cyrilzakka/clinical-trials huggingface dataset:
Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis

Research proposal to evaluate the impact of different phosphate binders on the progression of cardiovascular calcification and QT dispersion in new haemodialysis patients.

The risk of developing cardiovascular diseases in patients on hemodialysis is higher than in general population. Higher levels of serum phosphate are associated with adverse cardiovascular outcomes, especially in the setting of overt hyperphosphatemia. Given the biological importance of serum phosphorus, it is conceivable that also within the normal range values the higher serum phosphate levels may be associated with the worst outcome. Several paper have shown that vascular calcifications in dialysis patients are associated with increased relative risk of death; it has also been demonstrated in uremic patients that vascular calcifications decrease arterial elasticity. We previously observed that vascular calcification directly correlate with QT interval (QTc) as well as QT dispersion (QTd) in dialysis. Also, QT correction (obtained by the correction of phosphoremia and dyslipidemia) can ameliorate the development of arrhythmia and sudden death. Aim of this study is to evaluate the relationship between vascular calcifications and both QTd increase and mortality in incident hemodialysis patients, and to investigate the efficacy of sevelamer to reduce vascular calcifications and QTd.

Eligibility Criteria:
Inclusion Criteria:

* incident patients on haemodialysis (CKD stage 5);
* an informed consent will be provided at the study entry.

Exclusion Criteria:

* congenital prolongation of QT segment syndrome;
* QTc \>440 ms; increased QTd;
* bradycardia \<50 bpm;
* sintomatic arrhythmia or any other significant heart problems;
* electrolyte unbalances (especially hypokalemia, hypomagnesemia, hypocalcemia);
* abnormal liver function tests;
* hypothyroidism.
Efficacy of a Mobile Application in the Smoking Cessation Among Young People

AIM: To assess the efficacy of an intervention based on the specific design and implementation of a mobile application (APP) in order to reduce the prevalence of smoking consumption among young people motivated 18 to 30 years METHODS: Cluster randomised clinical trial. Unit of randomization: Primary Health Care Centers (PHCC). Intention to treat analysis. STUDY POPULATION: Motivated young smokers of 10 or more cigarettes per day aged 18 to 30 years consulting for any reason to PHCC and who provided written informed consent to participate in the trial.

INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation which includes mobile APPs application. Control group: usual care. OUTCOME MEASURES: Abstinence at 12 months confirmed by exhaled air carbon monoxide concentration of less or iqual 10 parts per million in each control.

RESULTS: The application of a smoking cessation intervention with a mobile APPs application will improve the smoking cessation success rate in smokers, besides of their intention or not to give up smoking at baseline.


Eligibility Criteria:
Inclusion Criteria:

* Participant between 18 t0 30 years old smoking 10 or more cigarretes at day
* To have a smarthphone (Android, ios Ihpone, ios Ipad)
* Normal and high motivation for smocking cessation

Exclusion Criteria:

* To have other addictions
* Participants with Blackberry smarthphone
The Balance Control Mechanism of DPN Patients

This study will evaluate the balance ability of DPN (diabetic peripheral neuropathy)patients, which will help us to understand the relationship between peripheral and central nervous system, in order to early diagnosis and prevent the fall in DPN patients.

DPN is one of the most common complications of diabetes. The clinical manifestation of DPN contains sensory reduction, pain, muscle wastage and so on. Sensory and motor nervous are one of the most important factors in balance control, the reduction of balance ability will result in high risk of fall.

Most studies about DPN are focus on peripheral nervous, however, the central nervous system may also be involved in DPN patients. In this study, force platform, proprioception test and fMRI will be used to evaluate balance ability, proprioception and the brain function information of DPN patients, which will help to understand the relationship between peripheral and central nervous system.

Eligibility Criteria:
Inclusion Criteria:

* diabetics
* normal cognitive ability
* walk normally
* normal vision

Exclusion Criteria:

* other nervous system disease, foot ulcer
ORAL T-8 Oral Testosterone for Male Hormonal Contraception

The purpose of this study is to test how the body absorbs a new form of oral testosterone (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at the University of Washington to monitor blood testosterone levels over a 24-hour period.

We will administer two experimental drugs, acyline and oral testosterone. Acyline shots will be given on Day 0 to turn off the body's testosterone production for about 10-14 days.

The next day, Day 1, subjects begin taking 300 mg modified slow-release testosterone pill by mouth, three times a day, around 9 AM, 1 PM, and 7 PM for a total of 27 pills.

There are overnight stays on Day 1 and Day 9 to allow monitoring of blood testosterone levels over a 24 hour period, from @9 AM to 9 AM the next morning. At those visits, blood is drawn at baseline (before taking the pill) and at 1, 2, 4, 5, 6, 8, 10, 11, 12, 14, 16, and 24 hours after the morning dose.

Acyline is an experimental drug. The FDA allows its use only in research with a small number of volunteers. We have used acyline in over 125 men without serious side effects. The use of testosterone in this study is experimental and there may be unknown or unanticipated risks.

Eligibility Criteria:
INCLUSION CRITERIA:

* able and willing to
* not participate in another drug study or donate blood, not take medications
* use contraception, comply with the protocol

EXCLUSION CRITERIA:

* abnormal evaluation, based on physical exam, medical history, blood tests (including serum chemistry, hematology, HIV, HCV, hormone levels)
* history or current use of alcohol, drug, steroid abuse, \>3 alcohol drinks/day
* history of testicular disease, severe testicular trauma, major psychiatric disorder, bleeding disorders, current use of anti-coagulants or testosterone
* participation in hormonal drug study within past month
Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation

in our study the investigators aim to assess the effect of terlipressin on cerebral oxygenation monitored by cerebral oxymetry and cerebral blood flow measured by transcranial doppler.

All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative fluid. If pulse pressure variations (PPV) is more than 15%, the patient will be considered as fluid responder and will receive a 250-ml bolus of albumin 5% to maintain PPV ≤15%. Blood transfusion will be given based on a hemoglobin level (\< 7 g/dl) in both (control group) and (terlipressin group). Other blood products will be transfused guided by lab result; Fresh frozen plasma will be given when INR \> 2 and platelets will be given when platelets \<30.000/mm3. The patients will be randomly allocated into 2 groups; Group T (Terlipressin group) and group S (Normal saline 0.9%).

For (terlipressin group) all patients will receive loading dose of terlipressin (1mg diluted with 50 ml of normal saline 0.9% solution over 30 min) and it will be maintained by continuous infusion at rate of 160 μg per hour (8 ml/h).

For (control group) all patient will receive 50 ml of normal saline 0.9% solution over 30 min and will be maintained continuous infusion at rate of 8 ml/h.

Drugs will be prepared by the nurse and the investigator will be blinded to the drug given.

Eligibility Criteria:
Inclusion Criteria:

* ASA II-IV undergoing orthotopic liver transplantation.
* Age above 18 years.

Exclusion Criteria:

* Age below 18 years.
* Patients on Terlipressin preoperative.
* Patients known allergic to Terlipressin.
* Portal vein thrombosis.
* Ischemic heart disease.
* Patients with T. bilirubin level above 7 mg/dl
Fecal Calprotectin Levels in Patients With Fibromyalgia

This study was designed to evaluate fecal calprotectin levels in patients with fibromyalgia syndrome. Fecal calprotectin levels from fibromyalgia patients with and without gastrointestinal symptoms as well as healthy controls will be measured and compared.

Fecal calprotectin (FC) is a calcium and zinc binding protein that is present in neutrophil granulocytes and is detected in the stool samples from subjects with inflammatory bowel disease and similar organic gastrointestinal pathologies. Fibromyalgia is often accompanied by irritable bowel syndrome, which is a non-inflammatory, functional disorder of the gastrointestinal tract. Due to the chronic nature of the disease, fibromyalgia patients' new symptoms related to underlying gastrointestinal organic disease may be overlooked. In this study we aimed to assess the FC levels in fibromyalgia patients and healthy controls in order to detect a possible difference in FC levels between patients with and without gastrointestinal symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Groups 1 and 2: patients diagnosed as having Fibromyalgia syndrome according to American College of Rheumatology 2016 classification criteria (8). Group 3 will consist of healthy controls
* Older than 18 years of age

Exclusion Criteria:

* Presence of gastrointestinal symptoms starting after the age of 50.
* Presence of inflammatory rheumatological disorder
* Presence of organic gastrointestinal disorder
* History of fever, infective gastroenteritis, endoscopy or colonoscopy in the previous month
* Family history of inflammatory bowel disease
* Patients with alarm symptoms that required further investigation such as weight loss, nocturnal diarrhea, rectal bleeding
* Illiteracy
Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy

Intravenous patient-controlled analgesia (PCA) is a popular technique for postoperative pain management. Although several drugs are recognized as effective therapeutic options, optimal selection of drugs in hysterectomy patients underwent different anesthesia treatments remains unknown explicitly. The investigators hypothesized that butorphanol and tramadol can produce different analgesic effects with intravenous PCA after abdominal hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II
* Chinese
* 19-64yr
* Uterus myoma

Exclusion Criteria:

* Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
* Participants younger than 18yr，older than 65yr or pregnancy was eliminated.
* Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.
* Those who were not willing to or could not finish the whole study at any time.
* Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.
* Allergy to local anesthetics.
* Failed to perform the epidural catheterization.
* Those who demonstrated significant nerve-associated side effects from the insertion of the epidural needle.
Evaluation of Gastrointestinal Transit Pre and Pos Treatment With Non Selective Betablocker in a Population of Cirrhotics

The purpose of this study is to evaluate the influence of non betablockers in gastrointestinal motility (transit time) in patients with liver cirrhosis.

There is some evidence that cirrhotic patients have increased gastrointestinal transit time, this issue may favor bacterial owergrowth, and consequently bacterial translocation. Translocation of bacterias and its products are linked to vascular and hemodynamics alterations that produce descompensation on the disease. There is evidence , in animal models , that the use of beta blockers favors the gastrointestinal movement; decompensated cirrhotics had significantly longer small bowel transit time as compared with compensated cirrhotics, there have described that this alteration is related to de cirrhosis severity as assessed by Child Pugh score. The purpose of this study is to evaluate the gastrointestinal transit time before and after treatment of non selective betablockers, we are going to evaluate the gastrointestinal time before and after of 4 weeks of non selectivebetablocker treatment, in decompensated cirrhotics. The gastrointestinal time is going to be evaluate by the ingestion of a device known as "smart pill", that allow ambulatory monitoring of gastrointestinal transit.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis of any ethiology
* Child Pugh A, B, C without beta-blocker treatment previously (min. 1 month without treatment)
* Patients with previous variceal bleeding (with liver cirrhosis) \* Patients with ascites or bacterial spontaneous peritonitis

Exclusion Criteria:

* Variceal disease without cirrhosis
* Cirrhotics patients that use antibiotics, prebiotics and probiotics during the study period and one month previously
* Patients under immunosuppressor treatment
* Patients with portal thrombosis
* Patients with Sd. Budd-Chiari or cava/suprahepatic thrombosis
* Patients with active infection process
Characterization of Dysmorphology in Subjects With Creatine Transporter Deficiency

Background:

Creatine transporter deficiency (CTD) is a genetic disorder that mainly affects the brain in males. CTD causes intellectual disability that can be mild to severe. People with CTD may have seizures and behavioral issues. They may have slow growth and tire easily. CTD may sometimes be confused with autism or other disorders. Better diagnostics are needed. The study team in an NIH study noted that the faces of children with CTD can look similar. For this natural history study, an expert will examine photos of children with CTD. Any shared traits found might help to diagnose CTD.

Objective:

To look for shared facial features of children with CTD.

Eligibility: Males aged 2 to 40 years old with CTD who were in study 17-CH-0020.

Design:

Some participants in study 17-CH-0020 had pictures taken of their faces. The NIH study team wants to share these photos with a colleague in Canada. This person is an expert at evaluating how genetic disorders affect people s bodies.

Participant data collected during the study may also be sent to this expert. This data may include diagnostic images and results from lab tests.

Some children did not have their pictures taken during study 17-CH-0020. Parents are asked to take pictures of these children and send them to the study team. These photos can be sent to a secure portal. The photos can also be taken in-person during a clinic visit.

The photos may be printed in clinical study journals. But this is not required. Parents will be asked to sign a separate consent before the photos are published....

Study Description:

The purpose of this study is to evaluate photographs of subjects enrolled in Creatine Natural History Study of Males with Creatine Transporter Deficiency (CTD) based on our observation that many of these subjects have common craniofacial features. This will involve the participation of an outside investigator who has significant expertise in dysmorphology. We seek to determine whether specific dysmorphic features exist in this population.

Objectives:

Primary Objective: To characterize the dysmorphic features in subjects with CTD

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Patient is male and between 2-40 years of age, inclusive.
  2. Patient has genomic confirmation of a pathologic mutation in the SLC6A8 gene.
  3. Patient is able to complete study-related procedures within limitations imposed by condition under study.
  4. Patients parents/guardians/caregivers must provide written consent (informed consent) to study-related procedures, and if appropriate, the patient will provide an assent.

EXCLUSION CRITERIA:

1. Patient has had status epilepticus within 3 months of screening.
2. Patients has had a seizure that lasts 5 minutes or longer, and a second seizure without recovering consciousness from the first one, or if a person has repeated seizures for 30 minutes or longer.
3. Patient is unable to comply with the study procedures or has a clinical disease or laboratory abnormality that in the opinion of the investigator would potentially increase the risk of participation.
Effect of PP-01 on Cannabis Withdrawal Syndrome

This study will be a randomized, double-blind, placebo-controlled, multicenter trial conducted to evaluate whether PP-01 mitigates the withdrawal symptoms associated with discontinuing cannabis in participants with moderate to severe Cannabis Use Disorder (CUD). The study will enroll approximately 225 participants with moderate to severe CUD and will include 5 arms, including a placebo arm, to help assess the incidence and severity of withdrawal symptoms in heavy long-term users of cannabis. Participants receive study medication for 34 days and participate in 11 visits (7 at a clinic and 4 telemedicine).


Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy individuals between the ages of 18 and 55, inclusive
2. Meets Diagnostic and Statistical Manual (DSM)-5 diagnostic criteria for current moderate to severe CUD as confirmed by a licensed physician or psychologist or addiction medicine specialist
3. BMI within 18.0 to 38.0 kg/m2, inclusive
4. Seeking to minimize withdrawal symptoms related to cannabis discontinuation in people seeking to discontinue cannabis
5. Meet DSM-5 Cannabis Withdrawal
6. Report heavy use of daily/near daily cannabis
7. Have a urine drug screen positive for tetrahydrocannabinol (THC)/THC metabolites at Screening and Randomization
8. Capable of giving informed consent and complying with study procedures
9. Stated willingness to comply with all study procedures including twice weekly visits, daily evening video calls, restrictions, and availability for the duration of the study

Exclusion Criteria:

1. Lifetime history of DSM-5 diagnosis of schizophrenia or schizoaffective disorder, or Bipolar 1 within the previous 2 years
2. Current DSM-5 criteria for a psychiatric disorder that in the Investigator's judgment is unstable, would be disrupted by the study medication, or is likely to require new pharmacotherapy or psychotherapy during the study period. Individuals who are currently stable on psychotropic medication for at least 3 months may be included at the discretion of the Investigator's judgement
3. Participants who meet DSM-5 criteria for any substance use disorder other than cannabis, nicotine, or caffeine use disorders
4. Participants using cannabis for a medical condition requiring use such as epilepsy
5. Clinically significant unstable medical disorders
6. Any clinically important abnormalities on Screening physical examination (PE), assessments, ECG, or laboratory tests
7. Use of an investigational drug or biologic within 30 days or 5 times the half-life (whichever is longer) prior to the Screening Visit
8. Pregnant or lactating female participants, or a positive urine pregnancy test
9. COVID-19
Freestyle Libre Use in Real Life: Efficacy and Acceptance

Aim of the study is to evaluate efficacy of freestyle Libre system (flash glucose monitoring) in real life in term of Glycated Haemoglobin reduction and acceptance of the system evaluated through validated questionnaires after 3 and 6 months of device's use.

Freestyle Libre is a new technology developed to monitor glycemic values in diabetic patients.

The system is available in Italy from 2014 but in Veneto region reimbursement for insulin treated diabetic patients is available from august 2017.

International trial (for example Impact trial) demonstrated efficacy of the system (reduction of the time spent in hypoglycemia).

Aim of this study is to evaluate efficacy in real life in term of glycated haemoglobin (HbA1c) reduction. The investigators will enrollee in this trial all type 1 diabetic patients that will start to use the system, on the basis of clinicians decisions and reimbursement criteria.

Investigators will evaluate changes in HbA1c and changes in hypoglycameia fear and therapy acceptance through validated questionnaires after 3 and 6 months of system use

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants of at least 18 years of age
* Diagnosis of type 1 diabetes mellitus (diagnosed according to World Health Organization criteria) for at least 1 year
* Availability to wear Freestyle Libre sensor
* Signature of informed consent

Exclusion Criteria:

* Pregnancy, breastfeeding, intention to undergo pregnancy
* Known allergies to skin patches or disinfectants used during the study.
* Skin lesions, irritation, redness, edema in sites where sensors can be applied, as this might interfere with sensor's placement
* Use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study period.
* Severe medical or psychological conditions, which, in the opinion of the medical team, may compromise patients' safety while using freestyle LIbre sensor
* Patients enrolled in other clinical trials.
* patients that usually wear other continuous glucose monitoring system
Effect of Inhibitors of the Proton Pump on Intestinal Transporters

Dabigatran etexilate is a novel oral anticoagulant. It is indicated in venous thromboembolic prevention in orthopedic surgery and has recently shown greater efficiency and tolerance as anticoagulants in preventing thromboembolism in atrial fibrillation. However, it increases the risk of gastrointestinal bleeding compared to standard treatment (AVK) \[3\]. In these circumstances the risk / benefit of dabigatran could be improved by combining it with gastric protectors such as inhibitor drugs proton pump (IPP).

Investigators want to evaluate the pharmacokinetic and pharmacodynamic effects of co-administration of these two IPP (omeprazole, rabeprazole) with dabigatran in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* weight between 60 and 85 kg
* normal clinical exam
* normal biological exam

Exclusion Criteria:

* hypersensitivity to dabigatran or any of its excipients
* hypersensitivity to omeprazole or rabeprazole or any of its excipients
* previous history of hemorrhagic disease
* insufficiency liver
* severe kidney failure
* peptic ulcer
* Any drug taken during the week before the start of the study
* smoker
* Consumption of grapefruit juice
* practice of violent sport