cyrilzakka/clinical-trials huggingface dataset:
Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients

This project will generate a prospective cohort of geriatric patients with polypharmacy which will be characterized for vulnerability profiles of adverse drug reactions.

Adverse drug reactions are common in older patients and can lead to severe outcomes such as falls, hospitalizations and death. They are dose-dependent and may for example be caused by inappropriate dosing due to a reduced kidney function. Also, the use of potentially inappropriate medications in older patients can result in a negative benefit-/ risk-ratio. Additionally, drug metabolism in older patients is altered due to a variety of reasons and pharmacogenetic variants of drug metabolizing enzymes can lead to a more than 10-fold interinidividual variation of drug clearance. The risk of the individual patient to experience an adverse drug reactions is determined by many reasons. Therefore, this study aims to identify patient risk profiles with regard to pharmacogenetics, drug interactions, impaired functional and cognitive status and individual drug metabolism.

Participants for this study will be consecutively recruited from patients admitted to the Interdisciplinary Polypharmacy Consultation Service of the Department of Geriatric's University Outpatient Clinic in cooperation with the Institute of Clinical Pharmacology. Regardless of their participation in this study, patients in the outpatient clinic will perform several tests and questionnaires following the comprehensive geriatric assessment. The purpose of the cohort study is to document and evaluate routine health data collected in the outpatient clinic for polypharmacy in geriatric patients (laboratory tests as well as a comprehensive medication history with therapy recommendations issued by a subsequent pharmaceutical council for both the patients and the primary care physicians).

Procedures conducted specifically for this study are a long-term capture and detailed history of all suspected adverse drug reactions, examining the fear of falling (FES-I questionnaire) and blood sampling for exploratory pharmacogenomic analyses (on cohort level, not patient diagnostics).

Aim of the long-term cohort of geriatric patients with polypharmacy is to identify risk profiles for adverse drug reactions that are specific for the population of older individuals.

Eligibility Criteria:
Inclusion Criteria:

* 70 years or older
* Current drug therapy with three or more drugs
* Being a patient in the interdisciplinary polypharmacy consultation service of the geriatric university outpatient clinic
* Sufficient mobility (minimum: Wheelchair mobility)
* Written informed consent of the patient or the legal representative

Exclusion Criteria:

* No sufficient communication possible
* Patients classified as terminally ill by the medical staff
* Patients, that are incapable to give their informed consent and who do not have a legal representative
Neurally Adjusted Ventilatory Assist and Synchrony in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NAVA used the electrical activity of the diaphragm (EAdi) to initiate and deliver in proportion of an inspiratory assistance. During inspiration, EAdi signal occurred earlier than airflow or pressure variations in the airway. The investigators hypothesized that NAVA improved patient-ventilator synchrony and reduced inspiratory workload as compared with pressure support ventilation delivered at two different cycling criteria (25 and 50 %).


Eligibility Criteria:
Inclusion Criteria:

* History of chronic obstructive pulmonary disease
* Admitted for acute respiratory failure requiring invasive mechanical ventilation
* Currently receiving pressure support ventilation

Exclusion Criteria:

* Age \< 18 years
* Respiratory rate \> 35 bpm
* Severe hypoxemia with SpO2 \< 88 % and FIO2 \> 50 %
* Heart rate \> 120 bpm
* Systolic arterial pressure \< 90 mmHg
* Contraindication to naso-gastric tube's insertion
Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit

People that have difficulty with balance have a higher risk of falling and reduced quality of life. Some individuals can learn to compensate using their vision, their sense of where their limbs are in space, and balance organs that are still intact. Rehabilitation exercises, which typically involve shaking and nodding of the head, are often prescribed for dizzy patients but are not effective for everyone. Our study aims to determine if specific exercises performed on footplate sensors with visual feedback is superior to traditional rehabilitation exercises done at home for improving balance and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Dizziness handicap inventory score at time of enrolment over 30
* Unilateral vestibular weakness confirmed one or more of:

  * Videonystagmography showing unilateral weakness to bithermal testing of greater than 25%
  * VEMP: IAD asymmetry of greater than 40% for both cVEMP and oVEMP
  * VEMP: absence of both ocular and cervical vemp responses in one ear in the context of normal and replicable other ear
  * Or unilateral vestibular weakness idiopathic, not yet diagnosed (NYD)
* Persistent imbalance following diagnosis of resolved benign paroxysmal positional vertigo (BPPV)
* Symptomatic
* Long-standing/persistent symptoms greater than six months

Exclusion Criteria:

* Orthopedic deficit (eg. lower body joint dysfunction or lower joint replacement)
* Neurological deficit or proprioception deficit
* Diabetes
* Poor vision or blindness
* Fluctuating vestibular symptoms, or condition known to fluctuate eg. Menière's disease, perilymphatic fistula (PLF) or superior canal dehiscence (SDCS)
* Active benign paroxysmal positional vertigo (BPPV)
* Undergoing treatment which may affect balance or ability to stand
* Cognitive impairment that prevents understanding and responding to instructions required to complete the study
* Inability to provide informed consent
Assessment of Health Literacy Among Adult Patients in the United Arab Emirates to Facilitate Clinical Trials Recruitment.

Health Literacy is the ability to understand health information and to use that information to make good decisions about health and medical care. Health informatin can overwhelm even people with advanced literacy skills. About one third of the adult population in the United States has limited health literacy.

Health literacy is the ability to understand health information and to use that information to make good decisions about health and medical care. Health information can overwhelm even people with advanced literacy skills.

About one third of the adult population in the United States has limited health literacy (Berkman ND, Davis TC, McCormack L. Health literacy:what is it? J Health Commun. 2010; 15 Suppl 2: 9-19). Initial assessment of regulatory compliance in research studies in the UAE indicated poor understanding of medical information by patients/subjects (AAMDHREC 12/55).

Health Literacy Survey (HLS) will be conducted on adults visiting the participating UAE hospitals/clinics. The survey will be conducted by a trained bilingual healthcare professional such as a team of medical residents.

The investigators study attempts to identify the population that are unable to understand health information or are impaired in their understanding of health information.

Eligibility Criteria:
Inclusion Criteria:

* 18 and above
* Willing to consent

Exclusion Criteria:

* Less than 18
* Severly ill
* Unable to consent
Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis

This is an randomized, double-blind, double-dummy trial, and the objective is to compare the efficacy and safety of Mycophenolic acid (MA) and Azathioprine (AZA), immunosuppressive drugs, in myasthenia gravis patients. This prospective study will enroll 40 myasthenia gravis (MG) patients who are poor controlled under prior steroid therapy. All subjects should be randomly assigned to MA group and AZA group that will receive routine pyridostigmine and prednisolone in combination with MA or AZA.

This will be a double-dummy study to keep the blinded quality.

* MA group: 1 tablet AZA placebo and 4 tables MA (180 mg/tab,720 mg/day) twice daily.
* AZA group: 1 tablet AZA (50mg/tab) and 4 tables MA placebo twice daily.

  * When patients achieve minimal manifestation (MM, i.e. complete remission), which lead to normal daily routine, the dose of pyridostigmine should reduce to 240 mg/day (4 tablets) or less. The dose of steroid should be stepped down by 10 mg qod (every other day) for every 2 weeks until the dose achieves 40 mg qod. After that, the dose should be stepped down by 5 mg qod for every month.
  * When disease progresses and is no longer maintaining minimal manifestation, the dose of steroid will be stepped up by 10 mg qod for every 2 weeks until achieve clinical stable remission. The taper rule of steroid could start again 1 month after stabilization.
  * Every patient will be treated for 1 year. If the patient could not achieve MM within 1 year, the blind of individual patient will be opened and the patients will be crossed over to another medical treatment. The efficacy and safety of second medication will be observed openly until the end of study.
  * When the muscle weakness worsens under established study schedule, plasmapheresis could be conducted to improve the condition rapidly.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age between 20-70 (including 20 and 70 years old).
* Osserman II and III Myasthenia Gravis.
* Positive serum anti-acetylcholine receptor antibodies.
* Poor control of disease with daily dose of prednisone ≥ 30 mg or 0.5 mg/kg at 3 months before enrollment.
* Without immunosuppressive therapy other than steroid.

Exclusion Criteria:

* Ocular MG or minimal clinical syndrome that would not require the therapy of steroids.
* Negative serum anti-acetylcholine receptor antibodies.
* Use immunosuppressants other than steroids in the preceding year.
* Previous use other investigational medication within 3 months or current participate other clinical study.
* Poor renal function: serum creatinine \> 3.0 mg/dl or estimated creatinine clearance \< 30 ml/min
* Females who are pregnancy or breast-feeding.
* Recent history, within 5 years, of malignancy
* Unwilling or unable to participate the necessary continuous visits and examinations.
Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)

The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects for registration purposes in China.


Eligibility Criteria:
Inclusion Criteria:

-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using

rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).

For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.

Exclusion Criteria:

-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the

(family of) study/sponsor staff.
A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686

A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers


Eligibility Criteria:
Inclusion criteria:

* Healthy as determined by a responsible physician
* Male, or only for the RDF cohort female of non-childbearing potential, between 18 and 65 years of age.
* Body weight greater than 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 (inclusive).
* QTcB or QTcF \< 450 msec
* Capable of giving written informed consent

Exclusion criteria:

* The subject has a positive pre-study drug/alcohol screen
* History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units
* Urinary cotinine levels indicative of active smoking or regular use of tobacco
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
* A positive test for HIV antibody
* The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives of the investigational product
* Exposure to more than four new chemical entities within 12 months
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices within 7 days
* Subject is receiving hormone replacement therapy
* History of sensitivity to any of the study medications
* History of sensitivity to heparin or heparin-induced thrombocytopenia
Comparison of the Post-operative Efficacy of Arch Bar With Single Plate and Two Plate Fixation in Mandibular Parasymphsis Fracture.

This clinical trial is designed to compare post-operative infection, symptoms of paresthesia, inferior border misalignment and operating time of one plate with arch bar against standard two miniplates in mandibular parasymphysis fracture in order to achieve the treatment which is beneficial for the patients. This study will contribute to literature for the betterment of patient.

The objective of this study is to compare the post-operative efficacy of arch bar with single plate and two plate fixation in mandibular parasymphsis fracture.


Eligibility Criteria:
Inclusion Criteria:

* All patients with mandibular unilateral parasymphysis fracture

Exclusion Criteria:

1. Mandibular defect fractures.
2. Grossly comminuted fractures.
3. Medically compromised patient.(e.g uncontrolled metabolic disease

   * immunocompromised patient, patient receiving radiation and chemotherapy).
4. Multiple fracture of Mandible.
PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer

The goal of this study is to determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant intra-prostatic lesions while meeting all current planning criteria.

This study aims to determine if multi-parametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging can help optimize the placement of the high dose inhomogeneity characterizing stereotactic body radiation therapy. All radiation plans have "hot spots" of radiation, and in current practice these regions are randomly located. This study will focus those hot spots on regions determined by mpMRI + PSMA-PET to have visible tumor.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
* Male subjects ≥ 18 years of age
* Histologically confirmed prostate adenocarcinoma
* Low or favorable intermediate risk, based on the NCCN criteria
* Subject has adequate performance status as defined by ECOG performance status of 0-2
* Subject is willing and able to comply with the protocol as determined by the Treating Investigator
* Subject speaks English (quality of life instrument is validated in English)

Exclusion Criteria:

* Contraindications for MRI
* Other prior or concomitant malignancies, with the exception of:
* non-melanoma skin cancer
* other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence
* Inflammatory bowel disease
* Previous transurethral resection of the prostate (TURP) or surgery of the prostate
A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome

This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into an observational cohort who will receive standard of care. Three doses of teduglutide are to be investigated for 12 weeks. All subjects will be screened prior to the start of treatment (SOT) to establish baseline characteristics including safety, eligibility and nutritional support parameters.


Eligibility Criteria:
Key Inclusion Criteria:

* Current history of SBS as a result of major intestinal resection, (eg, due to necrotizing enterocolitis, midgut volvulus, intestinal atresia, or gastroschisis) for at least 12 months prior to screening
* Short bowel syndrome that requires parenteral nutrition/intravenous (PN/IV) support
* Stable PN/IV support for at least 3 months prior to enrollment based upon the opinion of the investigator

Key Exclusion Criteria:

* Serial transverse enteroplasty or any other bowel lengthening procedure performed within the past 3 months
* Unstable absorption due to cystic fibrosis, untreated Hirschsprung's disease or known DNA abnormalities (ie, Familial Adenomatous Polyposis, Fanconi syndrome)
* Evidence of obstruction on upper gastrointestinal (GI) series done within 6 months prior to screening
* Major gastrointestinal surgical intervention within 3 months prior to screening (insertion of feeding tube or endoscopic procedure is allowed)
Myocardial Ischemia in Non-obstructive Coronary Artery Disease

The aim of the study is to assess presence of myocardial ischemia by contrast stress echocardiography in patients with symptomatic non-obstructive coronary artery disease (CAD) by CT-coronary angiography, and the clinical, vascular, biochemical and genetic markers of myocardial ischemia in such patients.

Non-obstructive coronary artery disease (CAD) is particularly common in women and associated with reduced quality of life and increased cardiovascular morbidity and mortality. The project will recruit patients with angina pectoris and non-obstructive CAD by CT- coronary angiography for further imaging with contrast stress echocardiography for diagnosis of myocardial ischemia. Better characterization of patients with symptomatic non-obstructive CAD due to myocardial ischemia will be done by vascular assessment by tonometry, biochemical and genetic markers as well as quality of life questionnaire. This interdisciplinary project is expected to add new knowledge to the impact of multimodality cardiac imaging in improving diagnosis in patients with symptomatic non-obstructive CAD.

Eligibility Criteria:
Inclusion Criteria:

* Age \>30 years
* Chest pain and or functional dyspnoea with a duration \> 6 months
* Non-obstructive coronary artery disease detected by CT coronary angiography

Exclusion Criteria:

* Significant coronary artery stenosis or normal coronary arteries by CT coronary angiography
* Unstable coronary artery disease
* Significant valvular heart disease
* Mechanical valve prosthesis
* Significant arrhythmia
* Severly reduced pulmonary function (GOLD 3-4)
* Known allergy to ultrasound contrast agents
* Pregnancy
* Inability to sign informed consent to participate
* Other severe disease
Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants

The purpose of this study is assess if the use of probiotic in very low weight could be other benefits a long time, as reduce atopic disease in this children.

In this study, the investigators analyse the influence of nutrition during the early neonatal period on the development and prevention of atopic dermatitis (AD) in children with a history of very low birth weight (VLBW). A retrospective cohort study was performed of VLBW preterm infants to assess the risk of their developing AD during childhood, according to nutrition with breastmilk and/or probiotic supplementation during the neonatal period. The analysis focused on nutritional and early childhood follow-up data for 437 newborns, of whom 184 received probiotics up to 36 weeks postmenstrual age.

The neonatal history of the patients was consulted in their electronic medical records (gestacional age; birth weight; anthropometry at birth, first week and week 36 post menstrual age; nutricional management; administration of probiotics), and the presence of atopic diseases at school age was corroborated by telephone interviews.

The descriptive date were summarized using medians and interquartile intervals for the continuous variables and distribution frequencies for the categorial variables. Univariate comparisons were made by the Mann-Whitney test for the continuous variables and by the chi-square test for the categorical variables. The association of comorbidities in VLBW newborns and supplementation with one type or another of probiotic was evaluated with a multinomial regression analysis, ajustando por las variables que mostraron diferencias en el análisis de homogeneidad de los grupos de estudio. The analysis was performed using IBM SPSS 20.0 for Windows software

Eligibility Criteria:
Inclusion Criteria:

* Newborn with a gestational age \< or = 32 weeks and/or birth weight \< or = 1500 grams.

Exclusion Criteria:

* Incomplete health history record o lack of data.
* Severe congenital anomalies.
Embryo Development Using Two Commercial Single-step Media

This prospective study with sibling oocytes will evaluate the efficiency of two commercial single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates. Embryos will be cultured continuously for up to 6 days under identical conditions.


Eligibility Criteria:
Inclusion Criteria:

* at least 10 oocytes retrieved

Exclusion Criteria:

* frozen oocytes
* testicular biopsy
* less than 10 oocytes retrieved
* older than 40 years