cyrilzakka/clinical-trials huggingface dataset:
A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fed Conditions

The purpose of this study is to evaluate and compare the relative bioavailability, and therefore the bioequivalence of two formulations of Citalopram after a single dose administration under fed conditions.

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

Official Title: Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fed State

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Eligibility Criteria:
Inclusion Criteria:

1. Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject.
2. Males aged from 18 to 50 years with a body mass index (BMI) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.
3. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the CRF.
4. Healthy according to the laboratory results and physical examination
5. Normal cardiovascular function according to ECG.
6. Subjects should be non- or ex-smokers.

Exclusion Criteria:

1. Significant history of hypersensitivity to citalopram or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
2. Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
3. Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
4. Use of MAO inhibitors within 14 days of day 1 of the study
5. Maintenance therapy with any drug, or significant history of drug dependency, alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious Psychological disease.
6. Any clinically significant illness in the previous 28 days before day 1 of this study.
7. Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
8. Participation in another clinical trial in the previous 28 days before day 1 of this study.
9. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
10. Positive urine screening of drugs of abuse.
11. Positive results to HIV, HBsAg or anti-HCV tests
12. History of fainting upon blood sampling
Fistiulation Rate Following Primary Cleft Repair≤

Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate.

Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length.

Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate. The goal was to predict the risk of velopharyngeal insufficiency and to decrease the fistiulation rate.

Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length from anterior reference point(incisive foramen) to posterior reference point(uvula) and calculation of change in palatal length.

Eligibility Criteria:
Inclusion Criteria:

1. patients suffering from complete wide cleft palate more than 10 mm
2. Patients age from 9 to 18 months
3. Patients free from any systemic disease that might affect normal healing or the predictable outcome
4. Patients who will agree to the consent and stick to the follow up period

Exclusion Criteria:

1. Patients with systemic disease
2. Patients who might not stick to the follow up period
3. Patients with Pierre Robin syndrome
4. Patients with previous palatal repair
Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes

By testing physiological responses to anxiety in people with nervous system developmental disorders, this study will identify specific physiological characteristics associated with response to anxiety treatments.

Anxiety is a common and significant problem for people suffering from disorders of nervous system development, including fragile X syndrome. There are few validated treatments for anxiety in people with these disorders, in part because the biological basis of anxiety in neurodevelopmental disorders has not been clearly described. This study will evaluate the physiological responses of people with fragile X syndrome, Down syndrome, and the fragile X premutation (a mild version of the genes that cause fragile X syndrome) to a variety of sensory, emotional, and social stimuli. By analyzing the data collected for this study, researchers aim to identify physiological characteristics linked to subgroups within the disorders, demonstrate links between physiological responses and behavioral or psychiatric symptoms, and measure physiological changes in people receiving treatment for their disorders.

Participation in this study will include one testing session, which will take between 3 and 3.5 hours. Participants who receive treatment for their anxiety may be asked to complete this testing a second time, after their treatment. During the testing session, sensors will be placed on participants' skin in several locations to measure heart rate, sweat response, and eye-blinks. Participants will then be asked to respond to multiple stimuli: sounds, lights, smells, pictures that elicit different types of emotions, an interaction with an unfamiliar person, and specialized toys. In addition, participants will undergo blood testing and have several samples of their saliva collected on the day of the testing session. Participants will also be asked to collect additional saliva samples at home three times a day on 4 different days. Child participants and their parents may also be asked to complete questionnaires and interviews about behavioral and emotional problems.

Eligibility Criteria:
Inclusion Criteria:

* Fragile X premutation or fragile X syndrome, measured by DNA testing; Down syndrome, confirmed by chromosomal analysis; or normally developing control
* Normal hearing
Sildenafil for Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.

Patients with chronic obstructive pulmonary disease (COPD) suffer from impaired exercise capacity and quality-of-life, largely related to shortness of breath. Many of the therapies currently available for COPD are aimed at improving these factors. Exercise capacity is limited in part by high blood pressure in the blood vessels in the lungs. Sildenafil, also known as Viagra, is an FDA-approved therapy for male erectile dysfunction. One of its effects is to relax (or open) the lung vessels, thereby lowering the blood pressure in the lungs. We hypothesize that sildenafil will result in an improvement in exercise capacity, quality-of-life, and shortness of breath.

Enrolled subjects will receive sildenafil or placebo for 4 weeks followed by exercise tests, breathing tests, and administration of quality-of-life questionnaires. Subjects will then receive placebo or sildenafil (whichever one they did not receive for the first 4 weeks) for another 4 weeks, followed by the same testing.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema
* FEV1/FVC ratio \< 70%
* FEV1 \< 80%
* Stable medication regimen

Exclusion Criteria:

* COPD exacerbation or hospitalization in the past 3 months
* Heart disease
* Contraindication to sildenafil
* Unrelated lung disease
* Inability to walk or pedal on a stationary bike
* Pregnancy or breast-feeding
* Pulmonary hypertension at rest
Naftopidil 75mg for Improving Clearance of Urinary Stones

The purpose of this study is to evaluate Efficacy and Safety of oral intake of Naftopidil 75mg once daily for the improving clearance of ureteral or renal stones.

Prospective, Single-center, Double blind, Randomized controlled trial

Treatment

- Oral Naftopidil 75 mg once daily are given to the patients who are scheduled for shockwave lithotripsy (ESWL) because of ureteral or renal stones.

Follow up Assessments including X-ray(KUB), visual analogue pain scale, are done 2, 4, and 6 weeks after the ESWL.

Eligibility Criteria:
Inclusion Criteria:

* Radio-opaque (identifiable in KUB) ureter or kidney calculi
* size criteria is from 5mm to 15mm

Exclusion Criteria:

* Symptomatic acute urinary tract infection during the run-in period
* severe hydronephrosis
* 2 or more urinary stones
* Radiolucent (non-visible in KUB) stone
* recent intervention for the urinary stone within 6 month
* Patients who have ureteral stent
* over 2.0 mg/dl of serum creatinine level
* severe hepatic dysfunction
* orthostatic hypotension
* current usage of alpha-adrenergic blocker or calcium channel blocker
* Pregnant or nursing women
* Age under 15 year
* severe or uncontrolled medical conditions
Observatory of Patients With Metastatic ProstAte Adenocarcinoma That is Resistant to Castration and Multi-LinE Strategies

Evaluation the overall survival of patients with metastatic prostate adenocarcinoma resistant to castration


Eligibility Criteria:
Inclusion Criteria:

* Patient monitored for castration-resistant metastatic prostate
* Patients starting a first or second line treatment as part of castration resistance
* Patient not objecting to the study after reading the information letter
* Patient aged over 18 years

Exclusion Criteria:

* Patient monitored for non-metastatic prostate cancer
* Patient monitored for castration-nonresistant prostate cancer
* Patient not able to understand the information letter
Risk Perception of Periodontal Disease

This study aimed at understanding the impact of educational pamphlet on Risk Perception of Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian outpatient dental clinic

This study aimed at understanding the impact of educational pamphlet on Risk Perception of Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian outpatient dental clinic. The outcome will help activate a success oriented periodontal disease prevention model

Eligibility Criteria:
Inclusion Criteria:

* consenting dental patients

Exclusion Criteria:

* non consenting dental patients
MACE CDS Software Master Enrollment Protocol

This protocol will collect real world EHR data to support the product development life cycle activities associated with developing the Major Adverse Cardiac Events (MACE) Clinical Decision Support (CDS) software.

The data will also be utilized in subsequent clinical validation to support an FDA application and/or applications to other regulatory agencies as needed.

The primary objective is to develop a machine learning tool which predicts risk of 30-day MACE (major adverse cardiac event) risk stratification among patients visiting ED with suspicion of ACS (Acute Coronary Syndrome).

The data will also be utilized in subsequent clinical validation. In addition to retrospective Electronic Health Record (EHR) data, Health Information Exchange (HIE) data and patient reported outcomes will be collected to capture 30-day MACE outcomes, as applicable.

Eligibility Criteria:
Inclusion Criteria:

* All genders, races, ethnicities

Exclusion Criteria:

* ≤ 18 years old presenting to the ED and for clinical validation only, adults \< 22 years old
The Effect of Enzyme Replacement Therapy in Mucopolysaccharidosis

Mucopolysaccharidosis (MPS) causes chronic, progressive systemic disorders due to enzyme deficiency. Musculoskeletal manifestations of MPS include bone and vertebral deformities, restricted joint function and ROM (range of motion), rib cage abnormalities, short stature and hip dysplasia as well as flexion contracture in the knee and interphalangeal joints and joint laxity. Currently, there is no treatment that cures the symptoms of MPS. However, there are some forms of treatment that can delay the progression of the disease. Enzyme replacement therapy is one such treatment and used for the management of some subtypes of MPS disease. Enzyme replacement therapy (ERT) is based on the concept of replacing the missing enzyme in the circulation to prevent the build-up of glycosaminoglycan (GAG) in the tissues. Very few studies in the literature have examined the impact of MPS in the lives of children affected by this disease. Studies investigating functional capacity, independence and quality of life in children receiving or not receiving enzyme replacement therapy have not provided a clear picture of the problems faced by these children. Secondly, psychological problems experienced by caregivers of children with MPS have not been studied specifically in former studies. Therefore, the aim of this study was to examine the impact of ERT on aerobic capacity, functional independence and quality of life in children with MPS and to determine the anxiety and depression levels of their caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Age must be range between 3 and 11 years
* Having diagnosis of MPS.

Exclusion Criteria:

* Patients refusing to participate in the study
* Patients without a definite diagnosis
* Patients and parents who are not cooperate with the study tests
The Effect of Methylprednisolone on the Reversal Time of Rocuronium by Sugammadex in the Pediatric Patient Group

The aim of this study is to thoroughly investigate the interaction between methylprednisolone and sugammadex in the pediatric patient population. Our hypothesis is that methylprednisolone will interact with sugammadex, leading to a prolonged reversal time of rocuronium by sugammadex and, at the same time, a reduction in the effect profile of methylprednisolone.

Approximately 80 volunteers will be included in the study. Patients will not have any additional responsibilities related to this study. There are no risks or benefits to patients associated with this research. The study will begin immediately before the patient's surgery and will end two hours after the operation. Volunteers participating in the study will be randomly assigned to one of two groups: one group will receive methylprednisolone during surgery, and the other group will not. Methylprednisolone is a medication used to prevent postoperative pain, swelling, nausea, and vomiting. If these complaints are detected in patients from either group after surgery, appropriate treatments will be administered to alleviate them.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are able to provide informed consent and reliably report symptoms to the research team,
* Classified as Physical Status 1 and 2 according to the American Society of Anesthesiologists (ASA).

Exclusion Criteria:

* Patients for whom parental or personal consent could not be obtained
* ASA Physical Status 3 or higher
* Known history of allergic reactions to the drugs specified in the protocol
* Patients requiring emergency surgery
* Expected difficult airway
* Preoperative corticosteroid use
* Presence of respiratory system diseases
* Presence of neuromuscular diseases
* Presence of enzymatic or endocrine disorders
* Presence of liver or kidney failure
* Presence of cardiovascular diseases
* Patients with abnormal cognitive or physical development
* History of treatment with drugs that have a high potential for interaction with sugammadex (e.g., toremifene, flucloxacillin, fusidic acid).
Cognitive Impairment and Cardiovascular Risk in Older

The objective of this project is to study cognitive yields in people of the town of Salamanca over 65, with particular emphasis on the acquisition of the initial symptoms of cognitive impairment in order to detect mild cognitive impairment and study the relationship between the clinical situation and cardiovascular risk factors. It will depart from a reference population of 420 people older than 65 years living in the municipality of Salamanca which took part in a survey prior to partner health needs of the elderly of 65 years in the municipality of Salamanca. This was a stratified sampling as stratum considering the area of health. The results of this study are expected to evidence the extent of the problem of cognitive decline in the population over 65 years. It is also expected to determine the relationship between the co-morbidity in this problem and specific factors of cardiovascular risk in this group of population.

A random sample population, the information obtained has a validity superior to other studies in which the sample has not followed very strict criteria of selection.

Protocol for measurement:

* variable demographic partner
* vascular risk factors
* co-morbidity
* functional level for the activities of daily life
* cognitive performance in attention, memory, language, praxias, gnosias (abbreviated neuropsychological battery)

Through a battery short neuropsychological specially adapted for the study of older people will carry out a study of the cognitive performance in people older than 65 years of age and will try to establish how much influence the controlled variables of cardiovascular risk.

Eligibility Criteria:
Inclusion Criteria:

* lives in the municipality of Salamanca
* over 65 years of age
Effectiveness and Tolerability of Eqwilate in Real-life Conditions

MOdalities of use, effectiveNEss and TOlerability of Eqwilate® a balanced combInatiON of VWF and FVIII in von WillEbrand patients in real-life conditions: the ONE-TO-ONE study


Eligibility Criteria:
Inclusion Criteria:

The study will involve patients (≥ 6 years of age) from the participating centres treated with Eqwilate® (either on-demand, as perioperative prophylaxis, or as prophylaxis) during the time inclusion period will be opened. Patients will be of any VWD type, previously treated or untreated.

Exclusion Criteria:

* N/A
Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

The purpose of this study is to compare opioid prescribing practices by either routine provider prescribing practices, or with the use of a calculator, i.e., the Opioid Calculator, published by the University of Michigan (www.opioidcalculator.org), with the intent of decreasing the number of pills.

The intent of this study is to validate the use of the Opioid Calculator, published at University of Michigan (www.opioidcalculator.org), which takes several variables into account, including age, risk factors (history of depression, alcohol abuse, others) to determine in a more scientific way the number of pills sufficient to prescribe. The sample size was determined by the number of routine post-op laparoscopic patients seen in our practice. The estimated necessary sample size is 6 participants per group (12 total). Patients will be randomized using 3 block groups of size 4 each. Patients will be approached at in clinic at the time they are consenting to laparoscopic hysterectomy and will be counseled about postoperative pain medication management. Randomization to either standard practice or calculator will be performed using computer-generated, permuted blocks of 4 participants. Sealed randomization envelopes will be opened for each subject on the day of surgery, after anesthesia is initiated. The study will be singled-blinded to the participant. Patients will be contacted on day 2 and day 7 to inquire where they are on the Visual Analog Scale (VAS) and how many pills they have taken. Two weeks after surgery patients will be seen in office for VAS and requested to bring unused pills for accounting purposes.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 80
* Undergoing planned laparoscopic hysterectomy as a day surgery procedure

Exclusion Criteria:

* Women aged 18 to 80
* Undergoing a non-laparoscopic unplanned surgical procedure
* Patients with a history of opioid use disorder or current opioid use disorder
A Study to Observe How Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16) Respond to Dupilumab Treatment

In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive/visible areas was not specifically evaluated. Further data about the effectiveness of dupilumab in adolescent participants with moderate to mild EASI score and severe itching and/or localized AD are therefore necessary to better understand the potential clinical benefits of dupilumab in these populations.

This is an Italian multicenter, 52-week observational (non-interventional) study which will collect data on the characteristics of adolescent (aged 12 to 17 years) participants who suffer from severe AD with EASI score less than (\<) 16, eligible for systemic dupilumab treatment according to Italian reimbursement criteria. It will study the real-world effectiveness and safety of dupilumab in this population, the effect of dupilumab on itching (pruritus), sleep, quality of life and related outcomes, localized AD in sensitive/visible areas, and on coexisting atopic conditions in adolescent participants who receive dupilumab for AD. It will also document dupilumab treatment satisfaction and dupilumab discontinuation in the study participants.

The individual observational period is planned to be up to 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged between 12 and 17 years at the baseline visit
* Patients with AD who have been prescribed dupilumab according to Agenzia Italiana del Farmaco (AIFA) reimbursement criteria and fulfilling the following criteria:

Patients with EASI\<16 and

1. Children's Dermatology Life Quality Index (CDLQI) ≥ 10 or
2. Peak Pruritus Numerical Rating Scale (PP-NRS) ≥ 7 or
3. localization in visible or sensitive areas (head/neck/hands or genitals)

   * Patients able to understand and complete study-related questionnaires
   * Provided signed informed consent or parental/legally acceptable representative consent and patient assent where applicable

Exclusion Criteria:

* Prior use of dupilumab within 6 months prior the study entry
* Patients currently participating in any interventional clinical trial which modifies patient care
* Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study (e.g., substance abuse)

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.