cyrilzakka/clinical-trials huggingface dataset:
Mechanisms and Phenotypes of Hypertension in Patients in Chronic Hemodialysis

The goal of this study is to evalluate the blood pressure changes of the patients in chronic hemodialysis.

The main question to be answered is: What is the relative importance of weight gain, the renin angiotensin system, the sympathetic nervous system and inflammatory immune reactivity in the hypertension of patients in chronic hemodialysis, The participantes will have hemodynamic evaluation (cardiac output and peripheral vascular resistance) at the end of dialysis, ambulatory monitoring of blood pressure in the interdialytic period and before the next dialysis (2-3 days later). Serum samples will be collected at the end of dialysis and before the start of the next dialysis, 2-3 days later.

This is a prospective observational study that will study stable patients in the chronic hemodialysis program of the INCMNSZ patients. There will be no modifications in the dialysis prescriptions and the patients with inclusion criteria will be studied after and before their usual hemodialysis sesion.

* Weight (kilograms) changes will be studied after dialysis and before the next dialysis sesion (2-3 days later)
* Serum samples will be obtained at the end of dialysis and before the next sesion (2-3 days later).
* ultrasound estimation of cardiac output and peripheral vascular rersistance will be done after dialysis
* Ambulatory blood pressure monitoring will be done in the interdialytic period (24-48 hours) between the end of dialysis and the next dialysis sesion.
* If possible there will be a predialysis study of bioimpedance. Associations of weight gain (kilograms), serum angiotensin II and angiotensin 1-7 (pg/ml), levels of IL-6 (pg/ml), IL-17 (pg/ml), IL-10 (pg/ml), TNFalpha (pg/ml), copeptin levels(pg/ml) and norepinephrin levels (pg/ml) with systolic and diastolic blood pressure (mmHg) before and after dialysis will be explored.
* Phenotypes of blood pressure (sustained hypertension, nocturnal and diurnal hypertension, dippers, non-dippers, extreme dippers and reverse dippers) hypertension determined by ambulatory monitoring will be studied in relation of levels of angiotensin II, immune inflammatory markers, copeptin and norepinephrin leves.

All serum levels will be determined by commercial ELISA kits,

Eligibility Criteria:
Inclusion Criteria:

-Patients with more than 3 months in the chronic hemodialysis program in the INCMNSZ and assumed to remained in the program for longer than 3 months

Exclusion Criteria:

* Patiens unable to give informed consent to the study
* Patients with active infection
* Patients with prostesis or pacemakers
* Patients with immunosuppresive treatment equivalent to more than 15mg Prednisone daily
MRI and Biomarkers for Lung Nodules Detected During Lung Cancer Screening

The primary objective of this pilot observational study is to evaluate the accrual and retention rate of a study population from a centralized lung cancer screening program to support MRI and blood-based biomarker research for lung cancer screening.


Eligibility Criteria:
Inclusion Criteria:

* Ability to read and understand informed consent
* Male or female adults who are at high risk for lung cancer and are enrolled in the centralized lung cancer screening program: Based on USPSTF guidelines: Age 50-80 with 20 or greater pack-year smoking story who continue to smoke or quit within the past 15 years without sign or symptoms of lung cancer. Or based on National Comprehensive Cancer Network (NCCN) guidelines but do not meet the USPSTF guidelines, age 50-unlimited
* Found to have one or more lung nodules that is 6mm or greater on screening LDCT

Exclusion Criteria:

* Persons with an active diagnosis of cancer
* Persons with active signs or symptoms of lung cancer
* Persons with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers, neurostimulators, and infusion pumps.
* Persons with ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
* Persons who are pregnant, nursing, are implanted with intrauterine devices (IUD's) that are not MR-compatible
* Persons unable to tolerate MRI imaging secondary to an inability to lie supine or severe claustrophobia.
* Persons who are non-compliant with visit instructions, including inability to lie still, hold breath or follow procedure instructions
Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome

Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64 patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre controlled clinical trial. Patients will be randomized to receive either 2 capsules/day Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL) scores will be also monitored.


Eligibility Criteria:
Inclusion Criteria:

* age: 18\~65 years
* diarrhea type irritable bowel syndrome (by ROME III criteria)
* no organic bowel disease (by colonoscopy or barium enema)

Exclusion Criteria:

* pregnant women or nursing mothers
* hypersensitivity to probiotics
* congestive heart failure or ischemic heart disease
* systolic blood pressure : more than 160 mmHg or diastolic blood pressure: more than 100 mmHg
* uncontrolled diabetes mellitus, secondary dyslipidemia, hyperthyroidism, or hypothyroidism
* abdominal surgery (exception: appendectomy, hernia surgery)
* more than moderate alcohol drinking
Quality of Life for Children With Zirconium Anteroir Crowns Versus Strip Composite Crowns

Early Childhood Oral Health Impact Scale (ECOHIS) will be used for detection of oral health related quality of life for children using strip composite crowns versus zirconium crowns at 6 and 12 months


Eligibility Criteria:
Inclusion Criteria:

* healthy children Cariuos primary anteroir teeth Cooperative children

Exclusion Criteria:

* children with systemic diseases Children with bad oral habits
Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

To study if a targeted gene expression profile of RNA, similar to the NETest, can be isolated from the peripheral blood of patients with melanoma, to identify active disease, provide an assessment of treatment responses, or predict risk of relapse, in conjunction with standard clinical assessment and imaging.

* Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage III melanoma at diagnosis (biopsy-proven lymph node positive) and compare this to LDH as a biomarker.
* Evaluate the diagnostic efficacy of a circulating melanoma gene signature in pathologically verified Stage IV melanoma (including pre-surgery patients as well as those on either targeted or immunotherapy) and compare this to LDH as a biomarker.
* Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.
* Monitor molecular signature levels in blood to assess efficacy of this tool as compared to imaging or other biomarkers to define disease progression or treatment responses in Stage III and IV treated patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Primary melanoma \> 1 mm in Breslow depth
3. Stage III or IV disease as determined either by sentinel node biopsy, biopsy of clinically enlarged lymph nodes, and/or imaging. If stage IV, must have tissue biopsy confirming presence of stage IV melanoma

Exclusion Criteria:

1. Pregnant patients
2. Contraindication to contrasted imaging (due to allergy or renal insufficiency)
3. Serum PCV \<30%
Metabolic Adaptations to Diabetes in African Americans

We do not know why diabetic patients cannot protect themselves against low blood sugar. Therefore, in this study, we will perform a comprehensive assessment of the body's response to low blood sugar by measuring changes in blood hormones, blood sugar production, and nerve signals.

Morning and afternoon hypoglycemic episodes of 70, 60, or 50 mg/dl produce increased blunting of subsequent counterregulation dependent upon the depth of preceding hypoglycemia. We wanted to test this hypothesis in healthy African American individuals to determine if there is a difference in their responses to varying depths of hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females aged 18-40 yrs with no family history of diabetes mellitus.
* All prospective volunteers will have routine blood tests to screen for biochemical, hormonal and hematological abnormalities.
* Female volunteers will also undergo an HCG urine pregnancy test.

Exclusion Criteria:

* Prior or current history of poor health
* Abnormal results following blood and physical examination
* Pregnancy
Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas

This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral selinexor in participants with recurrent gliomas.

This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral selinexor in participants with recurrent gliomas.

Initially, the study included 2 arms: an exploratory Surgical Arm (Arm A) with sequential enrollment for participants who require surgery and a medical arm (Arm B) for participants who are not eligible for surgery.

Enrollment in Arm B was stopped to explore alternative dosing in Protocol Versions ≥ 4.0 to potentially improve tolerability. Four arms (Arms C, D, E, and F) were added to the Medical Arm in Protocol Version 4.0. Arms E and F were eliminated in protocol version 6.0 and no participants were ever enrolled in these arms.

Participants in the primary population enrolled under Protocol Version ≥ 4.0 will be randomized to Arm C and Arm D (approximately 30 participants per arm) to explore alternative dosing to potentially improve tolerability.

After screening and registration/randomization in the study, participants enrolling in Arm A or randomized to Arm C will receive 60 mg selinexor orally twice weekly. Participants randomized to Arm D will receive 80 mg selinexor orally weekly.

Participants will be treated until progression of disease or the development of unacceptable toxicities. All participants will then undergo the End of Treatment (EOT) visit.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed GBM (including all histologic variants) at first diagnosis with radiographic evidence of recurrent disease after treatment with radiotherapy and temozolomide;
* 18 years of age or older
* Participants enrolling in the medical arm (Arms B, C and D) must be on a stable or decreasing dose of corticosteroids (or none) for at least 5 days prior to the baseline MRI;
* Measurable disease (according to RANO guidelines)
* Surgical arm (Arm A) must be predicted pre-operatively to have sufficiently sized tumor to be resected and provide tissue samples for exploratory assessments.

Exclusion Criteria:

* Markedly decreased visual acuity if attributed to other causes than GBM.
* Known active hepatitis A, B, or C
* Participants with coagulation problems and medically significant bleeding in the month prior to start of treatment (e.g., peptic ulcer, epistaxis, spontaneous bleeding). Prior history of DVT or PE is not exclusionary.
* Participants must not have significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow oral medications.
* Prior treatment with bevacizumab or other direct VEGF/ VEGFR inhibitors. For any question of the definition of a direct VEGF/VEGFR inhibitor, consult Sponsor.
* Arms C and D only: body surface area \< 1.2 m².
* \< 24 days from prior temozolomide, \< 6 weeks from nitrosourea, \< 4 weeks from other chemotherapy or investigational agents prior to start of treatment within study.
Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy

The sleeve gastrectomy that has been utilized as a first-stage bariatric procedure to reduce surgical risk in high-risk patients by induction of weight loss is now gaining popularity as a standalone procedure for the treatment of morbid obesity. It appears to be a technically easier and/or faster laparoscopic procedure than Roux-en-Y gastric bypass. It brings good weight loss results, in some studies even comparable to the RYGB and Biliopancreatic Diversion with Duodenal Switch.

The mechanism of action is assumed to be purely restrictive, but some neurohumoral interaction may exist. Almost no data exist on the influence of the sleeve gastrectomy on the medical and general quality of life or resolution of comorbidities.

The rates of the comorbidities resolution 12 to 24 months after sleeve gastrectomy has been reported in the range that seems to be higher than for the purely restrictive procedures.

Our goal is to to compare the surgical and weight loss outcomes between the two procedures, their influence on resolution of common comorbidities and on quality of life change.

150 eligible candidates will be randomized into two groups, one will undergo Laparoscopic Sleeve Gastrectomy, the other will have Laparoscopic Roux-en-Y Gastric Bypass done. Detailed evaluation and preoperative questionnaires will be used to obtain demographic and medical data, and quality of life will be assessed.

General metabolic and nutritional work up will be done, and will be reassessed at different intervals up to 5 years, in order to compare the short and long term results of the two procedures.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with morbid obesity

Exclusion Criteria:

* Pregnancy,
* Previous bariatric operation,
* IBD,
* Previous bowel or stomach surgery
Edinburgh Pain Assessment Tool (EPAT©) Study

To determine if the institutionalisation of a regular systematic approach to the assessment of pain in inpatient cancer units using the Edinburgh Pain Assessment Tool (EPAT©) leads to better control of pain than that achieved by usual care.

Background and relevance to cancer - Pain associated with cancer has a severe negative impact on quality of life and can also limit a patient's ability to tolerate potentially life-saving tumoricidal treatment. Unfortunately in practice only half of cancer patients receive adequate pain control. A fundamental reason for this is inadequate assessment of pain. The institutionalisation of pain assessment as a 5th vital sign on the bedside chart combined with training and guidance in pain management (EPAT) is a potentially effective solution.

We have already evaluated the feasibility and efficacy of EPAT in a randomised trial of 150 oncology inpatients and found that by Day 4 after admission 90% reported adequate pain control compared to only 52% of those who received usual care.

Aims - We now want to evaluate the effectiveness and cost-effectiveness of EPAT in practice and ask: Does it reduce cancer pain more that usual care? Are there adverse effects? Is it cost effective?

Outline plan - A UK-wide cluster randomised controlled trial of 18 inpatient cancer centres of which half will use the EPAT package and half usual care. The trial outcomes are clinically significant improvement, adverse effects such as opiate toxicity and cost effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Able and consent to complete a Brief Pain Inventory score
* Aged over 18 years
* Have a pain score equal to or greater than 4 out of 10 at first assessment point (within 24 hours of admission) and pain is cancer related
* Are expected to be available for pain assessment at 3 days after admission

Exclusion Criteria:

* Do not consent to take part in the study or who are too ill to take part, including those with severe mental health problems
* Do not have cancer-related pain
* Are under 18 years of age
* Have a pain score of less than 4
* Are not expected to be available for pain assessment at 3 days after admission
The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries

Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and ABI-related disability and functional impairments, and the resultant effects on psychological wellbeing, physical wellbeing and quality of life for those with SCI/ABI.

The investigators will conduct a longitudinal survey to examine the impact of COVID19 on those with SCI and ABI. An a priori sample size of 117 individuals based on an alpha level of .05 and level of acceptable error at 3% was calculated. Anticipating for loss to follow up rate of up to 20%, a total of 142 participants will be recruited. Patients will be recruited among those who attend virtual medical appointments at Parkwood Institute for ABI and SCI. We will also liaise with SCI-Ontario and the Ontario Brain Injury Association to assist in the recruitment of additional participants. Those who consent will complete an online survey on enrollment into the study, and subsequently at 3 and 6 months. Demographic data of the individuals participating in the study will be recorded. Participants' access to health care services will be evaluated using the following subdomains: medical care, complementary care, medications/equipment, satisfaction/acceptability, affordability, ability to engage, and indirect support.

Eligibility Criteria:
Inclusion Criteria:

* stroke, spinal cord injury (traumatic and non-traumatic) or acquired brain injury (of all severities, including concussion)
* live in the community
* have the cognitive capacity to understand and complete the measures

Exclusion Criteria:

* does not have the cognitive capacity to understand and complete the measures
* does not speak English
Relevance of the Activ'Dos App for Chronic Low Back Pain Patients

The purpose of this study is to compare a self rehabilitation program using ACTIV'DOS app versus using a standard sheet of paper.

This study involves patients with chronic low back pain. The purpose of this study is to compare a self-rehabilitation program using ACTIV'DOS app versus a standard sheet of paper. Disabilities are measured with a Roland-Morris questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain for more than 3 months
* Aged to 18 or more
* Possibility to use Activ'dos application with smartphone or tablet
* Initial score of Roland Morris questionnaire \>= 4
* Fit to consent
* Who has signed consent form

Exclusion Criteria:

* Any signs of severe illness underlying to radicular and lumbar pain like red flags
* Guardianship or protection of vulnerable adult
* Pregnant or nursing
* Refuse to participate
Pecs II Block and PaB Could be an Alternative in Breast Surgery

The association between ultrasound-guided Pecs II block and parasternal block can represent a valid alternative in the management of acute and postoperative pain syndrome after quadrantectomy with or without axillary dissection.

The combination of Pecs II block and PaB provides good management of postoperative pain and can be considered a viable alternative to common anesthetic procedures performed for breast cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age;
* American Society of Anesthesiologists (ASA) physical status I-III,
* patients scheduled for quadrantectomy with or without axillary dissection

Exclusion Criteria:

* pregnancy;
* body mass index (BMI) \>35;
* allergy to local anesthetics;
* skeletal or muscle abnormalities of the chest wall;
* presence of primary or secondary neurological diseases;
* presence of psychiatric diseases;
* history of chronic pain or neuropathic disorders;
* history of drug abuse;
* state of sepsis;
* infection
* tumors of the skin on the chest;
* primary;
* secondary coagulopathies
Early Versus Late Initiation of Anticoagulation in Mild-to-moderate AIS Patients With NVAF

The goal of this clinical trial is to compare the effectiveness between early and late initiation of anticoagulation therapy in acute ischemic stroke (AIS) patients with non-valvular atrial fibrillation (NVAF). Participants will be 1:1 randomized into early or late initiation group. The primary endpoint is early neurological deterioration (END) before discharge.

Anticoagulation therapy is effective to prevent ischemic stroke in patients with NVAF who have a history of stroke. Recent clinical trials have demonstrated that early initiation of anticoagulation therapy after AIS is safe, while no remarkable benefits have been observed. The goal of this clinical trial is to compare the effectiveness between early and late initiation of anticoagulation therapy in AIS patients with non-NVAF. Participants will be 1:1 randomized into early or late initiation group. The primary endpoint is END before discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Acute ischemic stroke with onset \< 48 hours
* Have a history or newly diagnosed as NVAF
* NIHSS on admission \<= 8

Exclusion Criteria:

* Chronic renal dysfunction (GFR \< 30ml/min) or severe hepatic injury
* Have a history or newly diagnosed as valvular heart disease
* Mural thrombus in heart
* Contraindications of anticoagulation therapy within 12 days after AIS, e.g. severe intracranial hemorrhage
* Received reperfusion therapy, e.g. intravenous thrombolysis and endovascular treatment
* Concomitant stenosis (\>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory
* Life expectancy less than 1 year
* Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding
* Pregnant or lactating women
* Individuals identified by researchers as unsuitable for participation in the study due to other reasons.