cyrilzakka/clinical-trials huggingface dataset:
A Food Effect Study of Apatinib Mesylate in Healthy Subjects

The primary objective of the study was to assess the effect of high-fat and low-fat meal on the pharmacokinetics of apatinib mesylate in Chinese adult healthy subjects.

The secondary objective of the study was to assess the safety of apatinib mesylate administered in adult healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. 18-45 years of age, male or female, each gender should be more than 1/4 of the whole sample size.
2. The weight of male subject ≥50kg, weight of female subject ≥45kg, 19≤BMI≤28kg/m2
3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG;
4. Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;
5. Able to comprehend and willing to sign an informed consent form (ICF)

Exclusion Criteria:

1. History of drug allergy, or allergic to apatinib or ingredients;
2. Drinking 14 units of alcohol per week within 6 months prior dosing(1 unit = 360 mL of beer, or 150mL of wine) ;
3. Take any prescription or traditional Chinese medicines within four weeks prior dosing; take any over-the-counter medication, vitamin products within two weeks before dosing;
4. Take any clinical trial drugs within 3 months prior dosing;
5. Participate in blood donation within 3 months before screening and donate blood volume ≥400mL or blood loss ≥400mL, or receive blood transfusion; or donate blood volume≥200mL or blood loss ≥200mL within 1 month prior dosing.
6. Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
7. Anyone who refuse to stop ingest foods or drinks containing caffeine, xanthine or alcohol from 48 hours before dosing to the end of the study;
8. Anyone who refuse to stop ingesting grapefruit or grapefruit-containing products from 7 days before dosing to the end of the study;
9. The investigator believes that the subjects are not eligible to participate in this trial.
Clinical Outcome After Implantation of Two Different Multifocal Toric IOLs: Liberty (677MTY) and PanOptix®

This study is to compare the rotational stability, visual outcome and patient satisfaction after implantation with either Liberty 677MTY, a multifocal diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. (Zsámbék, Hungary) or the multifocal toric IOL PanOptix®, manufactured by Alcon.

According to numerous estimations, 15% to 29% of patients with cataract have more than 1.5 diopters of refractive astigmatism. Corneal astigmatism can be reduced with a variety of surgical techniques including selective positioning of the phacoemulsification incision, corneal relaxing incision, implantation of toric IOLs, photorefractive keratectomy and there are first results of implantation of short arc-length intrastromal corneal ring segments for correcting astigmatism and myopia . The use of toric IOLs to reduce visually significant keratometric astigmatism offers a rational, more predictable and stable method of refractive correction. Implanting a toric intraocular lens offers the possibility of correcting not only spherical equivalent of refraction, but also astigmatism. The success of a toric IOL can be judged not only by its ability to reduce refractive astigmatism immediately postoperatively, but also by its ability to maintain a stable position in the capsular bag in the longer term. Even a small rotational deviation of the toric IOL from its intended axis can result in large reduction of the astigmatic correction.

The purpose of this study is to evaluate and compare the visual outcomes, spectacle independency, visual disturbances (glares, halos), neuronal adaptation and patient satisfaction after implantation of either the Liberty 677MTY (a multifocal diffractive apodized toric intraocular lens- diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. Zsámbék, Hungary) or the multifocal toric PanOptix® IOL, manufactured by Alcon.

Eligibility Criteria:
Inclusion Criteria:

The enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt.

Exclusion Criteria:

* astigmatism less than 1 dpt
* irregular astigmatism
* diabetic retinopathy
* iris neovascularisation
* serious intraoperative complications
* congenital eye abnormality
* glaucoma
* pseudoexfoliation syndrom
* amblyopia
* uveitis
* long-term anti-inflammatory treatment
* AMD (advanced AMD)
* retinal detachment
* prior ocular surgery in personal medical history
* corneal diseases
* severe retinal diseases (dystrophy, degeneration)
* severe myopia (if required IOL power is lower than 10 D)
* inadequate visualization of the fundus on preoperative examination
* patients deemed by the clinical investigator because of any systemic disease.
* eye trauma in medical history intraoperative exclusions:
* tear in capsulorhexis
* zonular dehiscence
* posterior capsular rupture
* vitreous loss and other unexpected surgical complication
A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function

The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild, moderate, or severe liver function impairment compared to participants with normal liver function. The study will also evaluate how well lepodisiran is tolerated and what side effects may occur in these participants.

The study will last up to approximately 9 weeks, excluding screening.


Eligibility Criteria:
Inclusion Criteria:

* Have a body weight of 55 kilogram (kg) or more and body mass index within the range 19.0 to 42.0 kilogram per square meter (kg/m²)
* Additional Inclusion Criteria for Participants Without Hepatic Impairment in Group 1:

  * Healthy participants with clinically normal hepatic function
* For Participants with Mild to Severe Hepatic Impairment in Groups 2 through 4:

  * Participants with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment). Diagnosis of chronic hepatic impairment of greater than 6 months, per physician diagnosis and standard-of-care practice

Exclusion Criteria:

* Have significant history of, or current, cardiovascular (CV), respiratory, hepatic (hepatic applies to Group 1 only), renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Have severe atopy or a history of clinically significant multiple or severe drug allergies
* Have known allergies to lepodisiran, related compounds, or any components of the formulation
* Have a history of, or current, psychiatric disorders
* Have had any malignancy within the past 5 years
* Have estimated glomerular filtration rate (eGFR) less than 60 milliliters per minute per 1.73 m² (mL/min/1.73 m²) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
* Have participated, within the last 1 month, in a clinical study involving an investigational product
Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)

In phase II, the main objective is to evaluate the efficacy of SHR-A2102 combined with Adebrelimab in the treatment of muscular invasive bladder cancer (MIBC); The main objective of phase III is to evaluate the efficacy of SHR-A2102 for injection combined with Adebrelimab compared with gemcitabine combined with cisplatin in the treatment of muscular invasive bladder cancer (MIBC).


Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years old, gender not limited.
2. The patient voluntarily joined this study and signed informed consent
3. ECOG score is 0 or 1
4. Expected survival period ≥ 2 years.
5. Pathology and imaging diagnosis of non metastatic muscle invasive bladder cancer
6. There are assessable lesions that meet the RECIST 1.1 criteria
7. Enough organ function

Exclusion Criteria:

1. Received systemic anti-tumor therapy 4 weeks before starting the study treatment
2. The toxicity and/or complications of previous anti-tumor treatments have not recovered to NCI-CTCAE ≤ 1 level
3. Subjects known or suspected to have interstitial pneumonia
4. Individuals with any active, known or suspected autoimmune diseases
5. There are clinical symptoms or diseases of the heart that have not been well controlled
6. Diagnosed with any other malignant tumor
7. Subjects who have experienced severe infections within 28 days prior to their first medication use
8. History of immunodeficiency
9. Use of attenuated live vaccine within 28 days prior to the first study medication
10. Have undergone major surgery within 28 days prior to the first administration of medication
Studying Survivorship Care Plans in Head and Neck Cancer

The study will focus on survivorship care for head and neck cancer patients cared for within Duke Cancer Center clinics. Standardized survivorship care plans (sSCP) are being implemented based on the American Society for Clinical Oncology's criteria. These documents provide a summary of treatment received, and list side effects and follow-up information after cancer treatment. Taking advantage of this transition, the investigator will study three groups of patients: (a) early survivors treated before the sSCP was implemented, (b) early survivors treated after the sSCP was implemented, and (c) current patients who will receive an individualized enhanced SCP (eSCP), which will include additional information tailored to patient preferences. The investigators hypothesize that patients receiving enhanced survivorship care plans will increase their knowledge regarding their health care plan and wellness trajectory; increase their ability to identify the symptoms they most likely can expect as a result of their cancer treatment; and be more likely to engage in conversations with their PCP about healthy behaviors and screening guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Completed treatment for a head or neck cancer at Duke Cancer Center within 4 months of consent OR
* Will complete treatment for a head and neck cancer at Duke Cancer Center within 3 weeks of consent AND
* Able to read and understand English
* Capable of giving informed consent
* Are at least age 18.

Exclusion Criteria:

* incompetent for interview (documented diagnosis of active psychosis or dementia) or unable to provide informed consent as assessed by the interviewer; or too sick to participate, as judged by a member of the research team
Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint

The study evaluates implant survival in total joint arthroplasty of the Trapeziometacarpal (TMC) joint by monitoring the survival of different implant types using radiostereometry (RSA) evaluation of the implants.

The study evaluates implant survival and clinical outcome in total joint arthroplasty of the TMC joint. Different implant designs are included in the study both cemented and uncemented implants. Also the influence of patient factors and surgical technique on implant survival is investigated. The primary outcome is implant migration and loosening. Evaluation is done by monitoring migration and loosening of different implant types using RSA evaluation of the implants. Secondary outcomes are patient reported function evaluated with the Disability of the arm, shoulder and hand score (DASH) and visual analog pain score (VAS). Tertiary outcome is range of movement (ROM) plus grip strength.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Eaton type 2+3 TMC osteoarthritis

Exclusion Criteria:

* Patients with Eaton type 4 TMC osteoarthritis
Fatigue in Dystonia (a Single Session, Questionnaire-based Study of Fatigue in Dystonia)

The purpose of this study is to determine how common fatigue and sleepiness are in patients with dystonia.

The purpose of the study is to determine the prevalence of fatigue in patients with dystonia. There are many factors which may impact fatigue but perhaps the most important of these is sleep. It is therefore critical that we collect data on sleep habits and sleepiness to help interpret our data on fatigue. We will be using the Epworth Sleepiness Scale to assess daytime somnolence and the Parkinson's Disease Sleep Scale to assess the presence or absence of common sleep disorders affecting patients with movement disorders along with the Multidimensional Fatigue Inventory and the Fatigue Severity Scale.

Eligibility Criteria:
Inclusion Criteria: diagnosis of dystonia

* Informed consent to be contacted about research

Exclusion Criteria:

* None
Low Power Laser and Exercise in Osteoarthritis of the Knee: a Randomized Clinical Trial

Indroduction: Knee osteoarthritis (OA) is a painful condition causing disability, weakness and poor quality of live. The results are very consistent about the benefits of laser and exercises to improve pain and function in subjects with knee osteoarthritis Objectives: To investigate the effects of Low Power Laser (LBP) associated with exercise in pain, function, range of motion, muscle strength and quality of life of patients with knee osteoarthritis.

Methods: Forty patients of both sexes aged between 50 and 75 years with knee osteoarthritis (grade 2-4) were randomized into two groups: Laser-LBP-active dose of 3J more exercises and Group Placebo-LBP- placebo and exercise. Were evaluated for pain, function, range of motion, muscle strength and quality of life on three occasions: before starting treatment (evaluation 1), 3 weeks after laser application (evaluation 2) and 8 weeks after completion of exercise (evaluation 3). There were 33 physical therapy sessions three times a week, on March 1 and the laser was applied in the other, only the exercises.

Pain: Pain intensity was measured with the Visual Analogue Scale (VAS) which is a straight 10 cm long devoid of numbers, in which there is only an indication of the extreme left of "no pain" and extreme right to "unbearable pain". The higher the score, the greater the pain.

Feature: Survey conducted by Lequesne, which is an index composed of 11 questions about pain, discomfort and function. The scores range from 0 to 24 (without affecting the extremely severe, respectively), the higher the score, the greater the impairment.

Range of motion (ROM): ADM flexion and knee extension was measured using a universal goniometer (AESCULAP) with the patient prone second methodology Marques.

Muscular Strength: To assess the maximal isometric strength of the quadriceps muscle was used Dynamometer model Lafayette ® Portable (USA), while seated at 60 ° of knee flexion and this gradation was controlled with a goniometer. Patients remained seated on the stretcher and held steady with thigh extension strength, the dynamometer being maintained in the distal leg. Three measurements were taken, and the mean value.

Quality of Life: The Questionnaire was used Western Ontario and McMaster Universities Osteoarthritis (WOMAC)a self-assessment that evaluates pain, stiffness and physical activity. The higher the score, the greater the impact of OA on quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnoses of osteoarthritis
* Knee pain
* Functional reduction in the last three months
* Grade 2-4 OA
* Fulfilled at least one of the classification criteria of the American College of Rheumatology

Exclusion Criteria:

* Cancer
* Diabetes mellitus
* Symptomatic hip OA
* Antidepressants
* Anti-inflammatory steroidal and nonsteroidal or tranquilizers in the last six months and throughout the treatment
Neurophysiological Effects of Dry Needling in Patients With Neck Pain

The present study aims to evaluate the differences that may be experienced in pain and cervical disability, before, during and just after the intervention of the Deep Dry Needling in the upper trapezius muscle in active, passive myofascial trigger points (MTP) or non-MTP in Patients with neck pain, assessing, in turn, the neurophysiological effects on the Autonomic Nervous System.

Hypothesis: Deep Dry Needling of active myofascial trigger points produces a greater decrease of pain and cervical disability index and increase of pressure pain threshold; Than the Deep Dry Needling of Myofascial Trigger Points latent or out of Myofascial Trigger Points in patients with chronic neck pain.

Objective: To determine the efficacy of Deep Dry Needling applied on Active Myofascial Triggers (MTP) vs. latent MTP versus MTP, on pain reduction and cervical disability, in patients with chronic neck pain attributable to Myofascial Pain Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Non-specific neck pain, unilateral or bilateral.
* Neck pain ≥ 3 months of duration.
* Presence of active and latent MTP in the upper, left, right or bilateral trapezius muscle, in relation to the patient's neck pain.
* Clinical criteria recommended to identify active and latent MTP:

  1. Tensile band palpable.
  2. Exquisite local pain at the pressure of a taut band node.
  3. Recognition by the patient of their usual pain when pressing on the sensitive nodule (to identify an active MTP).
  4. Painful limitation of range of mobility to complete stretching. It is considered positive when 3 of the 4 clinical criteria are found.

Exclusion Criteria:

* Unsurpassed fear of needles.
* Coagulation disorders.
* Specific alterations of the cervical region in the clinical history.
* Infiltration of corticosteroids or local anesthetics during a year before the study.
* Surgical intervention of the cervical region or previous shoulder.
* Skin lesions in the area, as well as infection or inflammation.
* Taking analgesic, anti-inflammatory or anticoagulant medication the week before the study.
* Treatment of MTP or Deep Dry Needling in the neck region in the 6 months prior to the intervention.
* Cognitive deficit in the medical history.
Spectrum of Serum Sodium Disturbances in Patients With Non-sellar/Suprasellar Supratentorial Tumors

This study was designed to quantify the incidence of hyponatremia in patients of supratentorial/supra-sellar lesions and observe their effect on neurological morbidity and mortality.

Disorders of sodium and water balance are one of the commonly encountered problems while managing patients with neurological diseases. Managing such problems are challenging because the pathophysiology behind these disorders are complex and poorly understood and treatment of the injured brain itself can contribute to, and complicate the diagnosis of sodium disorders. Serum sodium disturbance can manifest as hypernatremia or hyponatremia. Hypernatremia usually occurs in the diabetes insipidus syndrome, whereas hyponatremia develops as a syndrome of inappropriate secretion of antidiuretic hormone (SIADH) or cerebral salt-wasting syndrome (CSWS).

Because of the cerebral effects of hyponatremia, neurosurgical patients are at increased risk of complications including severe cerebral edema, mental status changes, seizures, vasospasm, and death.

Though the problem of hyponatremia has been addressed in patients with different brain pathologies, this has not been studied in patients with non-sellar/suprasellar supratentorial tumors. This study was envisioned to quantify the incidence and magnitude of hyponatremia in this patient population and their subsequent neurological morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing surgical management for supratentorial/suprasellar tumors.

Exclusion Criteria:

Glasgow Coma Score (GCS) \<4.
Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome

Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. One hundred post-menopausal women from 50 to 60 years old, affected by metabolic syndrome (criteria are described in NIH ATP III) will be randomized into two groups: 50 treated with myo-inositol 2 g twice per day and fifty treated with metformin for six months. Metformin is the drug usually used in diabetic and pre-diabetic conditions, as metabolic syndrome. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance as well as metformin.

OUTCOME MEASURE: HOMA-IR, blood pressure level, serum triglycerides and cholesterol, BMI and waist circumference


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal outpatients affected by the metabolic syndrome, whose criteria are described in NIH ATP III, 2001.

Exclusion Criteria:

* Post-menopausal outpatients without metabolic syndrome
* assumption of hypocholesterolemic or other insulin sensitizing drugs
Ventricular Reversed Remodeling After LTX in PAH Patients

The investigators will evaluate ventricular reversed remodelling after double lung transplantation (LTX) in patients with pulmonary arterial hypertension (PAH), measured with cardiac magnetic resonance imaging (MRI). Reversed remodelling will be compared with control patients without PAH (e.g. Cystic Fibrosis) who will also undergo LTX.

In this study, pre-LTX and six-months post-LTX measurements will be compared with each other and between the primary and control group.

Pre- and post-LTX measurements include:

Past medical history: Including basic diagnosis; interventions, surgery and transplant related complications (re-operations, hospitalizations, infections) and medication history; These data will be collected by studying the medical files including surgical reports.

Present medical history: Including NYHA class.

Physical examination: Including length and weight.

Cardiac Magnetic Resonance Imaging:

* Ventricular volume, function and mass measurements
* Flow measurements of the pulmonary artery and aorta
* Disease specific measurements (e.g. septal bowing, RV trabecularisation, etc.)
* T1-mapping

Transthoracic Echocardiography

Resting ECG: Disease specific electrophysiological findings (e.g. QRS-duration, right bundle branch block).

Laboratory evaluation:

* NT-pro-BNP
* eGFR
* Remaining serum will be stored.

Eligibility Criteria:
Inclusion criteria:

* Patients who are on the waiting list for double-LTX, in our institution, for pulmonary arterial hypertension.
* Eligible for CMR imaging
* No claustrophobia
* No pacemaker, ICD, etc.
* Informed consent

Exclusion criteria:

* Inability to comply with primary endpoint measures.
* Body mass index ≥40 kg/m2.
* Pregnant patients will not be included, they may be included \>3 months after pregnancy.
* Patients with age \<18 years.