cyrilzakka/clinical-trials huggingface dataset:
Paracetamol Effect on Prostaglandins and Blood Pressure

This research program aims to investigate the influence of paracetamol on blood pressure and the cyclooxygenase (COX) - prostaglandine (PG) pathway in patients with pain. Through an observational pilot study, we will use advanced LC/ESI-MS/MS methodology to analyze the COX-OG pathway in plasma and urine. The study will assess the effects of paracetamol compared to ibuprofen, considering different types of pain. The primary focus is to understand the changes in blood pressure and the COX-PG pathway upon initiation or discontinuation of paracetamol, with safety analysis as a secondary consideration.


Eligibility Criteria:
Inclusion Criteria:

* Headache and orosurgical patients treated at the respective charite outpatient clinic.
* Age 18 years or older
* Able to consent
* Patients with migraine type headache treated with paracetamol or ibuprofen within the last 12 hours or not treated with paracetamol or ibuprofen within the last 48 hours
* Patients treated with with paracetamol or ibuprofen undergoing orosurgery for wisedome tooth extraction

Exclusion Criteria:

* Pregnancy
* Arterial hypertension
* Use of beta blockers
* Use of COX inhibitors other than paracetamol or ibuprofen, including low-dose acetylsalicylic acid
* Stable prophylactic therapy of migraine for less than 3 weeks
* Use of tryptans in the last two days (Frovatriptane in the last 6 days)
* Oral surgery patients using paracetamol or ibuprofen in the last 24 hours
* Known allergy to paracetamol or ibuprofen
Risk Stratification and MRD-driven Maintenance for MM After ASCT

This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation.

This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. In other circumstances, for example, patients who are R2-ISS 3 or 4 will receive daratumumab combined with lenalidomide regardless of MRD status, while patients with MRD positivity will also receive daratumumab plus lenalidomide maintenance.


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT.
2. Must have a partial response (PR) or better response before maintenance.
3. Must have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2.
4. This study allows for post-ASCT consolidation therapy.
5. ANC ≥ 1.0 x 10\^9/L, Hb ≥ 85 g/L PLT ≥ 75 x 10\^9/L (if BMPC \< 50%) or PLT ≥ 50 x 10\^9/L (if BMPC ≥ 50%).
6. No active infection.
7. a).TBIL\<1.5 x upper limit of normal (ULN) (\<3 x ULN in patients with Gilbert's syndrome); b).AST and ALT \<3 x ULN.; c. Creatinine clearance ≥ 45mL/min.

Exclusion Criteria:

1. Must not refractory or non-tolerate to lenalidomide in Arm A.
2. Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B.
3. Must not have progressed on multiple myeloma (MM) therapy before screening
4. Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal；
5. Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
6. History of stroke or serious thrombotic event within 12 months prior to screening.
Reference Values of Cerebrospinal Fluid Outflow Resistance and Intracranial Pressure in Healthy Elderly

Objective. The intracranial pressure and cerebrospinal outflow resistance are essential parameters to describe the cerebrospinal fluid dynamic system. Outflow resistance effects intracranial pressure, pulse amplitudes, cerebrospinal fluid absorption as well as the compliance of the system. The objective of this study was to determine the reference values in the elderly.

Methods. Elderly people (60-82 years), considering themselves healthy, were recruited through an ad in the local paper. All were evaluated with a 3 Tesla magnetic resonance imaging apparatus. Subjects were eligible if they did not have any psychiatric or neurological disorder or signs of advanced atherosclerotic disease. Intracranial pressure and outflow resistance were determined by a constant pressure infusion method with the patient in the supine position. The study population consisted of 40 subjects (mean age 70 years; 23 women).


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* 60-82 years

Exclusion Criteria:

* Psychiatric or neurological disorder or advanced atherosclerotic disease
fMRI of Vulnerable Brain Regions in Persons at Risk for Alzheimer's Disease

The purpose of this study is to investigate the organization of memory and develop future methods for early detection of AD. Using functional magnetic resonance imaging (fMRI), we examine the responsiveness of the brain to memory tasks, specifically focusing on regions of the brain (the mesial temporal lobe and posterior cingulate) that are known to be involved in early stages of Alzheimer's disease (AD). Of interest are differences in brain activation between people with and without a family history of AD and other risk factors.


Eligibility Criteria:
Inclusion Criteria:

* MCI Group: Diagnosis of mild cognitive impairment
* AD Family History Group: Confirmed family history of Alzheimer's and concurrent enrollment in the Wisconsin Registry for Alzheimer's Prevention (WRAP)
* Control Groups: Cognitively healthy and both parents survived past age 70 with no memory problems

Exclusion Criteria:

* Claustrophobia
* Metallic or electronic implants or devices that are not MRI-safe
A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

Younger women with breast cancer experience substantially greater distress and depressive symptoms than older women. These symptoms can hamper recovery and healthy behaviors that can reduce the risk of recurrence and/or other chronic diseases. The primary objective of this study is to evaluate the feasibility and preliminary efficacy of a mindfulness meditation-based intervention for this at-risk group of women. The investigators hypothesize that a structured program of mindfulness meditation will lead to significant improvements in psychological well-being (i.e., depression, stress), with corresponding improvements in health behaviors and biomarkers of cancer risk, in women diagnosed with breast cancer, prior to age 50. The investigators will also examine mechanisms for intervention effects, including increased mindfulness and ability to relax.


Eligibility Criteria:
Inclusion Criteria:

* women diagnosed with early, resectable breast cancer (Stage 0, I, II, or III) prior to age 50
* have completed treatment with surgery, radiation, and/or chemotherapy at least 3 months previously.

Exclusion Criteria:

* have a breast cancer recurrence, metastasis, or another cancer diagnosis (excluding non-melanoma skin cancer
* unable to commit to intervention schedule.
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD

This is a project that will determine whether the use of daily bright light therapy has an effect on depressive symptoms experienced by adult inpatients with CF and COPD. The purpose of this project is to apply a daily 30-minute BLT intervention to hospitalized adult CF and COPD patients in order to decrease symptoms of depression as measured by depression inventory scoring.

This project will occur on a 29-bed pulmonary step-down unit at a 1,600-bed academic medical center. This unit commonly treats patients with CF, COPD, and other pulmonary complications. The unit's patient care staff will be educated on the bright light lamps in order to prevent interruptions and to encourage compliance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cystic fibrosis or chronic obstructive pulmonary disease (COPD)
* Adult age 18 or older
* Admitted to the pulmonary step-down and transplant unit
* Score greater than zero on pre-intervention Beck's Depression Inventory-II (BDI-II)

Exclusion Criteria:

* Pre-existing ophthalmological conditions or photosensitivity
* Migraines
* Receiving high dose steroids for transplant rejection (due to mood altering qualities),
* Antibiotics that increase light sensitivity
* Diagnosed with bipolar disorder (light therapy may trigger mania)
* Admissions anticipated to span less than 48 hours
* Children are being excluded due to the fact that only adult CF and COPD subjects are admitted to University of Pittsburgh Medical Center (UPMC) Presbyterian hospital
Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks

The interscalene block provides effective analgesia after shoulder surgery. It consists of injecting local anaesthetic within the brachial plexus, in the interscalene groove, between the anterior and middle scalene muscles. Unfortunately, this technique is associated with respiratory complications such as hemidiaphragmatic paresis due to the spread of the local anaesthetic towards the phrenic nerve that lies close to the brachial plexus, with an incidence up to 100%. The diaphragmatic paresis may be a serious side-effect, especially in patients suffering from a reduced respiratory function such as chronic obstructive pulmonary disease; this entity may even represent a contraindication to the performance of the block.

The shoulder is mainly innervated by the suprascapular and axillary nerves, both of them coming from C5 and C6 branches of the brachial plexus block. Recently, several authors have successfully identified and block these two nerves under ultrasound guidance. Only one randomised controlled trial compared interscalene block with a combination of suprascapular and axillary nerve blocks, and showed inconclusive results probably due to the absence of ultrasound guidance; indeed, analgesia was equivalent at the sixth postoperative hour, while patients with an interscalene block had reduced pain scores in the recovery room. Besides, the authors did not investigate the impact on the respiratory function.

In that randomised controlled trial, the investigators would like to compare the analgesic efficacy and the respiratory outcomes between the interscalene block and the combined suprascapular-axillary nerve blocks.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III;
* 18-85 years of age, inclusive;
* surgery less than 3 hours.

Exclusion Criteria:

* indication for catheter insertion;
* contraindications to brachial plexus block (e.g., allergy to local anaesthetics, malignancy or infection in the area);
* existing neurological deficit in the area to be blocked;
* pregnancy;
* history of neck surgery or radiotherapy;
* severe respiratory disease;
* chest deformity;
* inability to understand the informed consent and demands of the study;
* patient refusal.
Thrombotic Effects of Yellowstripe Scad

The study aimed to determine the thrombotic effects of YSS compared with salmon among healthy overweight subjects. It hypothesized that YSS may result significant, favorable thrombotic effects and the effects may be similar with salmon.

The project was a randomized, two-period, crossover trial with 8-week treatment periods and 8-week washout period. A total of 50 healthy overweight adults were recruited among staff and students in UPM. All the subjects were randomized into two groups. Each group was served with either cooked YSS (\~265 g/ day) or salmon (\~246 g/day) thrice per week. Blood and urine samples were collected for laboratory assessment.

Eligibility Criteria:
Inclusion Criteria:

* Malaysian
* Overweight participants (BMI 23-27.4 kg/m2)

Exclusion Criteria:

* Regular use of fish oil supplements during the last one month
* Regular consumption of fish twice or more per week
* Vegetarian who excluded all meat, fish, and poultry from their diet
* Diagnosed with cardiovascular disease, haemostasis disorder, inflammatory disease, diabetes mellitus, hypertension, or other significant medical history that may prohibits the participation
* Receiving warfarin or aspirin treatment, or medication to lower serum lipids, blood pressure, and inflammation
* Women who are menopause, pregnant or lactating
Management of Diabetes Mellitus Patients With Retinopathy

Aim of this NIS is to retrospectively document the management of diabetic patients with retinopathy in a naturalistic setting in Switzerland. Following elements are going to be analyzed:

* which medication are used to keep blood pressure under control?
* which medication are used for metabolic control?
* the average control level of metabolism and blood pressure is compliant with the international guidelines?
* laser photocoagulation plays a role in the control of metabolism and blood pressure?
* there are differences in the control of metabolism and blood pressure between patients with DM I or DM II?
* there is an influence of renal failure on the choose of medication?


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients
* Diabetic retinopathy
Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease

This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C virus (HCV) genotype 1a (GT1a) infection or genotype 4 (GT4) infection (HCV RNA level greater than 1,000 IU/mL at Screening).
* Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.
* Chronic kidney disease stage 4 or stage 5.

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
* HCV genotype performed during screening unable to genotype or co-infection with any other HCV genotype, no mixed genotypes.
* Abnormal laboratory tests
* Current enrollment in another investigational study
* Prior treatment with a direct acting antiviral agent (DAA) containing regimen with the exception of interferon or pegylated interferon with or without ribavirin
* Current treatment with a direct acting antiviral agent (DAA) containing regimen
* Any evidence of liver cirrhosis or liver cancer
Oxygen as a Limiting Factor for Performing Multitasking

The aim of the present study was to evaluate whether hyperbaric oxygen (HBO) environment, with increased oxygen supply to the brain, will enable better performance of complex and/or multiple activities.

The Brain uses 20% of the total oxygen supply consumed by the entire body. Even though, less than 10% of the brain is active at every given time, the brain utilizes almost all the oxygen delivered. In order to perform different tasks or more than one task (multi-tasking), the oxygen supply is shifted from one brain region to another, via modulation of blood perfusion.

The aim of the present study was to evaluate whether hyperbaric oxygen (HBO) environment, with increased oxygen supply to the brain, will enable better performance of complex and/or multiple activities.

Methods: a prospective, double blind randomized control, cross over trial including healthy volunteers. Participants were asked to perform a cognitive task, a motor task and a simultaneous cognitive-motor task (multi-tasking). Participants were randomized to perform the tasks at 2 environments: (a) normobaric air (1ATA 21% oxygen) (b) HBO (2ATA 100% oxygen). Two weeks later participants were crossed to the alternative environment. Blinding of the normobaric environment was achieved in the same chamber with masks on while hyperbaric sensation was simulated by increasing pressure in the first minute and gradually decreasing to normobaric environment prior to tasks performance.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers,
* minimum of 12 years of formal education

Exclusion Criteria:

* any inner ear pathologies,
* any lung disease,
* any mental or physical limitation of participat in going into oxygen chamber environment
Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria

Hutchinson-Gilford Progeria Syndrome (Progeria) is a rare autosomal disease that results in premature death at a median age of 13 years due to cardiovascular and cerebralvascular compromise. The mutation for this disease has been identified and results in a mutant form of lamin A that cannot be de-farnesylated. This study evaluates the combination of pravastain (a statin), lonafarnib (a farnesyltransferase inhibitor) and zoledronic acid (a bisphosphonate) in an open label phase II efficacy trial in children with Progeria. These agents all target farnesylation pathways at different points. Patients with genetically confirmed progeria will be eligible for this protocol. Treatment will be initiated for 24 months duration. Clinical and biologic parameters will be examined to assess response.


Eligibility Criteria:
Inclusion Criteria:

* Genetic Diagnosis: All patients must have confirmatory mutational analysis showing mutation in the lamin A gene.
* Clinical Diagnosis: Patients must display clinical signs of progeria as per the clinical trial team.
* Travel: Patients must be willing and able to come to Boston for appropriate studies and examinations at initiation of study and at months 6, 12, 18 and 24 on study.
* Patient must have adequate organ and marrow function as defined by the following parameters:
* Blood: APC (ANC + bands + monocytes = APC) \> 1,000/microliters, Platelets \> 75,000/microliters (transfusion independent); Hemoglobin \>9g/dl.
* Renal: creatinine Less than or equal 1.5 times normal for age or GFR \> 70 ml/min/1.73m2.
* Hepatic: bilirubin Less than or equal to 1.5 x upper limit of normal for age; SGPT (ALT) \< and SGOT (AST) \< 5 x normal range for age.
* PT/PTT: PT/PTT \< 120% upper limit of normal OR PI approval
* No overt renal, hepatic, pulmonary disease or immune dysfunction.
* 25-hydroxyvitamin D ≥ 20 ng/ml within 4 weeks of bisphosphonate infusion.
* Signed informed consent according to institutional guidelines must be obtained and patient must begin therapy within twenty eight (28) days.

Exclusion Criteria:

* Other than the drugs used in this protocol, drugs targeted to treat Progeria are excluded. Drugs to treat symptoms of Progeria are permitted.
* Patients must not be taking medications that significantly affect the metabolism of lonafarnib at the time they start lonafarnib
* Patient must have no uncontrolled infection.
* Subjects who have known or suspected hypersensitivity to any of the excipients included in the formulation should not be treated.
* Patients must not be pregnant or breast-feeding. Female patients of childbearing potential must have negative serum or urine pregnancy test. Male and female patients of reproductive potential must agree to use a medically accepted form of birth control while on study and up to 10 weeks after treatment. It is permissible for female patients to take oral contraceptives or other hormonal methods while receiving treatment with lonafarnib.
Automated Secretion Removal in ICU Patients

SUMMARY Rationale In intubated and mechanically ventilated critically ill patients, removal of airway secretions is typically performed by tracheal suctioning, an intervention that is labor-intensive and very unpleasant for the patient. The current study tests the hypothesis that a novel secretion removal technology named TrachFlush, that pushes airway secretions past and above the cuff of the endotracheal tube, reduces the need for tracheal suctioning.

Objective The primary objective of this study is to evaluate whether use of the TrachFlush reduces the need for tracheal suctioning. In a selection of patients, one secondary objective is to ascertain the exact volume of airway secretions that is pushed past and above the cuff of the endotracheal tube.

Study design Open prospective intervention study. Study population One hundred adult, intubated and mechanically ventilated ICU patients expected to need invasive ventilation \> 24 hours.

Intervention The attending nurses activate the TrachFlush when there are secretions present in the larger airways that need to be removed. If this results into a push of airway secretions past and above the cuff of the endotracheal tube, no further action is needed. If unsuccessful, the nurse will perform a standard tracheal suctioning procedure to remove the secretions. In a subset of patients with an endotracheal tube that allows subglottal suctioning, the exact amount of airway secretions present above the cuff will be measured each time the TrachFlush is used.

Main study parameters/endpoints The proportion of successful TrachFlush activations from start of the study to complete weaning from the ventilator, or a maximum of 7 days (primary). Secondary endpoints include the total number of TrachFlush activations during the same time window (all patients), and the exact amount of airway secretions pushed past and above the cuff of the endotracheal tube (in patients with a tube allows subglottal suctioning).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness Inappropriate deflation or inflation of the endotracheal cuff by the TrachFlush could cause harm. However, the cuff pressure will be checked regularly, and if necessary corrected, at least every time the TrachFlush has been used. Patients may benefit from the intervention, as the need for tracheal suctioning may reduce.


Eligibility Criteria:
Inclusion Criteria:

* admission to one of the participating ICUs;
* intubated with an endotracheal tube containing a cuff;
* receiving invasive mechanical ventilation; and
* expected to need invasive ventilation beyond the following calendar day at the moment of inclusion.

Exclusion Criteria:

* age \< 18 years;
* known or suspected tracheal damage, e.g., after inhalation trauma, thorax trauma, or intubation trauma;
* any condition for which deflation of the endotracheal cuff is deemed detrimental, e.g., in case high airway pressures are needed; and
* any infection, or colonization with pathogens that require strict single isolation of the patient (cohort isolation is allowed).