cyrilzakka/clinical-trials huggingface dataset:
Assessment of FOXP3 Gene Polymorphisms and Serum Interleukin 10 in Patients With ITP

Immune thrombocytopenia (ITP) is an autoimmune condition characterized by increased platelet destruction and suppression of production resulting in isolated thrombocytopenia. The exact etiology of ITP is unknown; however, multiple disease mechanisms exist and are mostly related to immune dysregulation \[1\].

Many studies in recent years have indicated that regulatory T cells (Tregs) play a critical role in the maintenance of immunological tolerance, and they have been reported to be defective in ITP patients, either numerically or functionally. \[2-6\]. They inhibit the activation and proliferation of effector T cells by the secretion of cytokines such as interleukin-10 (IL-10) and tumor growth factor-β (TGF-β) and by cell-to-cell interaction \[7, 8\].

The suppressor function of Treg cells may be compromised if the FOXP3 gene is deficient. FOXP3 gene single nucleotide polymorphisms (SNPs), particularly regulatory polymorphisms in the promoter regions, have been linked to a variety of autoimmune diseases, including allergic rhinitis, type I diabetes (TID), systemic lupus erythematosus (SLE), multiple sclerosis (MS), and autoimmune thyroid diseases (AITD), according to numerous studies \[9-13\].

The FOXP3 gene's promoter region, which is crucial in gene expression and Treg activation, may contain important SNPs. The 6054 del/ATT and 924A \> G SNPs are functionally well-defined and are distinguished by the relevance of studies on them among these SNPs. \[14, 15\].

The Interleukin 10 (IL-10) cytokine is required for regulating immune functions by promoting the widespread suppression of immune responses through its pleiotropic effects. IL-10 secretion from CD4+CD25+FoxP3+ regulatory cells (Tregs), macrophages and other leukocytes followed by subsequent binding to IL-10 receptors on macrophages and dendritic cells (DCs) has been linked to reduced antigen presentation and increased T-cell anergy \[16\]. The relationship between the two FOXP3 polymorphisms and ITP has not been well elucidated, hence the objective of this study is to explore if these functional polymorphisms are linked to ITP, how they correlate to IL-10 levels, and how they relate to other features of clinical presentation in adult patients with ITP.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary ITP and aged 18 and older will be included in the study.

Exclusion Criteria:

1. Patients under 18 and those with proven secondary ITP \[as cases initiated by or associated with infections due to human immunodeficiency virus (HIV-associated), hepatitis B virus, or hepatitis C virus-associated secondary ITP\] .
2. Patients with accompanying autoimmune disorders such as systemic lupus erythematosus (SLE).
3. Patients with malignancies will be excluded
DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis

This is a Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcoholic Steatohepatitis (NASH)


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, 18 to 75 years of age
* Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
* Presumed NASH diagnosed by prior biopsy and/or imaging criteria
* Written informed consent

Key Exclusion Criteria:

* History or clinical evidence of chronic liver diseases other than NAFLD
* History or known clinical evidence of cirrhosis, esophageal varices, hepatic decompensation or other severe liver impairment,
* History of liver transplant, or current placement on a liver transplant list
* Current diagnosis or history of pituitary or thyroid disorders - except for patients with primary hypothyroidism on a stable dose of thyroid hormone replacement therapy.
* Abnormal TSH or free T4 levels
* Weight loss of \> 5% total body weight within 3 months prior to Screening
* Uncontrolled diabetes
* Uncontrolled hyperlipidemia
* Unstable cardiovascular disease
* Excessive alcohol consumption

Other protocol-defined I/E criteria that apply.
The Appropriate Level of Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty (TKA)

Adductor canal catheters are being used to provide continuous postoperative analgesia after total knee arthroplasty surgery (TKA). There is much debate about where is the best position of continuous adductor canal block in patients undergoing TKA. Therefore, the investigators aim to compare the postoperative pain at three different level of continuous adductor canal block. Ninety six patients scheduled for total knee arthroplasty will be randomly divided into the three groups. In group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal). In group 2, the adductor canal catheter is inserted femur length/15\*2 cm above the location where the nerve block performed in group 1. In group 3, the adductor canal catheter is inserted femur length/15cm below the location where the nerve block performed in group 1.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients undergoing total knee arthroplasty

Exclusion Criteria:

* 1. Patients who have infection or had surgery on the thigh
* 2. The subject is a foreigner or illiterate
* 3. Patients who have cognitive dysfunction
Intranasal Nafarelin For Triggering Oocyte Maturation

This is a non-inferiority randomised, controlled clinical trial comparing subcutaneous triptorelin to intranasal nafarelin for the final maturation of oocytes in oocyte donors undergoing ovarian stimulation.

Oocyte donors meeting the inclusion criteria will be randomised to receive triggering for final oocyte maturation with 200 micrograms of subcutaneous triptorelin (control group) or 800 micrograms of intranasal nafarelin (experimental group). The primary outcome is the number of mature (metaphase 2 (MII)) oocytes collected.

The study has been designed with a non-inferiority limit of a difference of 2 mature oocytes, with 80% power and one-sided alpha of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Oocyte donor
* Undergoing a progesterone-primed ovarian stimulation cycle (PPOS) with any commercially available gonadotropin preparation(s)
* BMI 18 - 30 kg/m2
* ≥10 follicles of ≥14mm average diameter on the last ultrasound prior to trigger administration
* Able and willing to provide written informed consent

Exclusion Criteria:

* Allergy or hypersensitivity to either of the study drugs
* Hypopituitarism
* Known pituitary tumour
* Contraindication to intranasal medication administration
* Previous poor response to agonist trigger
Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the safety profile, to explore the feasibility of PM01183 dose optimization, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed and dated written informed consent (IC)
* Age between 18 and 75 years
* Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry.
* Life expectancy ≥ 3 months.
* Patients with a histologically/cytologically confirmed diagnosis of unresectable Metastatic Breast Cancer, Pancreatic Cancer or metastatic Colorectal Cancer.

Exclusion Criteria:

* Three or more prior chemotherapy-containing lines for advanced disease.
* Prior treatment with PM01183 or with capecitabine containing therapy for advanced disease.
* History within the last year or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically relevant valvular heart disease or symptomatic arrhythmia or any asymptomatic ventricular arrhythmia requiring ongoing treatment.
* Ongoing chronic hepatopathy of any origin.
* Active uncontrolled infection.
* Patients with dyspnea who are requiring any ongoing oxygen support.
* Known human immunodeficiency virus (HIV) infection.
* Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
* Men or women of childbearing potential who are not using an effective method of contraception
Digital Planning and Guided Dual Technique in Aesthetic Crown Lengthening

Excessive gingival exposure, commonly named gingival smile, results in a dentogingival disharmony. One of the gingival smile treatment is the aesthetics-related crown lengthening surgery (ACL) to provide a adequate clinical crown length and diminish gingival display. In this context, digital planning and guided dual technique have been proposed to increase the effectiveness and predictability of the ACL. In this technique, an facial and dental analysis of the patient is performed and transferred to a digital model obtained by intraoral digital scan. The digital model is used to create a double guide that will determine the final position of the gingival and alveolar margin in the ACL. Despite the technique showing promising results, clinical studies evaluating the effectiveness of this technique are scarce. The present study aims to evaluate the digital planning and guided dual technique in the ACL in comparison to conventional technique in relation to the predictability/stability of the gingival margin positioning and patient satisfaction after the ACL. Twenty-four patients diagnosed with altered passive eruption type I subcategory B will be selected and divided into two groups. In the control group (n = 12) patients will be submitted to the conventional ACL planned using clinical examination; in the test group (n = 12) patients will be submitted to ACL using cone beam computed tomography (CBCT), digital planning and guided dual technique. Periodontal clinical parameters including probing depth (PS), clinical attachment level (CAL), clinical crown length (CCL), anatomical crown length (ACL) and cemento-enamel junction to alveolar bone crest distance will be evaluated clinically at baseline, in the immediate postoperative, 4, 8 and 12 months after the procedure. Participants will be submitted to questionnaires to assess satisfaction with the smile, gum and tooth characteristics and experience with the procedure. The investigators aim to demonstrate with the study the effectiveness of the both techniques and evaluate the clinical cost benefit for the patient and the dentist of the guided dual technique in relation to the conventional ACL technique.


Eligibility Criteria:
Inclusion Criteria:

* Non smokers;
* Periodontal and systemically healthy;
* Patients with more than 20 teeth including the six maxillary anterior teeth;
* Altered passive eruption diagnosis (classified as type I subcategory B) in the quadratic anterior teeth.

Exclusion Criteria:

* Orthodontic treatment;
* Presence of prosthetic crowns;
* Extensive restorations;
* Extensive incisal edge attrition;
* Misalignment on maxillary anterior teeth.
Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture

Aim of our study is to compare immediate full weight-bearing and partial weight-bearing for 6 weeks after a tibial shaft fracture treated with intramedullary nailing. Co-primary outcome is return to work and physical component scale in the SF-36 questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* AO/OTA 42-A/B acute, noncomminuted diaphyseal fracture of the tibia treated with intramedullary nailing with or without posterior malleolus screw fixation
* operated within 72 hours of admittance
* age between 18-65 years

Exclusion Criteria:

* the inability to fill out the Finnish versions of the questionnaires
* previous arthroplasty of the knee or the ankle of the fractured limb
* previous ipsilateral below-knee fracture requiring surgical treatment or ankle arthrodesis
* inability to co-operate
* not living independently (institutionalized living before fracture)
* open fracture (Gustilo grade 2 or over)
* pathologic or stress fracture
* multiple fractures requiring operative treatment in polytrauma patient
* severe medical comorbidity impairing daily activities (inability to go climb three floors without assistance and stopping)
* Body Mass Index over 40
* unacceptably high risk of surgery due to severe medical comorbidities
* severe substance abuse
* patient is retired
* age is less than 18 or more than 65
* patient required a fasciotomy due to acute compartment syndrome during or after index surgery
* inability to walk before fracture or a daily need of walking aid, such as crutches
A Study of D3S 001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

This is a first-in-human (FIH), multicenter, open-label, dose-escalation, and dose-expansion Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 or combination therapy in subjects with advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.


Eligibility Criteria:
Inclusion:

* Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
* Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.
* Subject must have measurable disease per RECIST v1.1.
* Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject must have adequate organ and marrow function within the screening period.

Exclusion:

* Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
* Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
* Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
* Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
* Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).

Other protocol inclusion/exclusion criteria may apply
Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease

Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational AAB-001 Vaccine in Japanese patients with Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD
* Age 50-85
* MMSE 14-26
* Other Inclusion Criteria Apply

Exclusion Criteria:

* Significant Neurological Disease
* Major Psychiatric Disorder
* Clinically Significant Systemic Illness
* Other Exclusion Criteria Apply
The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients

Study to assess the feasibility of an external ultrasound fixator (ProbeFix)

Rationale: Study to assess the feasibility of an external ultrasound fixator (ProbeFix) Objective: Cardiac output measurements using transthoracic ultrasound (TTE) with and without the use of the probeFixR will be evaluated in terms of accuracy. The TTE measurements will be combined with another form of cardiac output measurements (FlotracR) after a passive leg rasing (PLR) test.

Study design prospective, feasibility study Study population: Adult Intensive Care patients ( \> 18 years)

Intervention (if applicable):

Consecutive adult patients on the ICU in which the FlotracR monitor is used will be evaluated after detection of hypovolemia.

Main study parameters/endpoints:

* Percentage of patients in which the ProbeFixR can be used
* The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR

Although no side effects are to be expected the investigators will monitor the patients after the ProbeFix is removed for any skin damage. The investigators will grade this damage into 3 categories:

* No skin marks
* Mild skin marks (no treatment necessary)
* Severe skin marks (surgical or medical treatment necessary)
* If the patients are awake the investigators will ask them whether they felt the ProbeFixR to be unpleasant on a scale of 0-10 (0 being: I did not feel anything and 10 being very unpleasant).

Eligibility Criteria:
Inclusion Criteria:

* Adult Intensive Care patients ( \> 18 years), with hypovolemia detected with Flotrac (SVV \> 10%)

Exclusion Criteria:

* Pregnancy
* Atrial fibrillation or other irregular heart rhythm
* Pulmonary edema
* PLR not possible (eg neurological disease, spinal trauma, restricted limb movement, deep venous thrombosis, or any other reason as indicated by the attending intensivist).
* age \< 18 years
Evaluation Of Pleural Effusion At Assiut University Hospital

Pleural effusion is an accumulation of fluid between the tissue layers that line the lungs and chest cavity. It has an estimated prevalence of 320 per 100,000 people in industrialized countries. The cause of the pleural effusion remains unclear in a substantial percentage of patients with persistently exudative effusions.

They are classified broadly into exudative and transudative effusion based on Light's criteria.

Several methods have been proposed for the identification of pleural effusion etiology including pleural fluid cytology, pleural biopsy, thoracoscopy and computerized tomography. However, these technologies have their own limitations.

The diagnosis of malignant pleural effusion is a vexing problem, since pleural fluid cytology findings are positive in only 60% of cases on average. Tumor marker carcinoembryonic antigen (CEA) can be positive in 80% of cases.

Thoracoscopy will establish the diagnosis in approximately 95% of cases, but this interventional procedure may not be available at all facilities.

A new approach is needed to detect the cause of undiagnosed pleural effusions. Diagnosis of idiopathic pleural effusion was made after a minimum of one year follow up with detailed exploration including computed tomographic scanning to exclude other causes of effusion such as malignant pleural effusion.

Because immunoglobulin G4 (IgG4)-related disease is recognized as a fibroinflammatory condition of unknown cause that can affect multiple organs including the lungs and pleura, IgG4 might be related to certain idiopathic pleural effusions.

The criteria of Common radiological findings of IgG4-related lung disease include hilar and mediastinal lymphadenopathy, thickening of perilymphatic interstitium with or without subpleural and/or peribronchovascular consolidation.

Eligibility Criteria:
Inclusion Criteria:

* All patients with exudative pleural effusion admitted to Assiut university hospital in period of October 2017 to October 2018

Exclusion Criteria:

* Patients with transudative pleural effusion
Evaluation of the Accuracy of the INRatio Prothrombin Time (PT) Monitoring System With a New Test Strip for the Oral Anticoagulation Therapy Patient in the Presence of Heparin and Low Molecular Weight Heparin (e.g., Enoxaparin or Dalteparin)

This is a multi-center study designed to evaluate the heparin insensitivity of the INRatio Prothrombin Time (PT) Monitoring System, utilizing an INRatio test strip additionally modified for low sample volume. The INRatio test strip is used for the quantitative determination of PT and International Normalized Ratio (INR) results in fingerstick blood from subjects on oral anticoagulation therapy (OAT) with warfarin. This study is designed to evaluate the accuracy of the modified INRatio test strip during heparin-warfarin bridge therapy with unfractionated heparin (UH) or low molecular weight heparin (LMWH), such as enoxaparin or dalteparin. These INR results will be compared to the INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the heparin-insensitive reference method: the Sysmex CA-560 System. The levels of UH or LMWH in the plasma samples will be assessed using activated partial thromboplastin time (aPTT) and anti-factor-Xa assays respectively.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years of age or older).
* Willing and able to provide written informed consent and comply with study procedures.
* Receiving warfarin/heparin bridge therapy.
* Therapy with both warfarin and one of the heparins listed below must have been initiated for at least 12 hours before the first study specimens are obtained.
* UH (last known aPTT prior to enrollment (if available†) must confirm heparin has been administered)
* Dalteparin (last known anti-factor Xa prior to enrollment (if available†) must confirm heparin has been administered)
* Enoxaparin (last known anti-factor Xa prior to enrollment (if available†) must confirm heparin has been administered) † If a pre-study aPTT or anti-factor Xa is not available, subsequent testing of the study phlebotomy or a phlebotomy as a part of routine medical care taken before or during the time of the study phlebotomy must confirm the presence of heparin (unfractionated or low molecular weight) in order for that data point to be included in the analysis.

Exclusion Criteria

* Known or suspected hematocrit less than 25 or greater than 55%;
* Auto-immune disorders known to interfere with INR measurements, such as lupus or anti-phospholipid syndrome (APS)
* Already participated in this specific study
Innovative Smartphone Application of a New Behavioral Method to Quit Smoking: Pilot Trial (Smart Quit)

This innovative study will compare a newly developed smartphone application for Acceptance and Commitment Therapy (ACT) to a smartphone application for traditional cognitive behavioral therapy (CBT).

The study matches these National Cancer Institute (NCI) research funding priorities: (1) increasing the dissemination of smoking cessation treatments and (2) new treatment approaches to boost the effectiveness of cessation interventions.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* smokes at least five cigarettes daily for at least past 12 months
* wants to quit in the next 30 days
* interested in learning skills to quit smoking
* willing to be randomly assigned to either smartphone application
* resides in US
* has at least daily access to their own personal Apple iPhone 4, 4s, or 5
* knows how to login and download a smartphone application from Apple's "App Store" Store
* willing and able to read in English
* not participating in other smoking cessation interventions (including our other intervention studies)
* has never used the NCI's Quit Guide smartphone application.\]
* willing to complete one follow-up survey
* provide email, phone, and mailing address.

Exclusion Criteria:

* The exclusion criteria are the opposite of the inclusion criteria above.