cyrilzakka/clinical-trials huggingface dataset:
A Study on the Effects of Nutritious Mushrooms in Adults With Metabolic Syndrome

Obesity, characterized by an increase in body weight that results in excessive fat accumulation, is a global health problem. Recently, it has also been shown that obesity is associated with low-grade chronic systemic inflammation in adipose tissue. This condition is mediated by activation of the innate immune system in adipose tissue that promotes inflammation and oxidative stress and triggers a systemic acute-phase response.

Previous research points towards the potential of phytochemicals in food as part of nutritional strategies for the prevention of obesity and associated inflammation, as well as, increase in insulin sensitivity in diabetic patients.

In addition, there is strong evidence that obesity is inversely associated with vitamin D levels. The major cause of vitamin D deficiency in humans is the lack of adequate sun exposure. Unfortunately, very few foods, i.e. mushrooms, naturally contain vitamin D and foods that are fortified with vitamin D are inadequate to satisfy vitamin D requirements.

The last decade, mushrooms have attracted the research interest as functional foods with desirable health benefits in several metabolic disorders without the side effects of pharmacological treatment. Edible mushrooms are highly nutritious and exhibit beneficial effects on several inflammatory diseases such as cancer, heart disease, diabetes,, high blood pressure.

Thus, the purpose of this study is to determine the effects of nutritious mushrooms in adults with Metabolic Syndrome. More specifically, 100 participants will be allocated to two groups, namely intervention group (N=50) and control group (N=50). Vitamin D2-enhanced mushrooms by UV-B will be provided as a snack to the intervention group, whereas the control group will not consume the snack. The intervention will last 3 months.The effects of the intervention will be evaluated via clinical and laboratory markers. Personal and family history, anthropometric, demographic data, body composition, dietary habits, physical activity and smoking status will be assessed pre- and post- intervention. Biochemical profile, oxidative stress and inflammation, as well as metabolomic profiles will be assessed in blood samples pre- and post- intervention. Both groups will receive standard nutritional counselling throughout the intervention and will be encouraged to report any adverse effects they may experience during the intervention.


Eligibility Criteria:
Inclusion Criteria:

* 30 years \< Age \< 65 years
* BMI \> 25 kg/ m2
* Metabolic Syndrome

Exclusion Criteria:

* Hepatotoxic Medication
* Diabetes Mellitus
* Dysthyroidism, hypopituitarism, Cushing syndrome / disease
* Pregnancy, lactation
* Psychiatric or mental disorder
* Any use of antioxidant-phytochemical rich supplement, vitamin D supplement, nti-, pre- or pro-biotics within 3 months pre-intervention
Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery

This study is conducted to evaluate the effects of preoperative oral pregabalin on postoperative pain and analgesic requirements in patients undergoing DCR surgery. The primary outcome is to compare pain scores by visual analogue scale (VAS). Secondary outcomes are the time of first analgesic request, the total analgesic requirements during the postoperative 24 hours, the incidence of PONV, in addition to effect on hemodynamic parameters between the two groups.

External dacryocystorhinostomy (DCR) is still considered the golden standard for lacrimal surgery. It is a bypass technique which creates an anastomosis between the lacrimal sac and the nasal mucosa through a bony ostium via an external skin incision. External DCR can be completed under either local or general anesthesia. It is a painful surgical procedure that involves intra- and extra-ocular dissection, with a high prevalence post-operative nausea and vomiting (PONV). So, it is necessary to ensure a stress-free peri-operative period with adequate pain relief and a low incidence of PONV after DCR surgery.

Pregabalin is a lipophilic gamma-amino-butyric acid (GABA) analogue that binds to the voltage-gated calcium channels. It reduces the excitability of the dorsal horn neurons after tissue damage. It has anticonvulsant, anxiolytic and sleep-modulating properties. It was shown to be effective in several models of neuropathic pain, incisional injury, and inflammatory injury.

Preoperative administration of pregabalin is supposed to be a promising technique of enhancing postoperative pain control and reduction in postoperative opioid consumption.

This study is a prospective randomized double-blind clinical trial included 100 ASA I and II patients of both sex with age between 18 and 65 years old, who are planned for elective DCR surgery under general anesthesia in Mansoura University ophthalmology center. Informed written consent is obtained from all subjects in the study after ensuring confidentiality. Details of the anesthetic technique and the study protocol are clarified to the entire involved cases. Patients are randomly assigned to two equal groups according to computer-generated randomization schedule.

A prospective analysis of the collected data is performed using the Statistical Package for the Social Sciences (SPSS) program for Windows (version 22). All data are considered statistically significant if P value is ≤ 0.05.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) I and II patients.
* Scheduled for DCR surgery.

Exclusion Criteria:

* Patient' refusal of consent.
* Mental, psychological or neurological disorders.
* Patients with history of drug or alcohol abuse.
* History of know sensitivity to the used drugs.
* Bleeding or coagulation diathesis.
* Obese patients (body mass index (BMI) \< 35).
* Pregnancy and lactation.
Long-term Outcome Following Concomitant Surgical Ablation for Atrial Fibrillation at University Hospital Basel: A Retrospective Study

This retrospective single-centre study aims to examine the success rate of concomitant surgical ablation in patients with atrial fibrillation (AF) with an up to eight years follow-up period. Moreover, the focus of this study was to identify variables which predict freedom from AF, such as the type of AF, lesion set performed, energy source used and the patient's characteristics.


Eligibility Criteria:
Inclusion Criteria:

* concomitant surgical ablation for atrial fibrillation
* performed between January 2011 and January 2017 at University Hospital Basel

Exclusion Criteria:

* stand-alone procedure
* surgical ablation for atrial flutter
New Genes Involved in Molecular Etiology of Rett Syndrome Through DNA Microarray Comparative Genomic Hybridization

Rett syndrome (RTT) is a genetic encephalopathy and the typical form is caused by mutations in the gene MECP2. It is a genetically heterogeneous pathology. CDKL5 and FOXG1 have been recently discovered being involved in other forms of RTT. However, at least 5% of typical forms and more other atypical forms are not linked to any of 3 genes known to be involved in the disease.

The purpose of this study is to identify new genes involved in molecular etiology of typical and atypical forms of RTT.

Search for pathogenic chromosomal imbalance through comparative genomic hybridization (aCGH) on DNA microarrays will be done in a group of patients having typical or atypical forms of RTT without known mutations in MECP2, CDKL5 et FOXG1B genes.

After imbalance confirmation by qPCR, the pathogenic potential of the segmental aneusomy will be assigned according to the interpretation of aCGH technique-dedicated DECEPHER, BACH and GVD databases. Analysis of parents will allow distinguishing between inherited polymorphic variants and potentially deleterious new imbalances.

In case of a new imbalance, a bioinformatics approach will look for candidate genes that will be possibly confirmed by classic mutation screening (sequencing and PCR) in all typical and atypical cases of RTT present in the cohort.

The identification of new genes involved in RTT will ameliorate the molecular diagnosis of the disease and genetic counseling for families. This project will allow progression in comprehension of physiopathological mechanisms of cerebral development abnormalities

Eligibility Criteria:
Inclusion Criteria:

* Patients: RETT syndrome
* Patients: Female
* Parents: parent of a patients
Effects of Quetiapine on Ultrastructural Hippocampal and Neurochemical Changes in Patients With Bipolar Disorder: Searching for Antidepressant and Mood Stabilising Neurophysiology

The aim of the study was to determine the pharmacological induced equivalents of neurogenesis and synaptic sprouting in the hippocampus, localized volume changes, changes in water content and neurochemical changes in the medial temporal regions.

Quetiapine is an antipsychotic that has mood stabilizing and antidepressant effects (Vieta, 2005). Animal studies showed that the expression of neurotrophins and the subsequent modulation of the neuroplastic processes, including neurogenesis in the hippocampus, play a key role in the mechanism of mood stabilizing (Kim et al., 2004) and antidepressant (Santarelli et al., 2003). Since atypical antipsychotics also have antidepressant and mood stabilizing effect, it is hypothesized that the common mechanism of action in all three pharmacological classes is neurogenesis and synaptic sprouting in the hippocampal region. Thus, the aim of this study was to test this hypothesis.

Quetiapine was associated with antidepressant and mood stabilizing effects in patients with bipolar disorder (Vieta, 2005). The evidence based on animal studies shows that administration of quetiapine attenuates the decrease in levels of brain-derived neurotrophic factor in the hippocampi. This may explain the improved cognitive symptoms in patients with schizophrenia and depression (Luo et al., 2005, Park et al, 2006).

The aim of the study was to determine the pharmacological induced equivalents of neurogenesis and synaptic sprouting in the hippocampus, localized volume changes, changes in water content and neurochemical changes in the medial temporal regions.

Eligibility Criteria:
Inclusion Criteria:

* age ranging 18 - 55 years old
* intelligence coefficient (IQ) of minimum 85 as estimated by MWT-B
* MRI compatibility
* for healthy volunteers - no DSM-IV diagnosis
* patients should have had a diagnosis of bipolar disorder in accordance with DSM-IV.

Exclusion Criteria:

* substances or alcohol abuse or dependence (except caffeine and nicotine) at enrollment;
* medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment;
* unstable or inadequately treated medical illness (diabetes, angina, pectoris, hypertension);
* diabetes mellitus
* patients who in the opinion of the investigator pose a risk of suicide or danger to self or others,
* patients who known intolerance or lack of response to Quetiapine fumarate,
* patients who use of any of the cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, nelfinavir, ritonavir, fluvoxamine and saquinavir) in the 14 days preceding enrollment,
* patients who use of any of the cytochrome P450 inducers (phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort and glucocorticoids) in the 14 days preceding enrollment,
* current treatment of Quetiapine or use of mood stabilizer or antidepressant as co-medication throughout the study.
* lack of inform consent
Vancomycin in the Target Site Treatment of Intracranial Infection

Vancomycin, a novel intravenously administered antibiotic, currently plays a key role in the management of complicated multi-organism infections. However,current LC-MS/MS methods briefly describe parameters and the only reported internal standard was sometimes difficult to obtain. In our study,an updated LC-MS/MS method for the quantitative analysis of vancomycin in human serum was developed.


Eligibility Criteria:
Inclusion Criteria:

In ICU; ventricle drainage was carried out; renal function is normal, namely creatinine clearance rate is \>60ml/min;

Exclusion Criteria:

women in pregnancy or lactation;in patients with renal insufficiency, the creatinine clearance rate (Clcr) is less than 60ml/min.
A Pilot Study of MONOtherapy of DOlutegravir in HIV-1 Virologically Suppressed Patients

Current HIV treatment guidelines recommend a combination of drugs for the maintenance of antiretroviral therapy (ART). Simplification is considered critical to further scale-up of treatment, to support retention in care and to reduce costs. Dolutegravir is a once daily integrase inhibitor that shows very good tolerability, efficacy, and distinctive resistance profile. The researchers aim at investigating the feasibility of dolutegravir monotherapy in maintenance therapy. Briefly, 10 virologically suppressed patients for at least six months on conventional triple ART of dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs) will be switched to dolutegravir monotherapy for 24 weeks. The primary endpoint is the number of patients completing 24 weeks of dolutegravir monotherapy without experiencing virological failure.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection;
* Patient included in the Swiss HIV Cohort Study (SHCS);
* ≥ 18 years of age;
* Virologically suppressed for at least 24 months on first line triple ART (changes for toxicity permitted) with at least 4 HIV-1 RNA measurements in plasma \<50 copies/ml;
* No history of previous failure on ART;
* No documented antiretroviral drugs resistance;
* No co-infection with Hepatitis B or C virus;
* Effective contraception in women;
* Willing to provide CSF and semen samples;
* Written informed consent

Exclusion Criteria:

* HIV-2 infection;
* Renal dysfunction (creatinine clearance \<50ml/min);
* aspartate transaminase or alanine aminotransferase \>5x upper limit normal;
* Concomitant use of carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John's wort, rifampicin or metformin;
* Previous AIDS defining conditions or active malignancy in the past five years;
* Positive HIV viral load in CSF at baseline;
* Known or suspected non-compliance;
* Women who are pregnant or breastfeeding.
Effects of Virtual Reality on Perioperative Pediatric Anxiety

This study evaluates the effect of virtual reality on anxiety levels in a pediatric surgical population. Half of participants will receive standard perioperative treatment, while the other half will receive additionally a virtual reality local program.

It is well known that there is a high incidence of significant anxiety in pediatric population perioperatively, with adverse side effects in terms of emergence delirium and maladaptive postoperative behaviors. Many different strategies have been designed in order to minimize these negative consequences.

Virtual reality is a new and simple technology that can be used at young ages. The aim of this study is to measure anxiety levels at different times in children scheduled for ambulatory surgery compared to patients with standard care without virtual reality.

Eligibility Criteria:
Inclusion Criteria:

* Child between 4 and 12 years old
* Elective ambulatory surgery
* Parents posses a smart phone
* Child and parents understand Spanish or Catalan
* Patient information has been explained
* Informed Consent is signed
* Surgery scheduled in the morning

Exclusion Criteria:

* Child has hearing impairment
* Child has visual impairment
* Child has previous experience of anesthesia
* American Society os Anesthesiologists (ASA) score of III or greater
* Children with history of seizures
* Children under psychiatric treatment
A Study of JNJ-77242113 in Healthy Japanese and Chinese Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of JNJ-77242113 after single ascending oral dose administration as an immediate-release (IR) tablet formulation in healthy Japanese participants and after single oral dose administration as an IR tablet formulation in healthy Chinese participants; and as a delayed release (DR) tablet formulation in healthy Japanese participants.


Eligibility Criteria:
Inclusion Criteria:

* For Parts 1 and 3: Japanese male or female of non-childbearing potential, who have parents and maternal and paternal grandparents who are of Japanese ethnicity
* For Part 2: Chinese male or female of non-childbearing potential, who have parents and maternal and paternal grandparents who are of Chinese ethnicity
* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
* Body weight not less than 50 kilograms (kg) and body mass index within the range 18 and 30 kilograms per meter square (kg/m\^2) (inclusive)
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted

Exclusion Criteria:

* History of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
* Use of a live vaccine within 30 days prior to screening or anticipated need for a live vaccine during the study or for 30 days following the dose of study drug
* Received an experimental drug (including investigational vaccines) or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the dose of the study intervention is scheduled
* Test positive for human immunodeficiency virus (HIV)-1 and 2 antigen/antibodies, test positive for hepatitis C antibodies, test positive for syphilis, or test positive for hepatitis B virus (HBV) infection at screening
A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe active RA (European League Against Rheumatism \[EULAR\] criteria)
* Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
* Initiating treatment with tocilizumab according to SPC

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA
* Prior history or current inflammatory joint disease other than RA
* Previous treatment with any biological drug used in the treatment of RA
* Previous treatment with tocilizumab
* Any contraindication to treatment with tocilizumab
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* Pregnant women or nursing (breastfeeding) mothers
Well-arm Exercise in Distal Radius Fractures

A single center randomized control study. Patients \>18 years with isolated distal radius fractures treated non-operatively will be randomly assigned to either the treatment group (exercise of contralateral "well" arm) or control group (standard fracture care and rehabilitation).

Distal radius fractures are common injuries, especially in the aging population. Fracture healing requires immobilization of the injury, which inevitably leads to muscle atrophy and joint stiffness. This strength lost during immobilization can be problematic in patients who are already de-conditioned at baseline. Previous research using healthy participants found that exercising a non-immobilized, "well", arm helped attenuate muscle atrophy in the contralateral immobilized arm. The study aims to answer the following questions: Does exercise of the contralateral arm prevent muscle atrophy and weakness of the injured arm? Does exercise of the contralateral arm improve pain scores in the injured arm

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years with an isolated distal radius fracture treated non-operatively

Exclusion Criteria:

* Operative treatment, additional injures, previous injury to same arm, neuropathy or neuromuscular disease, dementia
Evaluating the Bioequivalence of HIP1403, HGP0919

The purpose of this study is to investigate the bioequivalence after administration of HIP1403 and HGP0919 in healthy male volunteers

A randomized, open-label, single dose, crossover clinical trial to investigate and compare the pharmacokinetics between HIP1403 and HGP0919 in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers, age 19 to 45 years.
2. The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1.Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function

HIV infected subjects receiving antiretroviral treatment for greater than 6 years with be evaluated for clinical lipoatrophy and mitochondrial function after switching nucleoside analogues from stavudine (d4T) to tenofovir treatment and after 4.

Hypothesis: Tenofovir therapy will increase peripheral fat content as assessed by DEXA and mitochondrial function at 48 weeks.

HIV infected subjects receiving antiretroviral treatment (lopinavir/ritonavir, stavudine, and lamivudine) for greater than 6 years through the Abbott M97-720 protocol with be evaluated for clinical lipoatrophy and mitochondrial function prior to switching nucleoside analogues from stavudine (d4T) to tenofovir and after 48 weeks or tenofovir treatment.

Subjects with or without lipoatrophy are eligible for the study. Adipose tissue biopsies to measure mitochondrial function, metabolic laboratory tests, and DAXA scans and clinical evaluations of lipodystrophy will be performed at Entry and after 48 weeks of tenofovir treatment.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Receiving Kaletra, stavudine, and lamivudine for greater than 6 years (through Abbott M97-720 study)
* Planning to switch from stavudine to tenofovir

Exclusion Criteria:

* Will continue to receive stavudine