cyrilzakka/clinical-trials huggingface dataset:
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder

The investigators propose to evaluate the effectiveness of duloxetine in treating subjects with both Irritable Bowel Syndrome (IBS) and Generalized Anxiety Disorder (GAD). The investigators hypothesize that duloxetine as a single therapeutic agent will effectively target pain and other core symptoms of IBS as well as GAD in this patient population with both conditions.

Generalized Anxiety Disorder (GAD) is commonly associated with Irritable Bowel Syndrome(IBS). The etiology of IBS remains unknown and it is often refractory to treatment. Duloxetine has demonstrated efficacy in the treatment of GAD as well as other pain disorders including fibromyalgia and diabetic neuropathy.

We plan to study 30 subjects with diagnoses of IBS and GAD between the ages of 18 and 65 years. There will be a single-blind placebo-run-in for the first 2 weeks, followed by open-label duloxetine for 12 weeks flexibly titrated to 120 mg/day. Subjects will be informed that they will receive placebo for 2 weeks during the trial. All study visits will be at Allegheny General Hospital Department of Psychiatry. The study consists of a total of nine office visits.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Active IBS diagnosis by a gastroenterologist
* Generalized Anxiety Disorder diagnosed by DSM-IV TR criteria and the Mini International Neuropsychiatric Interview for the DSM-IV (Mini)
* No changes in any non study medication once starting the study

Exclusion Criteria:

* Current diagnoses of Major Depressive Disorder, Panic Disorder, Social Phobia, Post Traumatic Stress Disorder, Obsessive Compulsive Disorders, Eating Disorders, Somatoform Disorders, Drug or alcohol abuse or dependence, or severe personality disorder
* Lifetime history of any Bipolar Disorder or Psychotic Disorder
* Concurrent GI disorders falling outside of Rome III Functional GI disorders
* Pregnant women or sexually active female subjects not using medically acceptable method of contraception
* Current suicidal ideation
* Unstable medical condition
Maternal Psychopathology and Offspring Mental Health (PSI_PER)

Pregnant women consecutively referred to the Perinatal Psychiatric Outpatient Department, those in charge of the Psychiatric Outpatient Department and pregnant healthy controls from the general population will be recruited on a voluntary basis. Mothers will be tested with the EPDS, BAI, BDI, WHOQOL, SCID II and CTQ; their children will be tested with the CBCL between 18 months and 5 years.

in order to attest possible psychic outcomes in offspring of mothers affected by psychiatric disorders due to maternal psychopathology (with an in-depth evaluation about the role of maternal personality disorders), the investigators recruit all the women consecutively referred and admitted to the Perinatal Psychiatric Outpatient Department from January, 2011 to December, 2016, due to the manifestation of psychic suffering during pregnancy.

During their first appointment, patients are routinely administered the Structured Clinical Interview for DSM-IV Axis II Disorders (SCID II), Childhood Trauma Questionnaire (CTQ), World Health Organization Quality of Life Instruments (WHOQOL-BREF), Edinburgh Postnatal Depression Scale (EPDS), Beck Depression Interview (BDI) and Beck Anxiety Interview (BAI). The Mini-International Neuropsychiatric Interview (M.I.N.I.) is used to confirm clinical diagnosis.

As a control samples, the investigators recruited pregnant patients belonging to the Outpatients Psychiatric Department who did not have psychiatric issues linked to their pregnancy or in the relationship with their children and pregnant healthy controls among the general population, with no history of mental health issues. Controls were tested as the clinical sample.

All the patients will be asked to complete a caregiver report form, the Child Behavior Checklist (CBCL), once their children were at least 18 months old.

Eligibility Criteria:
Inclusion Criteria:

pregnancy; adequate comprehension; acceptance on a voluntary basis.

Exclusion Criteria:

incapacity; acute psychosis.
Evaluation of a New Mechanical Ventilation Weaning Strategy for Patients With Altered Level of Consciousness

The purpose of this study is to determine if a weaning strategy from artificial ventilation governs by respiratory behaviour status assessed by our method is safe enough.

Current guidelines for mechanical ventilation weaning do not apply for patients with altered level of consciousness. One major limitation is a failure of clinical assessment of the respiratory behaviour status of these patients that are not able to interact appropriately with the examiner. We propose a non-invasive method for the respiratory behaviour assessment of a patient under artificial ventilation that do not requires his participation. Our hypothesis is that, in case of normal respiratory behaviour status, it is possible to wean under security a patient despite his abnormal level of consciousness.We previously demonstrate that patients successfully wean by the clinical team also disclose a normal respiratory behaviour status while patients with weaning failure had abnormal respiratory behaviour. In the present study, we wonder to evaluate that a weaning strategy governs by respiratory behaviour status assessed by our method is safe. For this purpose, in this study, tracheal tube withdrawal is triggered by a recognition of a normal respiratory behaviour status assessed daily in patients under mechanical ventilation with an altered level of consciousness and a good tolerance to T tube challenge.

Eligibility Criteria:
Inclusion Criteria:

* Altered level of consciousness (-1 \< RASS \> +1)
* Mechanical ventilation ( \> 72 hours)
* Withdrawal of sedative drugs (\> 48 hours)
* T tube challenge tolerance
* Signed approval for the study by close relative or legal representative

Exclusion Criteria:

* Respiratory disease prior to the actual artificial ventilation requirement.
* Impairment of upper airway function prior to the actual artificial ventilation requirement.
* Pregnancy
* Minor
Study of Oral Conditions in Indigenous Populations in the State of Roraima - Brazil

The objective of this cross - sectional observational study will be to evaluate the oral conditions of indigenous people in the state of Roraima, comparing habits and hygiene conditions in each ethnicity evaluated. This project was submitted to the Coordination of the Yanomami Indigenous Special Sanitary District, the CONDISI presidency and the CASAI leadership. Around 200 indigenous people from the aforementioned ethnic groups, of both sexes, aged between 18 and 75 years, will be evaluated

The indigenous population, as well as the non-indigenous population, has been plagued by oral diseases throughout its history. Within the population in general, periodontal diseases exhibit great expressiveness, they appear as the most common chronic diseases, but in the indigenous population there is a certain epidemiological invisibility. In this population there is a shortage in the studies, some of these show that the higher prevalences of insertion level and depth of probing occur in individuals with more advanced age and that they are afflicted with periodontal diseases. The objective of this cross - sectional observational study will be to evaluate the oral conditions of indigenous people in the state of Roraima, comparing habits and hygiene conditions in each ethnicity evaluated. This project was submitted to the Coordination of the Yanomami Indigenous Special Sanitary District, the CONDISI presidency and the CASAI leadership. Around 200 indigenous people from the aforementioned ethnic groups, of both sexes, aged between 18 and 75 years, will be evaluated, with voluntary participation and by means of the signature of the free and informed consent form of the same or its person in charge. Due to the difficulties encountered in the indigenous communities in relation to the distance from health care, where there are no care centers near their residence and thus not obtaining the information necessary for basic health care, with the aggravation of contact with the culture. Indigenous people with often deleterious eating habits, we expect to find a population with many oral health problems, such as periodontal disease, dental caries and tooth loss. The insufficiency of studies with appropriate methodology gives the indigenous peoples of Latin America an epidemiological invisibility that impairs the production of knowledge about oral health conditions and the elaboration of strategies to prevent oral diseases and promote health in these populations.

Eligibility Criteria:
Inclusion Criteria:

* individuals of the Macuxi, Yanomami and Wapixana ethnic groups aged between 18 and 75 years

Exclusion Criteria:

* Individuals who have included periodontal treatment in the last 6 months;
* hospitalized with antibiotic therapy in the last 6 months;
* who need medication for clinical evaluation and
* total edentulous individuals.
Olanzapine in the Treatment of Anorexia Nervosa

This study compared 10 weeks of treatment with olanzapine versus placebo in adolescent females with anorexia nervosa-restricting type who were undergoing acute treatment on an inpatient unit or a day hospital program that specializes in the treatment of eating disorders.


Eligibility Criteria:
Inclusion Criteria:

* Females, ages 12-23

Exclusion Criteria:

* Binge-purge type
A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males

To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 12 weeks after test article administration.
* Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight \>45 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead ECG.
Comparison of Two Type of Laryngeal Mask : I-Gel & LMA ProSeal

The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal vent. The aim of this study is to compare this device to the LMA ProSeal. The study is approved by the institutional ethic committee. 222 patients will be enrolled in each group. The objectives of the study will be to compare insertion success rate, leak pressure, ventilatory parameters and adverse event rate.

Supraglottic airway devices are now widely used for surgery requiring general anesthesia. Airway devices are safe and their morbidity rate is very low. The i-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a new single-use non-inflatable supraglottic airway device that has not been evaluated in a comparative study.

The aim of this study is to compare i-gel with the LMA ProSeal in a randomized study. Anesthesia protocol is standardized. The supraglottic devices are compared in term of insertion success rate, leak pressure, ventilatory parameters and adverse events. The aim is to demonstrate an enhancement in term of insertion success rate and a diminution of the adverse events. Statistical analysis will used percentage, confidence interval and chi 2 or Fischer's exact test for qualitative data. Quantitative data will be analyzed in mean, standard deviation. Comparison will be made with a student t test or a wilcoxon test. P \< 0,05 is statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Weight \> 30 kg
* Surgery allowing the use of laryngeal mask as airway management
* Written informed consent

Exclusion Criteria:

* Difficult intubation criteria (defined by French Anesthesia-Reanimation Society)
* Pulmonary disease
* Gastroesophageal reflux antecedent
* Coeliosurgery
* Inhalation risk
* Hiatus hernia
A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis

1. Quantify how much PD-0332334 is removed from the blood with hemodialysis
2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments.
3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.

Assess the elimination of PD-0332334 from the blood with hemodialysis

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving regular hemodialysis
* Male or female patients 18 to 65 years

Exclusion Criteria:

* Severe heart failure
* Renal transplant or renal allograft
* Illicit drug use (with the exception of prescribed sedatives)
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia

The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.

The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

The two doses of AVE5530 tested in this study are 25 mg and 50 mg taken in the evening, with dinner dosing. The study will include a pre-randomization phase up to 6 weeks, a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults with severe primary hypercholesterolemia and cholesterol levels not controlled on ongoing stable statin treatment at maximum doses.

Exclusion Criteria:

* LDL-C levels \> 250 mg/dL (6.48 mmol/L) or \< 100 mg/dL (2.59 mmol/L)
* Triglycerides \>350 mg/dL (3.95 mmol/L)
* Conditions / situations such as:

  * Presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels
  * Active liver disease
  * Recent history of congestive heart failure, of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or Unstable or severe peripheral artery disease
  * Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody or Known to be Human Immunodeficient Virus (HIV) positive
* Pregnant or breast-feeding women,
* Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Effectiveness of Interventions Targeting Self-Perception of Aging in Older Adults with Subjective Cognitive Decline

Subjective cognitive decline (SCD) represents the initial clinical manifestation in the disease spectrum of Alzheimer's Disease (AD). It represents an essential stage for early prevention and treatment of cognitive impairment, making the SCD population an optimal target for prior intervention. This study aims to assess the feasibility and efficacy of an 8-week intervention targeting self-perception of aging in community-dwelling older adults with SCD.

Dementia, especially Alzheimer's Disease (AD), is a major healthcare issue in aging populations. It not only threatens the physical and mental health of older adults but also imposes significant economic and caregiving burdens on families and society. As a preclinical stage of AD, subjective cognitive decline (SCD) is regarded as the optimal phase for early intervention in cognitive impairment. When confronted with the threats of physical, psychological, and social aging, older adults with SCD often hold negative perceptions and emotional responses toward their own aging. They tend to attribute physical decline and memory loss to normal aging processes, overlooking controllable factors, which poses potential risks to their future cognitive outcomes, such as accelerated cognitive decline, elevated dementia risk, and increased accumulation of AD biomarkers. This study is based on the Transactional Model of Stress and Coping (TMSC) and identifies the mechanisms through which self-perception of aging influences cognitive function in older adults with SCD. A comprehensive 8-week intervention program was developed to target these mechanisms. The 8-week intervention program aims to provide practical evidence for delaying cognitive decline in older adults with SCD by enhancing their positive perceptions of aging.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥60 years;
* residing in the community for 6 months at least;
* experiencing a consistent decline in self-reported cognitive abilities;
* having standard cognitive test performance in the normal range;
* willing to participate in this study.

Exclusion Criteria:

* having diagnosis of any neurological diseases including Parkinson's disease, brain tumor, cerebral infarction, encephalitis, epilepsy, etc.;
* having diagnosis of mental illness such as depression, anxiety, bipolar disorder, and schizophrenia;
* with history of substance abuse or addiction;
* with severe visual or hearing impairment.
Assessment of Dynamic Balance in Idiopathic Scoliosis Compared to Normal Subjects

The purpose of this study is to assess dynamic balance in females with adolescent idiopathic scoliosis compared to normal subjects.

Adolescent idiopathic scoliosis (AIS) is one of the most common forms of scoliosis. It is a three-dimensional deformity of the spine and trunk with a lateral deviation of ≥ 10°, which can occur during the growing years from 10 years to puberty, with an apparent gender dominance rising with age and severity with a female to male ratio of 1.5:1 to 10:1.

Dynamic balance is the ability to maintain and regain the center of gravity within the base of support in response to outside perturbations or voluntary movements. It has been reported that AIS is associated with trunk imbalance and could negatively influence the sensorimotor control of posture and decrease postural balance capabilities, which increases susceptibility to injuries and impacts the individual's ability to engage in daily living activities.

Previous research reported that postural stability control in adolescents with idiopathic scoliosis is as good as in healthy individuals, and others found that AIS patients have poorer static balance control than age-matched patients without AIS. So the current study will be conducted to investigate the dynamic balance in females with adolescent idiopathic scoliosis compared to normal subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Females with age between 10-20 years.
2. Idiopathic scoliosis will be diagnosed based on clinical examination and radiological measures.
3. Cobb's angle will be between 20° and 40°.
4. Their BMI from 18 to 24.9 kg/m2.
5. They must be willing to participate in the study.

Exclusion Criteria:

1. History of previous back surgery.
2. Neurological deficit.
3. Current lower extremity symptoms.
4. Symptoms of vertigo or dizziness.
5. No other disorders in the vertebral column (disc prolapse, spondylosis, fracture).
Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)

The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1) Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.

The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). Participants will receive in Phase A: omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo and in Phase B: omarigliptin 25 mg once weekly.

Eligibility Criteria:
Inclusion Criteria:

* Has type 2 diabetes mellitus

Exclusion Criteria:

* History of type 1 diabetes mellitus or a history of ketoacidosis
* History of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime
The Evaluation of Airway Dimension by Using Ultrasonography

The aim of this study is to measure the dimension of airway in healthy Asian population. We recruit normal volunteer subjects aged more than 20 years old. Subglottic transverse diameter is measured and recorded by ultrasonography.

The aim of this study is to measure the dimension of airway in healthy Asian population. We recruit normal volunteer subjects aged more than 20 years old. Subglottic transverse diameter is measured and recorded by ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers (aged more than 20 years) without pre-existing airway or respiratory diseases, neck tumors and a history of neck operation.

Exclusion Criteria:

* pre-existing airway or respiratory diseases, neck tumors and a history of neck operation.
Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia

Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Endoscopic pneumatic dilation has been considered as the first line treatment option for persistent PFD. However, studies have not confirmed its effectiveness in this indication. Peroral endoscopic myotomy (POEM) became a standard treatment for the management of esophageal achalasia and moreover has also been assessed in a small cohort of patients with refractory PFD and some patients achieved significant treatment success. We plan to perform a prospective international cohort multicenter study assessing the efficacy of POEM in patients with persistent and severe PFD.


Eligibility Criteria:
Inclusion Criteria:

1. Patients after laparoscopic fundoplication procedure by Nissen (total, 360°), Dor (anterior, 180°) or Toupet (posterior, 270°) for gastroesophageal reflux disease no later than 10 years before enrolment.
2. Refractory (\> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline.
3. X-ray (contrasted radiographic examination of the esophagus) characterized by both: a.) tapered narrowing of the distal esophagus and GEJ; b.) partial/total stagnation of the contrast solution above the GEJ
4. Endoluminal planimetry: EGJ-DI \< 3 mm2/mmHg (with 40ml)
5. Age above 18 years
6. Signed informed consent form

Exclusion Criteria:

1. No previous attempt with at least one prokinetic drug
2. Previous esophageal myotomy (open, laparoscopic or endoscopic)
3. Primary esophageal motility disorder (achalasia etc.)
4. Active erosive esophagitis
5. Active peptic ulcer disease
6. Esophageal stricture (peptic, malignant, other)
7. Partial or complete supradiaphragmatic migration of the wrap and/or stomach (Hinder Type III - IV), Large hiatal hernia more than 5 cm
8. Known eosinophilic esophagitis
9. Severe coagulopathy
10. Esophageal or gastric varices
11. Advanced liver cirrhosis (Child B or Child C)
12. Pregnancy or puerperium
13. Malignant or pre-malignant esophageal diseases (dysplasia): patients with a history of such disease after its cure are eligible for enrolment
14. Any other condition, which in the opinion of the investigator would interfere with study requirements
15. Known gastroparesis