cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Malondialdehyde in Periodontal and Cardiovascular Disease

Malondialdehyde (MDA) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and coronary heart disease (CHD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum MDA levels.

The aim of this study was to evaluate a possible association between both saliva and serum MDA levels in patients with CP and with CHD and if the serum MDA levels are mediated by serum CRP

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least twenty teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Drug-drug Interaction (DDI) Study to Assess ODM-201 as a Victim of CYP3A4 Inhibition or Induction

Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of BAY1841788 (ODM-201)


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject - as determined by the investigator or medically qualified designee based on medical evaluations including medical history, physical examination, laboratory tests and cardiac monitoring.
* Gender: Male.
* Age: 45 to 65 years (inclusive) at the screening visit.
* Race: White.
* Body mass index (BMI): ≥18.0 and ≤30 kg/m\^2.
* Agree to use condoms as an effective contraception barrier method and refrain from sperm donation during the whole study (starting after informed consent) and for 3 months after the end of treatment with ODM-201. In addition, participants must agree to utilize a second reliable method of contraception simultaneously. The second method which has to be used by a female partner of childbearing potential can be one of the following methods: diaphragm or cervical cap with spermicide or intra-uterine device or hormone-based contraception.
* Results of alcohol tests are negative at screening and on Study Day -1.

Exclusion Criteria:

* Medical and surgical history
* Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus).

Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.

* Febrile illness within 1 week before the first study drug administration.
* A medical history of risk factors for Torsades de Pointes (e.g. family history of Long QT Syndrome) or other arrhythmias.
* Known severe allergies, non-allergic drug reactions, or (multiple) drug allergies (excluding untreated, asymptomatic seasonal allergies like non-severe hay fever during the time of study conduct).
* Known history of hypersensitivity (or known allergic reaction) to itraconazole, rifampicin or ODM-201.
* Relevant hepatic disorders like cholestasis, disturbances of bilirubin metabolism, any progressive liver disease.
* Relevant renal disorders like recurrent glomerulonephritis, renal injury, and renal insufficiency. However, a history of a single episode of uncomplicated nephrolithiasis will not prevent participation.
* Subjects with porphyria.
* Subjects with diagnosed malignancy within the past 5 years except for cured skin basal carcinoma.
Genetic Basis of Abdominal Aortic Aneurysm

To identify the genetic (major genes) and environmental factors responsible for the significant aggregation of abdominal aortic aneurysm (AAA) among relatives of affected individuals.

BACKGROUND:

Abdominal aortic aneurysm (AAA) is a dilatation of the abdominal aorta which can, if undetected, lead to rupture. The mortality associated with ruptured AAA is estimated to be 90 percent, while elective repair has a mortality risk of approximately 6 percent. Ruptured AAA is a leading cause of death among older Americans. The identification of markers of AAA risk could lead to preventive intervention. AAA aggregates in families, and segregation analysis shows that familial risk of AAA is best explained by the segregation of a major gene with an autosomal recessive mode of inheritance.

DESIGN NARRATIVE:

Affected relative pairs (primarily sibling pairs) with AAA and no evidence of a family history of a connective tissue disorder were genotyped for 150 highly informative microsatellite polymorphisms marking the autosomal genome at a resolution of 20 cM. The linkage between AAA and these loci was tested using robust affected pedigree member methods to identify genomic regions which might contain genes that predisposed individuals to develop AAA. The existence of predisposing gene(s) were confirmed and their location refined using a defined search strategy, genotyping at increasing levels of resolution, and re-analysis of family data. The predisposing gene(s) were identified by a combination of saturation mapping and molecular analysis of candidate loci. The association of AAA with environmental measures was investigated to determine an equation for estimating risk for relatives of AAA patients based upon environmental measures and genotype. Power calculations based upon the number and structure of families already collected demonstrated the feasibility of identifying genes that predisposed to AAA using this strategy, even in the presence of significant heterogeneity with respect to the loci involved. In addition to identifying genes that were necessary for AAA by linkage analysis, a series of analyses of association were undertaken to identify true susceptibility genes that were neither necessary nor sufficient to cause disease, but which modified an individual's risk of developing AAA.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

To perform preliminary clinical testing of diethylhomospermine (DEHSPM), a polyamine analogue, for refractory AIDS-related diarrhea.

Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory AIDS-related diarrhea.

Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory AIDS-related diarrhea.

Patients are initially hydrated for 24 hours, followed by a 3-day baseline period. They then receive intravenous infusions of DEHSPM three times per day for 3 days, followed by observation for 3 days.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* ARC or AIDS by CDC criteria.
* Uncontrolled diarrhea unresponsive to high-dose, nonspecific antidiarrheal therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known idiopathic ulcerative colitis or Crohn colitis.
* Acute stool-culture-positive bacterial colitis.
* Acute amoebic colitis.
* Pseudomembranous colitis with Clostridium difficile toxin positivity.
* Short-gut syndrome.
* Chronic pancreatitis.
* Ischemic bowel disease.
* Enteroenteric fistulae.
* Other gastrointestinal tract disorders known to cause diarrhea.
* Underlying evidence of immunosuppression other than that related to HIV infection.
* Unable or unwilling to have subcutaneous injections.
* Clinically significant CNS, hepatic, or renal disease.

Concurrent Medication:

Excluded:

* Other experimental antidiarrheal drugs.
* Antibiotic therapy.

Prior Medication:

Excluded:

* Other experimental drugs within 1 month prior to study entry.

Required:

* At least 2 weeks of prior high-dose, nonspecific antidiarrheal therapy (i.e., loperamide, diphenoxylate hydrochloride-atropine sulfate, or opiates) at maximally tolerable doses.
Effectiveness of Chest Physiotherapy in Infants With Acute Viral Bronchiolitis

The purpose of this study is to verify the effectiveness of chest physiotherapy (actual versus conventional) on respiratory distress in infants with acute viral bronchiolitis.

The infants were random in three groups: Conventional techniques, actual techniques and suction of upper airways On the first two groups the infants were evaluated on admission,48,72hours and before hospital discharge. On third group was evaluated only on admission when SRV was collected.

Respiratory distress was evaluated with Wang's score by the physiotherapists and nurses not participating in the research.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute viral bronchiolitis
* RSV positive

Exclusion Criteria:

* Heart diseases
* Chronic lung disease
* Neurological diseases
* Parental refusal
* Previous wheezing episode
* ventilatory support
The Impact of the COVID-19 (SARS-CoV-2 Disease) on Psychopathology

The outbreak of the SARS-CoV-2 pandemic may be considered a traumatic phenomenon.

In a sample of subjects suffering from different psychiatric disorders, psychopathological status and Post-Traumatic Stress Disorder (PTSD) symptoms over time are assessed using specific psychometric scales. In a sample of healthy controls PTSD symptoms are evaluated by Impact of Event Scale Revised (IES-R) and compared to patients' scores.

We hypothesize that a significant number of psychiatric outpatients have experienced a clinical psychopathological worsening and a greater prevalence of PTSD symptoms compared to the general population. The study of the potential psychopathological changes could represent a useful contribution to deepen the understanding of psychological consequences of the pandemic.

SARS-CoV-2 epidemic is a worldwide phenomenon which generated fear, anxiety, depression and PTSD symptoms, as a consequence of the high number of deaths and the restricted measures adopted by the Italian Government to stem the spread of the virus.

The aims of the study are: (1) to investigate potential psychopathological changes over time in a sample of patients affected by different psychiatric disorders (schizophrenia, bipolar disorder, major depression, anxiety/Obsessive-Compulsive Disorder (OCD), personality disorders); (2) to compare patients and healthy controls in terms of post-traumatic symptoms.

Outpatients affected by different psychiatric disorders are recruited during their routine visits and demographic/clinical variables are collected from their medical records.

Psychopathological status and PTSD symptoms are retrospectively assessed using specific psychometric scales, such as Brief Psychiatry Rating Scale (BPRS), Clinical Global Impression (CGI), Disability Scale (DISS), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), Montgomery and Asberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS), Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), IES-R.

The assessment is performed over time at three time points: T0 corresponding to the outbreak of the pandemic (January-February 2020), T1 which was the lockdown period (March-April 2020) and T2 corresponding to the reopening and restarting (May-June 2020).

Descriptive analyses of the whole sample will be performed. Then, mixed linear regression models will be run to investigate the change over time in patients' psychometric scores and whether it differs among different diagnostic groups. Moreover, same analyses will be performed to compare patients and healthy subjects in terms of change of IES-R scores over time.

Eligibility Criteria:
Inclusion Criteria:

* understanding of the Italian language
* ability to understand and sign written informed consent

Exclusion Criteria:

* severe mental retardation
* pregnancy or post-partum period
* severe or chronic medical condition
* health workers
Preventing Postpartum Depression With Intranasal Oxytocin

The purpose of this study is to test a new treatment for preventing childbirth-related mental illness in postpartum mothers. The treatment is aimed at enhancing maternal bonding, reducing postpartum depression (PPD) and anxiety in mothers at risk, and promoting child development. To this end, the investigators will test the clinical utility of intranasal (IN) oxytocin (OXT) administered to mothers during the first postpartum days.

Postpartum depression (PPD) is a debilitating disorder which imposes a threat to mother and infant health. An estimated 600,000 American women suffer from PPD annually, making it one of the most frequent complications of pregnancy. Available secondary preventive interventions are often ineffective, which calls for identifying novel means for prevention. Impaired mother-infant bonding is a hallmark of PPD. Depressed mothers may have difficulties developing maternal feelings and providing sensitive care. In turn, impaired bonding may worsen mother's depression. Conventional pharmacotherapy does not help with bonding impairment.

This study will attempt to fill in the current gap in effective preventive interventions for pregnant mothers at risk. Evidence in postpartum mothers indicates that high peripartum OXT levels are associated with enhanced maternal behavior and low levels with depression. Data also indicates that in depressed mothers, OXT levels may decrease during the first days following childbirth rather than increase as is the norm. Therefore, the investigators will test the therapeutic effects of OXT in women at risk for PPD. It is hypothesized that administration of IN-OXT (total daily dose 48 IU) over the course of four days from as early as day one postpartum in comparison to placebo will 1) enhance mother-infant bonding, 2) reduce depressive and anxiety symptoms at 5 days postpartum, and 3) facilitate child development.

Eligibility Criteria:
Inclusion Criteria:

* Third-trimester pregnant women being followed at the Massachusetts General Hospital (MGH) Obstetrics Program
* At risk of postpartum depression (PPD)

Exclusion Criteria:

* Failure to participate in regular prenatal check-ups
* Current diagnosis Diagnostic and Statistical Manual of Mental Disorders (DSM-5) mental disorder pertaining to psychosis or substance abuse
* Suicidality
* Obstetric complication (e.g., preeclampsia, excessive hemorrhaging)
* Use of potentially confounding or interacting medications
* Complicating pediatric medical condition in the newborn
Prospective Biomarkers of Bone Metabolism in Hemophilia A

One of the major shortcomings in studying bone disease in hemophilia is the lack of fracture outcome data demonstrating the clinical significance of decreased BMD and altered bone biomarkers in the hemophilia population. This study demonstrates that PwH have an increased risk of fracture compared to the general population and that the issue of bone health will increase in importance as the PwH population ages.

This is a pilot study to determine the impact of factor replacement on bone biomarkers in up to 20 hemophilia A subjects. Subjects will be recruited over 1 year for the 5-day protocol.

Following a 72-hour washout period, factor levels and bone biomarkers will be followed before and after 50 units/kg replacement on Day 1 and 20 units/kg replacement on Day 3. Each subject can serve as their Figure 4. Fracture rates in PwH compared to historic controls.

Eligibility Criteria:
Inclusion Criteria:

1. Males with a diagnosis of hemophilia A with a historic baseline FVIII level ≤ 2%.
2. Age \> 16 years old
3. Currently using ADVATE as FVIII replacement therapy

Exclusion Criteria:

1. Subject or guardian is unwilling or unable to give written informed consent and/or assent
2. Joint or muscle bleeding within 2 weeks of Study Day 1
3. Presence of a current factor inhibitor (\>0.6 BU/mL via Nijmegan-modified Bethesda assay)
4. Known collagen vascular bone disease.
Evaluation Program of the Benefit of the Coordination of the Course of the Elderly Patient in Health Establishment - Pilot Study.

The large share of chronic diseases correlated with an aging population calls to develop necessary coordination between the hospital and non-hospital (professional of the city, home ...) to create new complementarities.

Since July 2013, the Nantes University Hospital experiences the establishment of a coordinator route patient in Gerontology. The evaluation program of the benefit of coordinating the course in elderly patients in health establishment (PROCOPES) must allow to prove the efficiency of the intervention of a coordinator route patient, following elderly patients in complex situations, both within the hospital and outside the hospital (home, nursing home,...). The objective of PROCOPES is to show the added value of an innovative position that can make the link between the hospital and the city on deemed complex situations.The pilot study results present a strong interest for health care settings, nursing home and in the world of research. It will also permit to have preliminary data for bigest studies.


Eligibility Criteria:
Inclusion Criteria:

* Patient of 70 and more years old
* Patient living on Nantes
* Hospitalized in Nantes UH
* Patient whose the hospitalization is not relevant at the time of the request of trajectory case manager
* Patient whose the situation is complex (without solution at the time of the request)
* Patient (or legal representative) having given his assent of participation

Exclusion Criteria:

* Patient (or legal representative) refusing to participate in the protocol
* Patient whose follow-up is impossible (ex: programmed move, life expectation)
Spasmolytic in Upper Gastrointestinal Endoscopy

Upper gastrointestinal system endoscopy is widely used for diagnostic approach. To increase the tolerability and compliance of the patient, sedation is applied. There are many studies showing that sedation increases the patient compliance and the tolerability. However, spasmolytic use in GE has not been evaluated yet.


Eligibility Criteria:
Inclusion Criteria:

* no hypersensitivity to the agent.

Exclusion Criteria:

* Emergent cases,the cases with low mental compatibility and pregnant women were excluded from the study. Moreover, the procedures under sedation, cases with disorders decreasing the intestinal motility like hypothyroidism and diabetes were excluded.
Use of Probiotics to Aid in Weight Loss

The purpose of this study is to evaluate the success of daily supplementation of multiple probiotic bacterial cultures over 12 weeks in increasing the percentage of excess weight loss in the RNYGB (Gastric Bypass) weight loss population.

Hypothesis:

The daily supplementation of a probiotic will increase weight loss compared to a placebo supplement in the post-operative gastric bypass patients.

Study Design:

All patients in this study will be scheduled to undergo the RNYGB (Gastric Bypass) procedure to assist in weight loss. Patients in this study will be randomized to one of two groups: Group 1 (Probiotics) or Group 2 (Placebo). Patients will begin supplementation at the beginning of their 4 week pre-surgery Optifast© 800 diet. All patients will take supplements for a total of 12 weeks. Nutritional education and support will be provided to each patient enrolled in the study. Weight loss will be measured using a machine that measures body composition. All patients will complete a quality of life questionnaire with regard to gastrointestinal health and a hair loss survey pre treatment and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female at least 18 years of age
* Signed informed consent
* Willingness to take a supplement once a day for 12 weeks
* Undergoing a RNYGB (gastric bypass) procedure
* Willingness to complete quality of life questionnaire and hair loss survey

Exclusion Criteria:

* Pregnant Female
* Lactating Female
* Male or Female less than 18 years of age
* Patients on chronic antibiotic treatment (prescribed more than 2 courses of antibiotics over the 12 week study period)
* Patients who have demonstrated medical therapy non-compliance past or present
Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand

The investigational drug being studied in this protocol is Incobotulinumtoxin A (Xeomin®). Botulinum toxin (BoNT) prevents the release of the acetylcholine from peripheral nerves, inhibiting muscle contractions. BoNT is effective in relaxing overactive muscles. In musician's dystonia, the ability to reduce abnormally overactive muscles in the hand can be critical for the musical professional to continue his or her career. With the use of EMG/electrical stimulation and/or ultrasound guidance, the injector can precisely localize the individual muscles that are affected in this condition with great accuracy. Prior studies have shown that BoNT injections produce beneficial effects in forearm muscles, and less effect in shoulder or proximal arm muscles.

Possible risks in treating patients with BoNT include excessive weakness of the injected muscles. The drug may also affect non-targeted muscles. However these risks will be minimized during the screening period by carefully targeting the affected muscles and by administering low doses of BoNT. Small booster doses may be given at follow up visit (2, 4, 14 and 16-weeks after the primary injection date) if the initial injection was insufficient to produce sufficient efficacy in relief of the focal dystonia and did not produce excess weakness of the targeted muscle.


Eligibility Criteria:
Inclusion Criteria:

* Patients with focal task-specific dystonia of one or both hands, selectively triggered by performance on a musical instrument.
* Patients must have been evaluated by Dr. Frucht at the Movement Disorders Division of Mount Sinai Medical Center as part of their clinical care.
* Patients whose performance on an instrument is directly linked to their occupation.
* Patients must be between the ages of 18 and 80.
* Impairment in musical performance must be visible and demonstrable.

Exclusion Criteria:

* Patients whose dystonia is not severe enough to interfere with musical performance in the opinion of a skilled examiner.
* Patients with unstable medical conditions or psychiatric conditions.
* Patients with a medical condition that precludes them from receiving BoNT injections.
Missed Serious Medical Illness in Psychiatric Patients Seen in an Academic Emergency Department

Psychiatric presentations are common in the emergency department (ED), and determining whether or not a psychiatric presentation is due to medical illness can be a difficult task for the emergency physician. The investigators define "serious medical illness" (SMI) as a pathological condition that would necessitate inpatient treatment on a medical or surgical ward. It is important for patient safety that SMI be triaged by the emergency physician to the appropriate inpatient service. The rate of missed SMI in patients with psychiatric presentations to the ED is unknown. The investigators will research missed SMI in patients referred to adult psychiatry from the ED, with the intent to improve patient safety.


Eligibility Criteria:
Inclusion Criteria:

* All patients greater than or equal to 18 years of age presenting to London Health Sciences Centre, Victoria Hospital emergency department between October 1, 2014 - July 31, 2015 who were referred to adult psychiatry by the emergency physician.

Exclusion Criteria:

* None