cyrilzakka/clinical-trials huggingface dataset:
Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer

A prospective longitudinal cohort study that will assess the effect of a Personalized Medicine (PM) clinic recommendations on pharmacogenetic variation and/or interacting drugs on plasma drug exposure, effectiveness or toxicity of commonly used antidepressant, pain, and antiemetic medications in cancer patients. Such recommendations will entail genotype-guided treatment suggestions while also considering potential DDI, and will be provided to patients during their clinic visit, and referring physicians thereafter. Drug concentration and therapeutic effectiveness will be assessed before (baseline) and 6 months after recommendations have been provided. To assess effectiveness, patient-reported outcomes will be evaluated using validated scales for symptoms of depression, pain and chemotherapy-induced nausea/ vomiting

The investigators hypothesize that the pharmacogenetic variation and DDI, if applicable, determine steady state drug concentration and therapeutic response or toxicity of the investigated antidepressant, pain or antiemetic treatments at baseline, while there is a clinically significant reduction or absence of the effect 6 months after the PM clinic recommendations to referring physicians and patients.

This prospective longitudinal study will consist of three cohorts of adult cancer patients routinely referred to the PM clinic for genotype-guided chemotherapy including 5-FU or tamoxifen that are also taking antidepressant, analgesic and/or antiemetic medications.

Patients will be assigned to one or more cohorts, as appropriate, at the screening visit: Cohort 1 (n=200) if prescribed antidepressants including the selective serotonin reuptake inhibitors (SSRI) citalopram or escitalopram, or the selective norepinephrine reuptake inhibitors (SNRI) venlafaxine or desvenlafaxine; Cohort 2 (n=200) if prescribed opioid pain medications including codeine, oxycodone, hydrocodone, or tramadol; and/or Cohort 3 (N=200) if prescribed the antiemetic agent ondansetron.

Each patient will participate in a PM clinic screening visit. Eligible patients will attend three subsequent study visits at 0.5, 4 (virtual), and 7 months after screening. At each PM clinic visit, clinical information and a venous blood sample will be collected. Patients will also complete the ESAS survey and validated scores/ surveys to evaluate treatment effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Prescribed a chemotherapy medication
* Currently taking one or more study medications (citalopram, escitalopram, venlafaxine, desvenlafaxine, codeine, oxycodone, hydrocodone, tramadol or ondansetron)

Exclusion Criteria:

* Patients who are unable to complete study materials (surveys) with or without assistance, including non-English speaking patients
* Patients receiving palliative care
* Patients taking anti-depressants for reason other than depression or anxiety, i.e. hot flash (Only applies to antidepressant cohort)
* Patients with preexisting major depressive disorder prior to cancer diagnosis (Only applies to antidepressant cohort)
A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® KRS

This study is designed to evaluate implant survivorship, patient satisfaction, and patient-reported outcomes of subjects who have undergone surgery with any of the following ConforMIS knee implants: the iUni®, iDuo® or iTotal® Cruciate Retaining (CR) Knee Replacement Systems.

This study is designed to evaluate implant survivorship, patient satisfaction and patient-reported outcomes of subjects who have undergone surgery with any of the following ConforMIS knee implants: the iUni®, iDuo® or iTotal® Cruciate Retaining (CR) Knee Replacement Systems.This study is a retrospective, single-center study, with one single remote follow up contact. Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available.

Eligibility Criteria:
Inclusion Criteria:

* Previously underwent surgical implantation of a ConforMIS iUni, iDuo or iTotal knee replacement.
* Subject must be greater than 18 years of age.
Deep Infiltrating Endometriosis : Laparoscopic Nerve-sparing Surgery and Use of Neutral Argon Plasma

Medical treatment of endometriosis has a suspensive and sometimes incomplete effect on the symptoms, making surgical treatment necessary. The aim of surgical treatment of deep endometriosis is to restore normal anatomy and functional integrity. Resection of deep endometriosis lesions is recommended to relieve pain, gynecological and digestive symptoms, but rarely urinary disorders. Nerve-sparing surgery, when feasible, reduces post-operative dysuria by sparing the lower hypogastric plexus.

The major limitations of these surgical procedures are the experience of the surgeon and the extent of the disease. Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care.


Eligibility Criteria:
Inclusion Criteria:

* Adult woman (≥18 years old)
* Patient who benefited from treatment by nerve-sparing surgery and the use of neutral argon plasma in the context of symptomatic deep pelvic endometriosis at the Strasbourg University Hospital during 2021
* Patient who did not express, after information, the reuse of her data for the purposes of this research.

Exclusion Criteria:

* Patient who expressed her opposition to participating in the study
* Patient under legal protection, under guardianship or under curatorship
Efficacy of TEAS On Prevention of Propofol Injection Pain in Children

The purpose of this study is to determine the efficacy of transcutaneous electrical acupoint stimulation for the prevention of propofol injection pain in children.

Pain from the injection of propofol is a common side effect during anesthetic practice. Various methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in reducing propofol injection pain in children.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II and aged 6-13 years patents who will undergo elective surgery under general anesthesia

Exclusion Criteria:

* patients with propofol allergy
* patients who have renal, hepatic, cardiac, neurological, psychiatric disease
* Cardiac and cranial surgery
* Pacemaker,
* Emergency surgery and patients requiring rapid serial induction
Effects of Dohsa Hou Exercises on Functional Mobility

Trisomy 21 is a condition where there's an extra chromosome 21, which leads to a set of clinical signs called Down syndrome. Down syndrome is one of the most complicated genetic conditions that can occur post-term and is the most commonly survivable form of aneuploidy of the autosomal chromosomes.

Dohsa hou is a type of psychomotor therapy that helps improve psychological problems by using bodily movements, sensation and relaxation experience. It was first developed under the name psycho-rehabilitation to help children with cerebral palsy improve their movements and posture. By using Dohsa hou movement's issues were effectively addressed in children with cerebral palsy, despite their physical limitations being caused by physiological disorders. There are two kind of treatments of Dohsa hou exercises that are relaxation therapy to decrease the stress level in body and other one is to align the body to correct the posture and movements of the body.

This study will be a randomized control trial, used to compare the effects of Dohsa hou exercises on functional mobility in children with Down syndrome. Subjects with Down syndrome meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling techniques. Assessment will be done by using Test of trunk impairment scale and Time Up and Go Test. Subjects in one group will be treated with Dohsa hou therapy and in other group standard treatment protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Down syndrome
2. Age group of 6 to 12 years old
3. Male and female (both genders)
4. Body mass index (BMI) within normal range \<95%
5. Absence of any psychiatric and physical illness at the time of participation.

Exclusion Criteria:

1. Uncontrolled seizures
2. Any kind of autoimmune diseases
3. Registered visually impaired or hearing issues
4. Severe atlanto axial instability
5. Congenital heart defects (CHD)
6. Unable or unwilling to understand the commands
Tau PET Outcomes with Anti-amyloid Immunotherapies

This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.


Eligibility Criteria:
Inclusion Criteria

* Age 50-90 years
* Male or female
* Mild cognitive impairment due to AD or mild AD
* Amyloid positive via CSF or PET
* Meets other eligibility criteria for anti-amyloid immunotherapy
* Subject or delegate provides informed consent

Exclusion Criteria

* Subjects unable to lie down without moving for 10 minutes.
* Women who are pregnant or cannot stop breast feeding for 24 hours.
* Claustrophobic patients unable to tolerate the scans (no sedation can be offered).
Checklist Tool in Engaging Patients in the Discharge Planning Process

This clinical trial studies how well a checklist tool works in engaging patients in the discharge planning process. Engaging patients in the discharge process may increase participation in the discharge process and improve discharge outcomes, understanding of care after hospitalization, and decrease complications.

PRIMARY OBJECTIVES:

I. Measure the impact on discharge and transition satisfaction of utilizing questions from the Consumer Assessment of Healthcare Providers and Systems (CHAPS) patient satisfaction survey.

II. Measure the impact of the Tool to Engage Patients in Discharge (TEPID) on patient's Readiness for Hospital Discharge and Problems After Discharge Questionnaire-English (PADQ-E) results.

III. Measure the impact on decreasing healthcare utilization measures: readmission rates within 30 days from hospital discharge, hospital length of stay of admission in hospital, and emergency department visits within 30 days of hospital discharge.

OUTLINE:

Patients complete the TEPID checklist of items during hospital stay.

After completion of the study, patients are followed up for 35 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients fluent in English, conscious, coherent, and alert or have an adult caregiver present that is fluent in English will be identified for the TEPID research project

Exclusion Criteria:

* Patients discharged to another inpatient facility (hospice, skilled nursing facility, long term acute care hospital \[LTACH\], or acute rehab) or patients discharged home with hospice will be excluded
* Any patients that are transferred to another unit prior to discharge will be excluded
Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome

The study aims to demonstrate that a simple intravenous insulin algorithm can be implemented in Latin America and will result in safe and better glucose control in patients with Acute Coronary Syndrome (ACS) compared with SC insulin.

The proposed study is a one center open-label randomized controlled clinical trial.Coronary Intensive Care of one hospital in the city of Curitiba, PR, Brazil will be assessed.

Consenting eligible subjects will be randomized to either the intensive insulin infusion therapy group (ITG) or the conventional therapy group (CTG).

This particular insulin infusion was adapted of a protocol has been used before in patients who underwent to cardiothoracic surgery and its efficacy has been reported in the literature.

The control group will be selected following the same set of inclusion and exclusion criteria. Patients will be randomized to receive SC regular insulin 4 times daily (before meals and bedtime) or every 6 hours if they are NPO .

Data will be collected for history of diabetes, heart disease ; hypertension; hyperlipidemia; Current smoker; Cardiac treatment (Aspirin, Beta Blockers, ACE inhibitor/A2RB, Nitrates, Statin, Fibrate) Diabetes treatment(Insulin, Metformin, Sulphonylureas) Data will be collect for Baseline BGL , A1C level, Troponin, CPK, CKP-Mb, K, Creatinine. Classify Infarct type : Anterior/anteroseptal, Inferior, Non-ST-segment elevation myocardial infarction, Not classified Cardiac intervention : PTCA , Thrombolysis,No reperfusion, Heparin or low-molecular weight heparin.

Subjects allocated to ITG will be placed on Grady Health System protocol, and those in CTG will follow the sliding scale nomograms. Insulin replacement will start during first 24h of admission. Patients will be followed during all hospital stay, but only at ICU the CIII and SC insulin replacement will be compared. After ICU discharge they will follow they will be followed by their physician with recommendations to keep blod glucose\<180mg/dL.

Patients will be followed up to 90 days after hospital discharge with phone call.Subjects will be contacted to obtain information regarding the occurrence of cardiovascular events following discharge. If the subject is not contactable, the next of kin and/or the subject's general practitioner would be contacted. Where no information could be obtained, a request will be made to the Department of Births and Deaths.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18 or older
* Evidence of AMI within the last 24 h (troponin-T \>0.1mcg/l) or electrographic criteria of ST-segment elevation in two limb leads)
* Evidence of Unstable Angina
* Blood glucose \>180mg/dL at admission with or without preexisting diabetes
* Willing to give informed consent
* Access to telephone communications after hospital discharge

Exclusion Criteria:

* Under 18 years of age
* Pregnant or lactating female
* Diabetes ketoacidosis
* Heart failure
* Cardiogenic shock
Double-lumen Tubes (DLT) - Health Economic Study

The aim of this study is to make a health economic evaluation comparing novice physicians use of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung ventilation during thoracic surgery at a teaching hospital. The hypothesis is, that both double-lumen tubes are equally cost-effective and the the incidence of fiberoptic bronchoscope use it the same for both tubes.

A randomized, controlled single-centre investigation comparing the VivaSight double-lumen tube and the conventional double-lumen tube at a teaching hospital. A pilot study including up to 10 subjects will be performed prior to the investigation is initiated. The investigation will include a total of 50 adult subjects (25 subjects in each group) admitted to the investigational site with established indication of single lung ventilation.

The objective of the investigation is to compare the number of times the tube position needs to be verified with a scope and relevant costs between VivaSight double lumen tube and conventional double lument tube in a cost-effectiveness analysis.

Eligibility Criteria:
Inclusion Criteria:

* Oral explanation of the investigation and Patient Information has been given to the subject or legal representative
* The subject or legal representative has signed the Informed Consent
* The subject is admitted at Odense University Hospital (OUH), department V
* Subjects evaluated as eligible for single-lung ventilation with the use of a left sided DLT
* Subjects \> 18 years of age

Exclusion Criteria:

* Subjects with known tracheobronchial anatomic anomalies
* Subjects going for emergency procedures
* Subjects with anticipated difficult airways
* Subjects with known tracheal pathology
* Subjects requiring rapid sequence induction
* Surgeries in which other lung isolation devices or techniques may be warranted (e.g. tracheostomy, nasal intubation, bronchial blockers)
* Subjects who cannot be intubated with a double-lumen tube (VivaSight-DL or conventional DLT)
* Subjects requiring a right-sided DLT
* Subjects who had participated in the study before
Human Laboratory Study of the Effects of Nicotine Product Claims on Appeal, Perceptions, and Use Behavior

This study evaluates knowledge, feelings and thoughts regarding nicotine products among young adults who are susceptible to but do not use tobacco/nicotine and adults who use tobacco/nicotine.

PRIMARY OBJECTIVES:

I. Examine the effects of nicotine concentration and source claims on engagement with ONP packaging using laboratory-based psychophysiological assessment.

II. Examine the effects of nicotine concentration and source claims on participant self-reported ONP perceptions, behavioral intentions, and ONP trial.

This is an experimental behavioral study. Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Eligibility Criteria:
Inclusion Criteria:

* Young adult susceptible non-users aged 18-24 who have never used ONPs and have never used but are susceptible to using either:

  * combustible tobacco only (cigarettes, cigars, waterpipe)
  * non-combustible tobacco only (ST, ECs, heated tobacco products)
  * or both combustible and non-combustible tobacco (i.e., dual susceptibility)
* Adult tobacco users aged 18-65 who have never used ONPs OR have used ONPs \>3 months ago and 10 times or less in their lifetime. All adult tobacco users must also be:

  * exclusive combustible tobacco users
  * exclusive non-combustible tobacco users
  * dual users

    * For adult tobacco users, we will define current use as use of combustible and/or non-combustible tobacco every day or some days for 6 months or longer
* Willing and able to complete an in-person lab visit.

Exclusion Criteria:

* Age \< 18 or \> 65
* Are not susceptible non-users or current tobacco users
* Are unwilling or unable to complete and in person lab visit.
* Have used ONPs within the past 3 months
* Have used ONPs more than 10 times in their lifetime
Exercise and Vascular Function in Chronic Kidney Disease

The purpose of this study is to investigate the effects of 12 weeks of aerobic exercise training on blood vessel function in Stages 1-4 Chronic Kidney Disease.

The endothelium lines the inside of the blood vessels. A healthy endothelial lining acts as a defense mechanism against vascular injury, mediating vascular tone, vascular structure, and blood-vessel wall relations. Endothelial dysfunction marks the occurrence of cardiovascular injuries and is a critical step in the development of cardiovascular disease. Individuals with Chronic Kidney Disease (CKD) have an increased risk of cardiovascular disease and this may be related to poor blood vessel function. Interventions to improve blood vessel function in CKD are needed. Exercise training has been shown to improve blood vessel function in older subjects and those with heart disease but this has not been investigated in CKD. The National Kidney Foundation recommends exercise for dialysis patients to reduce cardiovascular risk however there is very little data regarding the benefits of exercise in earlier stages of CKD. The purpose of this study is to determine the effect of 12 weeks of exercise training on blood vessel function in moderate to severe CKD.

Eligibility Criteria:
Inclusion Criteria:

* CKD Exercise and CKD Control Arms: Stage 1 - 4 Chronic Kidney Disease (eGFR 15 - 90 ml/min/1.73m2)
* Healthy Control Arm: eGFR \> 90 ml/min/1.73m2)

Exclusion Criteria:

* History of cardiovascular disease
* Uncontrolled hypertension
* Lung disease
* Liver disease
* Cancer
* Immunosuppressant or antiretroviral therapy
* Current tobacco use
* Pregnancy
* Hormone replacement therapy
* Unable to give consent
Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers

This was a randomized, double-blind, placebo-controlled, ascending single dose safety, tolerability, and pharmacokinetic study of orally administered EDP-322. This study was conducted at a single site. EDP-322 has a benefit to risk profile that supports testing in target patient populations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males or females \[if documentation existed that they were surgically sterilized\].
* Were in good general health as determined by medical history, physical exam and clinical laboratory tests, and without evidence of clinically significant abnormality, in the opinion of the Investigator and Medical Monitor.
* The resting 12-lead ECG obtained at Screening shows no clinically significant abnormality and a QTc (Bazett's correction) \<450 msec.
* Weight less than 132 pounds (60kg) with BMI between 18-32 kg/m3, inclusive.
* Subject has read, understood, and signed the written informed consent form.

Exclusion Criteria:

* History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances.
* History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
* Any abnormal or screening clinical lab test results...
* Medication Related exclusions...
* Lifestyle related...
Developing and Treating a Mouse Model of Acute Myeloid Leukemia Using Tissue Samples From Younger Patients With Acute Myeloid Leukemia

These laboratory trial studies the development and treatment of a mouse model for acute myeloid leukemia (AML) using samples from younger patients with AML. Studying tissue samples from patients with cancer in the laboratory may help doctors learn more about cancer and how well patients will respond to treatment.

PRIMARY OBJECTIVES:

I. To determine the rate of engraftment of pediatric FMS-Like Tyrosine Kinase-3 (FLT3)-internal tandem duplication (ITD) acute myeloid leukemia (AML) samples in NOD scid gamma (NSG) mice.

II. To determine the efficacy of treatment of FLT3-ITD xenografts with tyrosine kinase inhibitors.

OUTLINE:

Human acute myeloid leukemia cells are injected into NSG mice. Mice are then treated with sorafenib or quizartinib via gavage once daily for 28 days. Peripheral blood and tissue samples are collected biweekly or weekly and analyzed for the presence of human CD45+ and CD33+ cells by quantitative flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Cryopreserved human AML samples

  * FLT3-ITD samples with high allelic ratios
Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

Hereditary hemorrhagic telangiectasia (HHT, Rendu-Osler-Weber Syndrome) is associated with frequent nosebleeds in the majority of cases. Several reports in the literature support the use of antifibrinolytics like Tranexamic acid to reduce nosebleeds. The objectives of the study are to test if Tranexamic acid taken orally can

1. improve anemia (lead to an increased hemoglobin level)
2. reduce nosebleeds.


Eligibility Criteria:
Inclusion Criteria:

* hereditary hemorrhagic telangiectasia with nosebleeds and desire to be treated.

Exclusion Criteria:

* pregnant,
* minor,
* had an increased risk of thrombotic events (history or signs of cerebrovascular events, cardiac arrhythmias, biochemically increased coagulation parameters),
* renal insufficiency,
* a history of massive hematuria or defects of color vision.