cyrilzakka/clinical-trials huggingface dataset:
Bioavailability Study of COQUN ORAL FORMULATION

The goal of the study is to evaluate the best dosage for COQUN ORAL FORMULATION in order to reach a level of plasma concentration which might assure its antioxidant effect if taken on a regular basis.

The study will include 24 healthy subjects who will test the CoQ10 formulation. All 24 subjects will test a single dose of 100mg CoQ10 in 1 day to assess bioavailability, which will be followed by a one week wash-out period and then by a 4 week period of continuous administration of COQUN ORAL FORMULATION in parallel groups (1:1): patients will be divided in the continuous treatment period into two groups, one group of 12 patients with intake of 100mg OD, the other one group of 12 patients with intake of 100mg BID, in order to assess multiple-dose profile of COQUN ORAL FORMULATION.

Patients will have to fast the night before enrolment, for at least 10 hours. Patients will be requested to fill in a short diary in the multidose phase, on a daily basis, for confirming the product correct intake, and informing on any experienced adverse event and eventual medication taken for its solving.

Eligibility Criteria:
Inclusion Criteria:

* Subject Informed consent form (ICF) is signed
* M \& F Aged between 35-75 years at the time of the signature of ICF
* A body mass index between 20 and 29 kg/m2
* Fasting the night before enrolment, for at least 10 hours
* Healthy, meaning absence of any prescribed medication for a month prior to the inclusion to the study and during the study
* Willing to avoid a consumption of any food supplements except vitamin D and calcium at least 2 weeks before and during the study
* Consumption of dairy and cereal products (standardized breakfast will include low lactose dairy and bread)
* Willing to follow all study procedures, including attending all site visits (including sessions during which a venous line will be inserted for blood sampling), and keeping a diary for the time of multiple-dose study (to follow their compliance and palatability)

Exclusion Criteria:

* Intake of any prescribed medication within 2 weeks of the beginning of the study
* Intake of any food supplements within 2 weeks of the beginning of the study, except vitamin D and calcium
* Hypotension
* Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or hematological disease, diabetes
* Gastrointestinal disorders or other serious acute or chronic diseases
* Known lactose/gluten intolerances/ food allergies (limitation for standardization of meals)
* Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal
* Known drug and/or alcohol abuse
* Using any form of nicotine or tobacco
* Mental incapacity that precludes adequate understanding or cooperation
* Participation in another investigational study or blood donation within 3 months prior to or during this study
Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Thoracotomy

Comparing efficacy of Ultrasound-guided Erector Spinae Plane Block versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Thoracotomy

Thoracotomy is one of the most painful surgical procedures. The reported incidence of persistent pain after thoracic surgery (post thoracotomy pain syndrome) has been reported in 20%-70% of patients. Inadequately treated post thoracotomy pain can have several negative consequences. Therefore, pain relief is essential to facilitate coughing and deep breathing and to promote early mobilization.

Thoracic epidural analgesia and thoracic paravertebral block are strongly recommended techniques for managing post thoracotomy pain to reduce opioid use and the related adverse effects as hypoventilation, depression of cough reflex, nausea and vomiting. However, they can be technically challenging to perform and are associated with up to 15% failure rate in Thoracic epidural analgesia and potential risk of pneumothorax in thoracic paravertebral block.

Erector spinae plane block is a relatively novel ultrasound-guided regional technique. Its application in patients with chronic thoracic neuropathic pain and acute surgical pain has been described by Forero et al.

Retrolaminar block is an easy and safe analgesic technique. It has been reported to be satisfactory for post-operative analgesia after breast surgery.

To our knowledge there is no clinical studies, comparing the effectiveness of both blocks on postthoracotomy pain, has been reported.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 21-65 years old of both sexes.
* Patients were scheduled for elective thoracotomy.
* Their ASA physical status classification is II-III.

Exclusion Criteria:

* Patients' refusal.
* Local infection at the site of block.
* Coagulation abnormalities.
* Sever spinal deformity e.g. scoliosis.
* Known hypersensitivity to local anesthetics.
* Mental dysfunction and cognitive disorders.
* History of drug abuse and chronic analgesic use.
COping With PAin Through Hypnosis, Mindfulness and Spirituality

The purpose of this study is to evaluate and compare the immediate effects of self-hypnosis, mindfulness meditation and a spiritual intervention relative to a control condition for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation.

The primary aim of this study (Aim 1) is to compare the immediate effects of self-hypnosis (SH), mindfulness meditation (MM), and Christian meditation (CM), relative to a control group (CN), for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation in a sample of healthy volunteers.

An exploratory aim of this study (Aim 2) is to identify possible shared and unique predictors of response to the three treatment conditions. The possible predictors we plan to test include sex, age, religious affiliation, hypnotic suggestibility, baseline mindfulness, acceptance, pain-related beliefs, religiosity, trait spirituality, previous experience with SH, MM and CP, outcome expectancies, and trait absorption.

This is a randomized quantitative experimental mixed-model repeated-measures study with three assessment points: baseline (T0), pre-test (T1), and post-test (T2). Eligible healthy adults will be randomized to one of the four study conditions. Interventions will be a 20-minutes audio-guided practice of either self-hypnosis, mindfulness meditation, or Christian prayer. Participants in the control group will not be instructed to use any specific strategy during the painful stimulation. Participants will be submitted to a first cycle of Cold Pressor Arm Wrap. They will then listen to a 20-minutes audio recording inducing one of the three interventions, or, in the case of the control group, to a 20-minutes recording of a natural history textbook. Primary outcomes are pain intensity, pain tolerance, and pain-related stress as measured by salivary cortisol level and heart rate variability.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older;
* able to read, speak and understand Portuguese;
* willing to be randomly assigned to all four conditions (regardless of participant's own religious affiliation)

Exclusion Criteria:

* reporting history of musculoskeletal problems, cancer, heart disease, stroke, epilepsy, diabetes, or Raynaud syndrome;
* having an open wound, cut, or fracture in any of the upper limbs;
* self-reported alcohol or substance dependence;
* cognitive or physical impairment, or severe psychopathology that could prevent participation.
Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS).

The aim of this study is to identify whether it is possible to safely discontinue treatment in relapsing-onset MS patients who have shown no evidence of active inflammation in the years prior to inclusion clinically and/or radiologically. The secondary objectives address the questions whether the discontinuation of first-line treatment has an effect on disability progression and whether the discontinuation of first-line treatment improves the quality of life for the patient. Furthermore, blood collections will be included to assess whether it is possible to retrospectively predict possible return of inflammatory activity with biomarkers such as neurofilament light (NFL) or patient characteristics such as disease activity prior to disease modifying therapy (DMT). In case of emerging disease activity after the cessation of therapy we will assess if reinitiation will lead to NEDA again, and if there are long-term consequences. If possible, post-hoc analysis are performed for the different types of treatment compounds.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local privacy regulations.
* Definite diagnosis of relapsing-onset MS according to the revised McDonald 2017 criteria
* Treatment with one of the first-line DMTs: any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide
* Complete absence of inflammatory activity (no objectively defined and confirmed relapses, no significant number (2 or more) of new-T2 lesions and no contrast-enhancing lesions) for 5 consecutive years under first-line treatment

Exclusion Criteria:

* A switch between first-line disease modifying therapy over two years prior to inclusion, in case the switch has been due to in effectivity of the first DMT.
* Women who want to discontinue medication because of a pregnancy wish and women who are pregnant or expect to become pregnant during the study period
* Patients that have previously used interferon-beta and have been tested positive for neutralizing antibodies (NAbs).
Assessment of Patients Treated With JETREA® for Vitreomacular Traction

The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period.

After receiving a single intravitreal injection as per country's product label (Day 0), subjects were followed for a 6-month period (Day 180).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA), with evidence of focal VMA visible on Spectral Domain Optical Coherence Tomography (SD-OCT).
* Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed consent form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential if pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
* Hypersensitivity to ocriplasmin or any of the JETREA® excipients.
* Active or suspected intraocular or periocular infection.
* Presence of Epiretinal Membrane (ERM) over the macula at baseline.
* Broad VMT/VMA \>1500 microns at baseline.
* History of vitrectomy in the study eye.
* History of laser photocoagulation to the macula in the study eye.
* Any relevant concomitant ocular condition that, in the opinion of the investigator, could be expected to worsen or require surgical intervention during the study period.
* Macular hole of \>400µm diameter in the study eye.
* High myopia in the study eye.
* Pseudo-exfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens/zonular instability.
* Aphakia.
* History of retinal detachment.
* Diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions.
* Recent ocular surgery or ocular injection.
* Vitreous hemorrhage.
* Exudative age-related macular degeneration (AMD).
* Therapy with another investigational agent within 30 days prior to Visit 1.
* Active, simultaneous enrollment in another ophthalmology clinical study.
* Other protocol-defined exclusion criteria may apply.
Recording by Patients and Relatives/Friends in the Maternity Unit

Increasingly, patients are keen to record aspects of their medical care, especially in obstetrics and paediatrics. The knowledge of patients and staff in relation to this area is thought to be variable. In addition, the attitudes of patients and staff regarding this practice has not been well studied. This study aims to gather information on patients' use of recording devices to capture audio recordings, photographs or videos. Furthermore it aims to assess patient and staff knowledge and attitudes in relation to this area.

This study will involve patients who have recently delivered a baby on the maternity unit or obstetric theatre completing a questionnaire. They will be approached by a study investigator and the study explained. They will then complete a consent form if they are happy to proceed. Following this they will complete the questionnaire.

It will also involve the surveying of staff, who will be approached by a study investigator when not directly involved in the clinical care of patients. They will also complete a consent form if they are happy to proceed and then complete the questionnaire.

The aim of the study is to evaluate the knowledge and attitudes of both patients and staff towards the recording by patients/relatives/friends within the obstetric environment.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Post natal following any form of delivery
* Between 4 and 48 hours after delivery
* Able to understand English adequately to give consent and complete the questionnaire

Exclusion Criteria:

- Women experiencing complications affecting themselves or their babies will be excluded if it is felt that approaching them for potential recruitment might be overly intrusive.
PD-1 Antibody Improve Mixed Chimerism

PD-1/PD-L1 pathway play an important role in Inhibiting the function of antigen-specific CD8+T cells, thus matter a lot in immune escape. We intend to use PD-1 antibody to improve the function of lymhocyte and improve the chimerism in patients after allo-HCT.

Mixed chimerism is a trouble condition after allogeneic hematopoietic cell transplantation (Allo-HCT),all targeted treatment are aimed to improve the function of lymphocyte recipient. PD-1 antibody was reported to restored the function of impaired lymphocyte. Therefore, we want to use PD-1 antibody to improve the function of lymhocyte and improve the chimerism in HLH patients after allo-HCT.

Eligibility Criteria:
Inclusion Criteria:

1. EBV-HLH according to the HLH-04 diagnostic criteria.
2. After allo-HCT, have achieved engraftment and reconstitute of hematopoiesis. have achieved full donor chimerism.
3. Withdraw immunosuppressive agent, chimeric rate was 80%-95%
4. Age \>18 years old, gender is not limited.
5. no graft-versus-host disease was observed.
6. No secondary graft failure (ANC \<0.5\*10\^9/l,PLT \<10\*10\^9/l)
7. Before the start of the study, aminopherase (ALT/AST) and total bilirubin were normal. Serum creatinine ≤ 1.5 times the upper limit of Normal (ULN); No thyroid dysfunction. The left ventricular ejection fraction (LVEF) was normal.
8. Informed consent.

Exclusion Criteria:

1. Allergic to the test drug ingredients or to a more severe allergic constitution.
2. Chimeric rate continue to decline after 2 weeks of toripalimab Injection used.
3. Serious immunoreaction: myocardial damage, hepatitis, pneumonia.
4. Central nervous system symptoms.
5. Serious mental illness.
6. Active bleeding of the internal organs
7. Uncontrollable infection；
8. Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase;
9. Participate in other clinical research at the same time.
The Study of Association of Helicobacter Infections in Biliary Tract Cancers

Biliary tract carcinoma (BTC) includes gallbladder carcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma, intrahepatic cholangiocarcinoma. Chronic infections of the biliary tract are major drivers of cancer. Helicobacter species is one of the most established pro-oncogenic pathogens for gastric malignancy. However, its role in biliary tract cancers is under investigation. Recently H. pylori has been associated with gallbladder pathologies like cholelithiasis, cholecystitis, choledocholithiasis, gallbladder polyps. However, some studies have also reported that chronic inflammation due to H. pylori infection causes biliary tract cancer. On the other hand, some studies have reported no association between H. pylori infection and gallbladder diseases.

In addition to H Pylori, H.bilis and H.hepaticus have a significantly higher incidence in bile from biliary tract and gallbladder cancer patients than in patients with gallstones/cholecystitis.This, together with the high prevalence of gallstones, makes it important to evaluate the role of Helicobacter in biliary tract cancers. This study aims to compare the prevalence of Helicobacter sp.(pylori, bilis, hepaticus). This study will include biliary tract carcinoma patients, benign biliary disease patients, high risk conditions for malignancy and Voluntary healthy liver donors with no gallbladder pathology. HPE samples will be assessed and association of Helicobacter sp will be studied among all 4 arms.

Patients who have received H pylori eradication therapy will be excluded. All the included samples will be assessed for Helicobacter species using giemsa stain and DNA PCR. Results will be studied to compare the prevalence of Helicobacter sp. in Biliary tract malignancy and benign biliary diseases.


Eligibility Criteria:
Inclusion Criteria:

* Biliary tract carcinoma patients who underwent resection Patients undergoing cholecystectomy for benign biliary disease. Voluntary healthy liver donors with no gallbladder pathology Patients undergoing cholecystectomy for conditions with high risk of malignancy

Exclusion Criteria:

* Patients who have taken H.pylori eradication previously in last three months.
Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing an elective Caesarean section.

* Group 1: bupivacaine 0.25% + dexamethasone 8 mg
* Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.

The pain and discomfort following cesarean delivery are mostly due to the abdominal wall incision and dissection of muscles; it delays early ambulation and breastfeeding. This can lead to postoperative complications such as thromboembolic disorders. So, providing an effective and safe postoperative analgesic method seems to be mandatory. Opioid analgesia remains the most effective means of relieving pain in a wide variety of conditions; however, it may cause adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. As the analgesia and the side effects of opioids are dose-dependent, a multimodal approach may enhance analgesia, which in turn would decrease the side effects .

Mc Donnell and colleagues have reported that a transversus abdominis plane (TAP) block can decrease the postoperative pain following abdominal surgery. The landmarks of this block were first described in 2001 by Rafi. The TAP block has been performed for postoperative analgesic control in patients undergoing radical prostatectomy, hysterectomy, cesarean delivery under spinal anesthesia, and laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* healthy parturient (ASA I and II) scheduled to undergo LSCS under spinal anesthesia

Exclusion Criteria:

* Participants had known sensitivity to bupivacaine
* patient refusal,
* localized infection over injection point
* patients with significant coagulopathies and
* with contraindications to regional anesthesia,
* patients with heart diseases, altered renal or liver functions,
* psychological disorders, patients with pregnancy-induced hypertension and
* gestational diabetes, chronic use of pain medications,
Subclinical Atherosclerosis in Patients With Familial Hypercholesterolemia Treated With Evolocumab®

Protein convertase subtilisin kexin type 9 (PCSK-9) inhibitors demonstrated efficacy in cholesterol reduction and in the prevention of cardiovascular events. The investigators will evaluate changes in lipid profile, oxidation markers and subclinical atherosclerosis in patients with familial hypercholesterolemia (FH) during 12 weeks of treatment with a PCSK-9 inhibitor, Evolocumab®.

Several studies emphasize the role of high levels of low-density lipoprotein cholesterol (LDL-C) as the main causative factor in atherosclerosis development. Among patients with hypercholesterolemia, those with very high levels of LDL-C exhibit increased prevalence of subclinical atherosclerosis and a higher atherosclerosis progression, thus leading to a significantly higher CV risk. Endothelial dysfunction is the earliest stage of the atherosclerotic process and even a trigger of CV events. Flow-mediated dilation (FMD) is widely accepted as an accurate and non-invasive method to assess vascular reactivity and, in turn, as a surrogate marker of subclinical atherosclerosis and an independent predictor of CV events. It's well known that hypercholesterolemia has been associated with decreased endothelial function and increased oxidative stress. Although statin treatment represented for years the gold standard as lipid lowering therapy, the target LDL-C is not always achieved, mainly among patients with very high levels of LDL-C. More recently, PCSK-9 inhibitors demonstrated efficacy in LDL-C reduction, in the prevention from CV events and in atherosclerotic burden regression. Some data showed an effect of PCSK-9 inhibitors on endothelial function, but no evidence is available on effect on LDL subfractions. Small dense LDL (sd-LDL) are considered an emerging risk factor for cardiovascular disease due to a greater atherogenic potential \[ \] and are important markers for predicting CV risk.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of FH (clinical and/or genetic)
* eligibility of patients to start a treatment with PCSK-9 according to 2016 ESC guidelines.

Exclusion Criteria:

* age \< 18 years
* inability to understand or sign the informed consent
* high level of transaminases ( \>3x upper normal limit)
* hypertriglyceridemia ( \>150 mg/dl)
* end-stage renal disease (filtration rate \< 30 ml/min/mq)
* current malignant disease or a diagnosis of malignancy in the 2 years prior to the first visit
* previous exposure to PCSK-9 inhibitors
* presence of hypercholesterolemia secondary to other causes (hypothyroidism, hormone therapies, corticosteroids etc.)
How do Patients, Nurses and Physicians Perceive Negative Postoperative Events?

The purpose of this study is to assess how patients, nurses and physicians perceive negative events following surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years
* Capacity to act and no legal guardian
* Patients with any underlying disease admitted to the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich with planned minor or major visceral surgery
* German language as daily language.

Exclusion Criteria:

* Patients with cognitive difficulties and diseases, which may yield unreliable answers
* Patients unable to read and write