cyrilzakka/clinical-trials huggingface dataset:
"Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects

The aim of this study is to evaluate the bioavailability of "Novo C Plus" vitamin C containing dietary supplement compared to licensed vitamin C medications. The novelty of this product is the liposomal formulation.


Eligibility Criteria:
Inclusion Criteria:

* 21-65 years old healthy volunteers
* body weight \>45 kg
* body height \>150 cm
* plasma ascorbic acid at screening \<75 µmol/l
* signed written informed consent
* subject agrees avoid vitamin C containing medications and dietary supplements from screening until V0 visit (maximum 15 days)
* subject agrees to avoid high activity physical exercise 72 hours prior to V0 visit

Exclusion Criteria:

* confirmed or suspected active infection
* liver or renal failure (equal or greater than CKD3)
* chronic disease that affects absorption or vitamin C metabolism
* severe metabolic disorder
* body mass index \>35 kg/m2
* malabsorption syndrome that affects vitamin C metabolism
* heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with \>100/min ventricular rate
* gastrointestinal bleeding in past three months
* uncontrolled diabetes mellitus (HbA1c\>8,5%)
* malignant disease
* alcohol or drug abuse
* active psychiatric disorder, intention for suicidal, disorders with unconsciousness
* psychopathic disorder, lack of cooperation
* known coagulopathy
* chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months)
* untreated hypertension if blood pressure is greater than 165/95 mmHg
* gravidity or breastfeeding
* taking more than 100 mg vitamin C daily within 2 weeks to screening
Turnip Consumption and Qigong Exercise Program on Weight Loss

Obesity and weight-related issues are prevalent concerns affecting individuals worldwide, with particular significance among the younger demographic, such as female students. As lifestyles evolve and dietary habits play a pivotal role in overall well-being, exploring innovative approaches to weight management becomes imperative. Thus, obesity is a huge public health importance with economic emotional and social consequences.

Obesity is an epidemic causing serious health consequences, including diabetes, dyslipidemia, and hypertension. Obesity in adolescents can cause chronic brain hypoxia and affect learning. Weight loss occurs when energy intake is less than energy expenditure, and achieving an energy deficit remains the main dietary target. The evidence for the specific impact of vegetables is qualified. Recently, there has been much scientific interest and debate on the potential link between dairy consumption and body weight regulation. The idea of turnip consumption and qigong exercise includes a broad variety of subjects. vegetables are high in water and fiber and low in energy density, so their consumption is suggested to prevent obesity. Moreover, Traditional Chinese exercises are an ancient way of exercise and fitness, which have been reported to have unique advantages in the treatment of obesity.

Eligibility Criteria:
Inclusion Criteria:

* aged from 10 to 12 years
* free from any chronic diseases
* accept to participate

Exclusion Criteria:

* have any digestive problems
* unable to communicate or participate
Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes

Aim 1: Characterize shared decision-making and unmet patient-caregiver dyads needs for patients with diabetes and Alzheimer's Disease and related dementias (ADRD) while using a continuous glucose monitoring (CGM) device.

Aim 2: Develop an interactive tool to enhance shared decision-making for diabetes management.

Aim 1: Patient-caregiver dyads will participant in a semi-structured interview to establish a baseline. The dyad will receive standard diabetes educational materials along with a CGM training and instructions for device use. Patients will then wear the CGM device for 14 days. Three follow-up interviews will take place during the 14-day scanning period, as well as a debrief interview following the scanning period for assessment and technical support.

Aim 2: Patient-caregiver dyads and clinicians will participate in a user-centered design session to guide the design of interactive information displays to improve the interpretability of CGM data.

Eligibility Criteria:
Patient-Caregiver Dyad Inclusion Criteria (Aims 1 + 2):

* patient must have dual diagnosis of MCI or ADRD and diabetes (DM)
* patient must have active prescriptions for DM
* patient must have had at least one visit to an Eskenazi or IU Health primary care clinic within 12 months
* patient must be able to provide assent and have a legally authorized representative (LAR) consent on their behalf if patient lacks capacity to consent
* patient must have a caregiver aged 18 years or older who interacts daily, or almost daily, with the patient
* patient and caregiver must both speak English
* patient and caregiver must both reside in the community
* dyad must have internet access

Patient-Caregiver Dyad Exclusion Criteria (Aims 1 +2):

* patient has terminal illness
* use of an automated insulin delivery system
* patient is receiving dialysis
* patient is taking ascorbic acid during monitoring period
* patient has existing implanted medical devices
* patient has a bleeding disorder
* patient has a pre-existing arm skin lesions
* patient has an allergy to medical adhesive or isopropyl alcohol
* patient has plans for imaging or diathermy treatment during the study period

Clinician Participant Inclusion Criteria (Aim 2):

* primary care physicians
* nurses
* pharmacists
* nutritionists
* psychologists
* medical residents

Clinician Participant Exclusion Criteria (Aim 2):

* only treats patients younger than 65 years
* does not manage patients' DM
Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients

The primary objective is to evaluate the efficacy of Ropanicant at two different dosage levels compared to placebo in patients with Major Depressive Disorder (MDD).

This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of Ropanicant versus placebo in patients with MDD. The study will be conducted at multiple centers located in the US.

This study consists of a 4-weeks screening period, 6-weeks treatment period, and a 2-weeks follow-up period. Approximately 195 patients will be randomly assigned to receive Ropanicant either 30 mg bid or 45 mg bid, or placebo bid for 6 weeks in a ratio of 1:1:1 (65 patients in each treatment group).

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for MDD without psychotic features based on the Mini International Neuropsychiatric Interview (MINI) with a current major depressive episode of at least 4 weeks of duration but no longer than 12 months.
* Patients must have a Clinical Global Impression-Severity (CGI-S) score of ≥4.
* Patients must have a Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) score of ≥20.
* Patients must have a Snaith-Hamilton Pleasure Scale (SHAPS) score of ≥20.
* Patients must have vision and hearing (corrected if needed) sufficient to comply with the testing procedures.

Exclusion Criteria:

* Patients who meet criteria for treatment-resistant depression (TRD) during the current major depressive episode, which is defined as being nonresponders (\<50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration.
* Patients not in good general health with clinically significant abnormalities as assessed by the investigator and determined by physical examination results, neurological examination results, ECG results, or laboratory assessments.
* Female patients who are pregnant, planning to become pregnant during the study or within 30 days after the last administration of study drug, or breastfeeding.
* Patients with bradycardia (\<50 bpm) or tachycardia (\>100 bpm) on the ECG results.
Early Directed Physical Therapy in the Management of Mechanically Ventilated Patients in a Medical Intensive Care Unit

To study all ICU patients with an independent baseline functional status, who experience a critical illness requiring intubation and mechanical ventilation, evaluating the role of protocol-directed, early physical and occupational therapy on the incidence of critical illness associated functional debilitation. Our goal is to hasten the recovery of independent physical functioning as well as to reduce ICU delirium in the group of patients who begin this intervention from the earliest hours of ventilator dependence.


Eligibility Criteria:
Inclusion Criteria

1. Patients intubated and mechanical ventilated for \< 72 hours
2. Age \> 18 years
3. Baseline independent functional status as assessed by a Barthel Index score \> 70 collected from a proxy reflecting baseline health 2 weeks prior to critical illness

Exclusion Criteria

1. Rapidly evolving neurological/neuromuscular disease
2. Cardiac arrest
3. Irreversible conditions with six month mortality estimated at \> 50%
4. Elevated intracranial pressure
5. Multiple absent limbs (precluding complete musculoskeletal examination)
6. Enrollment in another trial
A Clinical Study to Evaluate the Efficacy, Safety and PK/PD Profiles of Anticoagulation of HSK36273 for Injection in Continuous Renal Replacement Therapy Subjects

This study is divided into Stage I and Stage II. It is planned to include 156 subjects who need CRRT treatment for more than 48 hours.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥18 and ≤80;
2. 16 kg/m2 ≤BMI≤35 kg/m2;
3. Those who need CRRT treatment for more than 48 hours and plan to use CVVHDF treatment mode for femoral vein puncture;
4. Subjects or their guardians voluntarily sign the informed consent form in writing before any procedure related to the study starts, fully understand the purpose and significance of this trial, and are willing to comply with the trial protocol.

Exclusion Criteria:

1. Those who are known to be allergic to heparin, heparin drugs, investigational drugs or non-active ingredients of study intervention;
2. Subjects with severe coagulation dysfunction or bleeding tendency three months before the screening, such as HIT (heparin-induced thrombocytopenia), ITP (idiopathic thrombocytopenia purpura), TTP (thrombocytopenia purpura), persistent systolic blood pressure\>200 mmHg or diastolic blood pressure\>120 mmHg, active gastrointestinal bleeding, intracranial hemorrhage, cerebral aneurysm, severe retinopathy bleeding, hemophilia, hemolytic uremic syndrome, stroke, acute coronary syndrome;
3. Those who have undergone major cardiac surgery or craniocerebral surgery within 3 months before screening and who are judged by the study doctor to be at risk of serious bleeding;
4. Those whose platelet ≤ 50\*109/L and/or INR\>1.8 and/or aPTT\>55s at screening;
5. Those who need to combine other blood purification methods such as blood perfusion or ECMO;
6. The time from the point of randomization to the last use of anticoagulants (low-molecular-weight heparin, warfarin, apixaban, bivalirudin, etc.), antiplatelet drugs (clopidogrel, aspirin, etc.), fibrinolytic drugs (urokinase, etc.) is shorter than the 5 half-lives of the drug or the duration of drug efficacy (calculated by the longest time);
7. The time of administration is shorter than 1 half-life of low-molecular-weight heparin from the last preventive dose;
8. Child-Pugh liver function is grade C in screening period;
9. Those with positive hepatitis C antibody or HIV antibody screening;
10. Pregnant and lactating women; women or men with fertility are unwilling to use contraception throughout the study period; subjects with pregnancy plans within 6 months after the study (including male subjects);
11. Those who have participated in clinical trials of other drugs within 3 months before screening (defined as having received investigational drug or placebo);
12. Other conditions that the investigator judges are not suitable for the subject to participate in the clinical trial.
Effect of GnRH Agonist Treatment Protocols on Ovarian Reserve

This study aimed to compare the gonadotropin-releasing hormone agonist (ultra-short) protocol versus (short and long) protocols on ovarian reserve in women undergoing intracytoplasmic sperm injection

Infertility affects about 15% of all the couples attempting to generate pregnancy, of which can be attributed to female and male factors. For females, advanced age and poor ovarian reserve were the main causes which resulted in infertility.

Pituitary down-regulation with gonadotropin-releasing hormone (GnRH) agonists followed by ovarian stimulation with exogenous gonadotropins has been successfully used as standard hormonal treatment in women undergoing assisted reproductive technologies (ART) for the last 10 years. Ovulation induction is a frequently utilized therapeutic procedure for the management of infertility.

With the use of gonadotropin-releasing hormone agonists in controlled ovarian hyperstimulation (COH) protocols, the results of the ART improved in terms of reduction in cycle cancellation by the almost abolition of spontaneous LH surges (\<2%). The GnRHa also reduce inadequate follicular development and imprecise clinical pregnancy rate.

Intracytoplasmic sperm injection (ICSI), it has allowed successful pregnancies and proved to be a consistent treatment for the alleviation of infertility due to severe semen abnormalities including cryptozoospermia.

Eligibility Criteria:
Inclusion Criteria:

* women
* aged between 18- and 35-years old
* undergoing Intracytoplasmic sperm injection.

Exclusion Criteria:

* History of three or more previous In vitro fertilisation failures
* Karyotypic abnormalities in either partner
* Patients who previously undergo unilateral oophorectomy
* Patients with chronic diseases (uncontrolled diabetes mellitus, cardiovascular diseases, liver and kidney failure)
* Patients with diseases may affect In vitro fertilisation outcomes (Endometriosis, uterine fibroids, Hydrosalpinx, Adenomyosis, autoimmune diseases), polycystic ovary syndrome (PCOS) patients, poor responders (maternal age \>40, Antral follicle counts (AFC)\<5, Anti Mullerian Hormone (AMH)\<1 and previous trial \<5 oocyte retrieved)
* Severe male factor, uterine abnormalities, adenomyosis and endometriosis
* History of malignant tumors and related treatment, clinically significant systemic disease or abnormal hematology, chemistry, or urinalysis results at screening, non-ovarian causes (male or tubal factors with average ovarian reserve).
Audiovisual Aid Pilot Study

Little is known about perioperative stress responses and possible anxiety mitigating factors like audiovisual aids or IV sedation. Most studies use surrogate markers and retrospective questionnaires, and are not based on real-time gathered data. Skin conductance measurements allow the sympathetic discharge to be evaluated down to fractions of a second and enable us to continuously monitor stress responses as skin conductance responses/per second during the perioperative management. In our study, the investigators propose to examine the effect of personal audiovisual equipment (audio/video goggles) on perioperative stress, pain, and overall experience in patients undergoing ambulatory meniscectomy under spinal anesthesia. Patients will be randomly assigned to either receive traditional sedation or light sedation in addition to audiovisual equipment. The investigators hope to determine outcome estimates of the use of this equipment on stress levels using skin conductance measurements, request for further sedation, postoperative pain levels and analgesic consumption, time to discharge readiness, and overall patient satisfaction, and collect thus far unavailable data on the stress response to perioperative stresses (such as IV insertion and spinal placement) in order to allow for power analyses for future studies.

PLEASE NOTE: After conducting the interim analysis and plotting the skin conductance data, we have determined that the graphs are not consistent enough to draw any conclusions. Given the technical difficulties we have encountered with the Med-Storm Stress Detector, as well as the labor intensity associated with it, we have decided that we will no longer use it from patient 14 on. We will not mark the time points and hand movements described in the protocol, as this data was used to understand the skin conductance data. We will continue to enroll patients to complete this pilot/exploratory study, as the other secondary outcomes--in particular, the surveys--could provide valuable information.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for primary, ambulatory, arthroscopic meniscectomy under spinal anesthesia

Exclusion Criteria:

* Patients with psychiatric disease and those on antidepressants
* Contraindications to spinal anesthesia or allergy to study medication
* Age \< 18 years
* Patients with audiovisual impairments
* Patients with inability to communicate in English or understand the study requirements
* Chronic pain patients +/- opioid use
* Patients with (neuro)dermatoses encompassing the hand
* Patients with pacemakers
* Patients with diabetes or known neuropathic disease
* Patients with a history of epilepsy or seizure disorder
* Patients with a history of claustrophobia
* Patients with a history of epilepsy
* Patients with prior history of epilepsy or seizure disorder
* Patients undergoing a revision or open procedure
The Exercise Capacity and Quality of Life in the Patients With IPAH and Secondary PH

Pulmonary hypertension (PH) is a progressive disease with high mortality rate, but due to the development of drugs, the prognosis of the disease has improved. However patients still have poor exercise capacity and decrease of the quality of life. Past studies have shown that idiopathic and secondary PH are different in etiology and prognosis. It is necessary to further understand the difference between exercise capacity and quality of life of these two types of patients.

Background. Pulmonary hypertension (PH) is a progressive disease with high mortality rate, but due to the development of drugs, the prognosis of the disease has improved. However patients still have poor exercise capacity and decrease of the quality of life. Past studies have shown that idiopathic and secondary PH are different in etiology and prognosis. It is necessary to further understand the difference between exercise capacity and quality of life of these two types of patients.

Purpose. The purpose of this study is the comparison of idiopathic and secondary PH in exercise capacity and quality of life, and analyzed the factors affecting.

Method. The patients recruit from National Taiwan University hospital. Thirty patients who diagnosis with PH and willing to participant our study will recruited. According to the cause of disease patients will divided into two groups, idiopathic group and secondary PH group has fifteen patients. Both of group receive testing, including body composition, exercise capacity (six minutes walk test, cardiopulmonary exercise testing), record their regular physical activity( seven day physical activity recall questionnaire) , fatigue severity(fatigue severity scale), and quality of life (SF-36), monitor cardiac function (non-invasive cardiac output test instrument). Data are analyze using SPSS19.0 version. Data will be presented in mean ± standard deviation and percentage. Using Kolmogorov-Smirmov test to test, whether the data were normal distribution, when P\> 0.05 is considered as a normal distribution. Mann-Whitney U test or Chi-square test to processing parameters between two groups. Independent sample t test will be used to compare whether there are between-group differences. Pearson correlation coefficient will be used to test correlations between the parameters. The study defines significant level at α = 0.05, two-tailed.

Eligibility Criteria:
inclusion criteria

1. diagnose as pulmonary hypertension
2. clinical stable over 3 months
3. able to walk and can perform cardiopulmonary exercise testing by bicycle

exclusion criteria

1. acute right heart failure
2. sever arrythmia
3. the history of exercise induce syncope
DNA Methylation and Hydroxymethylation Levels in Patients With Coronary Heart Disease

The purpose of this trial is to investigate the relationship between DNA methylation and hydroxymethylation and the expression of DNMTs, TET family gene and the degree of coronary heart disease.

1. To determine the levels of DNA methylation and hydroxymethylation with coronary heart disease.
2. To investigate the relationship between DNA methylation and hydroxymethylation and the degree of coronary atherosclerosis.

Eligibility Criteria:
Inclusion Criteria:

Male and Female. Patients older than 65 years old who are willing to participate in the study. CHD patients was defined as at least one lesion in a coronary artery or branches in coronary angiograms. Control group was defined as people with negative findings in coronary angiograms.

Exclusion Criteria:

Patients with concurrent infection or any documented inflammatory illness, such as arthritis or connective tissue diseases, or any other malignancy. Patients with a history of cardiomyopathy. Pregnant women. Severe hepatic dysfunction or End-stage renal failure. Uncontrolled hypertension.
A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis

This multicenter study is being conducted to provide additional PF-06826647 safety and tolerability data, and to further explore the clinical efficacy of PF-06826647 in the treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to enable selection of oral dose and dosing regimen for the future clinical development of PF-06826647.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18 and 75 years.
* Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months.
* Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe).
* Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).

Exclusion Criteria:

* Have non-plaque forms of psoriasis.
* Drug-induced psoriasis.
* Current active infection.
* Infected with Mycobacterium tuberculosis (TB).
* Have any history of malignancies.
* Require treatment with prohibited concomitant medications(s).
* Positive for hepatitis B or C, or human immunodeficiency virus (HIV).