cyrilzakka/clinical-trials huggingface dataset:
Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer

The purpose of this study was to determine whether ixabepilone is effective in the treatment of unresectable or metastatic gastric cancer in Asian participants.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed gastric carcinoma originating from the stomach or gastroesophageal junction
* Must have unresectable or metastatic disease
* Asian ethnicity
* Must have failed prior fluoropyrimidine-based chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* measurable disease by with Response Evaluation Criteria in Solid Tumors (RECIST) guidelines

Exclusion Criteria:

* \>1 prior chemotherapy regimen in the metastatic setting or \>2 prior chemotherapy if subject also received adjuvant therapy
* Receipt of prior ixabepilone
* ECOG ≥2
* Known brain or meningeal metastasis
* Known viral hepatitis
* Prior taxane therapy
* Uncontrolled non-cancer related medical condition
* Second malignancy
* Peripheral neuropathy ≥ grade 2
* Inadequate hematologic, renal and hepatic function
Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery

LASIK (laser-assisted in situ keratomileusis) is a type of refractive surgery for correction of myopia, hyperopia and astigmatism. Yet approximately 30% of operated patients have symptoms like glare, halos, dry eyes and especially residual hypermetrop refractive errors.

Residual hypermetrop refractive errors are difficult to treat surgically, the current treatment is Refractive Lens Implantation - risks are similar to those of cataract surgery (endophthalmitis, loss of accommodation, etc.)

The main problem at young patients post - LASIK after one year is residual refractive errors.

The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual refractive error (min. +1.0D).

1. The flap of LASIK is lifted, cleaned and then the lenticule is gently inserted. The fresh myopic lenticule is implanted under the guidance of corneal topography in young patients with hypermetropic astigmatism residual refraction, according to the low K value. In cases where astigmatism is not present the lenticule is positioned in central position under the flap.
2. The flap of LASIK is not touched or lifted but using VisuMax femtosecond laser we created the stromal pocket with diameter 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness set to 140 μm from corneal surface and 4 mm superior incision. Hinge position flap was set at 90° angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision.

Eligibility Criteria:
Inclusion Criteria:

* residual hypermetropic refraction,
* low visual acuity

Exclusion Criteria:

* active anterior segment pathology,
* glaucoma,
* retinae detachment,
Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma

Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma

To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with Hepatocellular Carcinoma. This retrospective, observational study included clinicopathological and follow-up data of patients with Hepatocellular Carcinoma who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.

Eligibility Criteria:
1. Inclusion Criteria:

   1. Must be a pathologically proven Hepatocellular Carcinoma
   2. Must have been treated with regorafenib
   3. Regorafenib must be used after two lines of standard antitumor therapy
2. Exclusion Criteria:

   1. Application is less than one course of treatment with regorafenib
   2. First - or second-line treatment with regorafenib
   3. Patients with multiple primary cancers
Donepezil and Cognitive Training for Alcohol Use Disorder (AUD)

The goal of the project is to evaluate whether donepezil + cognitive remediation therapy is superior to placebo in reducing heavy drinking in patients with alcohol use disorder in a double-blind, placebo-controlled trial.


Eligibility Criteria:
Inclusion criteria:

1. Males and females 18-80 years of age
2. Fluency in English and a 6th grade or higher reading level
3. Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a current alcohol use disorder (subjects should have a primary alcohol use disorder \[AUD\] diagnosis, but may have concurrent occasional use of other substances)
4. Last alcohol use and at least one heavy drinking day within the past 30 days
5. Willingness to attend follow-up assessments at 13 weeks
6. Willingness to submit to Urine Toxicology screenings

Exclusion criteria:

1. Lifetime diagnosis of a psychotic disorder, not induced by drug use
2. Current treatment with opioids or benzodiazepines, which may affect new learning
3. Involvement in a legal case that may lead to incarceration during the study period
4. Residential plans that would interfere with participation
5. Medical illness that may significantly compromise cognition (e.g., Parkinson's, Alzheimer's, Huntington's chorea, moderate or greater TBI)
6. An uncorrected sensory impairment (hearing or sight) that would seriously interfere with cognitive training
7. Pre-morbid intelligence quotient (IQ) estimate below 70
8. Unstable housing or lack of commitment to staying within a geographic area that would make follow-up unlikely
9. Unwillingness to provide contact information of someone who can help study staff contact the subjects in the event that study staff are unable to maintain contact directly
10. Allergy to donepezil
11. Unstable cardiovascular disease or unstable medical condition-clinically determined by a physician
12. Imminent suicidal or homicidal risk
13. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent

SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.

Randomized clinical comparison of the Sirolimus eluting and endothelial progenitor cell Combo™ stent and the Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent in patients treated with percutaneous coronary intervention

Eligibility Criteria:
Inclusion Criteria:

All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in Aarhus, Odense and Aalborg can be included in the study.

Exclusion Criteria:

* Age \< 18 years
* The patient does not wish to participate
* The patient is not able to consent to randomization (eg. intubated patients)
* The patient do not speak Danish
* The patient is already included in the SORT OUT XI study
* Life expectancy \<1 year
* Allergic to study related treatment
Effect of Apollo Wearable on Long COVID-19 Symptoms.

The purpose of this study is to examine how Apollo wearable use impacts symptoms and quality of life following long COVID.

Post-Acute Sequelae of SARS-CoV-2 infection (PASC), also known as long-COVID, is a syndrome that describes the persistence of symptoms or other sequelae weeks or months after initial SARS-CoV-2 infection. Limited evidence exists for effective treatments for this syndrome.

In this observational study, the investigators will examine the effects of Apollo wearable use on symptoms and quality of life related to long-COVID. The Apollo Neuroscience System (combined wearable and mobile application) offers a convenient, non-invasive, non-habit-forming wearable solution to improve performance and recovery under stress in children and adults. Our sample will be composed of new purchasers of Apollo or previous users of Apollo who haven't used Apollo in the preceding 14 days who are currently experiencing symptoms related to long-COVID according to PASC (self report).

Clinically validated survey tools will be administered upon enrollment in the study to assess baseline symptoms and quality of life. Once consented and enrolled in the study, participants will complete 7 monthly surveys for 6 months. Usage data from subjects' use of the wearable is also saved on the wearable directly and periodically uploaded to Apollo Neuroscience's secure and confidential database to be stored for analysis. Participants will first complete a screener survey to assess eligibility to participate. Demographic information and medication, substance, and treatment usage will also be collected.

Participants may choose to provide biometric data at their discretion for purposes of comparison at least 8 weeks before the study period, during the study period for 6 months, and at most 8 weeks after the study period. With regular Apollo use, the investigators expect to see an improvement in the physical, cognitive, and psychological symptoms associated with PASC. Initial analysis will compare subjects' baseline scores before Apollo use to scores during/after Apollo and the scores of subjects who used Apollo according to the study protocol and the scores of those who did not. Information gained from this study will help evaluate the use of Apollo as a potential non-invasive and accessible solution to aid in reducing long-COVID symptoms.

Eligibility Criteria:
Inclusion Criteria:

* New purchasers of Apollo who haven't started using their Apollo device or previous users of Apollo who haven't used Apollo in the preceding 14 days.
* Age 18 years or over
* Currently experiencing symptoms related to long-COVID according to PASC (self report).
* Must be experiencing PASC symptoms in at least one of the following domains:

Respiratory-related symptoms Fatigue-related symptoms Neurologic-related symptoms Psychiatric-related symptoms Sleep-related symptoms Change in quality of life/functional status

Exclusion Criteria:

* Inability to use or access a compatible Android or iOS smartphone
* Are unable to complete consent and questionnaires written in English
* Current resident of a European Union (EU) country
Taxane Acute Pain Syndrome (TAPS) in Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer

The purpose of this study is to document what course of action physicians choose for their patients when they develop taxane acute pain syndrome (TAPS) and to identify patients at the greatest risk of TAPS by examining specific human genome markers such as single nucleotide polymorphisms (SNPs) and Copy Number Variations (CNVs) that may explain the genetic (hereditary) component.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with either invasive breast or prostate cancer (stage I-IV)
* Age ≥18 years
* ECOG performance status ≤2
* Scheduled to receive intravenous taxane-based chemotherapy for either adjuvant or metastatic disease
* Participants need to have ability to complete questionnaires by themselves or with assistance and have the ability to provide informed written consent

Exclusion Criteria:

* Concurrent use of any agents to try to prevent or treat neuropathy or TAPS, including gabapentin, glutamine, vitamin B6, and vitamin E.
* Pre-existing history of peripheral neuropathy greater than grade 1 NCI CTCAE version 4.0 from any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.) other medical conditions that would make study participation unreasonably hazardous
* Uncontrolled diabetes
* Medical or psychiatric illness that would interfere with patients' ability to complete the diary
Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma

This is an observational study with a prospective cohort design. This study enrolled patients with suspected hilar cholangiocarcinoma on imaging. This study aims to evaluate the histopathological diagnostic efficacy of endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) and endoscopic retrograde cholangiopancreatography (ERCP) with or without peroral cholangioscopy targeted biopsy (POCS-TB) in patients with suspected hilar cholangiocarcinoma. In addition, the incidence of complications was compared between the EUS-FNA/B and ERCP with or without POCS-TB. The impact of the histopathological diagnosis on survival outcomes in patients with suspected hilar cholangiocarcinoma was evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. 18-90 years old;
2. Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination

Exclusion Criteria:

1. Patients with a definite diagnosis of cholangiocarcinoma by imaging (enhanced CT, MRI, or MRCP) and surgical candidacy within 3 months;
2. Patients scheduled for liver transplantation;
3. patients with previous gastroduodenal diversion or biliary surgery;
4. Patients with hilar bile duct stenosis caused by tumor or lesion outside the bile duct;
5. Pregnant or lactating women;
6. Patients who cannot tolerate intravenous general anesthesia due to various reasons;
7. Patients with severe coagulation dysfunction, or patients who cannot stop antiplatelet/anticoagulant therapy for a short time and are unsuitable for low molecular weight heparin replacement therapy;
8. Patients who refused to sign informed consent.
Effect of Problematic Smartphone Use

There is no study that examines the effect of problematic use of smartphones, which has become a global problem today, on reaction time and cognitive functions together. This study was planned to examine the effect of problematic smartphone use on upper extremity functions and cognitive functions. Participants' problematic smartphone use will be evaluated with the Smartphone Addiction Scale Short Form. Within the scope of upper extremity functions, Quick Disabilities of Arm, Shoulder \& Hand Questionnaire, reaction time and grip strength will be evaluated. Reaction time will be measured with BlazePod Trainer (Blazepod Trainer Device, Play Coyotta Ltd, Tel Aviv, Israel). Jamar dynamometer (Performance Health, Warrenville, IL) will be used to evaluate grip strength. Cognitive functions will be assessed using the Stroop Test ÇAPA Form, Trail Making Test and Cognitive Failures Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* To be between 18-25 years old
* Using a smartphone for at least 1 hour a day
* Volunteering to participate in the study

Exclusion Criteria:

* Having undergone a surgical operation involving the upper extremity within the last 6 months
* History of trauma to the shoulder, elbow, hand and wrist in the last 6 months
* Presence of a diagnosed neurological, rheumatic or psychiatric disease
Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

Single arm, phase Ib/2a dose escalation study with an expansion cohort to determine the maximal tolerated dose (MTD) for stereotactic ablative radiotherapy of targets in the cardiac myocardium and to make a preliminary assessment of the efficacy of the treatment. The dose escalation will be guided by Time-to-Event Continual Reassessment Method (TITE-CRM) to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as minimal dose of maximal effect. This design also allows for continual accrual of patients when delayed adverse events may be observed.


Eligibility Criteria:
Inclusion Criteria:

Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for catheter based RFA ablative therapy

* Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for cardiac sympathetic denervation therapy
* Documented ventricular arrhythmias refractory to or not a suitable candidate for cardiac transplantation
* Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for additional medical management
* ICD in place with documented episodes recurrent VT despite best clinical management previous refusal of ICD with recurrent sustained ventricular arrhythmias
* If ischemic cardiomyopathy, myocardial infarction occurred more than one month prior to enrollment
* No history of prior radiotherapy to the chest
* Prescribed dose must be deliverable using SABR technique
* Age ≥ 18 years
* Karnofsky Performance Status (KPS) \> 70
* If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for at least 4 weeks after study treatment.
* Ability to understand and willingness to sign a written informed consent
Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab

Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune disorders. In some cases such as treatment of humoral acute rejection of renal transplant, thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by plasma exchange but the knowledge is poor in this matter.

The aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of rituximab.

The results of this study should conclude if plasma exchange leads to a significant decrease of plasma concentration of rituximab or not, and if the decreased of the concentration is associated with a decrease in efficacy.

Twenty patients will be enrolled: ten patients treated by rituximab and ten patients treated by rituximab and plasma exchange. The plasma concentration of rituximab and the efficacy of the treatment will be compared between the two groups of patients.

The enrollment in the study will not change the treatment of patients except for blood sampling.

Each patient will undergo fifteen blood samples between the start of infusion of rituximab and three months after the start of infusion. For the patients who will undergo plasma exchange, three additional blood samples will be performed at each plasma exchange (at the start, at the end and one day after the plasma exchange) and a sample of the plasma exchanged will be keep.

The plasma concentration of rituximab will be determined by ELISA method (Enzyme Linked ImmunoSorbent Assay) The pharmacokinetic analyse will consist in the determination of the Area Under the Concentration Curve (AUC) by a non compartmental approach.

The AUC levels will be compared (using the t Student test) between the two populations of patients (patients treated by rituximab, versus patients treated by rituximab and plasma exchange) The efficacy of the treatment will be evaluated by the CD19+ B Cell count.

Eligibility Criteria:
Inclusion Criteria:

* Patient who should be treated by rituximab for various autoimmune diseases or humoral acute rejection of renal transplant
* Patient older than 18 years old
* Patient who have signed the written informed consent form

Exclusion Criteria:

* Patient presenting a contra indication to rituximab (hypersensitivity, active infection, severe cardiac failure (NYHA class IV))
* Blood sampling impossibility
* Pregnant or breasting women
Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies

The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients that as part of their routine clinical care and according to the locally approved label, are either;
* Starting fingolimod at time of study entry.
* Starting another approved DMT or started within maximum 6 months prior to study entry.
* Patients, or a able legal representative of the patient, who are willing to provide written informed consent.

Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort

Exclusion Criteria:

* Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab
* Patients participating simultaneously in another study with inclusion/exclusion criteria more restrictive than the label or an interventional study unless this is a study on fingolimod lasting 1 month maximum

Other protocol-defined inclusion/exclusion criteria may apply
Resistance Exercise in Hemodialysis Patients

The goal of this clinical trial is to learn if an intradialytic resistance exercise intervention works to reduce the symptom burden in older maintenance hemodialysis patients. It will also learn about safety of the intradialytic resistance exercise intervention program. The main questions it aims to answer are:

1. Does intradialytic resistance exercise effectively improve the number, frequency, and severity of symptoms in older patients?
2. What adverse events may occur among older dialysis patients during exercise?

Researchers will compare older dialysis patients who undergo the intradialytic resistance exercise intervention with those receiving standard care to observe whether resistance exercise can improve symptom burden.

Participants will:

1. Take an intradialytic resistance exercise intervention program developed through joint decision-making by rehabilitation experts, dialysis center physicians, nurses, and patients, conducted three times a week for 20 minutes each session, over a duration of three months.
2. Visit the hospital a monthly for texts and examinations.
3. Keep a diary of the types and frequency of adverse events during and after the exercise sessions.


Eligibility Criteria:
Inclusion Criteria:

Age 60 years and above Stable on dialysis for ≥3 months Able to walk independently, no physical disability, and muscle strength ≥ Grade III Capable of understanding and complying with the requirements of this study Voluntarily signed an informed consent form

Exclusion Criteria:

Severe cardiovascular, cerebrovascular, respiratory, or neurological diseases, or other conditions that impair physical ability to exercise Serious infections, bleeding, trauma, or other conditions affecting physical status within the last 3 months Severe mental disorders or cognitive impairments Abnormal blood pressure (pre-dialysis systolic pressure ≥180mmHg, diastolic pressure ≥100mmHg) Hemoglobin (Hb) \&amp;lt; 90g/L, Albumin (Alb) ≤ 32g/L Participation in other exercise or pharmacological interventions in the past 6 months