cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2001 and Co-administration of Each Component in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2001 and co-administration of each component in fasting and fed conditions respectively in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 19\~54 years in healthy volunteers 19 kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS

Mood disorders, including depression and anxiety, are one of the main causes of the overall disease burden worldwide.

In recent years, the efficacy of certain botanicals as an alternative solution for depression has been evaluated in a number of clinical trials.

However, only few studies looked at the effects of these botanicals on mood in healthy subjects.

The aim of the proposed randomised, double-blind, placebo-controlled, parallel groups methodology is to assess the acute and chronic effects of daily supplementation with a proprietary and standardized botanical extract in comparison to placebo in healthy adults aged 18-60 years with self-reported low mood.

The chronic effect of the active product on mood, anxiety, perceived stress, quality of life and cortisol secretion \& metabolism will be assessed through validated questionnaires and urine collection after 2, 4 and 8 weeks of daily supplementation.

The acute effect of the product will be assessed after a single dose and exposure to an acute psychological stressor. Before, during and after the stressor, saliva samples will be collected and subjective levels of anxiety and mood will be measured. In addition, Galvanic Skin Response (GSR) and heart rate (HR) will be measured throughout the stressor session.

Eligibility Criteria:
Inclusion Criteria:

* With non-pathological feelings of anxiety and/ or stress in daily life:

  * Subjects self-reporting low mood;
  * Total score ≥ 40 at the Profile of Mood State (POMS 2);
  * Score \< 16 at the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire
  * Score ≤ 10 at the Patient Health Questionnaire 9-item (PHQ-9)
  * Not meeting the diagnosis criteria for any mental disorder
* Body Mass Index (BMI) in the normal range: 18.5 ≥ BMI ≤ 30 kg/ m2
* For non-menopausal women: using effective contraception/pregnancy is not physiologically possible.
* Subject showing no difficulty for salivary sampling
* Subjects capable of and willing to comply with the protocol and to give their written informed consent

Main Exclusion Criteria:

* Diagnosis of psychological pathology within the previous 3 years
* Diagnosis of cognitive pathology
* Anxiolytic or antidepressant treatment, within the previous 3 months
* Event likely to have impacted the subject's emotional and/ or psychological state within the last 8 weeks or planned during the next 8 weeks
* Menopausal transition
* High blood pressure
* Subjects diagnosed with diabetes, cardiovascular disease, recurrent infectious diseases or chronic inflammatory pathology
* Usual corticoid treatment/ steroidal anti-inflammatory treatment
* Unbalanced thyroid disease
* High physical activity practice
* Tobacco consumption
* Subjects consuming any food supplement
* Excessive alcohol or caffeine use
* Consumption of recreational drugs
* Subject currently participating in other clinical or nutrition intervention studies, or has done in the past 4 weeks.
Tinnitus Patient Preferences Survey

The goal of this survey is to assess several aspects related to patient preferences regarding interventions for alleviating tinnitus through invasive electrical brain stimulation (neuromodulation). This survey covers the acceptance of a surgically-placed brain implant, of its associated risks related to the neurosurgical procedure, usability considerations, and the willingness/ability to pay for such a treatment.

Neurosoft Bioelectronics will use the collected patients' feedback and usability preferences data for the development of a novel minimally invasive brain implant aimed at alleviating tinnitus.

Neurosoft Bioelectronics is developing a minimally invasive implantable solution for the treatment of chronic, subjective moderate-to-severe cases of tinnitus. The approach involves developing a state-of-the-art neurostimulation paradigm and incorporating invasive neuromodulation findings from leading experts in the field to create an effective solution. This solution aims to minimize patient's burden by offering a fully implantable system that does not require active patient engagement or repetitive adjustments of electrical stimulation parameters. Instead, it will use a closed-loop feedback algorithm, that will be optimized through multi-target recordings and stimulation, to continuously adapt and refine the treatment. This type of solution could significantly increase the quality of life of affected individuals living with severe chronic tinnitus, for which only palliative and symptom management solutions exist today. As Neurosoft Bioelectronics is at the early stage of device development, we will use the collected patients' feedback and usability preferences data for refining clear users' and product's requirements.

Eligibility Criteria:
Inclusion criteria:

* Individuals aged 18 or older suffering from subjective tinnitus
* Self-reported or healthcare professional-diagnosed chronic (lasting 3 months or longer), subjective, burdensome tinnitus

Exclusion criteria:

* Individuals under 18 years of age
* Healthy volunteers without tinnitus
Bone Accrual and Hormones in Response to Lactation

This is a prospective observational trial of healthy postpartum women to investigate changes in bone density and markers of bone turnover during lactation. The study hypothesis is that women who breast-feed 5 months or more will lose bone density and subsequently regain the bone density after weaning. This study seeks to define determinants of the regain in bone density.

This is a prospective observational trial enrolling healthy postpartum women, ages 20 years and older with the intent to breast-feed from the UNC outpatient obstetrical clinics and the UVA outpatient obstetrical clinics. These women were studied at 3-5 visits in the year following their delivery to assess bone density, nutritional intake, exercise, and breast-feeding choices. The number of study visits depended on the timing of return of menses and interest in participating in the follow-up study (timepoints are: immediate postpartum, 3 months postpartum, return of menses, 6 months after return of menses and follow-up visit 6 months after final visit). Blood was taken for analysis of bone-related hormones, bone turnover and calcium homeostasis markers. The study focuses on women with extended lactation (at least 5 months of lactation) whereas women who cease lactation prior to 3 months will be the primary comparison group.

Eligibility Criteria:
Inclusion Criteria:

* age \>20 at the time of delivery
* singleton pregnancy and
* \<2 prior pregnancies that were \>20 weeks gestation.

Exclusion criteria:

* maternal rheumatologic disorders
* maternal anorexia nervosa
* maternal endocrinologic disorders,
* medications known to affect bone density such as corticosteroids, thyroid hormone use, anticonvulsant therapy, bisphosphonates, long-term GnRH agonists use and calcitonin.
* Subsequent pregnancy during the study
Transvaginal Ultrasonography Guided Embryo Transfer

to evaluate the value of using transvaginal ultrasound guided embryo transfer in obese patients undergoing in vitro fertilization.

The 800 participants with body mass index more than 30kg/m2 were randomly allocated to two groups of equal size using an automated web-based randomization system. The first group 400 patient undergoing the transabdominal-guided embryo transfer, the second group 400 patient undergoing transvaginal-guided embryo transfer.

Eligibility Criteria:
Inclusion Criteria:

* BMI more than 35, good ovarian reserve, unexplained infertility more than 3 years.

Exclusion Criteria:

* severe male factor of infertility,uterine factor of infertility excluded by ultrasonography and hysteroscopy ,ovarian endometrioma or patients with poly cystic ovary syndrome, obesity caused by abnormal endocrine function (thyroid or adrenal disorder)
The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.

The objective of this study was to investigate the effect of the use of sonographic cervical length (CL) on the hospital stay in women admitted because of preterm labor.

Eligible women who agreed to participate in the study were randomized by means of a central randomization office into two groups:

CONTROL group: cervical length was measured but the result was blinded to the physician in charge and women was managed according to the standard protocol.

STUDY group: cervical length was measured and the result was reported to the physician in charge. If cervical length was of 25 mm or more, discharge in 12-24 h was recommended. If cervical length was less than 25 mm, decision on discharge was made following clinical criteria.

Eligibility Criteria:
Inclusion Criteria:

* Admitted because of preterm labor
* Not delivered after 24-48 h of admission
* Single pregnancy
* Intact membranes
* Gestational age between 24.0 and less tahn 36.0 weeks
* Bishop score \< 6

Exclusion Criteria:

* Fetal death or malformation
* Signs of chorioamnionitis
* Non-reassuring fetal test
Clinical Trial of the Dual Vector Base Editor for the Treatment of the CHD3-R1025W Mutation

To evaluate the safety, tolerability and preliminary efficacy study of a single intrathecal injection of the dual vector AAV-CHD3-R1025W base editor for the treatment of developmental disorders caused by the R1025W mutation in the CHD3 gene


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Snijders Blok-Campeau syndrome
* Heterozygous mutation of c.3073C\>T, p.(Arg1025Trp) in the CHD3 gene
* Normal liver, heart and immune function
* Normal coagulation and platelet counts

Exclusion Criteria:

* Brain tumor or intracranial space-occupying lesion
* Contraindications to administration of lumbar puncture or sheath injection administration
* Persistent status epilepticus or recurrent epileptic control instability
* Presence of unstable systemic disease including active bacterial, fungal or HIV, hepatitis A, hepatitis B infection
* Serum anti-AAV neutralizing antibody titer \>1:50 (ELISA immunoassay)
* Treatment with immunological agents other than protocol-specified prophylaxis within 3 months
* Prior gene therapy
* Participation in another clinical trial, or treatment with another investigational product within 30 days or 5 half-lives
* Known allergy to any investigational product
Evaluation of ReDS Pro System V2.7 and ReDS ICU in Patients With Heart Failure

The study is an investigator-initiated, prospective cohort trial. The trial aims to evaluate ReDS Pro System V2.7 and ReDS ICU in patients with heart failure (HF).

The study is an investigator-initiated, prospective cohort trial. The trial aims to evaluate ReDS Pro System V2.7 and ReDS ICU in patients with heart failure (HF). The overall purposes are:

* to evaluate the ReDS efficacy measurements of lung fluid compared to pulmonary artery pressure guided therapy with CardioMEMS in out-patients with HF.
* to describe the feasibility of ReDS ICU in patients admitted to an ICU with HF

For the out-patient part, the patients will be recruited from the outpatient clinic at Rigshospitalet. The patient must be at least 18 years, have a history of chronic HF, and already monitored using CardioMEMS and must not fulfill any of the exclusion criteria.

For the ICU part, the patients will be recruited at the ICU department at the Heart Center at Rigshospitalet. The patient must be at least 18 years, intubated, and unconscious or sedated (Glasgow Coma Score \<8), and already monitored using Swan-Ganz and arterial catherization and must not fulfill any of the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

ICU part:

* at least 18 years of age
* hospitalized in ICU setting at Rigshospitalet
* intubated
* unconscious or sedated (Glasgow Coma Score \<8)
* monitored using Swan-Ganz and arterial catherization.

Out-patient part:

* at least 18 years of age
* history of Chronic heart failure \> 3 months
* CardioMEMS

Exclusion Criteria:

ICU part:

* pacemaker or ICD on the right side
* congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma)
* wounds, burns, healing tissue, skin infection or recent skin graft or flap where the sensors should be attached to the skin
* habitus is out of range due to one or more of the following
* height less than 155 cm or higher than 195 cm
* estimated BMI of less than 22 or more than 36
* standard active therapy has been stopped as the patient is inevitably dying.

Out-patient part:

* pacemaker or ICD on the right side
* congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma)
* wounds, burns, healing tissue, skin infection or recent skin graft or flap where the sensors should be attached to the skin
* habitus is out of range due to one or more of the following Height less than 155 cm or higher than 195 cm BMI of less than 22 or more than 38 For BMI 36 to 38, chest size ruler should be 39 or less
* cancer or other severe non-cardiac disease with estimated life expectancy less than 1 year
* planned hospitalization for ICD, pacemaker, lung or heart surgery including heart transplantation during the study period.
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial

The goal of this clinical trial is to evaluate if a bariatric surgery strategy will improve clinical endpoints, cardiac parameters and functional status in patients with obesity (with BMI 32-40 kg/m2) and symptomatic HF with preserved or mildly reduced LVEF in combination with AF, as compared to standard of care. Patients will be randomized to either the Intervention group receiving bariatric surgery including an intensive pre- and postoperative treatment scheme or to the control group receiving standard of care.

The primary objective is to study the effect of a bariatric surgery strategy on the hierarchical occurrence of: 1) all-cause mortality within 2 years, 2) emergency room visit or hospitalization for HF within 2 years, 3) recurrent ECG-documented AF within 2 years, 4) decrease of ≥30gr of left ventricular (LV) mass on transthoracic echocardiography, and 5) improvement of ≥5 points on the Kansas City Cardiomyopathy Questionnaire (KCCQ).

Eligibility Criteria:
Inclusion Criteria:

1. Signs and symptoms of HF according to the Europeans Society of Cardiology guideline;
2. Left ventricular ejection fraction ≥40%;
3. HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test;
4. Between 45 and 70 years of age;
5. BMI 32-40 kg/m2;
6. Paroxysmal or persistent AF with a rhythm control strategy;
7. Willing to undergo both treatment strategies;
8. Written informed consent.

Exclusion Criteria:

1. BMI ≥40 kg/m2;
2. BMI \<32 kg/m2;
3. Patients unwilling or unable to sign informed consent;
4. More than moderate mitral valve regurgitation/aortic valve regurgitation;
5. More than mild mitral valve stenosis/aortic valve stenosis;
6. Inadequate echocardiographic window for the assessment of LV mass index and/or the echocardiographic criteria needed for the HFA-PEFF score;
7. History of myocardial infarction, myocarditis, any invasive cardiac intervention (e.g. surgery, percutaneous coronary intervention, ablation) or stroke, \<3 months before inclusion;
8. Scheduled for AF ablation;
9. Complex congenital heart disease;
10. Negative treatment advise from a specialized psychiatrist due to non-stabilized psychotic disorders, severe depression and/or personality disorders;
11. Patients unable to care for themselves or who are unable adapt to inherent lifestyle changes following bariatric surgery;
12. Any medical condition that limits life span \<2 years;
13. Diseases requiring long term use of anti-inflammatory treatments;
14. The use of medication associated with substantial effects (\>5 kg) on body weight.
Impact of Mulberry Leaf on Type 2 Diabetes

The purpose of this study is to evaluate whether mulberry leaf extract will help control blood sugar in patients with type 2 diabetes. We also want to look at the safety of mulberry leaf extract in these patients.

The methods for testing this hypothesis include: a 2-week placebo run-in, followed by a double-blind randomization into 2 groups: (1) mulberry leaf extract and (2) matching placebo. Evaluations of hemoglobin A1C (A1C) -- A measurement of blood glucose over the past 3 months -- will be done at baseline \[before placebo run-in period\] and 3 months. Evaluations of safety laboratories and adverse effect questionnaire will be done at 4 weeks and at 3 months following the randomization visit. Subjects will undergo a 2-week placebo run-in phase, and then will be divided into two groups: (1) mulberry leaf extract and (2) matching placebo. The subjects will ingest 1000 mg (#2 500 mg capsules) of standardized mulberry leaf extract (Nature-Gen, San Diego, CA) or matching placebo three times daily with meals for 3 months. Patients will be asked to monitor fasting morning blood glucose and 2-hour postprandial dinner blood glucose daily during the 2-week placebo run-in. To ensure compliance, only subjects compliant with both medication and monitoring instructions will be issued a 30-day supply of study medication at enrollment and the remainder at the 4-week safety visit. Each visit will consist of clinical examination, completed questionnaires, evaluation of self-monitoring blood glucose (SMBG), and donated blood for clinical laboratory tests. Standard recommendations for therapeutic lifestyle intervention will be given to both groups. All the clinical laboratory tests will be performed at the University of Mississippi Medical Center. All patients will receive identical 2-week placebo phase capsules, and then be randomized to each group using similar lookin

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* No diabetes medication adjustments for at least 2 months
* Stable hemoglobin A1C \[Between 7.0% to 8.0% (inclusive) and not varying by more than 10% since prior visit; If no A1C exists prior to the current visit and no medication adjustments are made, the current A1C may used as the baseline\]

Exclusion Criteria:

* On insulin
* History of overt cardiovascular disease
* History of missed appointments or non-compliance with medications
* History of hepatic or renal insufficiency
* History of hemoglobinopathies
* Women of reproductive potential not on oral contraceptives
* Pregnant/nursing women.
Tranexamic Acid in Hip Fracture Patients

This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture.

1. transfusion of allogeneic RBC's is not free of adverse events and has been associated with an increased risk of postoperative infection
2. Tranexamic acid in trauma patients has been shown to reduce 30-day mortality. Hospital trauma protocol includes tranexamic acid in patients with major bleeding.
3. Tranexamic acid in orthopedic elective joint reconstruction surgery has been shown to substantially decrease bleeding in knee and hip arthroplasty.
4. in hip fracture surgery, transexamic acid reduces erythrocyte transfusion rate but may promote a hypercoagulable state.
5. Tranexamic acid is an antifibrinolytic drug that inhibits plasminogen from turning into plasmin thereby inhibiting clot breakdown.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the emergency room with proximal hip fractures (31A-31B according to the Muller AO classification of fractures - long bones).
* Patients mentally capable of giving informed consent.

Exclusion Criteria:

1. Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis.
2. Patients receiving anticoagulation therapy with Coumadin or Plavix.
3. Pregnancy and breastfeeding females.
4. Previous arterial or venous thrombosis
5. History of seizures.
6. Creatinine \>2.
7. Oestroprogestive therapy.
8. Multiple fractures.
Clinical Evaluation of Approved Contact Lenses

This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be at least 18 and not more than 70 years of age (including 70).
4. The subject's refractive cylinder must be \< 0.75 Diopters (D) in each eye.
5. The subject must have best corrected visual acuity of 20/25 or better in each eye.
6. The subject must be a habitual and adapted wearer of ACUVUE® OASYS® brand contact lens in both eyes (at least 1 month of daily wear).
7. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
8. The subject's required spherical contact lens prescription must be in the range of -1.00 D to -6.00 D in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
6. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
7. Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.
8. Any ocular infection.
9. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
10. Monovision or multi-focal contact lens correction.
11. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
12. History of binocular vision abnormality or strabismus.
13. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
14. Suspicion of or recent history of alcohol or substance abuse.
15. History of serious mental illness.
16. History of seizures.
17. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)