cyrilzakka/clinical-trials huggingface dataset:
Cognition in Postoperative Total Hip Arthroplasty and Total Hip Resurfacing Patients

Transient cognitive changes after surgery may be due to many different factors. It is estimated that between 5-29% of patients undergoing orthopedic surgery experience a transient decline in their cognition. Fat and bone marrow debris embolization can cause cognitive changes if they enter the cerebral circulation in significant numbers. During total hip arthroplasty the placement of the femoral stem leads to a rise in intramedullary pressure which can cause fat and bone marrow debris to embolize into the systemic circulation. Total hip resurfacing arthroplasty avoids entrance into the femoral canal. The purpose of this study is to assess transient cognitive changes after total hip arthroplasty and compare them to patients undergoing total hip resurfacing arthroplasty. We hypothesize that patients undergoing total hip resurfacing arthroplasty will experience less transient cognitive changes due to the avoidance of violating the femoral canal during the procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Male and non-pregnant, non-lactating, female subjects who are 18 and older
2. Subjects who are able and willing to provide informed consent
3. Subjects deemed able to comply with study schedule visits and procedures
4. Subjects undergoing elective THA procedures
5. Subjects undergoing elective total hip resurfacing arthroplasty
6. Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.

Exclusion Criteria:

1. Subjects with or with a history of Parkinson's Disease
2. Subjects with a history of depression as reported in their past medical history
3. Subjects with a history of dementia as reported in their past medical history
4. Subjects currently using antidepressants
5. Subjects currently using antipsychotic medications
Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia

The study investigates whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI) of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.


Eligibility Criteria:
Inclusion Criteria:

* Have a positive blood culture.
* Undergo treatment with either intravenous penicillin, ampicillin, piperacillin/tazobactam, dicloxacillin, cefuroxime or meropenem.
* Hospitalised at Hvidovre University Hospital.
* Age ≥ 18.
* Able to understand and give informed consent.
* Included in the study within 24 hours after the final positive blood culture answer.

Exclusion Criteria:

* Positive blood culture is interpreted as contamination.
* The patient dies before the intervention.
Home-based Preoperative Exercise Training for Lung Cancer Patients Undergoing Surgery

Lung cancer accounts for over 11% of global cancer incidence and is the leading cause of cancer death, with numbers in 2020 reaching 1.8 million deaths worldwide.

For early-stage lung cancer patients, surgical resection is the recommended treatment and the intervention associated with a better prognosis. However, in consequence of surgery there is a substantial deterioration in health-related quality of life across most dimensions, especially in the first month, with 100% of lung cancer patients concerned about the limitations in their physical function and 96% about the levels of fatigue and pain after lobectomy.

Additionally, some patients developed postoperative pulmonary complications, which are associated with increased length of hospital stay and higher risk of mortality.

In this context, and considering that the number of lung cancer cases with an indication for surgery will increase by 60% from 2018 to 2040, to find feasible and effective interventions that could optimize postoperative recovery is of major clinical relevance.

The primary purpose of this study will be to evaluate the efficacy of home-based preoperative exercise training to improve health-related quality of life after lung cancer surgery. The secondary purpose of this study will be to evaluate the efficacy of the home-based exercise program to improve physical performance and to reduce postoperative complications /length of hospital stay. Participants will be randomly allocated to a preoperative exercise intervention, that will consist of combined aerobic and resistance exercise, or to a control group that will receive usual care (i.e., no exercise training).

Based on the strong evidence indicating a therapeutic effect of exercise training on fatigue and physical function, domains of HRQOL especially affected after lung cancer surgery, the investigators hypothesized that the home-based exercise program will be effective to improve these domains before surgery and attenuate its deterioration after surgery, optimizing the recovery in postoperative HRQOL.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for surgical treatment of suspected or confirmed lung cancer (clinical stage IIIA or less)
* Waiting time for surgery of at least two weeks from baseline assessment
* Medical clearance to exercise.
* Signed informed consent prior to initiation of study-related procedures

Exclusion Criteria:

* Metastatic cancer
* Presence of physical or mental disabilities that contraindicated exercise training or physical testing
* Unable to communicate in Portuguese or English
* Performing combined aerobic plus resistance training over the past month (self-reported ≥2 days a week, ≥30 minutes each session).
Usage of High Flow Nasal Cannula in Preventing Desaturations in Elderly Patients Going for Lower Limb Surgeries

To study the effect of high flow nasal cannula in comparisons with nasoprong used intraoperatively in patients oxygenation status

To observe the effect of high flow nasal cannula used intraoperatively compared to normal oxygen therapy (nasoprong) at a same fraction of inspired oxygen (FiO2) in elderly patients who are going for orthopaedic surgeries under central neuraxial block.

oxygenation will be access with intermittent blood gas. atelectasis will be access via chest x-ray , compared to a baseline chest x-ray, validated by a blinded radiologist

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) I, II or III patients.
2. Patients age 60 years and above
3. Patients scheduled for total knee replacement therapy and hip surgeries under central neuraxial block under the elective and emergency list.

Exclusion Criteria:

1. Patients with pre-operative spO2\<94%
2. Patients delirious or demented / unable to give consent.
3. Patients with pre-existing pneumonia (defined as the initiation of antibiotics for suspected infection with one or more of the following: new or changed sputum; new or changed lung opacities; fever; white blood cell count \>12 × 109 litre-1 )15
4. BMI ≥35
3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency

To determine whether the use of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution for injection provides a visualization advantage compared to saline when used as an aid in the determination of ureteral patency

This is an open-label, randomized, multicenter study to evaluate the efficacy, safety, and pharmacokinetics of two doses (2.5 mL and 5.0 mL) of 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium solution for injection when used as an aid in the determination of ureteral patency. Study will enroll up to 116 subjects from approximately 10 study centers in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between ≥ 18 and ≤ 85 years old.
* Subjects who signed written, IRB approved, informed consent form.
* Subjects scheduled for urological or gynecological surgical procedures in which the patency of the ureter must be assessed by the surgeon during the procedure

Exclusion Criteria:

* Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR \<30 mL/min/1.73m2 (using the MDRD) or need for dialysis in the near future, or having only 1 kidney.
* Subjects with known severe hypersensitivity reactions to IC or other dyes including contrast agents.
* Known history of drug or alcohol abuse within 6 months prior to the time of screening visit.
* Subjects, as assessed by the Investigator, with conditions/concomitant diseases precluding their safe participation in this study (e.g. major systemic diseases).
* Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to non-compliance with the study procedures.
* Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol;
* Subjects with life expectancy \< 6 months;
* Requirement for concomitant treatment that could bias primary evaluation.
* Subjects who are pregnant or breast-feeding.
Studying Common Genetic Mutations Related to Mucositis in Patients With Multiple Myeloma Receiving High-Dose Melphalan

RATIONALE: Studying blood or mouthwash samples in the laboratory from patients receiving melphalan for cancer may help doctors learn more about changes that occur in DNA, identify biomarkers related to cancer, and help predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying common genetic mutations related to mucositis in patients with multiple myeloma receiving high-dose melphalan.

OBJECTIVES:

* To determine whether single nucleotide polymorphisms (SNPs) in genes that encode the melphalan transporters are associated with the development and/or severity of mucositis in patients with multiple myeloma receiving high-dose melphalan.
* To determine whether SNPs in genes that influence melphalan metabolism are associated with the development and/or severity of mucositis in these patients.

OUTLINE: This is a multicenter study.

Blood or mouthwash samples are collected and DNA isolated from these specimens is analyzed for single nucleotide polymorphisms (SNPs) in LAT1 or other candidate genes. Public databases (i.e., dbSNP and HapMap) are reviewed to select representative SNPs for genotype analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of multiple myeloma
* Receiving treatment with high-dose melphalan for an autologous stem cell transplantation at any of these facilities:

  * Vanderbilt University Medical Center
  * Nashville Veteran's Administration Medical Center (VAMC)
  * Seattle VAMC
  * San Antonio VAMC

PATIENT CHARACTERISTICS:

* Not pregnant

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No palifermin
Flourish™ Pediatric Esophageal Atresia

This study is continued evaluation of the safety and probable benefit of the Flourish Pediatric Esophageal Atresia device through the Humanitarian Device Exemption (HDE) pathway.


Eligibility Criteria:
Inclusion Criterion:

* Patient treated for esophageal atresia with Flourish device starting May 12, 2017
Vascular Reactivity in Metabolic Syndrome and Diabetic Patients Using Diffuse Optical Spectroscopy

Metabolic Syndrome is a highly prevalent condition that is comprised of several major clustering factors that increase the risk for developing cardiovascular disease. Diffuse Optical Spectroscopy is a non-invasively measure can show changes in the microvasculature of human. Diffuse Optical Spectroscopy measures the optical absorption and scattering properties of near-infrared light in tissues such as muscle in order to quantify the absolute concentration of oxygenated and deoxygenated hemoglobin, water, and lipids. It provides quantitative and functional information on the microvasculature related to tissue perfusion, metabolic changes, and indicators of tissue damage.

The researchers can use Diffuse Optical Spectroscopy to monitor changes in the microvasculature of patients with Metabolic Syndrome and diabetic mellitus, and patients with Diabetic Peripheral and Autonomic Neuropathy, versus non-diseased and predisposed subjects by evaluating the changes in oxygen metabolism. The Diffuse Optical Spectroscopy measure the changes in the concentration and oxygen saturation of hemoglobin in the microvasculature under stress, for example, during exercise and in response to changes in breathing habits. The sensitivity of Diffuse Optical Spectroscopy to tissue hemodynamics provides an impressive arena of useful clinical applications..

Eligibility Criteria:
Inclusion Criteria:

* Adult ages of 45 to 75
* Have been clinically diagnosed with Type II Diabetes Mellitus
* Have a diagnosis of Metabolic Syndrome

Exclusion Criteria:

* taking light-sensitive drugs for use in photodynamic therapy
* pregnant
Reduction of Excessive Calories From Beverages in Children

Objective: to test the hypothesis that an intervention comprised of targeted physician and print messages can influence parents to reduce the amount of sugar-sweetened beverages (SSB) and fruit juice they give to their children 1 - 12 years of age.

The study will be conducted through a practice-based research network of community pediatric practices. Participating sites will be randomized to the intervention or control condition (usual care) using a pre-specified randomization scheme derived using computer generated random numbers. The intervention sites will participate in a 30-minute training for using the "Milk. Water. Period" intervention (brochures, posters, key talking points and phone messages) in their office. The goal is for them to discuss beverage consumption and encourage "Milk. Water. Period" for all children 12 months to 12 years old (not yet reached their 13th birthday) at their checkup visit. The primary care provider (PCP) will use the talking points to facilitate the discussion about drink milk and water only and will give a brochure to each family. Assessments will be by telephone interview of the parent 2 to 4 weeks after a check-up visit for the index child.

Eligibility Criteria:
Inclusion Criteria:

* Parent of child age 12 months to 12 years attending for a check-up visit during the study period

Exclusion Criteria:

* Cannot speak English
* No phone access
* Already completed the survey for another child.
Dopamine Release in the Human Brain Following Alcohol Administration

The purpose of this study is to examine whether there is an increase in dopamine levels in the human striatum following an oral administration of alcohol, as has been evidenced in animal models. This will be a Positron Emission Tomography (PET) study using the radiotracer, \[11C\]-(+)-PHNO (11C\]-( + )-4-propyl- 3,4,4a,5,6,10b-hexahydro-2H-naphtho\[1,2-b\]\[1,4\]oxazin-9-ol).

This will be a within subjects study in 8 heavy drinkers ages 21-45. The within factors will be PET scans following an alcoholic beverage and following a non-alcoholic beverage. Participants will also have a baseline session prior to the scans where they will complete various cognitive tasks and questionnaires. During each PET scan, subjective drug effects as well as heart rate, blood pressure, blood alcohol content and cortisol levels will be collected. The change in PHNO binding potential between the two scan conditions will be the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females of any ethnic origin between 21 and 45 years old.
* Reported consumption of at least two heavy drinking episodes (according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criterion of 5 drinks for males or 4 for females) in the past 30 days prior to assessment.
* Willing and capable to provide written informed consent
* Good command of the English language

Exclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of alcohol dependence; receiving treatment for alcohol dependence
* Taking medications or have any medical condition for which alcohol is contraindicated
* Any medical condition requiring immediate investigation or treatment
* Previous head trauma/neurological condition such as clinically significant history of seizure disorder, a history of clinically significant head trauma (i.e., concussion resulting in clinically significant loss of consciousness) or past intracranial surgery
* Beck Depression Inventory score \>16
* Current active or past suicidal ideation
* Pregnancy tested by urine and blood screen each PET study day or lactation
* Current DSM-IV diagnosis of any Axis I psychiatric disorder
* Regular use of any therapeutic or recreational psychoactive drug use during the last three months (with the exception of nicotine and alcohol) or other substance use disorder (including nicotine)
* Abnormal body mass (as defined as not within 20% of normal body mass index).
* Current past or anticipated exposure to radiation exceeding 20 mSv in the last year.
* Metal implants or paramagnetic objects within the body which may interfere with the magnetic resonance imaging (MRI).
* Claustrophobia or a history of panic attacks
* Abnormal clinical laboratory findings including serum creatinine greater than 2.0 mg/dl, abnormal liver function tests, elevated serum bilirubin (more than 1.5 times upper limit of normal), or pre-trial electrocardiogram (EKG) results demonstrating clinical significant abnormality
Melanated Group Midwifery Care (MGMC)

This study is being conducted to determine if a multi-level intervention for delivering maternity care can improve patient trust and engagement among Black birthing people.

Low-risk pregnant participants will be randomized into Melanated Group Midwifery Care or usual individualized obstetric care. In Melanated Group Midwifery Care (MGMC), Black women will receive prenatal care from a Black midwife in groups with the same 8-10 other Black women throughout pregnancy. In pregnancy and into the first year postpartum, MGMC patients will stay connected to the health system through a proactive care coordinator, who is a Black licensed nurse. For the first year after giving birth, patients in MGMC will also be supported by a trained postpartum doula.

All participants (intervention and usual care groups) will complete study measures that include validated surveys on patient trust, respect and engagement at 6 time points:

* 3 time points in pregnancy \[baseline (\<20 weeks), 26-28 weeks, and 35- 37 weeks\] and
* 3 in the postpartum at 2-, 6-, and 12-months
* Additional qualitative interviews will be done to track the care received by medically and socially complex patients, including all who experience a severe maternal morbidity.

The investigators will also document how MGMC gets embedded in practice through a qualitative process evaluation.

Eligibility Criteria:
Inclusion criteria for patients:

* pregnant women who self-identify as Black on a standard prenatal intake form
* less than 20 weeks pregnant
* 15 years old or older
* present to the general obstetrics group at the University of Chicago Medical Center for their new prenatal visit
* speak and understand English

Inclusion criteria for providers:

• All black midwives, care coordinators, and community postpartum doulas at the University of Chicago are eligible to participate.

Exclusion criteria for patients:

* having a condition for which they present to a higher level of obstetrics care (e.g., maternal fetal medicine) for their new prenatal visit
* having a cognitive issue that impairs their ability to give informed consent.
Effect of Aerobic Training on Sleep Problems and Pulmonary Functions in Children With Down Syndrome

The study will be conducted to determine the effect of aerobic training on sleep problems and pulmonary functions in children with Down syndrome.

The study will be carried out on 30 children with Down syndrome (trisomy 21) of both sexes, with ages ranging from 7 to 12 years old. Children will be recruited from schools for children with special needs. Children will be randomly assigned into two equal groups (control and study groups), 15 for each group. The control group will receive a selected physical therapy program only, while the study group will receive the same selected physical therapy program as the control group in addition to aerobic exercise in the form of treadmill training. The Arabic version of the Children's Sleep Habits Questionnaire (CSHQ) will be used to assess sleep problems, while a handheld spirometer will be used to assess pulmonary functions (forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC ratio, and peak expiratory flow rate (PEFR)) pre- and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Children with Down syndrome (trisomy 21).
* Their ages range from 7 to 12 years old.
* Both sexes will be included.
* Children should be able to understand and follow simple verbal commands or instructions (intelligence quotient (IQ) range: 50-70).
* Children should be able to walk independently.
* Their total scores on the Arabic version of the Children's Sleep Habits Questionnaire (CSHQ) equal 41 or higher.

Exclusion Criteria:

Children will be excluded from the study if they:

* Have visual or hearing defects.
* Have spinal abnormality such as kyphosis and scoliosis.
* Have history of pulmonary infection and surgery of thoracic and abdominal region within the past 6 months.
* Play any specific sport or exercises.
* Have physical activity restrictions.
* Have musculoskeletal disorder.
* Take medications known to affect sleep.