cyrilzakka/clinical-trials huggingface dataset:
Effect of Ticagrelor on Endothelial Function

This study is to assess the function of blood vessels while being treated with different types of blood thinners to determine the effect of these medications on blood vessels.


Eligibility Criteria:
Inclusion Criteria:

1. Age\>18 years old
2. At least two cardiovascular risk factors
3. Demonstrated endothelial dysfunction
4. Evidence of coronary artery disease

Exclusion Criteria:

1. Second (II) or third (III) degree heart block without a pacemaker
2. Known active pathological bleeding, history of stroke, or bleeding diathesis
3. Dyspnea classified as NYHA class III-IV
4. Need for oral anticoagulants
5. Clinically significant valvular heart disease
6. Any concurrent life threatening condition with a life expectancy less than 1 year
7. History or evidence of drug or alcohol abuse within the last 12 months
8. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
9. History of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs.
10. Latex allergy
11. History of noncompliance to medical regimens or unwillingness to comply with the study protocol
12. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer Positive pregnancy test, breast feeding women or women of child bearing potential not using highly effective methods of contraception.
13. Patients who are also taking strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir)
14. patients taking antiplatelet medications which cannot be stopped
15. severe liver disease
Preventing Depression Recurrence in Diabetes

To study the effectiveness of sertraline (Zoloft) in treating depression in adults with diabetes. The study will also determine whether depressed diabetic patients who have successfully responded to sertraline (Zoloft) are more likely to have depression recur if the sertraline (Zoloft) is discontinued.

Part A: Prevention of Depression Recurrence in Diabetes

1. To determine the efficacy of maintenance antidepressant medication in preventing or delaying recur-rence of major depression in diabetes.
2. To determine the relationship of sustained depression remission to social, occupational, and global func-tioning, and to quality of life and compliance with diabetes treatment.
3. To determine clinical features predictive of depression recurrence in diabetes.

Part B. Longitudinal Study of the Interrelationship of Glycemic Control and Depression

1. To determine the effects of depression remission and recurrence on glycemic control.
2. To determine the efficacy of maintenance antidepressant medication in producing sustained benefits in glycemic control.
3. To determine the interrelationship of daily mood with blood glucose and the effect of maintenance treatment on this relationship.

Eligibility Criteria:
Inclusion Criteria:

* 18-80
* Type 1 or Type 2 Diabetes
* Screen positive for depression

Exclusion Criteria:

* Are pregnant or lactating
* Are known to be hypersensitive to the drug
* Have a recent history of myocardial infarction or unstable heart disease
* Have severe hepatic disease or renal impairment (serum creatinine \> 3 mg/dl)
* The subset of patients with psychiatric disorders thought to affect management (e.g., schizophrenia, alcohol and drug dependence) will also be excluded from participation
Cognitive-Behavioral Intervention to Increase Tummy Time Practice and Maintain Healthy Weight in Infants

Childhood obesity is a serious health problem worldwide evidenced by its high prevalence, specifically for the age group called the first 1000 days of life. This condition has serious consequences on the health of infants who suffer from it, being a precursor for the development of diseases such as diabetes and hypertension. For this reason, international organizations have proposed physical activity as a priority component for the prevention of childhood obesity. The objective of this study is to evaluate the preliminary effect of an intervention based on social cognitive theory aimed at Mexican mothers with children under six months of age to increase the practice of Tummy Time and maintain the healthy weight of the infant compared to usual care. The methodology will be a pilot randomized clinical trial with randomization to the Experimental Group and Control Group, the intervention will be with a single-blind approach and repeated measurements. A non-probabilistic sampling will be used for convenience and the sample will be 144 participants who will be dyads of mothers and children who are in the immediate postpartum hospitalized in a second-level hospital in Mexico.


Eligibility Criteria:
Inclusion Criteria:

* Mother-child dyads that are in the postpartum
* mothers who declare that they know how to read and write in spanish
* have an electronic device (cell phone, tablet or computer),
* have an internet connection.
* Have the social network WhatsApp®
* Agree to participate voluntarily evidenced by informed consent will be considered

Exclusion Criteria:

* Women who report having received information about TT one month before the intervention.
* Women who are actively participating in programs related to early stimulation
* Who declare that they have a premature infant born before 37 SDG,
* who has a low birth weight \&lt;2,500g,
* who has a medical condition or complication at birth that impacts their physical mobility and
* who has chronic health problems or congenital anomalies.
Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication

This is a long-term follow-up of a prospective randomized trial comparing open and laparoscopic Nissen fundoplication.


Eligibility Criteria:
Inclusion Criteria:

* moderate / severe gastrointestinal reflux disease (GERD) requiring operative treatment
Effects of Acute Dietary Changes on Estimates of Body Composition

The present study sought to investigate the effects of acute dietary changes on estimates of body composition. Specifically, the impact of an acute high-carbohydrate diet (9 g/kg body weight of carbohydrate) and an acute very low-carbohydrate diet (1 - 1.5 g/kg body weight of carbohydrate) were examined.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Recreationally active (\>150 min/week of moderate or vigorous physical activity)
* Pre-menopausal with regularly occurring menstrual cycles over past 6 months (in females only)

Exclusion Criteria:

* Failure to meet inclusion criteria
* Commencement or cessation of taking the dietary supplement creatine within the past month
* Pregnant or may become pregnant during the study
* Known or suspected food allergy to any items used in study
* Presence of medical condition that could reasonably be negatively affected by participation
Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations

The identification of the operative site of lumbar ductal stenosis and lumbar disc herniation is classically done by radioscopy, thus inducing irradiation of the patient.

The use of ultrasound in spine surgery is little studied and poorly mentioned in the scientific literature. However, it is commonly used for other types of scouting (especially anesthetics). Thus, in the absence of consensus and clear recommendations, some practitioners perform ultrasound scans . Methodological developments also validate the feasibility of the ultrasound approach.

The double benefit of an ultrasound identification is firstly a lack of exposure to X-rays for both the patient and the operating team and secondly a lower cost than a conventional radiography.

The main objective is to demonstrate the interest of the ultrasound identification of the surgical site in the intervention of lumbar ductal stenosis and lumbar disc herniations in terms of concordance of the operating site between ultrasound and fluoroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Patients who gave their consent
* Patients requiring surgery for the treatment of lumbar stenosis or lumbar disc herniation

Exclusion Criteria:

* Pregnant or lactating women according to article L1121-5 of the CSP.
* Vulnerable persons according to article L1121-6 of the CSP.
* Major persons placed under guardianship or curatorship
Treatment of Prisoners With Attention Deficit Hyperactive Disorder in Trondheim Prison

The treatment of ADHD in jail will help the prisoners in their rehabilitation process

Prisoners with ADHD will be offered treatment with Stratera, and we wanted to study their use of the prisons rehabilitation offers as school, programs and work training before and after treatment with Stratera.

Eligibility Criteria:
Inclusion Criteria:

All prisoners that fullfill the diagnostic criterias for ADHD -

Exclusion Criteria:

All other prisoners -
Dietary Monosaccharide Supplementation in Patients With Congenital Disorders of Glycosylation

Researchers are trying to assess whether the use of simple sugars given as a daily dietary supplement can improve the health of children with congenital disorders of glycosylation (CDG).

The goal of this study is to collect data from patients diagnosed with congenital disorders of glycosylation and taking a simple sugar supplement. The study team wants to expand the evidence on the beneficial effects of this treatment in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patient has a biochemically and genetically proven congenital disorder of glycosylation
* Patient is receiving (or planning to receive) oral simple sugar supplementation

Exclusion Criteria:

* Aldolase B deficiency
* Galactosemia
* Hemolytic uremic syndrome
* Severe anemia
* Galactose intolerance
Long Study - Longitudinal Thrombosis in End Stage Renal Disease

The primary focus of this study is to collect information through diagnostic testing, blood sample analysis and patient data collection on patients starting hemodialysis to determine risk and preventative factors of bleeding and clotting events.

Hemodialysis patients have a very high rate of heart attacks, strokes and amputation. These problems are caused by a blood vessel problem called atherosclerosis (hardening of the arteries), and by clotting. Clotting is also a problem in the access, which is their lifeline for hemodialysis. We have early results which show that some risk factors for clotting in the general population are common in dialysis patients. Bleeding is another significant problem within this population. In this pilot study we will measure bleeding/clotting factors in the blood of consenting patients who are just starting dialysis. We will also do special tests to show how much calcium build up and atherosclerotic build up has happened in the arteries and whether the arteries are becoming stiff. We will then follow patients for up to four years and record any health problems that might reflect bleeding, clotting or a blood vessel problem. At the end of the study, we will compare people who have had bleeding, clotting or blood vessel problem with those who have not, and learn which of the measurements predicted problems. We will go on to study potential treatments, such as anti-clotting drugs, which might prevent or delay the occurrence of such problems. This would improve the health of dialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (aged \> 18 years)
* Patient on hemodialysis between 30 and 90 days

Exclusion Criteria:

* Anticipated recovery of renal function (on dialysis \< 90 days)
* Critical illness at time of recruitment (patients who are critically ill \[ICU\] when first screened, who survive to 80 days, will be rescreened and will be able to participate at that point if no longer critically ill)
* Planned live-donor renal transplant within 6 months
* Patient cannot consent due to language barrier
* Patient cannot consent due to cognitive difficulties
* Patient cannot consent due to hearing impairment
* Patient cannot consent due to speech impairment
* Patient or decision maker declines consent
* Patient is unable to give consent and no substitute decision maker is available
* Patient on dialysis longer than 90 days
Detection of IDH2 Mutations and Monitoring Molecular Residual Disease in Patients With AML

1. Detection of IDH2 mutations in AML patients to define it incidence and correlation with clinical characteristics, relapse-free and overall survival.
2. Identify AML patients who are potential candidates for IDH2 inhibitor treatment.
3. Monitoring minimal residual disease (MRD) following therapy to evaluate its possible role in the strategy of MRD-directed therapy in the future in patients carrying IDH2 mutations at initial diagnosis.

Isocitrate dehydrogenase 2 (IDH2) was found to be one of the recurrently mutated genes in acute myeloid leukemia, indicating its critical role in leukemogenesis. IDH2 mutations account for about 10%-20% of AML patients. IDH2 mutation is found to be associated with production of 2-HG, which interferes with histone methylation and DNA modification, results in partial block of myeloid cell differentiation. IDH inhibitors have shown in preclinical model to reverse differentiation blockage in tumor cells. The assessment of IDH2 inhibitors is ongoing with phase I/II clinical trials. The analysis of IDH2 mutation in AML patients will help to identify AML patients who might benefit from IDH inhibitor treatment.

Bone marrow samples from 300 adult patients (\>20 years old) with newly diagnosed AML since 2014/1/1 and received standard chemotherapy in hospitals which has jointed Ministry of Health and Welfare AML program will be examined. The mononuclear cells are extracted from bone marrow samples at the initial diagnosis. The mutational analysis of exon 4 of IDH2 gene will be performed by PCR amplication followed by pyrosequencing to detect IDH2-R140 and R172 mutations and mutant levels. Follow-up samples of patients carrying IDH2 mutations at the time of achieving hematologic remission, subsequent samples during different time points including at least following two post-remission chemotherapy, at the end of therapy and every 3 months thereafter in the first year and then every 6 months up to 24 months, as well as at time of relapse, will be measured by LNA-quantitative real-time PCR with TaqMan probe assay to determine the changes of IDH2 mutant levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with AML, age ≥ 20 years, and are willing to sign the informed consent

Exclusion Criteria:

* Not AML patients
* Patients diagnosed with AML but age \< 20 years
A Study of Usage of Paliperidone Palmitate in Patients With Schizophrenia in a Hospital Setting

The purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate use and pattern of paliperidone palmitate usage in participants with schizophrenia in the hospital setting.

This is a prospective (look forward using periodic observations collected predominantly following patient enrollment), multicenter, observational study (a type of study in which participants are observed or certain outcomes are measured). This study will consist of 6-week observational period during which data will be collected for participants who are hospitalized due to schizophrenia exacerbation and are receiving treatment with paliperidone palmitate (treatment initiated within 3 weeks after admission to hospital). The participant satisfaction will be evaluated at week 6 (or early discontinuation). Safety evaluations will include body weight, extrapyramidal symptom (eg, inability to initiate movement and inability to remain motionless) rating scale scores, concomitant therapy and assessment of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with schizophrenia
* Participant admitted to hospital due to an exacerbation of their schizophrenia prior to any study-related activity
* Participant may, in the opinion of the participating physician, benefit from treatment with paliperidone palmitate which will be initiated within 3 weeks after admission to hospital

Exclusion Criteria:

* Participant has a known hypersensitivity to paliperidone or risperidone
* Participant has previously been treated with paliperidone palmitate
* Participant has a history of neuroleptic malignant syndrome
* Participant was on clozapine or has previously been treated with any long-acting injectable antipsychotic during the last 3 months
Association Between Resuscitation Orders and Mortality in ICU Patients

The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to ICU

Exclusion Criteria:

* Second or subsequent admission to ICU during the study period.
Infectious Agents Exposure : Archiving in Dental Plaque

We are studying the possibility of using dental calculus as a reservoir for the genes of an infectious agent that has infected the patient in previous months; as it is done to highlight climate change in ice samples.

From a sample of people who have had a microbiologically well-documented infection, we will study the possibility after genomic amplification to find, three to 12 months after genetic sequences of the infectious agent in the dental calculus of the person. The people will be recruited according to a large panel of infectious agent (gram + and gram bacterium, mycobacteria, parasite, fungus, DNA, RNA or retrovirus) and, of course, the presence of dental calculus.

Eligibility Criteria:
Inclusion Criteria:

* three months before, having been infected with a documented pathogen
* this infection must have been clinically obvious
* the patient must have dental calculus

Exclusion Criteria:

* to be under 18 years old
* to be incapable to consenting
* a tartar removal since the infection
Acute Fatty Acid Intervention Study (AFAST)

The main objective of this study is to elucidate whether different dietary fatty acids (SFA, PUFA, butter fat and margarine fat) in a high fat load will have different effects on PBMC gene expression profiles. Secondary objectives are to elucidate the effects of these fat loads on individual plasma free fatty acid profiles, triglycerides and cholesterol levels.

Nutrition plays a key role in the development of metabolic disorders like cardiovascular disease and the metabolic syndrome. Nutrients that can contribute to the risk of developing such diseases are fatty acids (FAs). It is known that fatty acids mediate their metabolic effects via changes in gene expression, through binding and subsequent activation of the transcription factor peroxisome proliferator-activated receptor (PPAR). In addition, it is known that unsaturated fatty acids are better ligands for PPAR than saturated fatty acids. Peripheral blood mononuclear cells (PBMC) express PPARalpha and are relatively easy to isolate from whole blood. We previously showed that the gene expression profiles of these cells can reflect free fatty acid increases during fasting. The question still remains whether dietary FA can influence gene expression in a similar way and, if so, whether different dietary FA result in different gene expression changes and subsequent activation of other pathways.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian men
* age between 18 and 30 years

Exclusion Criteria:

* Allergic to fish oil
* Allergic to margarine
* Allergic to cow milk or dairy products
* Current or recent (\<4 weeks) use of fish oil supplements or more then four times fish/week; 24.35 g of EPA-DHA of fish per month (800 mg/day) as judged by the questionnaire.
* Body mass index (BMI) \< 18 or \> 25 kg/m2
* Urine glucose concentrations outside normal ranges (low to non-detectable)
* Fasting blood glucose outside the normal range (3 - 5.5 mmol/L)
* Tobacco smoking
* Taking medication that may influence the study results
* Received inoculations within 2 months of starting the study or planned to during the study
* Donated or intended to donate blood from 2 months before the study till two months after the study
* Diagnosed with any long-term medical condition (eg., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease)
* Vegetarian
Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in Cesarean Section

The quality of the spinal anesthesia has beenreported to be improved by the addition of opioids (such as morphine, fentanyl and sufentanil) and other drugs (such as dexmedetomidine, clonidine, magnesium sulfate (Mg), neostigmine, ketamine, and midazolam).

Opioids such as fentanyl in combination with bupivacaine improvesthe quality of intraoperative and early postoperative subarachnoid block. Although, fentanylensures superior quality of analgesia, it is associated with many side effects. This has directed theresearch toward the use of newer and betteradjuvants for spinal anesthesia such as clonidineand dexmedetomidine

Spinal anesthesia is still the first choice for cesarean section due to its deep sensoryblock as well as fewer side effects on mother and fetus. Despite many benefits ofthismethod, it has a short duration and cannot provide sufficient postoperativeanalgesia.Adequate postoperative analgesia plays a crucial role in cesarean delivery because itallows better breastfeeding and caring for newborns.

Dexmedetomidine is a relatively newer highly selectivealpha-2 adrenoceptor agonist agent that producesanalgesic and sedative effects. It has also been used asan adjuvant in Spinal anesthesia resulting in prolonged duration ofblock and improved postoperative analgesia without anyassociated hypotension or other adverse events

Fentanyl is a synthetic opioid with central action,which is used widely for pain control. Intrathecal fentanyl is usually added to other local anesthetics to increase anesthesia and analgesia. It has improved spinal anesthesia and reduced the anesthetic drug-related side effects including pruritus,nausea, and vomiting.

Adjuvant drugs added to the intrathecal bupivacaine can decrease the dose of local anesthetics and guarantee sensory and motor block. Intrathecal adjuvants include fentanyl and dexmedetomidine as receptor agonists, which have sedative, analgesic, perioperative sympatholytic, anesthetic-sparing, and hemodynamic-stabilizing properties.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the childbearing period
* aged 18 to 40 years
* Gestational age ≥37 weeks of pregnancy
* ASA I and II candidates for elective cesarean section under spinal anesthesia.

Exclusion Criteria:

* The patients with emergency conditions,
* Contraindication of spinal anesthesia,
* History of valvular heart disease,
* History of allergy or sensitivity to applied drugs and
* Patients with placenta previa
* Failed blockade or need for induction of general anesthesia