cyrilzakka/clinical-trials huggingface dataset:
A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract

The particle size of the active ingredient may impact dissolution rate in the gastro intestinal tract and hence the amount of drug available for absorption. Similarly, differences in the percentage of the excipients used in the formulated capsules may affect dissolution rate. The purpose of this study is to estimate the effect that particle size and percentage of excipients could have in drug absorption, which will improve the manufacturing process of the formulated capsules.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or female subjects with no physical possibility of getting pregnant.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) preceding the first dose of study medication.
* Pregnant females; breastfeeding females; females with physical possibility of getting pregnant .
A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial

A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial. Approximately 300 children (males and females) with GHD will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia, Russia and Australia.


Eligibility Criteria:
Inclusion Criteria:

1. Children who have completed a prior phase 3 TransCon hGH trial
2. Children who have not permanently discontinued study drug in the prior trial
3. Written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by the IRB/HREC/IEC

Exclusion Criteria:

1. Poorly-controlled diabetes mellitus (HbA1c ≥ 8.0%) or diabetic complications
2. Evidence of closed epiphyses, defined as bone age \> 14.0 years for females or \> 16.0 years for males
3. Major medical conditions unless approved by Medical Expert
4. Known hypersensitivity to the components of the trial medication
5. Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver)
6. Pregnancy
7. Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule
A Pharmacokinetic Study of Cefepime After Administration Into Dialysate in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis

Cefepime is a broad-spectrum antibiotic used in treating CAPD peritonitis. However, medical knowledge has been lacking with regard to its pharmacokinetic profile after it has been administered intraperitoneally. The current study aims at determining the drug level at different time after the drug has been added into the peritoneal fluid in patients with CAPD peritonitis. The results of this study will finally leads to rational prescription of this drug at correct dosages.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years \& has been put on CAPD for \>= 4 weeks before entering into the study

Exclusion Criteria:

* Known hypersensitivity to cefepime or other cephalosporin; CAPD peritonitis \<= 28 days before being enrolled into the study
* Antibiotic treatment within 1 week prior to entry into the study
* Severe exit site or tunnel infection on the day of presentation
* Any conditions that prompt early removal of Tenckhoff catheter irrespective of clinical response to antibiotic treatment
* Abdominal malignancy; Any surgical causes of peritonitis
* Suspected or known fungal or tuberculous peritonitis
* History of dementia or known mental incompetency
Tibialis Posterior Fatigue and Plantar Pressure

The purpose of this study is to find out the changes in the measurable parameters of the dynamic and static position of the foot, caused by the tibialis posterior muscle which is activated by the fatigue protocol. The study includes 30 healthy patients whose socio-demographic and descriptive characteristics are held. The changes in the dynamic and static position of foot were measured by pedobarography whereas the level of fatigue was measured by Borg Fatigue Scale.

The purpose of this study is to find out the changes in the measurable parameters of the dynamic and static position of the foot, caused by the tibialis posterior muscle which is activated by the fatigue protocol. The study includes 30 healthy patients whose socio-demographic and descriptive characteristics are held. The changes in the dynamic and static position of foot were measured by pedobarography whereas the level of fatigue was measured by Borg Fatigue Scale. The variables were investigated using Shapiro-Wilk's test to determine the normality. The student's t-test for paired samples were used to analyse, means (X), standard deviations (SD), 95% confidence intervals (95%CI), mean difference and Cohen's d-effect size were calculated. The significance level was set at .05. The effect size was considered 'small' if d= .20; 'medium' if .d=.5; 'large' if d= .8.

Eligibility Criteria:
Inclusion Criteria:

* All participants were currently free from congenital or traumatic deformity to either lower extremity,
* A history of foot pain,
* Prior history of surgery to the foot and lower extremity
* A traumatic injury to the ankle or foot 12 months prior to the start of data collection.

Exclusion Criteria:

* Participants were excluded from this study if they had any orthopedic or neurological disorder, need to use an assistive device or orthoses.
Measuring G Protein-coupled Receptor Kinase-2 (GRK2) in the Blood to Diagnose and Treat Patients With Heart Failure

The primary objective of this study is to determine the utility of GRK2 to differentiate between normal patients and patient groups that differ by the presence/absence of HF symptoms, systolic or diastolic left ventricular dysfunction, and risk factors; and to evaluate if a new assay provides similar values as traditional methods for measuring GRK2 levels.

This study seeks to define a beta-adrenergic receptor kinase molecule in the blood and its role as an improved biomarker to be used for the diagnosis, assessment and management of patients with heart failure. We will test blood cell samples for the levels of this molecule, called "G protein-coupled receptor kinase-2" (GRK2) using both the existing method of GRK2 quantification in the Koch laboratory and using a prototype enzyme immunoassay (EIA) method being developed by Johnson \& Johnson, Ortho-Clinical Diagnostics (OCD).

Eligibility Criteria:
Inclusion Criteria:

* Normal Controls: Individuals without HF, hypertension, diabetes, hyperlipidemia, coronary artery disease or obesity;
* Group I: Symptomatic Subjects with Reduced LV Function, HF symptoms, EF ≤ 40%.
* Group II: Asymptomatic Patients with LV dysfunction, no HF symptoms (NYHA class I and ATS score 0 or 1, EF ≤ 40%.
* Group III: Symptomatic Subjects with Preserved LV Function, HF symptoms, EF ≥ 50%, and diastolic dysfunction.
* Group IV: Asymptomatic High Risk Subjects - Individuals with normal heart function, no HF symptoms (NYHA class I and ATS score 0 or 1), Preserved LV function (EF ≥ 50%), no diastolic dysfunction. Also possess one or more cardiovascular high risk factors: diagnosis of diabetes; hyperlipidemia; coronary artery disease; renal insufficiency; hypertension; age \>70 years

Exclusion Criteria

* Pregnancy
* Not providing consent
* Inability to provide consent
* Participation in a clinical study involving an experimental therapy.
Immediate Effect of Non-invasive Auricular Acupoint Stimulation for the Performance and the Meridian Activities of Archery Athletes

In our hypothesis, auricular acupoint stimulation might improve the attention and heart rate variability in archery athletes. The meridian activities regarding the attention and action in Chinese medicine systems might be influenced.

During the execution of archery, attention is the key of performance in elite players, especially in the initial period.

Auricular acupoint stimulation is one of the therapeutic methods of traditional Chinese medicine. It is widely applied in various diseases. Researches had concluded the use of auricular acupoint stimulation on amplifying the anesthesia effect, weight reduction and the cessation of substance abuse. This study aimed to investigate the immediate effect of non-invasive auricular acupoint stimulation on the performance and the meridian activities of archery athletes.

The investigators will collect the meridian activities and balance index with Ryodoraku device, the continuous heart rate record and the scores of the two sections as the performance. The participants will rate their attention and fatigue levels through filling the self-reported questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Health volunteers, age between 13-26 years old
* Received training of archery for more than one year

Exclusion Criteria:

* History of psychiatric disorders
* History of cardiovascular diseases
* Previous operation history of dominant hand
* Unwilling or unable to sign the informed consent of this study
To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Fed Conditions

To demonstrate the relative bioavailability of Cefzil 250 mg/5 ml oral suspension fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
High Tidal Volume Induces Inflammation In Normal Lungs

Objective: To compare the effects of a protective versus a conventional ventilatory strategy, on systemic and in lung production of tumor necrosis factor-alpha (TNF-alpha) and interleukin-8 (IL-8) in patients without lung disease.

Hypothesis: High tidal volumes induce inflammation in patients without lung disease Design: Prospective control-randomized study. Patients and Setting: Twenty patients without lung disease and submitted to mechanical ventilation admitted to one trauma and one general adult intensive care unit of two different university hospitals.

Interventions: Patients were randomized to receive mechanical ventilation either with tidal volume (VT) of 10-12 ml/kg predicted body weight (high VT group) or with VT of 5-7 ml/kg predicted body weight (low VT group) with an O2 inspiratory fraction (FIO2) enough to keep arterial oxygen saturation \> 90% with positive end-expiratory pressure (PEEP) of 5 cmH2O during 12 hours after admission to the study.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 16 years;
2. anticipated survival \> 24 hours;
3. need for mechanical ventilation for at least 12 hours and
4. hemodynamic stability (MAP\>65 mmHg, HR\<100 beats/min, diuresis \> 1 ml/kg/h, no catecholamine requirement or fluid challenge).

Exclusion Criteria:

1. history of any lung disease, use of immunosuppressive medication, recent infections, previous thromboembolic disease, recent ventilatory support, and participation in another clinical trial. Absence of lung disease was defined by the following clinical criteria: (a) no evidence of respiratory infection (white blood cell count \<10x103/µl, temperature \> 380C, purulent sputum), (b) normal chest roentgenogram, (c) PaO2/FIO2 ratio \> 300, (d) and a normal clinical respiratory history.
Identification of Early Cardiovascular Disease Risk Factors in Normal-weight Obesity

The purpose of this study is to identify early cardiovascular disease risk factors in those with "normal-weight obesity" (i.e., normal body, but high body fat percentage) that better track with their long-term cardiovascular disease risk.


Eligibility Criteria:
Inclusion Criteria:

Control group: normal BMI, body fat percentage \< 25% for men and 35% for women

Normal-weight obesity group: normal BMI, body fat percentage \> 25% for men and 35% for women

Metabolic syndrome group: BMI \> 30 and 2 or more of the following: blood pressure \>130/85 mmHg, fasting glucose \>100 mg/dL, fasting triglycerides \>150 mg/dL, HDL cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women).

Exclusion Criteria:

* Presence of pacemaker
* Pregnant
* use of tobacco products
* using lipid lowering drugs
Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means

Heightened levels of aggression are fuelling violent incidents at all levels, especially in post-war regions. Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) aims to address trauma symptoms along with reactive and instrumental/appetitive aggression to encounter the downward cycle of perpetration and enforce a sustainable (re-)integration into civil life. In the present study, the investigators provide an adapted version of FORNET to former combatants in the North Kivu, Eastern DR Congo. Structured baseline, 3 and 6 month follow up interviews will be administered to assess the main outcome measures recent violent acts and appetitive aggression.

Participants will be recruited through local NGOs and eligible clients randomized to the treatment or waitlist control group, respectively. The treatment will be provided by supervised local counsellors after a 4-week training. At baseline, 3-month and 6-month follow up, sociodemographic data, trauma exposure, perpetrated violent acts, PTSD, recent aggression, functionality and drug dependency will be assessed. The interviews will be conducted by blind Congolese psychological interviewers after an intensive 3-weeks training and continuous supervision.

Eligibility Criteria:
Eligibility criteria

* Former participant of an armed group in DR Congo
* Involvement in violent attacks

Inclusion Criteria:

* PTSD diagnosis or AAS sum score of 22 or higher

Exclusion Criteria:

* Acute intoxification (alcohol or other drugs)
* Acute psychotic symptoms
* Sign of cerebro-organic diseases
Vascular Structure, Vascular Function and Vascular Aging in Adults Diagnosed With Persistent COVID

The ICOPER study aims to analyze the structure, vascular function, vascular aging and determining factors in 300 adults diagnosed with Persistent Covid in the field of Primary Health Care.

Objective: To analyze the structure, the vascular function, the vascular aging and the determining factors in adults with a diagnosis of Persistent Covid and the differences by gender.

Design: Cross-sectional descriptive observational study. Setting: The study will be carried out at the Salamanca Primary Care Research Unit (APISAL). Study Subjects: The study includes the basis of the Persistent Covid Monographic consultation in the Internal Medicine Service of the University Hospital of Salamanca and the subjects with the diagnosis of Persistent Covid in the MEDORA Primary Care clinical history. Thus, 300 subjects have been obtained who are diagnosed with Persistent Covid, who meet the diagnostic criteria established by the Spanish Society of General and Family Physicians and sign the informed consent.

Measurements: The variables reflected in the Integrated Assistance process for the Care of People Affected by SARS CoV-2 of the Junta de Castilla y León will be collected, to evaluate the functional status of the patient and persistent symptoms, their impact on activities of daily life and quality of life of patients with Persistent Covid and the perception of their health. Lifestyles (diet, physical activity, tobacco and alcohol), psychological factors and cognitive impairment will be collected using validated questionnaires, and physical activity will be objectively measured with a 7-day pedometer. Vascular structure and function will be analyzed by measuring the thickness of the carotid intima media (Sonosite Micromax); pulse wave analysis and carotid-femoral pulse wave velocity (VOPcf) (Sphygmocor System). Cardio Ankle Vascular Index (CAVI), ankle-brachial pulse wave velocity (VOPbt) and ankle-brachial index (Vasera VS-2000®). Vascular aging will be calculated using the 10 and 90 percentiles of the VOPcf and the VOPbt. Demographic, analytical variables and to assess retinal, cardiac, renal, cerebral vascular lesion and cardiovascular risk will be collected.

Eligibility Criteria:
Inclusion Criteria:

* History of probable or confirmed SARS-CoV-2 infection, usually 3 months after onset, with symptoms that last at least 2 months and cannot be explained by an alternative diagnosis.
* Common symptoms should include fatigue, shortness of breath, and cognitive dysfunction, and an impact on daily functioning.

Exclusion Criteria:

* Subjects in a terminal situation.
* Inability to travel to health centers.
* Presenting a history of cardiovascular disease (ischemic heart disease or cerebrovascular disease).
* Glomerular filtration rate of less than 30%.
Would Artificial Intelligence Reduce Delays to Nurse Response Times

Patients are admitted to wards at all times of day and night and in various states of ill health. As this research is non interventional and does not impact on patient safety, the guidance from the ethics committee was reviewed and agreed that it would be appropriate to enrol every admission into the 2 bed bays and gain consent within 24 hours of admission.All data collected within the trial using the smart tablets will be associated to a study number, no patient details will be stored on the smart tablet and therefore the cloud data store.It has been discussed with the trust information governance and this complies with their regulations.

Any patient identifiable data will be kept by the research team. All data will be archived and stored as per the Sponsors policy. The novel nurse call system has been designed to be user friendly to all patients regardless of age, learning ability and first language used. By using colours, images and words in the hope that this will be accessible to all. The nursing staff on the ward advised on the main reasons for the nurse call system activation and therefore the icons used in the novel system were adapted from this. This trial was discussed in the patient and public involvement group. As this is a pilot trial, any adaptions that need to be made will be made before the large scale trial.


Eligibility Criteria:
Inclusion Criteria:

All adults 18 years who are admitted to the cardiology admissions ward will be eligible to take part.

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Exclusion Criteria: Any patient who does not wish to participate will have their anonymised data removed from the trial.

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Speech Motor Learning and Retention (Aim 3)

The overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well. The strategy for the proposed research is to identify individual brain areas that contribute causally to retention by disrupting their activity with transcranial magnetic stimulation (TMS). Investigators will also use functional magnetic resonance imaging (fMRI) which will enable identification of circuit-level activity which predicts either learning or retention of new movements, and hence test the specific contributions of candidate sensory and motor zones. In other studies, investigators will record sensory and motor evoked potentials over the course of learning to determine the temporal order in which individual sensory and cortical motor regions contribute. The goal here is to identify brain areas in which learning-related plasticity occurs first and which among these areas predict subsequent learning.

The focus of this registration is Aim 3. Excitability will be assessed. In Aim 3, resting-state fMRI will be interleaved with speech motor adaptation, again using Harvard Sentences. Additional scans and retention tests will be conducted 24 hours later, to assess motor memory consolidation.

The Speech Motor Learning and Retention Master Protocol is NCT06467292.

Eligibility Criteria:
Inclusion Criteria:

* Fluent English speakers
* Right-handed
* Normal hearing
* No speech disorder or reading disability

Exclusion Criteria:

* Cardiac pacemaker
* Aneurysm clip
* Heart or Vascular clip
* Prosthetic valve
* Metal implants
* Metal in brain, skull, or spinal cord
* Implanted neurostimulator
* Medication infusion device
* Cochlear implant or tinnitus (ringing in ears)
* Personal and/or family history of epilepsy or other neurological disorders or history of head concussion
* Psychoactive medications
* Pregnancy
Restorative Yoga for Stress Management

The study examined Restorative Yoga as a method of stress reduction for the HFA Addiction Medicine Clinic staff volunteers.

The purpose of this study is to determine if there is a perceived benefit from adding a restorative yoga class as a method of stress reduction for the HFA Addiction Medicine Clinic staff. Working in a busy clinic can be very stressful. While it is not always possible to completely eliminate stress from our lives, it is known that stress reduction techniques help to diminish the negative consequences of stress. This study was designed to answer the following question "How much change in perceived stress is obtained through weekly Restorative Yoga sessions?" Study population were members of the HFA Addiction Medicine Clinic. All staff completed the Spielberger Job Stress Survey and the State-Trait Anxiety Inventory at baseline and at six months following intervention onset. Volunteers from the Addiction Medicine Clinic attended weekly restorative yoga sessions 45 minutes in length held over the noon hour. Serial State-Trait Anxiety Inventory and weekly questionnaire regarding the perceived effects of the restorative yoga on aspects fo patient care were completed by study volunteers.

Eligibility Criteria:
Inclusion Criteria:

* member of HFA Addiction Medicine Clinic staff
* willing to participate in the restorative yoga sessions and to complete study instruments

Exclusion Criteria:

* unwilling to participate in the restorative ygoa sessions (assigned then to the control group)
The Efficacy & Safety of the UAS Immunotherapy Protocol

Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as protocols described in the Allergy literature.

Patients will be assessed for efficacy of the immunotherapy protocol by completing Consented-IRB approved clinical, medication, quality of life survey questions comparing current status while on therapy in contrast to 12 months before the inception of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinitis between 18 and 65 years old who have chosen to undergo immunotherapy.

Exclusion Criteria:

* No beta blocker use,
* no pregnancy,
* no systemic steroids,
* no severe asthma/copd,
* no severe collagen vascular disorders,
* no neoplastic or uncontrolled seizure activity,
* no previous anaphylaxis, no significant cardiovsacular disease.