cyrilzakka/clinical-trials huggingface dataset:
Expanded Access Program of TAK-755 for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

The expanded access program allows people to gain access to unlicensed treatment on compassionate grounds. TAK-755 also known as rADAMTS13, is a medicine that treats people born with severe congenital or hereditary thrombotic thrombocytopenic purpura (cTTP). This expanded access program enables continued access to those participants who have no other treatment options available for cTTP.

This is an expanded access program in which the drug being given is called TAK-755. This study will provide access to TAK-755 prior to marketing authorization for eligible participants with severe congenital or hereditary TTP who cannot adequately be treated via current standard of care and who cannot enter a clinical trial.

All participants will receive TAK-755 as intravenous (IV) injection based on their weight as measured at each dosing visit.

This is a multi-center, international program. Participants will continue treatment until benefit is no longer derived from the treatment (or treatment is no longer tolerable), sponsor decision, the participant chooses to discontinue the treatment, or TAK-755 becomes commercially available.

Eligibility Criteria:
Inclusion Criteria:

1. Participant or legally authorized representative has provided signed informed consent (≥18 years of age) and/or assent form (signed by legal representative if participants is \<18 years of age).
2. Participant has a documented diagnosis of severe congenital ADAMTS13 deficiency, defined by:

   1. Confirmed molecular genetic testing, or
   2. ADAMTS13 activity and a negative test for ADAMTS13 antibodies.
3. Participant is currently on a prophylactic regimen or has a documented history of at least 1 TTP event.
4. Standard of Care (SoC) is considered inadequate, or the participant is intolerant to SoC\*.

   * SoC are plasma-based therapies, e.g., fresh frozen plasma or S/D treated plasma

Exclusion Criteria:

1. Participant is currently eligible to enter into an interventional clinical trial for cTTP.
2. There is a suitable alternative commercially available treatment for the treatment of cTTP.
3. Participant has been diagnosed with any other thrombotic microangiopathies (TMAs) like disorder (microangiopathic hemolytic anemia), including acquired TTP.
4. Participant has a known hypersensitivity/allergies/intolerance or contraindications to TAK-755 or its excipients, such as hamster proteins.
5. Participant has a medical history or presence of a functional ADAMTS13 inhibitor.
6. Participant has a medical history of genetic or acquired immune deficiency that would interfere with the assessment of product immunogenicity, including Participants who are human immunodeficiency virus (HIV)-positive with an absolute cluster of differentiation 4 (CD4) count \<200 per millimeter cube (\<200/mm\^3) or who are receiving chronic immunosuppressive drugs
Assessment of Natural Killer Cells in Unexplained Recurrent Pregnancy Loss

To assess natural killer cells frequency and activation in cases of unexplained recurrent abortion in comparison to fertile cases

* 2. . To study the expression of stimulatory receptors of natural killer cell.
* 3-To study the expression of inhibitory receptors of natural killer cell.

NK-cell functioning is controlled by a wide range of receptors that are expressed on the cell surface. These receptors are either inhibitory or activating in nature. The family of inhibitory receptors consists of the killer immunoglobulin-like receptors (KIR) or Ig-like receptors (CD158), the C type lectin receptors (CD94-NKG2A) and leukocyte inhibitory receptors (LIR1, LAIR-1). Activating receptors are the natural cytotoxic receptors (NKp46, NKp44), C type lectin receptors (NKG2D, CD94-NKG2C), and Ig-like receptors (2B4). A particular NK cell typically expresses two to four inhibitory receptors in addition to an array of activation receptors. The killing by NK cells is mediated through several activating NK receptors. Among these are NKG2D and the three natural cytotoxicity receptors (NCRs), NKp30, NKp44, and NKp46 (Yang et al., 2000) Osne of the natural cytotoxicity receptors (NCRs) NKp46, , is a unique marker that functions in NK cell cytotoxicity and cytokine production. Expression of NKp46 on NK cells is lower in women with recurrent pregnancy loss, so evaluation of NKp46 on peripheral blood NK cells may provide a means of screening for reproductive abnormalities (Fukui et al., 2015).

During pregnancy, decidual NK cells comprise ∼70-80% of the decidual lymphocytes and are considered a special NK subset that does not exert cytolytic functions against trophoblast cells and has generally reduced cytotoxicity (Hanna and Mandelboim, 2007).

These cells express activating NK receptors, including all the NCRs and NKG2D. However, instead of triggering cytotoxicity, these receptors act to stimulate secretion of cytokines and angiogenic factors, which are essential for trophoblast invasion and vascular modifications (Hanna et al., 2006).

One study reported that pNK cell levels show changes in decidual NK cell levels (Park et al., 2010). Whereas some other reports have shown that the assessment of peripheral blood NK cells would not

Eligibility Criteria:
Inclusion Criteria:

* 1.Age less than 40 years. 2.History of two or more spontaneous miscarriages .

Exclusion Criteria:

* 1. Age more than 35 years. 2. Women with elevated level of TSH above (2.5 mIU/ml) or prolactin above( 19.5 ng/mL)and uncontrolled DM.

  3. Women with autoimmune disorder (antiphospholipid antibody syndrome)with LA1/LA2 ratio more than( 1.2).

  4.Women receiving oral contraceptive pills.
Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment

tTe investigators estimate pomegranate supplementation effect on oxidative stress in infertile women with PCOS, endometriosis and advanced maternal age during IVF treatment. The primary aim is to compare the obtained oxidative stress markers in follicular fluid with pomegranate supplementation vs control.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergo IVF treatment with diagnosis of PCOS/Endometriosis/MF or AMA

Exclusion Criteria:

* Patients who do not meet the inclusion criteria, as above
Measurement of the Intolerance to Uncertainty in Osteopaths

Clinical reasoning is a challenging, complex, multi-dimensional, essentially introspective and poorly understood cognitive process, as well as a crucial skill for osteopaths and health professionals. It can be agreed that this includes diagnosing the patient's condition, making therapeutic decisions to improve that condition, and the practitioner's ability to assess the patient's prognosis. Individual clinical expertise is acquired through experience. Each healthcare professional develops their own approach to problem-solving and decision-making, influenced by factors such as personality, preferences, clinical perception, and professional practices. It is important to be aware that certain factors can influence their judgement and potentially affect the quality of their work. It is possible that certain factors may influence their judgement and potentially lead to errors in their decision-making, as they can be influenced by cognitive biases such as intolerance of uncertainty. Uncertainty intolerance is defined as a personal disposition characterised by negative beliefs about uncertainty and its consequences, coupled with an underlying apprehension about the unknown. Uncertainty affects the behaviour of individuals by creating a need for certainty, which in turn affects the clinical reasoning and decision-making of healthcare professionals.

The objective of this study is to assess the level of intolerance to uncertainty among osteopathic students and osteopaths using an online self-report questionnaire. A second questionnaire will be sent out six months after the first, allowing to assess individual changes in this intolerance over time. Furthermore, the impact of being a graduate, anxiety and the type of osteopath responding to the questionnaire will be examined. The final measure will be evaluated using a classification method called latent class analysis. This will be based on responses to questions about their relationship to evidence-based practice, dogmatism and their thoughts about the impact of osteopathic treatment.

The aim of this study is to carry out a psychometric validation of the intolerance to uncertainty questionnaire on a population of osteopaths.


Eligibility Criteria:
Inclusion Criteria:

* Student in osteopathy (3rd, 4th or 5th year) or have a diploma in osteopathy
* Provide an informed consent

Exclusion Criteria:

* Patients refusing to take part in the study.
* Pregnant women
* Patients under legal protection
* Patients who are protected adults or adults unable to express their consent.
* Withdrawal of consent to participate in the study
Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy

The objective of this study is to determine the effect of the sealant patch Hemopatch, compared to current practice without any sealant, on the decrease of the postoperative pancreatic fistula on patients undergoing pancreatoduodenectomy for benign or malignant tumors or other benign process.

Pancreaticoduodenectomy (PD) is the most common surgical procedure to treat pancreatic tumors in the head of the pancreas and periampullary region, as well as benign processes such as chronic pancreatitis. Recent advances in surgical techniques and perioperative treatments have reduced perioperative mortality below 10% in high volume centers. However, PD is associated with considerable morbidity (40-58.5%) like postoperative pancreatic fistula, delayed gastric emptying, biliary fistula, postoperative hemorrhage, and pulmonary complications.

Several surgical techniques and perioperative care have been described to prevent or reduce the incidence of pancreatic fistula after PD, including reconstruction of the digestive tract with pancreaticogastrostomy, duc-to-mucosa reconstruction or pancreaticojejunostomy by intussusception, use of somatostatin and prophylactic analogues, the use of stents in the main pancreatic duct, and use of different sealants.

Although perioperative morbidity and mortality associated with PD have improved significantly over the years, even in high-volume centers, the incidence of postoperative fistula remains at 9.9-28.5%. Therefore, the ideal pancreatic reconstruction technique that prevents fistula is not yet available.

The use of sealants has been one of the approaches taken to try to reduce the rate of fistulas. Some uncontrolled or non-randomized studies have shown that the use of fibrin glue-based adhesives in combinations with felting patches can lead to a B / C grade fistula rate of 0-10%. Only 2 randomized clinical trials have been performed with fibrin glue, with opposite results in terms of significant reduction of pancreatic fistula.

Hemopatch is a patch consisting of a soft, thin and flexible pad of collagen derived from the bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate). It is intended to be a surgical sealant for procedures in which control of leakage by conventional surgical techniques is ineffective or impractical, making it a plausible option to use during PD in order to decrease postoperative pancreatic fistula.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
* ASA score \< 4.
* Male and female patients ≥ 18 and ≤ 80 years of age.
* With the consent form signed.

Exclusion Criteria:

* Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
* ASA score \< 4.
* Male and female patients ≥ 18 and ≤ 80 years of age.
* With the consent form signed.
Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa

6 monthly treatments with IPL laser in patients with Hidradenitis Suppurativa. The effect in measured on several severity scores.

Patient suffering from bilateral HS in the axilla or groin area are threated with IPL laser monthly for 6 months.

Patients are randomized to treatment in either left or right side, the other side works as control.

No sham treatment, but observers are blinded.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral HS in the axilla or groin area
* Fitzpatrick skin type I-II

Exclusion Criteria:

* Pregnant
* Unable to understand or communicate with study personnel
Hypomagnesemia and Diabetic Nephropathy

To find if there is a corrolatation between Microalbuminurea and diabetic retinopathy, in daibetic patients

40 Daibetic patients with microalbuminurea will be subjeted to full clinical examination and fundus examination,20 control diabetics with out microalbuminurea will also be included for comparison,patients will be selected from the outpatient clinic 0f fayoum university hospital.

Eligibility Criteria:
Inclusion Criteria:

* Diabetics on oral treatment,diabetics on insulin

Exclusion Criteria:

* Healthy volunteers,,hypertensive patients with normal blood glucose
Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT)

SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing the use of non-isotope based imaging modalities has the potential to change the standard of care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography) has its own distinct potential advantages over SPECT.

Obtain a better understanding of the clinical utility of advanced non-isotope-based imaging modalities to detect relevant CAD as potential alternatives to SPECT. Approximately 450 subjects will be enrolled in total. Three groups of about 150 patients per group. Each group will undergo imaging with 2 modalities; Group 1: 99mTcSPECT plus CMR, Group 2: 99mTcSPECT plus CT, Group 3:99mTcSPECT plus stress echocardiography. All 450 patients will undergo standard invasive coronary angiography following completion of non-invasive imaging, except for patients in whom both nuclear and non-nuclear imaging modalities reveal a normal result confirming the absence of significant coronary artery disease (i.e invasive angiography would not be clinically indicated and FFR would be considered to be above 0.8). Thrombolysis in Myocardial Infraction (TIMI) flow will be measured in all patients undergoing angiography, and fractional flow reserve (FFR) will be measured in all patients except those with TIMI flow =0, 1 and 2. All imaging procedures must be completed within 6 weeks. All patients will have a follow-up visit at 6 months after enrollment. During the 6 month follow-up visit major adverse cardiovascular events will be collected and adjudicated by a clinical endpoint committee (CEC).

Eligibility Criteria:
Inclusion Criteria:

* clinically indicated request for SPECT
* ability to undergo at least one of three non-nuclear imaging tests; CMR, CT or Stress Echocardiography
* History of recent symptoms suggestive of myocardial ischemia
* High risk for ischemic cardiovascular events

Exclusion Criteria:

* severely reduced systolic function (LV ejection fraction less than 35%)
* Recent (less than 3 days) acute coronary syndrome including acute myocardial infarction
* contraindications to dipyridamole SPECT including : i)severe reactive airway disease; ii) less than 3 days post Myocardial Infarction - Acute Coronary Syndrome (MI-ACS); iii) high-grade Atrioventricular block (AV block); iv)allergy to dipyridamole or theophylline; v) caffeine within 12 hours; vi) theophylline use within 48 hours; vii) severe claustrophobia; or viii) women who may be pregnant
* kidney dysfunction (i.e estimated Glomerular Filtration Rate (eGFR) less than 45)
* use of investigational drug or device within 30 days of screening visit
* Coronary Artery Bypass Graft(s) surgery (CABG)
Patient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Liver Resection

The purpose of this study is to learn whether patient-controlled epidural analgesia (PCEA) is a better method for managing pain after liver resection compared to patient-controlled analgesia (IV PCA). Currently, the standard pain control method for liver resection patients is IV PCA. There is not enough data on how epidural (PCEA) relieves pain and movement on a day to day basis after liver resection.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18 years or older) who are able to provide informed consent.
* Patients undergoing open elective liver resection for primary liver pathology (benign or malignant) or secondary metastatic liver disease, including patients undergoing concomitant surgical procedures (such as colorectal resection or debulking procedures), with no contraindication to the insertion of an epidural catheter (localized infection, septicemia, or pre-operative coagulopathy).

Exclusion Criteria:

* Patients with a history of documented anaphylaxis or contraindication to any of the study medications or standardized intra-operative medications. These include dilaudid, fentanyl, and bupivacaine.
* Patients with pain at rest or with movement measured by NRS \>2.
* Patients receiving high dose opioids on a chronic basis (greater than or equivalent to 60mg of morphine per day).
* Patients with severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 \<50%.
* Patients with significant cognitive impairment or documented psychologic impairment.
* Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myelo-opticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100,000/μL, or evidence of infection at potential epidural site.
* Cirrhotic patients. When incidentally discovered intra-operatively, patients will be excluded from the study and replaced, but will be followed for primary and secondary endpoints.
* Patients with poor performance status preoperatively such that they are unable to walk up two flights of stairs.
* Patients taking any opioid agonist/antagonist medication (i.e. Buprenorphine)
A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)

A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.

Study with completed results acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian is able to provide written informed consent and patient is able to provide written assent if appropriate.
* Male and female adolescents aged 12 to 16 years at the time of enrollment.
* Diagnosed with JIA, including all the International League of Associations for Rheumatology JIA subtypes: oligoarthritis, polyarthritis (both rheumatoid factor \[RF\]+ and RF-), psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis, and systemic arthritis.
* Based upon investigator judgment, it is determined appropriate for the patient to undergo 6 months of continuous treatment with VIMOVO.
* Body weight \> 31 kg (68.2 lbs) and within the 5th to 95th percentile of body mass index for age.

Exclusion Criteria:

* In systemic JIA patients, presence of systemic features (ie, fever, rheumatoid rash, serositis, lymphadenopathy, macrophage activation syndrome) within 6 months prior to start of study drug.
* Currently taking (ie, within 4 weeks prior to start of drug) naproxen \> 20 mg/kg/day or \> 1000 mg total daily dose.
* Hemoglobin ≤ 8.5 g/dL.
* Individuals who have cardiovascular or cerebrovascular disease, based on history or risk factors.
* Any significant hepatic, renal, pulmonary, ophthalmologic, neurologic, or any other medical conditions indicated by medical/surgical history, physical, or laboratory examination that might put the patient at greater risk during the study.
Clinical Significance of Platelet Reactivity on Clopidogrel During Off-pump Coronary Artery Bypass

Objective: To evaluate the early and late prognoses of patients according to platelet reactivity after clopidogrel administration and determine whether the measurement of platelet inhibition predicted 1-year clinical outcomes after off-pump coronary bypass (OPCAB) Study design

* Prospective, observational, single-center study
* Subjects with OPCAB surgery who meet all inclusion and exclusion criteria will be enrolled.
* Platelet reactivity after 7-days clopidogrel treatment from the day of surgery will be measured by VerifyNow system.
* Dual antiplatelet therapy including aspirin and clopidogrel will be administered for 1 year after surgery and subjects will be followed-up for 1 year about primary endpoint.
* Cutoff value of P2Y12 reactivity units (PRUs) for primary endpoint will be assessed and the cohort will be divided by the PRU cutoff value (low/high platelet reactivity groups).
* The primary and secondary endpoints will be compared between two groups


Eligibility Criteria:
Inclusion Criteria:

* Patients with indications for surgical myocardial revascularization
* Patients who undergo off-pump coronary artery bypass
* Age between 19\~80 years
* Patients with signed informed consent

Exclusion Criteria:

* Patients with combined surgery with coronary bypass grafting
* On-pump conversion
* Patients with moderate renal dysfunction (creatinine\>2.0mg/dl) or need for dialysis
* Patients with chronic treatment with proton pump inhibitors
* Patients with preoperative bleeding
* Thrombocytopenia (Platelet count 70,000/ml)
* Re-do surgery
* Early death before the measurement of platelet reactivity
Knowledge and Interpersonal Skills to Develop Exemplary Relationships

This pilot study will test the effect of an online asynchronous psychoeducational intervention to improve relationship quality and prevent verbal-type elder mistreatment in caregiving dyads. The investigators will use a pre-post test design to test the feasibility and acceptability of this video-based intervention, and to determine the likelihood that participation in this program may improve caregiver relationship quality.


Eligibility Criteria:
Inclusion Criteria:

* Provides assistance to someone over the age of 60 with an illness or a disability ("care recipient") who requires personal assistance from another person (e.g., bathing, preparing meals). (Assistance provided with at least 1 activity of daily living and/or at least 2 instrumental activities of daily living.)
* Person receiving care from the study participant has a cognitive impairment. This does not have to be diagnosed.
* Participant provides at least 8 hours of assistance to the care recipient per week
* Participant does not intend to place the care recipient in a skilled nursing facility or assisted living facility within 3 months of consenting into the study

Exclusion Criteria:

* Does not read and speak English
* Cannot access a computer and internet (needed to complete lessons)