cyrilzakka/clinical-trials huggingface dataset:
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Healthy Volunteers

This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin administered as an individual tablets with repaglinide and metformin administered as a combination tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers (female not pregnant, lactating or breastfeeding)
* BMI (Body Mass Index) between 19-29 kg/m\^2, both inclusive
* Fasting plasma glucose from 70-115 mg/dl
* Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data

Exclusion Criteria:

* Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease
* Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening
* Positive results on Screening for Hepatitis B surface antigen, Hepatitis C antibody and HIV (human immunodeficiency virus) antibody
* Positive results on the drug abuse/alcohol screen
* Any regular use of prescription or nonprescription drugs, including mega-vitamin, health food or dietary supplement regimens, with the exception of contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product administration) and for the duration of the study
* Subject is currently a smoker (more than one cigarette per day or equivalent)
* Use of grapefruit or grapefruit juice within 7 days of trial product administration
* Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing
CD19-targeting CAR T Cells for B Cell Lymphoma

The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory CD19+ B-cell lymphoma.
2. Measurable disease.
3. Performance status ECOG 0-2.
4. Age:18-80.
5. Fertile females/males must consent to use contraceptives during participation of the trial.
6. Signed informed consent

Exclusion Criteria:

1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
2. Patients with primary CNS lymphoma.
3. Known human immunodeficiency virus (HIV) infection.
4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
7. Patients that do not consent to that tissue and blood samples are stored in a biobank.
8. Pregnancy.
Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion

Colloid solution is generally used to maintain intravascular volume. It is reported to impair blood coagulation in vivo and in vitro more than crystalloid does by prolonging coagulation time and decreasing clot strength. The formed fibrin clot is more vulnerable for fibrinolysis in a case of using colloid. Dilution of plasmin in vitro with colloid enhances fibrinolysis primarily by diminishing α2-antiplasmin-plasmin interaction.

Tranexamic acid is an antifibrinolytics that competitively inhibits the activation of plasminogen, by binding to specific site of both plasminogen and plasmin, a molecule responsible for the degradation of fibrin, a protein that forms the framework of blood clot. It is used to treat or prevent excessive blood loss during surgery and in other medical conditions. Gastrointestinal effect, dizziness, fatigue, headache, hypersensitivity reaction, or potential risk of thrombosis is reported as the adverse effect of tranexamic acid.

We hypothesized that inhibition of plasmin by tranexamic acid after colloid administration can improve the colloid-induced clot strength impairment.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total hip replacement arthroplasty, who are diagnosed with the avascular necrosis of femoral head or degenerative arthritis of hip
* American Society of Anesthesiologist I or II

Exclusion Criteria:

* Patients receiving an intraoperative transfusion
* Patients receiving thrombin
* Patients having venous thromboembolism
* Patients having renal or hepatic disease
* Patients having coagulopathy
* Patient having heart failure
Patient Guided Psychiatric Admissions

To meet the requirement for increased patient involvement, several Community Mental Health Centres (CMHC) have initiated a service called "patient-guided admissions". The investigators will compare a group with "patient guided admission/self-referral to inpatient beds" with a group having treatment as usual.

It is expected that patients in the intervention group will experience more increased feeling of coping (patient activation) after 4 months and 12 months as a result of participating in "patient-guided admissions" than patients getting treatment as usual. In addition the total number of inpatient days either in the CMHC, psychiatric hospital or community rehabilitation centre is expected to be clearly lower in the intervention group than in the 'treatment-as-usual' group during one year after intake. Also the number of involuntary admissions either as inpatient or outpatient will be significant lower in the intervention group than the 'treatment-as-usual' group.The number of admissions in CMHC and psychiatric hospital, as well as the number of outpatient consultations in primary care, CMHC and psychiatric hospitals, will be lower in the intervention group than in the 'treatment-as-usual' group. Patients in the intervention group will experience improved mental health, increased feeling of coping (patient activation) and increased experience of recovery after 4 months and 12 months as a result of participating in "patient-guided admissions".

Participants will be patients with psychosis or bipolar disorders. Patients in the intervention group will have a contract on "self-referral to inpatient beds" for one year. They can call the CMHC directly and ask for a bed for until 5 nights.

The patients in the 'treatment-as-usual' group will follow common procedures by either contacting their general practitioner, emergency department or duty doctor, and they will be offered a "self-referral to inpatient bed" contract after a year if they satisfy the inclusion criteria.

Regardless of the participation in the intervention group, the patients can also be ordinary admitted during the project period by a doctor via regular procedures in both hospital and CMHC if there is a need for this. All admissions will appear in the register data.

Eligibility Criteria:
Inclusion Criteria:

* schizophrenia or bipolar disorder
* long term care
* established relationship with the ward

Exclusion Criteria:

* extensive substance use problems
* self-destructive behavior
* not able to consent
Effect of Verapamil as an Adjuvant to Local Anaethetics in Supraclav Block for Hand Surgery

The aim of this study is to evaluate the role of verapamil when added to bupivacaine in ultrasound-giuded supraclavicular Brachial plexus block regarding the duration of action of the block, onset of action and the need of rescue analgesia.

Preoperative Period All patients will clinically be assessed and routine preoperative investigations will be done: Complete blood picture, Coagulation profile, liver function tests, kidney function tests, fasting blood sugar and ECG. The initial vital data will be measured after applying the standard monitoring including pulse oximetry, non-invasive blood pressure and ECG. All patients will be admitted after fasting for 6 hours.

Intraoperative Period On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. Baseline parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), and oxygen saturation (SpO2) will be recorded. Intravenous (IV) line will be inserted and IV lactated Ringer will be started.

The block will be performed using a portable ultrasound system (sonosite M-turbo USA) with linear high-frequency transducer (12HZ) to get the sonographic anatomy of brachial plexus in the transverse and longitudinal planes.

Under aseptic conditions, the ultrasound probe will be situated parallel to the clavicle in the supraclavicular area to show the plexus as a "bunch of grapes" or as having a "honeycomb" appearance. The block will be done with a short beveled echogenic needle 5 cm, 22 G for optimal control and visibility. The predetermined volume of 22 ml will be injected around the brachial plexus after negative aspiration to avoid inadvertent intravascular injection keeping in mind adequate block of lower trunk. Distension of brachial plexus sheath will be regarded as an indication of successful block "Donut sign". A massage for 5 min will be applied to aid an equal volume distribution.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 21-70 years old
* Patients with ASA I / II
* patients undergoing hand surgeries

Exclusion Criteria:

* Patients refusal
* Skin infection at the injection site.
* Contraindications to regional anaesthesia as bleeding disorders
* Allergy to bupivacaine or other drugs involved in the study.
* Uncooperative patients.
* BMI \>35
* Patients taking medications for psychiatric illness
Sevoflurane/Dexmedetomidine Vs. Isoflurane for Pediatric Emergence Delirium

The purpose of this study is to measure the incidences of pediatric emergence delirium between the group receiving Isoflurane and the group receiving Sevoflurane plus intravenous push dexmedetomidine.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 2-7 years.
* Surgeries include ENT cases (i.e., tonsillectomy/adenoidectomy), ophthalmology cases (i.e., strabismus), and urology cases.
* Can be outpatient or General Care inpatient procedures.
* All cases must include an IV and an endotracheal tube (ETT).

Exclusion Criteria:

* Severe developmental/cognitive delay (unable to make eye contact, nonverbal, or inability to interact with providers for PAED scale assessment requirements)
* TIVA cases.
* No PIV in place during the case, planned PICU admission postoperatively.
* Previous history of severe emergence delirium documented by a provider (via interventions or explicitly stated).
Home-Based Walking Study in Older Adults With Type 2 Diabetes

Older persons with diabetes have a harder time maintaining blood pressure when standing up. When blood pressure drops when standing up, fainting may occur. This study will see how regular exercise can improve the ability of the body to keep blood pressure up when standing. We want to see how this improvement varies with a home-based walking program.

Detailed Summary

1. PURPOSE: Older adults with diabetes faint frequently, due to an impairment in the cardiovascular control mechanisms (arterial baroreceptor function, autonomic nervous system function and cerebral autoregulation) that prevent syncope. The purpose of this study is to examine the ability of a home based walking program to reverse these impairments.
2. HYPOTHESES: a) A home-based walking program will improve the compensatory cardiovascular responses that prevent syncope in older adults with Type 2 diabetes. A moderate, regular exercise program will:

   * increase arterial baroreflex sensitivity
   * increase heart rate variability (marker of autonomic nervous system function)
   * decrease cerebrovascular resistance
   * improve cerebral autoregulation during upright tilt. b) There will be relationship between the improvement in compensatory cardiovascular responses and regular exercise.

     c) Design of more practicable training prescriptions than that used in a research setting.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 5 years treated with diet alone or oral agents
* Nonsmoker for at least 5 years
* Subjects must be sedentary (as defined by no strength training and less than 30 minutes brisk walking/moderate exercise per week and no vigorous exercise in the preceding 6 months)
* All subjects will have a fasting glucose of \<12 mM and a hemoglobin A1c \< 8.5%
* Orthostatic hypotension defined as a decrease in systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of assuming an upright posture on the initial screening visit as per current American Academy of Neurology guidelines.

Exclusion Criteria:

* Abnormalities on complete blood count, electrolytes or creatinine, on resting ECG, treadmill exercise stress test
* Significant pulmonary, exercise-limiting orthopedic or neurological impairment
* Evidence of valvular disease, exercise-induced syncope, angina, arrhythmias or peripheral vascular disease
* Poor blood pressure control as defined as systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg
* Total cholesterol/HDL cholesterol greater than or equal to 5.0 or LDL cholesterol greater than or equal to 4.21 mmol/L
* Peripheral neuropathy severe enough to cause discomfort (for safety reasons)
* Overt diabetic nephropathy excluding subjects with a urine albumin to creatinine ratio of greater than 2.0 in men or 2.8 in women
* Diabetic retinopathy
Thigh Swelling, Hip-muscle Strength, and Functional Performance Following Total Hip Arthroplasty

By this study the investigators wish to (1) quantify hip strength and functional-performance deficits at discharge after fast-track total hip arthroplasty (THA), and (2) investigate if changes in thigh circumferences, or hip pain are correlated to changes in hip strength and functional-performance after fast-track THA.

The investigators intend to use the results to optimize the rehabilitation programs for THA patients shortly after surgery

Eligibility Criteria:
Inclusion Criteria:

* Total hip arthroplasty patients

Exclusion Criteria:

* inability to speak and understand Danish
* inability to perform the functional measurements due to other conditions
Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction

Photodynamic therapy (PDT) is a palliative treatment for malignant biliary obstruction. The aim of this study is to assess the feasibility and safety of this technique in the context of a nationwide retrospective analysis.

INTRODUCTION

Malignant biliary obstruction is a life threatening condition in patients suffering from primary or secondary bile duct malignancies. Palliative therapies aim to prevent complications associated with the obstruction. Photodynamic therapy (PDT) aims to reduce the local tumor mass by inducing tumor necrosis after light activation of a photosensitizer during endoscopic retrograde cholangiography (ERC).

STUDY AIMS

The aim of the present study is to evaluate the feasibility and safety of PDT with polyhematoporphyrin, the photosensitizer most commonly used for PDT in Austria, in the context of a nationwide analysis.

METHODS

This retrospective study will be conducted at seven Austrian referral centers for bilio-pancreatic endoscopy. The study protocol was approved by the internal review board of the Medical University of Vienna (EK 1448/2012). Patients who underwent PDT with polyhematoporphyrin as therapy for malignant biliary obstruction after 2004 will be identified using examination report databases. Examination reports and patient charts will be analyzed to assess underlying diseases, oncological co-therapies, intra-procedural adverse events, hospital stay, adverse events within 30 days post intervention as well as 30-day, 90-day, and overall mortality. All patient data will be de-identified using pseudonymization prior to any further processing. Descriptive statistics will be used to present the study parameters. Survival will be assessed using Kaplan-Meier statistics and compared between the different underlying tumor entities using the Log Rank test. Cox regression will be used to identify independent predictors of survival. Significant factors at univariate analysis will be entered into multivariate testing. P-values less than 0.05 will be considered significant. SPSS version 23.0 will serve for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Undergone photodynamic therapy as a treatment for malignant biliary obstruction.

Exclusion Criteria:

* None
Sensory Mapping Following Video-assisted Thoracic Surgery

This is a prospective observational cohort study on changes in sensory mapping.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years old
* Elective lung cancer surgery (VATS)

Exclusion Criteria:

* does not understand Danish
* cognitive reduction
* bilateral procedure planned
* previous thoracic surgery
* pregnant or nursing
* known nerve affection from other cause
* alcohol/substance abuse
* inability to cooperate to pain scoring/sensory examination
* \> 5 mg methylprednisolone/day
Influence of Spinal Deformity on THA

The aim of the study is to understand the effect of spinal deformity and altered sagittal plane parameters of lumbosacral complex on acetabular cup position in THA.

Investigators will Find out if there is change in the acetabular cup including the abduction and anteversion angles in patients who had THA and has spinal deformity

Eligibility Criteria:
Inclusion Criteria:

* all patients who had primary THA in 6 month duration
* patients from 30 to 70 years old with primary THA

Exclusion Criteria:

* patients who have ankylosing spondylitis
* patients with revised THA
* patients with associated injuries in lower limb
Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation

The final goal of the present study is to propose a new approach in the Parkinson's Disease rehabilitation, focused on the use of robotic devices and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.

Parkinson's disease is one of the most frequent causes of disability among the elderly. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. The balance disorder is a symptom that involves the body axis; it is due to a reduction in the straightening reflexes, so the subject is not able to correct any imbalances. Balance disorders do not respond to dopaminergic therapy used in Parkinson's disease. Therefore, physiotherapy becomes an important intervention for the management of motor disorders. Originally, these rehabilitative approaches were based on empirical experiences, but several scientific evidence suggests that neuronal plasticity is exercise-dependent. In this context, robotic rehabilitation performs an important role because it allows to perform task-oriented exercises and to increase the number of repetitions and their intensity. This protocol study aims to evaluate an innovative rehabilitation treatment of the elderly patients with Parkinson's disease, designed to improve the gait and to reduce the risk of falling. The treatment involves the use of two robotic devices: Tymo system and Walker View.

This study is a single-blinded randomized controlled trial. 195 patients with PD will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation using Tyro system or Walker View in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. A 10 treatment sessions will be conducted, divided into 2 training sessions per week, for 5 weeks. The control group will perform traditional therapy sessions lasting 50 minutes. The technological intervention group will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system.

Eligibility Criteria:
Inclusion Criteria:

* Hoen and Yahr scale: 1-3 stage
* FAC ≤ 2
* Ranking scale score ≤ 3
* Stability of drug treatment for at least 1 month
* Geriatric Depression Scale 5-items: negative

Exclusion Criteria:

* Concomitant participation in other studies
* Lack of written informed consent
* Clinical dementia rating (CDR) score ≥ 3
* History of syncopal episodes, epilepsy and vertigo not controlled pharmacologically
* Serious dysfunction of the autonomic system
* Severe behavioral syndromes not compensated by drugs
* Concurrent neurological diseases
* Severe systemic diseases with life expectancy \< 1 year
* Patients unable to follow up.
Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients

A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients.


Eligibility Criteria:
Inclusion Criteria:

* More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration.
* Class 1 or 2 back pain patients along Quebec Task Force Classification
* Patients with pain at least 40mm test results at visit2
* The voluntary or legal guardian 's written consent to participate in this clinical trial subjects

Exclusion Criteria:

* Severe gastrointestinal disease, heart disease, high blood pressure patients
* Patients with secondary causes are obvious
* Within 24 weeks patient who has back surgery before clinical trial participation
* Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation
* Within 4 weeks patient who treated steroid drug by oral or injection
* Within 2 weeks patient who treated MAO inhibition drugs
* Patients with severe respiratory depression status
A Study to Assess Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Participants With Moderate-To-Severe Plaque Psoriasis

The purpose of this study is to achieve a better understanding of clinical characteristics, treatment patterns and clinical outcomes of participants with moderate-to-severe plaque psoriasis (PsO) as well as their unmet medical needs and disease burden in real-world setting in China.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate-to-severe plaque PsO either confirmed by a dermatologist or meeting criteria of: BSA ≥ 3% or PASI ≥ 3 or Dermatology Life Quality Index (DLQI) ≥ 6.

Exclusion Criteria:

* Participating in Randomized controlled trial (RCT) between 1st January 2018 and 31st December 2021, if there was any.
* Diagnosis of erythrodermic psoriasis, pustular psoriasis or guttate psoriasis.