cyrilzakka/clinical-trials huggingface dataset:
CKD-828 Drug Interaction Study (Telmisartan)

The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of Telmisartan between free combination of Telmisartan and S-amlodipine and Telmisartan monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Between 20 aged and 50 aged in healthy males
* Weight more than 55kg, BMI 19kg/m2-26kg/m2 at the period of screening
* 100mmHg ≤ sit SBP \< 140mmHg and 60mmHg ≤ sit DBP \< 90mmHg and 50 per/min ≤ Pulse rate \< 95 per/min
* AST, ALT, Total bilirubin \< UNL x 1.5
* Signed the informed consent from prior to the study participation

Exclusion Criteria:

* Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
* Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, hernia repair) affected by the absorption of medications
* galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
* Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of telmisartan or Amlodipine
* drug abuse, or have a history of drug abuse showed a positive for the Triage TOX drug on urine : amphetamine, barbiturate, cocaine, opiates, benzodiazepines, THC(cannabinoids), methadone etc.
* Subject takes herbal medicine within 30 days, ethical drug within 14 days, OTC within 7 days before the beginning of study treatment
* unusual diet affected by the absorption, distribution, metabolism, excretion of medications
* Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
* Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
* Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days
* A heavy caffeine consumer (caffeine \> 5 units/day),
* A heavy alcohol consumer (alcohol \> 21 units/week, 1 unit=pure alcohol 10mL) or cannot stop drinking
* A heavy smoker (cigarette \> 20 cigarettes per day)
* Positive for Hepatitis B, Hepatitis C, HIV or syphilis
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result, EKG result
A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of MSiHy Silicone Hydrogel Soft Contact Lens

This is a prospective, randomized, double-blind, parallel, active-controlled, multi-center clinical study. The purpose is to evaluate the safety and effectiveness wearing "MSiHy Silicone Hydrogel Soft Contact Lens".

Subjects will be randomized in 1:1 ratio to wear either the investigational device "MSiHy Silicone Hydrogel Soft Contact Lens" or the control device Monthly Silicone Hydrogel Contact Lenses(oA)".


Eligibility Criteria:
Inclusion Criteria:

1. Must be 18 years of age inclusive
2. Beside myopia and astigmatism, subjects with normal eyes and are not using any ocular medications (excluding ocular lubricants and artificial tears)
3. Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes
4. With +8.00D \~ -12.00 D spherical component myopia, and ≤1.00 astigmatism (based on manifest refraction measurements)
5. Have worn soft contact lens for at least 2 month prior to the study
6. Willing to comply with the required wearing time
7. Agree to comply with all study procedures, sign and date the informed consent form before starting the clinical study

Exclusion Criteria:

1. Anterior segment infection, inflammation or abnormality
2. Any active ocular disease that would affect contact lens wear or vision (such as acute and subacute inflammation of the anterior chamber of the eye, eye infection, uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epithelium abrasion, dry eye and tear duct defection, ocular allergies, highly suspected glaucoma) upon evaluation by the investigators or slit lamp findings
3. Currently using systemic or ocular medications that would contraindicate contact lens wear (such as glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines)
4. History of herpetic keratitis
5. History of refractive surgery, keratoconus or irregular cornea
6. Slit lamp findings that are not suitable for inclusion (Details of the grading standards for each eye condition are specified in CIP section 5.7.5)
7. A pathologically dry eye (Schirmer test 1 \<5 mm)
8. Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection)
9. Currently pregnant, lactating, or planning to be pregnant during the trial
10. Have experienced discomfort when wearing silicone hydrogel contact lens, or a known allergy to hyaluronic acid and sodium alginate
11. Allergy to any contact lens care product ingredient
12. Corrected visual acuity in either eye does not reach 1.0 when wearing the trial lens
13. Subjects who are judged by the investigators as unsuitable for the study
BOO and DU and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele

Prevalence rates of bladder outlet obstruction (BOO) and detrusor underactivity (DU) and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage II cystocele are important for clinical consultation. Thus, the aim of this study was to elucidate the above findings and between-group associations.

Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20 min pad testing and urodynamic studies in a medical center were reviewed. Only those with complete data of maximum flow rate (Qmax) and detrusor pressure at maximum flow rate (PdetQmax) were enrolled. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. Woman were defined as having DU when Qmax was \<12 mL/s and PdetQmax was \<10 cmH2O, and were defined as having BOO when Qmax was \<12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 20y/o
2. Cystocele \> stage II
3. Complete pad test and urodynamic study

Exclusion Criteria:

1. Pregnancy
2. Urinary tract infection
3. Had received pelvic reconstruction surgery
Acupuncture for Post COVID-19 Condition (Long COVID) Neuropsychiatric Symptoms

In this study, a 12-week pragmatic, randomized, double-blinded clinical trial will be conducted to evaluate the efficacy of acupuncture for the treatment of long Covid neuropsychiatric symptoms and provide reference for clinical non-drug treatment.

This is a pragmatic, randomized, double-blinded clinical trial on acupuncture for treating neuropsychiatric symptoms in long Covid patients. A total of 160 participants will be diagnosed by a registered Chinese medicine practitioner and randomly assigned to the acupuncture and the control group with a 1:1 ratio. The acupuncture group will receive 24 sessions of interventions during a 12-week treatment duration (2 sessions per week) and will be followed up at week 18. The control group will only receive conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

* meet the clinical diagnosis of Long COVID by the World Health Organization (WHO), with no neuropsychiatric symptoms 1 year before infection with Covid-19, and continue to have at least one neuropsychiatric symptom for 2 months after SARS-CoV-2 turned negative 3 months above;
* aged 12 to 80 years;
* willing and able to consent, and complete all assessment and study procedures

Exclusion Criteria:

* patients with a history of chronic neuropsychiatric symptoms;
* cardiovascular diseases pre-existing to the Covid-19 episode such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers;
* documented pre-existing history of psychiatric illness, including substance abuse;
* suicidal tendencies (attempted suicide in the 12 months before the study);
* any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy, tumor);
* those who participated in other clinical trials within one month;
* pregnant or lactating female patients;
* have surgery within two months before the study or will have a scheduled surgery during the study;
* acute brain injury or acute encephalopathy from another etiology than Covid-19 (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity);
* open-heart cardiac surgery or cardiac arrest during the last 6 months;
* patients who received acupuncture treatment 1 month before the start of the study;
* patients who were unable to complete the assessment during screening due to severe mental, cognitive, or emotional impairment
Exercise and Patient Education for Patients With Lateral Hip Pain

This prospective cohort trial will investigate a progressive exercise protocol and patient education for patients with hip abductor tendon pathology. The primary outcome is patient reported pain measured by the revised Copenhagen Hip And Groin Outcome Score (HAGOS), that will be conducted at baseline and at a 12 week follow-up.

This study protocol describes an interventional pragmatic prospective single-group cohort study, where the primary endpoint is change in hip pain measured with the revised HAGOS pain subscale following a 12 week intervention. Throughout the 12 weeks, eight physiotherapist-led exercise sessions will take place at Horsens Regional Hospital (HRH). Further, at the sessions at HRH patient education will be performed by the supervising physiotherapist. The first supervised sessions will be performed in continuation of the baseline assessment. The patients will be instructed to do the exercises daily at home in the time period between the physiotherapist-led sessions.

The primary aim is to investigate changes in patient-reported hip pain based on the subscale "pain" from the revised Copenhagen Hip And Groin Outcome Score (HAGOS) from baseline to 12 week follow-up.

It is hypothesized that the revised HAGOS pain score will improve from baseline to 12 week follow-up.

Secondarily explorative subgroup analyses regarding whether patients with different MRI findings, pain profiles, age, sex and body mass index (BMI) respond differently to the intervention, will be performed.

All outcomes conducted will be published. That is, patient-reported outcomes, muscle strength, functional capacity and adherence to the exercise protocol.

A full study protocol will be published and made available.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* MRI verified HATP
* Lateral hip pain duration \> 6 months
* Ability to read and understand Danish.

Exclusion Criteria:

* Corticosteroid injection in the affected hip joint within the last six weeks prior to the intervention
* Previous bone-related surgery to the affected hip,
* Signs of bilateral HATP
* X-ray verified hip osteoarthritis
* Pregnancy
Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance

The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in cardiac function after 12 months of pacing in patients with pacing leads placed in different positions within the right ventricle (apically or septally).

Prolonged pacing from the right ventricular (RV) Apex has been shown to be associated with progressive left ventricular (LV) dysfunction. This has led to an interest in alternative right ventricular pacing sites. Only very few studies investigated the effect of alternative right ventricular pacing sites using three dimensional imaging. Using cardiac MRI volumetric left- and right ventricular analysis and three-dimensional reconstruction is more accurate compared to trans-thoracic echocardiogram. St. Jude Medical has developed a MRI conditional pacemaker system enabling for the first time to investigate alternative pacing sites using cardiac MRI.

Patients already implanted with an MRI conditional pacemaker system from St. Jude Medical will be enrolled in that study and subdivided into 4 groups (right ventricular pacing lead positioned apically or septally subdivided in patients paced for \<50% of time or 50% or more). All patients will undergo cardiac MRI at enrollment and again 12 months later. Patients paced \<50% of the time will undergo cardiac MRI with and without pacemaker stimulation at both visits.

Eligibility Criteria:
Inclusion Criteria:

* Have been implanted with an Accent MRI pacemaker and Tendril MRI leads.
* Have an RV lead implanted apically (group A) or septally (Group B)
* Are RV paced for \<50% of the time (groups A2 and B2)
* Are RV paced for \> 50% of the time (Groups A1 and B1)
* Are ≥ 18 years of age.
* Are able to provide written informed consent.
* Are willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion Criteria:

* Have permanent atrial fibrillation with preserved intrinsic conduction
* Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
* Have a lead extender, plug or adaptor.
* Do not have an RV lead implanted apically or septally.
* Are eligible for groups A1 or B1 but appropriate group already has 20 patients enrolled.
* Are eligible for groups A2 or B2 but appropriate group already has 5 patients enrolled
* Are currently participating in another device or drug investigation which includes an active treatment arm.
* Are pregnant or planning to become pregnant during the duration of the study.
* Have a life expectancy of less than 12 months from Screening due to any life-threatening condition.
* Are contraindicated for an MRI scan due to any other reason.
Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers

The purpose of this research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects.

The purpose of this research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects. The primary research procedures are:

Subjects will be randomized into either BFR or conventional strengthening groups.

BFR and conventional strengthening programs will be implemented. Force plate and force frame data will be collected at baseline, 4, 6, 8, 12, and 16 weeks.

Subject Population. The study will enroll 18 healthy volunteers. The study includes 6 visits.

The total study duration for each subject is 16 weeks.

The device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be "subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers without history of knee pathology requiring physical therapy or surgery
* Individuals between 18 and 40 years old

Exclusion Criteria:

* History of venous thromboembolism or other hematologic disorder Pregnant
* Coronary artery disease, peripheral arterial disease, or hypertension (\> 140/90 mmHg)
Comparison of Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy Versus Percutaneous Radiofrequency Ablation

To date, the majority of studies that have evaluated the efficacy of microwave ablation (MWA) in the treatment of hepatocellular carcinoma (HCC) lesions in cirrhotic patients and compared its efficacy with that of percutaneous radiofrequency ablation (RFA) for local recurrence and survival have been retrospective. There have been no prospective randomized studies comparing percutaneous microwave ablation (PMWA) with RFA for ablated tumour volume, the response after one session, local recurrence rates in the first year, complication rates and survival at 3 and 5 years for HCC lesions \> 2 cm in patients with Child-Pugh A and B cirrhosis. The hypothesis the investigators wish to explore is that though the 2 methods are equivalent for lesions ≤ 2 cm, MWA could show better efficacy with a similar risk for lesions \> 2 cm and for lesions close to vessels ≥ 3 mm in diameter, as shown in retrospective studies.


Eligibility Criteria:
Inclusion Criteria:

* Patient who have been informed about the research and given their oral consent
* Patients with national health insurance cover
* Patients ≥ 18 years
* ≤ 3 CHC lesions ≤ 4 cm, with a maximum of 3 lesions with a diagnosis of HCC based on histology, or according to European Society for the Study of the Liver (EASL) criteria
* Chronic liver disease or cirrhosis with a Child-Pugh score between 5 and 8 points
* Contra-indication for surgical resection at the time of the therapeutic decision made during a multidisciplinary meeting

Exclusion Criteria:

* Informed consent not obtained (refusal of patient or patient lacking discernment)
* Kidney failure with creatinine clearance \< 30 ml/min thus preventing the injection of contrast for the initial or follow-up radiological imaging
* Presence of a malignant tumour other than the HCC at the time of the diagnosis, unless a basocellular carcinoma
* Cirrhosis with a Child-Pugh score \> 8
* Contra-indication for percutaneous treatment according to Barcelona Clinic Liver Cancer (BCLC) criteria
* Patients without national health insurance cover
Ultrasound-Guided Continuous Sciatic Nerve Blocks: Popliteal Versus Subgluteal Catheters

To determine the relationship between perineural catheter location along the sciatic nerve (popliteal versus subgluteal placement) and infusion effects for ultrasound-guided continuous sciatic nerve blocks.


Eligibility Criteria:
Inclusion Criteria:

* undergoing foot surgery with a sciatic perineural catheter for postoperative analgesia
* spending the first postoperative night hospitalized
* age 18 years or older

Exclusion Criteria:

* pregnancy
* inability to communicate with the investigators and hospital staff
* incarceration
* clinical neuropathy in the surgical extremity
A Comparative Analysis of Two Types of Exercise on Outcomes Following Total Knee Arthroplasty

The purpose of this study was to compare the effects of two exercise programs, using low velocity (LV) and high velocity (HV) contractions, on outcomes of individuals who have undergone total knee arthroplasty (TKA). The experimental hypothesis was that individuals performing HV exercise, compared to LV, would exhibit superior outcomes.

The most effective type of exercise has not been identified for individuals who undergo total knee arthroplasty (TKA). High velocity (HV) exercise when compared to low velocity (LV) exercise produces greater gains in power and certain functional activities in older adults. The use of HV exercise for patients who undergo TKA has not been investigated.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 60- 89 years of age.
* primary unilateral TKA 10-21 days prior to the outpatient PT evaluation
* received inpatient rehabilitation at Helen Hayes Hospital

Exclusion Criteria:

* Any other lower extremity joint or back pain (not inclusive of recent Total knee arthroplasty) rated greater than four out of ten with weight-bearing
* any other lower extremity joint replacement surgery
* diagnosis of osteoporosis with history of fractures, uncontrolled hypertension, unstable cardiac or pulmonary problems, neurological disease affecting motor control, uncontrolled diabetes
* chest pain or shortness of breath on stair-climbing
* requirement of human assistance to walk in addition to the ambulation device
* inability to follow instructions to perform testing and/or exercise,
* participants who stated that they would not be available to complete 12 exercise sessions
* individual adherence with performance of a home exercise program (HEP) less than five of seven days at the end of the treatment period
SPME For Metabolomics And Concomitant Measurements Of Rocuronium Bromide Levels In Liver Transplantation

Standard anesthetic management of liver transplantation patients includes a general anesthetic using multiple drugs, including the neuromuscular relaxant rocuronium. Pharmacokinetic modelling of this agent has been poorly described during liver transplantation, which impacts on appropriate dosing of this agent within this population where plasma concentrations can vary with fluid shifts and hepatic drug metabolism during the various phases of liver transplantation. Plasma drug and drug metabolite concentrations will be measured using the technique of solid phase micro-extraction (SPME). Measuring and correlating the levels of rocuronium and other liver metabolites with the degree of post transplantation hepatic dysfunction may serve as a simple and cost-effective marker to aid diagnosis, identify those at risk of hepatic dysfunction and potentially grade the severity


Eligibility Criteria:
Inclusion Criteria:

* First time liver transplant recipients above 18 years of age
* Elective cadaveric or living donor liver transplant patients will be recruited

Exclusion Criteria:

* All patients under 18 years of age
* Unable to give consent
Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects

This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of PB-119 in drug-naïve subjects with T2DM.

Subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week run-in period and a 12-week double-blind treatment period,4-week follow up period. The eligible patients will be randomized to 1 of 3 dose cohorts (A, B, or C). Each patient will subsequently be randomized within the designated cohort to active drug or placebo at a 3:1 active drug:placebo ratio.

Eligibility Criteria:
Inclusion Criteria:

1. Males and/or females between the ages of ≥18 and ≤70 years at Screening
2. Patients in whom T2DM has been diagnosed according to 1999 WHOT2DM diagnostic criteria
3. HbA1c ≥7.5% and ≤11% at Screening and at Week -1
4. Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at Screening

Exclusion Criteria:

1. Female who is pregnant, intends to become pregnant or breast-feeding or is of child-bearing potential and not using adequate contraception methods throughout the trial
2. Treatment with any glucose lowing agent(s) within 3 months prior to screening.An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness
3. Calcitonin ≥50 ng/L at screening
4. Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2
5. Fasting triglyceride ≥500 mg/dL at Screening, or patients with a history of lipid disorders taking unstable treatment dosage (eg, statins) within 3 months prior to screening
6. Any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this trial
7. Blood amylase or lipase \>3x ULN, history of acute or chronic pancreatitis, or history of symptomatic gallbladder disease at Screening
8. Serum creatinine ≥1.5 mg/dL (male patients) or ≥1.4 mg/dL (female patients), or estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m2 at Screening
9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2x upper limit of normal (ULN) at Screening and pre-randomization
10. Severe cardiovascular diseases occurring within 6 months prior to screening