cyrilzakka/clinical-trials huggingface dataset:
Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

To investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus.

This is a 22-week (2 week screening, 18-week treatment period followed by a 2 week followup), phase II, open label, exploratory study to investigate the potential efficacy of FDA approved dupilumab in the treatment of adults with moderate to severe chronic hepatic pruritus. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, baseline values will be established and subjects will begin treatment and follow-up for the next 20 weeks. A final visit will be needed for evaluation and questionnaire completion.

Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects 18 years or older with chronic pruritus of moderate to severe severity in the setting of intrahepatic or extrahepatic cholestatic liver disease. Chronic is defined as greater than 6 weeks of symptom duration. Pruritus severity is based on the peak pruritus numerical rating score of ≥ 4 (moderate severity).
* Documentation of a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial.
* Willingness and ability to comply with scheduled clinic visits, physical exams, laboratory tests, questionnaires, and other trial procedures.

Exclusion Criteria:

* Male and/or female subjects under 18 years of age.
* Pruritus due to a primary inflammatory skin dermatosis or other forms of psychogenic pruritus utilizing skin biopsies as needed.
* Pregnant females
* History of intrahepatic cholestasis of pregnancy
* Any form of chronic hepatic pruritus associated with underlying malignancy
* Liver transplant recipients
* Allergy to dupilumab or its ingredients
* Inability to provide informed consent
* Concomitant use of selective opioid antagonists
* Subjects with severe asthma (requiring high-dose inhaled or systemic corticosteroids) will be excluded from the study.
* Patients with known helminth infections
Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)

The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.


Eligibility Criteria:
Inclusion Criteria:

* Women requiring surgery for SUI following failed conservative treatment

Exclusion Criteria:

* Under 18 years of age
* Previous surgery for SUI
* Evidence of neurological disease
* Pelvic Organ Prolapse (POP) greater than Grade 2
* Women with any evidence of Detrusor Overactivity or bladder hypocompliance on urodynamic assessment
Utility of Whole-body MRI in the Detection of Traumatic Injuries of Undetermined Origin in Children

The diagnosis of abuse in children relies heavily on the presence of skeletal and extraskeletal injuries. However, some lesions are not seen by initial skeletal survey. And the investigators have to complete the skeletal survey with either bone-scan or CT scan or whole-body MRI. whole-body MRI has proved its worth in the pediatric population for the evaluation of skeletal and extraskeletal lesions in children with cancer or infectious diseases. Thus, whole-body MRI would allowed to have total picture of children without ionising radiation exposure.


Eligibility Criteria:
Inclusion Criteria:

* Infant hospitalised for sub-dural hematoma or skeletal injuries due to non accidental traumatism or skin lesions or abdominal injuries of undetermined origin

Exclusion Criteria:

* Sub-dural hematoma of accidental origin or skeletal injuries of accidental
* Origin or known origin of lesions.
* Subject already included in the study
Understanding Barriers and Facilitators to the Participation of Women Living With HIV in Clinical Trials : a Mixed-method Study (EVA)

To identify the most important barriers and facilitators to the participation of cisgender women living with HIV in clinical trials (perceived and real) and to establish possible mechanisms leading to refusal of trial participation. Specifically, psychosocial factors and/or cultural environments that enhance or undermine HIV-positive cisgender women's participation. These can include social inclusion, confidence in research, perceived personal vulnerability, cultural, familial and professional environment.

The investigators expect to propose pragmatic solutions to enhance participation of HIV-positive cisgender women in clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Cisgender women
* Adult (\>18 years) HIV-infected
* Informed consent documented by signature
* Patients under stable antiretroviral therapy
* French speaking (sufficient fluency for a conversation)

Exclusion Criteria:

* Having participated in a previous qualitative study about Cure Trials acceptability among HIV patients
* Incapable of discernment
Anticoagulation in Blunt Cerebrovascular Injuries

Originally thought to be a rare occurrence, BCVI are now diagnosed in approximately 1% of blunt trauma patients. Initially BCVI were thought to have unavoidable devastating neurologic outcomes. But early reports suggested anticoagulation might decrease these events. If untreated, carotid artery injuries (CAI) have a stoke rate up to 50% depending on injury grade, with increasing stroke rates correlating with increasing grades of injury. Current studies report early treatment with antithrombotics - either heparin or anti-platelet agents - in patients with BCVI markedly reduces stroke rates and resultant neurologic morbidity. As reports of bleeding complications have altered heparin protocols in these patients, the use of antiplatelet agents is attractive. Although heparin has been has been proposed as the gold standard treatment due to its initial empiric use, no comparative studies of antithrombotic agents has been performed.

In sum, Grade I-III blunt carotid and vertebral arterial injuries (BCVI) have the potential for stroke, and should be treated. Heparin has not been shown to clearly improve healing rates compared with antiplatelet therapy. The purpose of this study is to determine whether systemic anticoagulation alters the course of Grade I-III BCVI compared with antiplatelet therapy. The investigators study hypothesis is that Grade I-III BCVI will heal or progress to pseudoaneurysm formation, independent of systemic antithrombotic regimen, and that the combination of aspirin and clopidogrel is equally efficacious in preventing neurologic symptoms compared to systemic heparin associated with Grade I-III BCVI.


Eligibility Criteria:
Inclusion Criteria:

* Patients greater than 18 years old with documented grade I-III blunt cerebrovascular injuries.

Exclusion Criteria:

* Pregnancy
* Nasal polyps
* Previous gastrointestinal bleeding secondary to antiplatelet medications
* Contraindication to systemic anticoagulation.
Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)

The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000, in participants with Major Depressive Disorder (MDD).


Eligibility Criteria:
Key Inclusion Criteria:

1. Eligible participants must have successfully completed the Treatment/Randomization Phase of parent studies.
2. WOCBP must have a negative urine pregnancy test at Baseline Visit.
3. WOCBP must not be breastfeeding or lactating at Baseline Visit or at any point during the study.

Key Exclusion Criteria:

1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
2. Participant non-compliance with study procedures, study drug or visit attendance in the parent study that the Investigator deems as clinically significant or unacceptable risk potential for this study.
3. Investigator deems participant at imminent risk of danger to others.
Differences in Epicardial Plaque and Microvascular Function in Women With an Acute Myocardial Infarction

The broad objective is to advance our understanding of both in vivo anatomical and functional changes that are present in the coronary arteries in women who have an acute coronary syndrome. Specific focus will be placed on the age of the women as there may be distinct differences in younger women (\< 50 years) given the marked increase in mortality in this population.

The hypothesis of the current study is that plaque erosion and microvascular dysfunction are key features responsible for the increased peri-MI mortality in young women. In order to test this hypothesis the following specific aims are proposed using a special intravascular ultrasound technique called virtual histology and microvascular function (effect of intracoronary adenosine on coronary blood flow) in patients coming to the cardiac catheterization laboratory with an acute MI:

1. To determine if plaque rupture or plaque erosion is more prevalent in young women (\<50 years) compared with older women (≥ 50 years) and men in the development of an acute MI
2. To determine if inflammatory mediators of plaque rupture are higher in older women and men with an acute MI compared with younger women
3. To determine if microvascular function is abnormal in young women undergoing percutaneous coronary revascularization with an acute MI compared to older women and men
4. To determine if alterations exist in the number and function of EPCs in young women (\<50 years) compared with older women (≥ 50 years) and men who have had an acute MI and to determine the association with microvascular function

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Acute coronary syndrome defined as at least two of the following:

A) an elevated cardiac biomarker (troponin or CK-MB), B) new or dynamic ECG changes in at least 2 contiguous standard electrocardiographic leads of ST depression \> 1 mm or ST elevation of \>1 mm or T-wave inversions, C) chest pain or discomfort of at least 15 minutes duration, D) a new wall motion abnormality by echocardiography

* Patient who is undergoing coronary angiography
* Physician planning to perform IVUS for treatment of the infarct-related vessel

Exclusion Criteria:

* Creatinine \> 2.0 mg/dL (most recent)
* Hemodynamically unstable patients (systolic blood pressure \< 90 mmHg or heart rate \> 110 beats/ minute or presence of an intra-aortic balloon pump)
* Coronary revascularization (percutaneously or surgically) within 6 months
* The use of chronic immunosuppressive agents
* No target lesion was found at the time of cardiac catheterization that will be percutaneously intervened upon (the patient must undergo percutaneous coronary intervention)
* Inability to give informed consent
* Pregnant or lactating women
* Prisoners
A Social Network Approach for Improving Medication Assisted Treatment and HIV Prevention and Medical Care Among People Who Inject Drugs in Ukraine

The aim of this study is to pilot a peer education for people on medication assisted treatment (MAT). People on MAT will be trained to be peer educators and provide outreach to the educators social network members who inject drugs, some of whom will be HIV positive.

The, goal of the intervention is to increase medication assisted treatment (MAT) uptake and retention in order to enhance as well as HIV medical care and antiretroviral therapy (ART) adherence among those social network members who use drugs and those living with HIV who use drugs. The project will quantitatively and qualitatively assess barriers to MAT and ART uptake and adherence, while using peer educators to promote MAT and ART among their network members. Finally, the project aims to determine the effect size for guiding the planning of larger intervention and the feasibility and acceptability of this intervention for HIV prevention and improvement in HIV-related health outcomes among people living with HIV who inject drugs (PLWH PWID). The intervention will be deployed in Ukraine, a setting with high HIV incidence rates among PWID, low levels of viral suppression among HIV positive PWID, and low rates of MAT uptake.

Eligibility Criteria:
Inclusion Criteria:

* On methadone for at least 1 year and rated by the staff as low risk for relapse
* Report at least 1 drug network member living with HIV, not on methadone, and seen weekly
* Willing to talk with drug users in their network about medication for drug dependence and accompany them to methadone clinic

Exclusion Criteria:

• Persons that are currently psychotic, suicidal, or cognitively impaired such that they cannot provide informed consent will be excluded from participation.
Platelet-rich Plasma in the Treatment of Intractable Postherpetic Neuralgia

used ultrasound-guided platelet rich plasma nerve block to treat Intractable Postherpetic Neuralgia.

Postherpetic neuralgia (PHN) is a kind of pain caused by varicella zoster virus invading the human body and infecting the corresponding ganglia. The affected ganglia are inflamed or even necrotic, affecting the nerve endings, the dorsal horn of the spinal cord and the sensory nerve tissues below, and the course of the disease is more than one month or more. Most patients can avoid PHN by timely and effective treatment in the acute herpes zoster period. However, some patients with intractable postherpetic neuralgia fail to receive timely and effective pain control treatment in the early stage of the disease, and the current commonly used clinical treatment methods often fail to achieve effective treatment results. Such patients often have a long course of disease, which can last for three to five years or even longer, Nerve damage is also more serious. Long term pain has seriously affected the quality of life of such patients. Therefore, how to quickly and effectively control pain has become the diagnosis and treatment goal of such patients with intractable post herpetic neuralgia. Platelet rich plasma (PRP) was widely used in muscle and bone repair due to its function of promoting tissue repair in the early stage. Recently, it was found that PrP can also promote nerve repair. Therefore, in order to further explore the therapeutic effect of PRP on refractory PHN patients, our department used ultrasound-guided platelet rich plasma nerve block to treat Intractable PHN.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria of PHN: have a history of acute herpes zoster, the pain lasts for more than half a year, and there is paroxysmal pain in the affected nerve distribution area;
* Preoperative visual analog scale (VAS) score ≥ 5;
* Those who can cooperate with the treatment;
* We agreed to inject platelet rich plasma into nerve block under the guidance of ultrasound, and signed the informed consent form.

Exclusion Criteria:

* Systemic infection or puncture local infection;
* Serious disturbance of cardiovascular and cerebrovascular function;
* Abnormal bleeding and coagulation function or complicated with blood system diseases;
* Mental disorders;
* Severe dysfunction of important organs in the body
Study of Epigenetic and Inflammatory Markers of Accelerated Biological Ageing in the Follow up of Patients With Hodgkin's Lymphoma

Study design: It is a monocentric and exploratory study, experimental on human tissues in vitro which involves the analysis of peripheral blood in patients with Hodgkin's lymphomas with the following characteristics:

* in complete remission for at least two years after first-line therapy with stage IIb, III or IV at onset (Ann Arbor classification).
* newly diagnosed (stage IIb, III or IV, Ann Arbor Classification).

The study aims to evaluate patients with hodgkin lymphoma in complete remission for at least 2 years and newly diagnosed (stage II b, stage III or stage IV) as they are currently characterised by a long life expectancy during which there is an increased and early incidence of non-neoplastic systemic complications as well as, of course, manifestations of secondary malignancies.

Eligibility Criteria:
Inclusion Criteria:

* hodgkin lymphoma stage II b, III or IV at onset in remission for at least two years after the first line of therapy for lymphoma
* Newly diagnosed histologically confirmed stage II b, III or IV patients who require first-line therapy
* Patients of both sexes aged ≥ 18 years at enrollment
* Signature of informed consent

Exclusion Criteria:

* Concomitant second neoplasm
Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator, ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle but, rarely reaches the lumbar plexus.

The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of resistance technique. Feeling two tactile ''pops'' due to loss of resistance occurred during the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of FIB will increase the success rate and the efficacy of sensory blockade by decreasing the needed local anesthetic amount.

This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal. Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were secondary goals. The hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II.

Exclusion Criteria:

* Patients with previous same lower limb surgery
* Neuromuscular disease
* Severe cardiovascular disease
* Any contraindications to regional anesthesia
* patient refusal
* coagulation abnormality
* Known allergy to local anesthetics
* Infection at the injection site
Assessment of Glycemic Index of Different Dates

Glycemic Index is a system of classification of different foods with significant levels of carbohydrates based on how they affect blood glucose levels after being consumed. In this study we will compare glycemic index of different varieties

Glycemic Index is a system of classification of different foods with significant levels of carbohydrates based on how they affect blood glucose levels after being consumed. Despite being a significant parameter of blood glucose, GI does not depict the effect of the food when taken in a controlled recommended amount, and so the Glycemic Loads (GL) must also be calculated, thereby measuring the impact on glycemic levels after consumption of standard food portion sizes. Dates are high energy foods consumed in various parts of the world, are known to be a source of several important nutrients and are also shown to have significant impacts in preventing illnesses due to their anti-inflammatory and anti-microbial actions as well as preventative action against oxidative reactions The greatly frequent consumption of dates necessitates the identification of their GI and GL to ensure whether consumption is beneficial and safe for individuals. The objective of the study is to determine and compare the values of GI and GL of three varieties of dates in order to assess their safe consumption by individuals

Eligibility Criteria:
Inclusion Criteria:

* General population from AKU
* Adult ages (18- 60 years) will be included in the study

Exclusion Criteria:

* Individuals with Dates/Ajwa allergy
* Pregnant women and individuals with diabetes, metabolic syndrome or any other co-morbidity will be excluded
A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants

QRL-101-03 is a multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of QRL-101 in healthy participants. QRL-101-03 is a follow-on study to QRL-101-01, an ongoing Phase 1, single ascending dose study to determine the safety, tolerability, and PK profile of QRL-101 after a single dose (ClinicalTrials.gov ID: NCT05667779).

Phase 1, single-site, multiple-dose study to evaluate the safety, tolerability, and PK of multiple ascending doses of QRL-101 in healthy participants. Up to 5 cohorts of 8 participants each, randomized 6:2 (QRL-101: placebo) will be tested. The approximate total duration of study participation for each participant may be up to 39 days.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 70 years of age inclusive at the time of signing the informed consent.
2. Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment.
3. Body mass index of 18 to 32 kg/m2 (inclusive).
4. Willing and able to practice effective contraception.

Exclusion Criteria:

1. Currently enrolled in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study.
2. Any participant in \>4 studies a year and/or has participated in a clinical trial within 1 month of expected dosing date.
3. History or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
The Effectiveness of an On-line Training Program on Hospital Medical Staff to Improve Fire Knowledge

Objective: To investigate the effectiveness of an online training program on medical staff in five public hospitals located in Sichuan, Yunnan, Hubei, and Fujian Provinces of China, on improving fire knowledge.

Methods: Participants will be randomly divided into control (receiving non-fire video training) and intervention (receiving hospital fire video training) groups. All participants will complete a questionnaire of fire knowledge before and after receiving the training.

Hypothesis: If the online training is effective, it can be promoted as a convenient and effective use of training and be promoted to other hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Physicians or nurses working in the recruiting hospitals

Exclusion Criteria:
Cerebral Oxygen, Blood Flow and Ammonia Uptake in Patients With Cirrhosis and an Acute Episode of Hepatic Encephalopathy (HE)

We wish to study patients with liver cirrhosis during and 2 weeks after an acute episode of liver coma (hepatic encephalopathy). By means of Positron Emission Tomography we investigate; brain blood flow, brain ammonia uptake and brain oxygen consumption. We hypothesize that blood flow an oxygen consumption is diminished and ammonia uptake increased during an acute episode of hepatic encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

* patients with an acute episode of hepatic encephalopathy

Exclusion Criteria:

* previous stroke