cyrilzakka/clinical-trials huggingface dataset:
Development of Oral Amino Acid Tracers to Study Protein Turnover in Humans

Previous studies have used a combination of oral L-\[1-13C\]leucine and intravenous labeled L-\[5,5,5-2H3\]leucine to assess the acute postprandial changes in whole-body protein turnover (12, 19). Intravenous and dietary-labeled amino acid tracers have also been used in tandem to assess rates of myofibrillar protein synthesis in response to bolus protein ingestion and resistance exercise (46). By validating whole-body net balance to myofibrillar protein synthesis, our proposed multi-tracer approach will develop minimally invasive models to study protein turnover in a variety of populations in which traditional infusions and/or repeated blood samples are not possible (i.e. pediatric, free-living populations).

The primary objective of the proposed study is to validate the use of a novel oral tracer model to accurately and reliably measure myofibrillar protein synthesis. It is hypothesized that oral L-\[1-13C\]leucine and L-\[ring-2H5\]phenylalanine, ingested as a bolus to mimic an intravenous 'pulse dose' administration (51, 65), will reveal similar rates of myofibrillar protein synthesis when compared to traditional intravenous L-\[5,5,5-2H3\]leucine infusion. Moreover, it is hypothesized that both methods will reveal the expected graded changes in myofibrillar protein synthesis in response to feeding and resistance exercise (i.e. fasted\<feeding\<exercise \& feeding).

The secondary objective of the proposed study is to develop and validate non-invasive models to measure whole-body amino acid oxidation and net balance in response to feeding and resistance exercise. It is hypothesized that whole-body net balance, as determined by a novel oral tracer model (i.e. L-\[1-13C\]leucine) , will align with traditional intravenous tracer methodology (i.e. L-\[5,5,5-2H3\]leucine) and reveal the expected physiological changes in whole-body protein turnover in response to feeding and resistance exercise (i.e. fasted\<feeding\<exercise \& feeding).

Eligibility Criteria:
Inclusion Criteria:

* Male
* Currently performing structured physical activity 2-5 days per week

Exclusion Criteria:

* Unable to safely perform exercise as per PARQ+ guidelines
* Currently using tobacco products
* Currently using or have history of anabolic steroid use
* Diagnosed with medical condition including type 2 diabetes, cancer, heart disease
* Unable to abstain from supplement use (HMB, branched chain amino acids, phosphatidic acid) for at least three weeks prior to trial
* currently using medications known to affect protein metabolism e.g. corticosteroids, NSAID, prescription-strength acne medication
* allergic to local anesthetics
* female: Hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism during exercise and may influence indices of the post-exercise myofibrillar protein synthetic response. Accordingly, the study will include males to ensure a stable hormonal environment and to increase the homogeneity of the physiological response.
Study of the Antidepressant Efficacy of a Combination Herbal Drug Preparation (NEURAPAS Balance)

The efficacy and tolerability of Neurapas® balance was compared against placebo in this single-centre, controlled, double-blind study in patients with a mild depressive episode.

After a one-week placebo run-in phase to exclude placebo responders, patients were given the study medication (Neurapas® balance or placebo) for 6 weeks in a dose of 3 x 2 tablets daily.

The improvement in symptoms of depression was assessed on the basis of the internationally established Hamilton Depression Scale 21. The Self-Rating Depression Scale (SDS), the Hamilton Anxiety Scale (HAM-A), the Clinical Global Impressions (CGI), Quality of Life questionnaire (SF-36) according to Bullinger (German version) and a Sleep questionnaire (SQ) were used as further efficacy criteria.

The efficacy and tolerability of Neurapas® balance was compared against placebo in this single-centre, controlled, double-blind study in patients with a mild depressive episode according to ICD 10, F32.0 and F33.0.

After a one-week, placebo run-in phase to exclude placebo responders, patients were given the study medication (Neurapas® balance or placebo) for 6 weeks in a dose of 3 x 2 tablets daily. The study was conducted in accordance with the relevant requirements of the German Medicines Act (AMG), the Declaration of Helsinki (48th General Assembly, Sommerset West, Rep. of South Africa, October 1996) and ICH GCP guidelines.

The improvement in symptoms of depression was assessed on the basis of the internationally established Hamilton Depression Scale 21 (primary efficacy criterion). The Self-Rating Depression Scale (SDS), the Hamilton Anxiety Scale (HAM-A), the Clinical Global Impressions (CGI), Quality of Life questionnaire (SF-36) according to Bullinger (German version) and a Sleep questionnaire (SQ) were used as secondary efficacy criteria.

Eligibility Criteria:
Inclusion Criteria:

* Depressive symptoms of mild intensity, as defined in the International Classification of Mental Disorders (ICD 10), codes F32.0 (mild depressive episode) and F33.0 (recurrent depressive disorder, current episode mild)
* SDS Index between 51 and 59 (this criterion was declared null and void on 21.02.02 in the 2nd Amendment)
* HAM-D21 scores between 10 and 17
* Between 18 and 70 years of age
* Duration of depression: not less than 4 weeks and not longer than 2 years
* Signed informed consent to take part in the clinical study after verbal and written information.
Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioid Based Anaesthesia in Cleft Palate Repair Ketodex Versus Opioids in Cleft Palate Repaire

This study will be conducted to compare Ketodex versus opioid based anaesthesia in cleft palate repair surgeries .

According to patients' randomized groups, study medication is given at induction and continues intraoperative not more than 2hours.\[8\]. Induction of anaesthesia with inhalational anaesthetic will be done through a face mask and Ayres T piece (sevoflurane )8%on 100% oxygen and fresh gas flow of at least double patient minute volume and IV line will be inserted and secured in place .After confirmation of intermittent positive pressure ventilation , 1.5 mg/kg IV suxamethonium will injected. The child will be intubated with an appropriate sized tube, and a throat pack will be placed. Ventilation will be performed with a standard ventilator equipped with a paediatric circle circuit (Datex Ohmeda, Helsinki, Finland), tidal volume of 6-8 ml/kg, and a rate adjusted to maintain the ETCO2 concentration between 32 and 35 mmHg at a total gas flow of 2 L/min. General anaesthesia will be maintained with 50% O2 + 50% air with atracurium and isoflurane, which will be titrated according to the hemodynamic parameters. Dexamethasone (0.2 mg/kg) will be given as an antiemetic and to reduce airway oedema. Post-intubation, Group (KD) will receive 1mg/kg IV ketamine and 1 µg/kg dexmiditomidine IV diluted in 20 ml NS as a loading dose over 10 min followed by a maintenance infusion of ketamine at 0.1 mg/kg/hr and dexmiditomidine 0.2 µg/kg/hr. IV diluted in 20 ml NS till the end of surgery.(15-16-17) Group (OP) will receive fentanyl 2ug /kg IV diluted in 20 ml NS and another loading syringe containing 20 ml normal saline as a loading dose over 10 min followed by a maintenance infusion of another 20 ml syringes, one containing fentanyl and the other containing normal saline . Maintenance dose of fentanyl in this group will be 0.5 µg /kg/hr . Pre-operative fasting fluid deficits and intraoperative losses will be replaced with crystalloid. A single shot of intravenous antibiotic will be given. At the end of surgery, patients will be reversed with 0.05mg/kg IV neostigmine and 0.02 mg/kg atropine, and extubated after meeting the standard extubation criteria

Eligibility Criteria:
Inclusion Criteria:

* Age 6 months to 5 years; both sex, American Society of anaesthesiologists' physical status I or II; no associated any other congenital anomalies.

Exclusion Criteria:

* Patients with a history of prematurity delayed motor , mental or developmental milestones, long QT syndrome, are excluded from the study allergy to study drugs
Phase I Study of Cetuximab in Combination With 5-fluoruracil, Mitomycin C and Radiotherapy in Patients With Anal Cancer Stage T2 (>4 cm) - T4 N0-3 M0 or Any T N2-3 M0

* To establish maximum tolerated dose of the two cytotoxic drugs 5-fluoruracil and mitomycin C when given together with the antibody cetuximab in patients with locally advanced cancer in the anal region
* To evaluate acute toxicity
* To evaluate late toxicity
* To evaluate response rate
* To evaluate recurrence free survival
* To evaluate overall survival


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Histologically or cytologically confirmed squamous cell cancer of the anal region (anal canal or anal margin or distal rectum)
* Stage T2 (≥4 cm) - T4 N0-3 M0 or any T N2-3 M0
* ECOG performance status 0-1
* Hb \> 100 g/L
* ANC \> 1.5 x 10 9/L
* Platelets ≥ 100 x 10 9/L
* Creatinine \< 1.5 x ULN
* Bilirubin \< 1.5 x ULN
* ALAT \< 3.0 x ULN
* Competent to comprehend, sign and date an approved informed consent form

Exclusion Criteria:

* Previous pelvic irradiation
* Previous chemotherapy for anal cancer
* Previous malignancy within the last 5 years, except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix uteri
* Pregnant or nursing females or patients of child-bearing potential not using adequate methods of birth control
* Patients with active infections or any other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment
* Known hypersensitivity to any of the components of the treatment
* Clinically significant cardiovascular disease, e.g. cardiac failure (\<12 months before treatment start), unstable angina, congestive heart failure, arrythmia requiring medication, or uncontrolled hypertension
* Known positive test for hepatitis C virus, chronic active hepatitis B infection
* Known HIV infection
* Any other condition or therapy which in the investigator´s opinion may pose a risk to the patient or interfere with the study objectives
* Any investigational agent within 30 days before enrolment
* Surgery (excluding diagnostic biopsy or central venous catheter placement) and/or radiotherapy within 28 days prior to inclusion in the study
Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension

The goals of this study were two-fold. First, the attempt to quantify the relationships between pulmonary arterial stiffness, right ventricular function and the efficiency of ventricular-vascular interactions in patients with pulmonary arterial hypertension (PAH). Second, the attempt to quantify the effects of exercise on pulmonary arterial stiffness, pulmonary vascular resistance, right ventricular function and the efficiency of ventricular-vascular interactions in patients with PAH.

The goals of this study are to quantify right ventricular-pulmonary vascular interactions in different types of PAH, to determine the temporal changes in these interactions with PAH progression and to quantify the effects of exercise on right ventricular function. The inclusion of the subpopulation of PAH patients with systemic sclerosis (SSc) was a result of the anticipation that this group has worse arterial stiffening than other groups, and consequently more inefficient right ventricular-pulmonary vascular interactions, which account for their worse prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of pulmonary arterial hypertension or a subtype
2. Referred for right heart catheterization
3. Age between 18 and 80 years
4. New York Heart Association (NYHA) functional class I, II, or III

Exclusion Criteria:

1. Recent syncope (within 1 year)
2. Severe skeletal or muscle abnormalities prohibiting exercise
3. Mixed etiology pulmonary arterial hypertension
4. Severe lung disease

   1. Test results indicating severe obstruction
   2. Total lung capacity \< 60%
5. Pregnancy or breastfeeding
6. NYHA class IV patient
7. Contraindications to magnetic resonance imaging
8. Kidney dysfunction as determined by an estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73m2
9. Contraindication to gadolinium
Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years

Women have a natural protection that gives them greater longevity. One hypothesis most commonly used is the estrogen protection in the premenopausal period. However many studies of various forms of hormone replacement therapy proved ineffective in promoting additional protection for women. Thus, it is discussed other ways of protection associated with longevity in women. Of these, the sirtuin system was found in several animal studies to be associated with longevity. This system also showed, through the involvement of several metabolic pathways, an important protection against the process of atherosclerosis. But the activity of this system in humans is unknown and if it is more active in women than in men. The study's main objectives are to analyze this system in healthy 24 women and 24 men aged 55 to 65 years, and their influence on the main metabolic pathways related to longevity and the process of atherosclerosis. The research protocol includes analysis of the influence of sirtuin (SIRT1) in vascular reactivity, lipid profile, antioxidant capacity, markers of inflammation and homeostasis, before and after the interventions with caloric restriction or resveratrol administration. It is expected of this study mechanistic conclusion for longevity and possible clinical applications in the mechanism of atherosclerosis prevention.

After a washout period of 15 days without medication, men and women will be randomized to the group of calorie restriction or resveratrol so that in 24 individuals (12 women and 12 men) will be given a hypocaloric diet (1000 calories per day) and the remaining 24 individuals (12 women and 12 men), a daily pill of 500mg of resveratrol. In the two moments, after the washout period and before the intervention (baseline) and after 30 days of intervention (final) will evaluate the clinical, laboratory and vascular reactivity of all subjects.

Eligibility Criteria:
Inclusion Criteria:

* clinical history, physical examination and electrocardiogram normal

Exclusion Criteria:

* premenopausal women (less than 1 year of natural amenorrhea)
* Body mass index ≥ 35 kg/m2
* Smoking
* Severe hypertension (diastolic blood pressure ≥ 110 mmHg)
* Severe dyslipidemia (triglycerides ≥ 500mg/dL, total cholesterol ≥ 300mg/dL)
* Diabetes
* Previous using previous statins or hormone replacement therapy. Other exclusion criteria are: chronic renal failure (serum creatinine ≥ 2.0 mg / dl), hepatic, endocrine, hematologic, respiratory or metabolic clinically significant.
Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder

This study seeks to address two key questions related to sensory dysregulation in Tourette syndrome (TS) and obsessive compulsive disorder (OCD): 1) Is sensory dysregulation in OCD clinically distinct from that in TS? 2) To what extent does sensory dysregulation affect QOL in each of these disorders? Patients with TS, patients with OCD, and healthy controls will complete an online battery of validated questionnaires assessing sensory dysregulation, psychiatric symptoms, and quality of life.

Tourette syndrome (TS) is a neurodevelopmental disorder affecting 1% of school-aged children, with one-third of patients suffering persistent tics into adulthood. Obsessive-compulsive disorder (OCD) is a common comorbidity with TS. Individuals with either TS or OCD frequently exhibit sensory dysregulation, manifesting as heightened awareness of internal and external stimuli. For patients with OCD, sensory dysregulation has been linked to obsessive-compulsive symptoms and is an important consideration in treatment strategies. Sensory dysregulation remains largely unexplored in TS, but preliminary data suggests it is dissociable from tics, linked with obsessive-compulsive symptoms, and associated with poorer quality of life (QOL). This study seeks to address two key questions related to sensory dysregulation in TS and OCD: 1) Is sensory dysregulation in OCD clinically distinct from that in TS? 2) To what extent does sensory dysregulation affect QOL in each of these disorders? To do so, we will recruit patients with TS, patients with OCD, and healthy controls to complete an online battery of validated questionnaires assessing sensory dysregulation, psychiatric symptoms, and QOL. Addressing these knowledge gaps will enhance our understanding of bothersome sensory symptoms in TS and OCD, shed light on clinical overlap and/or distinctions between these commonly co-occurring psychiatric diagnoses, and clarify QOL impact and the potential need for more direct targeting of these symptoms.

Eligibility Criteria:
Inclusion criteria for the patient groups:

* age 18 years or older
* previous diagnosis of Tourette syndrome and/or obsessive compulsive disorder

Exclusion criteria for the patient groups:

- none

Inclusion criteria for healthy controls includes:

- 18 years of age or older

Exclusion criteria for the patient groups:

- history of any neurologic or psychiatric diagnoses
Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors

The clinical trial compares the reproducibility and accuracy of cardiac tonometry-based portable systems that may detect early cardiac dysfunction (SphygmoCor® Xcel and Oscar 2™ ambulatory blood pressure monitor) at home and in the clinic to currently available screening tests for heart failure including echocardiogram (echo) and cardiovascular magnetic resonance (CMR). The SphygmoCor® Xcel and Oscar 2™ systems may help detect cardiac dysfunction earlier than other available screening tests because it can be self-administered outside of the clinic. This study aims to test the accuracy and practicality of these devices in the clinic setting and at home.

Primary Objective(s)

Validate the accuracy of ejection fraction, as measured using a tonometry-based system (SphygmoCor® Xcel), in the clinic setting, and determine the reproducibility (Oscar 2™) at home.

Secondary Objective(s)

Determine the cost-effectiveness of tonometry-based screening in the clinic setting and at home.

Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled in IRB# 14154.
* Able to understand and sign the study specific informed consent form (ICF).

Exclusion Criteria:

* Participants cannot be actively receiving cancer-directed therapy.
* Standard exclusion criteria for CMR imaging will be incorporated, and these include: implanted pacemaker or defibrillator, insulin pump, cochlear implant, central nervous system aneurismal clips, implanted neural stimulator, ocular foreign body (metal), other implanted medical devices (e.g.: drug infusion ports).
Pulmonary Pathophysiology and Inflammatory Response in Patients Treated With Ecmo for Severe Respiratory Failure

The purpose of this study is the observation of the course of

* the mechanics of the respiratory system
* the endexpiratory lung volume
* and the inflammatory response in patients undergoing treatment with extracorporeal life support (ECLS) due to severe refractory respiratory failure at our department.


Eligibility Criteria:
Inclusion Criteria:

* patients accepted for extracorporeal life support at our department due to the most severe forms of ARDS/respiratory failure not responding to conventional therapy.

Exclusion Criteria:

* malignant disease with a poor prognosis
* massive intracranial bleeding
Validation and Exploration of Sleep and Mood Predictors

To determine whether objectively recorded sleep durations were mortality risk factors, whether sleep duration could be distinguished from depression as a risk factor in Women's Health Initiative (WHI) data, and whether sleep-associated risks were attributable to specific pathophysiologic processes such as sleep apnea, circadian rhythm phase advances, or deficiencies of melatonin, or deficiencies of reproductive steroids. The study was ancillary to the WHI.

BACKGROUND:

Both reported short sleep and reported long sleep are major predictors of excess mortality risk, but the importance of reported sleep duration as a risk factor is not yet known. Sleep-related risks are of special interest to The Women's Health Initiative (WHI), because insomnia increases among women at menopause, and because WHI's hormone replacement therapy (HRT) and dietary modification (DM) may influence sleep. The WHI is an exciting opportunity to examine whether risks associated with reported sleep durations can be explained by a selection of intercurrent conditions, but the broad WHI design does not control for important potential confounders. Explicitly, the broad WHI design by itself cannot determine if behaviorally-modifiable objective sleep durations are the primary risk factor.

DESIGN NARRATIVE:

This ancillary project supplemented the WHI Observational Study (OS) by performing additional examinations on 600 San Diego OS women. These volunteers underwent home sleep recordings, hormone measurement, and detailed psychiatric interviews. To facilitate distinction of affective and sleep factors in WHI outcomes, the types and severity of depression in the OS subsample and the validity and reliability of sleep items in questionnaires given to WHI women were examined.

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

Eligibility Criteria:
No eligibility criteria
Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

The purpose of this study is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* BMI≥18.5 and ≤27.0 kg/m2
* No clinically significant findings
* Age 19-55 years at screening

Exclusion Criteria:

* Who has allergy to investigational product