cyrilzakka/clinical-trials huggingface dataset:
PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study

The purpose of this study is to examine if chronic paracetamol dosing increases blood pressure in patients with known high blood pressure.

A prospective randomised, double-blind, crossover trial, comparing the effects of paracetamol 1g (500mg x2) four times daily with matched placebo on ambulatory and clinic BP, each given for 14 days, with a 14-day washout period.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old, men or post-menopausal women (women with no periods for 12 months or more, or those who have had a surgical menopause)
* Treated hypertensive patients with an average daytime ambulatory blood pressure measurement (ABPM) \<150/95mmHg on stable doses of one or more antihypertensive medication (at least one of which should be; an ACE inhibitor, angiotensin receptor blocker or diuretic) for 3 months, or untreated hypertensive patients with an average daytime ABPM ≥135/85 but \<150/95.

Exclusion Criteria:

* History of ischaemic heart disease, cardiac failure, cerebrovascular disease, liver impairment (ALT/AST\>50IU/L) or stage 3-5 chronic kidney disease.
* History of overdose or suicidal ideation
* Patients weighing \<55kgs.
* Patients with chronic pain requiring treatment, with a known allergy to paracetamol, or concomitant use of non-steroidal anti-inflammatories , oral anticoagulants or corticosteroids.
Adapting Single Sessions Interventions for Type 1 Diabetes

The goal of this clinical trial is to learn if implementing a single-session depression intervention for youth with type 1 diabetes (T1D) is feasible and acceptable to patients. can help improve mood and health outcomes. It will also learn about the initial efficacy of the intervention. The main questions it aims to answer are:

1. Is a single-session depression intervention for youth with T1D feasible to recruit and implement?
2. Is a single-session depression intervention for youth with T1D acceptable to patients (i.e., do they find it helpful)?
3. Does a single-session depression intervention for youth with T1D lead to improvements in low mood?

Researchers will compare a single-session depression intervention for youth with to a education control to see if a single-session depression intervention works to improve depressive symptoms.

Participants will:

* Participate in a single-session depression intervention
* Complete questionnaires and provide a sample for A1c at a baseline, 3-month, and 6-month visit
* Complete daily questionnaires once a day for two weeks before and after the single-session depression intervention


Eligibility Criteria:
Inclusion Criteria:

* Child or adolescent age between 11-18 years, inclusive
* Physician confirmed T1D diagnosis of at least 6 months duration prior to study enrollment
* Positive depression screening score of \>5 on the PHQ-9 in the last year
* Not currently engaged in outpatient mental healthcare
* English fluency

Exclusion Criteria:

* Another systemic chronic medical illness except for celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma
* Any score of 1, 2, or 3 on item 9 (indicating suicidal ideation) of the PHQ-9 in the last year.
Ultrasound of the Inferior Vena Cava in the Prevention of Hypotension After Induction of General Anesthesia

Based on the preoperative ultrasound detection of various parametric indicators of the inferior vena cava cross-section, including the ratio of the inferior vena cava's long and short axes, cross-sectional area and circumference during two-dimensional and three-dimensional imaging, as well as the changes in respiratory variability of each parameter, we explored the predictive value of IVC ultrasound indicator parameters on hypotension after induction of general anesthesia in elderly patients undergoing elective non-cardiac surgery, screened the sensitive indicators, and calculated the cut-off values.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients undergoing elective non-cardiac surgery under general anesthesia;
* Age 65-85 years old;
* Body mass index (BMI) 18-28 kg/m2;
* American society of anesthesiologists (ASA) class I-III.

Exclusion Criteria:

* Patient refusal or lack of cooperation;
* Inability to communicate properly;
* Severe sinus bradycardia, pacemaker implantation, atrioventricular block, and atrial fibrillation;
* Presence of severe hepatic and renal function abnormalities;
* Preoperative cardiac ultrasound suggesting LVEF \<50%;
* Tricuspid valve displacement \<16 mm by preoperative cardiac ultrasound;
* Chronic obstructive pulmonary disease;
* Pulmonary hypertension;
* Administration of drugs that inhibit the renin-angiotensin-aldosterone system;
* Possibility of a difficult airway.
Study of the BDNF-Val66Met Polymorphism in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal

This study is complementary to the main study "Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal " NCT01491347.

The purpose of this study is to evaluate the Bdnf gene - Val66Met polymorphism in subjects with alcohol dependence according to their alcohol consumption status 6 months after withdrawal (relapse or abstinence), in relation to the presence of psychiatric co-morbidities.


Eligibility Criteria:
Inclusion Criteria:

* participation to the study "BDNF serum levels evolution during 6 months after alcohol withdrawal" (main study)
* criteria from the main study

Exclusion Criteria:

* criteria from the main study
* released or out from the main study before the follow-up at 4 months after withdrawal
Effect of Aerobic Exercise Training on Balance, Walking Capacity, and Quality of Life in Sub-acute Stroke.

Stroke is one of the major cause of morbidity and mortality and the leading cause of disability in adults all around the world. Stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social services. After stroke, impairments in ADLs and functional status, deterioration in health related quality of life can be seen.

The purpose of this study is to Determine the effect of Aerobic exercise training on Balance, Walking capacity and quality of life in sub-acute stroke.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of age.
* Stroke that occurred in the recent 3 months.
* Who can walk independently or by using assistive device.
* Have a minimum Chedoke McMaster Stroke Assessment (CMSA) leg impairment score of 3 but less than 7.

Exclusion Criteria:

* Patients were excluded from the study if they have a stroke that occurs more than 3 months.
* If resting blood pressure more than 160/100 even after taking medications
* Have by-pass surgery in recent 3 months.
* Other musculoskeletal problems which restrict the patient's ability to do aerobic activity.
Uterine Cavity and Blood Flow After Conservative Management of Placenta Previa/Accreta

Bleeding is the most significant cause of maternal death worldwide with more than half of those occurring within the first day of delivery. About 10.5% (some estimate as high at 12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum hemorrhage; a woman dies every 4 minutes from postpartum hemorrhage. Uterine atony and placenta accreta are the two leading causes of postpartum hysterectomies with up to 64% of Cesarean hysterectomies done for abnormally adherent placentation

No previous studies performed for evaluation of the effect of those procedures on the uterine cavity or uterine blood flow. Most of the studies in the literature evaluated the menstrual and fertility outcome after conservative measures for intraoperative hemorrhage due to placenta previa/accreta were retrospective and depend on the resumption of menses and pregnancy rate

Eligibility Criteria:
Inclusion Criteria:

1. Women Age 18-40 years
2. Gestational age of pregnancy 28-40 weeks
3. Diagnosed antenatally as placenta previa/accreta
4. Patients who will be managed by conservative surgical techniques for intraoperative hemorrhage
5. Women who will accept to participate in the study and are reliable for follow-up

Exclusion Criteria:

* 1- Patients who will be managed by hysterectomy 2- Patients who will be managed by conservative leaving the placenta in-situ 3- Diabetic or hypertensive women 4- Women who will refuse to participate in the study
Genetic Testing of CYP2C19 in Prognostic Evaluation of Long-Term Major Adverse Cardiac and Vascular Events

Several studies have shown that the efficacy of clopidogrel for secondary prevention of major adverse cardiovascular events (MACE), including acute coronary syndrome, depends on the polymorphism of the CYP2C19 gene. However, studies with large sample sizes and long-term follow-up are missing. Moreover, the impact of this polymorphism on the risk of major adverse limb events (MALE), particularly in patients with peripheral artery disease of the lower limb, is unexplored. Additionally, the impact of CYP2C19 gene polymorphism on clopidogrel effectiveness in preventing recurrent stroke in diverse populations is unknown since most of the data are from Asian ancestry populations. We hypothesize that patients with CYP2C19 gene loss of function alleles are at high risk of MACE and MALE compared to those without loss of function alleles at long-term follow-up. We propose to assess MACE and MALE in a large cohort of patients with available CYP2C19 genotypes treated at the University of Florida Health to evaluate the impact of CYP2C19 gene polymorphisms on the risk of new or recurrent events at long-term follow-up. Our specific aims are Aim 1) to determine the impact of CYP2C19 gene polymorphisms (loss of function alleles vs. non-loss of function alleles) on the risk of MACE (a composite of all-cause death, non-fatal MI, and non-fatal stroke) at long-term follow-up; Aim 2) to evaluate the impact of CYP2C19 gene polymorphisms (loss of function alleles vs. non-loss of function alleles) on the risk of MALE (a composite of limb amputations, chronic threatening limb ischemia, acute limb ischemia, and limb revascularization) at long-term follow-up; and Aim 3) to evaluate the impact of CYP2C19 gene polymorphisms (loss of function alleles vs. non-loss of function alleles) on the risk of cerebrovascular events (CVE, a composite of any stroke and transient ischemic attack) at long-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged ≥18 years with available CYP2C19 genotyping results obtained within the predefined period.

Exclusion Criteria:

* Absence of CYP2C19 genotyping results obtained within the predefined period.
Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony

The aim of the study is to evaluate the Skeletal stability of Le Fort I osteotomy using patient-specific osteosynthesis compared to Mini-plate fixation for patients with skeletal class III malocclusion.

postsurgical relapse is one of the most common observations that have been reported after fixation of Le Fort I osteotomy cases.

Fixation systems with plates and screws are used in oral maxillofacial surgery for the treatment of facial fractures and orthognathic surgery cases. Although they have been used for decades and have become the standard treatment, the materials used in these systems may fail due to excess loading and other causal factors during the surgical procedure, including failure in plate adaptation and fixation to bone, material design, fabrication, and degree of purity of the plate material.

In the fixation system, non-customized plates of standard size are used, and are bent to adapt them to the distances required for planning orthognathic surgeries. Therefore, mandatory use of larger plates than those programmed for use in surgeries is required so that they can be bent to enable insertion. Moreover, there are variations in the number of screws required to retain the plates to enable better fixation. The folds of non-customized plates generate stresses that are minimized when using customized plates, because these plates are fabricated individually, with predetermined sizes for each patient.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with skeletal class III malocclusion planned for traditional Orthognathic Approach and requiring bimaxillary orthognathic surgeries in which there will be Le Fort I osteotomy with maxillary advancement ranging from 2mm to 5 mm in addition to mandibular setback.
2. Patients with no signs or symptoms of active TMDs.
3. Highly motivated patients.

Exclusion Criteria:

1. Patients who refused to be included in the research.
2. Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
3. Patients with intra-bony lesions or infections that may retard the osteotomy healing.
Cervical Kinematics' Reliability: Zero Positioning Using a 3-D-bulls Eye Spirit Level

The measurement of cervical spine range of motion (ROM) figures among the most common aspects of clinical diagnosis. Good reliability has been demonstrated for assessments using ultrasonic movement analysis systems, such as Zebris CMS 70 (Isny, Germany). However, in contrast to combined measurements of movement amplitudes (e.g., flexion plus extension in the sagittal plane), separating the respective components provides less reliable results. Current research suggest that this is due to the participants' determination of the zero position. This position is influenced by possible disposed treatments and, in particular, by the subject in case of subjective determination. The present study therefore aims to examine the test-retest reliability of separate ROM assessments using a bulls eye spirit meter.

Twenty healthy participants will be included in the trial that adopts a two-armed randomized, crossover design. With a washout-period of one week in between, each subject participates in two sessions in a randomised order. In both sessions, cervical ROM (flexion/extension, rotation, lateral flexion) will be measured twice (with a five-minute wait period). In all measurements, the zero position will be determined by means of a bulls eye spirit level. The difference of the two sessions consists in the design of the waiting period. In one session, the subjects will keep the mask carrying the ultrasound markers on their head. In the other session, the mask will be removed during the break.


Eligibility Criteria:
Inclusion Criteria:

* Subscribing informed consent
* Healthy

Exclusion Criteria:

* Severe orthopedic, cardiovascular, neurological, psychiatric or endocrine diseases
* Not completely healed traumata
* Drug intake in the past 48 hours
* Pregnancy
* Muscle soreness
A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025)

The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib \[Tarceva (TM)\] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Once the safest maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years of age and older with a confirmed diagnosis of non-small-cell lung cancer (NSCLC) who have failed at least one prior treatment for NSCLC.
* Patients must have proven disease by CT scan or MRI.
* Patients must be at least 4 weeks from any chemotherapy for cancer or from any surgeries or from any treatment using an investigational drug.
* Patients must be 2 weeks out from radiation therapy.
* At screening the patient must have normal lab results and can not be pregnant.
* Women and men must agree to practice adequate birth control during the study.
* Patient has the ability to understand and sign the consent form.

Exclusion Criteria:

* Patient had prior treatment with vorinostat or erlotinib.
* Patient has any of the following conditions: active infections including hepatitis B or C, unstable brain metastases, swallowing difficulties, heart problems, significant eye abnormalities, drug or alcohol abuse, mental illness or pregnancy.
Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cancer

Phase II, multicenter, open labelled, uncontrolled study to evaluate the efficacy and safety profile of panitumumab in patients affected by Head and Neck cancer after at least one cisplatin or carboplatin-based chemotherapy. A translational research study is also planned to evaluate Estimated Glomerular Filtration Rate (EGFR) status by FISH, KRAS, B-RAF, HRAS, NRAS and PIK3CA mutation by DNA sequencing, PTEN protein expression by immunohistochemistry, and Human Papilloma Virus (HPV) genotyping by reverse hybridization.

Panitumumab is administered iv on days 1 and 15 of a 28 days cycle, until progressive disease, unacceptable toxicity, pregnancy, or patient's refusal


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-2, not pregnant.
* Histologically or cytologically confirmed Squamous Cell Cancer of the Head and Neck either metastatic or recurrent, judged incurable by surgery or radiation.
* Baseline tumor tissue, sufficient material available for EGFR determination (therapeutic target of panitumumab) and biomarker studies. Patients without available tissue at baseline or with tissue collected longer than 1 year before, may undergo tumor biopsy.
* Progression after or not responding to treatment with at least one cis-platin or carboplatin containing regimen.
* Measurable disease (Response Evaluation Criteria in Solid Tumours - RECIST 1.1).
* Adequate hematological values, renal and hepatic function.
* Patients may not be receiving any other investigational agents

Exclusion Criteria:

* Platinum-naïve patients.
* Patients previously progressed after a regimen containing EGFR-inhibiting agents (as cetuximab, panitumumab, gefitinib, erlotinib), even if there was an initial response.
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year before enrollment/randomization.
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest computed tomography scan.
* Known or suspected brain metastases.
* Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent
* Known hypersensitivity to panitumumab active ingredient or excipients.
* Any concomitant drugs contraindicated for use with the trial drug according to the Swissmedic approved product information - Human Immunodeficiency Virus (HIV) positive patients
Development of Hardware and Software for Pulmonary Magnetic Resonance Imaging Using Inhaled Tracer Gases

This is a single centre study. The overarching hypothesis of this study is that MRI with inhaled tracer gases can provide high quality images of lung function to complement conventional 1H MRI. The study interventions do not affect the standard of care.

Respiratory diseases are a significant healthcare burden worldwide. In Canada, this is expected to increase. Non-invasive medical imaging tests are able to provide regional functional and structural information of the lung and may aid in the diagnosis and treatment of respiratory diseases. Current examples include chest x-ray, x-ray computed tomography (CT), and nuclear medicine techniques. However, these techniques suffer from various associated limitations. X-ray based methods offer high resolution and rapid acquisitions, but only reflect lung structure and anatomy by measuring tissue density. Nuclear medicine techniques may be used to measure lung function but suffer from poor resolution and long acquisition times. Furthermore, both x-ray based and nuclear medicine imaging techniques make use of ionizing radiation, which may not be suitable for longitudinal imaging, or imaging in vulnerable populations such as children.

Conventional Magnetic Resonance Imaging (MRI) images the 1H nucleus (proton) attached to water molecules in biological tissues. MRI can provide high-resolution anatomical and functional information of the lung with multiparametric contrast without the use of ionizing radiation. However, major drawbacks associated with conventional 1H MRI of the lung are the low tissue density, large magnetic susceptibility differences between numerous air/tissue interfaces, and image corruption by cardiorespiratory motion during the necessarily long image acquisition time frame. Wo;;

One strategy which may be employed to overcome the limitations associated with conventional 1H MRI is the application of safe MR-sensitive inhaled tracer gases. This allows for the direct visualization of the spatial distribution of these gases, revealing regional ventilation directly. In this study we aim to develop, implement, and test these technologies for improved in-vivo imaging of lung structure and function in adults and children with no history of respiratory disease.

Eligibility Criteria:
Inclusion Criteria:

* Consent provided
* Aged 6-75 years old
* In good general health as evidenced by medical history
* Meets MRI screening criteria

Exclusion Criteria:

* Has diagnosis of pulmonary disease
* FEV1 \<70%
* Requires supplemental oxygen
* Has had a respiratory infection within the past 2 weeks
* Pregnant or lactating\*
Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols

There is a significant unmet need for optimized treatment in rhabdomyolysis. There are few prospective interventional studies on treatment for rhabdomyolysis, a condition which affects diverse and underrepresented populations at a higher rate. While steroids are often used off-label, a systematic study has not yet been initiated, and steroids have not been yet considered in as a consideration to standard care guidelines.

The hypothesis is that patients who receive dexamethasone in addition to standard care versus placebo and standard care will have improvement in pain, length of hospital stay, and decrease in kidney complications.

Study Objective:

This is a single center, 2-year, blinded prospective randomized study for those diagnosed with rhabdomyolysis age six months-25 years using dexamethasone versus placebo treatment in addition to standard care in up to 50 patients.

Study Design:

Patients will be enrolled with a 2:1 ratio of treatment of dexamethasone for 5 days versus placebo treatment for 5 days in addition to receiving standard care. The treatment period for each subject will be five days treatment with oral treatment once per day with study drug (dexamethasone versus placebo). All patients will also receive standard care. Patients and their parent/ caregiver will have the option to complete surveys before and after treatment in order to assess pain level and treatment improvement. Chart review will be performed on all patients throughout and after the five-day study treatment period. There will be no additional interventions.

Eligibility Criteria:
Inclusion Criteria

1. Diagnosis of rhabdomyolysis defined as creatine kinase\> 5000 with trauma excluded
2. Ability of parents/patients to understand and the willingness to sign a written informed consent document.
3. Patients ages 12 and older will sign written assent

Exclusion Criteria:

* Already taking systemic steroids.
* Inability to comply with study instructions.
* Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women.

  o A urine pregnancy test will be performed for women of child-bearing potential.
* Below gestational age of 40 weeks
* Allergy to fluconazole, clotrimazole or nystatin.
* Cannot tolerate PO medications