cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis

The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.

Hypothesis: Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis. This will result in shorter time to maximal drug concentration, greater maximal concentration, and greater total area under the curve of the concentration vs. time plot.

Primary Objective: To compare the pharmacokinetics of omeprazole between immediate-release suspension and delayed-release capsules in patients with heartburn associated with gastroparesis.

Study design: randomized, open-labeled, crossover treatment for 7 days with 10-14 days washout. Pharmacokinetic studies will be performed after 7 days on study drug.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of heartburn \>2 days per week off antireflux therapy, defined by "a burning feeling rising from the stomach or lower chest up towards the neck"
* Symptoms of gastroparesis \>1 month in duration, defined by nausea, vomiting, bloating, dyspepsia, early satiety, or effortless regurgitation.
* Prior abnormal 4-hour gastric emptying scan within the past 3 years

Exclusion Criteria:

* History of esophageal or gastric surgery
* Severe gastroparesis with any of the following: vomiting with dehydration requiring IV hydration, hospitalization, weight loss \>10 % pre-illness weight, requiring feeding jejunostomy tubes
* Presence of gastric electrical stimulator
* Symptoms of retching with vomiting more than 2 days per week
* Diagnosis of diabetes
* Disorders of small bowel motility (such as pseudo-obstruction or dumping syndrome)
* Disorders of small bowel absorption
* Diagnosis of gastric outlet, small bowel or colon mechanical obstruction
* Diagnosis of acid hypersecretory syndrome
* Disorders affecting proton pump inhibitor metabolism (such as liver failure)
* Known allergy or side effects to proton pump inhibitor
* Non-ambulatory patients: bed-ridden, nursing home resident, etc.
* Pregnancy
Effect of Increased Enteral Protein on Body Composition of Preterm Infants

The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.

Qualifying participants will be randomly assigned to receive either standard protein supplementation (control group) or high protein supplementation (intervention group).

Intervention group: A fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk after establishment of full enteral feeding.

Control group: Hydrolyzed bovine protein will not be added to fortified human milk after establishment of full enteral feeding.

If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 25 and 28 weeks of gestation
* Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.

Exclusion Criteria:

* Necrotizing enterocolitis (NEC) stage 2 or greater.
* Gastrointestinal or neurologic malformations.
* Terminal illness needing to limit or withhold support will be exclusion criteria.
68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma

The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1.

Researchers will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.

Carbonic anhydrase IX (CAIX) is a transmembrane protein which is highly expressed in approximately 95% of clear cell renal cell carcinomas, and it is closely related to tumor progression, patients prognosis and treatment response. Here, we developed a CAIX specific small molecule probe 68Ga-C1, which has shown a good diagnostic accuracy in PET/CT imaging in our preclinical mouse model of clear cell renal cell carcinoma. This enables high-contrast imaging of clear cell renal carcinoma, providing a new imaging method for the precise diagnosis of clear cell renal carcinoma. In this clinical trail, we will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent；
2. Age ≥18；
3. Patients with confirmed or suspected clear cell renal cell carcinoma;
4. Expected survival ≥6 months.

Exclusion Criteria:

1. Renal mass is known to be a metastasis of another primary tumor;
2. Have other malignancies that require treatment;
3. Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks;
4. Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m²;
5. Pregnant and lactating women or female patients plan to become pregnant within 6 months;
6. Uncontrolled psychiatric disorders;
7. Vulnerable population (e.g., being in detention) or have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease).
Rectal Spacers Use in Prostate Cancer Radiation Therapy

This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study.

Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.


Eligibility Criteria:
Inclusion Criteria

1. Subjects greater than 18 years old with prostate cancer
2. Subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer
3. Subjects must have clinical stage T1-T3 with no posterior extra capsular extension of the prostate cancer
4. PSA less than or equal to 20 ng/mL
5. Gleason Score less than or equal to 7
6. Capacity to comprehend and readiness to sign a written informed consent form

Exclusion Criteria

1. Planned Pelvic lymph node radiotherapy.
2. Metastatic disease.
3. Prior local prostate cancer therapy
4. Active Inflammatory bowel disease requiring treatment with steroids.
5. Prior radical prostatectomy.
6. Active urinary tract infection.
7. Acute or chronic inflammation or infection of the prostate.
Chronic Postsurgical Pain

The study purpose is to document the typical trajectory of perioperative pain experience in Cerebral Palsy (CP) and to identify important predictive factors for the development of chronic postsurgical pain. The main aims of the investigators are to:

1. Quantify the trajectory of pain and opioid use in the context of orthopedic surgery in children with CP.
2. Identify predictors for CPSP in children with CP and develop an applicable risk index.
3. Examine relationships between perioperative pain severity and functional/mobility outcomes achieved by orthopedic surgery in children with CP.

Participants will complete:

1. Questionnaires/Surveys via email and text message
2. In-person Sensory Tests
3. In-person Gait and Motion Analysis


Eligibility Criteria:
Inclusion Criteria:

* CP diagnosis
* Have a scheduled lower extremity or spine orthopedic surgery

Exclusion Criteria:

* Non-English speaking and reading parent/guardian
Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders

In this protocol, a combination of MRI, blood, and cerebrospinal fluid (CSF) analysis will be used to understand the natural history, underlying immunologic mechanisms, and clinical implications of central nervous system (CNS) lesions, in particular lesions in the cerebral cortex, in multiple sclerosis (MS) and other inflammatory and autoimmune disorders affecting the CNS. Patients with these disorders, as well as healthy controls, will undergo baseline clinical evaluation and testing, bloodwork, and MRI, with follow up clinical evaluation, bloodwork, and MRI at years 1, 3, and 6. Additional MRIs may be performed in patients with possible new lesion formation or to compare MRI techniques. Lumbar puncture will be performed on participants who are not currently being treated with disease modifying therapies and who are willing to undergo the procedure.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* able to provide consent in English
* able to undergo MRI

Exclusion Criteria:

* contraindication to MRI
* pregnancy
The FOUNDATION Study

The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit for the infant consuming breast milk when B. infantis is colonized in the gut.

This is a single-center, open-label, prospective, cohort study of an infant probiotic (Food for Special Dietary Use) conducted in the neonatal intensive care unit (NICU). Each subject enrolled will be in the study from the time of consent (within 10 days of birth) to hospital discharge. A prospective control cohort of 15 infants will initially be enrolled. Fifteen (15) infants will then be enrolled into the B. infantis cohort. Infants in the B. infantis cohort will receive a daily feeding of B. infantis EVC001 in MCT oil until hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Birth weight \< 1500 grams or gestational age at birth \< 33 and 0/7 weeks
2. ≤ 10 days of life and considered viable
3. Consuming exclusive human milk diet (mother's milk or donor milk) with or without fortifier at time of enrollment
4. Toleration of 1.0 mL bolus enteral feeds

Exclusion Criteria:

1. Presence of septicemia or active infection as determined by positive 48-hour blood cultures
2. Necrotizing enterocolitis
3. Pulmonary hypoplasia
4. Presence of clinically significant congenital heart disease or other major congenital malformation
5. Any infant the Investigator deems to be ineligible for participation
Effect of High-intensity Low-volume Training on Insulin Sensitivity in Type 2 Diabetes

High intensity interval training is applied for several diseases.

Hypothesis: High intensity interval training improves insulin sensitivity in patients with type 2 diabetes.

Type 2 diabetes mellitus is a multifactorial metabolic disease that is characterized by reduced insulin sensitivity and insulin production leading to impaired glucose tolerance. Overweight and low physical activity are the main risk factors for the development of type 2 diabetes. Increased physical activity has shown to improve insulin sensitivity, hence, exercise plays a significant role in the prevention and therapy of type 2 diabetes. This study aims at investigating the acute and chronic effects of high-intensity low-volume training, that consists of brief bursts of very vigorous exercise separated by recovery periods, on metabolic function in patients with type 2 diabetes, people at high risk for the disease and healthy, lean individuals. Study participants take part in 30 min training session three times a week for a period of 12 weeks. Participants are studied on four occasions, prior to the intervention, after an acute bout of exercise as well as after 6 and 12 weeks of training in order to assess physical fitness, body composition, insulin sensitivity, energy metabolism in muscle, adipose tissue inflammation and neurological function. It is hypothesized that this type of exercise leads to significant improvements in insulin action and oxidative phosphorylation in muscle

Eligibility Criteria:
Inclusion criteria:

* Men and women
* Age: 30 - 65 years
* Typ-2-Diabetes (BMI \> 25 kg/m²)
* Increased risk for diabetes (BMI \>25 kg/m²)

Exclusion criteria:

* Acute Infection within the last 2 weeks prior to the intervention
* Autoimmune diseases and immune suppressive diseases (Leukocytes \< 5000/μl)
* Intake of immunomodulating drugs (Glucocorticoids, Antihistamine, ASS)
* Pregnancy, Breastfeeding, Menstruation
* Kidney insufficiency (Creatinine \> 1,5 mg/dl)
* Cardiovascular diseases
* Anemia (Hb \< 12g/l), disorders of wound healing or blood clotting
* Participation in another study within the last 2 months before the investigation
* Metallic or magnetic items on or in the body
* Claustrophobia
* Thyroid dysfunction
* Intake of glitazones or insulin therapy
* Smoking (Non-smoking since \> 1 year), alcohol consumption (Men \> 30 g/d, Women \> 20g/d) or illegal drugs
* Psychiatric disorders
* Risk for/or manifest AIDS (HIV) or Hepatitis B or C
* Night shift working
* Hypersensitivity to local anesthetics
* Cancer disease
* Lung diseases
* Systematic endurance training (\>1x per week \> 60min.)
* Maximal oxygen consumption (VO2 max) \<20ml/min/kg
* Orthopedic disorders
* Musculoskeletal diseases
Copeptin and Acute Coronary Syndrome Without ST-segment Elevation

The purpose of this study is to determine whether the combination of copeptine and troponin adds diagnosis information to that provided by troponin alone or the combination of troponin and myoglobin.

Hypothesis : If the values of troponin and copeptin are not elevated, diagnosis of acute myocardial infarction can be ruled out without prolonged monitoring and serial blood sampling.

Patients older than 18 years with pain suggestive of Acute Coronary Syndrome, with onset within the last 12 hours, presenting to the Emergency Department of the University Hospital Gabriel Montpied (Clermont-Ferrand, France) and the General Hospital Henri Mondor (Aurillac, France) are enrolled.

Upon admission to the hospital, all patient underwent an initial clinical assessment, including medical history, temperature, respiratory rate, cardiac frequency, blood pressure, pulse oxymetry, 18-lead ECG, chest X-ray and screening blood test including C reactive protein, natremia, Troponine T, myoglobin, creatin kinase and copeptine.

Patients with hyponatremia \< 135 mmol/L or troponin \> 1 μg/L are released study.

Blood sampling are taken for Troponine T, myoglobin, creatin kinase and copeptine analysis and 18-lead ECG was performed after 2, 4, 6 and 12 h.

Copeptin and myoglobin are measured at the end of the patients inclusion, after to be centrifugrd end frozen at -80°C at each time point.

The treatment of patients is not modified by the study. At 90 days, clinicals and paraclinicals events are collected.

Eligibility Criteria:
Inclusion Criteria:

* Chest pain suggestive of Acute Coronary Syndrome
* Chest pain with onset within the last 12 h
* Patients older than 18 years

Exclusion Criteria:

* ST-Elevation Myocardial infarction
* Legal incapacity
* Sepsis
* Hyponatremia \< 135 mmol/L
* Shock
* Lung neoplasms
* life expectancy of less than 6 months
* Refuse to consent
Study on the Efficacy of Vetiver Essential Oil Aroma on Depression/Anxiety People

In this study, subjects with depression/anxiety inhaled the essential oil, which contained sedative, soothing, and relaxing active ingredients to stimulate the olfactory nerve. The essential oil further transmitted to the limbic system that controls emotions in the brain, and then affected the human's mood. The natural aroma can not only awaken the limbic system's memory of aroma but also reflect the subconscious area of the brain, with physiological changes (such as controlling blood pressure, breathing, heartbeat, stress changes, memory, and hormonal coordination.) This study monitors the subject's autonomic nerve parameters before and after aromatherapy to obtain the olfactory cerebral nervous system to convey the message. When the study finishes, we expected to help the subject to relax and soothe the mind.

Subjects receive three times 30 mins aromatherapy of Limon or Vetiver essential oil per time for the month. Anthropometric measurements such as blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]), autonomic nerve parameters including a. SDNN (standard deviation of all normal to normal intervals index); b. HRV（heart rate variability）; c. LF（0.04-0.15 Hz）and HF（0.15-0.4 Hz）were measured every week. PSQI（Pittsburgh sleep quality index）and HADS (Hospital Anxiety and Depression Scale) were measured initial and ten ends.

Eligibility Criteria:
Inclusion Criteria:

1. Depressed/anxious people (diagnosed as a single episode of major depression, recurrence of major depression, mild depression, panic disorder, and anxiety.) Those diagnosed with symptoms of depression, and anxiety related to stress adjustment disorder, and willing to cooperate with the study.
2. Age 20-65 years old

Exclusion Criteria:

1. an alcoholic
2. Uncontrolled diabetes
3. Those who have had a stroke in the last year
4. Pregnant and lactating women
5. People with liver or heart disease
6. Arrhythmia or those with a heart rhythm regulator
7. Those whose heart has already been fitted with a cardiac catheter stent
8. Those who have used central nervous system stimulants (regardless of the length of time)
9. Those who are allergic to essential oils
10. Those who have used aromatherapy within a month
11. Subjects request to withdraw from the trial
12. The host feels unsuitable to continue the study
The Purpose of This Study is to Reveal the Influence of Active Video Games on Children's Motor Coordination

The goal of the study was to understand the effects of active video games on motor coordination in children. The main questions it aims to answer are:

The effect of positive video games on children's motor ability.

Researchers will compare traditional physical activities to see if active video games are effective in improving motor coordination in children.

Participants will:

Play active video games twice a week for 12 weeks Data were collected during the first and twelfth weeks


Eligibility Criteria:
Inclusion Criteria:

1. Children who meet the age requirements；
2. Have basic language skills;
3. Not require medication;
4. The parents agrees to participate.

Exclusion Criteria:

1. Those with the eye, ear, or physical disabilities or other physical health problems that prevent them from participating in training.
2. Those with severe organic diseases of the heart, liver, kidneys, and other organs
3. Patients with severe central system pathology.
4. Patients with acute infectious diseases, Etc., who are not suitable to participate in training.
Tobacco Control-Related Policy Survey

Aim: to collect further information on issues related to tobacco control which should be addressed and advocated in further tobacco control measures in Hong Kong

The objectives of this policy-related survey are as follows:

1. to update information on trends and prevalence of secondhand smoke, smoking attributable health effects, cessation services, and e-cigarette;
2. to investigate the level of public support on current and future tobacco control measures and taxation;
3. to address the timely impacts of smoke-free policies, public support for further tobacco control measures and assist COSH in shaping policy direction for government.

Current study is a cross-sectional retrospective telephone survey based on questionnaires. In total, 5,104 subjects will be randomly selected for a telephone interview. The subjects will be categorized into three groups, i.e. never smokers (1,700), ex-smokers (1,700) and current smokers (1,704). They will be required to answer a questionnaire via telephone. All data shall be collected using a Computer Assisted Telephone Interview (CATI) system, which allows real-time data capture and consolidation. All interviews shall be conducted anonymously. Analysis of survey data will aim to identify current opinion on tobacco control policies and implications for future policies. Analyses will be controlled for confounding variables as required by stratification into sub-groups based on important pre-defined characteristics and/or by multivariate analysis. Comparison with past trends and, where possible, extrapolation of future trends will be explored. Weights will be applied to adjust for the sex and age of Hong Kong population, and to handle the over-sampling issues of current smokers. The data analysis will be conducted by statisticians.


Eligibility Criteria:
Inclusion Criteria:

* Aged 15 or above
* Cantonese or Mandarin speakers

Exclusion Criteria:

* Unable to provide a consent form
* Speak language other than Cantonese and Mandarin
Prone Position for Non-intubated Patients With Acute Respiratory Failure

The study will test the hypothesis that the prone position can be used to reduce the need for intubation and mechanical ventilation in patients with acute respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* bilateral pulmonary infiltrates or unilateral infiltrates involving more than one lobe on CXR
* PaO2/FIO2 \< 40 kPa
* RR \> 25, or attending intensivist considering likelihood of intubation \> 50%

Exclusion Criteria:

* unsuited for the prone position
* fulfilled inclusion criteria for more than 5 days (120 h)
* immunosuppression
* chronic lung disease
* decision of withdrawal or limitation of therapy
* pulmonary infiltrates of cardiac origin
* decreased GCS level
* PaCO2 \> 10
* attending intensivist considering the patient unsuited for the prone position
* BMI \> 33