cyrilzakka/clinical-trials huggingface dataset:
Blood Pressure Changes After Bariatric Surgery

The aim of the study is to assess changes in blood pressure, cardiac function and selected laboratory measurements after bariatric surgery and to find most important factors associated with blood pressure reduction after weight loss.

Description of the study

Patients: consecutive patients with class III obesity (BMI ≥ 40kg/m2) or class II obesity (BMI 35-40kg/m2) with comorbidities, admitted for sleeve gastrectomy

Methods: bedside and 24-hour blood pressure measurement, cardiac ultrasound and laboratory tests performed before surgery and at 1 week, 4 weeks, 6 months and 12 months after bariatric surgery

Pathogenesis of blood pressure reduction associated with weight loss is not established. We hypothesize that monitoring of blood pressure changes after weight loss, with concomitant evaluation of cardiac output and selected biochemical parameters related to blood pressure regulation may help in the understanding of weight loss-associated decrease in blood pressure.

The study protocol include measurement of blood pressure (bedside and 24h blood pressure monitoring), assessment of the cardiac function and biochemistry 1-2 days before laparoscopic sleeve gastrectomy and at the time of routine surgical follow-up visits after surgery ie. one week, one month, six and twelve months. Blood pressure measurements will be performed using automatic oscillometric monitors (OnTrak , Spacelabs,USA). Cardiac evaluation will include an echocardiographic assessment of the systolic and diastolic left ventricular function as well as cardiac output measurement using Doppler method. Biochemistry measures, in addition to routine blood tests needed for surgical follow-up, will include fasting insulin, high sensivity C-reactive protein, cystatin C, and NT-proBNP.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥40kg/m2 or ≥35 kg/m2 with comorbidities

Exclusion Criteria:

* Lack of informed consent
* Expected lack of compliance
* Psychiatric illness
* Previous bariatric surgery
* Severe gastroesophageal reflux disease
* Active neoplastic disease
* Pregnancy
* Chronic atrial fibrillation or other persistent arrhythmia
Prognostic Biomarkers in Patients With Urothelial Carcinoma

Bladder cancer (BC) is a heterogeneous malignancy with dismal outcome.Despite treatment, the 5-year overall survival rates for MIBC are \<50%, with many patients unresponsive or inapt, necessitating biomarkers to select those most likely to respond or fit for treatment

In this study was assessed the associations among most frequently mutated genes and with clinicopathological features, as well as the prognostic significance of the presence of mutations in the top mutated and DNA Damage response (DDR) mutated genes in terms of Overall Survival (OS). Moreover, overall tumor-infiltrating lymphocytes (TILs) density was measured, analyzed immunohistochemically the expression of PD-L1, the four MMR proteins (MLH1, MSH2, MSH6 and PMS2) and tumor or stromal CD8+ cytotoxic T lymphocyte infiltrates and assessed their association with each other, top mutated genes and available clinicopathological parameters together with their role in prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Urothelial carcinoma located in bladder
* Patients treated with platinum regimens at the neoadjuvant . adjuvant setting
* Written informed consent for the use of biological material

Exclusion Criteria:

-
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction

Prospective, single center, postmarket clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.


Eligibility Criteria:
Inclusion Criteria:

To be eligible for enrollment, the subject must:

1. Be female, ≥ 18 years of age
2. If the subject is a female of childbearing potential, have a pregnancy test evaluated as negative prior to surgery, per the site's standard of care
3. Have a nicotine test evaluated as negative prior to surgery and agree not to smoke for the duration of the study
4. Be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon
5. Be eligible to enroll in one of the following three cohorts:

1. Subject had radiation therapy (XRT) prior to direct-to-implant (DTI) reconstruction, but will not have XRT following reconstruction;

2. Subject did not have XRT prior to DTI reconstruction and will not have XRT following reconstruction;

3. Subject did not have XRT prior to DTI reconstruction, but will have XRT following reconstruction.

Exclusion Criteria:

To be eligible for enrollment, the subject must not:

1. Have collagen-vascular, connective tissue, or bleeding disorders
2. Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
3. Have an autoimmune disease, an immune deficiency, or is on immune-suppression drugs for reasons other than current treatment for breast cancer
4. Have a BMI that is ≥ 32
5. Have a nicotine test evaluated as positive prior to surgery or unwilling to quit smoking for the duration of the study
6. Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
7. Be pregnant, lactating, or expecting to be within the next 24 months
8. Have concomitant unrelated condition of breast/chest wall/skin (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum)
9. Require the use of any additional implant for soft tissue support of the contralateral non-study breast, except in bilateral breast reconstructions, where the use of SERI® Surgical Scaffold is allowed
10. Have had a prior soft tissue support implant
11. If enrolled into the Pre-Radiated cohort, have had recent radiation (\< 1 year) to the breast/chest wall
12. If enrolled into the Post-Radiated cohort, radiation to the breast/chest wall is planned more than 1 year from the time of SERI® Surgical Scaffold placement
13. Have clinical evidence of severe radiation tissue damage (e.g. pigmentation, indentation, atrophy, no elasticity to skin of radiated breast) from previous XRT to the breast/chest wall
14. Have large or multiple scars on the breast(s) that may interfere with blood supply to the mastectomy flaps
Web-based Collection of Data on Obesity and Health Behavior

Low socioeconomic status (low SES), as defined by educational attainment and income, has been associated with obesity in industrialized nations. Low SES has been related to impulsive decision-making characterized by steep devaluation of future outcomes (delay discounting, DD) and a greater motivation to obtain food (food reinforcement, FR). DD and FR have been shown to interactively predict ad libitum energy intake in laboratory studies, such that participants exhibiting high FR as well as high DD consume the most food. Obesity often results from energy intake in excess of physiologic needs, and thus a plausible mechanism is that low SES environments increase FR and DD, leading to overeating and obesity. The primary aims of this study are to determine whether FR and DD interact to predict BMI, and whether differences in FR and DD mediate the relationship between low SES and obesity, in a large sample of US adults of varying BMI. In addition, whether high FR and high DD are related to unhealthy food purchasing and eating behaviors will be assessed. It is anticipated that high FR and DD will be related to unhealthy food purchasing and eating behaviors.

In this study potential participants who log in to the Amazon Mechanical Turk website as a worker and who have a HIT approval rate of at least 90% will be allowed to view and participate in the study. If a potential participant agrees to participate in the study by accepting the HIT, the participant will be asked to complete a brief survey (approximately 150 questions; see sample survey in "other supporting documents") and various decision making tasks (e.g., delay discounting assessment, reinforcer valuation assessment etc.). This survey and accompanying tasks will solicit: (a) general demographic information such as gender, age, income, and education; (b) information about their health and health behavior practices, such as eating habits, alcohol and cigarette use; (c) questions about their food preferences and value of foods; (d) information about their valuation of immediate versus distant events/rewards.

Eligibility Criteria:
Inclusion Criteria:

* Be a registered Amazon Mechanical Turk user.
Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients

The study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional Mesenchymal Stem Cell infusion can benefit the promising clinical islet transplantation through the following mechanisms: protection of islet from inflammatory damage, immunological modulation, engraftment promotion, thus decrease or eliminate the need of exogenous insulin and improve β-cell function.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18 to 60 years of age
* Ability to provide written informed consent
* Manifest signs and symptoms that are severe enough to be incapacitating
* Patients with poor diabetes control (HbA1c \> 7% but \< 12%)
* Progressive diabetic complications

Exclusion Criteria:

* age \< 18 years or \> 60 years
* diabetic history \< 5 years
* BMI \> 27
* body weight \> 80 kg
* exogenous insulin requirement \> 1 unit/kg/day
* severe anemia (male \< 8 g/dl, female \< 7 g/dl)
* low white blood cell count (\< 3000/dl)
* liver dysfunction
* Active infection including hepatitis B, hepatitis C, HIV, or TB
* panel reactive antibody \> 20%
* Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
Effects of a Prehabilitation Program in Patients Undergoing Lumbar Radiculopathy Surgery

The purpose of the following study is to analyze the effects of a prehabilitation program based on therapeutic exercise, back care education and pain neuroscience education through the visualization of videos, compared to standardized written therapeutic exercise in patients undergoing lumbar radiculopathy surgery.

So far, there are no previous studies that analyze the effects of a prehabilitation program including therapeutic exercise, back care education and pain neuroscience education through the visualization of videos in patients undergoing lumbar radiculopathy surgery.

This is a multicenter randomized clinical trial aimed at analyzing the effects of a 4 weeks prehabilitation program based on video visualization versus the performance of standardized written exercises in patients undergoing lumbar radiculopathy surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older, diagnosed with lumbar radiculopathy, and scheduled for surgery. The symptoms will be predominantly leg pain with or without neurological deficit, with surgical decompression justified.

Exclusion Criteria:

* Patients currently receiving any other non-pharmacological treatment or physical therapy for the management of lumbar radiculopathy.
* Proposed for surgery with instrumentation (e.g., spinal fusion, arthrodesis).
* Suffering from a chronic pain-related condition (e.g., fibromyalgia, chronic fatigue syndrome).
* Symptoms of spinal cord compression.
* Diagnosed with a malignant tumor.
* Mental illness.
* Previously undergone spinal surgery.
* No access to any internet-enabled device.
Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma

In this mono-center pilot trial, polytrauma patients admitted to intensive care will be included. Investigators are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing.

Aim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for ICUAW or can be used as marker for ICUAW.


Eligibility Criteria:
Inclusion Criteria:

* acute polytrauma patient
* age ≥ 18 years old
* expected intensive care stay ≥ 3 days
* American Society of Anesthesiologists classification I or II

Exclusion Criteria:

* patient had received cardiopulmonary resuscitation
* limitation of therapy or comfort care
Does the New Fall- and Fracture Prevention Initiative in Oslo Have Effect?

The goal of this controlled before and after study is to evaluate a new patient pathway for patients 65 years and older who have suffered a fall injury.

The main questions the study aims to answer are whether this preventive initiative with improved care coordination reduces risk of subsequent hip fractures, admittance to nursing homes or death.

Researchers will compare two boroughs in Oslo who implemented the new patient pathway with the 13 other boroughs who did not reorganize their follow-up, but continued their care as usual.

The study is an evaluation of a new patient follow-up for fall prevention in Oslo with improvement of coordination of care for elderly at risk of fall injuries.

The intervention were introduced to the boroughs of Nordstrand and Østensjø, which are compared to the other 13 boroughs of Oslo in this controlled before and after study.

THE COHORT

All persons 65 years and older in Oslo are included in Oslo Fall Cohort and we follow all cohort participants prospectively.

OUTCOME VARIABLES

* Hip fracture
* Long term admittance to nursing home
* Death

TIMELINE

The investigators have defined the following dates as the start of intervention:

1. Start of intervention in Nordstrand borough is set to January 1, 2015.
2. Start of intervention Østensjø borough is set to September 1, 2016.

In the main analysis, fallers from the two intervention boroughs, Nordstrand and Østensjø, will be compared with fallers from the control boroughs during the intervention. Any differences between the intervention and control boroughs before the intervention started will be taken into account.

Data on all participants are available from 2010, and the participants will be followed from January 2012 until December 2019.

For each analysis, persons with a hip fracture or living in a nursing home at baseline will be excluded.

The analysis in the evaluation is based on registry data and no analysis relating the intervention to the outcomes has been done before registration in clinicaltrials.gov.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* Living on Oslo, Norway in the period January 1. 2012 - December 31. 2019

Exclusion Criteria:

* Hip fracture before baseline
* Living in nursing home at baseline
Intensive Executive Function Training

The investigators intent to recruit 80 attention deficit hyperactivity disorder families. The attention deficit hyperactivity disorder families had received executive function training one year before.They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in intensive executive function training immediately,while the control group will receive executive training after 3 months.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of child attention deficit hyperactivity disorder
* full-scale intelligence quotient (FSIQ) ≥70
* stable on medication for attention deficit hyperactivity disorder children at least 3 months
* participation in the early implementation of functional training one year before

Exclusion Criteria:

* individuals with major neurological disorders
* a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders
"Carotid Web Incidence and Radiological Classification, Determination of Its Relationship With Ischemic Stroke"

In our research, we aim to increase awareness on this issue by classifying the frequency of carotid webs and their radiological classification; Evaluating the clinical data and vascular risk factors of carotid web cases and determining their relationship with ischemic stroke and determining the measures that can be taken for future optimal treatment.

We aimed to contribute to their approach.

Carotid web is a thin membrane-like tissue that extends from the wall to the lumen of the carotid artery bulb, identified radiologically. It is considered that stroke may be related to altered hemodynamics, blood stasis and fibrin-based clot embolization mechanisms in the distal carotid web. Radiologically, in DSA and CTA, there is a thin membrane-like intraluminal filling defect extending along the posterior carotid wall in oblique-sagittal sections and a corresponding defect in axial sections.

It is seen as a thin septum; There is no study on its classification in the literature. Determination of the incidence of carotid web, determination of its relationship with ischemic stroke / TİA, Facilitating distinctions such as dissection etc. by making radiological classification is important in terms of increasing awareness on this issue and early diagnosis. Demonstrating the relationship between carotid webs, which are shown as a cryptogenic cause of stroke, and vascular risk factors and taking protective measures against them will be effective in preventing strokes. In our research, we aim to increase awareness on this issue by classifying the frequency of carotid webs and their radiological classification; We aimed to evaluate the clinical data and vascular risk factors of carotid web cases, determine their relationship with ischemic stroke, and determine the precautions that can be taken to contribute to future optimal treatment approaches.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old

  * Having a preliminary diagnosis of cerebrovascular disease
  * Having carotid CTA and/or DSA imaging performed

Exclusion Criteria:

* Being under 18 years of age
* Patients who cannot undergo CTA and/or DSA imaging due to the risk of contrast material allergy or renal failure.
* Patients for whom consent for imaging cannot be obtained by the patient and their relatives and for whom CTA/DSA examination is not required in terms of etiology
Testing the Effectiveness of Cognitive Training Among Depressed Patients Receiving Esketamine Treatment

In a sample of patients already receiving esketamine treatment as part of their clinical care, this project seeks to test whether we can improve depression by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat depression more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.


Eligibility Criteria:
Inclusion Criteria:

Any patient aged 18-80 in the esketamine clinic in the Center for Interventional Psychiatry. The clinic's extensive screening and eligibility criteria for esketamine treatment will not be altered in any way, other than imposing the study-specific age range and the two exclusion criteria below.

Exclusion Criteria:

1. Patients who do not expect to remain located in the Pittsburgh area for a minimum of 1 month beyond study enrollment.
2. Patients who, in the judgment of the esketamine clinical medical director, show signs of intellectual disability, developmental disability, and/or cognitive impairment (including age-related cognitive decline) of a sufficient degree to interfere with engagement in any study procedure.
Analgesic Effect to Postoperative Pain After Mastectomy: Ultrasound-guided Serratus Anterior Plane Block

Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and consumption of opioid after mastectomy.


Eligibility Criteria:
Inclusion Criteria:

1. ASA 1\~3
2. Age 20\~80
3. Breast cancer patient twho are scheduled for elective mastectomy

Exclusion Criteria:

1. Allergy to local anesthetics or contraindication to use of ropivacaine
2. Pregnancy
3. Severe cardiovascular disease
4. Renal failure
5. Liver failure
6. Neurologic and psychologic disease
7. Chronic treatment with analgesics
8. Previous history of mastectomy or thoracic surgery.
Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial

Many youth with chronic disease have difficulty taking medication every day and therefore do not receive full benefit from treatment. Sickle Cell Disease (SCD) is an inherited blood disease that affects African Americans and other underserved communities. Hydroxyurea (HU) is the sole FDA-approved drug therapy for SCD and is highly effective and improves quality of life. The proposed study, a 5-site four-year randomized control trial (RCT), builds upon the investigators' recent feasibility study of the same title. Overall goals are reducing barriers to HU use and improving adherence for youth 10-18 years through creation of a daily medication habit. The goal of the proposed multi-site study is to test the efficacy of the HABIT intervention at 6 months and sustainability of the effect at 12 months.

Barriers to medication adherence are common in youth with chronic illness and are a source of racial/ethnic disparities in underserved communities. An inherited blood disease, Sickle Cell Disease (SCD) is characterized by chronic and acute illness and reduced quality of life (QOL). It affects African Americans and other underserved communities. Hydroxyurea (HU) is the sole FDA-approved drug therapy for SCD and is highly effective and improves QOL. Poor adherence is common among youth and young adults with SCD.

The importance of poor medication adherence, use of community-based health workers (CHWs) to bridge the gap between health services and underserved parent-youth dyads affected by SCD, the strength of the science, the success of the investigators' multi-ethnic feasibility study, and the potential application of study findings to youth with other serious chronic illnesses speak to the importance of this trial.

Eligibility Criteria:
Inclusion Criteria - Youth:

* One of the two most common sickle cell disease variants (HbSS or HbS-B0 thalassemia)
* Age 10 through18 years (inclusive)
* Currently prescribed hydroxyurea (HU) ≥18 months (for identifying historical Personal best HbF)
* Current HU dose is within 5% of dose at Personal Best HbF
* Pre-enrollment HbF ≥15% below historical Personal best, based on mean of ≥2 HbF assessments over preceding 12 months
* Youth able to speak/read English or Spanish

Inclusion Criteria - Parent:

* Parent/guardian speaks/reads English or Spanish
* Parent/ legal guardian willing to participate
* Family expects to reside in community for ≥ 1.5 years

Exclusion Criteria - Youth:

* Youth not prescribed HU
* \<2 HbF assessments over past 12 months
* Transfusion within 3 months preceding enrollment
* Final screen HbF (visit 0) of ≤15% decrease below Personal best HbF
* Sexually active female 10 years or older and not using reliable contraception (due to HU teratogenic risk)
* Pregnancy
* Cognitive impairment (\>2 levels below expected grade)
* Youth not residing with parent/legal guardian

Exclusion Criteria - Parent:

* Parent/legal guardian does not reside with youth