainage (anterior, posterior, or both)
   * Nasal obstruction (congestion)
   * Facial pain-pressure-fullness, or
   * Decreased sense of smell

   AND inflammation is documented by one or more of the following findings:
   * Purulent (not clear) mucus or edema in the middle meatus or ethmoid region
   * Polyps in nasal cavity or the middle meatus, and/or
   * Radiographic imaging showing inﬂammation of the paranasal sinuses
4. SNOT-20 total score ≥ 41
5. CT scan (coronal view) confirms inflammation / involvement of the ethmoid sinuses
6. CT scan (coronal view) confirms depth of olfactory fossa is Keros classification 1 or 2.

Exclusion Criteria:

1. Sinus opacification score of ≤ 8 or ≥ 18 measured using the CT derived Lund -- Mackay scoring system
2. Isolated sinus disease evident on CT scan that would be unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid or frontal disease)
3. Severe polyposis defined as Grade III or Grade IV polyposis using the adapted scale from Meltzer, 2006.
4. Prior ocular and/or sinus surgery for CRS
5. CT scan (coronal view) shows depth of olfactory fossa is Keros classification 3.
6. Prior surgical history, physical exam, nasal endoscopy and/or imaging studies suggest significant distortion of the craniofacial anatomy thus prohibiting adequate placement of the SLS
7. Presence of a sinonasal encepholocele as determined by CT scan
8. Presence of active HEENT infection including acute dacryocystitis
9. Febrile illness within 2 weeks and/or active pus from nose
10. Any sign of active ophthalmic disease, infection, or inflammation including the presence of severe ocular surface inflammatory disease or signs and symptoms of "dry eye disease" as determined by physical exam which could be exacerbated by the presence of the device
11. Current use of topical medications for the eye to treat an active ophthalmic disease
12. HbA1c level of ≥ 7.5% at the time of screening, current chemotherapy, or other immune compromised conditions
Effect of Acitretin Versus Narrowband Ultraviolet B on Neopterin Level in Psoriatic Patients .

To evaluate effect of acitretin versus Narrowband UVB on serum level of neopterin in psoriatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with psoriasis diagnosed clinically Aged (15-60).

Exclusion Criteria:

* Patient with history of skin cancer.
* Patient with history of photosensitivity.
* Pregnancy and lactation.
* Liver failure.
* Renal failure.
* Patient with psoriatic artheritis.
* Patient with allergy to product or any of its components.
* Patient with poorly controlled dyslipidemia.
* Patient receiving tetracyclines.
First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy

The goal of this clinical trial is to investigate the use of \[89Zr\]Zr-DFO-emapalumab as an IFN-γ PET imaging agent to detect lesions and response to therapy among treatment-naïve non-small cell lung cancer (NSCLC) patients. PET scans following the imaging agent will be completed prior to and about 30 days after starting immunotherapy.

Participants will be enrolled into the clinical trial once confirmed eligible. Screening activities include, standard of care blood work, medical history and a physical exam.

-Within 14 days of starting immunotherapy, participants will complete PET scans 1-2 hours post-tracer administration, again on the day following tracer administration, and 3-5 days after the tracer administration. This sequence may be repeated 25-45 days after the start of treatment with immunotherapy for a total of two tracer injections and up to six PET scans.

Eligibility Criteria:
Inclusion

* Prior histologic or cytologic diagnosis of non-small cell lung cancer.
* FDG PET done within 2 months of the baseline imaging, as part of standard-of-care.
* measurable disease by RECIST 1.1 with at least one lesion of at least 2 cm in a region of the body that can be imaged by PET (e.g.,outside of the liver)
* must be able to lie still for the tests. Their girth and weight must be suitable to enter the gantry, which varies per tomograph.
* must be \>18 years old.
* Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the cancer center.
* Physical exam, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST, and ALT) must be done within 28 days prior to PET imaging

Exclusion

* No prior immunotherapy for current stage of NSCLC (Non Small Cell Lung Cancer). Immunotherapy in neoadjuvant or adjuvant setting and have recurrence at least 12 months following completion of immunotherapy are eligible after discussion with the principle investigator.
* Pregnant or breast feeding individuals.
Real-world Study of Inetetamab in HER2-positive Metastatic Breast Cancer

A multicenter real-world study was conducted to gather clinicopathological data from patients with HER2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. The study aimed to estimate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) associated with inetetamab therapy.


Eligibility Criteria:
Inclusion Criteria:

1. An age of at least 18 years or older
2. Pathologically diagnosed with HER2-positive recurrent or metastatic breast cancer
3. Having at least one measurable lesion as defined
4. Receiving inetetamab-based therapy in the recurrent or metastatic stage
5. Having traceable medical history records

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients with other conditions deemed unsuitable for participating in this study by the researcher
Management of Women With BRCA1/2 Mutation

The aim of this study is to determine general practitionners' role in management of women with BRCA1/2 mutation.

This study will be conduct between April 2017 and December 2017 at Montpellier University Hospital on women followed-up in the department of genetics and their general practitionners (GP). Patients and their GP will be called by the investigators and questionnaire will be given to them. Questionnaire includes questions for patients and their GP. The primary endpoint was to determine the rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation. Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions. Secondary endpoint was to determine women' opinion on their GP : whether or not well managed for their BRCA 1 / 2 mutation.

PURPOSE: The aim of this study is to determine general practitionners' role in management of women with BRCA1/2 mutation.

METHODS:

This study will be conduct between April 2017 and December 2017 at Montpellier University Hospital on women followed-up in the department of genetics and their general practitionners (GP). Patients and their GP will be called by the investigators and questionnaire will be given to them. Questionnaire includes questions for patients and their GP. The primary endpoint was to determine the rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation. Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions. Secondary endpoint was to determine women' opinion on their GP : whether or not well managed for their BRCA 1 / 2 mutation.

Eligibility Criteria:
Inclusion criteria

* Aged over 18
* Women
* Living in France
* Having a medical insurance

Exclusion criteria

* Men
* Dementia
* Non frenchspeaker
* Mental retardation
* Being the subject of a guardianship or tutelage measure
In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II

Excessive inflammation is associated with tissue damage caused by over-activation of the innate immune system. This can range from mild disease to extreme conditions, such as multiple organ dysfunction syndrome (MODS) and acute respiratory distress (ARDS). In marked contrast to adaptive immunity which is very sensitive to immune modulators such as steroids, the innate immune system cannot be sufficiently targeted by currently available anti-inflammatory drugs.

The investigators hypothesize that pre-treatment with C1-esterase inhibitor in a human endotoxemia model can modulate the innate immune response.

In this study, human endotoxemia will be used as a model for inflammation. Subjects will, prior to endotoxin administration, receive C1 esterase inhibitor or placebo. Blood will be sampled to determine the levels of markers of the innate immune response.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers (18-35 years old)

Exclusion Criteria:

* Relevant medical history
* Drug-, nicotine-abuses
* Tendency towards fainting
* Hyper- or hypotension
* Use of any medication
Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty

To evaluate the effect of early postoperative oral carbohydrate on postoperative recovery of the unilateral knee arthroplasty

Currently, most clinical studies on the impact of oral carbohydrates on postoperative recovery are focused on the preoperative stage, with only a few small sample studies indicating that postoperative oral carbohydrates can improve patient comfort. Orthopedic surgery, especially joint surgery, requires patients to start functional exercise as soon as possible after surgery. Joint replacement surgery requires reducing the consumption of muscle tissue caused by protein breakdown. Perioperative nutritional support for patients is of great significance for postoperative muscle function recovery and good functional exercise. However, further systematic research on the impact of early postoperative oral carbohydrates on postoperative recovery is still lacking.

This study selected patients who underwent unilateral total knee arthroplasty or single condylar arthroplasty. All surgical patients undergo homogenized preoperative preparation and intraoperative anesthesia management. Eligible patients were screened before surgery, and an informed consent form was signed. Patients enrolled in the experiment were randomly assigned into one of the three groups. They are the early feeding group (EOF1, EOF2group) and the late feeding group （control group）. Evaluate the effectiveness and safety of early postoperative feeding （EOF） in orthopedic surgery patients by measuring indicators such as insulin resistance index, QoR-15, and prealbumin and retinol binding protein.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-79 years.
* Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
* Normal diet.
* ASA grade I\~Ⅲ;
* BMI 18-30kg /m2.
* No intraspinal anesthesia contraindications.

Exclusion Criteria:

* Preoperative existence of gastric emptying disorders, such as gastrointestinal obstruction, gastroesophageal reflux, or previous gastrointestinal surgery.
* Patients with diabetes mellitus, severe renal dysfunction, or other severe metabolic diseases.
* History of motion sickness.
* Mental disorder, alcoholism, or a history of substance abuse.
* Patients with abnormal swallowing function.
* The operation time is greater than 3 hours.
* Maltodextrin fructose allergy or intolerance.
Evaluation of Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis

Symptomatic knee osteoarthritis greatly impacts the quality of life, mobility, independence, and even safety of the individuals who suffer from it. One of the most powerful tools for these patients can be education on self-care and self-management strategies that can be taught to a patient by a physician, physical or occupational therapist, or a nurse. These self-management strategies can help patients treat daily stiffness through exercise or manage flares of osteoarthritis. There is a lack of consensus on the best teaching methods to accomplish the goal of educating our patients. Feedback from both patients and providers regarding teaching methods is needed. This study will evaluate teaching methods on self-management strategies for patients who are undergoing hyaluronic acid injections for knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients of co-investigator physicians
* Age 18+ years
* Diagnosis of symptomatic knee osteoarthritis
* Scheduled for a hyaluronic acid injection into the knee
* Provider is available to administer teaching method

Exclusion Criteria:

* Patients who are already enrolled in the study
* Non-English speaking
A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe Hypertension

To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based regimen in the treatment of severe hypertension


Eligibility Criteria:
Inclusion Criteria

* Patients with essential severe hypertension Exclusion Criteria
* History or evidence of a secondary form of hypertension
* History of hypertensive encephalopathy or cerebrovascular accident.
* Diabetic patients requiring insulin Other protocol-defined inclusion/exclusion criteria also apply
Remote Speech Analysis in HF Patients Undergoing Haemodialysis

This is an observational, non-interventional, prospective, single-arm, open study for database establishment for R\&D purposes. The study will be conducted in 1 site in Israel with up to fifty (50) patients. Patients under hemodialysis supervision will be enrolled in the clinical trial. Clinical information for the study will be collected at the hospital and at home. The patient will conduct recordings at home every day.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hemodialysis every 5-10 days in order to balance their volume overload.
* Class C Heart Failure patient with reduced EF CHF (EF\<40%) and NYHA 2-3.
* Patients with dyspnea clinically related to pulmonary congestion
* Patient with more than 3 months HF disease duration.
* The patient is willing to participate as evidenced by signing the written informed consent.
* Male or non-pregnant female patient

Exclusion Criteria:

* Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia).
* Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit.
* Patients likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit or baseline functional capacity of NYHA 4.
* Patients with evidence of active Infection.
* Patient with severe alcohol or drug use.
* Psychological instability, inappropriate attitude or motivation.
* Patient with life threatening debilitating disease other than cardiac.
* Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.